Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ACICLOVIR
Ranbaxy Ireland Limited
ACICLOVIR
200 mg Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellvirax 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 200 mg tablet contains 200 mg aciclovir. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Capsule shaped, biconvex, uncoated white to off-white tablets with ‘200’ embossed on one side and ‘ACV’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bellvirax Tablets are indicated for the following: treatment of herpes simplex virus infections involving the skin and mucous membranes, including initial and recurrent genital herpes, suppression of recurrence of herpes simplex virus infections in immunocompetent patients, prophylaxis against herpes simplex virus infections in immunocompromised individuals, treatment of herpes zoster (shingles) and varicella (chicken pox) infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bellvirax Tablets should be dissolved in 100 ml (a glassful) of water immediately before taking, or swallowed whole with water, according to the following dosage schedules: Adults: TREATMENT OF HERPES SIMPLEX VIRUS INFECTIONS: 200 mg, five times a day at four-hourly intervals, omitting the night time dose. Treatment is usually for 5 days, but can be extended, depending on the severity of the infection. In patients who are severely immunocompromised or with malabsorption, the dose may be increased to 400 mg. Treatment should be started as soon as infection is evident; i.e. when lesions first appear, or for recurrent infections, during the prodromal phase. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/02/2012_ _CRN 2109649_ _page number: 1_ SUPPRESSION OF RECURRENT HERPES SIMPLEX INFECTIONS IN Прочитайте повний документ