国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
tenofovir disoproxil fumarate, Quantity: 300 mg; emtricitabine, Quantity: 200 mg
Gilead Sciences Pty Ltd
Emtricitabine,Tenofovir disoproxil fumarate
Tablet, film coated
Excipient Ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of HIV-1 infection,TRUVADA is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.,Pre-Exposure Prophylaxis TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see CLINICAL STUDIES).
Visual Identification: Blue, capsule shaped, film coated tablets debossed with "GILEAD" on one side of the tablet and "701" on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-09-22
TRUVADA Consumer Medicine Information v16.0 – (15 July 2020) Page 1 of 6 TRUVADA ® TABLETS _300_ _ _ _mg tenofovir disoproxil fumarate / 200 mg emtricitabine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Read all of this leaflet carefully before you start taking this medicine. This leaflet answers some of the common questions about TRUVADA tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist about your medical condition or treatment. If you have further questions, please ask your doctor or your pharmacist. Keep this leaflet with your TRUVADA medicine. You may need to read it again. WHAT IS TRUVADA _HOW TRUVADA WORKS _ TRUVADA consists of two medicines combined in one tablet: • tenofovir disoproxil fumarate, also called tenofovir DF • emtricitabine or FTC These are combined in one tablet to help control Human Immunodeficiency Virus (HIV) infection. TRUVADA contains two active ingredients that belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). _ _ _WHAT IS TRUVADA USED FOR _ • to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults when taken in combination with other anti-HIV medicines; • to help reduce the risk of getting HIV infection when used with safer sex practices in: • HIV-negative men who have sex with men, who are at high risk of getting infected with HIV-1 through sex. • Male-female sex partners when one partner has HIV-1 infection and the other does not. _WHEN TRUVADA IS USED TO _ _TREAT HIV INFECTION _ When used with other HIV-1 medicines to treat HIV-1 infection, TRUVADA may help: • Reduce the amount of HIV-1 in your blood. This is called “viral load”. • Increase the number of CD4+ (T) cells in your blood that help fight off other infections. Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or infections that can happ 完全なドキュメントを読む
AUSTRALIA PRODUCT INFORMATION - TRUVADA ® TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE TABLETS 1 NAME OF THE MEDICINE TRUVADA (tenofovir disoproxil fumarate/emtricitabine) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate (tenofovir DF) which is equivalent to 245 mg of tenofovir disoproxil and 200 mg emtricitabine. Tenofovir DF is a white to off-white crystalline powder. Emtricitabine is a white to off-white crystalline powder. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The tablets are blue, capsule-shaped, film-coated, debossed with “GILEAD” on one side and with “701” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HIV-1 INFECTION TRUVADA is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents. PRE-EXPOSURE PROPHYLAXIS TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see section 5.1 Pharmacodynamic properties, Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION ADULTS : The recommended dose of TRUVADA is one tablet (containing 300 mg tenofovir DF and 200 mg emtricitabine), taken orally, once daily. In order to optimise the absorption of tenofovir, it is recommended that TRUVADA should be taken with food. RECOMMENDED DOSE FOR PRE-EXPOSURE PROPHYLAXIS ADULTS: The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 300 mg tenofovir DF and 200 mg of emtricitabine), taken orally, once daily. In order to optimise the absorption of tenofovir, it is recommended that TRUVADA should be taken with food. CHILDREN_:_ The safety and efficacy of TRUVADA has not b 完全なドキュメントを読む