TELADO

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM

Disponible depuis:

SAMPHARINDO RETROVIRAL INDONESIA - Indonesia

DCI (Dénomination commune internationale):

LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM

Dosage:

300 Mg /300 Mg /52,6 Mg

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Fabriqué par:

MACLEODS PHARMACEUTICALS LIMITED - India

Date de l'autorisation:

2020-02-25

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT
CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
TELADO
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film - coated tablet contains:
50 mg of Dolutegravir equvivalent 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.
FOR EXCIPIENTS SEE POINT 6.1
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Dolutegravir
50mg + Lamivudine 300mg + Tenofovir
disoproxil
fumarate 300mg Tablet
is
indicated for
thetreatment of HIV infection in adults and adolescents over 12 years
of age.
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.
4.3. 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
of
dolutegravir
is
considerably
compromised
for
viral
strains
harbouring
Q148+
≥
2 secondary
mutations from G140A/C/S,
E138A/K/T,
L74I.
To what
extent
dolutegravir
provides added efficacy in the
presence of such integrase class resistance is uncertain.
HYPERSENSITIVITY REACTIONS
Hypersensitivity
reactions
have
been