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" There are. however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed... "
Code of Federal Regulations: Containing a Codification of Documents of ... - 18. lappuse
2000
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Oversight on Efforts to Reduce Infant Mortality and to Improve Pregnancy ...

United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Child and Human Development - 1981 - 720 lapas
...shall state; "Pregnancy Category B. Reproduction studies have been performed in (AwiolsJ of animafo}) at doses up to (x\ times the human dose and have revealed...pregnant women. Because animal reproduction studies arc not always predictive of human response, thia drag should b* used during pregnancy only if clearly...
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In the Heart of the Village: The World of the Indian Banyan Tree

Barbara Bash - 2002 - 234 lapas
...harm to the fetus due to esomeprazole. There are. however, no adequate and well-controlled studies m pregnant women Because animal reproduction studies...response, this drug should be used during pregnancy only il clearly needed. Teratology studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day...
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Multiple Sclerosis and Having a Baby: Everything You Need to Know about ...

Judy Graham - 1999 - 196 lapas
...to 36 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled...should be used during pregnancy only if clearly needed. It is important for women taking Copaxone to inform their physician if they become pregnant or plan...
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Departments of Commerce, Justice, and State, the Judiciary, and ..., 10. daļa

United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies - 2001 - 334 lapas
...HO, CONTROLLEDRELEASE) TABLETS AND THE PUBLIC HEALTH evidence of harm to the fetus due to oxycodone. There are, however, no adequate and well-controlled...should be used during pregnancy only if clearly needed. Labor and Delivery OxyContin® is not recommended for use in women during and immediately prior to...
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Translator Self-training, French: Practical Course in Technical Translation

Morry Sofer - 2000 - 120 lapas
...fertility or harm to the fetus due to CURITOL®. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction...should be used during pregnancy only if clearly needed. 10 NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs...
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Principles of Clinical Pharmacology

Arthur J. Atkinson Jr., Arthur J. Atkinson - 2001 - 490 lapas
...drugs that are marketed in the United States, therefore, carry the statement in their labeling that: There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy...
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107-1 Hearings: Departments Of Commerce, Justice, and State, The Judiciary ...

2002 - 332 lapas
...HO, CONTROLLEDRELEASE) TABLETS AND THE PUBLIC HEALTH evidence of harm to the fetus due to oxycodone. There are, however, no adequate and well-controlled...should be used during pregnancy only if clearly needed. Labor and Delivery OxyContin® is not recommended for use in women during and immediately prior to...
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Specious Science: How Genetics and Evolution Reveal why Medical Research on ...

C. Ray Greek, Jean Swingle Greek - 2002 - 308 lapas
...times the human dose and have revealed no evidence of impaired fertility or harm to fetus due to the drug. There are, however, no adequate and wellcontrolled...studies are not always predictive of human response, the drug should not be used during pregnancy unless clearly needed. — Physicians' Desk Reference...
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Principles of Gender-specific Medicine, 2. sējums

Marianne J. Legato, John P. Bilezikian - 2004 - 696 lapas
...Currently, most drugs that are marketed in the United States carry the statement in their labeling that There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy...
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Gentlemen and Scholars: College and Community in the "Age of the University"

322 lapas
...metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose). There are, however, no adequate and well-controlled...studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed. Nursing Mothers: Desloratadine...
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