Lamivudine/Zidovudine Viatris 150/300

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Lamivudine 150mg; Zidovudine 300mg

Dostupno od:

Viatris Limited

INN (International ime):

Lamivudine 150 mg

Farmaceutski oblik:

Film coated tablet

Sastav:

Active: Lamivudine 150mg Zidovudine 300mg Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Opadry white Propylene glycol Purified water Sodium starch glycolate

Jedinice u paketu:

Blister pack, PVDC/PVC aluminium foil, 60 tablets

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Mylan Laboratories Limited

Terapijske indikacije:

indicated for the treatment of HIV infected adults and adolescents over the age of 12 years, with progressive immunodeficiency (CD4+ Count = < 500 cells/mm³).

Proizvod sažetak:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC aluminium foil - 60 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, HDPE with PP cap - 60 tablets - 48 months from date of manufacture stored at or below 30°C

Datum autorizacije:

2010-01-07

Uputa o lijeku

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300
_LAMIVUDINE AND ZIDOVUDINE FILM COATED TABLETS_
_150MG + 300MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 tablets.
This leaflet answers some common
questions about
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 tablets.
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
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 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 LAMIVUDINE/
ZIDOVUDINE
VIATRIS 150/300 IS
USED FOR
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 is used alone or
with other antiretroviral medicines,
to slow down the progression of
Human Immunodeficiency Virus
(HIV) infection. HIV can lead to
Acquired Immune Deficiency
Syndrome (AIDS) and other related
illnesses.
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 tablets contain
two active ingredients, lamivudine
and zidovudine, which belong to a
group of medicines called
antiretrovirals.
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 does not cure or
prevent AIDS or HIV infection, but
hinders the growth of human
immunodeficiency virus. In this way
it stops on going damage to the
body’s immune system, which fights
infection.
While taking
LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 and/or any other
therapy for HIV, you may continue
to develop other infections and
other complications of HIV infection.
You should keep in regular contact
with your doctor.
The long-term risks and benefits of
taking LAMIVUDINE/ZIDOVUDINE
VIATRIS 150/300 are not known.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason. This medicine is
not addictive

Svojstava lijeka

Page 1 of 18
NEW ZEALAND DATA SHEET
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300
1. PRODUCT NAME
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 film-coated tablets contain 150
mg lamivudine and
300 mg zidovudine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 are white to off-white
capsule-shaped biconvex film-
coated tablets, debossed with ‘M’ on the left of the score-line
and ‘103’ on the right on one side, and
scored on the other.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 are indicated for the treatment
of HIV infected adults,
and adolescents over the age of 12 years, with progressive
immunodeficiency (CD
4
+ Count = < 500
cells/mm
3
).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 therapy should be initiated and
monitored by a
physician experienced in the management of HIV infection.
ADULTS AND ADOLESCENTS OVER THE AGE OF 12 YEARS WEIGHING AT LEAST 30
KG
The recommended dose of LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 is one
tablet twice daily.
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 may be administered with or
without food.
If a reduction in dose of LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300
appears clinically indicated,
or if one of the components of LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300
(lamivudine or
zidovudine)
requires
reduction
or
discontinuation,
separate
preparations
of
lamivudine
and
zidovudine should be used.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, tablets may
be crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately (see section
5.2).
Page 2 of 18
_SPECIAL POPULATIONS_
RENAL IMPAIRMENT
Lamivudine and zidovudine concentrations are increased in patients
with renal impairment due to