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

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Abacavir; Lamivudine

Disponibbli minn:

Accord Healthcare Ireland Ltd.

Kodiċi ATC:

J05AR; J05AR02

INN (Isem Internazzjonali):

Abacavir; Lamivudine

Dożaġġ:

600 mg/300 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

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

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2017-10-27

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR/LAMIVUDINE 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 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 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 is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine
3.
How to take Abacavir/Lamivudine
4.
Possible side effects
5.
How to store Abacavir/Lamivudine
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION IN ADULTS,
ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG.
Abacavir/Lamivudine 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 does not completely cure HIV infection; it reduces
the amount of virus in your body,
and keeps

Karatteristiċi tal-prodott

Health Products Regulatory Authority
31 January 2020
CRN009K87
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine 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 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 is one tablet once daily.
_Children Under 25 kg:_
Abacavir/Lamivudine 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 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.
_Special Populations_
_Elderly:_
No pharmacokinetic data are currently available in patients over 65
years of age. Special care is