… data currently available from clinical studies is not sufficient to conclude that treatment with aciclovir reduces the incidence of chickenpox-associated complications in immunocompetent patients.
Paediatric population:
Oral aciclovir should be used in paediatric population mainly for the treatment of non-severe skin and mucosa HSV infections. For the treatment of neonatal HSV and severe HSV infections in immunoco …
… n should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3.
Lactation
Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
Fertility
There is no information on the effect of aciclovir on human female fertility.
See clinical studies in section 5.2
… hould however be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3.
Breast-feeding:
Following oral administration of 200 mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
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 …
… birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
Breast-feeding:
Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3mg/kg/day. Caution is therefore advised if Aciclovir suspension is to be administered to a nursing woman.
Fertility:
See clinical studies in Section 5.3
… udies do not indicate reproductive toxicity (see section 5.3).
The use of Aciclovir 25mg/ml Concentrate for Solution for Infusion may be considered during pregnancy, if necessary.
Breast-feeding
Aciclovir is excreted in human milk, caution is therefore advised if aciclovir is to be administered to a nursing woman. It is unlikely that therapeutic doses of aciclovir have effects on the breastfed newborns/infants. Aciclovir may be considered for use during breast-feeding.
Fertility
There is no information on the effect of aciclovir on human female fertility. No effects were shown on male fertility. Animal studies do not show effects on fertility at relevant doses …
… igible. When necessary, Aciclovir Agepha eye ointment can be used during pregnancy.
Breast Feeding
Limited 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 Aciclovir Agepha eye ointment would be insignificant. The use of Aciclovir Agepha eye ointment can be considered during breast feeding.
… vir tablets on human female fertility. Aciclovir tablets have been shown to have no definite effect upon sperm count, morphology or motility in man. See Clinical Studies in section 5.2.
Lactation
Following oral administration of 200 mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose breast fed infants to aciclovir doses of up to 0.3 mg/kg/day. The dosage received by a nursing infant following maternal use of aciclovir cream would be expected to be insignificant.
… 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.
Lactation:
As there is only minimal systemic absorption of aciclovir, adverse effects on the infant during lactation are unlikely. Limited human data show that the drug does pass into breast milk following systemic administration. The dosage received by a nursing infant following maternal use of aciclovir cream would be insignificant.
… should however be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3.
Breast-feeding:
Following oral administration of 200 mg Zovirax five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
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 1 …
… am should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of aciclovir cream is very low.
Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of Zovirax Cold Sore Cream would be expected to be insignificant.
Fertility
There is no information on the effect of aciclovir on human female fertility.
See Clinical Studies in section 5.2.