Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Valganciclovir hydrochloride 496.3mg Equivalent to 450 mg valganciclovir
Roche Products (NZ) Ltd
Valganciclovir hydrochloride 496.3 mg (Equivalent to 450 mg valganciclovir)
450 mg
Film coated tablet
Active: Valganciclovir hydrochloride 496.3mg Equivalent to 450 mg valganciclovir Excipient: Crospovidone Microcrystalline cellulose Opadry pink 15B24005 Povidone Stearic acid
Bottle, plastic, HDPE, 60 tablets
Prescription
Prescription
F Hoffmann-La Roche Ltd
Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. Valcyte is indicated for the prevention of CMV disease in solid organ transplant patients at risk.
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C
2001-02-20
Valcyte 171129 1 CONSUMER MEDICINE INFORMATION VALCYTE ® VALGANCICLOVIR 450 MG TABLETS 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 expected 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. After taking Valcyte tablets, valganciclovir is quickly changed in your body to release ganciclovir, which is the active medicine. Valcyte belongs to a class 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 the 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 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. Valcyte 171129 2 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: 1. YOU HAVE HAD AN ALLERGIC REACTI Izlasiet visu dokumentu
NEW ZEALAND DATA SHEET Valcyte 170907 1 of 22 1. PRODUCT NAME Valcyte 450 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pink convex oval tablets with “VGC” on one side and “450” on the other 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. Valcyte is indicated for the prevention of CMV disease in solid organ transplant patients at risk. 4.2 Dose and method of administration Caution – Strict adherence to dosage recommendations is essential to avoid overdose. Standard Dosage Valcyte is administered orally, and should be taken with food (see section 5.1). Valcyte is rapidly and extensively converted into the active ingredient ganciclovir. The bioavailability of ganciclovir from Valcyte tablets is up to 10-fold higher than from oral ganciclovir. The dosage and administration of Valcyte tablets as described below should be closely followed (see section 4.4). Treatment of cytomegalovirus (CMV) retinitis Adult Patients Induction treatment of CMV retinitis For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) with food twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity (see Warnings and Precautions). NEW ZEALAND DATA SHEET Valcyte 170907 2 of 22 Maintenance treatment of CMV retinitis Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) with food once daily. Patients whose retinitis worsens may repeat induction treatment (see Induction treatment of CMV retinitis). The duration of maintenance treatment should be determined on an individual basis. Prevention of CMV disease in transplantation For kidney tran Izlasiet visu dokumentu