Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ACYCLOVIR
SPG PHARMA (MALAYSIA) SDN BHD
ACYCLOVIR
5 gm
SIAM BHEASACH CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VIVERE CREAM 5% W/W Acyclovir (5% w/w) 1 WHAT IS IN THIS LEAFLET 1. What Vivere Cream is used for 2. How Vivere Cream works 3. Before you use Vivere Cream 4. How to use Vivere Cream 5. While you are using Vivere Cream 6. Side Effects 7. Storage and Disposal of Vivere Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT VIVERE CREAM IS USED FOR Vivere Cream is used to treat cold sores and genital infections caused by the herpes simplex virus. HOW VIVERE CREAM WORKS Vivere Cream contains a medicine called acyclovir. It belongs to a group of medicines called antivirals. Vivere Cream works by killing or stopping the growth of viruses that cause cold sores or genital herpes. BEFORE YOU USE VIVERE CREAM _- When you must not use it _ Do not use Vivere Cream if: _ _ ▪ you are allergic to acyclovir, valacyclovir or any other ingredients listed at the end of this leaflet - _Before you start to use it_ Tell your doctor or pharmacist if: ▪ you have a condition where your immune system works less well, and your body is less able to fight infections (e.g. if you have human immunodeficiency virus (HIV) or AIDS or if you have had a bone marrow transplant) _Pregnancy and breast-feeding _ Ask your doctor or pharmacist before using any medicine. _- Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes traditional products or medicines bought without a prescription. HOW TO USE VIVERE CREAM _- How much to use_ Always use Vivere Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. _Adults and children_ ▪ Apply a thin layer of cream to the affected area five times a day ▪ You should space each application of Vivere Cream by four hours. Suggested times are: 7am, 11am, 3pm, 7pm and 11pm ▪ If your cold sore has not healed after 4 days, or your genital herpes sore has not healed aft Прочетете целия документ
Vivere Cream 5% w/w should be applied to the lesions or impending lesions as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages. Treatment should be continued for at least 4 days for herpes labialis and for 5 days for genital herpes. If healing has not occurred treatment may be continued for up to 10 days. ROUTE OF ADMINISTRATION: Topical CONTRAINDICATION(S): Contraindicated in patients known to be hypersensitive to acyclovir, valacyclovir or any of the excipients of Vivere Cream 5% w/w. WARNINGS AND PRECAUTIONS: For External Use Only. Vivere Cream 5% w/w is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye. In severely immune-compromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral acyclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. INTERACTIONS WITH OTHER MEDICAMENTS: No clinically significant interactions have been identified. NAME AND STRENGTH OF ACTIVE SUBSTANCE: Acyclovir 5% w/w. PRODUCT DESCRIPTION: A smooth odourless white cream. PHARMACODYNAMICS: Acyclovir is an antiviral agent which is highly active in vitro against herpes simplex virus (HSV) types I and II and varicella zoster virus. Toxicity to mammalian host cells is low. Acyclovir is phosphorylated after entry into herpes infected cells to the active compound acyclovir triphosphate. The first step in this process is dependent on the presence of the HSV-coded thymidine kinase. Acyclovir triphosphate acts as an inhibitor of and substrate for, the herpes- specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes. PHARMACOKINETICS: Only minimal systemic absorption of acyclovir following repeated topical administration of Vivere Cream 5% w/w. INDICATIO Прочетете целия документ