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資料1-2 調査結果報告書 (27 ページ)

公開元URL https://www.mhlw.go.jp/stf/newpage_24579.html
出典情報 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会(令和3年度第31回 3/22)《厚生労働省》
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GENOTROPIN/GENOTONORM (somatropin),

NORDITROPIN FlexPro (somatropin) 5 mg/1.5 ml ,

HUMATROPE (somatropin) 6 mg, 12mg, or

1.3 mg, 5.0 mg, 5.3 mg, or 12 mg, powder and

10 mg/1.5 ml, or 15 mg/1.5 ml, solution for

24mg, powder and solvent for solution for

solvent for solution for injection

injection in pre-filled pen

injection

be administered.

sensitivity, patients should be monitored for

hormone should not be administered until the

evidence of glucose intolerance (see section

patient has been stabilised for diabetes care. Then

Interaction with other medicinal products and

growth hormone may be introduced with careful

other forms of interaction). For patients with

monitoring of the diabetic metabolic control. An

diabetes mellitus, the insulin dose may require

increase in insulin dosage may be required.

adjustment after somatropin containing product
therapy is instituted. Patients with diabetes or
glucose intolerance should be monitored closely
during somatropin therapy.
Interaction with other medicinal products and

Interaction with other medicinal products and

Interaction with other medicinal products and

other forms of interaction

other forms of interaction

other forms of interaction

Also see section Special warnings and precautions

In insulin treated patients adjustment of insulin

Patients with diabetes mellitus who receive

for use for statements regarding diabetes mellitus

dose may be needed after initiation of somatropin

concomitant somatropin may require adjustment

and thyroid disorder.

treatment (see section Special warnings and

of their doses of insulin and/or other anti-

precautions for use).

hyperglycaemic agents.

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