Кіріспе
Дәрі-дәрмек қолданудан туындайтын ұрыққа зиян келтіру қаупі. Дәрі-дәрмектің жүктілік санаты – егер оны жүктілік кезінде анасының көрсеткішінше қолданса, дәрілік заттан туындайтын ұрыққа зиян келтіру қаупінің бағасы. Бұл препараттың ана сүтіндегі дәрілік заттар мен олардың метаболиттерінен туындайтын қауіптерді қамтымайды. Әрбір дәрі-дәрмек туралы ерекше ақпарат оның өнімдік құжаттамасында келтірілген. Британдық Ұлттық формуляры бұрын жүктілік кезінде сақтануға немесе сақтықпен қолдануға болатын дәрі-дәрмектердің тізімін берді және оны шектеулі негізгі сөздермен жасады, бірақ қазір 4-қосымша (бұл жүктілік тізімі) алынып тасталды. 4-қосымша енді "Көктамырға енгізілетін қоспалар" деп аталады. Дегенмен, бұрын 4-қосымшада (жүктілік) және 5-қосымшада (емшек сүтімен тамақтандыру) болған ақпарат енді жеке дәрі-дәрмектердің сипаттамаларында қолжетімді.
Risk of fetal injury due to the use of a pharmaceutical
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives". However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs.
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives". However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs.
Америка Құрама Штаттары
Америка заңдары белгілі бір дәрі-дәрмектер мен биологиялық өнімдерді нақты белгілеуді талап етеді. Федералды ережелер жинағының 201.57 (9) (i) бөлімі жүкті әйелдерге тигізетін әсеріне қатысты дәрілік заттарды таңбалауға қатысты нақты талаптарды, соның ішінде "жүктілік санаты" анықтамасын қамтиды. Бұл ережелерді Азық-түлік және дәрі-дәрмек басқармасы (FDA) жүзеге асырады. Осы ақпаратты толықтыру үшін FDA жүктілік және лактация кезеңіндегі таңбалауға қатысты қосымша ережелерді жариялайды. FDA барлық қауіпті және қауіпсіз заттардың таңбалануын реттемейді. Көптеген заттар, соның ішінде алкоголь, жүкті әйелдер мен олардың ұрықтары үшін, соның ішінде ұрықтық алкоголь синдромы үшін де қауіпті болып саналады. Көптеген басқа ластағыштар мен қауіпті материалдар да репродуктивті зиян келтіруі мүмкін. Алайда, кейбір заттар дәрілік заттарды таңбалау заңдарына бағынбайды, сондықтан оларға 21 CFR 201.57 бойынша "жүктілік санаты" тағайындалмайды.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
Жүктілік санаты сипаттамасы
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
A Бақыланатын зерттеулерде қауіп жоқ: Адамдарда жүргізілген жеткілікті және жақсы бақыланатын зерттеулер жүктіліктің бірінші триместрінде ұрыққа қауіп төндіретінін көрсетпеді (кейінгі триместрлерде қауіптің жоқтығына дәлелдер жоқ).
