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

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Abacavir; Lamivudine

Dostępny od:

Generics (UK) Limited

Kod ATC:

J05AR; J05AR02

INN (International Nazwa):

Abacavir; Lamivudine

Dawkowanie:

600/300 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

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

Dziedzina terapeutyczna:

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

Status autoryzacji:

Marketed

Data autoryzacji:

2016-10-07

Ulotka dla pacjenta

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 transcriptase i

Charakterystyka produktu

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
600 mg abacavir and 300 mg lamivudine.
Excipient(s) with known effect: sunset yellow (E110) 1.4 mg 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 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 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 medicinal products.
_Special Populations_
_Elderly_
H
E
A
L
T
H
P
R
O
D
U
C
T