英文药名: NORDITROPIN S（somatropin[genetical recombination]）
Growth Hormone Human（genetical recombination）
NORDITROPIN S 10mg for injection [for adult growth hormone deficiency/for short stature due to growth hormone deficiency, etc.]（ノルディトロピンS注10mg［用于成人生长激素缺乏症/生长激素缺乏性侏儒症等］）
Brand name : NORDITROPIN S 10mg for injection [for short stature due to growth hormone deficiency, etc.]
Active ingredient: Somatropin (genetical recombination)
Dosage form: clear and colorless injectable solution, (cap) blue
Print on wrapping:
Effects of this medicine
This medicine contains growth hormone, a kind of anterior pituitary hormones and shows growth promoting effect on the body.
It is usually used to treat short stature due to growth hormone deficiency/Turner's syndrome/chondrodystrophia/SGA(small-for-gestational age) without closure of epiphyseal lines.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have diabetes or malignant tumor.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•For treatment of short stature due to growth hormone deficiency without closure of epiphyseal lines: In general, inject 0.175 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously.
For treatment of short stature due to Turner's syndrome or chondrodystrophia without closure of epiphyseal lines: In general, inject 0.35 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously.
For treatment of short stature born SGA without closure of epiphyseal lines: In general, inject 0.23 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously. If the dose seems to be insufficient, it is increased up to 0.47 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously. In any cases, inject the medicine with special pen-shaped injector. This product contains 10 mg of the active ingredient in a cartridge (1.5 mL). Strictly follow the instructions.
•Inject the medicine with special pen-shaped injector (NordiPen 10) and JIS (Japan Industrial Standard) A type special needles adapting to JIS T 3226-2 (Pen Needles, etc.).
•Do not inject to the same site repeatedly in short time. Change the injection site broadly in the body in an orderly manner such as upper arms, thighs, abdomen, buttocks, etc.
•If you miss a dose, skip the missed dose and continue your regular dosing schedule. Missing 1 to 2 doses may not be a problem. You should never inject two doses at one time.
•If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop injecting this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash (hives, erythema, etc.), itch, redness in injection site, growing pain such as joint pain or pain in lower limbs and pain in limbs. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•both knees are apart when standing erect [worsening of bowlegs]
•muscle spasmodically contracting [convulsion]
•sweating, weight loss, increase of pulse [hyperthyroidism]
•apparent swelling of whole body, decrease of urine output, breathing difficulty [nephrotic syndrome]
•dry mouth, excess intake of fluid, fatigability [diabetes]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out the reach of children. Store away from direct sunlight. Keep in the refrigerator (at 2 to 8 ℃) avoiding freezing. Use within 35 days after starting use.
•Discard the remainder. Do not store them.
Novo Nordisk Pharma Ltd.Self-injection
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.