Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
emtricitabine, Quantity: 200 mg; tenofovir disoproxil fumarate, Quantity: 300 mg
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of HIV-1 infection: CIPLA TENOFOVIR + EMTRICITABINE 300/200 is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents. Pre-exposure prophylaxis: CIPLA TENOFOVIR + EMTRICITABINE 300/200 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.
Visual Identification: Blue coloured capsule shaped, biconvex film-coated tablet, plain on both sides; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-12-09
CIPLA TENOFOVIR + EMTRICITABINE 300/200 _T_ _ABLETS _ _300 mg tenofovir disoproxil fumarate / 200 mg emtricitabine_ CONSUMER MEDICINE INFORMATION WHA T IS IN THIS LEAFLET Read all of this leaflet c arefully before you start taking this medicine. This leaflet answers some of the common questions about CIPLA TENOFOVIR + EMTRICITABINE 300/200. 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 CIPLA TENOFOVIR + EMTRICITABINE 300/200 medicine. You may need to read it again. WHAT CIPLA TENOFOVIR + EMTRICITABINE 300/200 IS USED FOR _WHAT IS IT USED FOR_ to treat Hum an Im munodeficiency Virus-1 (HIV-1 ) infection in adults when tak en in combinatio n with o ther anti-HIV medicines ; to help reduce the risk of getting HI V infection w hen used with safer sex practices in: HIV-negativ e men wh o have sex with men, who are at high risk of get ting infected with HIV-1 through sex. Male-female sex partners when on e pa rtner has HIV- 1 infection and the othe r does not. _HOW CIPLA TENOFOVIR _ _+ EMTRICITABINE _ _300/200 WORKS_ CIPLA TENOFOVIR + EMTRICITABINE 300/200 consists of two medicines combined in one tablet: tenofovir disoproxil fum arate, al so called tenofovir DF emtricitabine or FTC Thes e are combined in one tablet to help control Human Immunodeficiency Virus (HIV) infection. CIPLA TENOFOVIR + EMTRICITABINE 300/200 contains two active ingredients that belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). _WHEN CIPLA _ _TENOFOVIR + _ _EMTRICITABINE 300/200 _ _IS USED TO TREAT HIV _ _INFECTION_ When used with other HIV- 1 medicines to treat HIV-1 infection, CIPLA TENOFOVIR + EMTRICITABINE 300/200 may help: Reduce the amount of HIV-1 in your blood. This is called “viral load”. In crease the number o f CD 4+ Preberite celoten dokument
AUSTR ALIA PRODUCT INFORMATION – CIPLA TENOFOVIR + EMTRICITABINE 300/200 (TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE) TABLETS 1. NAME OF THE MEDICINE Tenofovir disoproxil fumarate/Emtricitab ine 2. QUA LITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate which is equivalent to 245 mg of tenofovir disoproxil and 200 mg emtricitabine. Excipients with known effect: lactose. For the full list of excipients, see section 6.1 List of excipients. 3. PHARM ACEUTICAL FORM Film-coated tablets. The tablets are blue, coloured capsule shaped, biconvex film-coated tablet, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of HIV-1 infection CIPL A TENOFOVIR + EMTRICITABINE 300/200 is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents. Pre-exposure prophylaxis CIPL A TENOFOVIR + EMTRICITABINE 300/200 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). 4.2 DOSE AND METHOD OF ADMINISTRATION Recommended dose for treatment of HIV-1 infection _Adults_ The recommended dose of CIPLA TENOFOVIR + EMTRICITABINE 300/200 is one tablet (containing 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine), taken orally, once daily. In order to optimise the absorption of tenofovir, it is recommended that CIPLA TENOFOVIR + EMTRICITABINE 300/200 should be taken with food. Recommended dose for pre-exposure prophylaxis _Adults_ The dose of CIPLA TENOFOVIR + EMTRICITABINE 300/200 in HIV-1 uninfected adults is one tablet (containing 300 mg tenofovir disoproxil fumarate and 200 mg of emtricitabine), taken orally, once daily. In order to optimise the absorption of tenofovir, it is recommended that CIPLA TE Preberite celoten dokument