TRIMBOW (BECLOMETASONE DIPROPIONATEFORMOTEROL FUMARATEGLYCOPYRRONIUM BROMIDE 100612.5 MICROGRAMS PRESSURISED INHALATION SOLUTION)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM BROMIDE

Boleh didapati daripada:

Orient Europharma (M) Sdn Bhd

INN (Nama Antarabangsa):

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM BROMIDE

Unit dalam pakej:

120 ACTUATIONS

Dikeluarkan oleh:

CHIESI FARMACEUTICI SPA

Risalah maklumat

TRIMBOW PRESSURISED INHALATION SOLUTION
Beclometasone dipropionate / Formoterol Fumarate Dihydrate /
Glycopyrronium bromide ( 100/6/12.5 mcg/dose)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Trimbow is used for
2.
How Trimbow works
3.
Before you use Trimbow
4.
How to use Trimbow
5.
While you are using Trimbow
6. Side effects
7.
Storage and disposal of Trimbow
8. Product description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
_ _
HOW TRIMBOW WORKS
Trimbow is a pressurised inhalation
solution containing beclometasone
diproprionate, formoterol fumarate
dehydrate and glycopyrronium bromide.
Beclometasone dipropionate is a
glucocorticoid with anti-inflammatory
action to reduce the swelling and
irritation in the walls of the small air
passage in the lungs. Formoterol
fumarate and glycopyrronium are long-
acting bronchodilators which act in
different ways to relax the muscle in
your airways, helping to open the
airways wider and allowing to breathe
more easily. The combination of these
three active substances make breathing
easier, by providing relieve and prevent
symptoms such as shortness of breath,
wheezing and cough in adult patients
with chronic obstructive pulmonary
disease (COPD). Trimbow can reduce
flare-ups of COPD symptoms.
_ _
BEFORE YOU USE TRIMBOW
-
When you must not use it:
_ _
_Warnings and precautions_
Trimbow is used as a maintenance
treatment for your COPD. Do not use
this medicine to treat a sudden attack of
breathlessness or wheezing.
-If you are allergic or think you are
allergic to one or other of the active
ingredients of Trimbow, or if you are
allergic to other medicines or inhalers
used to treat asthma or to any of the other
ingredients of Trimbow, contact your
doctor for advice.
_Pregnancy and breast feeding _
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 using
this medicine.
You should only use Trimbow during
pregn

Ciri produk

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains
87 micrograms of beclometasone dipropionate, 5 micrograms
of formoterol fumarate dihydrate and 9 micrograms of
glycopyrronium (as 11 micrograms glycopyrronium bromide).
Each metered dose (the dose leaving the valve) contains 100
micrograms of beclometasone dipropionate, 6 micrograms
of formoterol fumarate dihydrate and 10 micrograms of
glycopyrronium (as 12.5 micrograms glycopyrronium bromide).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pressurised inhalation, solution (pressurised inhalation).
Colourless to yellowish liquid solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maintenance treatment in adult patients with moderate to severe
chronic obstructive pulmonary disease (COPD) who are not
adequately treated by a combination of an inhaled corticosteroid
and a long-acting beta2-agonist (for effects on symptoms control
and prevention of exacerbations see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose is two inhalations of Trimbow twice daily.
The maximum dose is two inhalations of Trimbow twice daily.
Special populations
_Elderly _
No dosage adjustment is required in elderly patients (65 years of
age and older).
_Renal impairment _
Trimbow can be used at the recommended dose in patients with
mild to moderate renal impairment. Use of Trimbow in patients
with severe renal impairment or end-stage renal disease requiring
dialysis, especially if associated with significant body weight
reduction, should be considered only if the expected benefit
outweighs the potential risk (see section 4.4 and section 5.2).
_Hepatic impairment _
There are no relevant data on the use of Trimbow in patients with
severe hepatic impairment and the medicinal product should be
used with caution in these patients (see section 4.4 and section
5.2).
_Paediatric population _
There is no relevant use of Trimbow in the paediatric population
(under 18