Friday, September 30, 2016

Actopril




Actopril may be available in the countries listed below.


Ingredient matches for Actopril



Captopril

Captopril is reported as an ingredient of Actopril in the following countries:


  • Tunisia

International Drug Name Search

Azitromicina Farmoz




Azitromicina Farmoz may be available in the countries listed below.


Ingredient matches for Azitromicina Farmoz



Azithromycin

Azithromycin is reported as an ingredient of Azitromicina Farmoz in the following countries:


  • Portugal

International Drug Name Search

Lipiodol Ultra Fluid




Lipiodol Ultra Fluid may be available in the countries listed below.


Ingredient matches for Lipiodol Ultra Fluid



Ethiodized Oil (131I)

Ethiodized Oil (131I) is reported as an ingredient of Lipiodol Ultra Fluid in the following countries:


  • Denmark

International Drug Name Search

Acneclin




Acneclin may be available in the countries listed below.


Ingredient matches for Acneclin



Minocycline

Minocycline hydrochloride (a derivative of Minocycline) is reported as an ingredient of Acneclin in the following countries:


  • Argentina

International Drug Name Search

Ciazil




Ciazil may be available in the countries listed below.


Ingredient matches for Ciazil



Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Ciazil in the following countries:


  • Australia

Epirubicin

Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Ciazil in the following countries:


  • Greece

International Drug Name Search

Thursday, September 29, 2016

Azitromicina Mabo




Azitromicina Mabo may be available in the countries listed below.


Ingredient matches for Azitromicina Mabo



Azithromycin

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina Mabo in the following countries:


  • Spain

International Drug Name Search

Damicol




Damicol may be available in the countries listed below.


Ingredient matches for Damicol



Fluconazole

Fluconazole is reported as an ingredient of Damicol in the following countries:


  • Argentina

International Drug Name Search

Actonel




In the US, Actonel (risedronate systemic) is a member of the drug class bisphosphonates and is used to treat Osteoporosis, Paget's Disease and Prevention of Osteoporosis.

US matches:

  • Actonel

  • Actonel with Calcium

UK matches:

  • Actonel 30mg Film Coated Tablets (SPC)
  • Actonel 5mg Film Coated Tablets (SPC)
  • Actonel Combi film-coated tablets + effervescent granules (SPC)
  • Actonel Once a Week 35mg film coated tablets. (SPC)

Ingredient matches for Actonel



Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Actonel in the following countries:


  • Australia

  • United Kingdom

Risedronic Acid

Risedronic Acid is reported as an ingredient of Actonel in the following countries:


  • Australia

  • Bulgaria

  • Colombia

  • Peru

  • Tunisia

Risedronic Acid monosodium (a derivative of Risedronic Acid) is reported as an ingredient of Actonel in the following countries:


  • Antigua & Barbuda

  • Argentina

  • Aruba

  • Australia

  • Austria

  • Bahamas

  • Bahrain

  • Barbados

  • Belgium

  • Bermuda

  • Brazil

  • Canada

  • Cayman Islands

  • Chile

  • Colombia

  • Costa Rica

  • Croatia (Hrvatska)

  • Czech Republic

  • Ecuador

  • El Salvador

  • Estonia

  • France

  • Georgia

  • Germany

  • Greece

  • Guatemala

  • Guyana

  • Haiti

  • Honduras

  • Hong Kong

  • Hungary

  • India

  • Indonesia

  • Ireland

  • Israel

  • Italy

  • Jamaica

  • Japan

  • Latvia

  • Lithuania

  • Luxembourg

  • Malaysia

  • Malta

  • Mexico

  • Netherlands

  • Netherlands Antilles

  • Nicaragua

  • Panama

  • Philippines

  • Portugal

  • Romania

  • Saint Lucia

  • Saint Vincent & The Grenadines

  • Serbia

  • Singapore

  • Slovakia

  • Slovenia

  • South Africa

  • Spain

  • Switzerland

  • Thailand

  • Trinidad & Tobago

  • Turkey

  • United Kingdom

  • United States

  • Venezuela

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Terbinafin KSK




Terbinafin KSK may be available in the countries listed below.


Ingredient matches for Terbinafin KSK



Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafin KSK in the following countries:


  • Germany

International Drug Name Search

Alprazomed




Alprazomed may be available in the countries listed below.


