ADEC Pregnancy Categories (Australia) |
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Pregnancy Category A |
藥物經過大量孕婦及育齡期婦女服用數據,觀察顯示沒有明顯增加傷害或是構成畸胎的可能。 Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. |
Pregnancy Category B1 |
一定數量的孕婦以及育齡期婦女服用資料顯示沒有明顯傷害或是導致畸胎的可能。 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. 動物實驗並為顯示出對胎兒的傷害。 |
Pregnancy Category B2 |
極度有限數量的孕婦及育齡期婦女服用資料顯示沒有明顯傷害或是導致畸胎的可能,或是觀察到在人類胎兒有間接的傷害 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. 動物實驗的數據可能缺乏但是可以查遇到的資料顯示沒有增加胎兒上海的證據。 |
Pregnancy Category B3 |
極度有限數量的孕婦及育齡期婦女服用資料顯示沒有明顯傷害或是導致畸胎的可能,或是觀察到在人類胎兒有間接的傷害。 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 有動物研究顯示胎兒損傷的發生率增加的證據,但是在人類上面的意義並不明確。 |
Pregnancy Category C |
藥理作用可能引起或是被懷疑是引起胎兒或是新生兒的傷害,但是影響是可逆的。 Drugs which, owing to their pharmaceutical effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. |
Pregnancy Category D |
藥物會引起或是被懷疑或是已經可能預期增加對人類的胎兒有畸胎或是不可逆的傷害,這些藥物也可能有藥理上的副作用。 Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. |
Pregnancy Category X |
藥物具有引起胎兒永久性傷害的風險,不應該使用在孕婦或是可能懷孕的婦女身上。 Drugs that have such a high risk of causing permanent damage to the fetus that they should NOT be used in pregnancy or when there is a possibility of pregnancy. |
Drugs in Category D are not absolutely contraindicated in pregnancy, unlike Category X. In some cases Category D was assigned to a drug on the basis of suspicion.The subcategorisation of Category B, while offering additional information which may be of benefit in evaluating the risk vs benefit, presents its own problem of data reliability - since human data is lacking or inadequate, the subcategorisation is based on animal data. Furthermore, allocation of a drug in Category B does not necessarily imply greater safety than Category C.
Pharmaceutical agent | Australia | United States |
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Acetaminophen/Paracetamol | A | C |
Acetylsalicylic acid/Aspirin | C | D third trimester |
Amoxicillin | A | B |
Amoxicillin with clavulanic acid | B1 | B |
Cefotaxime | B1 | B |
Diclofenac | C | D third trimester |
Isotretinoin | X | X |
Leflunomide | X | X |
Loperamide | B3 | C |
Paroxetine | D | D |
Phenytoin | D | D |
Rifampicin | C | C |
Thalidomide | X | X |
Theophylline | A | C |
Temazepam | C | X |
Tetracycline | D | D |
Triamcinolone (skin) | A | C |
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