Bretaris Genuair
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-01-2023
Produktets egenskaber
(SPC)
05-01-2023
Offentlige vurderingsrapport
(PAR)
19-06-2017
Aktiv bestanddel:
aclidinium bromide
Tilgængelig fra:
Covis Pharma Europe B.V.
ATC-kode:
R03BB
INN (International Name):
aclidinium bromide
Terapeutisk gruppe:
Drugs for obstructive airway diseases,
Terapeutisk område:
Pulmonary Disease, Chronic Obstructive
Terapeutiske indikationer:
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Produkt oversigt:
Revision: 18
Autorisation status:
Authorised
Autorisation dato:
2012-07-20
Indlægsseddel
24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRETARIS GENUAIR 322 MICROGRAMS INHALATION POWDER
Aclidinium (aclidinium bromide)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Bretaris Genuair is and what it is used for
2.
What you need to know before you use Bretaris Genuair
3.
How to use Bretaris Genuair
4.
Possible side effects
5.
How to store Bretaris Genuair
6.
Contents of the pack and other information
Instructions for Use
1.
WHAT BRETARIS GENUAIR IS AND WHAT IT IS USED FOR
WHAT BRETARIS GENUAIR IS
The active ingredient of Bretaris Genuair is aclidinium bromide, which
belongs to a group of
medicines called bronchodilators. Bronchodilators relax airways and
help keep bronchioles open.
Bretaris Genuair is a dry powder inhaler that uses your breath to
deliver the medicine directly into
your lungs. This makes it easier for chronic obstructive pulmonary
disease (COPD) patients to breathe.
WHAT BRETARIS GENUAIR IS USED FOR
Bretaris Genuair is indicated to help open the airways and relieve
symptoms of COPD, a serious, long-
term lung disease characterised by breathing difficulties. Regular use
of Bretaris Genuair can help you
when you have ongoing shortness of breath related to your disease to
help you minimise the effects of
the dise
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Bretaris Genuair 322 micrograms inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 375 µg
aclidinium bromide equivalent
to 322 µg of aclidinium. This corresponds to a metered dose of 400
µg aclidinium bromide equivalent
to 343 µg aclidinium.
Excipients with known effect
Each delivered dose contains approximately 12 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White or almost white powder in a white inhaler with an integral dose
indicator and a green dosage
button.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bretaris Genuair is indicated as a maintenance bronchodilator
treatment to relieve symptoms in adult
patients with chronic obstructive pulmonary disease (COPD) (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one inhalation of 322 micrograms aclidinium
twice daily.
If a dose is missed the next dose should be taken as soon as possible.
However, if it is nearly time for
the next dose, the missed dose should be skipped.
_Elderly _
No dose adjustments are required for elderly patients (see section
5.2).
_ _
_Renal impairment _
No dose adjustments are required for patients with renal impairment
(see section 5.2).
_Hepatic impairment _
No dose adjustments are required for patients with hepatic impairment
(see section 5.2).
_ _
_Paediatric population_
There is no relevant use of Bretaris Genuair in children and
adolescents (under 18 years of age) for the
indication of COPD.
3
_ _
Method of administration
For inhalation use.
Patients should be instructed on how to administer the product
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