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Generic Name: Somatropin (rDNA origin - Nonrefrigerated) (GHD) (soe-ma-TROE-pin)
Brand Name: Saizen
Saizen is used for:
Treating growth hormone deficiency (GHD), a condition that occurs when the body does not produce enough growth hormone. It may also be used to treat conditions as determined by your doctor that may not be listed in the professional package insert.
Saizen is a growth hormone that produces effects that are identical to the body"s naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.
Do NOT use Saizen if:
- you are allergic to any ingredient in Saizen
- you have or are currently being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing
- you have vision problems due to diabetes (diabetic retinopathy),
premature epiphyseal closure (your bone growth is complete), or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)
- you have Prader-Willi syndrome and are severely overweight or have severe breathing problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Saizen :
Some medical conditions may interact with Saizen . 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 pituitary or adrenal gland problems, diabetes or a family
history of diabetes, an underactive thyroid, curvature of the spine (scoliosis), kidney or liver problems, breathing problems, or Prader-Willi syndrome
- if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer
- if you are severely overweight or have had recent major surgery or trauma
Some MEDICINES MAY INTERACT with Saizen . However, no specific interactions with Saizen are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Saizen 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 Saizen :
Use Saizen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Saizen is sometimes used at home as an
injection. Before you use Saizen , a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Saizen or giving injections.
- If you are using Saizen at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
- Always change the location where you inject Saizen .
- Do not shake Saizen . Swirl the vial gently to mix it.
- If you miss a dose of Saizen , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If 2 or more treatments with Saizen are missed, contact your health care provider for instructions.
Ask your health care provider any questions you
may have about how to use Saizen .
Important safety information:
- Saizen may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.
- Never reuse needles and syringes. Follow your health care provider"s instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.
- Saizen may contain benzyl alcohol. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol.
- Diabetes patients - Saizen may affect your blood sugar levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.
- LAB TESTS, including blood electrolytes, thyroid function, and eye exams, may be performed to
monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Saizen with caution in the ELDERLY because they may be more sensitive to its effects.
- Rare, sometimes fatal, lung and breathing problems may be caused by Saizen in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Saizen , contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Saizen . Saizen may need to be stopped.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Saizen during pregnancy
with your doctor. It is unknown if Saizen is excreted in breast milk. If you plan to breast-feed while you are using Saizen , talk with your doctor about the risks to your baby.
Possible side effects of Saizen :
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; bone pain; breast growth; breast milk production; bronchitis; carpal tunnel syndrome; decreased sensitivity of the skin; dizziness; fatigue; flu-like symptoms; gas; headache; increase in breast size; increased sweating; muscle pain; nausea; reactions at the injection site (redness, pain, numbness, and swelling); runny nose; sleeplessness; tingling, burning, or prickling sensation on the skin; upper respiratory tract infection; weakness.
Severe allergic reactions (rash;
hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; depression;
constant feeling of need to empty the bowel; curvature of the spine; ear infection;
excessive thirst or hunger; fast heartbeat; fever; frequent urination; infection;
pain or stiffness in joints; severe headache; severe or persistent nausea and vomiting; stomach pain; swelling of the ankles, legs, hands, or feet;
Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain;
leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.
This is not a complete list of all side effects that may occur. If you have questions or need medical
advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include: excessive thirst or hunger;
frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.
Proper storage of Saizen :
Store unmixed medicine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. After mixing, store Saizen according to the product label. Contact your pharmacist if you have questions about the proper storage of Saizen . Keep Saizen , as well as needles and syringes, out of the reach of children and away from pets.
- If you have any questions about Saizen , please talk with your doctor, pharmacist, or other health care provider.
- Saizen 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.
This information is a summary only. It does not contain all information about Saizen . 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: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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