よむ、つかう、まなぶ。
資料１－２ 調査結果報告書 (28 ページ)
出典
| 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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3.
カナダ添付文書の記載状況
GENOTROPIN GoQuick (somatropin)
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
2020 年 7 月版
2021 年 7 月版
2021 年 9 月版
Contraindications
Contraindications
Contraindications
Somatropin is contraindicated in patients with
Growth hormone should not be administered in
Somatropin should not be administered to patients
active proliferative or severe non-proliferative
patients with proliferative or preproliferative
with active proliferative or severe nonproliferative
diabetic retinopathy.
diabetic retinopathy.
diabetic retinopathy.
Warnings and Precautions
Warnings and Precautions
Warnings and Precautions
Serious Warnings and Precautions
Endocrine and Metabolism
Endocrine and Metabolism:
Therapy with GENOTROPIN should be excluded
Treatment with somatropin may decrease insulin
Patients with diabetes mellitus or glucose
for pediatric patients with Prader- Willi syndrome
sensitivity, particularly at higher doses. New onset
intolerance should be monitored closely during
who have one or more of the following risk
type 2 diabetes mellitus has been reported in
therapy with somatropin, as an adjustment of their
factors: uncontrolled diabetes, active cancer,
patients taking somatropin. Previously
antidiabetic therapy may be required (see
active psychosis.
undiagnosed impaired glucose tolerance and overt
Monitoring and Laboratory Tests).
Endocrine and Metabolism
diabetes mellitus may be unmasked during
Treatment with somatropin may decrease insulin
Patients with diabetes mellitus or glucose
somatropin treatment. Therefore, glucose levels
sensitivity, particularly at higher doses in patients
intolerance should be monitored closely during
should be monitored periodically in all patients
with risk factors for diabetes mellitus, such as
GENOTROPIN is contraindicated in patients with
Prader-Willi syndrome who have uncontrolled
diabetes, or active psychosis, or have active
cancer.
28
カナダ添付文書の記載状況
GENOTROPIN GoQuick (somatropin)
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
2020 年 7 月版
2021 年 7 月版
2021 年 9 月版
Contraindications
Contraindications
Contraindications
Somatropin is contraindicated in patients with
Growth hormone should not be administered in
Somatropin should not be administered to patients
active proliferative or severe non-proliferative
patients with proliferative or preproliferative
with active proliferative or severe nonproliferative
diabetic retinopathy.
diabetic retinopathy.
diabetic retinopathy.
Warnings and Precautions
Warnings and Precautions
Warnings and Precautions
Serious Warnings and Precautions
Endocrine and Metabolism
Endocrine and Metabolism:
Therapy with GENOTROPIN should be excluded
Treatment with somatropin may decrease insulin
Patients with diabetes mellitus or glucose
for pediatric patients with Prader- Willi syndrome
sensitivity, particularly at higher doses. New onset
intolerance should be monitored closely during
who have one or more of the following risk
type 2 diabetes mellitus has been reported in
therapy with somatropin, as an adjustment of their
factors: uncontrolled diabetes, active cancer,
patients taking somatropin. Previously
antidiabetic therapy may be required (see
active psychosis.
undiagnosed impaired glucose tolerance and overt
Monitoring and Laboratory Tests).
Endocrine and Metabolism
diabetes mellitus may be unmasked during
Treatment with somatropin may decrease insulin
Patients with diabetes mellitus or glucose
somatropin treatment. Therefore, glucose levels
sensitivity, particularly at higher doses in patients
intolerance should be monitored closely during
should be monitored periodically in all patients
with risk factors for diabetes mellitus, such as
GENOTROPIN is contraindicated in patients with
Prader-Willi syndrome who have uncontrolled
diabetes, or active psychosis, or have active
cancer.
28