Triumeq 50mg600mg300mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Lamivudine; Dolutegravir sodium; Abacavir sulfate

Tilgængelig fra:

ViiV Healthcare UK Ltd

INN (International Name):

Lamivudine; Dolutegravir sodium; Abacavir sulfate

Dosering:

300mg ; 50mg ; 600mg

Lægemiddelform:

Tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Never Valid To Prescribe As A VMP

Produkt oversigt:

BNF: 05030100; GTIN: 5000123114412

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIUMEQ 50 MG/600 MG/300 MG FILM-COATED TABLETS
dolutegravir/abacavir/lamivudine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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. Abacavir and lamivudine belong to a group
of anti-retroviral medicines
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
‘hy

Produktets egenskaber

OBJECT 1
TRIUMEQ 50MG, 300MG, 600MG TABLETS
Summary of Product Characteristics Updated 20-Mar-2018 | ViiV
Healthcare UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 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 i