Χώρα: Τανζανία
Γλώσσα: Αγγλικά
Πηγή: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium
Macleods Pharmaceuticals Limited, INDIA
DIRECT ACTING ANTIVIRALS
Dolutegravir Sodium
10
Film Coated Tablet
Macleods Pharmaceuticals Limited, INDIA
Physical description: Pink colored, capsule shaped, film coated tablets, debossed “K” and “1” separated by breakline on one side and breakline on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)
Registered/Compliant
2022-09-21
Page of 20 2 1. NAME OF THE MEDICINAL PRODUCT Dolutegravir Sodium 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dispersible tablet contains 10 mg dolutegravir (as sodium). _Excipients with known effect: _ Each dispersible tablet also contains 29 mg of mannitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersible tablets. Pink-coloured, capsule-shaped, film-coated tablet debossed with ‘K’ and ‘1’ and separated by a break-line on one side and another break-line on the other side. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dolutegravir Sodium is indicated, in combination with other antiretroviral medicines, for the treatment of human immunodeficiency virus (HIV) infection in children at least 4 weeks of age or older and weighing at least 3 kg. Consideration should be given to the most recent official treatment guidelines for HIV-1 infection, e.g. those issued by WHO. For use of antiretroviral agents for post-exposure prophylaxis the most recent official guidelines (e.g. those issued by WHO) should be consulted. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Dolutegravir Sodium should be prescribed by a health care provider experienced in the management of HIV infection. _POSOLOGY _ _Children weighing from 3 to 25 kg _ The dose of dolutegravir for children at least 4 weeks of age and weighing from 3 to 25 kg is based on the child’s weight as shown in the table below. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children. Page of 20 3 DOSE RECOMMENDATIONS FOR CHILDREN WEIGHING FROM 3 TO 25 KG *For patients weighing at least 20 kg, the film-coated tablets containing 50 mg of dolutegravir are preferred. However, patients weighing between 20 and 25 kg who are unable to swallow tablets can take 30 mg (3 tablets) of dolutegravir dispersible tablets instead. The dolutegravir dispersible tablets and dolutegravir film-coated tablets are not bi Διαβάστε το πλήρες έγγραφο