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

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Abacavir; Lamivudine

Dostupné z:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC kód:

J05AR; J05AR02

INN (Medzinárodný Name):

Abacavir; Lamivudine

Dávkovanie:

600mg/300 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

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

Terapeutické oblasti:

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

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2016-10-07

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR/LAMIVUDINE MYLAN
600 MG/300 MG FILM-COATED T
ABLETS
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 MYLAN CONTAINS ABACAVIR
(which is also an active substance in medicines
such as
TRIZIVIR, TRIUMEQ
and
ZIAGEN
). 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 Mylan pack includes an
ALERT CARD
, to remind you and medical staff about
abacavir hypersensitivity.
KEEP THIS CARD WITH YOU AT ALL TIMES.
WHAT IS IN THIS LEAFLET
1.
What Abacavir/Lamivudine Mylan is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Mylan
3.
How to take Abacavir/Lamivudine Mylan
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Mylan
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE MYLAN IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE MYLAN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION IN
ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG
.
Abacavir/Lamivudine Mylan 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 transcripta

Súhrn charakteristických

Health Products Regulatory Authority
15 January 2024
CRN00DZPX
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film -coated tablet contains abacavir hydrochloride equivalent to
600mg abacavir and 300mg lamivudine.
Excipient(s) with known effect: sunset yellow (E 110) 1.4mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Orange coloured, modified capsule shaped, biconvex, 20.6 mm x 9.1 mm
film-coated tablets, debossed with “300” on one side
and “600” on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abacavir/Lamivudine Mylan is indicated in antiretroviral combination
therapy for the treatment of Human Immunodeficiency
Virus (HIV) infection in adults, adolescents and children weighing at
least 25kg (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 Mylan is one tablet once
daily.
_Children Under 25 kg_:
Abacavir/Lamivudine Mylan 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 Mylan 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
medic