देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
etravirine, Quantity: 200 mg
Janssen-Cilag Pty Ltd
Etravirine
Tablet
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; magnesium stearate
Oral
60 tablets
(S4) Prescription Only Medicine
Etravirine, in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,This indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N(t)RTI, PI) treatment-experienced adults (see section 5.1 Pharmacodynamic properties ? Clinical trials).,Treatment history of patients and genotypic testing should be performed to guide the use of etravirine.
Visual Identification: White to off-white, biconvex, oblong tablet with "T200" on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-08-22
INTELENCE ® (170905) ACMI 1 INTELENCE ® TABLETS _etravirine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about INTELENCE tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given INTELENCE against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN INTELENCE ASK YOUR DOCTOR. KEEP THIS LEAFLET WHILE YOU ARE TAKING INTELENCE. You may need to read it again. WHAT INTELENCE IS USED FOR INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of anti-HIV medicines called non- nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE works by reducing the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. INTELENCE is used to treat adults who are infected by HIV and who have used other anti-HIV medicines before. INTELENCE can be used by patients infected with HIV that is resistant to other NNRTIs. INTELENCE must be taken in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY INTELENCE HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE INTELENCE WHEN YOU MUST NOT USE IT: DO NOT TAKE INTELENCE: • if you are allergic (hypersensitive) to etravirine, or other ingredients of INTELENCE. See Product Description at the end of this leaflet for a list of ingredients. DO NOT TAKE INTELENCE: • if the packaging is torn or shows signs of tampering. • if the expiry date (month and year) printed on the pack has passed. If you take INTELENCE after the expiry date it may not work. DO NOT COMBINE INTELENCE WITH ANY OF THE FOLLOWING MEDICINES: • ca पूरा दस्तावेज़ पढ़ें
CCDS181010v20 INTELENCE (190408) API INTELENCE ® E TRAVIRINE A USTRALIAN P RODUCT I NFORMATION 1. NAME OF THE MEDICINE Etravirine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION INTELENCE etravirine is available as 100 mg and 200 mg tablets. Each tablet contains 100 mg or 200 mg of etravirine. Excipient(s) with known effect: The 100 mg tablets contain 160 mg of lactose monohydrate. For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Tablet INTELENCE 100 mg tablet: white to off-white, oval tablet, debossed with “T125” on one side and “100” on the other side*. INTELENCE 200 mg tablet: white to off-white, biconvex, oblong tablet, debossed with “T200” on one side. Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). INTELENCE (etravirine) is a substituted diarylpyrimidine (DAPY) derivative, with potent _in vitro _activity against wild-type HIV-1 as well as NNRTI-resistant HIV-1. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etravirine, in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents. This indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N(t)RTI, PI) treatment-experienced adults (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). Treatment history of patients and genotypic testing should be performed to guide the use of etravirine. CCDS181010v20 2 INTELENCE (190408) API 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) INTELENCE must always be given in combination with other antiretroviral medicinal products. _ADULTS: _ The recommended oral dose of INTELENCE is 200 mg (one 200 mg tablet or two 100 mg table पूरा दस्तावेज़ पढ़ें