よむ、つかう、まなぶ。
資料１－３ 海外添付文書の記載状況 (1 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（第27回 1／24）《厚生労働省》 |
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令和４年１月 24 日
令和３年度医薬品等安全対策調査会
資料１－３
海外添付文書の記載状況
国
米国
製品名
（添付文書の版）
Plan B One-Step
（2009 年 7 月版）
記載状況（網かけ部は、投与前の妊娠していないことを確認する方法に関する記載）
4 CONTRAINDICATIONS
Plan B One-Step is contraindicated for use in the case of known or suspected pregnancy.
5 WARNINGS AND PRECAUTIONS
5.2 Existing Pregnancy
Plan B One-Step is not effective in terminating an existing pregnancy.
英国
Levonelle One Step
1500 microgram
tablet
（2018 年 11 月版）
5.5 Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B One-Step. A follow-up
physical or pelvic examination is recommended if there is any doubt concerning the general
health or pregnancy status of any woman after taking Plan B One-Step.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use
of contraceptive doses of oral progestins. The few studies of infant growth and development
that have been conducted with progestin-only pills have not demonstrated significant adverse
effects.
4.3 Contraindications
（関連記載なし）
4.6 Fertility, pregnancy and lactation
Pregnancy
Levonelle One Step should not be given to pregnant women. It will not interrupt a pregnancy.
In the case of continued pregnancy, limited epidemiological data indicate no adverse effects
on the fetus but there are no clinical data on the potential consequences if doses greater
than 1.5 mg of levonorgestrel are taken (see section 5.3.).
5.3 Preclinical safety data
Animal experiments with levonorgestrel have shown virilisation of female fetuses at high
doses.
Preclinical data from conventional studies on chronic toxicity, mutagenicity and
1
令和３年度医薬品等安全対策調査会
資料１－３
海外添付文書の記載状況
国
米国
製品名
（添付文書の版）
Plan B One-Step
（2009 年 7 月版）
記載状況（網かけ部は、投与前の妊娠していないことを確認する方法に関する記載）
4 CONTRAINDICATIONS
Plan B One-Step is contraindicated for use in the case of known or suspected pregnancy.
5 WARNINGS AND PRECAUTIONS
5.2 Existing Pregnancy
Plan B One-Step is not effective in terminating an existing pregnancy.
英国
Levonelle One Step
1500 microgram
tablet
（2018 年 11 月版）
5.5 Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B One-Step. A follow-up
physical or pelvic examination is recommended if there is any doubt concerning the general
health or pregnancy status of any woman after taking Plan B One-Step.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use
of contraceptive doses of oral progestins. The few studies of infant growth and development
that have been conducted with progestin-only pills have not demonstrated significant adverse
effects.
4.3 Contraindications
（関連記載なし）
4.6 Fertility, pregnancy and lactation
Pregnancy
Levonelle One Step should not be given to pregnant women. It will not interrupt a pregnancy.
In the case of continued pregnancy, limited epidemiological data indicate no adverse effects
on the fetus but there are no clinical data on the potential consequences if doses greater
than 1.5 mg of levonorgestrel are taken (see section 5.3.).
5.3 Preclinical safety data
Animal experiments with levonorgestrel have shown virilisation of female fetuses at high
doses.
Preclinical data from conventional studies on chronic toxicity, mutagenicity and
1