TRIUMEQ

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ABACAVIR AS SULFATE; DOLUTEGRAVIR AS SODIUM; LAMIVUDINE

Disponible desde:

GLAXO SMITH KLINE (ISRAEL) LTD

Código ATC:

J05AR13

formulario farmacéutico:

FILM COATED TABLETS

Composición:

DOLUTEGRAVIR AS SODIUM 50 MG; ABACAVIR AS SULFATE 600 MG; LAMIVUDINE 300 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

VIIV HEALTHCARE UK LIMITED, UK

Área terapéutica:

LAMIVUDINE AND ABACAVIR AND DOLUTEGRAVIR

indicaciones terapéuticas:

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.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. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Fecha de autorización:

2020-02-29

Información para el usuario

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according
to a physician’s prescription only
TRIUMEQ,
FILM-COATED TABLETS
EACH TABLET CONTAINS:
DOLUTEGRAVIR (AS SODIUM) 50 MG
ABACAVIR (AS SULFATE) 600 MG
LAMIVUDINE 300 MG
For the list of inactive and allergenic ingredients in the
preparation, see section 2 – “Important information about
some of the ingredients of the medicine” and section 6 –
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have any other questions, refer to the physician or the
pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them even if it seems to you that
their medical condition is similar.
IMPORTANT — HYPERSENSITIVITY REACTIONS
TRIUMEQ CONTAINS ABACAVIR AND DOLUTEGRAVIR. Both of these
active ingredients can cause a serious allergic reaction known
as a hypersensitivity reaction, which can be life-threatening in
people who continue to take abacavir-containing products.
!
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER
‘HYPERSENSITIVITY REACTIONS’ IN THE PANEL IN SECTION
4.
The Triumeq pack includes an ALERT CARD, to remind you
and the medical staff about hypersensitivity to abacavir.
DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES.
This card contains important safety information that
you must know and act upon before starting and during
treatment with Triumeq. Read the Alert Card and the patient
leaflet before starting to use the preparation.
1. WHAT IS THE MEDICINE INTENDED FOR?
Triumeq is used to treat HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION in adults and adolescents over 12 years old
who weigh at least 40 kg.
Before you are prescribed Triumeq your physician 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
w

Ficha técnica

1
TRIUMEQ
1.
NAME OF THE MEDICINAL PRODUCT
Triumeq 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.
PATIENT ALERT CARD
The marketing of Triumeq is subject to risk management plan (RMP)
including a "Patient Alert
card". The "Patient Alert card", emphasizes important safety
information that the patient should be
aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
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.
2
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 preparatio