Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
30-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
30-01-2017
Public Assessment Report Public Assessment Report (PAR)
30-01-2017

Active ingredient:

Budesonide, formoterol

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol fumarate dihydrate

Therapeutic group:

Ravimid hingamisteede obstruktiivsete haiguste,

Therapeutic area:

Astma

Therapeutic indications:

Budesonide / Formoterol Teva Pharma B. on näidustatud ainult 18-aastastel ja vanematel täiskasvanutel. AsthmaBudesonide/Formoterol Teva Pharma B. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Product summary:

Revision: 1

Authorization status:

Endassetõmbunud

Authorization date:

2014-11-19

Patient Information leaflet

                                40
B. PAKENDI INFOLEHT
Ravimil on müügiluba lõppenud
41
PAKENDI INFOLEHT: TEAVE PATSIENDILE
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. 160 MIKROGRAMMI / 4,5
MIKROGRAMMI,
INHALATSIOONIPULBER
(budesoniid/formoteroolfumaraatdihüdraat)
ENNE RAVIMI KASUTAMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti, apteekri või
meditsiiniõega.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti,
apteekri või meditsiiniõega.
Kõrvaltoime võib olla ka selline, mida selles infolehes ei ole
nimetatud. Vt lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Budesonide/Formoterol Teva Pharma B.V. ja milleks seda
kasutatakse
2.
Mida on vaja teada enne Budesonide/Formoterol Teva Pharma B.V.
kasutamist
3.
Kuidas Budesonide/Formoterol Teva Pharma B.V.’d kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Budesonide/Formoterol Teva Pharma B.V.’d säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. JA MILLEKS SEDA
KASUTATAKSE
Budesonide/Formoterol Teva Pharma B.V. sisaldab kahte toimeainet:
budesoniidi ja
formoteroolfumaraatdihüdraati.
•
Budesoniid kuulub ravimite rühma, mida nimetatakse
kortikosteroidideks ehk steroidideks.
Ravim vähendab ja ennetab turset ja põletikku kopsudes ja kergendab
teie hingamist.
•
Formoteroolfumaraatdihüdraat kuulub ravimite rühma, mida nimetatakse
pikatoimelisteks
beeta2-adrenoretseptori agonistideks või bronhodilataatoriteks. See
toimib hingamisteede
silelihaseid lõõgastavalt. See aitab avada hingamisteid ja teil on
kergem hingata.
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. ON NÄIDUSTATUD KASUTAMISEKS
AINULT 18-AASTASTEL JA
VANEMATEL TÄISKASVANUTEL.
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. EI OLE NÄIDUSTATUD
KASUTAMISEKS 12 AASTA VANUSTEL JA
NOOREMATEL LASTEL JA 13…17 AA
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
Ravimil on müügiluba lõppenud
2
1.
RAVIMPREPARAADI NIMETUS
Budesonide/Formoterol Teva Pharma B.V. 160 mikrogrammi / 4,5
mikrogrammi inhalatsioonipulber
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks manustatav annus (Spiromax’i huulikult väljuv annus) sisaldab
160 mikrogrammi budesoniidi ja
4,5 mikrogrammi formoteroolfumaraatdihüdraati.
See vastab 200 mikrogrammi budesoniidi ja 6 mikrogrammi
formoteroolfumaraatdihüdraadi
mõõdetud annusele.
Teadaolevat toimet omav(ad) abiaine(d):
Üks annus sisaldab ligikaudu 5 milligrammi laktoosi
(monohüdraadina).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Inhalatsioonipulber.
Valge pulber.
Valge inhalaator poolläbipaistva veinpunase huulikukattega.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Budesonide/Formoterol Teva Pharma B.V. on näidustatud ainult
18-aastastel ja vanematel
täiskasvanutel.
Astma
_ _
Budesonide/Formoterol Teva Pharma B.V. on näidustatud astma
regulaarseks raviks, kui inhaleeritava
kortikosteroidi ja pikatoimelise beeta2-adrenoretseptori agonisti
kombineeritud kasutamine on sobiv:
- patsientidel, kellel inhaleeritavad kortikosteroidid ja „vastavalt
vajadusele“ inhaleeritavad
lühitoimelised beeta2-adrenoretseptori agonistid ei taga piisavat
kontrolli;
või
- patsientidel, kellel on juba saavutatud piisav kontroll
inhaleeritavate kortikosteroidide ja
pikatoimeliste beeta2-adrenoretseptori agonistidega.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Budesonide/Formoterol Teva Pharma B.V. on näidustatud ainult
18-aastastel ja vanematel
täiskasvanutel. Budesonide/Formoterol Teva Pharma B.V. ei ole
näidustatud 12 aasta vanustel ja
noorematel lastel ega 13…17 aasta vanustel noorukitel.
Annustamine
_Astma _
_ _
Ravimil on müügiluba lõppenud
3
Budesonide/Formoterol Teva Pharma B.V. ei ole mõeldud astma
esmaraviks.
Budesonide/Formoterol Teva Pharma B.V. ei ole sobiv raviks
täiskasvanud patsiendile, kelle astma on
kergekujuline ning ravi inhaleeritavate kortikosteroididega ja
„vastavalt vajadusele“ inhaleeri
                                
                                Read the complete document

Similar products

Active ingredient Budesonide, formoterol

Budesonide, formoterol

ATC code R03AK07

R03AK07

Marketed by Teva Pharma B.V.

Teva Pharma B.V.

INN (International Name) budesonide, formoterol fumarate dihydrate

budesonide, formoterol fumarate dihydrate

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Summary of Product characteristics Summary of Product characteristics Bulgarian 30-01-2017
Public Assessment Report Public Assessment Report Bulgarian 30-01-2017
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Summary of Product characteristics Summary of Product characteristics Spanish 30-01-2017
Public Assessment Report Public Assessment Report Spanish 30-01-2017
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