Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg; ; Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg
GlaxoSmithKline NZ Limited
Valaciclovir hydrochloride 556 mg (equivalent to valaciclovir 500 mg)
500 mg
Film coated tablet
Active: Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Edible ink blue brilliant 5312 Magnesium stearate Microcrystalline cellulose Opadry white YS1-18043 Povidone Purified water Active: Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white YS1-18043 Povidone Purified water
Blister pack, HSV treatment pack, 10 tablets
Prescription
Prescription
Divi's Laboratories Limited
· VALTREX is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster - associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration.
Package - Contents - Shelf Life: Blister pack, HSV treatment pack - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, HSV suppression treatment pack - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Shingles treatment pack - 42 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, polypropylene - 20 tablets - 24 months from date of manufacture stored at or below 30°C
1994-06-30
VALTREX tablets 1 VALTREX TABLETS _valaciclovir 500 mg _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using VALTREX tablets. This leaflet answers some common questions about VALTREX tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking VALTREX tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VALTREX TABLETS ARE USED FOR VALTREX tablets belong to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegolovirus (CMV). VALTREX tablets can be used to: • treat shingles (herpes zoster) • treat HSV infections of the skin and genital herpes. It is also used to help prevent these infections from returning • treat shingles affecting the eye region (ophthalmic zoster) • prevent infection with CMV after organ transplants. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. There is not enough information to recommend the use of this medicine for children. BEFORE YOU TAKE VALTREX TABLETS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VALTREX TABLETS IF YOU HAVE AN ALLERGY TO: • any medicine containing valaciclovir or aciclovir • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR BREASTFEEDING, Pročitajte cijeli dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME VALTREX 500 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains valaciclovir hydrochloride equivalent to 500 mg valaciclovir For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTCIAL FORM Film coated tablets. White, biconvex, elongated, film coated tablets with a white to off-white core, unscored and engraved ‘GX CF1’ on one side. 4. CLINCAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS VALTREX is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster - associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration. VALTREX is indicated for the treatment of herpes simplex infections of the skin and mucous membranes including initial and recurrent genital herpes in immunocompetent patients. VALTREX can prevent lesion development when taken at the first signs and symptoms of a herpes simplex virus (HSV) recurrence. VALTREX is indicated for the prevention (suppression) of recurrent herpes simplex infections of the skin and mucous membranes, including genital herpes in immunocompetent and immunocompromised patients. VALTREX is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease, following organ transplantation. CMV prophylaxis with VALTREX reduces acute graft rejection (renal transplant patients), opportunistic infections and other herpes virus infections (herpes simplex virus (HSV), varicella zoster virus (VZV)). 4.2 DOSE AND METHOD OF ADMINISTRATION_ _ DOSE Treatment of varicella zoster virus infections Herpes zoster (shingles) including ophthalmic zoster 2 The dosage in adults is 1000 mg of VALTREX to be taken 3 times daily for 7 days. Treatment of herpes simplex infections The dosage in adults is 500 mg of VALTREX to be taken twice daily. For recurrent episodes, treatment should be for 5 days. For initial episodes, which can be more severe, treatment may have to be ext Pročitajte cijeli dokument