DUAKLIR GENUAIR 34012 MCG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ACLIDINIUM AS BROMIDE; FORMOTEROL FUMARATE DIHYDRATE

Tilgjengelig fra:

ASTRAZENECA (ISRAEL) LTD

ATC-kode:

R03BB05

Legemiddelform:

POWDER FOR INHALATION

Sammensetning:

FORMOTEROL FUMARATE DIHYDRATE 11.8 MCG; ACLIDINIUM AS BROMIDE 340 MCG

Administreringsrute:

INHALATION

Resept typen:

Required

Produsert av:

INDUSTRIAS FARMACEUTICAS ALMIRALL, S.A., SPAIN

Terapeutisk område:

ACLIDINIUM BROMIDE

Indikasjoner:

Maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD)

Autorisasjon dato:

2021-01-31

Informasjon til brukeren

Patient Package Leaflet in Accordance With
the Pharmacists’ Regulations (Preparations) – 1986
The medicine is dispensed with a doctor’s prescription only
Duaklir® Genuair®
340/12 micrograms
inhalation powder
Active ingredients:
Each dose for inhalation contains:
396 mcg aclidinium bromide, equivalent to 340 mcg aclidinium and 11.8
mcg formoterol
fumarate dihydrate.
For a list of inactive ingredients please refer to Section 6.
See also ‘Important information about some of the ingredients of the
medicine’ in Section
2.
Read this leaflet carefully in its entirety before using the medicine.
Keep this leaflet, you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
This medicine is not intended for children and adolescents under the
age of 18 years.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is used as maintenance bronchodilator treatment in order
to relieve
symptoms in adults who suffer from COPD (chronic obstructive pulmonary
disease). In
this disease the airways in the lungs become damaged or blocked. By
opening the
airways, the medicine helps relieve symptoms such as shortness of
breath. Using the
inhaler regularly will help to minimise the effects of COPD on your
everyday life.
Therapeutic group:
This medicine contains two active ingredients from the bronchodilators
group.
Aclidinium bromide: anticholinergic.
Formoterol fumarate dihydrate: beta-agonist (long lasting activity).
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
Special warnings regarding use of the medicine:
Before treatment with Duaklir Genuair, tell the doctor if you have:
•
asthma. This medicine should not be used for the treatment of asthma
•
heart problems
•
epilepsy
•
thyroid gland problems (thyrotoxicosis)
•
a tumour in one of your adrenal gla

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Duaklir Genuair 340 micrograms /12 micrograms inhalation powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 396
micrograms of
aclidinium bromide (equivalent to 340 micrograms of aclidinium) and
11.8 micrograms of
formoterol fumarate dihydrate. This corresponds to a metered dose of
400 micrograms of
aclidinium bromide (equivalent to 343 micrograms of aclidinium) and a
metered dose of 12
micrograms of formoterol fumarate dihydrate.
Excipients with known effect:
Each delivered dose contains approximately 11 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 an orange
dosage button.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Duaklir Genuair is indicated as a maintenance bronchodilator treatment
to relieve symptoms
in adult patients with chronic obstructive pulmonary disease (COPD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one inhalation of Duaklir Genuair 340
micrograms /12 micrograms
twice daily.
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.
Elderly
No dose adjustments are required in elderly patients (see section
5.2).
Renal impairment
No dose adjustments are required in patients with renal impairment
(see section 5.2).
Hepatic impairment
No dose adjustments are required in patients with hepatic impairment
(see section 5.2).
Paediatric population
There is no relevant use of Duaklir Genuair in children and
adolescents (under 18 years of
age) for the indication of COPD.
Method of administration
For inhalation use.
Patients should be instructed on how to administer the product
correctly
as the Genuair
inhaler may work differently from inhalers the patients may have