Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium
Macleods Pharmaceuticals Limited, INDIA
Dolutegravir Sodium
10
Film Coated Tablet
Macleods Pharmaceuticals Limited, INDIA
Physical description: Pink colored, caplet shaped, film coated tablets, debossed “K” and “1” separated by breakline on one side and breakline on other side; Local technical representative: Barnabas Maganga Shija (3292)
Registered/Compliant
2022-01-10
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1. NAME OF THE MEDICINAL PRODUCT Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains: Dolutegravir Sodium equivalent to Dolutegravir 10 mg _For excipients see point 6.1 _ 3. PHARMACEUTICAL FORM Film coated dispersible tablet Pink colored, caplet shaped, film coated tablets, debossed “K” and “1” separated by breakline on one side and breakline on other side 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mgare indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults (treatment-naïve or - experienced) and in paediatric patients (treatment-naïve or experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg_. This product is intended for use in children. _ _Nonetheless, safety information is provided with respect to adult health issues, to allow full _ _access to all relevant information. _ 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Recommended Dosage in Paediatric Patients Weighing 3 to 14 kg The recommended weight-based dosage of Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mg in paediatric patients weighing 3 to 14 kg (4 weeks and older, treatment-naïve or treatment-experienced but naïve to INSTI treatment) is described in below Table 1. Do not use Dolutegravir tablets in patients weighing 3 to 14 kg. Table 1: Recommended Dosage of Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mg in Paediatric Patients 4 Weeks and Older Weighing 3 to 14 kg BODY WEIGHT DOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10 MG DAILY DOSE A NUMBER OF 10 MG TABLETS 3 kg to less than 6 kg 5mg once daily 0.5 6 kg to less than 10 kg 15mg once daily 1.5 10 kg to less than 14 kg 20mg once daily 2 a If certa Prečítajte si celý dokument