Abacavir 600mg / Lamivudine 300mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Abacavir; Lamivudine

متاح من:

Lupin Healthcare (UK) Ltd

ATC رمز:

J05AR02

INN (الاسم الدولي):

Abacavir; Lamivudine

جرعة:

600mg ; 300mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05030100; GTIN: 8901107029722

نشرة المعلومات

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR/LAMIVUDINE LUPIN
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 LUPIN 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 Lupin 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 Lupin is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Lupin
3.
How to take Abacavir/Lamivudine Lupin
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Lupin
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE LUPIN IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE LUPIN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION
IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG
.
Abacavir/Lamivudine Lupin 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

خصائص المنتج

OBJECT 1
ABACAVIR/LAMIVUDINE 600 MG/300 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 07-Sep-2016 | Lupin
Healthcare (UK) Ltd
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 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 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