Ingredient matches for Alprazomed



Alprazolam

Alprazolam is reported as an ingredient of Alprazomed in the following countries:


  • Belgium

International Drug Name Search

Cecon


Generic Name: ascorbic acid (Oral route)


as-KORE-bik AS-id


Commonly used brand name(s)

In the U.S.


  • Ascocid

  • C-500

  • Cecon

  • Cemill 1000

  • Cemill 500

  • Cevi-Bid

  • C-Time w/Rose Hips

  • Mega-C

  • One-Gram C

  • Protexin

  • Sunkist Vitamin C

In Canada


  • Ce-Vi-Sol

  • Revitalose-C-1000

  • Revitonus C-1000 Yellow Ampule

  • Vitamin C Powder

Available Dosage Forms:


  • Tablet

  • Powder

  • Powder for Solution

  • Capsule, Liquid Filled

  • Tablet, Chewable

  • Granule

  • Capsule

  • Syrup

  • Powder for Suspension

  • Liquid

  • Solution

  • Tablet, Extended Release

  • Lozenge/Troche

  • Capsule, Extended Release

  • Wafer

Therapeutic Class: Nutritive Agent


Pharmacologic Class: Vitamin C


Uses For Cecon


Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.


Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.


Some conditions may increase your need for vitamin C. These include:


  • AIDS (acquired immune deficiency syndrome)

  • Alcoholism

  • Burns

  • Cancer

  • Diarrhea (prolonged)

  • Fever (prolonged)

  • Infection (prolonged)

  • Intestinal diseases

  • Overactive thyroid (hyperthyroidism)

  • Stomach ulcer

  • Stress (continuing)

  • Surgical removal of stomach

  • Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:


  • Infants receiving unfortified formulas

  • Smokers

  • Patients using an artificial kidney (on hemodialysis)

  • Patients who undergo surgery

  • Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.


Vitamin C may be used for other conditions as determined by your health care professional.


Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.


Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.


Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vitamin C is used in certain patients with the following medical conditions:


  • Overdose of iron (to help another drug in decreasing iron levels in the body)

  • Methemoglobinemia (a blood disease)

Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.


Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.


The daily amount of vitamin C needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for vitamin C are generally defined as follows:





























PersonsU.S.

(mg)
Canada

(mg)
Infants and children

Birth to 3 years of age
30–4020
4 to 6 years of age4525
7 to 10 years of age4525
Adolescent and adult males50–6025–40
Adolescent and adult females50–6025–30
Pregnant females7030–40
Breast-feeding females90–9555
Smokers10045–60

Before Using Cecon


If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Problems in children have not been reported with intake of normal daily recommended amounts.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Amygdalin

  • Deferoxamine

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Indinavir

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood problems—High doses of vitamin C may cause certain blood problems

  • Type 2 diabetes mellitus—Very high doses of vitamin C may interfere with tests for sugar in the urine

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency—High doses of vitamin C may cause hemolytic anemia

  • Kidney stones (history of)—High doses of vitamin C may increase risk of kidney stones in the urinary tract

Proper Use of ascorbic acid

This section provides information on the proper use of a number of products that contain ascorbic acid. It may not be specific to Cecon. Please read with care.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (capsules, tablets, oral solution, syrup):
    • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
      • For the U.S.

      • Adult and teenage males—50 to 60 milligrams (mg) per day.

      • Adult and teenage females—50 to 60 mg per day.

      • Pregnant females—70 mg per day.

      • Breast-feeding females—90 to 95 mg per day.

      • Smokers—100 mg per day.

      • Children 4 to 10 years of age—45 mg per day.

      • Children birth to 3 years of age—30 to 40 mg per day.

      • For Canada

      • Adult and teenage males—25 to 40 mg per day.

      • Adult and teenage females—25 to 30 mg per day.

      • Pregnant females—30 to 40 mg per day.

      • Breast-feeding females—55 mg per day.

      • Smokers—45 to 60 mg per day.

      • Children 4 to 10 years of age—25 mg per day.

      • Children birth to 3 years of age—20 mg per day.


    • To treat deficiency:
      • Adults and teenagers—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 500 mg a day for at least 2 weeks.

      • Children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 100 to 300 mg a day for at least 2 weeks.



For those individuals taking the oral liquid form of vitamin C:


  • This preparation is to be taken by mouth even though it comes in a dropper bottle.

