よむ、つかう、まなぶ。
資料２－２ 調査結果報告書 (27 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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effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m2) basis. A noeffect dose for embryo-fetal developmental toxicity in rhesus monkeys was not established.
EU 添付文書
4.3 Contraindications
（2020 年 12 月版）
（関連記載なし）
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and postmarketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure
during the first trimester of pregnancy. However, the duration of exposure during the first trimester is uncertain, because
data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when
pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited.
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion. The risk of spontaneous
abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available
data, but the data do not suggest an increased risk so far.
If clinically needed, the use of Betaferon may be considered during pregnancy.
ドイツ添付文書
4.3 Gegenanzeigen
（2020 年 12 月版）
（関連記載なし）
4.6 Fertilität, Schwangerschaft und Stillzeit
Schwangerschaft
Weitreichende Erfahrungen (mehr als 1000 Schwangerschaftsausgänge) aus Interferon-beta-Registern, nationalen
Registern und nach Markteinführung deuten nicht auf ein erhöhtes Risiko für schwerwiegende angeborene Fehlbildungen
27
EU 添付文書
4.3 Contraindications
（2020 年 12 月版）
（関連記載なし）
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and postmarketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure
during the first trimester of pregnancy. However, the duration of exposure during the first trimester is uncertain, because
data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when
pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited.
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion. The risk of spontaneous
abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available
data, but the data do not suggest an increased risk so far.
If clinically needed, the use of Betaferon may be considered during pregnancy.
ドイツ添付文書
4.3 Gegenanzeigen
（2020 年 12 月版）
（関連記載なし）
4.6 Fertilität, Schwangerschaft und Stillzeit
Schwangerschaft
Weitreichende Erfahrungen (mehr als 1000 Schwangerschaftsausgänge) aus Interferon-beta-Registern, nationalen
Registern und nach Markteinführung deuten nicht auf ein erhöhtes Risiko für schwerwiegende angeborene Fehlbildungen
27