Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALGANCICLOVIR HYDROCHLORIDE
CIPLA MALAYSIA SDN BHD
VALGANCICLOVIR HYDROCHLORIDE
1 x 60 Tablets
Cipla Limited
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ VALCIVIR 450 MG FILM COATED TABLET _Valganciclovir (450mg) _ 1 WHAT IS IN THIS LEAFLET 1. What Valcivir is used for 2. How Valcivir works 3. Before you use Valcivir 4. How to use Valcivir 5. While you are using Valcivir 6. Side effects 7. Storage and disposal of Valcivir 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 10.11. Serial Number WHAT VALCIVIR IS USED FOR Valcivir 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. Valcivir 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 Valcivir has been prescribed for you. Valcivir is not addictive. Valcivir is available only with a doctor’s prescription HOW VALCIVIR WORKS Valcivir contains the active ingredient valganciclovir hydrochloride. Valcivir belongs to a class of medicines used to prevent the growth of viruses. Valcivir 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. BEFORE YOU USE VALCIVIR _ _ _When you must not use it _ _ _ _ _ Do not use Valcivir 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), neutrophils (a type of white blood cell used as defence against Baca dokumen lengkap
1 _For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for _ _Specialist Use only _ VALCIVIR 450 MG TABLET Valganciclovir 450 mg USP tablets COMPOSITION Each film coated tablet contains Valganciclovir Hydrochloride USP equivalent to Valganciclovir …………………………… 450 mg Colour: Titanium Dioxide, Red Oxide of Iron DOSAGE FORM Film coated tablet PRODUCT DESCRIPTION Pink coloured, capsule shaped biconvex film coated tablet plain on both sides. PHARMACOLOGY _ _ _PHARMACODYNAMICS _ Mechanism of action Valganciclovir is a L-valyl ester (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-6, 7 and 8 (HHV-6, HHV-7, HHV- 8), Epstein-Barr virus (EBV), varicella zoster virus (VZV) and hepatitis B virus. In CMV-infected cells ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, UL97. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolised intracellularly. This has been shown to occur in HSV- and HCMV- infected cells with half-lives of 18 and between 6 and 24 hours respectively after 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 2 termination of, or very limited further viral DNA elongation. Typical anti-viral IC 50 against CMV _in Baca dokumen lengkap