Triumeq

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

dolutegravir sodium, lamivudine, abacavir (as sulfate)

Διαθέσιμο από:

ViiV Healthcare B.V.

Φαρμακολογική κατηγορία (ATC):

J05AR13

INN (Διεθνής Όνομα):

abacavir sulfate / dolutegravir sodium / lamivudine

Θεραπευτική ομάδα:

Antivirals for systemic use

Θεραπευτική περιοχή:

HIV Infections

Θεραπευτικές ενδείξεις:

Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults,  adolescents and children  weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in Triumeq.

Περίληψη προϊόντος:

Revision: 32

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-08-31

Φύλλο οδηγιών χρήσης

92
B. PACKAGE LEAFLET
93
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 substances used to
treat HIV infection: abacavir,
lamivudine and dolutegravir. 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, adolescents and
children who weigh at least 25 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 amount of virus in
your body, and keeps it at a
low level. It also inc

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 tablets, approximately 22 x 11 mm,
debossed with “572 Trı” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Triumeq is indicated for the treatment of Human Immunodeficiency Virus
(HIV) infected adults,
adolescents and children weighing at least 25 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,adolescents and children (weighing at least 25kg) _
The recommended dose of Triumeq in adults,adolescents and children is
one tablet once daily.
_ _
Triumeq film-coated tablets should not be administered to adults,
adolescents or children who weigh
less than 25 kg because it is a fixed-dose tablet that cannot be dose
reduced. Triumeq dispersible
tablets should be administered to children who weigh at least 14 kg to
less than 25 kg.
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.
A separate dose of dolutegravir (film-coated tablets or dispersible
tablets) is applicable where a dose
adjustment is indicated due to drug-drug interactions