  • This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins.


Storage


Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Cecon


Vitamin C is not stored in the body. If you take more than you need, the extra vitamin C will pass into your urine. Very large doses may also interfere with tests for sugar in diabetics and with tests for blood in the stool.


Cecon Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare - with high doses
  • Side or lower back pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common or rare - with high doses
  • Diarrhea

  • dizziness or faintness (with the injection only)

  • flushing or redness of skin

  • headache

  • increase in urination (mild)

  • nausea or vomiting

  • stomach cramps

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cecon side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Cecon resources


  • Cecon Side Effects (in more detail)
  • Cecon Use in Pregnancy & Breastfeeding
  • Cecon Drug Interactions
  • Cecon Support Group
  • 0 Reviews for Cecon - Add your own review/rating


  • Cecon Concise Consumer Information (Cerner Multum)

  • Cecon Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ascorbic Acid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ascorbic Acid Monograph (AHFS DI)

  • Acerola Natural MedFacts for Consumers (Wolters Kluwer)

  • Acerola Natural MedFacts for Professionals (Wolters Kluwer)

  • Ascot Concise Consumer Information (Cerner Multum)

  • Cenolate Injection MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cevi-Bid Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Cecon with other medications


  • Dietary Supplementation
  • Scurvy
  • Urinary Acidification

Antagon


Generic Name: ganirelix (Subcutaneous route)

ga-ni-REL-ix

Commonly used brand name(s)

In the U.S.


  • Antagon

Available Dosage Forms:


  • Solution

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Luteinizing Hormone Releasing Hormone Antagonist


Uses For Antagon


Ganirelixis used as a fertility medicine to prevent premature luteinizing hormone (LH) surges in women undergoing the fertility procedure of controlled ovarian hyperstimulation. LH is involved in ovulation, which is the development of eggs in the ovaries. Ganirelix may help reduce the need for follicle-stimulating hormone (FSH) , which is also involved in ovulation.


Ganirelix is available only with your doctor's prescription.


Before Using Antagon


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of ganirelix. Make sure you tell your doctor if you have any other medical problems.


Proper Use of Antagon


To make using ganirelix as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of ganirelix. Read this paper carefully and ask your health care professional for any additional information or explanation.


Sometimes ganirelix can be given by injection at home. If you are using this medicine at home:


  • Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.

  • Wash your hands with soap and water and use a clean work area to prepare your injection.

  • Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.

  • Do not inject more or less of the medicine than your doctor ordered.

  • Remember to move the site of injection to different areas to prevent skin problems from developing.

  • Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

  • Tell your doctor when you use your last dose of ganirelix. Your doctor will give you another medicine called human chorionic gonadotrophin (hCG) or arrange for you to get this medicine at the right time.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For injection dosage form:
    • For treatment of female infertility:
      • Adults—After receiving FSH treatment on Day 2 or 3 of your menstrual cycle, 250 micrograms (mcg) of ganirelix is injected under the skin once a day during the early to midfollicular phase (about Day 7 or Day 8 of your menstrual cycle).



Missed Dose


Call your doctor or pharmacist for instructions.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Antagon


It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.


If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.


If severe abdominal pain occurs with use of ganirelix, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.


Antagon Side Effects


Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Stop taking this medicine and get emergency help immediately if any of the following effects occur:


Less common
  • Abdominal pain (severe)

  • nausea and vomiting

  • weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Nausea

  • vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Headache

  • redness, pain or swelling at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Antagon side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Antagon resources


  • Antagon Side Effects (in more detail)
  • Antagon Use in Pregnancy & Breastfeeding
  • Antagon Drug Interactions
  • Antagon Support Group
  • 0 Reviews for Antagon - Add your own review/rating


  • Antagon Concise Consumer Information (Cerner Multum)

  • Ganirelix MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ganirelix Prescribing Information (FDA)

  • Ganirelix Acetate Monograph (AHFS DI)



Compare Antagon with other medications


  • Gonadotropin Inhibition

Athyrazol




Athyrazol may be available in the countries listed below.


Ingredient matches for Athyrazol



Thiamazole

Thiamazole is reported as an ingredient of Athyrazol in the following countries:


  • Bosnia & Herzegowina

  • Croatia (Hrvatska)

  • Slovenia

International Drug Name Search

Factor IX Grifols




Factor IX Grifols may be available in the countries listed below.


