Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
VALACICLOVIR AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AB11
FILM COATED TABLETS
VALACICLOVIR AS HYDROCHLORIDE 500 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
VALACICLOVIR
VALACICLOVIR
Varicella zoster virus (VZV) infections – herpes zoster:Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression.Herpes simplex virus (HSV) infections:Valtrex is indicated for the treatment and suppression of HSV infections of the skin and mucous membranes including- treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults- treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults- suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adultsTreatment and suppression of recurrent ocular HSV infections in immunocompetent adults and adolescents and in immunocompromised adults Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection.Cytomegalovirus (CMV) infections:Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents
2021-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a physician’s prescription only VALTREX TABLETS 500 MG EACH TABLET CONTAINS 500 MG VALACICLOVIR (AS HYDROCHLORIDE) The list of additional ingredients is detailed in section 6. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Valtrex works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV). Valtrex is intended to: • Treat shingles in adults. • Treat VZV infections of the eye (ophthalmic zoster) in adults with a weakened immune system. • Treat HSV infections of the skin (e.g., cold sores) and genital herpes in adults and adolescents. It is also used to help prevent recurrence of these infections. • Treat and prevent recurrence of HSV infections of the eye in adults and adolescents. • Prevent infection with CMV after organ transplants in adults and adolescents. THERAPEUTIC GROUP: Valtrex belongs to a group of medicines called antivirals. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to valaciclovir or aciclovir or to any of the additional ingredients contained in the medicine (as detailed in section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH VALTREX, TELL THE PHYSICIAN IF: • You have kidney problems. • You have liver problems. • You are over 65 years of age. • Your immune system is weak. TAKE SPECIAL CARE WITH VALTREX - IMPORTANT INFORMATION: Drug reaction with eosinophilia and systemic symptoms (also called DRESS) has been reported with the use of valaciclovir. DRESS appears initially as fl Lugege kogu dokumenti
Page 1 of 13 VALTREX TABLETS 500 MG _ _ 1. NAME OF THE MEDICINAL PRODUCT VALTREX TABLETS 500 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains valaciclovir (as hydrochloride) equivalent to 500 mg valaciclovir For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 500 mg tablet White, biconvex, elongated tablet with a white to off-white core, engraved “GX CF1” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Varicella zoster virus (VZV) infections – herpes zoster Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see section 4.4). Valtrex 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 Valtrex is indicated • for the treatment and suppression of HSV infections of the skin and mucous membranes including: - treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults. - treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults. - suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adults. • Treatment and suppression of recurrent ocular HSV infections in immunocompetent adults and adolescents and in immunocompromised adults (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 Valtrex 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 ADMINISTRATION Varicella zoster virus (VZV) infections – herpes zoster and ophthalmic zoster Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster. Page 2 Lugege kogu dokumenti