TRIXEO AEROSPHERE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

R03BA02

الشكل الصيدلاني:

SUSPENSION FOR INHALATION

تركيب:

FORMOTEROL FUMARATE DIHYDRATE 5 MCG; GLYCOPYRRONIUM 7.2 MCG; BUDESONIDE 160 MCG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASTRA ZENECA DUNKERQUE PRODUCTION (AZDP), FRANCE

المجال العلاجي:

BUDESONIDE

الخصائص العلاجية:

Trixeo Aerosphere is indicated as a 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 combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist

تاريخ الترخيص:

2022-05-12

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
TRIXEO
®
AEROSPHERE
®
5 mcg / 7.2 mcg / 160 mcg
Suspension for inhalation
Each dose (inhalation) contains:
Budesonide micronized 160 mcg
Glycopyrronium 7.2 mcg
Formoterol fumarate dihydrate micronized 5 mcg
For inactive ingredients in the medicine - please see section 6
“Further Information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor
or pharmacist.
This medicine has been prescribed for you. 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?
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 combination of a
long-acting beta2-
agonist and a long-acting muscarinic antagonist.
Therapeutic group
Formoterol fumarate dihydrate and glycopyrronium belong to a group of
medicines
called ‘bronchodilators’.
Budesonide belongs to a group of medicines called
‘corticosteroids’.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients of
this medicine (see section 6).
Special warnings regarding the use of Trixeo Aerosphere:
•
This medicine is intended for a long-term maintenance treatment for
COPD. Do
not use it to treat a sudden attack of breathlessness or wheezing.
•
Breathing difficulties immediately after using the medicine -
If you get tightness in the chest, coughing, wheezing or
breathlessness
immediately after using Trixeo Aerosphere,
stop using this medicine and tell your
doctor straight away (see ‘Serious side effects’ at the top of
Section 4).
•
If your br

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Trixeo Aerosphere
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation (delivered dose, ex-actuator) contains 5
micrograms of formoterol fumarate
dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2
micrograms of glycopyrronium,
and budesonide 160 micrograms.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trixeo Aerosphere is indicated as a 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 combination
of a long-acting beta2-agonist
and a long-acting muscarinic antagonist
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended and maximum dose is two inhalations twice daily (two
inhalations in the morning
and two inhalations in the evening).
If a dose is missed, it should be taken as soon as possible and the
next dose should be taken at the
usual time. A double dose should not be taken to make up for a
forgotten dose.
Special populations
_Elderly _
No dose adjustments are required in elderly patients (see section
5.2).
_Renal impairment _
This medicinal product can be used at the recommended dose in patients
with mild to moderate renal
impairment. It can also be used at the recommended dose in patients
with severe renal impairment or
end-stage renal disease requiring dialysis, only if the expected
benefit outweighs the potential risk (see
sections 4.4 and 5.2).
_Hepatic impairment _
This medicinal product can be used at the recommended dose in patients
with mild to moderate
hepatic impairment. It can also be used at the recommended dose in
patients with severe hepatic
impairment, only if the expected benefit outweighs the potential risk
(see sections 4.4 and 5.2).
_Paediatric population _
Trixeo Aerosphere is not indicated in children and adolesc