Trimbow
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
01-04-2022
Charakterystyka produktu
(SPC)
01-04-2022
Sprawozdanie z oceny publicznego
(PAR)
26-02-2021
Składnik aktywny:
Beclometasone dipropionate, formoterol fumarate dihydrate, Glycopyrronium bromide
Dostępny od:
Chiesi Farmaceutici S.p.A.
Kod ATC:
R03AL09
INN (International Nazwa):
beclometasone, formoterol, glycopyrronium bromide
Grupa terapeutyczna:
Drugs for obstructive airway diseases,
Dziedzina terapeutyczna:
Pulmonary Disease, Chronic Obstructive
Wskazania:
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.COPDMaintenance 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 or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).AsthmaMaintenance 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.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Authorised
Data autoryzacji:
2017-07-17
Ulotka dla pacjenta
95
B. PACKAGE LEAFLET
96
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMBOW 87 MICROGRAMS/5 MICROGRAMS/9 MICROGRAMS PRESSURISED
INHALATION, SOLUTION
beclometasone dipropionate/formoterol fumarate
dihydrate/glycopyrronium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trimbow is and what it is used for
2.
What you need to know before you use Trimbow
3.
How to use Trimbow
4.
Possible side effects
5.
How to store Trimbow
6.
Contents of the pack and other information
1.
WHAT TRIMBOW IS AND WHAT IT IS USED FOR
Trimbow is a medicine to help breathing that contains the three active
substances:
•
beclometasone dipropionate,
•
formoterol fumarate dihydrate and
•
glycopyrronium.
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
obstructive lung disease.
Trimbow is used for the regular treatment of
•
chronic obstructive pulmonary disease (COPD) in adults
•
asthma in adults.
Trimbow can reduce exacerbations (flare-ups) of COPD and asthma
symptoms.
COPD is a serious long-term disease in which the airways become
blocked and air sacs
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised
inhalation, solution
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).
Excipient with known effect:
Trimbow contains 8.856 mg ethanol per actuation.
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
Chronic obstructive pulmonary disease (COPD)
Maintenance treatment in adult patients with moderate to severe COPD
who are not adequately treated
by a combination of an inhaled corticosteroid and a long-acting
beta2-agonist or a combination of a
long-acting beta2-agonist and a long-acting muscarinic antagonist (for
effects on symptoms control
and prevention of exacerbations see section 5.1).
Asthma
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is two inhalations twice daily.
The maximum dose is two inhalations twice daily.
Patients should be advised to take Trimbow every day even when
asymptomatic.
If symptoms arise in the period between doses, an inhaled,
short-acting beta2-agonist should be used
for immediate relief.
3
_Asthma _
When choosing the starting dose strength of Trimbow (87/5/9 micro
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