よむ、つかう、まなぶ。
資料１－２ 調査結果報告書 (24 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
別添 2
海外添付文書の糖尿病合併患者への投与に関する記載状況
1.
米国添付文書の記載状況
GENOTROPIN (somatropin) for injection, for
NORDITROPIN (somatropin) for injection, for
HUMATROPE (somatropin) for injection, for
subcutaneous use
subcutaneous use
subcutaneous use
2020 年 1 月版
2020 年 3 月版
2019 年 10 月版
Contraindications
Contraindications
Contraindications
Diabetic Retinopathy
Active proliferative or severe non- proliferative
Active proliferative or severe non- proliferative
Somatropin is contraindicated in patients with
diabetic retinopathy.
diabetic retinopathy.
Warnings and precautions
Warnings and precautions
Warnings and precautions
Impaired Glucose Tolerance and Diabetes
Glucose Intolerance and Diabetes Mellitus
Glucose Intolerance and Diabetes Mellitus
Mellitus
Treatment with somatropin may decrease insulin
Treatment with somatropin may decrease insulin
Treatment with somatropin may decrease insulin
sensitivity, particularly at higher doses. New onset
sensitivity, particularly at higher doses. New onset
sensitivity, particularly at higher doses in
type 2 diabetes mellitus has been reported in
type 2 diabetes mellitus has been reported in
susceptible patients. As a result, previously
patients taking somatropin. Previously
patients taking somatropin.
undiagnosed impaired glucose tolerance and overt
undiagnosed impaired glucose tolerance and overt
Previously undiagnosed impaired glucose
diabetes mellitus may be unmasked during
diabetes mellitus may be unmasked. Monitor
tolerance and overt diabetes mellitus may be
somatropin treatment. New-onset Type 2 diabetes
glucose levels periodically in all patients receiving
unmasked. Monitor glucose levels periodically in
mellitus has been reported. Therefore, glucose
Norditropin, especially in those with risk factors
all patients receiving HUMATROPE, especially in
levels should be monitored periodically in all
for diabetes mellitus, such as obesity, Turner
those with risk factors for diabetes mellitus, such
patients treated with somatropin, especially in
syndrome or a family history of diabetes mellitus.
as obesity, Turner syndrome, or a family history of
active proliferative or severe non-proliferative
diabetic retinopathy.
24
海外添付文書の糖尿病合併患者への投与に関する記載状況
1.
米国添付文書の記載状況
GENOTROPIN (somatropin) for injection, for
NORDITROPIN (somatropin) for injection, for
HUMATROPE (somatropin) for injection, for
subcutaneous use
subcutaneous use
subcutaneous use
2020 年 1 月版
2020 年 3 月版
2019 年 10 月版
Contraindications
Contraindications
Contraindications
Diabetic Retinopathy
Active proliferative or severe non- proliferative
Active proliferative or severe non- proliferative
Somatropin is contraindicated in patients with
diabetic retinopathy.
diabetic retinopathy.
Warnings and precautions
Warnings and precautions
Warnings and precautions
Impaired Glucose Tolerance and Diabetes
Glucose Intolerance and Diabetes Mellitus
Glucose Intolerance and Diabetes Mellitus
Mellitus
Treatment with somatropin may decrease insulin
Treatment with somatropin may decrease insulin
Treatment with somatropin may decrease insulin
sensitivity, particularly at higher doses. New onset
sensitivity, particularly at higher doses. New onset
sensitivity, particularly at higher doses in
type 2 diabetes mellitus has been reported in
type 2 diabetes mellitus has been reported in
susceptible patients. As a result, previously
patients taking somatropin. Previously
patients taking somatropin.
undiagnosed impaired glucose tolerance and overt
undiagnosed impaired glucose tolerance and overt
Previously undiagnosed impaired glucose
diabetes mellitus may be unmasked during
diabetes mellitus may be unmasked. Monitor
tolerance and overt diabetes mellitus may be
somatropin treatment. New-onset Type 2 diabetes
glucose levels periodically in all patients receiving
unmasked. Monitor glucose levels periodically in
mellitus has been reported. Therefore, glucose
Norditropin, especially in those with risk factors
all patients receiving HUMATROPE, especially in
levels should be monitored periodically in all
for diabetes mellitus, such as obesity, Turner
those with risk factors for diabetes mellitus, such
patients treated with somatropin, especially in
syndrome or a family history of diabetes mellitus.
as obesity, Turner syndrome, or a family history of
active proliferative or severe non-proliferative
diabetic retinopathy.
24