Aciclovir 200mg/5ml Oral Suspension

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 …

… continued aciclovir treatment (see section 5.1). Hydration status Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. Excipients Warnings: Sorbitol (E420): This medicinal product contains 1575mg sorbitol in each 5ml which is equivalent to 315mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed). Propylene glycol (E1520): This medicinal product contains 5mg propylene glycol in each 5 ml which is equivalent …

… continued aciclovir treatment (see section 5.1). Hydration status Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. Excipients Warnings: Sorbitol (E420): This medicinal product contains 1575mg sorbitol in each 5ml which is equivalent to 315mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed). Propylene glycol (E1520): This medicinal product contains 5mg propylene glycol in each 5 ml which is equivalent …

… 315mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed). Propylene glycol (E1520): This medicinal product contains 5mg propylene glycol in each 5 ml which is equivalent to 1mg/ml.

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 …

… ical 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 aciclovir treatment (see section 5.1). Hydration status Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. Excipients Warnings: Sorbitol (E420): This medicinal product contains …

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 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 …

… e in the number of 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 …

… els. 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

… 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

Pregnancy: The use of acyclovir should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing aciclovir pregnancy registry has documented pregnancy outcome …

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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.