Trizivir

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

abacavir (as sulfate), lamivudine, zidovudine

Fáanlegur frá:

ViiV Healthcare BV

ATC númer:

J05AR04

INN (Alþjóðlegt nafn):

abacavir (as sulfate) / lamivudine / zidovudine

Meðferðarhópur:

Antivirals for systemic use

Lækningarsvæði:

HIV Infections

Ábendingar:

Trizivir is indicated for the treatment of human-immunodeficiency-virus (HIV) infection in adults.This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages. It is recommended that treatment is started with abacavir, lamivudine,and zidovudine separately for the first six to eight weeks. 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.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. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Trizivir therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.

Vörulýsing:

Revision: 43

Leyfisstaða:

Authorised

Leyfisdagur:

2000-12-27

Upplýsingar fylgiseðill

39
B. PACKAGE LEAFLET
40
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 i

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
Excipient(s) with known effect:
Each 300 mg/150 mg/300 mg tablet contains 2.7 mg sodium.
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). Ab