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make the most Saizen Generic Name: somatropin, mammalian derived (Injection route, Subcutaneous route) soe-ma-TROE-pin, mam-MAY-lee-un dee-RIVED Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Commonly used brand name(s) In the U.S. Saizen Serostim Zorbtive In Canada Nutropin Nutropin Aq Available Dosage Forms: Powder for Solution Therapeutic Class: Endocrine-Metabolic Agent Pharmacologic Class: Somatropin Slideshow Treatment of Opioid-Induced Constipation: The Hard Facts Uses For Saizen Somatropin injection is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth failure caused by growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), or Turner syndrome. Somatropin injection is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly. This medicine is available only with your doctor's prescription. Before Using Saizen 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. Pediatric Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin injection in children with growth hormone deficiency. Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin injection. Pregnancy Pregnancy Category Explanation All Trimesters C Animal 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 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Brain tumor or Cancer, active or Closed epiphyses (normal bone growth stopped) in children or Diabetic retinopathy (eye condition) or Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or Severe illness after surgery or major medical emergency (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure) Should not be used in patients with these conditions. Cancer, history of or Fluid retention, history of or Hypopituitarism (pituitary gland produces low hormone levels) or Hypothyroidism (underactive thyroid gland) or Otitis media (ear infection) in children, history of or Pancreatitis (inflammation or swelling of the pancreas) or Scoliosis (abnormally curved spine) Use with caution. May make these conditions worse. Diabetes, or a family history of Use with caution. May prevent insulin from working properly. . Kidney disease Use with caution. The effects may be increased because of slower removal of the medicine from the body. Turner syndrome May increase risk of having thyroid and hearing problems. Proper Use of somatropin, mammalian derived This section provides information on the proper use of a number of products that contain somatropin, mammalian derived. It may not be specific to Saizen. Please read with care. This medicine is given as a shot under your skin or into a muscle. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected . If you are using this medicine to treat short bowel syndrome , carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment. This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions. There are many different forms (eg, vial, cartridge, injection device) available for this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medication. Also, read all instructions carefully to be sure you know how to use your device. Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given. You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot . Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Use a new needle, unopened vial, or syringe each time you inject your medicine. You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. 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 growth hormone deficiency: Adults Nutropin or Nutropin AQ : Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed. Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.025 to 0.0125 mg per kg of body weight per day. Saizen : Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 mg per kg of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. Children Nutropin or Nutropin AQ : Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 to 0.7 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. Saizen : Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 mg per kg of body weight, given 3 times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed. . For treatment of growth failure due to chronic kidney disease: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. For treatment of idiopathic short stature: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. For treatment of short bowel syndrome: Adults Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed. Children Use and dose must be determined by your doctor. For treatment of short stature with Turner syndrome: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into equal doses 3 to 7 times per week. Your doctor may adjust your dose if needed. Missed Dose This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions. Storage Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store unopened vials, cartridges, and injection devices of Nutropin and Nutropin AQ in the refrigerator, away from heat and direct light. Do not freeze. Store unopened vials of Saizen and Zorbtive at room temperature, away from heat and direct light. Do not freeze. Store the medicine that has been mixed in the refrigerator. The Nutropin or Saizen vials and Zorbtive that has been mixed should be used within 14 days. The Saizen click.easy cartridge that has been mixed should be used within 21 days. Nutropin AQ vial, cartridge, and injection device should be used within 28 days. Make sure you understand how long you can store the medicine after it has been mixed . Throw away any mixed medicine that has not been used within this time. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets. Precautions While Using Saizen It is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection. This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee. Pancreatitis (an inflamed pancreas) may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in stomach, side, or abdomen possibly radiating to the back, vomiting, or yellow eyes or skin. This medicine may affect blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions. This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor). This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects. This medicine is usually mixed with Bacteriostatic Water for Injection . You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix this medicine. Saizen 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 immediately if any of the following side effects occur: More common Abnormal or decreased touch sensation bleeding after defecation bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings changes in skin color cold flu-like symptoms cold hands and feet confusion constipation cough or hoarseness darkened urine decreased urination diarrhea difficult urination dizziness dry mouth fainting or loss of consciousness fast heartbeat fast or irregular breathing feeling unusually cold fever or chills full or bloated feeling general feeling of discomfort or illness headache increase in heart rate itching or skin rash joint pain light-colored stools lightheadedness loss of appetite lower back or side pain muscle aching or cramping muscle pain or stiffness nausea pain pain, redness, or swelling in the arm or leg pains in the stomach, side, or abdomen, possibly radiating to the back pressure in the stomach rapid, shallow breathing rapid weight gain rectal bleeding runny nose shivering sneezing sore mouth or tongue sore throat stomach bloating, burning, cramping, or pain sudden decrease in the amount of urine sweating swelling of the abdominal or stomach area swelling of the eyes or eyelids swelling or puffiness of the face swollen joints thirst tightness in the chest tingling of the hands or feet trouble breathing trouble sleeping uncomfortable swelling around the anus unpleasant breath odor unusual tiredness or weakness unusual weight gain or loss vomiting vomiting of blood white patches in the mouth, tongue, or throat wrinkled skin yellow eyes or skin Less common Bone or skeletal pain burning, numbness, pain, or tingling in all fingers except smallest finger chest pain depressed mood dry skin and hair feeling cold hair loss hoarseness or husky voice slowed heartbeat swelling of the ankles Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose Anxiety blurred vision changes in vision cold sweats coma cool, pale skin decrease in the amount of urine depression excessive sweating extreme weakness flushed, dry skin frequent urination fruit-like breath odor increase in hands and feet size increased hunger increased thirst increased urination increased volume of pale, diluted urine nightmares noisy, rattling breathing pain in the arms or legs seizures shakiness slurred speech stop in menstruation swelling of the fingers or hands troubled breathing at rest 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: More common Body aches or pain breast pain change in the color, amount, or odor of vaginal discharge congestion discoloration of the fingernails or toenails dryness or soreness of the throat excess air or gas in the stomach or intestines frequent urge to defecate increased sweating passing gas sneezing straining while passing stool stuffy nose tender, swollen glands in neck trouble with swallowing voice changes Less common Discouragement feeling sad or empty irritability lack of appetite loss of interest or pleasure tiredness trouble concentrating 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. Side Effects (complete list) The information contained in the Truven Health 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 Truven Health 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. Truven Health 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, TRUVEN HEALTH 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. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Saizen (somatropin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: growth hormones Consumer resources Saizen Other brands: Genotropin , Humatrope , Omnitrope , Norditropin , ... +9 more Professional resources Saizen (FDA) Related treatment guides Pediatric Growth Hormone Deficiency Adult Human Growth Hormone Deficiency Prader-Willi Syndrome Short Stature for Age} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer EMD Serono, Inc. Drug Class Growth hormones Related Drugs Adult Human Growth Hormone Deficiency somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Nutropin , More... Pediatric Growth Hormone Deficiency somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Zomacton , More... Short Stature for Age somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Zomacton , More... Prader-Willi Syndrome somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Serostim , More... Saizen Rating 1 User Review 9.0 /10 1 User Review 9.0 Rate it! Related Questions & Answers Can I use saizen for bodybuilding? what is the dose and for how long? I am 49 and taking 25 on the insulin syringe of siazen for two months now daily. I wake up with? I left the reconstituted vial of saizen outside the refrigerator for 24 hours. Can I still use it? Saizen - does anyone have any advice for me? my 8yr old has to take this drug because he had a brain Saizen - is it very important to wait 30 min. after you take it out of the fridge? Read more questions} } each person


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