Pregnancy & Lactation : הריון/הנקה

4.6.   Fertility, pregnancy and breast-feeding

Pregnancy
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The registry findings have not shown an increase in the number of birth defects described amongst Zovirax exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.

Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

The use of Zovirax Ophthalmic Ointment should be considered only when the potential benefits outweigh the possibility of unknown risks.

Breast-feeding
Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by the nursing infant following maternal use of Zovirax Ophthalmic Ointment would be insignificant.

Fertility
There is no information on the effect of aciclovir on human female fertility.

In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

See Clinical Studies in section 5.2.