ABACAVIR/LAMIVUDINE

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

ABACAVIR SULFATE ; LAMIVUDINE

Disponibil de la:

Generics (UK) Limited

Codul ATC:

J05AR02

INN (nume internaţional):

ABACAVIR SULFATE ; LAMIVUDINE

Dozare:

600mg/300 Milligram

Forma farmaceutică:

Film Coated Tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

lamivudine and abacavir

Statutul autorizaţiei:

Not Marketed

Data de autorizare:

2017-11-10

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
(or any other medicine
containing 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. REMOVE 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.
This medicine 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).
It does not completely cure HIV infection; it reduces the amount of
virus in your

Caracteristicilor produsului

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 abacavir sulfate equivalent to 600 mg
of abacavir and 300 mg lamivudine.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oblong, biconvex, film-coated tablet (approximately 20.8 mm x
9.2 mm), debossed with ‘AL12’ on one side and
‘M’ on the other side.
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 advised in this age
group due to age