国: タンザニア
言語: 英語
ソース: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium, Lamivudine , Tenofovovir Disoproxil Fumarate
Macleods Pharmaceuticals Limited, INDIA
Antivirals for systemic use, antivirals for treatm
Dolutegravir Sodium+ Lamivudine + Tenofovovir Disoproxil Fumarate
Dolutegravir 50mg, Lamivudine 300mg and Tenofovir disoproxil fumerate 300mg
Oral tablet
Macleods Pharmaceuticals Limited, INDIA
Physical description: White to off white, capsule shaped, film coated tablets, debossed with F67 on one side and plain on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)
Registered/Compliant
2022-08-04
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300mg/300mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film - coated tablet contains: 50 mg of Dolutegravir equivalent to 52.6 mg of Dolutegravir sodium 300 mg of Lamivudine USP 300 mg of Tenofovir disoproxil fumarate equivalent to 245 mg of Tenofovir disoproxil. 2.6 mg per tablet of Sodium 120 mg of Mannitol (USP-NF/ Ph.Eur) 21 mg of Sodium Starch Glycolate (USP-NF/ Ph.Eur) 9 mg of Sodium Stearyl Fumarate (USP-NF/ Ph.Eur) FOR EXCIPIENTS SEE POINT 6.1 3. PHARMACEUTICAL FORM Tablet White to off white, capsule shaped, film coated tablets, debossed with 'F67' on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dolutegravir 50mg + Lamivudine 300mg + Tenofovir disoproxil fumarate 300mg Tablet is indicated for the treatment of HIV- infection in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the treatment of HIV that is resistant to other medicines similar to Dolutegravir, Tenofovir Disoproxil Fumarate and Lamivudine Tablets 50mg/300mg/300mg , the usual dose of Dolutegravir, Tenofovir Disoproxil Fumarate and Lamivudine Tablets 50mg/300mg/300mg is one tablet, once a day. Swallow the tablet with some liquid. Dolutegravir, Tenofovir Disoproxil Fumarate and Lamivudine Tablets 50mg/300mg/300mg can be taken with or without food. 3. CONTRAINDICATIONS • Hypersensitivity to the active substances or to any of the excipients. • Co-administration with dofetilide 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE DOLUTEGRAVIR While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines. _INTEGRASE CLASS RESISTANCE OF PARTICULAR CONCERN _ The decision to use dolutegravir in the presence of integrase class resistance should take into account that the activity 完全なドキュメントを読む