Abacavir/Lamivudine Accord Healthcare 600mg/300mg film-coated Tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

ABACAVIR, LAMIVUDINE

MAH:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC_code:

J05AR02

INN:

ABACAVIR 600 mg LAMIVUDINE 300 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

ABACAVIR 600 mg LAMIVUDINE 300 mg

prescription_type:

POM

therapeutic_area:

ANTIVIRALS FOR SYSTEMIC USE

authorization_status:

Withdrawn

authorization_date:

2016-03-18

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ABACAVIR/LAMIVUDINE ACCORD HEALTHCARE 600 MG/300 MG FILM-COATED
TABLETS
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE ACCORD HEALTHCARE 600 MG/300 MG FILM-COATED
TABLETS CONTAINS
ABACAVIR
(which is also an active substance in other related medicines). 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
Abacavir/Lamivudine
Accord Healthcare
600 mg/300
mg
film-coated
tablets
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 Abacavir/Lamivudine Accord Healthcare 600 mg/300 mg film-coated
tablets is
and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Accord
Healthcare 600
mg/300 mg film-coated tablets
3.
How to take Abacavir/Lamivudine Accord Healthcare 600 mg/300 mg
film-coated
tablets
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Accord Healthcare 600 mg/300 mg
film-coated
tablets
6.
Contents of the pack and other information
1.
WHAT
ABACAVIR/LAMIVUDINE
ACCORD
HEALTHCARE
600
MG/300
MG
FILM-COATED
TABLETS IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE ACCOR

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Accord Healthcare 600 mg/300 mg film-coated
tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg abacavir and 300 mg lamivudine
Excipient with known effect:
Sunset Yellow FCF Aluminium Lake (E110) 1.86 mg per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, film-coated, modified capsule shaped tablets. The dimensions
of the tablets are 19.4 mm x
10.4 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir/Lamivudine
Accord
Healthcare
600
mg/300
mg
film-coated
tablets
is
indicated
in
antiretroviral
combination
therapy
for the
treatment
of
Human
Immunodeficiency
Virus
(HIV)
infection in adults, adolescents and children weighing at least 25 kg
(see sections 4.4 and 5.1).
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 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 25 kg_
The recommended dose of Abacavir/Lamivudine Accord Healthcare 600
mg/300 mg film-coated
tablets is one tablet once daily.
_Children Under 25 kg _
Abacavir/Lamivudine
Accord
Healthcare
600
mg/300
mg
film-coated
tablets
should
not
be
administered to children who weigh less than 25 kg because it is a
fixed-dose tablet that cannot be
dose reduced.
Abacavir/Lamivudine Accord Healthcare 600 mg/300 mg film-coated
tablets is a fixed-dose tablet and
should not be prescribed for patients requiring dose adjustments.
Separate preparations of 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