Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RALTEGRAVIR POTASSIUM
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
RALTEGRAVIR POTASSIUM
60Tablet Tablets
MSD International GmbH T/A MSD Ireland (Ballydine)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ISENTRESS ® TABLET _ _ Raltegravir (400mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Isentress is taken for 2. How Isentress works 3. Before you take Isentress 4. How to take Isentress 5. While you are taking Isentress 6. Side effects 7. Storage and Disposal of Isentress 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11.Serial Number WHAT ISENTRESS IS USED FOR Isentress is taken in combination with other antiretroviral medicinal to treat those who are infected with HIV, the virus that causes AIDS (Acquired Immune Deficiency Syndrome). WHAT IS HIV? HIV (Human Immunodeficiency Virus) is a blood-borne disease spread by contact with blood, sexual contact with an infected individual, or from a mother to infant transmission during pregnancy or through breastfeeding. Your doctor has prescribed Isentress to help control your HIV infection. Isentress is not a cure for HIV infection. When taken with other anti-HIV medicines, Isentress may reduce the amount of HIV in your blood (called "viral load") and increase the number of CD4 (T) cells. Reducing the amount of HIV in the blood may keep your immune system healthy, so it can help fight infection. Isentress may not have these effects in all individuals. Isentress does not cure HIV infection or AIDS. It is very important that you stay under the care of your doctor during treatment with Isentress. Isentress does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. Continue to practice safer sex. Use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Never re-use or share needles. Ask your doctor if you have any questions about safer sex or how to prevent passing HIV to other people. HOW ISENTRESS WORKS Isentress blocks HIV integrase, an enzyme that is needed for HIV to make more virus. BEFORE YOU TAKE ISENTRESS _- Прочитайте повний документ
LOCAL PRODUCT CIRCULAR LPC-MK0518-T-112020B-MALAYSIA TABLETS ISENTRESS ® 400MG (RALTEGRAVIR) ISENTRESS (raltegravir) is an HIV integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV -1). The chemical name for raltegravir potassium is N -[(4- Fluorophenyl)methyl] -1,6-dihydro-5- hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4- oxadiazol -2- yl)carbonyl]amino]ethyl] -6-oxo-4- pyrimidinecarboxamide monopotassium salt. The empirical formula is C 20 H 20 FKN 6 O 5 and the molecular weight is 482.51. The structural formula is: N N H N O H N O O H 3 C CH 3 H 3 C O N N O H 3 C F K C AS Registry Number: 871038 -72-1 Raltegravir potassium is a white to off - white powder. It is soluble in water, slightly soluble in methanol, very s lightly soluble in ethan ol and acetonitrile and insoluble in isopropanol. I. DESCRIPTION II. COMPOSITION I IA. ACTIVE INGREDIENTS Each 400mg film - coated tablet of ISENTRESS contains 434.4 mg of raltegravir potassium (as salt), equivalent to 400 mg of raltegravir (free phenol). Each 400mg film-coated tablet of ISENTRESS contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide. Raltegravir inhibits the catalytic activity of HIV integrase, an HIV-encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of the HIV genome into the host cell genome during the early phase of infection. HIV genomes that fail to integrate cannot direct the production of new infectious viral particles, so inhibiting integration prevents propagation of the viral infection. Raltegravir did not significantly inhibit human phosphoryltr Прочитайте повний документ