Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Aciclovir sodium
Laboratórios Azevedos - Indústria Farmacêutica S.A
J05AB; J05AB01
Aciclovir sodium
250 milligram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir
Marketed
2017-10-06
Room temperature Refrigerator (15ºC – 25ºC) (2ºC – 8ºC) Sodium Chloride Intravenous Infusion (0.9% w/v) 24 hours 24 hours Sodium Chloride (0.18% w/v) and Glucose 12 hours Do not refrigerate (4% w/v) Intravenous Infusion or freeze Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion 24 hours 8 hours Compound Sodium Lactate Intravenous Infusion Do not store 12 hours (Hartmann's Solution) – after reconstituted with below 25ºC purified water Compound Sodium Lactate Intravenous Infusion Do not store 8 hours (Hartmann's Solution) - after reconstituted with below 25ºC Sodium Chloride (0.9% w/v) 1. WHAT ACICLOVIR IS AND WHAT IT IS USED FOR Aciclovir 250 mg powder for solution for infusion contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses. Aciclovir can be used to: • treat recurrent chickenpox and shingles in people whose immune system works well • treat primary and recurrent chickenpox and shingles in people whose immune systems work less well, which means their bodies are less able to fight infections • treat severe cases of genital herpes • treat and stop cold sores and genital herpes in people whose immune systems work less well, which means their bodies are less able to fight infections • treat serious virus infections in children up to 3 months of age. This can rarely be caused by the virus responsible for cold sore infection and genital herpes • treat inflammation of the brain. This can rarely be caused by the virus responsible for cold sore infection and genital herpes. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACICLOVIR DO NOT USE ACICLOVIR • if you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Aciclovir if: • you have kidney problems • you are over 65 years of age • your immune system is weak. If you are not sure if the abo Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aciclovir Azevedos 250 mg Powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg of aciclovir (as aciclovir sodium). One ml of reconstituted solution contains 25 mg of aciclovir. Excipients with known effect: sodium hydroxide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. Homogenous solid white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir Azevedos is indicated for the treatment_ of Herpes simplex_ infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. Aciclovir Azevedos is indicated for the prophylaxis_ of Herpes simplex_ infections in immunocompromised patients. Aciclovir Azevedos is indicated for the treatment of_ Varicella zoster_ infections. Aciclovir Azevedos is indicated for the treatment of herpes encephalitis. Aciclovir Azevedos 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 Aciclovir Azevedos 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 Aciclovir Azevedos is determined by the duration of the period at risk. The required dose of aciclovir for infusion should be administered by slow intravenous infusion over a one-hour period. After reconstitution aciclovir for infusion may be administered by a controlled-rate infusion pump. Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not great Прочитајте комплетан документ