TRIMBOW 200/6/10 beclometasone dipropionate 200 ug formoterol fumarate dihydrate 6 ug glycopyrronium 10 ug pressurised inhalation solution pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

formoterol fumarate dihydrate, Quantity: 6 microgram; beclometasone dipropionate, Quantity: 200 microgram; glycopyrronium bromide, Quantity: 12.5 microgram (Equivalent: glycopyrronium, Qty microgram)

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: ethanol absolute; norflurane; dilute hydrochloric acid

Administration route:

Inhalation

Units in package:

3 x 120 actuations, 1 x 60 actuations, 2 x 120 actuations, 1 x 120 actuations

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma TRIMBOW 200/6/10 Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Product summary:

Visual Identification: An aluminium canister with metering valve and grey polypropylene actuator with a green cap and a dose counter or dose indicator; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: PP/Al; Container Life Time: 20 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-05-26

Patient Information leaflet

TRIMBOW CMI v7.0
1
TRIMBOW
®
100/6/10 AND 200/6/10
_Beclometasone dipropionate 100 or 200 micrograms, formoterol
(eformoterol) fumarate dihydrate _
_6 micrograms and glycopyrronium (as bromide) 10 micrograms per spray
_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
TRIMBOW. 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 being given this
medicine against the benefits this
medicine is expected to 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 TRIMBOW IS
USED FOR
TRIMBOW is a pressurised metered-
dose inhaler that contains medicines
to help you breathe.
TRIMBOW contains the three active
ingredients:
•
beclometasone dipropionate
•
formoterol (eformoterol)
fumarate dihydrate
•
glycopyrronium bromide
(glycopyrrolate).
Beclometasone dipropionate belongs
to a group of medicines called
corticosteroids which act to reduce
the swelling and irritation in your
lungs.
Formoterol (eformoterol) fumarate
dihydrate and glycopyrronium
bromide (glycopyrrolate) are
medicines called long-acting
bronchodilators. They act in different
ways to relax the muscles in your
airways, helping to open the airways
wider and allowing you to breathe
more easily.
Regular treatment with this medicine
helps to relieve and prevent
symptoms such as shortness of
breath, wheezing and cough in adult
patients with chronic obstructive
pulmonary disease (COPD) and
asthma.
COPD is a serious long-term disease
in which the airways become blocked
and air sacs inside the lungs become
damaged, leading to difficulty in
breathing.
Asthma is a serious, long-term
disease where the muscles
surrounding the airways become tight
(bronchoconstriction), and swollen
and irritated (inflammation).
Symptoms can come and go, which
can

Summary of Product characteristics

TRIMBOW PI v8.0
1
AUSTRALIAN PRODUCT INFORMATION - TRIMBOW
®
(BECLOMETASONE DIPROPIONATE, FORMOTEROL (EFORMOTEROL) FUMARATE
DIHYDRATE AND
GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE) PRESSURISED INHALATION
SOLUTION
1.
NAME OF THE MEDICINE
Beclometasone dipropionate, formoterol (eformoterol) fumarate
dihydrate and glycopyrronium
bromide (glycopyrrolate).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIMBOW 100/6/10
Each metered dose (the dose leaving the valve) contains 100 micrograms
of beclometasone
dipropionate (BDP), 6 micrograms of formoterol fumarate dihydrate (FF)
and 10 micrograms of
glycopyrronium (equivalent to 12.5 micrograms of glycopyrronium
bromide) (GB).
Each delivered dose (the dose leaving the mouthpiece) contains 87
micrograms of
beclometasone dipropionate (BDP), 5 micrograms of formoterol fumarate
dihydrate (FF) and
9 micrograms of glycopyrronium (equivalent to 11 micrograms of
glycopyrronium bromide)
(GB).
TRIMBOW 200/6/10
Each metered dose (the dose leaving the valve) contains 200 micrograms
of beclometasone
dipropionate (BDP), 6 micrograms of formoterol fumarate dihydrate (FF)
and 10 micrograms of
glycopyrronium (equivalent to 12.5 micrograms of glycopyrronium
bromide) (GB).
Each delivered dose (the dose leaving the mouthpiece) contains 172
micrograms of
beclometasone dipropionate (BDP), 5 micrograms of formoterol fumarate
dihydrate (FF) and
9 micrograms of glycopyrronium (equivalent to 11 micrograms
glycopyrronium bromide) (GB).
List of excipient(s) with known effect: ethanol absolute.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Pressurised inhalation solution (pressurised inhalation).
Colourless to yellowish liquid solution.
The inhalation solution is contained in a pressurised aluminium
container sealed with a metering
valve. The canister is inserted into a polypropylene plastic actuator
which incorporates a
mouthpiece and is fitted with a plastic protective cap. The actuator
is grey with a red cap
(TRIMBOW 100/6/10) or green cap (TRIMBOW 200/6/10)