Dolutegravir Tablets 50 mg Tablet, Film-coated

Pays: Tanzanie

Langue: anglais

Source: Tanzania Medicinces & Medical Devices Authority

Ingrédients actifs:

Dolutegravir Sodium

Disponible depuis:

LAURUS LABS LIMITED, INDIA

Code ATC:

DIRECT ACTING ANTIVIRALS

DCI (Dénomination commune internationale):

Dolutegravir Sodium

Dosage:

50

forme pharmaceutique:

Tablet, Film-coated

Fabriqué par:

LAURUS LABS LIMITED (UNIT-II), INDIA

Descriptif du produit:

Physical description: Light orange coloured, round shaped,biconvex film coated tablets debossed with ''LA54'' on one side and plain on other side; Local technical representative: Atas Pharmaceutical (8234)

Statut de autorisation:

Registered/Compliant

Date de l'autorisation:

2019-08-02

Résumé des caractéristiques du produit

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
TIVICAY (Dolutegravir sodium 50 mg Film coated Tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg
dolutegravir.
Each film-coated tablet contains NNN of mannitol and NNN of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Light orange coloured, round shaped,biconvex film coated tablets debossed with ’’LA54’’ on one side
and plain on other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
TIVICAY is indicated, in combination with other antiretroviral medicines, for the treatment of
human immunodeficiency virus (HIV) infection in patients weighing at least 20 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 by WHO) should be consulted.
4.2 Posology and method of administration
TIVICAY should be prescribed by a health care provider experienced in the management of HIV
infection.
Posology
Adults
The dose in adults with HIV-1 infection not resistant to integrase inhibitors is 50 mg dolutegravir (one
tablet) once daily.
The dose should be 50 mg twice daily if:
• dolutegravir is used with medicines such as efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin (see section 4.5)
• the patient’s HIV-1 infection is known or suspected to be resistant to integrase inhibitors.
When HIV-1 genotype testing is available and for patients whose treatment options are limited
(fewer than 2 active antiretrovirals) due to advanced multi-class resistance, a higher dose of
dolutegravir may be considered. Such resistance may include Q148 with two or more secondary
mutations from G140A/C/S, E138A/K/T, L74I.