EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter)

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

fluticasone propionate, Quantity: 250 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)

थमां उपलब्ध:

Alphapharm Pty Ltd

INN (इंटरनेशनल नाम):

fluticasone propionate,Salmeterol xinafoate

फार्मास्यूटिकल फॉर्म:

Inhalation, pressurised

रचना:

Excipient Ingredients: norflurane

प्रशासन का मार्ग:

Inhalation

पैकेज में यूनिट:

Sample Pack, 120 doses

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include:,*Patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Evocair is not indicated for the initiation of bronchodilator therapy in COPD.

उत्पाद समीक्षा:

Visual Identification: Actuator & metal can with concave base fitted with a metering valve and a plastic doese counter. The canister contains a white to off-white suspension. The internal surfaces of the can & the valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2014-05-07

सूचना पत्रक

EVOCAIR
® MDI
_Fluticasone propionate/Salmeterol xinafoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using EVOCAIR
MDI.
This leaflet answers some common
questions about EVOCAIR MDI. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking EVOCAIR
MDI against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EVOCAIR MDI IS
USED FOR
EVOCAIR MDI is available a
Metered Dose Inhaler (MDI) also
known as an "inhaler".
•
EVOCAIR MDI: 125/25, 250/25
EVOCAIR MDI is used to help with
asthma and chronic obstructive
pulmonary disease (COPD) in people
who need regular treatment.
Asthma is a condition affecting the
lungs. Symptoms of asthma include
shortness of breath, wheezing, chest
tightness and cough. Two main
causes of asthma symptoms are
bronchoconstriction (tightening of
the muscle surrounding the airways)
and inflammation (swelling and
irritation of the airways).
Chronic obstructive pulmonary
disease (COPD) is a long-term
condition affecting the lungs,
resulting from chronic bronchitis or
emphysema. Symptoms of COPD
include shortness of breath, cough,
chest discomfort and coughing up
phlegm. The COPD symptoms are
mainly due to bronchoconstriction
(tightening of the muscle
surrounding the airways) and
inflammation (swelling and irritation
of the airways).
EVOCAIR MDI contains two
medicines, fluticasone propionate
and salmeterol xinafoate.
Fluticasone propionate belongs to a
group of medicines known as
corticosteroids, frequently called
'steroids'. They are not 'anabolic
steroids' which are the steroids
sometimes misused by athletes.
Corticosteroids have an
anti-inflammatory action. They
reduce the swelling and irritation in
the walls of the small air passag

उत्पाद विशेषताएं

AUSTRALIAN PRODUCT INFORMATION
EVOCAIR
® MDI
_Fluticasone propionate/ salmeterol xinafoate _
_ _
1
NAME OF THE MEDICINE
Fluticasone propionate/ salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation provides 125 or 250 micrograms of fluticasone
propionate and 25 micrograms
of salmeterol (as xinafoate)
LIST OF EXCIPIENTS WITH KNOWN EFFECT
: None.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pressurised inhalation with counter
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the regular treatment of asthma, where the use of a combination
product is appropriate. This may
include:
•
Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled
corticosteroids
•
Patients who are symptomatic on current inhaled corticosteroid therapy
•
Initiation of maintenance therapy in those patients with moderate
persistent asthma not
adequately controlled on ‘as needed’ reliever medication, and who
have moderate/severe
airway limitation and daily symptoms requiring reliever medication
every day (see Section
5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).
For the symptomatic treatment of patients with severe COPD (FEV1<50%
predicted normal) and a
history of repeated exacerbations who have significant symptoms
despite regular beta-2 agonist
bronchodilator therapy. EVOCAIR is not indicated for the initiation of
bronchodilator therapy in
COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
EVOCAIR MDI is for inhalation only.
EVOCAIR MDI must be used regularly for optimum benefit, even when
asymptomatic.
Patients should be regularly assessed by a doctor, so the dose of
EVOCAIR they are receiving
remains optimal. Strength of dose should only be increased or
decreased on medical advice.
The use of one puff twice daily (bd) of the MDI has not been
investigated in clinical trials.
EVOCAIR MDI is supplied with a counter. The MDI comprises a suspension
of fluticasone
propionate and salmeterol in a CFC-free propellant. The suspension is