Zovirax IV 250mg

4.7 Effects on Ability to Drive and Use Machines

No data available.

Zovirax IV for Infusion is generally used in an in-patient hospital population and information on ability to drive and operate machinery is not usually relevant. There have been no studies to investigate the effect of Zovirax on driving performance or the ability to operate machinery.

4.8 Undesirable Effects

Gastrointestinal: Nausea and vomiting have been reported in patients receiving therapy with Zovirax IV for Infusion.

Haematological: Decreases in haematological indices (anaemia, thrombocytopenia, and leucopenia).

Hypersensitivity and skin: Rashes including photosensitivity, urticaria, pruritus, fevers and rarely dyspnoea, angioedema and anaphylaxis

Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when Zovirax IV for Infusion has been inadvertently infused into extravascular tissues.

Kidney: Rapid increases in blood urea and creatinine levels may occasionally occur in patients given Zovirax IV for Infusion. This is believed to be related to peak plasma levels and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one-hour period.

Adequate hydration of the patient should be maintained. Renal impairment developing during treatment with Zovirax IV for Infusion usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of the drug. Progression to acute renal failure, however, can occur in exceptional cases.

Liver: Reversible increases in bilirubin and liver-related enzymes, hepatitis and jaundice have been reported on very rare occasions,

Neurological: Reversible neurological reactions such as confusion, hallucinations, agitation, tremors, somnolence, psychosis, convulsions and coma have been associated with Zovirax IV for Infusion therapy, usually in medically complicated cases.

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.

The following convention has been used for the classification of undesirable effects in terms of frequency: Very common ³1/10, common ³1/100 and <1/10, uncommon ³1/1000 and <1/100, rare ³1/10,000 and <1/1000, very rare <1/10,000.

Blood and lymphatic system disorders

Uncommon:    Decreases in haematological indices (anaemia, thrombocytopenia, leukopenia)

Immune system disorders

Very rare:       Anaphylaxis

Psychiatric and nervous system disorders

Very rare:       Headache, dizziness, agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.

The above reversible events are usually seen in medically complicated cases.

Vascular disorders

Common:        Phlebitis.

Respiratory, thoracic and mediastinal disorders

Very rare:       Dyspnoea.

Gastrointestinal disorders

Common:        Nausea, vomiting.

Very rare:       Diarrhoea, abdominal pain.

Hepato-biliary disorders

Common:        Reversible increases in liver-related enzymes.

Very rare:       Reversible increases in bilirubin, jaundice, hepatitis.

Skin and subcutaneous tissue disorders

Common:        Pruritus, urticaria, rashes (including photosensitivity).

Very rare:       Angioedema.

Renal and urinary disorders

Common:        Increases in blood urea and creatinine.

Rapid increases in blood urea and creatinine levels are believed to be related to the peak plasma levels and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one-hour period.

Very rare:       Renal impairment, acute renal failure.

Adequate hydration should be maintained. Renal impairment usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of the drug. Progression to acute renal failure, however, can occur in exceptional cases.

General disorders and administration site conditions

Very rare:       Fatigue, fever, local inflammatory reactions.

Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when Zovirax I.V. for Infusion has been inadvertently infused into extracellular tissues.

5.3 Preclinical Safety Data

There is no information on the effect of aciclovir oral formulations or i.v. for infusion 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.

NON-CLINICAL INFORMATION

      Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not is unlikely to pose a genetic risk to man.

      Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

      Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.