Abacavir Accord 300 mg film-coated tablets

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Abacavir

থেকে পাওয়া:

Accord Healthcare Ireland Ltd.

এটিসি কোড:

J05AF06

INN (International Name):

Abacavir

ডোজ:

300 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

Therapeutic area:

abacavir

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2020-11-13

তথ্য লিফলেট

PACKAGE LEAFLET
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

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
30 August 2021
CRN00CG55
Page 1 of 19
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