Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
valganciclovir hydrochloride
Juno Pharmaceuticals Pty Ltd
Valganciclovir hydrochloride
Registered
Valganciclovir Juno Consumer Medicine Information Juno Pharmaceuticals Pty Ltd 39 xxxxx 1 VALGANCICLOVIR JUNO _VALGANCICLOVIR HYDROCHLORIDE 450MG TABLETS_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALGANCICLOVIR JUNO 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 VALGANCICLOVIR JUNO 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 JUNO IS USED FOR VALGANCICLOVIR JUNO contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir. VALGANCICLOVIR JUNO belongs to a class of medicines used to prevent the growth of viruses. VALGANCICLOVIR JUNO 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. VALGANCICLOVIR JUNO 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 JUNO is not effective against any underlying HIV infection. VALGANCICLOVIR JUNO is also used to prevent CMV infection in patients following organ transplantation. Your doctor, however, may have prescribed VALGANCICLOVIR JUNO for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VALGANCICLOVIR JUNO HAS BEEN PRESCRIBED FOR YOU. VALGANCICLOVIR JUNO is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE VALGANCICLOVIR JUNO Animal and other laboratory studies have shown VALGANCICLOVIR JUNO causes Izlasiet visu dokumentu
Valganciclovir Juno PI Juno Pharmaceuticals Pty Ltd Doc ID: xxxxx Page 1 of 29 VALGANCICLOVIR JUNO VALGANCICLOVIR HYDROCHLORIDE 450MG FILM COATED TABLETS PRODUCT INFORMATION NAME OF THE MEDICINE AUSTRALIAN APPROVED NAME Valganciclovir hydrochloride CAS: 175865-59-5 The chemical name for valganciclovir hydrochloride is L-valine, 2-[(2-amino-1, 6-dihydro-6-oxo-9H- purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. The molecular formula is C14H22N6O5 HCl and molecular weight is 390.83. DESCRIPTION Valganciclovir hydrochloride (valganciclovir HCl) is the hydrochloride salt of the L-valyl ester of ganciclovir. Ganciclovir is a synthetic nucleoside analogue of guanine. Valganciclovir HCl is a white to off-white crystalline powder. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir is 7.6. Each tablet contains 496.3 mg valganciclovir HCl (corresponding to 450 mg valganciclovir), and inactive ingredients: microcrystalline cellulose, crospovidone, povidone, and stearic acid. The film- coat applied Valganciclovir Juno PI Juno Pharmaceuticals Pty Ltd Doc ID: xxxxx Page 2 of 29 to the tablets contains OPADRY complete film coating system 04F54165 PINK which consists of hypromellose, titanium dioxide, macrogol 6000 and iron oxide red. PHARMACOLOGY MECHANISM OF ACTION Valganciclovir is an L-valyl ester salt (prodrug) of ganciclovir which, after oral administration, is rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2’- deoxyguanosine, which inhibits replication of herpes viruses in vitro and in vivo. Sensitive human viruses include human cytomegalovirus (HCMV), herpes -simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus type 6, 7 and 8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella- zoster virus (VZV) and hepatitis B virus. In cytomegalovirus (CMV)-infected cells, ganciclovir is i Izlasiet visu dokumentu