MAVILEX TABLET 0.02MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
06-04-2023
Ciri produk Ciri produk (SPC)
15-11-2022

Bahan aktif:

CLENBUTEROL HYDROCHLORIDE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

CLENBUTEROL HYDROCHLORIDE

Unit dalam pakej:

1000 Tablet Tablets; 500 Tablet Tablets; 250 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

                                _Consumer Medication Information Leaflet (RIMUP) _
MAVILEX TABLET
Clenbuterol hydrochloride 0.02mg
WHAT IS IN THE LEAFLET?
1.
What
MAVILEX
is
used
for
2.
How MAVILEX works
3.
Before you use MAVILEX
4.
How to use MAVILEX
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
MAVILEX
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT MAVILEX IS USED FOR
MAVILEX is used in people
with
asthma,
bronchitis
(inflammation
or
swelling
of
bronchial
tubes)
and
other
breathing problem.
Ask your doctor if you have
any
questions
about
why
MAVILEX
has
been
prescribed for you.
Your doctor may prescribe it
for another reason.
HOW MAVILEX WORKS
MAVILEX
contains
clenbuterol
hydrochloride.
Clenbuterol is a bronchodilator
and
belongs
to
a
group
of
medicines
called
beta-2-
agonists.
MAVILEX is used to open up
the
airways
so
that
you
can
breathe more easily.
BEFORE YOU USE MAVILEX
_When you must not use it _
Do not take MAVILEX if you
have
ever
had
an
allergic
reaction to:
•
any
medicine
containing
clenbuterol
or
any
other
medicines
used
to
treat
breathing problems.
•
any of the ingredients listed
at the end of this leaflet.
Do not take MAVILEX after
the expiry date (EXP) printed
on the pack.
Do
not
take
it
if
the
bottle
shows
signs
of
having
been
tampered with.
If you are not sure whether you
should
start
using
this
medicine, talk to your doctor or
pharmacist.
_Before you start to use it _
Tell
your
doctor
if
you
are
allergic to any other medicines
or
any
foods,
dyes
or
preservatives.
Tell your doctor if you have
any of the following medical
conditions:
•
heart problems
•
hypertension
(high
blood
pressure)
•
diabetes
•
thyroid problems
It may not be safe for you to
take
MAVILEX
if
you
have
any of these conditions.
Tell
your
doctor
if
you
are
pregnant
or
plan
to
become
pregnant, or breastfeeding.
Your doctor will advise you of
the risks and benefits of using
MAVILEX
during
pregnancy
and while breastfeeding.
If
you
have
not
told
your
doctor
about
any
of
these
things
                                
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Ciri produk

                                MAVILEX TABLET 0.02 MG
[DUOPHARMA (M) SDN BHD]
DESCRIPTION:
MAVILEX TABLET 0.02 MG: An oval, scored tablet, white in colour with
markings ‘DUO’ and ‘861’.
COMPOSITION:
MAVILEX TABLET 0.02 MG: Each tablet contains Clenbuterol HCl 0.02 mg.
PHARMACODYNAMICS:
It is a broncholytic agent which acts through selective stimulation of
the β2-receptors. It differs from other β2-specific sympathomimetics
by its low
dose, long biological half-life and rapid and complete absorption by
oral administration. It has no significant effects on β1-cardiac
receptors.
PHARMACOKINETICS:
Invasion half-life of Clenbuterol is 1 hour the distribution
corresponds to an open two compartment model with a side-compartment.
Elimination
from plasma takes place in 2 phases, the half-life of the α-phase
being 1 hour and that of β-phase 34 hours. Elimination is primarily
renal (87%
after 168 hours) 43% of Clenbuterol is recovered unchanged in the
urine. Dose intervals of 12 hours suffice to maintain a plasma level.
Five
metabolites have been found in humans.
INDICATIONS:
Prophylaxis and therapy of bronchospasm in bronchial asthma, acute and
chronic bronchitis associated with emphysema.
RECOMMENDED DOSAGE:
The recommended total daily dose for adults and children over 12 years
is 0.04 mg / day. In severe bronchospasm the dose may be increased to
0.08 mg / day twice daily; as therapy continues, the dose may often be
reduced to 0.02 mg / day. The recommended total daily dose for
children is
0.0012 mg / kg body weight, ranging from 0.0008 – 0.0015 mg Mavilex.
TABLET: _ADULTS AND CHILDREN OVER 12 YEARS: _0.02 mg twice daily.
Twice daily doses morning and evening provide for constant blood
levels. The duration of treatment depends upon the symptoms and there
is no
objection to long-term treatment.
ROUTE OF ADMINISTRATION: Oral
CONTRAINDICATIONS:
Thyrotoxicosis, idiopathic hypertrophic subvalvular aortic stenosis,
tachycardia, tachyarrhythmia. Known sensitivity to sympathomimetic
amines.
WARNINGS AND PRECAUTIONS:
Care must be exercised when a
                                
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