...known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the po-tential for serious adverse reactions...account the im-portance of the drug to the mother." U the drug is not associated with serious adverse reactions and does not have a known tumorigenic potential,...

...drug] [or, "Because of the potential tot tumorigenidry shown for (name of drug] ta [anjmal or huanza] studies* a decision should be made whether to discontinue...the drug, taking into account the importance of the drag to the mother." If the drug ia not associated with serious advene reaction* and does not have...

..."Because of the potential for tumorigen)clly shown for [name of drug} in [anima! or human) studies), • decision should be made whether to discontinue nursing...associated with serious adverse reactions and does not have e known tumorigenic potential, the labeling shall alate: "It is not known whether this drug is excreted...

...adverse effect* in infant*, a 33 decision should b* Bad* whether to discontinue nursing or discontinue 34 the drug, taking into account the importance of the drug to the Bother. Proposed Package In»»rt Pag* 13 1 Pediatric U*e. Ih« safety and eff«ctiv»n»*« of TAMBOCOR...

..."Because of the potential for tumorlgenicity shown for (name ' drug) in (animal or human) studies). * decision should be made whether to discontinue nursing...account the importance of the drug to the mother." И the drug is not associated with serio-- adverse reactions and does not have a known tumorigenic...

...foi tumorigenicity shown tor omeprazole in rat carcinogenicity studies, a decision should be irade whether to discontinue nursing or to discontinue the drug, taking into account the importance ol the drug to the mother Pediotric Use: Safety and effectiveness in pediatric patients have not been...

...because of the potential for serious adverse reactions in nursing infants from mycophenolate mofetil, a decision should be made whether to discontinue nursing...account the importance of the drug to the mother. 4.7 Effects on ability to drive and use machines No specific studies have been performed. The pharmacodynamic...

...not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, 1 5 taking into account the importance of the drug to the mother. ADVERSE REACTIONS: CURITOL® (Levocarnitine)...

...pregnancy only if clearly needed. Nursing Mothers: Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother. Pediatric Use: The safety...

...excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue...account the importance of the drug to the mother. 66 Chapter 9 ADVERSE In clinical trials, the most frequent adverse reactions to albuterol REACTIONS...