Vivaxim Use In Pregnancy & Lactation

Pregnancy: Data on a limited number (more than 150 cases for the monovalent typhoid Vi polysaccharide vaccine, more than 40 cases with monovalent inactivated hepatitis A vaccine and more than 10 cases for VIVAXIM or the two components given simultaneously) of exposed pregnancies indicate no adverse effects of VIVAXIM on pregnancy or on the foetus/newborn.
To date, no other relevant epidemiological data are available.
Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, and post-natal development.
VIVAXIM should only be administered after careful consideration in pregnant women (see Pharmacology: Pharmacokinetics under Actions).
When the patient is considered to be at risk only for hepatitis A or typhoid fever, the monovalent vaccine should be used.
Breastfeeding: It is unknown whether VIVAXIM is excreted in human milk. The excretion of VIVAXIM in milk has not been studied in animals. The decision of whether to discontinue breast-feeding or to discontinue/abstain from VIVAXIM therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No fertility data are available.