よむ、つかう、まなぶ。
資料１－２ 調査結果報告書 (31 ページ)
出典
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| 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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4.
オーストラリア添付文書の記載状況
GENOTROPIN and GENOTROPIN GoQuick
NORDITROPIN SimpleXx and NORDITROPIN
HUMATROPE (somatropin) POWDER FOR
(somatropin) powder for injection with diluent
FlexPro (somatropin) injection solution
INJECTION
2021 年 4 月版
2019 年 1 月版
Contraindications
Contraindications
Growth hormone is contraindicated in patients
Somatropin is contraindicated in patients with
with proliferative or preproliferative diabetic
active proliferative or severe non-proliferative
retinopathy.
diabetic retinopathy.
Special warnings and precautions for use
Special warnings and precautions for use
Special warnings and precautions for use
Somatropin reduces insulin sensitivity and
In SGA children it is recommended that fasting
Abnormal Glucose Metabolism and Diabetes
therefore patients should be observed for evidence
insulin and blood glucose be measured before
Mellitus
of glucose intolerance. In rare cases the diagnostic
start of treatment and annually thereafter. In
Because somatropin may induce a state of insulin
criteria for type 2 diabetes mellitus may be
patients with increased risk for diabetes mellitus
resistance, patients who receive somatropin
fulfilled as a result of growth hormone therapy but
(e.g. familial history of diabetes, obesity, Turner
should be observed for evidence of abnormal
risk factors such as obesity (including obese PWS
syndrome, severe insulin resistance, acanthosis
glucose metabolism and/or diabetes mellitus.
patients), family history, steroid treatment or pre-
nigricans), oral glucose tolerance testing (OGTT)
New-onset type 2 diabetes mellitus has been
existing impaired glucose tolerance have been
should be performed. If overt diabetes occurs,
reported in children and adults receiving
present in most cases where this has occurred.
growth hormone should not be administered.
somatropin. Patients with diabetes mellitus who
(with preservative)
2020 年 2 月版
Growth hormone can be used in patients with
receive concomitant somatropin may require
already manifest diabetes mellitus, however, its
adjustment of their doses of insulin and/or other
use requires special care and the dose of anti-
anti-hyperglycaemic agents.
31
オーストラリア添付文書の記載状況
GENOTROPIN and GENOTROPIN GoQuick
NORDITROPIN SimpleXx and NORDITROPIN
HUMATROPE (somatropin) POWDER FOR
(somatropin) powder for injection with diluent
FlexPro (somatropin) injection solution
INJECTION
2021 年 4 月版
2019 年 1 月版
Contraindications
Contraindications
Growth hormone is contraindicated in patients
Somatropin is contraindicated in patients with
with proliferative or preproliferative diabetic
active proliferative or severe non-proliferative
retinopathy.
diabetic retinopathy.
Special warnings and precautions for use
Special warnings and precautions for use
Special warnings and precautions for use
Somatropin reduces insulin sensitivity and
In SGA children it is recommended that fasting
Abnormal Glucose Metabolism and Diabetes
therefore patients should be observed for evidence
insulin and blood glucose be measured before
Mellitus
of glucose intolerance. In rare cases the diagnostic
start of treatment and annually thereafter. In
Because somatropin may induce a state of insulin
criteria for type 2 diabetes mellitus may be
patients with increased risk for diabetes mellitus
resistance, patients who receive somatropin
fulfilled as a result of growth hormone therapy but
(e.g. familial history of diabetes, obesity, Turner
should be observed for evidence of abnormal
risk factors such as obesity (including obese PWS
syndrome, severe insulin resistance, acanthosis
glucose metabolism and/or diabetes mellitus.
patients), family history, steroid treatment or pre-
nigricans), oral glucose tolerance testing (OGTT)
New-onset type 2 diabetes mellitus has been
existing impaired glucose tolerance have been
should be performed. If overt diabetes occurs,
reported in children and adults receiving
present in most cases where this has occurred.
growth hormone should not be administered.
somatropin. Patients with diabetes mellitus who
(with preservative)
2020 年 2 月版
Growth hormone can be used in patients with
receive concomitant somatropin may require
already manifest diabetes mellitus, however, its
adjustment of their doses of insulin and/or other
use requires special care and the dose of anti-
anti-hyperglycaemic agents.
31