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" ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. "
Code of Federal Regulations: Containing a Codification of Documents of ... - 23. lappuse
1997
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Code of Federal Regulations: Containing a Codification of Documents of ...

1980 - 260 lapas
...increases the risk of abnormalities when administered during the first (second, third, or all) trimester(s) of pregnancy. Despite the animal findings, it would...are no animal reproduction studies and no adequate ana well-controlled studies in humans, the labeling shall state: "Pregnancy Category C. Animal reproduction...
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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 - 716 lapas
...(x) times the human dose. There are no adequate and wellcontrolled studies in pregnant women. (Nome of drug] should be used during pregnancy only if the...studies and no adequate and well-controlled studies in humant, the labeling shall state: "Pregnancy Category C. Animal reproduction studies have not been...
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In the Heart of the Village: The World of the Indian Banyan Tree

Barbara Bash - 2002 - 234 lapas
...human exposure based on the AUCo-24 at 200 mg BID). There are no studies in pregnant women. CELEBREX should be used during pregnancy only if the potential benefit justifies the potential risk to the ; etus. Nonteratogenic effects: Celecoxib produced preimplantation and post-implantation losses and...
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Cardiac Problems in Pregnancy: Diagnosis and Management of Maternal and ...

Uri Elkayam, Norbert Gleicher - 1998 - 1110 lapas
.... [On pregnancy:] There are no adequate and well controlled studies in pregnant women. Cyclosporine should be used during pregnancy only if the potential...benefit justifies the potential risk to the fetus. Azathioprine Azathioprine is an imidazole derivative of 6-mercaptopurine. Its active metabolites cross...
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Psychologists' Psychotropic Drug Reference

Louis A. Pagliaro, Ann M. Pagliaro - 1999 - 732 lapas
...and the embryo, fetus, or neonate (see Opiate Analgesics General Monograph). Prescribe buprenorphine during pregnancy only if the potential benefit justifies the potential risk to the embryo, fetus, or neonate. Collaboration with the patient's obstetrician is indicated. Women who are...
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European Blue List: European Drug Registrations. Grundwerk

Karl Feiden - 1999 - 670 lapas
...pregnancy Crixivan has not been studied in pregnant women. Until additional data become available, Crixivan should be used during pregnancy only if the potential...benefit justifies the potential risk to the fetus. Hyperbilirubinaemia, reported predominantly as elevated indirect bilirubin, has occured in 10% of patients...
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Principles and Practice of Travel Medicine

Dr. Jane N. Zuckerman - 2002 - 520 lapas
...humans, or animal studies are either positive for fetal risk or lacking as well. Drugs should be given only if the potential benefit justifies the potential risk to the fetus There is positive evidence of human fetal risk. Nevertheless, potential benefits may outweigh the potential...
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Quality Assurance/quality Improvement

572 lapas
...Pregnancy and lactation: • Corticosteroids are classified in FDA pregnancy category C and should be given only if the potential benefit justifies the potential risk to the fetus • Fetal adrenal hypoplasia may occur with large doses of corticosteroids for prolonged periods during...
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Women and Cannabis: Medicine, Science, and Sociology

Ethan Russo, Melanie Creagan Dreher, Mary Lynn Mathre - 2002 - 208 lapas
...to the fetus with no controlled human studies). The drug labeling states that Marinol should be used only if the potential benefit justifies the potential risk to the fetus. Likewise, its use in nursing mothers is not recommended since Marinol is concentrated in and secreted...
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Antiemetic Therapy

Josef Donnerer - 2003 - 241 lapas
...are no controlled studies in women or studies in women and animals are not available. Drugs should be only if the potential benefit justifies the potential risk to the fetus. Subscript M (eg, BM): Many drugs have not been given a letter rating by the manufacturers. Subscript...
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