Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
lamivudine, Quantity: 300 mg; dolutegravir sodium, Quantity: 52.6 mg (Equivalent: dolutegravir, Qty 50 mg)
ViiV Healthcare Pty Ltd
Tablet, film coated
Excipient Ingredients: sodium starch glycollate type A; povidone; mannitol; titanium dioxide; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; hypromellose; macrogol 400
Oral
30
(S4) Prescription Only Medicine
DOVATO (a fixed dose combination of dolutegravir and lamivudine) is indicated for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in adults and adolescents (from 12 years of age weighing at least 40kg): ? in antiretroviral treatment-na?ve patients with no antiretroviral treatment history who have no known or suspected resistance to either antiretroviral component; or ? to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).
Visual Identification: Oval, biconvex, white, film-coated tablet, debossed with SV 137 on one face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-09-12
DOVATO _Dolutegravir/lamivudine combination tablet_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DOVATO. 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 taking DOVATO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOVATO IS USED FOR DOVATO is used to treat HIV (human immunodeficiency virus) infection in adults and in children over the age of 12 years. DOVATO contains two active ingredients that are used to treat HIV infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). DOVATO does not cure HIV infection, it reduces the amount of virus in your body and keeps it at a low level. DOVATO also increases the CD4 cell count in your blood. CD4+ cells are a type of white blood cell that are important in helping your body to fight infection. Not everyone responds to treatment with DOVATO in the same way. Your doctor will monitor the effectiveness of your treatment. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DOVATO is not addictive. DOVATO is not recommended for children under the age of 12 years as the dosage cannot be modified. DOVATO is only available with a doctor's prescription. DOVATO is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE DOVATO _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DOVATO IF: • you have ever had an allergic reaction to any medicine containing dolutegravir or lamivudine. • you are allergic to any of the ingredients listed at the end of Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION DOVATO (DOLUTEGRAVIR/LAMIVUDINE FIXED-DOSE COMBINATION) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Dolutegravir (as dolutegravir sodium) and lamivudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DOVATO film-coated tablets contain 50 mg of dolutegravir (as dolutegravir sodium) and 300 mg of lamivudine. Product information for dolutegravir and lamivudine contain additional information. Dolutegravir sodium is a white to light yellow powder. Lamivudine is a white to off-white crystalline solid. DOVATO tablets also contain mannitol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Oval, biconvex, white, film-coated tablet, debossed with “SV 137” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DOVATO (a fixed dose combination of dolutegravir and lamivudine) is indicated for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in adults and adolescents (from 12 years of age weighing at least 40 kg): • in antiretroviral treatment-naïve patients with no antiretroviral treatment history who have no known or suspected resistance to either antiretroviral component; or • to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION DOVATO therapy should be initiated by a physician experienced in the management of HIV infection. DOVATO can be taken with or without food. DOVATO is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 50 mL/min. 2 Separate preparations of dolutegravir or lamivudine should be administered in cases where discontinuation or dose adjustments are required. In these cases, the physic Preberite celoten dokument