Tivicay 5mg Dispersible Tablets

Country: Tanżanija

Lingwa: Ingliż

Sors: Tanzania Medicinces & Medical Devices Authority

Ingredjent attiv:

Dolutegravir Sodium

Disponibbli minn:

GlaxoSmithKline Pharmaceutical Kenya Limited, KENYA

Kodiċi ATC:

DIRECT ACTING ANTIVIRALS

INN (Isem Internazzjonali):

Dolutegravir Sodium

Dożaġġ:

5

Għamla farmaċewtika:

Dispersible Tablets

Manifatturat minn:

Glaxo Wellcome S.A, SPAIN

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Registered/Compliant

Data ta 'l-awtorizzazzjoni:

2021-10-09

Karatteristiċi tal-prodott

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