よむ、つかう、まなぶ。
資料１－３ 海外添付文書の記載状況 (3 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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国
製品名
（添付文書の版）
Tablet 1.5 mg
（2018 年 4 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）
pregnant due to a previous act of intercourse, especially if there is recent abnormal bleeding,
a pregnancy test should be performed before taking Plan B.
WARNINGS AND PRECAUTIONS
General
Plan B® is not an abortifacient and should not be taken by pregnant women, as it will not be
effective.
Sexual Function/Reproduction
Suspected Pregnancy: A pregnancy test is warranted if pregnancy is suspected. Women should
be counselled to abstain from sexual intercourse or use an alternative contraceptive method
until the onset of their next normal menstrual period. If a normal menstrual period is delayed
beyond 1 week, the patient’s pregnancy status should be confirmed with a pregnancy test and
follow-up with a health professional.
Special Populations
Pregnant Women: Plan B® is not an abortifacient and should not be taken by pregnant women,
as it will not be effective. Studies involving women who have taken combined oral
contraceptives containing levonorgestrel inadvertently during early pregnancy do not suggest
that these drugs have an adverse effect on the fetus and there is no evidence that Plan B®
(levonorgestrel 1.5 mg tablet) taken as an emergency contraceptive would have an adverse
effect on an established pregnancy. However, there are insufficient data to rule out the
possibility of adverse effects on the fetus if Plan B® is used after a woman is already
pregnant or in cases of method failure.
TOXICOLOGY
Reproductive Toxicity: A large number of reproductive toxicity studies were performed by
repeat dose administration to evaluate the effects on mating fertility, fecundity, posttreatment recovery of fertility, effects on the estrous cycle, claudogenic effects as well
as classic Segment I, II, and III reproductive studies. Of greatest possible relevance to
emergency contraception are the studies of recovery of fertility and birth defects. In a
study in mice treated with up to 50x the human contraceptive dose, no irreversible impairment
of fertility was noted.
3
製品名
（添付文書の版）
Tablet 1.5 mg
（2018 年 4 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）
pregnant due to a previous act of intercourse, especially if there is recent abnormal bleeding,
a pregnancy test should be performed before taking Plan B.
WARNINGS AND PRECAUTIONS
General
Plan B® is not an abortifacient and should not be taken by pregnant women, as it will not be
effective.
Sexual Function/Reproduction
Suspected Pregnancy: A pregnancy test is warranted if pregnancy is suspected. Women should
be counselled to abstain from sexual intercourse or use an alternative contraceptive method
until the onset of their next normal menstrual period. If a normal menstrual period is delayed
beyond 1 week, the patient’s pregnancy status should be confirmed with a pregnancy test and
follow-up with a health professional.
Special Populations
Pregnant Women: Plan B® is not an abortifacient and should not be taken by pregnant women,
as it will not be effective. Studies involving women who have taken combined oral
contraceptives containing levonorgestrel inadvertently during early pregnancy do not suggest
that these drugs have an adverse effect on the fetus and there is no evidence that Plan B®
(levonorgestrel 1.5 mg tablet) taken as an emergency contraceptive would have an adverse
effect on an established pregnancy. However, there are insufficient data to rule out the
possibility of adverse effects on the fetus if Plan B® is used after a woman is already
pregnant or in cases of method failure.
TOXICOLOGY
Reproductive Toxicity: A large number of reproductive toxicity studies were performed by
repeat dose administration to evaluate the effects on mating fertility, fecundity, posttreatment recovery of fertility, effects on the estrous cycle, claudogenic effects as well
as classic Segment I, II, and III reproductive studies. Of greatest possible relevance to
emergency contraception are the studies of recovery of fertility and birth defects. In a
study in mice treated with up to 50x the human contraceptive dose, no irreversible impairment
of fertility was noted.
3