Trizivir tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Abacavir sulfate; Zidovudine; Lamivudine

Available from:

ViiV Healthcare UK Ltd

ATC code:

J05AR04

INN (International Name):

Abacavir sulfate; Zidovudine; Lamivudine

Dosage:

300mg ; 300mg ; 150mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 05030100; GTIN: 5000123110247

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIZIVIR 300 MG/150 MG/300 MG FILM-COATED TABLETS
_abacavir/lamivudine/zidovudine _
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
IMMEDIATELY
.
THIS INCLUDES
ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
See section 4.
IMPORTANT — HYPERSENSITIVITY REACTIONS
TRIZIVIR CONTAINS ABACAVIR
(which is also an active substance in medicines such as
KIVEXA, TRIUMEQ
and
ZIAGEN
). Some people who take abacavir may develop a
HYPERSENSITIVITY REACTION
(a serious
allergic reaction), which can be life-threatening if they continue to
take abacavir containing products .
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE PANEL IN
SECTION 4
.
The Trizivir pack includes an
ALERT CARD
, to remind you and medical staff about abacavir
hypersensitivity.
DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Trizivir is and what it is used for
2.
What you need to know before you take Trizivir
3.
How to take Trizivir
4.
Possible side effects
5.
How to store Trizivir
6.
Contents of the pack and other information
1.
WHAT TRIZIVIR IS AND WHAT IT IS USED FOR
TRIZIVIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS
.
Trizivir contains three active ingredients that are used to treat HIV
infection: abacavir, lamivudine and
zidovudine. All of these belong to a group of anti-retroviral
medicines called
_nucleoside analogue _
_reverse transcriptase inhibitors (NRTIs)_
.
Trizivir helps to control your condition. Trizivir does not cure HIV
infection; it reduces the amount of
virus in your body, and keeps

Summary of Product characteristics

OBJECT 1
TRIZIVIR FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Feb-2018 | ViiV
Healthcare UK Ltd
1. Name of the medicinal product
TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 300 mg of abacavir (as sulfate), 150
mg lamivudine and 300 mg
zidovudine.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Blue-green capsule-shaped film-coated tablets engraved with “GX
LL1” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Trizivir is indicated for the treatment of Human Immunodeficiency
Virus (HIV) infection in adults (see
sections 4.4 and 5.1). This fixed combination replaces the three
components (abacavir, lamivudine and
zidovudine) used separately in similar doses. It is recommended that
treatment is started with abacavir,
lamivudine, and zidovudine separately for the first 6-8 weeks (see
section 4.4). The choice of this fixed
combination should be based not only on potential adherence criteria,
but mainly on expected efficacy
and risk related to the three nucleoside analogues.
The demonstration of the benefit of Trizivir is mainly based on
results of studies performed in treatment
naive patients or moderately antiretroviral experienced patients with
non-advanced disease. In patients
with high viral load (> 100,000 copies/ml) choice of therapy needs
special consideration (see section 5.1).
Overall, the virologic suppression with this triple nucleoside regimen
could be inferior to that obtained
with other multitherapies notably including boosted Protease
inhibitors or non nucleoside reverse
transcriptase inhibitors, therefore the use of Trizivir should only be
considered under special
circumstances (e.g. co-infection with tuberculosis).
Before initiating treatment with abacavir, 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