EKLIRA GENUAIR 322 MCG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ACLIDINIUM BROMIDE

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

R03BB05

الشكل الصيدلاني:

POWDER FOR INHALATION

تركيب:

ACLIDINIUM BROMIDE 0.4 MG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

INDUSTRIAS FARMACEUTICAS ALMIRALL, S.A., SPAIN

المجال العلاجي:

ACLIDINIUM BROMIDE

الخصائص العلاجية:

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

تاريخ الترخيص:

2019-03-31

نشرة المعلومات

Patient Leaflet According to the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Eklira
®
Genuair
®
Powder for inhalation
Active ingredient:
Each delivered dose contains 375 mcg of
aclidinium bromide
equivalent to 322 mcg of
aclidinium
.
For a list of inactive ingredients, please see section 6.
Also see 'Important information about some of the medicine's
ingredients' in section 2.
Read this entire leaflet carefully before using this medicine.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them, even if it seems to you that their illness
is similar to yours.
This medicine is not intended for children and adolescents under 18
years of age.
1.
What is the medicine intended for?
This medicine is indicated for maintenance bronchodilator treatment to
relieve symptoms
in adult patients with COPD (chronic obstructive pulmonary disease),
a serious, longterm
lung disease characterised by breathing difficulties.
Regular use of Eklira inhaler can help you when you have ongoing
shortness of breath
related to your disease and will help you to minimise the effects of
the disease on your
everyday life.
Therapeutic group:
Anticholinergics, bronchodilators.
2.
Before you use the medicine
X Do not use this medicine if:
•
Do not use if you are sensitive (allergic) to the active ingredient or
to any of the
other ingredients of this medicine (for a list of inactive
ingredients, please see
section 6).
Special warnings regarding the use of this medicine:
!
Before the treatment with Eklira tell your doctor:
•
if you have had heart problems recently.
•
if you see halos around lights or coloured images (glaucoma).
•
if you have an enlarged prostate, problems passing urine, or a
blockage in your
bladder.
Eklira is indicated for maintenance treatment and the inhaler is not

خصائص المنتج

1
EU PI 06 2018
The content of this leaflet was approved by the ministry of Health in
Feb 2016 and updated according
to the guidelines of the Ministry of Health in Dec 2018
1.
NAME OF THE MEDICINAL PRODUCT
Eklira Genuair
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 metered dose contains 12.6 mg lactose 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
Eklira 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 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 Eklira Genuair in children and adolescents
(under 18 years of age) for the
indication of COPD.
_ _
2
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 used previously.
It is important to instruct the
patients to carefully read the instructions for use in the Packa