くすりのしおり

Self-injection
Revised: 3/2015

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.
Brand name :
Genotropin TC inj. 12mg [growth hormone deficiency dwarfism etc.]
 Active ingredient:
Somatropin (genetical recombination)
 Dosage form:
injection of cartridge type that consists of white powder in a lump form and limpid colorless liquid
 Print on wrapping:

Effects of this medicine

This medicine is a growth hormone which is one of the anterior pituitary hormones, has action to promote growth.
It is usually used for treatment of growth hormone deficiency dwarfism without epiphyseal line atresia, Turner's syndrome, short stature in Prader-Willi syndrome, SGA (small-for-gestational age) dwarfism.

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 mellitus, malignant tumor, Prader Willi syndrome with obesity and respiratory impairment, growth hormone deficiency dwarfism due to brain tumor (craniopharyngioma, pituitary adenoma, pinealoma, etc.), cardiac disease, renal disease or chronic renal failure.
  • 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 growth hormone deficiency dwarfism without epiphyseal line atresia: In general, intramuscular inject 0.175 mg of the active ingredient per kilogram of the body weight in 2 to 4 divided doses or subcutaneously inject in 6 to 7 divided doses per week.
    For Turner's syndrome without epiphyseal line atresia: In general, intramuscular inject 0.35 mg of the active ingredient per kilogram of the body weight in 2 to 4 divided doses or subcutaneously inject in 6 to 7 divided doses per week.
    For Prader-Willi syndrome without epiphyseal line atresia: In general, subcutaneously inject 0.245 mg of the active ingredient per kilogram of the body weight in 6 to 7 divided doses per week.
    For SGA (small-for-gestational age) dwarfism without epiphyseal line atresia: In general, subcutaneously inject 0.23 mg of the active ingredient per kilogram of the body weight in 6 to 7 divided doses per week. If it is not effective enough, then subcutaneously inject increase the dose up to 0.47 mg per kilogram of the body weight in 6 to 7 divided doses per week.
    This preparation contains 12.0 mg of the active ingredient in a cartridge. In any case, strictly follow the instructions.
  • Avoid injection to the site overlapped to previously injected sites.
  • If you feel sharp pain when you insert the needle or if you see the bloodstream flow back, remove the needle immediately and inject into another site.
  • Do not use it in more than one person this medicine each, because there is a possibility that the cause of the infection.
  • If you miss a dose, use the missed dose as soon as possible. You should never use two doses at one time. In addition, tell your doctor that you have forgotten the injection.
  • If you accidentally use 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 headache, edema, aggressiveness, hair loss, growing pains such as pain of joint/lower limbs, muscle pain, bleeding at the injection site, eczema, rash, hives, generalized itching, erythema, papilledema/abnormal vision/headache/nausea/vomiting from increased intracranial pressure, progressing spine deformity such as scoliosis and adenoid hypertrophy. 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.
  • muscle spasmodically contracting [convulsion]
  • sweating, weight loss, increase in pulse rate  [hyperthyroidism]
  • general edema, decreased urine output, respiratory distress [nephrotic syndrome]
  • dry mouth, excessive water drinking, easy fatigability [diabetes mellitus]
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 of the reach of children. Store at 2 to 8 ℃ avoid freezing and in a light shielding condition.
  • After dissolution, use it within 4 weeks while being attached injector or dissolver for exclusive use, and store at 2 to 8 ℃ avoid freezing and in a light shielding condition. Do not use if it froze.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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