DIVTRIDA TABLET

Krajina: Južná Afrika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné z:

Novagen Pharma (Pty) Ltd

Dávkovanie:

See ingredients

Forma lieku:

TABLET

Zloženie:

EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg

Stav Autorizácia:

Renewal -In Progress

Dátum Autorizácia:

2020-07-08

Príbalový leták

PAGE 1 OF 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
DIVTRIDA
(film-coated tablet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIVTRIDA.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your
pharmacist.
-
DIVTRIDA HAS
been prescribed for you personally and you should not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1.
WHAT DIVTRIDA CONTAINS
The active substances are dolutegravir, lamivudine and tenofovir
disoproxil fumarate.
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg of dolutegravir, lamivudine 300 mg
and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg
of tenofovir disoproxil.
The other ingredients of
DIVTRIDA ARE
colloidal silicon dioxide, croscarmellose sodium, ferric oxide,
hypromellose, magnesium stearate, microcrystalline cellulose, opadry
II pink 85F94172, povidone, sodium
starch glycolate and sodium stearyl fumarate.
In addition opadry II pink 85F94172 contains iron oxide red (C.I. No:
77491), oxide black (C.I. No: 77499),
polyethylene glycol, talc and titanium dioxide (C.I. No: 77891).
Contains sugar: 145,37 mg mannitol.
WARNING
PAGE 2 OF 10
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL
CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE
OR
IN COMBINATION WITH OTHER ANTIRETROVIRALS.
DIVTRIDA IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B
VIRUS
(HBV)
INFECTION.
THE
SAFETY
AND
EFFICACY
OF
DIVTRIDA
HAS
NOT
BEEN
ESTABLISHED
IN
PATIENTS
CO-INFECTED
WITH
HBV
AND
HIV.
SEVERE
ACUTE
EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE
CO-
INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE COMBINATION
TABLET.
HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND
LABORATORY
FOLLOW-UP
FOR
AT
LEAST
SEVERAL
MONTHS
IN
PATIENTS
WHO
DISCONTINUE DIVTRIDA AND ARE CO-INFECTED WITH HIV AND HBV. IF
APPROP

Súhrn charakteristických

PAGE 1 OF 40
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
DIVTRIDA
(film-coated tablet)
COMPOSITION:
Each
DIVTRIDA
contains dolutegravir sodium equivalent to 50 mg of dolutegravir,
lamivudine 300 mg
and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg
of tenofovir disoproxil.
The other ingredients of
DIVTRIDA
are colloidal silicon dioxide, croscarmellose sodium, ferric oxide,
hypromellose, magnesium stearate, microcrystalline cellulose, opadry
II pink 85F94172, povidone, sodium
starch glycolate and sodium stearyl fumarate.
In addition opadry II pink 85F94172 contains iron oxide red (C.I. No:
77491), oxide black (C.I. No:
77499), polyethylene glycol, talc and titanium dioxide (C.I. No:
77891)
Contains sugar: 145,37 mg mannitol.
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL
CASES,
HAVE
BEEN
REPORTED
WITH
THE
USE
OF
NUCLEOSIDE
ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE
WARNINGS AND SPECIAL PRECAUTIONS).
DIVTRIDA IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B
VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF DIVTRIDA HAS NOT
BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE
ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS
WHO ARE CO-INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE
COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY
WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL
PAGE 2 OF 40
MONTHS IN PATIENTS WHO DISCONTINUE DIVTRIDA AND ARE CO-INFECTED
WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B
THERAPY
MAY BE WARRANTED (SEE WARNINGS AND SPECIAL PRECAUTIONS).
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Antimicrobial (Chemotherapeutic) Medicines. Antiviral
Medicines.
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
LAMIVUDINE
Lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), is a
selective inhibitor of HIV-1 and
HIV-2 replication
_in vitro. _
Lamivudine is metabolised intracellularly to the activ