Ingredient matches for Factor IX Grifols



Coagulation Factor IX, Human

Coagulation Factor IX, Human is reported as an ingredient of Factor IX Grifols in the following countries:


  • Spain

International Drug Name Search

Sprycel


Generic Name: dasatinib (da SAT in ib)

Brand Names: Sprycel


What is dasatinib?

Dasatinib is a cancer medication that slows the growth and spread of cancer cells in the body.


Dasatinib is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.


Dasatinib may also be used for purposes not listed in this medication guide.


What is the most important information I should know about dasatinib?


Do not use dasatinib if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving dasatinib, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects.

Before taking dasatinib, tell your doctor if you have liver disease, low levels of potassium or magnesium in your blood, heart disease or a heart rhythm disorder, or if you have a personal or family history of "Long QT syndrome."


Do not crush, chew, or break a dasatinib tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. There are many other drugs that can interact with dasatinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Dasatinib can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.


Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

What should I discuss with my health care provider before taking dasatinib?


You should not use dasatinib if:

  • you have not first received a medication called imatinib (Gleevec); or




  • if you are pregnant or planning to become pregnant during treatment with dasatinib.




Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH occurs when blood pressure increases inside the arteries in your lungs. This makes it harder for your heart to pump blood through the lungs, which also weakens muscles in the heart. PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

To make sure you can safely take dasatinib, tell your doctor if you have any of these other conditions:



  • low levels of potassium or magnesium in your blood;




  • anemia (lack of red blood cells);




  • liver disease;




  • lung disease;




  • heart disease or a heart rhythm disorder; or




  • a personal or family history of Long QT syndrome.




FDA pregnancy category D. Do not use dasatinib if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving dasatinib, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects. A man taking dasatinib should use a condom during any sexual activity.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.


It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking dasatinib.

Dasatinib tablets contain lactose. Talk to your doctor before using this medication if you are lactose-intolerant.


How should I take dasatinib?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


This medicine is usually taken once per day in the morning or evening. Follow your doctor's instructions. You may take the medication with or without food.


Your doctor may occasionally change your dose to make sure you get the best results.


Do not crush, chew, or break a dasatinib tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

Dasatinib can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.


Store at room temperature away from moisture and heat.

See also: Sprycel dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while taking dasatinib?


Avoid taking an antacid within 2 hours before or 2 hours after you take dasatinib. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb dasatinib.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.


Grapefruit and grapefruit juice may interact with dasatinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.


Dasatinib side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking dasatinib and call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

  • feeling tired or short of breath (even with mild exertion);




  • swelling in your feet or lower legs;




  • rapid weight gain;




  • blue-colored lips and skin; and




  • feeling light-headed or fainting.




Stop using dasatinib and call your doctor at once if you have any of these other serious side effects:

  • pale skin, rapid heart rate, trouble concentrating;




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;




  • black, bloody, or tarry stools;




  • coughing up blood or vomit that looks like coffee grounds; or




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.



Less serious side effects may include:



  • headache;




  • tired feeling;




  • nausea, diarrhea; or




  • mild skin rash.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect dasatinib?


Tell your doctor about all other medicines you use, especially:



  • alfentanil (Alfenta), fentanyl (Abstral, Actiq, Fentora, Duragesic, Ionsys, Lazanda, Onsolis);




  • bosentan (Tracleer);




  • conivaptan (Vaprisol);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);




  • ergotamine (Ergomar, Cafergot, Migergot);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • pimozide (Orap);




  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);




  • St. John's wort;




  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);




  • an antidepressant such as nefazodone;




  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);




  • phenobarbital (Solfoton) and other barbiturates;




  • aspirin, or a blood thinner such as warfarin (Coumadin, Jantoven);




  • heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Kaletra, Norvir);




  • medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil);




  • medication used to prevent blood clots, such as bivalirudin (Angiomax), clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine, Aggrenox), enoxaparin (Lovenox), fondaparinux (Arixtra), lepirudin (Refludan), ticlopidine (Ticlid);




  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);




  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline); or




  • stomach acid reducers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), or ranitidine (Zantac).




