TRIMBOW

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BECLOMETASONE DIPROPIONATE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM AS BROMIDE

متاح من:

KAMADA LTD, ISRAEL

ATC رمز:

R03AL09

الشكل الصيدلاني:

PRESSURISED SOLUTION

تركيب:

GLYCOPYRRONIUM AS BROMIDE 9 MCG/DELIVERED DOSE; FORMOTEROL FUMARATE DIHYDRATE 5.2 MCG/DELIVERED DOSE; BECLOMETASONE DIPROPIONATE 87.4 MCG/DELIVERED DOSE

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

CHIESI FARMACEUTICI S.P.A, ITALY

المجال العلاجي:

FORMOTEROL, GLYCOPYRRONIUM BROMIDE AND BECLOMETASONE

الخصائص العلاجية:

COPD 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 or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. 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.…

تاريخ الترخيص:

2020-06-24

نشرة المعلومات

CHIESI ITEM
PAG. 1/4 EN
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a
doctor’s prescription only
Trimbow
Pressurised inhalation solution
Composition
The active ingredients and their quantities:
Each delivered dose (the dose leaving the
mouthpiece) contains:
87 micrograms of beclometasone dipropionate,
5 micrograms of formoterol fumarate dihydrate,
9
micrograms
of
glycopyrronium
(as
11 micrograms glycopyrronium bromide).
Inactive ingredients and allergens: see section
6 in the leaflet “further information”.
Read this leaflet carefully in its entirety before
using
the
medicine.
This
leaflet
contains
concise information about the medicine. If you
have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your
ailment. Do not pass it on to others. It may harm
them even if it seems to you that their ailment
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
• Chronic
Obstructive
Pulmonary
Disease
(COPD)
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 or a combination of a long-acting beta2-
agonist and a long-acting muscarinic antagonist.
• 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.
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 t

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trimbow
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)
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 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
_Adults_
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.
_Asthma _
When choosing the starting dose strength of Trimbow 87/5/9 micrograms,
the pat