Budesonide/Formoterol Teva

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
31-01-2017
Public Assessment Report Public Assessment Report (PAR)
31-01-2017

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol

Therapeutic group:

Ravimid hingamisteede obstruktiivsete haiguste,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Budesonide/Formoterol Teva on näidustatud täiskasvanutele 18-aastased ja vanemad ainult. AsthmaBudesonide/Formoterol Teva on näidustatud regulaarne astma raviks, kui kasutada kombinatsiooni (inhaleeritava kortikosteroidi ja pika toimeajaga β2 adrenoceptor agonist) on asjakohane:patsientidel ei ole piisavalt kontrollitud inhaleeritava kortikosteroide ja "nii nagu vaja" sisse hingata lühikese toimeajaga β2 adrenoceptor agonistid. orin patsiendid juba piisavalt kontrollitud, nii inhaleeritava kortikosteroide ja pika toimeajaga β2 adrenoceptor agonistid. COPDSymptomatic patsientide ravi raske COPD (FEV1 < 50% prognoositav tavaline) ja ajaloo korduvad ägenemised, kes on märkimisväärne sümptomid hoolimata regulaarne ravi pika toimeajaga bronhodilataatorite.

Product summary:

Revision: 2

Authorization status:

Endassetõmbunud

Authorization date:

2014-11-19

Patient Information leaflet

                                42
B. PAKENDI INFOLEHT
Ravimil on müügiluba lõppenud
43
PAKENDI INFOLEHT: TEAVE PATSIENDILE
BUDESONIDE/FORMOTEROL TEVA 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 ja milleks seda kasutatakse
2.
Mida on vaja teada enne Budesonide/Formoterol Teva kasutamist
3.
Kuidas Budesonide/Formoterol Teva’t kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Budesonide/Formoterol Teva’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON BUDESONIDE/FORMOTEROL TEVA JA MILLEKS SEDA KASUTATAKSE
Budesonide/Formoterol Teva 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 ON NÄIDUSTATUD KASUTAMISEKS AINULT
18-AASTASTEL JA VANEMATEL
TÄISKASVANUTEL.
BUDESONIDE/FORMOTEROL TEVA EI OLE NÄIDUSTATUD KASUTAMISEKS 12 AASTA
VANUSTEL JA NOOREMATEL
LASTEL JA 13…17 AASTA VANUSTEL NOORUKITEL.
Arst on teile selle ravimi määranud astma või kroonilise
obstruktiivse kopsuhaig
                                
                                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 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 on näidustatud ainult 18-aastastel ja
vanematel täiskasvanutel.
Astma
_ _
Budesonide/Formoterol Teva on näidustatud astma regulaarseks raviks,
kui inhaleeritava
kortikosteroidi ja pikatoimelise beeta2-adrenotseptori 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.
KOK
_ _
Raske kroonilise obstruktiivse kopsuhaiguse (KOK) (FEV
1
< 50% normist) ja korduvate ägenemiste
anamneesiga patsientide sümptomaatiline ravi, kui väljendunud
haigussümptomid püsivad vaatamata
regulaarsele ravile pikatoimeliste bronhodilataatoritega.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Budesonide/Formoterol Teva on näidustatud ainult 18-aastastel ja
vanematel täiskasvanutel.
Budesonide/Formoterol Teva ei ole näidustatud 12 aasta vanustel ja
noorematel lastel ega
13…17 aasta vanustel noorukitel.
Ravimil on müügiluba lõppenud
3
Annustamine
_Astma _
_ _
Budesonide/Formoterol Teva ei ole mõeldud astma esmaraviks.
Budesonide/
                                
                                Read the complete document

Similar products

Active ingredient Budesonide, formoterol fumarate dihydrate

Budesonide, formoterol fumarate dihydrate

ATC code R03AK07

R03AK07

Marketed by Teva Pharma B.V.

Teva Pharma B.V.

INN (International Name) budesonide, formoterol

budesonide, formoterol

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Public Assessment Report Public Assessment Report Bulgarian 31-01-2017
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