Země: Jihoafrická republika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
GlaxoSmithKline South Africa (Pty) Limited
See ingredients
INJECTION
EACH VIAL CONTAINS ACICLOVIR SODIUM EQUIVALENT TO ACICLOVIR 250 mg
Registered
1984-09-01
Page 1 of 7 ZOVIRAX IV PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 ZOVIRAX IV INJECTION ACYCLOVIR 250 MG PER VIAL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN ZOVIRAX IV. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • ZOVIRAX IV has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET: 1. What ZOVIRAX IV is and what it is used for 2. What you need to know before you use ZOVIRAX IV 3. How to use ZOVIRAX IV 4. Possible side effects 5. How to store ZOVIRAX IV 6. Contents of the pack and other information. 1. WHAT ZOVIRAX IV IS AND WHAT IT IS USED FOR: ZOVIRAX is an antiviral agent. ZOVIRAX is used to treat herpes encephalitis, shingles and chicken pox. Page 2 of 7 ZOVIRAX is also used to treat herpes simplex infections and to prevent recurrent attacks of herpes simplex infections in people whose immune systems are weakened. ZOVIRAX prevents a virus called cytomegalovirus (CMV) in people who have had a bone marrow transplant. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOVIRAX IV: ZOVIRAX IV SHOULD NOT BE ADMINISTERED TO YOU: • if you have an allergy to, or if you have previously experienced an allergic reaction to acyclovir, or valaciclovir. WARNINGS AND PRECAUTIONS: TAKE SPECIAL CARE WITH ZOVIRAX IV: Tell your doctor or healthcare provider before being given the injection if: • you are pregnant or trying to become pregnant • you are breastfeeding or planning to breastfeed • you suffer from kidney or liver disease • if you are elderly. If you are elderly or if you have kidney problems, it is important that you drink adequate fluids whilst you are having treatment. The doctor will monitor you closely as there is a risk of experiencing nervous system side effects (see section 4). If any of the above applies to you or if you are unsure if they apply to you, and if you have not already discussed with Přečtěte si celý dokument
Page 1 of 16 GDS-30 ZOVIRAX IV PROFESSIONAL INFORMATION SCHEDULING STATUS: S4 1. NAME OF MEDICINE: ZOVIRAX IV Injection Powder for Injection Acyclovir 250 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each vial supplies acyclovir 250 mg as the freeze-dried sodium salt. The sodium ion content is approximately 26 mg per vial. 3. PHARMACEUTICAL FORM:_ _ Powder for Injection Vial containing a white to off-white powder. 4. CLINICAL PARTICULARS: 4.1 INDICATIONS: I Herpes simplex infections in immunocompromised patients: ZOVIRAX IV is indicated for the treatment of herpes simplex infections. ZOVIRAX IV is indicated for the prophylaxis of herpes simplex infections in patients. II ZOVIRAX IV is indicated in the treatment of varicella zoster infections in immuno- compromised patients: Chickenpox - prophylaxis and therapy of pneumonial complications. Shingles - only if the lesions are not older than 72 hours. Page 2 of 16 GDS-30 III ZOVIRAX IV is indicated for treatment of herpes simplex infections in the neonate. IV ZOVIRAX IV is indicated for the treatment of herpes simplex encephalitis. V ZOVIRAX IV is indicated for the prevention of reactivation of cytomegalovirus infection in seropositive patients following bone marrow transplantation. 4.2 POSOLGY AND METHOD OF ADMINISTRATION: The required dose of ZOVIRAX IV should be administered by slow intravenous infusion over a one hour period. A course of treatment with ZOVIRAX IV 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 usually lasts 14-21 days. The duration of prophylactic administration of ZOVIRAX IV is determined by the duration of the period at risk. DOSAGE IN ADULTS: INDICATION IMMUNE STATUS DOSAGE Herpes simplex infection (except herpes encephalitis) Immunocompromised 5 mg/kg body weight every 8 hours Varicella zoster infection Immunocompromised (normal renal function) 10 mg/kg body weight every 8 hours Herpes simplex Přečtěte si celý dokument