Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
maraviroc, Quantity: 300 mg
ViiV Healthcare Pty Ltd
Maraviroc
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; Colour
Oral
60 tablet blister pack
(S4) Prescription Only Medicine
CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for adult patients infected with only CCR5-tropic HIV-1.,The use of other active agents with CELSENTRI is associated with a greater likelihood of treatment response.
Visual Identification: Blue, biconvex, oval film-coated tablets debossed with "MVC" followed by the tablet strength on one tablet side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2008-02-04
CELSENTRI _FILM-COATED TABLETS_ _Maraviroc_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CELSENTRI. It does not contain all the information available. 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 using CELSENTRI against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CELSENTRI IS USED FOR _WHAT CELSENTRI DOES_ CELSENTRI is used in combination with other anti-HIV medicines to treat HIV. It reduces the amount of HIV in your body and helps your immune system. CELSENTRI is not a cure for HIV or AIDS. You should take appropriate precautions to prevent transmission. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELSENTRI HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed CELSENTRI for another medical condition. This medicine is available only with a doctor's prescription. _HOW CELSENTRI WORKS_ CELSENTRI's active ingredient (maraviroc) belongs to a group of medicines called 'CCR5 blockers'. CELSENTRI stops the HIV-1 virus entering the CD-4 cells in your blood (also called T-cells). These are the cells in your immune system that the HIV virus attacks. CELSENTRI works by blocking the most common entry point into the CD-4 cells – called the 'CCR5 receptor'. Because the virus cannot enter the cell, it cannot attack it, and this prevents further damage to your immune system. CELSENTRI only stops the HIV-1 virus entering the cell, not HIV-2 (another rarer kind of the HIV virus). CELSENTRI also only stops types of HIV-1 that enter using the CCR5 receptor. Because of this, your doctor would have done a blood test to check what strain of HIV-1 you have before they prescribed CELSENTRI. CELSENTRI has not been studied in children less than 18 years of age. More treatment-naïve patients in clinical stud Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION CELSENTRI (MARAVIROC) TABLETS 1 NAME OF THE MEDICINE Maraviroc 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains either 150 or 300 mg of maraviroc. Tablets contain no excipients with a known effect. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CELSENTRI 150 mg and 300 mg film-coated tablets. CELSENTRI is supplied for oral administration in two strengths: 150 and 300 mg blue, biconvex, oval film-coated tablets debossed with “MVC” followed by the tablet strength on one tablet side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for adult patients infected with only CCR5-tropic HIV-1. The use of other active agents with CELSENTRI is associated with a greater likelihood of treatment response. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. The following points should be considered when initiating therapy with CELSENTRI: • Tropism testing using an assay with appropriate validation and sensitivity, resistance testing and treatment history should guide the use of CELSENTRI. • Adult patients infected with only CCR5-tropic HIV-1 should use CELSENTRI. • CCR5 tropism should be confirmed using a highly sensitive, appropriately validated tropism assay prior to initiation of CELSENTRI therapy. Outgrowth of pre-existing low- level CXCR4 or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on CELSENTRI. • CELSENTRI is not recommended in patients with dual/mixed or CXCR4-tropic HIV-1. • In treatment-naïve subjects, more subjects treated with CELSENTRI experienced virologic failure and developed lamivudine resistance compared to efavirenz. 2 • The safety and efficacy of CELSENTRI have not been established in children younger than 18 years of age. ADULTS The recommended dose of CE Soma hati kamili