Atectura Breezhaler

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

indacaterol acetate, Mometasone furoate

Saatavilla:

Novartis Europharm Limited 

ATC-koodi:

R03AK

INN (Kansainvälinen yleisnimi):

indacaterol, mometasone

Terapeuttinen ryhmä:

Drugs for obstructive airway diseases,

Terapeuttinen alue:

Asthma

Käyttöaiheet:

Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2020-05-30

Pakkausseloste

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 62.5 mcg of mometasone furoate.
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 127.5 mcg of mometasone furoate.
Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 260 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains approximately 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powder, with the
product code “IM150-80”
printed in blue above one blue bar on the body and with the product
logo printed in blue and
surrounded by two blue bars on the cap.
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powd

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 62.5 mcg of mometasone furoate.
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 127.5 mcg of mometasone furoate.
Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 260 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains approximately 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powder, with the
product code “IM150-80”
printed in blue above one blue bar on the body and with the product
logo printed in blue and
surrounded by two blue bars on the cap.
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powd