BRONKINE TABLET 2.5MG

País: Malàisia

Idioma: anglès

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

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
30-10-2019

ingredients actius:

TERBUTALINE SULPHATE

Disponible des:

IDAMAN PHARMA MANUFACTURING SDN BHD

Designació comuna internacional (DCI):

TERBUTALINE SULPHATE

Unidades en paquete:

1000 Tablets; 500 Tablets

Fabricat per:

IDAMAN PHARMA MANUFACTURING SDN BHD

Informació per a l'usuari

                                BRONKINE TABLET 2.5MG
Terbutaline sulphate (2.5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Bronkine Tablet 2.5mg is used for
2.
How Bronkine Tablet 2.5mg works
3.
Before you use Bronkine Tablet 2.5mg
4.
How to use Bronkine Tablet 2.5mg
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Bronkine
Tablet 2.5mg
8.
Product Description
9.
Product
Registration
Holder
and
Manufacturer
10.
Date of Revision
WHAT
BRONKINE TABLET 2.5MG IS USED FOR
Bronkine Tablet 2.5mg is used to relief and
prevent tightening of chest and difficulties
in breathing.
HOW
BRONKINE TABLET 2.5MG WORKS
It helps to open up the airways in the lung
by relaxing muscle of the airways.
BEFORE YOU USE BRONKINE TABLET 2.5MG
-
_When you must not use it _
Do not take this medicine if you are allergy
or hypersensitive to:
1.
Terbutaline sulphate.
2.
Any of the other ingredients listed at the
end of this leaflet.
Do not take this medicine after the expiry
date.
If you are not sure whether you should be
taking
this
medicine,
talk
to
your
pharmacist or doctor.
-
_Before you start to use it _
This medicine should not be used if you
have medical conditions such as:
1. Heart disease.
2. Diabetes.
3. Overactive thyroid gland.
4. High blood pressure
_ _
_Pregnancy and breast-feeding _
If you are pregnant, trying to get pregnant
or
think
you
may
be
pregnant
or
are
breastfeeding ask your doctor or pharmacist
for advice before taking any medicine.
Terbutaline should be taken with caution
during the early pregnancy since it relaxes
the womb.
Terbutaline released in breast milk does not
give therapeutic effects in infant.
-
_Taking other medicines _
Please tell your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines.
This
includes
medicines
that
you buy without a prescription and herbal
medicines.
Bronkine Tablet 2.5mg can affect the way
that
some
medicines
work
and
some
medicines can have an effect on Bronkine
Tablet 2.5mg.
In particular, tell your doctor or pharmacist
if
you

                                
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Fitxa tècnica

                                IDAMAN PHARMA MANUFACTURING
BRONKINE TABLET 2.5MG
DESCRIPTION
Clean,
uniform,
small,
round,
flat,
bevel
edged
tablet
and
scored on one side. Colour: White to off white.
Each tablet contains Terbutaline Sulphate 2.5mg.
Source of Lactose: Bovine
ROUTE OF ADMINISTRATION
Oral
PHARMACODYNAMICS
Terbutaline is a selective beta2-adrenergic stimulant having
the following pharmacological effects:-
i)
In
the
lung
-
bronchodilation;
increased
mucociliary
clearance; suppression of oedema and anti-allergic effects.
ii)
In skeletal muscle - stimulates Na+/K+ transport and also
causes
depression
of
subtetanic
contractions
in
slow-
contracting muscle.
iii)
In uterine muscle - inhibition of uterine contractions.
iv)
In the CNS - low penetration of the blood-brain barrier at
therapeutic doses, due to the highly hydrophilic nature of
the molecule.
v)
In
the
CVS
-
administration
of
terbutaline
results
in
cardiovascular effects mediated through beta2-receptors in
the peripheral arteries and in the heart e.g. in healthy
subjects, 0.25 - 0.5mg injected s.c. is associated with an
increase in cardiac output (up to 85% over controls) due to
an increase in heart rate and a larger stroke volume. The
increase in heart rate is probably due to a combination of a
reflex tachycardia via a fall in peripheral resistance and a
direct positive chronotropic effect of the drug.
PHARMACOKINETICS
Basic
parameters
have
been
evaluated
in
man
after
oral
administration of therapeutic doses:-
_Oral dose: _
Renal clearance (CLR) - 1.925 ml/min. (males)
Renal clearance (CLR) - 2.32 ml/min. (females)
Terminal half-life t½ has been determined after single and
multiple dosing (mean values varied between 16-20 hours).
_Bioavailability: _
Food reduces bioavailability following oral dosing (10% on
average).
Fasting values of 14-15% have been obtained.
_Metabolism: _
The main metabolite after oral dosing is the sulfate conjugate
and also some glucoronide conjugate can be found in the
urine.
INDICATIONS
Indicated for the relief and prevention of bronchospasm in
bronch
                                
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