Abacavir/Lamivudine Viatris

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Abacavir sulfate 702.78mg equivalent to Abacavir 600 mg;  ; Lamivudine 300mg

Prieinama:

Viatris Limited

Vaisto forma:

Film coated tablet

Sudėtis:

Active: Abacavir sulfate 702.78mg equivalent to Abacavir 600 mg   Lamivudine 300mg Excipient: Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white 13B58894 Purified talc Silicified microcrystalline cellulose

Recepto tipas:

Prescription

Terapinės indikacijos:

Antiretroviral combination therapy for the treatment of HIV in adults and adolescents from 12 years of age.

Produkto santrauka:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium - 30 dose units - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 30 dose units - 24 months from date of manufacture stored at or below 25°C

Leidimo data:

2015-10-16

Pakuotės lapelis

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ABACAVIR/LAMIVUDINE VIATRIS
_ABACAVIR (AS SULFATE) & LAMIVUDINE FILM COATED TABLETS 600MG/300MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Abacavir/Lamivudine Viatris.
This leaflet answers some common
questions about
Abacavir/Lamivudine Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Abacavir/Lamivudine Viatris against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ABACAVIR/
LAMIVUDINE VIATRIS IS
USED FOR
Abacavir/Lamivudine Viatris
contains the active ingredients
abacavir (as sulfate) and
lamivudine_._ It belongs to a group of
medicines called antiretrovirals.
Abacavir/Lamivudine Viatris is used
together with other antiretrovirals to
slow down the progression of
human immunodeficiency virus
(HIV) infection, which can lead to
Acquired Immune Deficiency
Syndrome (AIDS) and other related
illnesses (eg AIDS-related Complex
or ARC).
This medicine belongs to a group of
medicines called antiretrovirals.
Abacavir/Lamivudine Viatris tablets
does not cure AIDS or kill the HIV
virus, but delays further damage to
the immune system by stopping
production of new viruses.
While taking Abacavir/Lamivudine
Viatris and/or any other therapy for
HIV disease, you may continue to
develop other infections and other
complications of HIV infection. You
should keep in regular contact with
the doctor who is looking after you.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
ABACAVIR/
LAMIVUDINE VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT

Prekės savybės

Page 1 of 16
NEW ZEALAND DATA SHEET
ABACAVIR/LAMIVUDINE VIATRIS
1. PRODUCT NAME
Abacavir/Lamivudine Viatris, 600 mg/300 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg of lamivudine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A white, film-coated, modified capsule shaped, biconvex tablet
debossed with AL12 on one side of
the tablet and M on the other side. Dimensions: approx. 20.8 mm x 9.2
mm.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Abacavir/Lamivudine
Viatris
is
a
combination
of
two
nucleoside
analogues
(abacavir
and
lamivudine). It is indicated in antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infection in adults and adolescents from
12 years of age.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Abacavir/Lamivudine Viatris should not be administered to adults or
adolescents who weigh less
than 40 kg because it is a fixed-dose tablet that cannot be dose
reduced.
Abacavir/Lamivudine Viatris is a fixed-dose tablet and should not be
prescribed for patients requiring
dosage adjustments, such as those with creatinine clearance less than
50 mL/min. Separate
preparations of abacavir or lamivudine should be administered in cases
where discontinuation or
dose adjustment is indicated. In these cases the physician should
refer to the individual product
information for these medicinal products.
DOSE
The recommended dose of Abacavir/Lamivudine Viatris in adults and
adolescents is one tablet once
daily.
_SPECIAL POPULATIONS_
ELDERLY
The pharmacokinetics of abacavir and lamivudine have not been studied
in patients over 65 years
of age. When treating elderly patients, consideration needs to be
given to the greater frequency of
decreased hepatic, renal and cardiac function, concomitant medicinal
products or disease.
Page 2 of 16
RENAL IMPAIRMENT
Whilst no dosa