Country: Tanzania
Bahasa: Inggeris
Sumber: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium
GlaxoSmithKline Pharmaceutical Kenya Limited, KENYA
DIRECT ACTING ANTIVIRALS
Dolutegravir Sodium
5
Dispersible Tablets
Glaxo Wellcome S.A, SPAIN
Physical description: Dolutegravir Dispersible Tablets, 5 mg, for oral administration are round (6 mm diameter), biconvex, white, film coated tablets, debossed “SV H7S” on one face and “5” on the other face.; Local technical representative: JD PHARMACY LIMITED
Registered/Compliant
2021-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TIVICAY DOLUTEGRAVIR 5 MG DISPERSIBLE TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of dolutegravir (as dolutegravir sodium). 3. PHARMACEUTICAL FORM Dispersible tablet. White, round, biconvex tablets debossed with ‘SV H7S’ on one side and ‘5’ on the other side. 4. CLINICAL PARTICULARS 4.1.THERAPEUTIC INDICATIONS Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TIVICAY therapy should be initiated by a physician experienced in the management of HIV infection. _TIVICAY _is available as dispersible tablets for patients aged at least 4 weeks and weighing at least 3 kg, or for patients in whom film-coated tablets are not appropriate. _TIVICAY _is available as film- coated tablets for patients aged at least 6 years and weighing at least 14 kg. The bioavailability of dispersible tablets and film-coated tablets is not comparable therefore they must not be used as direct replacements (_see Pharmacokinetics_). For example, the recommended adult dose for dispersible tablets is 30 mg versus 50 mg for film-coated tablets. Patients changing between dispersible and film-coated tablets should follow the dosing recommendations that are specific for the formulation. _TIVICAY _can be taken with or without food. The dispersible tablets may be swallowed whole with drinking water or dispersed in drinking water. When dispersed, the amount of water will depend on the number of tablets prescribed. The tablet(s) should be fully dispersed before swallowing (_see Instructions for _ _Use_). Do not chew, cut or crush the tablets. ADULTS PATIENTS INFECTED WITH HIV-1 WITHOUT RESISTANCE TO THE INTEGRASE CLASS The recommended dose of dolutegravir dispersible tablets is 30 mg once daily. PATIENTS INFECTED WITH Baca dokumen lengkap