小Per asked in 健康其他:保健 · 1 decade ago

三種懷孕用藥等級

如題

我搜尋到有

(1) 美國的FDA (Food and Drug Administration)

(2) 澳洲的 ADEC (Australian Drug Evaluation Committee)

(3) 瑞典的 FASS (Swedish Catalogue of Approved Drugs)

這三種

我想請大家幫我找找有沒有關於第2ˋ3種等級的定義

英文的也可以

謝謝!!!

2 Answers

Rating
  • 1 decade ago
    Favorite Answer

    圖片參考:http://tw.yimg.com/i/tw/ugc/rte/smiley_22.gif

    澳洲的懷孕用藥分級

    Category A

    Drugs which have been taken by a large number of pregnant women and women of

    childbearing age without any proven increase in the frequency of malformations or other

    direct or indirect harmful effects on the fetus having been observed.

    Category C

    Drugs which, owing to their pharmacological 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. Accompanying texts should be consulted for further

    details.

    Category B1

    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.

    Category B2

    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.

    Category B3

    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.

    2008-07-22 16:00:13 補充:

    Category D

    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. Accompanying texts should be

    consulted for further details.

    2008-07-22 16:00:36 補充:

    Category X

    Drugs which 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.

    2008-07-22 16:00:48 補充:

    瑞典的懷孕用藥分級

    http://www.ncbi.nlm.nih.gov/pubmed/8852521

    2008-07-22 16:01:01 補充:

    Category A includes drugs that have been extensively used and/or for which there are reliable clinical data indicating no evidence of disturbance of the reproductive process.

    2008-07-22 16:01:10 補充:

    Category B includes drugs for which data from pregnant women are insufficient for making any solid estimation of human teratogenic risk, and classification is therefore based on animal data, with allocation to 3 subgroups.

    2008-07-22 16:01:20 補充:

    Category C, the pharmacological action of the drug may have undesirable effects on the human fetus or newborn infant.

    2008-07-22 16:01:26 補充:

    Category D contains drugs for which human data indicate an increased incidence of malformations.

    2008-07-22 16:03:52 補充:

    不好意思 受字數限制

    必需分段

    有關澳洲部分 如有問題可以到我的澳洲藥師知識團留言

    Source(s): www.pubmed.gov
  • Anonymous
    6 years ago

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