Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALGANCICLOVIR HYDROCHLORIDE
CAMBER LABORATORIES SDN. BHD.
VALGANCICLOVIR HYDROCHLORIDE
10x10'stablet Tablets; 60tablet Tablets
Hetero Labs Limited
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 VALGAN 450 (VALGANCICLOVIR TABLETS 450MG) Valganciclovir (450mg)_ _ WHAT IS IN THIS LEAFLET 1. What _VALGAN 450_ is used for 2. How _VALGAN 450_ works 3. Before you take _VALGAN 450_ 4. How to use _VALGAN 450_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _VALGAN 450_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number 1. WHAT _VALGAN 450_ IS USED FOR. _VALGAN 450_ is used to treat cytomegalovirus (CMV) retinitis (an eye infection caused by a type of herpes virus) in acquired immunodeficiency syndrome (AIDS) patients as it can cause blindness if untreated. _VALGAN 450_ is also used to prevent CMV disease in patients who are not infected with CMV but received organ transplantation from a CMV infected donor. Ask your doctor if you have any questions about why _VALGAN 450_ has been prescribed for you. _VALGAN 450_ is not addictive. _VALGAN 450_ is available only with a doctor’s prescription. 2. HOW _VALGAN 450_ WORKS. VALGAN 450 contains the active ingredient valganciclovir hydrochloride. VALGAN 450 belongs to a class of medicines used to prevent the growth of viruses. VALGAN 450 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. 3. BEFORE YOU USE _VALGAN 450 _ _ _ When you must not use it Do not use VALGAN 450 if: 1. You are allergic to: - valganciclovir, acyclovir, ganciclovir, valaciclovir or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: - shortness of breath - wheezing or difficulty in breathing - swelling of the face, lips, tongue or other parts of the body - rashes, itching, hives on the skin 2. You have very low blood counts for platelets (used for clotting), neutro Lesen Sie das vollständige Dokument
1 HETERO NAME OF THE PRODUCT VALGAN 450 (Valganciclovir Tablets 450 mg) NAME AND STRENGTH OF ACTIVE INGREDIENT Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of Valganciclovir. PRODUCT DESCRIPTION Pink, oval, biconvex, film-coated tablets, debossed with ‘J’ on one side and ‘156’ on the other side PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMICS: MECHANISM OF ACTION: Valganciclovir is an L-valyl ester (prodrug) of ganciclovir. After oral administration, valganciclovir is rapidly and extensively metabolised to ganciclovir by intestinal and hepatic esterases. It was reported that ganciclovir is a synthetic analogue of 2'- deoxyguanosine and 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 -6, -7 and -8 (HHV-6, HHV-7, HHV8), Epstein- Barr virus (EBV), varicella-zoster virus (VZV) and hepatitis B virus (HBV). In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, pUL97. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolised intracellularly. Triphosphate metabolism has been shown to occur in HSV- and HCMV- infected cells with half-lives of 18 and between 6 and 24 hours respectively, after the 2 HETERO removal of extracellular ganciclovir. As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells. The virustatic activity of ganciclovir is due to inhibition of viral DNA synthesis by: (a) competitive inhibition of incorporation of deoxyguanosine-triphosphate into DNA by viral DNA polymerase, and (b) incorporation of ganciclovir triphosphate into viral DNA causing termination of, or very limited, further viral DNA elongation. PHARMACOKINETICS Absorption Valganciclovir is a prodrug of ganciclovir. It is well a Lesen Sie das vollständige Dokument