Aciclovir 25 mg/ml Concentrate for Solution for Infusion

… ons of aciclovir are alkaline (pH of approximately 11) and intended for intravenous infusion only and should not be used by any other route. Contact with eyes or unprotected skin should be avoided. Although the aqueous solubility of aciclovir exceeds 100 mg/ml, precipitation of aciclovir crystals in renal tubules and the consequent renal tubular damage can occur if the maximum solubility of free aciclovir (2.5 mg/ml at 37°C in water) is exceeded. Infusions of aciclovir must be given over a period of at least one hour in order to avoid renal tubular damage. Rapid or bolus injection should be avoided. Aciclovir infusions must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion particular attention should be given to establish sufficient urine flow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by aciclovir. Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2). …

… stablish sufficient urine flow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by aciclovir. Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2). Elderly patients are likely to have reduced renal function and …

… ons of aciclovir are alkaline (pH of approximately 11) and intended for intravenous infusion only and should not be used by any other route. Contact with eyes or unprotected skin should be avoided. Although the aqueous solubility of aciclovir exceeds 100 mg/ml, precipitation of aciclovir crystals in renal tubules and the consequent renal tubular damage can occur if the maximum solubility of free aciclovir (2.5 mg/ml at 37°C in water) is exceeded. Infusions of aciclovir must be given over a period of at least one hour in order to avoid renal tubular damage. Rapid or bolus injection should be avoided. Aciclovir infusions must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion particular attention should be given to establish sufficient urine flow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by aciclovir. Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2). …

Solutions of aciclovir are alkaline (pH of approximately 11) and intended for intravenous infusion only and should not be used by any other route. Contact with eyes or unprotected skin should be avoided. Although the aqueous solubility of aciclovir exceeds 100 mg/ml, precipitation of aciclovir crystals in renal tubules and the consequent rena …

… ients with renal impairment (see section 4.2). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued acicl …

… xicity. Animal studies 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 breas …

… 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 (see section …

… 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 …

Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes, mostly orally given) indicate no malformative nor feto/neonatal toxicity. Animal studies do not indicate reproduct …

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.