Airexar Spiromax
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
12-10-2018
Vara einkenni
(SPC)
12-10-2018
Opinber matsskýrsla
(PAR)
05-09-2016
Virkt innihaldsefni:
salmeterol, fluticasone propionate
Fáanlegur frá:
Teva B.V.
ATC númer:
R03AK06
INN (Alþjóðlegt nafn):
salmeterol xinafoate, fluticasone propionate
Meðferðarhópur:
Drugs for obstructive airway diseases,
Lækningarsvæði:
Pulmonary Disease, Chronic Obstructive; Asthma
Ábendingar:
Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1
Vörulýsing:
Revision: 2
Leyfisstaða:
Withdrawn
Leyfisdagur:
2016-08-18
Upplýsingar fylgiseðill
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AIREXAR SPIROMAX 50 MICROGRAMS/500 MICROGRAMS INHALATION POWDER
salmeterol/fluticasone propionate
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 Airexar Spiromax is and what it is used for
2.
What you need to know before you use Airexar Spiromax
3.
How to use Airexar Spiromax
4.
Possible side effects
5.
How to store Airexar Spiromax
6.
Contents of the pack and other information
1.
WHAT AIREXAR SPIROMAX IS AND WHAT IT IS USED FOR
Airexar Spiromax contains two medicines, salmeterol and fluticasone
propionate:
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay open.
This makes it easier for air to get in and out. The effects last for
at least 12 hours.
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
Your doctor has prescribed this medicine for the treatment of either
Severe asthma, to help prevent attacks of breathlessness and
wheeziness,
or
Chronic obstructive pulmonary disease (COPD), to reduce the number of
flare ups of symptoms.
You must use Airexar Spiromax every day as directed by your doctor.
This will make sure that it works
properly in controlling your asthma or COPD.
AIREXAR SPIROMAX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING
ON. HOWEVER, AIREXAR SPIROMAX
SHOULD NOT BE USED TO RELIEVE AN ATTACK OF BREATHLESSNESS OR WHEEZING.
IF THIS HAPPENS YOU NEED TO USE A
FAST-ACTING ‘RELIEVER’ (‘RE
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Airexar Spiromax 50 micrograms/500 micrograms inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 50 micrograms of salmeterol (as salmeterol
xinafoate) and 500 micrograms of
fluticasone propionate.
Each delivered dose (the dose from the mouthpiece) contains 45
micrograms of salmeterol (as salmeterol
xinafoate) and 465 micrograms of fluticasone propionate.
Excipient(s) with known effect:
Each dose contains approximately 10 milligrams of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White powder.
White inhaler with a semi-transparent yellow mouthpiece cover.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Airexar Spiromax is indicated for use in adults aged 18 years and
older only._ _
Asthma
Airexar Spiromax is indicated for the regular treatment of patients
with severe asthma where use of a
combination product_ _(inhaled corticosteroid and long-acting β
2
agonist) is_ _appropriate:
-
patients not adequately controlled on a lower strength corticosteroid
combination product
or
-
patients already controlled on a high dose inhaled corticosteroid and
long-acting β
2
agonist.
Chronic Obstructive Pulmonary Disease (COPD)
Airexar Spiromax is indicated for the symptomatic treatment of
patients with COPD, with a FEV
1
<60%
predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have significant
symptoms despite regular bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Airexar Spiromax is indicated in adults 18 years of age and older
only.
Airexar Spiromax is not indicated for use in children, 12 years of age
and younger or adolescents, 13 to 17
years of age.
_ _
3
Posology
Route of administration: Inhalation use
Patients should be made aware that Airexar Spiromax must be used daily
for optimum benefit, even when
asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
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