Abacavir/Lamivudine Teva 600 mg/300 mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Abacavir; Lamivudine

Disponibbli minn:

Teva B.V.

Kodiċi ATC:

J05AR; J05AR02

INN (Isem Internazzjonali):

Abacavir; Lamivudine

Dożaġġ:

600 mg/300 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

Antivirals for treatment of HIV infections, combinations; lamivudine and abacavir

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2016-10-07

Fuljett ta 'informazzjoni

1
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 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 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 is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Teva
3.
How to take Abacavir/Lamivudine Teva
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Teva
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE TEVA IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE TEVA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION IN ADULTS,
ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG.
Abacavir/Lamivudine Teva contains two active ingredients that are used
to treat HIV infection: abacavir and
lamivudine. These belong to a group of anti-retroviral medicines
called _nucleoside analogue reverse _
_transcriptase inhibitors (NRTIs)_.
Abacavir/Lamivudine Teva does not completely cure HIV infection;

Karatteristiċi tal-prodott

Health∼Products∼Regulatory∼Authority
08∼February∼2022
CRN00CPKC
Page∼1∼of∼19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine∼Teva∼600∼mg/300∼mg∼film-coated∼tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each∼film-coated∼tablet∼contains∼600∼mg∼abacavir∼and∼300∼mg∼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∼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∼is∼one∼tablet∼once∼daily.
_Children Under 25 kg:_
Abacavir/Lamivudine∼Teva∼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∼is∼a∼fixed-dose∼tablet∼and∼should∼not∼be∼prescribed∼for∼patients∼requiring∼dose∼adju