Abacavir Accord 300 mg film-coated tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

ABACAVIR

Disponibil de la:

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

Codul ATC:

J05AF06

INN (nume internaţional):

ABACAVIR 300 mg

Forma farmaceutică:

FILM-COATED TABLET

Compoziție:

ABACAVIR 300 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIVIRALS FOR SYSTEMIC USE

Rezumat produs:

Licence number in the source country: NOT APPLICAPABLE

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2020-10-20

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR ACCORD 300 MG FILM-COATED TABLETS
Abacavir
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 ACCORD CONTAINS ABACAVIR
(which is also an active substance in medicines such as
ABACAVIR+LAMIVUDINE,
ABACAVIR+LAMIVUDINE+ZIDOVUDINE
and
DOLUTEGRAVIR+ABACAVIR+LAMIVUDINE
). 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 Accord 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 Accord
is and what it is used for
2.
What you need to know before you take Abacavir Accord
3.
How to take Abacavir Accord
4.
Possible side effects
5.
How to store Abacavir Accord
6.
Contents of the pack and other information
1.
WHAT ABACAVIR ACCORD IS AND WHAT IT IS USED FOR
ABACAVIR ACCORD IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS)
INFECTION.
Abacavir Accord
contains the active ingredient abacavir. Abacavir belongs to a group
of anti-
retroviral medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)_
.
Abacavir Accord
does not completely cure HIV infection; it reduces the amount of virus
in your
body, and keeps it at a low level. It al

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abacavir Accord 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of abacavir.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablets)
The scored tablets are yellow, biconvex, 18.50 x 7.30 mm, capsule
shaped and are debossed with
‘H’ on one side and with ‘A’ and ‘26’ on the other side
separated by the score line.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Abacavir Accord is indicated in antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infection in adults, adolescents and
children (see sections 4.4
and 5.1).
The demonstration of the benefit of Abacavir Accord is mainly based on
results of studies
performed with a twice daily regimen, in treatment-naïve adult
patients on combination therapy
(see section 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
Abacavir Accord should be prescribed by physicians experienced in the
management of HIV
infection.
Abacavir Accord can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
Abacavir may also be available as an oral solution for use in children
over three months of age
and weighing less than 14 kg and for those patients for whom the
tablets are inappropriate.
Alternatively, for patients who are unable to swallow tablets, the
tablet(s) may be crushed and
added to a small amount of semi-solid food or liquid, all of which
should be consumed
immediately (see section 5.2).
_Adults, adolescents and children (weighing at least 25 kg): _
The recommended dos