This list is not complete and there are many other drugs that can interact with dasatinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Sprycel resources


  • Sprycel Side Effects (in more detail)
  • Sprycel Dosage
  • Sprycel Use in Pregnancy & Breastfeeding
  • Drug Images
  • Sprycel Drug Interactions
  • Sprycel Support Group
  • 4 Reviews for Sprycel - Add your own review/rating


  • Sprycel Prescribing Information (FDA)

  • Sprycel Monograph (AHFS DI)

  • Sprycel Advanced Consumer (Micromedex) - Includes Dosage Information

  • Sprycel Consumer Overview

  • Sprycel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dasatinib Professional Patient Advice (Wolters Kluwer)



Compare Sprycel with other medications


  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Leukemia


Where can I get more information?


  • Your pharmacist can provide more information about dasatinib.

See also: Sprycel side effects (in more detail)


Ampicilina Pentacoop




Ampicilina Pentacoop may be available in the countries listed below.


Ingredient matches for Ampicilina Pentacoop



Ampicillin

Ampicillin is reported as an ingredient of Ampicilina Pentacoop in the following countries:


  • Peru

International Drug Name Search

Acnogen




Acnogen may be available in the countries listed below.


Ingredient matches for Acnogen



Isotretinoin

Isotretinoin is reported as an ingredient of Acnogen in the following countries:


  • Greece

International Drug Name Search

Adehl




Adehl may be available in the countries listed below.


Ingredient matches for Adehl



Colforsin

Colforsin daropate hydrochloride (a derivative of Colforsin) is reported as an ingredient of Adehl in the following countries:


  • Japan

International Drug Name Search

Wednesday, September 28, 2016

Fosaprepitant pimozide


Pronunciation: FOS-ap-RE-pi-tant
Generic Name: Fosaprepitant
Brand Name: Emend for Injection


Fosaprepitant pimozide is used for:

Preventing nausea and vomiting associated with certain types of cancer medicines (chemotherapy). It is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Fosaprepitant pimozide is an antiemetic. It works by blocking certain substances in the brain, which helps to prevent nausea and vomiting.


Do NOT use Fosaprepitant pimozide if:


  • you are allergic to any ingredient in Fosaprepitant pimozide, or if you are allergic to aprepitant or polysorbate 80

  • you are taking astemizole, cisapride, pimozide, or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.



Before using Fosaprepitant pimozide:


Some medical conditions may interact with Fosaprepitant pimozide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have liver problems

  • if you currently have nausea or vomiting

Some MEDICINES MAY INTERACT with Fosaprepitant pimozide. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Azole antifungals (eg, ketoconazole), diltiazem, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), nefazodone, or troleandomycin because they may increase the risk of Fosaprepitant pimozide's side effects

  • Carbamazepine or rifampin because they may decrease Fosaprepitant pimozide's effectiveness

  • Astemizole, benzodiazepines (eg, alprazolam), cisapride, corticosteroids (eg, dexamethasone), ifosfamide, narcotic pain medicines (eg, fentanyl), pimozide, terfenadine, vinblastine, or vincristine because the risk of their side effects may be increased by Fosaprepitant pimozide

  • Anticoagulants (eg, warfarin), hormonal contraceptives (eg, birth control pills), paroxetine, phenytoin, or tolbutamide because their effectiveness may be decreased by Fosaprepitant pimozide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosaprepitant pimozide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Fosaprepitant pimozide:


Use Fosaprepitant pimozide as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Fosaprepitant pimozide. Talk to your pharmacist if you have questions about this information.

  • Tell your doctor if you already have nausea or vomiting before you receive Fosaprepitant pimozide.

  • Fosaprepitant pimozide is usually given as an injection at your doctor's office, hospital, or clinic 30 minutes before chemotherapy treatment.

  • If you miss a dose of Fosaprepitant pimozide, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Fosaprepitant pimozide.



Important safety information:


  • Fosaprepitant pimozide may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fosaprepitant pimozide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fosaprepitant pimozide; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Fosaprepitant pimozide. To prevent pregnancy, be sure to use an extra form of birth control (eg, condoms) while using Fosaprepitant pimozide and for 1 month following the last dose of Fosaprepitant pimozide.

  • Lab tests, including liver function, kidney function, and white blood cell counts, may be performed while you use Fosaprepitant pimozide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Fosaprepitant pimozide with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosaprepitant pimozide while you are pregnant. It is not known if Fosaprepitant pimozide is found in breast milk. Do not breast-feed while taking Fosaprepitant pimozide.


