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Binozyt

Binozyt Use In Pregnancy & Lactation

azithromycin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no adequate data from the use of azithromycin in pregnant women. In reproduction toxicity studies in animals azithromycin was shown to pass the placenta, but no teratogenic effects were observed (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). The safety of azithromycin has not been confirmed with regard to the use of the active substance during pregnancy. Therefore azithromycin should only be used during pregnancy if the benefit outweighs the risk.
Breastfeeding: Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in breastfeeding women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk.
Serious adverse effects of azithromycin on breast-fed infants have not been observed. A decision needs to be made as to whether breast-feeding should be interrupted or whether the azithromycin therapy should be dispensed with or the treatment interrupted. In this context, both the benefits of breast-feeding for the child and the therapeutic benefits for the woman should be taken into account.
Fertility: In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin. The relevance of this finding to humans is unknown.
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