Aerivio Spiromax
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-01-2020
Charakterystyka produktu
(SPC)
15-01-2020
Sprawozdanie z oceny publicznego
(PAR)
15-01-2020
Składnik aktywny:
salmeterol xinafoate, fluticasone propionate
Dostępny od:
Teva B.V.
Kod ATC:
R03AK06
INN (International Nazwa):
salmeterol, fluticasone propionate
Grupa terapeutyczna:
Drugs for obstructive airway diseases,
Dziedzina terapeutyczna:
Pulmonary Disease, Chronic Obstructive; Asthma
Wskazania:
Aerivio Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAerivio 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 product orpatients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2016-08-18
Ulotka dla pacjenta
30
B. PACKAGE LEAFLET
Medicinal product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AERIVIO 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 Aerivio Spiromax is and what it is used for
2.
What you need to know before you use Aerivio Spiromax
3.
How to use Aerivio Spiromax
4.
Possible side effects
5.
How to store Aerivio Spiromax
6.
Contents of the pack and other information
1.
WHAT AERIVIO SPIROMAX IS AND WHAT IT IS USED FOR
Aerivio 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 Aerivio Spiromax every day as directed by your doctor.
This will make sure that it works
properly in controlling your asthma or COPD.
AERIVIO SPIROMAX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING
ON. HOWEVER, AERIVIO SPIROMAX
SHOULD NOT BE USED TO RELIEVE AN ATTACK OF BREATHLESSNESS OR WHEEZING.
IF THIS HAPPENS YOU NEED TO
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Aerivio 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
Aerivio Spiromax is indicated for use in adults aged 18 years and
older only._ _
Asthma
Aerivio 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)
Aerivio 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
Aerivio Spiromax is indicated in adults 18 years of age and older
only.
Aerivio Spiromax is not indicated for use in children, 12 years of age
and younger or adolescents, 13 to 17
years of age.
_ _
Medicinal product no longer authorised
3
Posology
Route of administration: Inhalation use
Patients should be made aware that Aerivio Spiromax must be used daily
for optimum benefit, even when
a
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