البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
valganciclovir hydrochloride
Juno Pharmaceuticals Pty Ltd
Valganciclovir hydrochloride
Registered
Valganciclovir AN CMI v2.0 1 VALGANICLOVIR AN _TABLETS_ Pronounced _val gan SYE kloh veer_ _contains the active ingredient valganciclovir hydrochloride_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALGANICLOVIR AN 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 VALGANICLOVIR AN 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 VALGANICLOVIR AN IS USED FOR VALGANICLOVIR AN contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir. VALGANICLOVIR AN belongs to a class of medicines used to prevent the growth of viruses. VALGANICLOVIR AN 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. VALGANICLOVIR AN 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. VALGANICLOVIR AN is not effective against any underlying HIV infection. VALGANICLOVIR AN is also used to prevent CMV infection in patients following organ transplantation. Your doctor, however, may have prescribed VALGANICLOVIR AN for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VALGANICLOVIR AN HAS BEEN PRESCRIBED FOR YOU. VALGANICLOVIR AN is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE VALGANICLOVIR AN Animal and other laboratory studies have shown VALGANICLOVIR AN causes infertility, birth defects and cancer. It i اقرأ الوثيقة كاملة
PRODUCT INFORMATION VALGANCICLOVIR AN VALGANCICLOVIR HYDROCHLORIDE 450 MG TABLET NAME OF THE MEDICINE The name of the medicine is 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 C 14 H 22 N 6 O 5 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. VALGANCICLOVIR AN is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg valganciclovir HCl (corresponding to 450 mg valganciclovir), and inactive ingredients: microcrystalline cellulose, povidone, crospovidone, and stearic acid. The film-coat applied to the tablets contains Opadry Pink ® which consists of hypromellose, titanium dioxide, macrogol 400, and Allura Red AC aluminium lake. 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 initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, UL97. Further phosphorylat اقرأ الوثيقة كاملة