Possible side effects of Fosaprepitant pimozide:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; headache; hiccups; loss of appetite; nausea; pain or hardening at the injection site; tiredness; upset stomach; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever; shortness of breath; sore throat.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Fosaprepitant side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include drowsiness; headache.


Proper storage of Fosaprepitant pimozide:

Fosaprepitant pimozide is usually handled and stored by a health care provider. If you are using Fosaprepitant pimozide at home, store Fosaprepitant pimozide as directed by your pharmacist or health care provider.


General information:


  • If you have any questions about Fosaprepitant pimozide, please talk with your doctor, pharmacist, or other health care provider.

  • Fosaprepitant pimozide is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fosaprepitant pimozide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fosaprepitant resources


  • Fosaprepitant Side Effects (in more detail)
  • Fosaprepitant Use in Pregnancy & Breastfeeding
  • Fosaprepitant Drug Interactions
  • Fosaprepitant Support Group
  • 0 Reviews for Fosaprepitant - Add your own review/rating


Compare Fosaprepitant with other medications


  • Nausea/Vomiting, Chemotherapy Induced

Kaolin Pectin Suspension




KAOLIN-PECTIN ANTI-DIARRHEAL LIQUID

INDICATIONS


A palatable oral suspension for use in controlling simple diarrhea in horses, cattle, dogs and cats.



DOSAGE AND ADMINISTRATION


Administer orally after first sign of diarrhea and after each loose bowel movement or as needed.


Cattle and Horses:  6 to 10 fl. ozs.


Calves and Foals:   3 to 4 fl. ozs.


Dogs and Cats:  1 to 3 tablespoons





Warning


If symptoms persist after using this product for 2 or 3 days, consult a veterinarian.



EACH FLUID OUNCE CONTAINS


Kaolin (colloidal) ................. 90 gr.

Pectin (citrus) ...................... 2 gr.


In a palatable vehicle.

Flavorings and color added.



SHAKE WELL BEFORE USING


PROTECT FROM FREEZING


TAKE TIME OBSERVE LABELING DIRECTIONS











KAOLIN-PECTIN 
kaolin-pectin  suspension










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)58005-501
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KAOLIN (KAOLIN)KAOLIN5.8 g  in 29.57 mL
PECTIN (PECTIN)PECTIN0.13 g  in 29.57 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY FLAVOR) , VANILLA (VANILLA FLAVOR)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
158005-501-503785 mL In 1 JUGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/11/1995


Labeler - Sparhawk Laboratories, Inc (958829558)
Revised: 12/2010Sparhawk Laboratories, Inc



Aova




Aova may be available in the countries listed below.


Ingredient matches for Aova



Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Aova in the following countries:


  • Greece

International Drug Name Search

Equeta




Equeta may be available in the countries listed below.


Ingredient matches for Equeta



Quetiapine

Quetiapine fumarate (a derivative of Quetiapine) is reported as an ingredient of Equeta in the following countries:


  • Slovakia

International Drug Name Search

Amlodipin Hexal




Amlodipin-Hexal may be available in the countries listed below.


Ingredient matches for Amlodipin-Hexal



Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipin-Hexal in the following countries:


  • Austria

  • Germany

  • Luxembourg

Amlodipine maleate (a derivative of Amlodipine) is reported as an ingredient of Amlodipin-Hexal in the following countries:


  • Hungary

  • Sweden

International Drug Name Search

Isoprenaline Haiderun Pharm




Isoprenaline Haiderun Pharm may be available in the countries listed below.


Ingredient matches for Isoprenaline Haiderun Pharm



Isoprenaline

Isoprenaline hydrochloride (a derivative of Isoprenaline) is reported as an ingredient of Isoprenaline Haiderun Pharm in the following countries:


  • China

International Drug Name Search

Pirafene




Pirafene may be available in the countries listed below.


Ingredient matches for Pirafene



Chlorphenamine

Chlorphenamine maleate (a derivative of Chlorphenamine) is reported as an ingredient of Pirafene in the following countries:


  • Oman

International Drug Name Search

Aflozon




Aflozon may be available in the countries listed below.


