Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg
Viatris Limited
Valganciclovir hydrochloride 496.3 mg (= valganciclovir 450 mg)
450 mg
Film coated tablet
Active: Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg Excipient: Crospovidone Microcrystalline cellulose Opadry brown 15B565009 Purified water Stearic acid
Prescription
Mylan Laboratories Limited
For the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. For the prevention of CMV disease in solid organ transplant patients at risk.
Package - Contents - Shelf Life: Bottle, HDPE white bottle with white opaque polypropylene cap with Al induction sealing wad - 60 tablets - 36 months from date of manufacture stored at or below 25°C
2013-10-10
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION VALGANCICLOVIR VIATRIS _VALGANCICLOVIR FILM COATED TABLET 450 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Valganciclovir Viatris. This leaflet answers some common questions about Valganciclovir Viatris. 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 Valganciclovir Viatris 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 VALGANCICLOVIR VIATRIS IS USED FOR Valganciclovir Viatris 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. Valganciclovir Viatris is not effective against any underlying HIV infection. Valganciclovir Viatris is also used to prevent CMV infection in patients following organ transplantation. Valganciclovir Viatris contains the active ingredient valganciclovir. It belongs to a group of medicines used to prevent the growth of viruses. Valganciclovir Viatris 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. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Valganciclovir Viatris is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE VALGANCICLOVIR VIATRIS Animal and other laboratory studies have shown valganciclovir causes infertility, birth defects and cancer. It is possible that these Lugege kogu dokumenti
Page 1 of 29 NEW ZEALAND DATA SHEET VALGANCICLOVIR VIATRIS 1. PRODUCT NAME Valganciclovir Viatris 450 mg film-coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir. Excipient with known effect: Crospovidone Allergen Declaration: Sulfites For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A pink film-coated, oval, biconvex, beveled edge tablet debossed with “M” on one side of the tablet and “V45” on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Valganciclovir Viatris is indicated for the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. Valganciclovir Viatris 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. DOSE Valganciclovir Viatris is rapidly and extensively metabolised to ganciclovir after oral dosing. Oral valganciclovir 900 mg twice daily is therapeutically equivalent to intravenous ganciclovir 5 mg/kg twice daily. The dosage and administration of Valganciclovir Viatris tablets as described below should be closely followed (see section 4.4). TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS _ADULT PATIENTS_ _INDUCTION TREATMENT OF CMV RETINITIS_ Page 2 of 29 For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days and whenever possible, taken with food. Prolonged induction treatment may increase the risk of bone marrow toxicity (see section 4.4). _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) once daily and, whenever possible, taken with food. Patients whose retinitis worsens may repeat induction treatment; however, consideration should be given to Lugege kogu dokumenti