TELADO

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM

제공처:

SAMPHARINDO RETROVIRAL INDONESIA - Indonesia

INN (International Name):

LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM

복용량:

300 Mg /300 Mg /52,6 Mg

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Manufactured by:

MACLEODS PHARMACEUTICALS LIMITED - India

승인 날짜:

2020-02-25

제품 특성 요약

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