Duaklir Genuair 340/12 mcg Inhalation Powder

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

FORMOTEROL FUMARATE DIHYDRATE; Aclidinium Bromide

Disponível em:

ASTRAZENECA SDN. BHD.

DCI (Denominação Comum Internacional):

FORMOTEROL FUMARATE DIHYDRATE; Aclidinium Bromide

Unidades em pacote:

1units Units

Fabricado por:

Industrias Farmaceuticas Almirall, S.A. (IFA)

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
DUAKLIR GENUAIR INHALATION POWDER
340MCG ACLIDINIUM (396 MCG ACLIDINIUM BROMIDE) / 11.8 MCG FORMOTEROL
FUMARATE DIHYDRATE
1
WHAT IS IN THIS LEAFLET
1.
What Duaklir Genuair is
used for
2.
How Duaklir Genuair
works
3.
Before you use Duaklir
Genuair
4.
How to use Duaklir
Genuair
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Duaklir Genuair
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DUAKLIR GENUAIR IS
USED FOR
Duaklir Genuair is used for
adult patients who have
breathing difficulties due to a
lung disease called chronic
obstructive pulmonary disease
(COPD), in which the airways
and air sacs in the lungs
become damaged or blocked.
By opening the airways, the
medicine helps relieve
symptoms such as shortness of
breath. Taking Duaklir Genuair
regularly will help to minimise
the effects of COPD on your
everyday life.
HOW DUAKLIR GENUAIR WORKS
This medicine contains two
active ingredients called
aclidinium and formoterol
fumarate dihydrate. Both
belong to a group of medicines
called bronchodilators.
Bronchodilators relax the
muscles in your airways, which
allow the airways to open more
widely and help you to breathe
more easily. The Genuair
inhaler delivers the active
ingredients directly into your
lungs as you breathe in.
BEFORE YOU USE DUAKLIR
GENUAIR
_When you must not use it _
Do not use Duaklir Genuair if
you are allergic to aclidinium,
formoterol fumarate dihydrate
or to the other ingredient of
this medicine, lactose (see
section
_Things to be careful of_
under “Duaklir Genuair
contains lactose”).
_Before you start to use it _
Talk to your doctor, pharmacist
or nurse before using Duaklir
Genuair, if you have any of the
following conditions/
symptoms:
-
If you have asthma. This
medicine should not be used
for the treatment of asthma.
-
If you have heart problems.
-
If you have epilepsy.
-
If you have thyroid gland
problems (thyrotoxicosis).
-
If you have a tumour in one
of your adrenal

Características técnicas

1. NAME OF THE MEDICINAL PRODUCT
Duaklir Genuair 340/12 mcg inhalation powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 396 mcg of aclidinium bromide
(equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate dihydrate. This
corresponds to a metered dose of 400 mcg of aclidinium bromide (equivalent to 343 mcg of
aclidinium) and a metered dose of 12 mcg of formoterol fumarate dihydrate.
Excipients with known ef fect:
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 in halation of Duaklir Genuair 340 /12 mcg 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 d ose 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.