البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Aciclovir sodium
Pfizer Healthcare Ireland
J05AB; J05AB01
Aciclovir sodium
25 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir
Marketed
1999-01-22
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (STERILE CONCENTRATE) ACICLOVIR SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aciclovir Sterile Concentrate is and what it is used for 2. What you need to know before you use Aciclovir Sterile Concentrate 3. How to use Aciclovir Sterile Concentrate 4. Possible side effects 5. How to store Aciclovir Sterile Concentrate 6. Contents of the pack and other information 1. WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS USED FOR Aciclovir 25 mg/ml concentrate for solution for infusion contains aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses. Aciclovir Sterile Concentrate can be used in patients with a working immune system to: • treat recurring chicken-pox and shingles • treat severe first cases of genital herpes In patients with an impaired immune system (which means their bodies are less able to fight infections) to: • treat primary and recurring chickenpox and shingles • treat and stop cold sores and genital herpes • prevent _herpes simplex_ infections It can also be used to: • treat inflammation of the brain caused by the virus responsible for cold sore infection and genital herpes • treat _herpes simplex_ infections in very young babies or in infants up to 3 months of age 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE DO NOT USE ACICLOVIR STERILE CONCENTRATE IF: • if you are allergic (hypersensitive) to aciclovir or valaciclovir or any of the other ingredients (listed in section 6). WARNINGS AND PRECAUTIONS Tal اقرأ الوثيقة كاملة
Health Products Regulatory Authority 21 September 2021 CRN00C3HY Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aciclovir 25mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 25 mg aciclovir as aciclovir sodium. Each vial of 10 ml of solution contains 250 mg aciclovir (sodium salt formed _in situ_) Each vial of 20 ml of solution contains 500 mg aciclovir (sodium salt formed _in situ_) Each vial of 40 ml of solution contains 1 g aciclovir (sodium salt formed _in situ_) Excipient with known effect: Each vial of 10 ml of solution contains 26.7 mg sodium. Each vial of 20 ml of solution contains 53.4 mg sodium. Each vial of 40 ml of solution contains 106.8 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). A clear, colourless or almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated for: NON-IMMUNOCOMPROMISED PATIENTS IMMUNOCOMPROMISED PATIENTS Severe initial genital herpes Herpes simplex infection Recurrent _varicellazoster_ virus infection Primary and recurrent _varicellazoster_ infection Prophylaxis of herpes simplex infection Herpes simplex encephalitis Herpes simplex in neonates and infants up to 3 months of age 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The required dose of Aciclovir 25 mg/ml Concentrate for Solution for Infusion should be administered by slow intravenous infusion over 1 hour. A course of treatment with Aciclovir 25 mg/ml Concentrate for Solution for Infusion 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 days for mucocutaneous (skin-eye-mouth) infections and 21 days for dissemination or central nervous system disease. The duration of prophylactic administrat اقرأ الوثيقة كاملة