DRUG INTERACTIONS
There are no known drug interactions. (See INDICATIONS AND USAGE, Use with Other Vaccines.)
Carcinogenesis, Mutagenesis, Impairment of Fertility
RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with the vaccine. It is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The vaccine should be given to a pregnant woman only if clearly needed. Nursing Mothers
It is not known whether the vaccine is excreted in human milk. Because many drugs are excreted in human milk, cautions should be exercised when the vaccine is administered to a nursing woman. Pediatric Use
RECOMBIVAX HB has been shown to be usually well-tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine. See DOSAGE AND ADMINISTRATION for recommended pediatric dosage and for recommended dosage for infants born to HBsAg positive mothers.
The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.
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