TRIMBOW 100/6/10 beclometasone dipropionate 100 ug formoterol fumarate dihydrate 6 ug glycopyrronium 10 ug pressurised inhalation solution pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

formoterol fumarate dihydrate, Quantity: 6 microgram; beclometasone dipropionate, Quantity: 100 microgram; glycopyrronium bromide, Quantity: 12.5 microgram (Equivalent: glycopyrronium, Qty 10 microgram)

Sẵn có từ:

Chiesi Australia Pty Ltd

Dạng dược phẩm:

Inhalation, pressurised

Thành phần:

Excipient Ingredients: ethanol absolute; norflurane; hydrochloric acid

Tuyến hành chính:

Inhalation

Các đơn vị trong gói:

1 x 120 actuations, 1 x 180 actuations, 1 x 60 actuations, 3 x 120 actuations, 2 x 120 actuations

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

COPD TRIMBOW 100/6/10 is indicated for 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 (ICS) and a long-acting beta2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA). Asthma TRIMBOW 100/6/10 Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Tóm tắt sản phẩm:

Visual Identification: An aluminium canister with metering valve and grey polypropylene actuator with a red 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

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2020-06-24

Tờ rơi thông tin

TRIMBOW AU CMI Ver 6.0
1
TRIMBOW
®
_Beclometasone dipropionate, formoterol (eformoterol) fumarate
dihydrate and _
_glycopyrronium (as bromide) (100/6/10 micrograms per spray)
pressurised inhalation _
_solution_
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
TRIMBOW.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. 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, YOU
MAY NEED TO READ IT
AGAIN.
WHAT
TRIMBOW IS
USED FOR
TRIMBOW is a medicine to
help breathing that contains
the three active substances:
•
beclometasone
dipropionate,
•
formoterol (eformoterol)
fumarate dihydrate and
•
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 and
glycopyrronium 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 these
three active substances helps to
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. COPD is a serious
long-term disease in which the
airways become blocked and
air sacs inside the lungs
become damaged, leading to
difficulty breathing.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
TRIMBOW HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE
GIVEN
TRIMBOW
_WHEN YOU MUST NOT BE _
_GIVEN IT _
TRIMBOW should not be taken
if you are allergic to beclometa

Đặc tính sản phẩm

TRIMBOW Product Information
TRIMBOW PI v7.0
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
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, 5 micrograms of formoterol fumarate
dihydrate and 9 micrograms
of glycopyrronium (equivalent to 11 micrograms of glycopyrronium
bromide) (GB).
List of excipient(s) with known effect: alcohol.
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. The
actuator has a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRIMBOW is indicated for 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 (ICS) and a long-acting
beta2-agonist (LABA) or a
combination of a LABA and a long-acting muscarinic antagonist (LAMA)
4.2
DOSE AND METHOD OF ADMINISTRATION
TRIMBOW is for inhalation use.
DOSAGE
TRIMBOW is not to be used as initial therapy but may be considered as
step-up from
LABA/LAMA or ICS/LAB