Ingredient matches for Aflozon



Afloqualone

Afloqualone is reported as an ingredient of Aflozon in the following countries:


  • Japan

International Drug Name Search

Norditropin Simplexx 5mg / 1.5ml





Norditropin



SimpleXx



5 mg/1.5 ml



solution for injection in cartridges



Somatropin




Read all of this leaflet carefully before you start using this medicine.



Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





In this leaflet:



  • 1. What Norditropin SimpleXx is and what it is used for


  • 2. Before you use Norditropin SimpleXx


  • 3. How to use Norditropin SimpleXx


  • 4. Possible side effects


  • 5. How to store Norditropin SimpleXx


  • 6. Further information.





What Norditropin Simplexx is and what it is used for



Norditropin SimpleXx contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow, but adults also need it for their general health. Norditropin SimpleXx comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen.




Norditropin SimpleXx is used to treat growth failure in children:



  • If they have no or very low production of growth hormone


  • If they have Turner syndrome (a genetic problem which may affect growth)


  • If they have reduced kidney function


  • If they are short and were born small for gestational age (SGA).



Norditropin SimpleXx is used as a growth hormone replacement in adults:



In adults Norditropin SimpleXx is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour or a disease that affects the gland which produces growth hormone.






Before you use Norditropin Simplexx




Do not use Norditropin SimpleXx



  • If you are allergic (hypersensitive) to somatropin, to phenol or to any of the other ingredients of Norditropin SimpleXx (listed in section 6, Further information)


  • If you have had a kidney transplant


  • If you are pregnant or breast-feeding (See pregnancy and breast-feeding)


  • If you have a cancer, a tumour or are still in anti-tumour therapy


  • If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.




Take special care with Norditropin SimpleXx



  • If you have diabetes


  • If you have ever had a cancer or another kind of tumour


  • If you have recurrent headaches, eyesight problems, nausea or if vomiting occurs


  • If you have abnormal thyroid function


  • If you develop scoliosis


  • If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited


  • If you suffer from kidney disease your kidney function should be monitored by your physician.

Tell your doctor if any of these apply to you as Norditropin SimpleXx may not be suitable.





Using other medicines



Your doctor needs to know if you are already being treated with:



  • Glucocorticoids or sex steroids – your adult height may be affected if you use Norditropin SimpleXx and glucocorticoids or sex steroids at the same time


  • Insulin - as your dose may need to be adjusted


  • Thyroid hormone.

Tell your doctor or pharmacist if you are taking other medicines or have recently taken any. This includes medicines obtained without a prescription.





Pregnancy and breast-feeding



  • Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin SimpleXx


  • Breast-feeding. Do not use Norditropin SimpleXx while you are breast-feeding as somatropin might pass into your milk.




Driving and using machines



Norditropin SimpleXx does not affect the use of any machines or the ability to drive safely.






How to use Norditropin Simplexx



Always use Norditropin SimpleXx exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.




Usual dose



The dose for children depends on their body weight and body surface area. The adult dose depends on height, weight, gender and growth hormone sensitivity and will be adjusted until you are on the right dose.



  • Children with low production or lack of growth hormone: The usual dose is 25 to 35 microgram per kg body weight per day or 0.7 to 1.0 mg per m² body surface area per day.


  • Children with Turner syndrome: The usual dose is 45 to 67 microgram per kg body weight per day or 1.3 to 2.0 mg per m² body surface area per day.


  • Children with kidney disease: The usual dose is 50 microgram per kg body weight per day or 1.4 mg per m² body surface area per day.


  • Children born small for gestational age (SGA): The usual dose is 35 microgram per kg body weight per day or 1.0 mg per m² body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 33 and 67 microgram per kg body weight per day have typically been used.)


  • Adults with low production or lack of growth hormone: The usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day.




When to use Norditropin SimpleXx



  • Inject your daily dose into the skin every evening just before bedtime.




Using the cartridges to inject yourself



  • Norditropin SimpleXx solution comes in cartridges ready to be used in the matching NordiPen. The NordiPen instruction manual tells you how to use the cartridges in the injection pen


  • Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked


  • Only use a Norditropin SimpleXx cartridge if the solution inside is clear and colourless


  • Vary the area you inject so you do not harm your skin


  • Do not share your Norditropin SimpleXx cartridge with anyone else.




