ACRIPTEGA TABLET

Χώρα: Νότια Αφρική

Γλώσσα: Αγγλικά

Πηγή: South African Health Products Regulatory Authority (SAHPRA)

Διαθέσιμο από:

Mylan Pharmaceuticals (Pty) Ltd

Δοσολογία:

See ingredients

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-07-08

Φύλλο οδηγιών χρήσης

Viatris Healthcare (Pty) Ltd
Acriptega
Each tablet contains 300 mg tenofovir disoproxil fumarate/ 300 mg
lamivudine/ 50 mg dolutegravir
_ _
APPROVED: 27 November 2023
_ _
_ _
Page
1
of
14
_ _
INITIAL AND DATE
PROPSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
ACRIPTEGA (FILM-COATED TABLETS)
Lamivudine/ Tenofovir disoproxil fumarate/
Dolutegravir sodium
Contains sugar: Lactose monohydrate 136 mg
ACRIPTEGA contains less than 1 mmol sodium (23 mg) per tablet, that is
to say essentially
‘sodium-free’.
ACRIPTEGA may lead to serious problems with your liver or cause too
much acid in your
blood. If left untreated, this may even cause death. The safety and
efficacy of ACRIPTEGA
in patients who are infected with both human immunodeficiency virus
(HIV) and hepatitis
B virus (HBV) have not been established. ACRIPTEGA should not be used
for the
treatment of chronic HBV infection. You should be closely monitored by
your doctor for
several months if you are infected with HBV and discontinue the use of
ACRIPTEGA.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ACRIPTEGA
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
ACRIPTEGA 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.
WHAT IS IN THIS LEAFLET
1. What ACRIPTEGA is and what it is used for.
2. What you need to know before you take ACRIPTEGA.
S4
Viatris Healthcare (Pty) Ltd
Acriptega
Each tablet contains 300 mg tenofovir disoproxil fumarate/ 300 mg
lamivudine/ 50 mg dolutegravir
_ _
APPROVED: 27 November 2023
_ _
_ _
Page
2
of
14
_ _
INITIAL AND DATE
3. How to take ACRIPTEGA.
4. Possible side effects.
5. How to store ACRIPTEGA.
6. Contents of the pack and other information.
1.
WHAT ACRIPTEGA IS AND WHAT IT IS USED FOR
Each film-coated tablet contains the active substances:
Lamivudine
Tenofovir disoproxil fumarate
Dolutegravir sodium

Αρχείο Π.Χ.Π.

Viatris Healthcare (Pty) Ltd
Acriptega
Each tablet contains 300 mg tenofovir disoproxil fumarate/300 mg
lamivudine / 50 mg dolutegravir
Approved: 27 November 2023
Page 1 of 47
Professional Information for medicines for human use
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 SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
ACRIPTEGA IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B
VIRUS
(HBV) INFECTION. SAFETY AND EFFICACY OF ACRIPTEGA 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 INFECTED
WITH HBV WHO DISCONTINUE ACRIPTEGA AND ARE CO-INFECTED WITH HIV AND
HBV.
IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE
WARRANTED
(SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Viatris Healthcare (Pty) Ltd
Acriptega
Each tablet contains 300 mg tenofovir disoproxil fumarate/300 mg
lamivudine / 50 mg dolutegravir
Approved: 27 November 2023
Page 2 of 47
SCHEDULING STATUS
1 NAME OF THE MEDICINE
ACRIPTEGA (film-coated tablets)
2 QUALITIVE AND QUANTITIVE COMPOSITION
Each ACRIPTEGA film-coated tablet contains:
Tenofovir disoproxil fumarate 300 mg
Lamivudine 300 mg
Dolutegravir sodium equivalent to dolutegravir 50 mg
_Excipients with known effect: _
Contains sugar: Lactose monohydrate 136 mg
ACRIPTEGA contains less than 1 mmol sodium (23 mg) per tablet, that is
to say essentially
‘sodium-free’.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to off white, film-coated, capsule-shaped, biconvex bevelled
edge tablet debossed with “M”
on one side and “LTD” on the other side of the tablet.
4 CLINICAL PARTI