Land: Israël
Taal: Engels
Bron: Ministry of Health
ACICLOVIR
GLAXO SMITH KLINE (ISRAEL) LTD
J05AB01
POWDER FOR SOLUTION FOR INFUSION
ACICLOVIR 250 MG/VIAL
I.V
Required
GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY
ACICLOVIR
ACICLOVIR
Zovirax I.V. is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised.Zovirax I.V. is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.Zovirax I.V. is indicated for the treatment of Varicella zoster infections.Zovirax I.V. is indicated for the treatment of herpes encephalitis.Zovirax I.V. is indicated for the treatment of Herpes simplex infections in the neonate and infant up to 3 months of age.
2023-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician’s prescription only ZOVIRAX I.V. POWDER FOR PREPARATION OF A SOLUTION FOR INFUSION Each vial contains: aciclovir 250 mg/vial. For the list of inactive and allergenic ingredients in the preparation, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Zovirax I.V. is indicated: • for the treatment of Herpes simplex infections in immunocompromised pa- tients and for the treatment of severe initial genital herpes in non-immuno- compromised patients. • for the prophylaxis of Herpes simplex infections in immunocompromised patients. • for the treatment of chickenpox ( Varicella zoster ). • to treat inflammation of the brain caused by the herpes virus (herpes en- cephalitis). • for the treatment of Herpes simplex infections in neonates and infants up to 3 months of age. THERAPEUTIC GROUP: Zovirax I.V. belongs to a group of medicines called antivirals. Zovirax I.V. contains a medicine called aciclovir. It works by killing or stopping the growth of viruses. 2. BEFORE USING THE MEDICINE DO NOT USE ZOVIRAX I.V. IF: • you are sensitive (allergic) to aciclovir or valaciclovir or to any of the addi- tional ingredients contained in the medicine (listed in section 6). Do not take Zovirax I.V. if this applies to you. If you are not sure, refer to the physician or pharmacist before taking Zovirax. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE Before treatment with Zovirax I.V., tell the physician or pharmacis Lees het volledige document
ZOVIRAX I.V. SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zovirax I.V. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 250 mg aciclovir in each vial Excipients with known effect: Sodium hydroxide For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Intravenous injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zovirax I.V. is indicated for the treatment of _Herpes _ _simplex_ infections in immunocompromised patients and severe initial genital herpes in the non- immunocompromised. Zovirax I.V. is indicated for the prophylaxis of _Herpes _ _simplex_ infections in immunocompromised patients. Zovirax I.V. is indicated for the treatment of _Varicella zoster_ infections. Zovirax I.V. is indicated for the treatment of herpes encephalitis. Zovirax I.V. is indicated for the treatment of _Herpes simplex _ infections in the neonate and infant up to 3 months of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: _ _ Slow intravenous infusion over 1 hour. A course of treatment with Zovirax I.V. usually lasts 5 days, but this may be adjusted according to the patient's condition and response to therapy. Treatment for herpes encephalitis usually lasts 10 days. Treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease. The duration of prophylactic administration of Zovirax I.V. is determined by the duration of the period at risk. Dosage in adults: Patients with _Herpes simplex_ (except herpes encephalitis) or _Varicella zoster _ infections should be given Zovirax I.V. in doses of 5 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment). Immunocompromised patients with _Varicella zoster_ infections or patients with herpes encephalitis should be given Zovirax I.V. in doses of 10 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment). In obese patients dosed Lees het volledige document