Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
valaciclovir hydrochloride monohydrate
Apotex Pty Ltd
Valaciclovir hydrochloride monohydrate
Registered
CHEMMART VALACICLOVIR _FOR CYTOMEGALOVIRUS_ _Contains the active ingredient valaciclovir hydrochloride monohydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about valaciclovir. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet • if you are worried about taking your medicine • to obtain the most up-to-date information All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Chemmart Valaciclovir. It contains the active ingredient valaciclovir hydrochloride monohydrate. Valaciclovir belongs to a group of medicines called antivirals. It is used to prevent cytomegalovirus (CMV) infection and disease, following solid organ transplantation. CMV is another type of herpes virus. It can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands). Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _USE IN CHILDREN_ THERE IS NOT ENOUGH INFORMATION TO RECOMMEND THE USE OF THIS MEDICINE IN CHILDREN. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ • DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD AN ALLERGIC REACTION TO ACICLOVIR, VALACICLOVIR O Կարդացեք ամբողջական փաստաթուղթը
Product Information – Australia Chemmart Valaciclovir Tablets Page 1 of 21 CHEMMART VALACICLOVIR TABLETS NAME OF THE MEDICINE Valaciclovir Hydrochloride Monohydrate Chemical Name: (1) L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9_H_-purin-9- yl)methoxy]ethylester, monohydrochloride(2) L-Valine, ester with 9-[(2-hydroxyethoxy) methyl] guanine, monohydrochloride Structural Formula: Molecular Formula: C 13 H 20 N 6 O 4 HCl.H 2 O Molecular Weight: 378.8 CAS Registry Number: 124832-27-5 DESCRIPTION Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine nucleoside analogue. The maximum solubility of valaciclovir hydrochloride monohydrate in water is 174 mg/mL at 25°C. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Valaciclovir is rapidly and almost completely converted in man to aciclovir probably by the enzyme valaciclovir hydrolase. Aciclovir is a specific inhibitor of the herpes viruses with _in vitro _ activity against herpes simplex viruses (HSV) type 1 and type 2 (IC 50 0.1 - 3.0μM), varicella- zoster virus (VZV) (IC 50 1.6 – 5.1μM) and human cytomegalovirus (HCMV) (IC 50 10 - > 200μM). Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form. The first stage of phosphorylation requires the activity of a virus-specific enzyme: thymidine kinase in HSV and VZV infected cells or protein kinase in HCMV infected cells. This requirement for activation of aciclovir by a virus specific enzyme largely explains its unique selectivity. The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases. Aciclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and thus blocking virus replication. Product Information – Australia Chemmart Valaciclovir Tablets Page 2 of 21 PHARMACODYNAMIC EFFECTS PHARMACODYNAMICS/ RESISTANCE DEVELOPMENT: Resistance to aciclovir is normally due to a thymidine kinase deficien Կարդացեք ամբողջական փաստաթուղթը