Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
VALACICLOVIR HYDROCHLORIDE
Helsinn Birex Therapeutics Ltd
500 Milligram
Film Coated Tablet
2009-11-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valherp 500mg film coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 556.24mg of valaciclovir hydrochloride equivalent to 500 mg valaciclovir Excipients include: Lactose Monohydrate 58.76mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Creamy, oblong film coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Varicella zoster virus (VZV) infections – herpes zoster Valherp is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4). Valherp is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4). Herpes simplex virus (HSV) infections Valherp is indicated o for the treatment and suppression of HSV infections of the skin and mucous membranes including - treatment of first-episode of genital herpes in immunocompetent patients - recurrences of genital herpes in immunocompetent and immunocompromised patients IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/01/2011_ _CRN 2093586_ _page number: 1_ - suppression of recurrent genital herpes in immunocompetent and immunocompromised patients o Treatment and suppression of recurrent ocular HSV infections (see section 4.4) Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1). _Cytomegalovirus (CMV) infections:_ Valherp is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4) 4.2 POSOLOGY AND METHOD OF ADMINISTRATIO Olvassa el a teljes dokumentumot