Abacavir 600mg / Lamivudine 300mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Abacavir; Lamivudine

זמין מ:

Viatris UK Healthcare Ltd

קוד ATC:

J05AR02

INN (שם בינלאומי):

Abacavir; Lamivudine

כמות:

600mg ; 300mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05030100; GTIN: 5016695007083

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Abacavir/Lamivudine
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
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 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 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.
Abacavir/Lamivudine 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).
Abacavir/Lamivudine does not completely cure HI

מאפייני מוצר

OBJECT 1
ABACAVIR/LAMIVUDINE MYLAN 600 MG/300 MG
FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Jun-2017 | Generics UK
T/A Mylan
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 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 informati