Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
valganciclovir, Quantity: 450 mg (Equivalent: valganciclovir, Qty 496.3 mg)
Pharmaco Australia Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; povidone; crospovidone; stearic acid; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400
Oral
60 tablet
(S4) Prescription Only Medicine
VALCYTE is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). VALCYTE is indicated for the prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk.
Visual Identification: Pink, convex, oval, film-coated tablet with 'VGC' on one side and '450' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2002-06-17
VALCYTE ® _TABLETS_ Pronounced VAL-SITE _contains the active ingredient valganciclovir_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALCYTE 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 VALCYTE 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 VALCYTE IS USED FOR VALCYTE contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir. VALCYTE belongs to a group of medicines used to prevent the growth of viruses. VALCYTE acts against a virus called cytomegalovirus or CMV (a type of herpes virus). It prevents this virus from growing and multiplying in the body. CMV causes infections, mainly in people with poor immunity. Poor immunity can be caused by HIV/AIDS or by medications taken after an organ transplant. VALCYTE is used to treat CMV eye infections (known as CMV retinitis) in AIDS patients, which, if left untreated can cause blindness. It is not a cure for CMV eye infections. VALCYTE is not effective against any underlying HIV infection. VALCYTE is also used to prevent CMV infection in patients following organ transplantation. Your doctor, however, may have prescribed VALCYTE for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VALCYTE HAS BEEN PRESCRIBED FOR YOU. VALCYTE is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE VALCYTE Animal and other laboratory studies have shown VALCYTE causes infertility, birth defects and cancer. It is possible that these effects may also occur in humans. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE VALCYTE IF YOU HAVE HAD AN ALLERGIC REACTION TO VALCYTE, GANCICLOVIR, VALACICLOVIR OR ACICLOVIR OR Прочитајте комплетан документ
ropvaley11020 1 AUSTRALIAN PRODUCT INFORMATION VALCYTE ® (VALGANCICLOVIR HYDROCHLORIDE) 1. NAME OF THE MEDICINE Valganciclovir (as hydrochloride) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Valcyte is available as film-coated tablets and as powder for oral solution. Each film coated tablet contains 496.3 mg valganciclovir HCl (corresponding to 450 mg valganciclovir). The powder is reconstituted to form an oral solution, containing 55 mg valganciclovir HCl per mL (equivalent to 50 mg valganciclovir). Excipients with known effect The powder for oral solution contains a total of 0.188 mg/mL sodium. For the full list of excipients, see section 6.1. List of excipients 3. PHARMACEUTICAL FORM VALCYTE TABLETS Valcyte (valganciclovir HCl) is available as 450 mg pink convex oval tablets with "VGC" on one side and "450" on the other side. Each film-coated tablet contains 450 mg valganciclovir. Valcyte is supplied in bottles of 60 tablets. VALCYTE POWDER FOR ORAL SOLUTION Valcyte powder is white to slightly yellow. The reconstituted solution contains 50 mg/mL valganciclovir and appears clear, colourless to brownish-yellow in colour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valcyte is indicated for the prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Caution – Strict adherence to dosage recommendations is essential to avoid overdose. Valganciclovir is rapidly and extensively converted to the active ingredient ganciclovir. The bioavailability of ganciclovir from Valcyte is up to 10-fold higher than from oral ganciclovir, ropvaley11020 2 therefore the dosage and administration of Valcyte tablets or powder for oral solution as described below should be closely followed (see sections 4.4 Special warnings and precautions for use and 4.9 Overdose). Treatment of CMV Retinitis _A Прочитајте комплетан документ