BEROTEC N 100MCG/PUFF METERED DOSE INHALER

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENOTEROL HYDROBROMIDE

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

FENOTEROL HYDROBROMIDE

Unit dalam pakej:

10ml mL

Dikeluarkan oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Risalah maklumat

BEROTEC
® N METERED DOSE INHALER
Fenoterol hydrobromide (100mcg/puff in 10ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What BEROTEC is used for
2.
How BEROTEC works
3.
Before you use BEROTEC
4.
How to use BEROTEC
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BEROTEC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BEROTEC IS USED FOR
BEROTEC is used for the:
a)
treatment of acute asthma attacks
b)
prevention of exercise-induced
asthma
c)
treatment of asthma and/or other
conditions associated with
temporary narrowing of the airways
such as chronic obstructive
bronchitis. Concomitant anti-
inflammatory therapy should be
considered for people with asthma
and steroid responsive chronic
obstructive pulmonary disease
(COPD)
HOW BEROTEC WORKS
BEROTEC is a bronchodilator (anti-
asthmatic agent / beta
2
-agonist).
Fenoterol is an active substance that
rapidly dilates the constricted airways in
shortness of breath associated with
asthma and inflammation.
BEFORE YOU USE BEROTEC
-
_When you must not use it_
_ _
•
if you are hypersensitive (allergic)
to fenoterol or any of the other
ingredients of this medicine
(listed in
_Product description_
).
•
if you suffer from thickened heart
muscle that blocks the blood
outflow from the heart or with an
increased heart rate.
_ _
_Children and adolescents _
In children BEROTEC should only be
used on medical advice and under the
supervision of an adult.
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
-
_Before you start use it _
Take special care with BEROTEC:
•
If you have an overactive thyroid
gland
•
If you have an uncontrolled
diabetes
•
If you have a phaeochromocytoma
(tumour of the adrenal gland)
•
If you have a severe blood vessel
disease, suffer from a severe
underlying disease of the heart
(e.g. recent heart at

Ciri produk

Proposed Package Insert – Final Text
0237-05
20200323
BEROTEC

N 100 MCG/PUFF METERED DOSE INHALER
Abcd
COMPOSITION
BEROTEC
®
100MCG PRESSURISED INHALATION, SOLUTION; HFA
1 metered dose (actuation) contains
1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-
ethanol hydrobromide (= fenoterol hydrobromide)
100 mcg
propellant:
1,1,1,2-Tetrafluoroethane (HFA 134a)
other excipients:
citric acid anhydrous, purified water, ethanol absolute
DESCRIPTION
Clear, colourless liquid, free from suspended particles.
INDICATION
a)
Symptomatic treatment of acute asthma attacks
b)
Prophylaxis of exercise induced asthma.
c)
Symptomatic treatment of bronchial asthma and other conditions with
reversible airway narrowing e.g.
chronic obstructive bronchitis. Concomitant anti-inflammatory therapy
should be considered for patients
with bronchial asthma and steroid responsive chronic obstructive
pulmonary disease (COPD).
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Adrenergics for inhalative use in
obstructive airway diseases, selective beta-2-
adrenoreceptor agonists
ATC code: R03AC04
BEROTEC
®
is an effective bronchodilator for use in acute asthma in other
conditions with reversible airway
narrowing such as chronic obstructive bronchitis with or without
pulmonary emphysema.
Following inhalation of fenoterol hydrobromide in obstructive lung
diseases, bronchodilatation occurs within a
few minutes. The bronchodilator effect lasts 3-5 hours.
Mode of Action
Fenoterol hydrobromide is a direct acting sympathomimetic agent,
selectively stimulating beta
2
-receptors in the
therapeutic dose range. The stimulation of beta
1
-receptors comes into effect at a higher dose range. Occupation
of beta
2
-receptors activates adenyl cyclase via a stimulatory G
s
-protein. The increase in cyclic AMP activates
protein kinase A which then phosphorylates target proteins in smooth
muscle cells. This in turn leads to the
phosphorylation of myosin light chain kinase, inhibition of
phosphoinositide hydrolysis, and the opening of large-