How long you will need treatment for



  • If you are using Norditropin SimpleXx for growth failure because of Turner syndrome, a kidney disease or if you were born small for gestational age (SGA), continue using Norditropin SimpleXx until you stop growing


  • If you lack growth hormone, continue using Norditropin SimpleXx into adulthood


  • Do not stop using Norditropin SimpleXx without discussing it with your doctor first.




If you use too much:



  • Tell your doctor if you inject too much Norditropin SimpleXx. Long-term overdosing can cause abnormal growth and coarsening of facial features.



If you forget a dose:



  • Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose.





Possible side effects



Like all medicines, Norditropin SimpleXx can cause side effects, although not everybody gets them.




Very rare effects in children and adults



(may affect up to 1 in 10,000 people):



  • Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of allergic reactions


  • Headache, eyesight problems, feeling sick (nausea) and being sick (vomiting). These may be signs of raised pressure in the brain


  • Serum thyroxin levels may decrease.

If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin SimpleXx until your doctor says you can continue treatment.



Formation of antibodies directed against somatropin has been rarely observed during Norditropin therapy.



Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin SimpleXx), although there is no evidence that somatropin was responsible. If you think you are suffering from any of these diseases, speak to your doctor.





Other side effects in children:



Uncommon effects



(may affect up to 1 in 100 children):



  • Headache


  • Redness, itching and pain in the area of injection.

Rare effects



(may affect up to 1 in 1000 children):



  • Rash


  • Muscle and joint pain


  • Swollen hands and feet due to fluid retention.

In rare cases, children using Norditropin SimpleXx have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calvé disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin SimpleXx.



In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed in clinical trials.



A clinical trial in children with Turner syndrome has shown that high doses of Norditropin can possibly increase the risk of getting ear infections.





Other side effects in adults:



Very common effects



(may affect more than 1 in 10 adults):



  • Swollen hands and feet due to fluid retention.

Common effects



(may affect up to 1 in 10 adults):



  • Headache


  • Feeling of skin crawling (formication) and numbness or pain mainly in fingers


  • Joint pain and stiffness; muscle pain.

Uncommon effects



(may affect up to 1 in 100 adults):



  • Type 2 diabetes


  • Carpal tunnel syndrome tingling and pain in fingers and hands


  • Itching (can be intense) and pain in the area of injection


  • Muscle stiffness.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, as you may need to reduce your dose.






How to store Norditropin Simplexx



Keep out of the reach and sight of children. Do not use Norditropin SimpleXx after the expiry date which is stated on the package. The expiry date refers to the last day of that month.



Store unused Norditropin SimpleXx cartridges in a refrigerator (2°C to 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.



After starting to use a Norditropin SimpleXx 5 mg/1.5 ml cartridge in an injection pen you can either:



  • Keep it in the pen for up to 4 weeks in a refrigerator (2°C to 8°C), or


  • Keep it in the pen for up to 3 weeks at room temperature (below 25°C).

Do not continue to use Norditropin SimpleXx cartridges which have been frozen or exposed to excessive temperatures. Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked.



Do not use any Norditropin SimpleXx cartridge if the solution inside is not clear and colourless.



Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further information




What Norditropin SimpleXx contains



  • The active substance is somatropin


  • The solution also contains mannitol; histidine; poloxamer 188; phenol; water for injections; hydrochloric acid and sodium hydroxide.




What Norditropin SimpleXx looks like and contents of the pack



Norditropin SimpleXx is a clear and colourless solution in a 1.5 ml glass cartridge ready for injection in the NordiPen injection pen.



1 ml of solution contains 3.3 mg somatropin.



1 mg of somatropin corresponds to 3 IU of somatropin.



Norditropin SimpleXx is available in three strengths:



5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml (equivalent to 3.3 mg/ml, 6.7 mg/ml and 10 mg/ml, respectively).





Manufacturer:



Norditropin SimpleXx is made by:




Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark





Marketing authorisation holder




Novo Nordisk Limited

Broadfield Park

Brighton Road

Crawley

West Sussex

RH11 9RT

UK





This leaflet was last approved in 02/2010.



Norditropin and SimpleXx are Trademarks owned by Novo Nordisk Health Care AG Switzerland



NordiPen is a trademark owned by Novo Nordisk A/S, Denmark



© 1999/2008





8-2070-01-002-4






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