Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
ACICLOVIR SODIUM
Medochemie Iberia S.A Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisbon, Portugal
J05AB01
ACICLOVIR SODIUM
POWDER FOR SOLUTION FOR INFUSION
ACICLOVIR SODIUM 250 milligram(s)
POM
ANTIVIRALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-11-23
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER MEDOLONE 250 MG POWDER FOR SOLUTION FOR INFUSION Aciclovir 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Medolone is and what it is used for 2. What you need to know before you use Medolone 3. How to use Medolone 4. Possible side effects 5. How to store Medolone 6. Contents of the pack and other information 1. WHAT MEDOLONE IS AND WHAT IT IS USED FOR Medolone contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses. Medolone can be used to: - Treat recurring chicken-pox and shingles in people whose immune system works well. - Treat severe first cases of genital herpes in people whose immune system works well. - Treat primary and recurring chickenpox and shingles in people whose immune systems work less well, which means their bodies are less able to fight infections. - 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. - Prevent herpes simplex infections in people whose immune systems work less well, which means their bodies are less able to fight infections. - 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 USE MEDOLONE DO NOT USE MEDOLONE: - If you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicin Đọc toàn bộ tài liệu
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Medolone 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. Excipient with known effect: contains less than 1 mmol of sodium (23 mg) per dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Medolone is indicated: - For the treatment of _Herpes simplex_ infections in immunocompromised patients and severe initial genital herpes in non-immunocompromised patients. - For the prophylaxis of _Herpes simplex_ infections in immunocompromised patients. - For the treatment of recurrent _Varicella zoster_ infections in non-immunocompromised patients. - For the treatment of primary and recurrent _Varicella zoster_ infections in immunocompromised patients. - For the treatment of herpes encephalitis in immunocompromised and non-immunocompromised patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents _ Patients with _Herpes simplex_ (except herpes encephalitis) or _Varicella zoster_ infections should be given aciclovir 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 aciclovir 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 with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see section 5.2). Consideration should therefore be given to dosage reduction in obese patients and especially in those with renal impairment or the elderly. Page 2 of 11 _Paediatric population _ The dose of aciclovir for infan Đọc toàn bộ tài liệu