Triumeq tablets film-coated

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

dolutegravir (dolutegravir sodium), abacavir (abacavir sulfate), lamivudine

Boleh didapati daripada:

Glaxo Wellcome S.A.

Kod ATC:

J05AR13

INN (Nama Antarabangsa):

dolutegravir (dolutegravir sodium), abacavir (abacavir sulfate), lamivudine

Dos:

50mg+ 600mg+ 300mg

Borang farmaseutikal:

tablets film-coated

Unit dalam pakej:

(30) in plastic container

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2022-06-10

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIUMEQ 50 MG/600 MG/300 MG FILM-COATED TABLETS
dolutegravir/abacavir/lamivudine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Triumeq is and what it is used for
2.
What you need to know before you take Triumeq
3.
How to take Triumeq
4.
Possible side effects
5.
How to store Triumeq
6.
Contents of the pack and other information
1.
WHAT TRIUMEQ IS AND WHAT IT IS USED FOR
Triumeq is a medicine that contains three active ingredients used to
treat HIV infection: abacavir, lamivudine
and dolutegravir. It is a purple, biconvex, film-coated oval tablet,
debossed with “572 Trı” on one face.
Abacavir and lamivudine belong to a group of anti-retroviral medicines
(medicines used to treat HIV infection)
called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)_,
and dolutegravir belongs to a group of
anti-retroviral medicines called _integrase inhibitors (INIs)_.
Triumeq is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
in adults and children over 12 years
old who weigh at least 40 kg.
Before you are prescribed Triumeq your doctor will arrange a test to
find out whether you carry a particular
type of gene called HLA-B*5701. Triumeq should not be used in patients
who are known to carry the HLA-
B*5701 gene. Patients with this gene are at a high risk of developing
a serious hypersensitivity (allergic)
reaction if they use Triumeq (see ‘hypersensitivity reactions’ in
section 4).
Triumeq does not cure HIV infection; it reduces the amo

Ciri produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Triumeq 50 mg/600 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600
mg of abacavir (as sulfate) and
300 mg of lamivudine.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Purple, biconvex, film-coated oval tablet, debossed with “572
Trı” on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Triumeq is indicated for the treatment of Human Immunodeficiency Virus
(HIV) infected adults and
adolescents above 12 years of age weighing at least 40 kg (see
sections 4.4 and 5.1).
Before initiating treatment with abacavir-containing products,
screening for carriage of the HLA-
B*5701 allele should be performed in any HIV-infected patient,
irrespective of racial origin (see
section 4.4). Abacavir should not be used in patients known to carry
the HLA-B*5701 allele.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults and adolescents (weighing at least 40kg) _
The recommended dose of Triumeq in adults and adolescents is one
tablet once daily._ _
Triumeq should not be administered to adults or adolescents who weigh
less than 40 kg because it is a
fixed-dose tablet that cannot be dose reduced.
Triumeq is a fixed-dose tablet and should not be prescribed for
patients requiring dose adjustments.
Separate preparations of dolutegravir, abacavir or lamivudine are
available in cases where
discontinuation or dose adjustment of one of the active substances is
indicated. In these cases the
physician should refer to the individual product information for these
medicinal products.
2
_Missed doses _
If the patient misses a dose of Triumeq, the patient should take it as
soon as possible, providing the
next dose is not due within 4 hours. If the next dose is due within 4
hours, the patient should not take
the missed d