Введение
Риск повреждения плода вследствие применения лекарственного препарата. Категория лекарственного препарата для беременных – это оценка риска повреждения плода при использовании препарата в соответствии с инструкцией матерью во время беременности. Она не включает в себя риски, связанные с лекарственными препаратами или их метаболитами, попадающими в грудное молоко. Информация о каждом препарате содержится в инструкции по применению. Британский национальный формуляр ранее предоставлял таблицу препаратов, которых следует избегать или использовать с осторожностью во время беременности, используя для этого ограниченное количество ключевых фраз, но теперь Приложение 4 (которое ранее представляло собой таблицу для беременных) было удалено. Приложение 4 теперь называется «Внутривенные добавки». Однако информация, которая ранее была доступна в Приложении 4 (беременность) и Приложении 5 (кормление грудью), теперь содержится в отдельных монографиях о лекарственных препаратах.
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.
Соединенные Штаты
Американское законодательство требует, чтобы определенные лекарственные средства и биологические препараты маркировались очень конкретно. Раздел 21, часть 201.57 (9)(i) Кодекса федеральных правил содержит конкретные требования к маркировке лекарственных средств в отношении их воздействия на беременных, включая определение "категории беременности". Эти правила соблюдаются Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов (FDA). В дополнение к этой информации FDA публикует дополнительные правила, касающиеся маркировки лекарств при беременности и кормлении грудью. FDA не регулирует маркировку всех опасных и неопасных веществ. Многие вещества, включая алкоголь, широко известны как факторы, представляющие серьезную опасность для беременных женщин и их плодов, включая фетальный алкогольный синдром. Многие другие загрязнители и опасные материалы также, как известно, оказывают вредное воздействие на репродуктивную функцию. Однако некоторые из этих веществ не подпадают под действие законов о маркировке лекарственных средств и, следовательно, не имеют "категории беременности" в соответствии с 21 CFR 201.57.
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.
**Описание категории беременности**
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** Отсутствие риска в контролируемых исследованиях на людях: адекватные и хорошо контролируемые исследования на людях не выявили риска для плода в первом триместре беременности (и нет данных о риске в более поздних триместрах).
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** Отсутствие риска в других исследованиях: исследования на животных не выявили риска для плода, и нет адекватных и хорошо контролируемых исследований на беременных женщинах, или исследования на животных показали неблагоприятные эффекты, но адекватные и хорошо контролируемые исследования на беременных женщинах не выявили риска для плода ни на одном триместре.
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** Риск не исключен: исследования на животных показали неблагоприятное воздействие на плод, и нет адекватных и хорошо контролируемых исследований на людях, но потенциальная польза может оправдать использование препарата у беременных женщин, несмотря на потенциальные риски.
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** Положительные данные о риске: имеются положительные данные о риске для плода человека, основанные на данных о побочных реакциях, полученных в ходе исследовательских или маркетинговых исследований, или исследований на людях, но потенциальная польза может оправдать использование препарата у беременных женщин, несмотря на потенциальные риски.
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** Противопоказано при беременности: исследования на животных или людях выявили аномалии плода и/или имеются положительные данные о риске для плода человека, основанные на данных о побочных реакциях, полученных в ходе исследовательских или маркетинговых исследований, и риски, связанные с использованием препарата у беременных женщин, явно перевешивают потенциальную пользу.
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 еще не классифицировало препарат в определенную категорию беременности.
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.
Одной из особенностей определений FDA категорий беременности является то, что FDA требует относительно большого объема высококачественных данных о фармацевтическом препарате для отнесения его к категории беременности А. В результате этого многие лекарственные средства, которые в других странах считались бы безопасными, FDA относит к категории C.
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
Категория Описание группы Группа 1 Обширные исследования на людях и животных не выявили эмбриотоксичности/тератогенности препарата. Группа 2 Обширные исследования на людях не выявили эмбриотоксичности препарата. Группа 3 Обширные исследования на людях не выявили эмбриотоксичности препарата. Однако, препарат, по-видимому, проявляет эмбриотоксические/тератогенные свойства в исследованиях на животных. Группа 4 Нет достаточных и хорошо контролируемых исследований влияния препарата на людей. Исследования на животных не показали эмбриотоксических/тератогенных эффектов. Группа 5 Нет достаточных и хорошо контролируемых исследований влияния препарата на людей. Группа 6 Нет достаточных и хорошо контролируемых исследований влияния препарата на людей. Исследования на животных показали эмбриотоксические/тератогенные эффекты. Группа 7 Существует риск эмбриотоксичности/тератогенности препарата для человека, особенно в первом триместре беременности. Группа 8 Существует риск токсичного воздействия препарата на плод во втором и третьем триместрах беременности. Группа 9 Существует риск возникновения пренатальных осложнений или врожденных аномалий развития, вызванных препаратом. Группа 10 Существует риск специфического гормонального воздействия препарата на человеческий плод. Группа 11 Известно о риске мутагенного/канцерогенного действия препарата.
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.