国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
INOSINE ACEDOBEN DIMEPRANOL
Newport Pharmaceuticals Limited
INOSINE ACEDOBEN DIMEPRANOL
250 MG/5ml
Oral Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2008-02-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoprinosine Syrup 250mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of syrup contains 250mg Inosine Acedoben Dimepranol. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A clear viscous oral solution with a mirabelle plum aroma. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isoprinosine syrup is indicated: a) As an immunomodulator for the management of patients with immunodepression suffering from viral infections such as subacute sclerosing panencephalitis, varicella, herpes simplex Type 1 & 2. b) In the management of recurrent herpes simplex Type 1 & 2. c) As an adjunct in the treatment of genital warts. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION a) Route of administration: Oral b) Dosing: Dosage is determined on the basis of lean body weight of the patient and the severity of the disease. Daily administration should be divided evenly during waking hours. The normal duration of acute treatment is 5-14 days. Adults and the Elderly: 50mg/kg of body weight daily, up to a maximum of 4g, (usually, 20ml x 3-4 times a day). Children over the age of 1 year: 50mg/kg of body weight daily, (10ml per 10 kg up to 20kgs; thereafter, use adult dose). SSPE Dosage: 100mg/kg of body weight daily, up to a maximum of 3-4g, continuously, with regular monitoring to evaluate patient status and requirement for extended treatment. Genital Warts Dosage: 3g (20ml x 3 times a day) for a total of 14-28 days, as an adjunct to conventional topical or surgical procedures, IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/02/2011_ _CRN 2091681_ _page number: 1_ according to the following schedules: a. 14-28 days 完全なドキュメントを読む