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
B Басқа зерттеулерде қауіп жоқ: Жануарлардағы репродукциялық зерттеулер ұрыққа қауіп төндіретінін көрсетпеді және жүкті әйелдерде жеткілікті және жақсы бақыланатын зерттеулер жоқ, немесе жануарлар зерттеулері жағымсыз әсерлер көрсеткенімен, жүкті әйелдерде жүргізілген жеткілікті және жақсы бақыланатын зерттеулер ұрыққа қауіп төндіретінін көрсетпеді.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
C Қауіп жоққа шығарылмаған: Жануарлардағы репродукциялық зерттеулер ұрыққа зиянды әсерін көрсеткен, ал адамдарда жеткілікті және жақсы бақыланатын зерттеулер жоқ, бірақ ықтимал қауіптерге қарамастан, препаратты жүкті әйелдерде қолданудың ықтимал пайдасы болуы мүмкін.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
D Қауіпке қатысты оң дәлелдер: Зерттеулер немесе маркетингтік тәжірибелер немесе адамдардағы зерттеулер бойынша алынған жағымсыз реакциялар деректеріне негізделген адам ұрығына қатысты оң дәлелдер бар, бірақ ықтимал қауіптерге қарамастан, препаратты жүкті әйелдерде қолданудың ықтимал пайдасы болуы мүмкін.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
X Жүктілік кезінде қолдануға қарсы: Жануарлар мен адамдардағы зерттеулер ұрықтағы аномалияларды көрсеткен және/немесе зерттеулер мен маркетингтік тәжірибеден алынған жанама әсерлер деректеріне сүйене отырып, адам ұрығына қатысты оң дәлелдер бар, және жүкті әйелдерде препаратты қолданудың тәуекелдері ықтимал пайдасынан айқын артық.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
N FDA әлі препаратты белгілі бір жүктілік санатына жатқызған жоқ. FDA-ның жүктілік санатын анықтау принциптерінің бірі – препараттың жүктілік санаты А ретінде анықталуы үшін оның тиімділігі мен қауіпсіздігін растайтын жоғары сапалы деректердің көп мөлшері қажеттігі. Осы себепті, басқа елдерде қауіпсіз деп саналатын көптеген препараттар FDA-мен C санатына жатқызылады.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration. To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling. The FDA does not regulate labeling for all hazardous and non hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. Pregnancy Category Description A No risk in controlled human studies: Adequate and well controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). BNo risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women, or animal studies have shown adverse effects, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. C Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D Positive evidence of risk: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. N The FDA has not yet classified the drug into a specified pregnancy category. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
Германия
Санаттық топтардың сипаттамасы Топ 1 Кең ауқымды адамдарға жасалған сынақтар мен жануарлар зерттеулері препараттың эмбриотоксикалық/тератогендік әсерін көрсетпеді. Топ 2 Кең ауқымды адамдарға жасалған сынақтар препараттың эмбриотоксикалық әсерін көрсетпеді. Топ 3 Кең ауқымды адамдарға жасалған сынақтар препараттың эмбриотоксикалық әсерін көрсетпеді. Алайда, препарат жануарларда эмбриотоксикалық/тератогендік әсер етеді. Топ 4 Препараттың адамға әсері туралы жеткілікті және жақсы бақыланған зерттеулер жоқ. Жануарлар зерттеулері эмбриотоксикалық/тератогендік әсерлердің жоқтығын көрсетті. Топ 5 Препараттың адамға әсері туралы жеткілікті және жақсы бақыланған зерттеулер жоқ. Топ 6 Препараттың адамға әсері туралы жеткілікті және жақсы бақыланған зерттеулер жоқ. Жануарлар зерттеулері эмбриотоксикалық/тератогендік әсерлерді көрсетті. Топ 7 Препараттың адамдарда, кем дегенде бірінші триместрде эмбриотоксикалық/тератогендік әсер ететін қаупі бар. Топ 8 Препараттың екінші және үшінші триместрде ұрыққа зиянды әсер ететін қаупі бар. Топ 9 Препараттың туа біткен кемістіктерге немесе асқынуларға себеп болатын қаупі бар. Топ 10 Препараттың адам ұрығына гормоналды түрде ерекше әсер ететін қаупі бар. Топ 11 Препараттың мутагенді/канцерогенді екені белгілі қаупі бар.
Category Group Description Group 1 Extensive human tests and animal studies have not shown the drug to be embryotoxic/teratogenicGroup 2 Extensive human tests of the drug have not shown the drug to be embryotoxic. Group 3 Extensive human tests of the drug have not shown the drug to be embryotoxic. However, the drug appears to be embryotoxic/teratogenic in animals. Group 4 No adequate and well controlled studies of the drug's effects on humans are available. Animal studies have shown no embryotoxic/teratogenic effects. Group 5 No adequate and well controlled studies of the drug's effects on humans are available. Group 6 No adequate and well controlled studies of the drug's effects on humans are available. Animal studies have shown embryotoxic/teratogenic effects. Group 7 There is a risk that the drug is embryotoxic/teratogenic in humans, at least in the first trimester. Group 8 There is a risk that the drug is toxic to fetuses throughout the second and third trimesters. Group 9 There is a risk that the drug causes prenatal complications or abnormalities. Group 10 There is a risk that the drug causes hormone specific action on the human fetus. Group 11 There is a known risk that the drug is a mutagen/carcinogen.