Abacavir/Lamivudine Teva Tablet, film coated 600mg/300mg

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

ABACAVIR, LAMIVUDINE

Beszerezhető a:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC-kód:

J05AR02

INN (nemzetközi neve):

ABACAVIR 600 mg LAMIVUDINE 300 mg

Gyógyszerészeti forma:

FILM-COATED TABLET

Összetétel:

ABACAVIR 600 mg LAMIVUDINE 300 mg

Recept típusa:

POM

Terápiás terület:

ANTIVIRALS FOR SYSTEMIC USE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2018-05-23

Betegtájékoztató

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR/LAMIVUDINE TEVA 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 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.
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE TEVA 600 MG/300 MG FILM-COATED TABLETS CONTAINS
ABACAVIR
. 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 Teva 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 Teva 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 Teva 600
mg/300 mg Film-coated Tablets
3.
How to take Abacavir/Lamivudine Teva 600 mg/300 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Teva 600 mg/300 mg Film-coated
Tablets
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE TEVA 600 MG/300 MG FILM-COATED TABLETS IS AND
WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE TEVA 600 MG/300 MG FILM-COATED TABLETS IS USED TO
TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS, ADOLESCENTS AND IN
CHILDREN WEIGHING AT LEAST 25 KG.
Abacavir/Lamivudine T

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Teva 600 mg/300 mg Film-coated Tablets 600 mg/300
mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir and 300 mg of
lamivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, oblong, biconvex film-coated tablets with debossing 600 on one
side and 300 on the other side with
dimension of

20.5 mm x 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir/Lamivudine Teva 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 Teva 600 mg/300 mg
Film-coated Tablets is one tablet once daily.
_Children Under 25 kg:_
Abacavir/Lamivudine Teva 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 Teva 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 to the individual product
information for these medicinal products.
_Sp