Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Romanian

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:

Medicamente pentru afecțiuni obstructive ale căilor respiratorii,

Therapeutic area:

Astm

Therapeutic indications:

Budesonidă / Formoterol Teva Pharma B. este indicat numai la adulți cu vârsta de 18 ani și peste. 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:

retrasă

Authorization date:

2014-11-19

Patient Information leaflet

                                43
B. PROSPECTUL
Medicamentul nu mai este autorizat
44
PROSPECT: INFORMAŢII PENTRU PACIENT
BUDESONIDĂ/FORMOTEROL TEVA PHARMA B.V. 160 MICROGRAME/4,5 MICROGRAME
PULBERE DE INHALAT
budesonidă/fumarat de formoterol dihidrat
CITIŢI CU ATENŢIE ŞI ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A
ÎNCEPE SĂ UTILIZAŢI ACEST MEDICAMENT
DEOARECE CONŢINE INFORMAŢII IMPORTANTE PENTRU DUMNEAVOASTRĂ.
-
Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.
-
Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului
dumneavoastră, farmacistului sau
asistentei medicale.
-
Acest medicament a fost prescris numai pentru dumneavoastră. Nu
trebuie să-l daţi altor
persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală
ca dumneavoastră.
-
Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului
dumneavoastră, farmacistului sau
asistentei medicale. Acestea includ orice posibile reacţii adverse
nemenţionate în acest prospect.
Vezi pct. 4.
CE GĂSIŢI ÎN ACEST PROSPECT
1.
Ce este Budesonidă/Formoterol Teva Pharma B.V. şi pentru ce se
utilizează (pagina 3)
2.
Ce trebuie să ştiţi înainte să utilizaţi Budesonidă/Formoterol
Teva Pharma B.V. (pagina 5)
3.
Cum să utilizaţi Budesonidă/Formoterol Teva Pharma B.V. (pagina 9)
4.
Reacţii adverse posibile (pagina 18)
5.
Cum se păstrează Budesonidă/Formoterol Teva Pharma B.V. (pagina 21)
6.
Conţinutul ambalajului şi alte informaţii (pagina 22)
1.
CE ESTE BUDESONIDĂ/FORMOTEROL TEVA PHARMA B.V. ŞI PENTRU CE SE
UTILIZEAZĂ
Budesonidă/Formoterol Teva Pharma B.V. conţine două substanţe
active diferite: budesonidă şi
fumarat de formoterol dihidrat.
•
Budesonida aparţine unui grup de medicamente denumite
„corticosteroizi”, cunoscute şi sub
denumirea de „steroizi”. Acţionează prin reducerea şi
prevenirea umflării şi inflamaţiei din
plămânii dumneavoastră şi vă ajută să respiraţi mai uşor.
•
Fumaratul de formoterol dihidrat aparţine grupului de medicamente
denumite „agonişti β
2
-

                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
Medicamentul nu mai este autorizat
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Budesonidă/Formoterol Teva Pharma B.V. 160 micrograme/4,5 micrograme
pulbere de inhalat
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
Fiecare doză administrată (doza care este eliberată prin piesa
bucală a inhalatorului Spiromax) conţine
budesonidă 160 micrograme şi fumarat de formoterol dihidrat 4,5
micrograme.
Aceasta este echivalentă cu o doză măsurată de budesonidă 200
micrograme şi fumarat de formoterol
dihidrat 6 micrograme.
Excipient(ţi) cu efect cunoscut:
Fiecare doză conţine lactoză aproximativ 5 miligrame (sub formă de
lactoză monohidrat)
Pentru lista tuturor excipienţilor, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Pulbere de inhalat.
Pulbere de culoare albă.
Inhalator de culoare albă cu o piesă bucală cu capac
semi-transparent de culoare roşu închis.
4.
DATE CLINICE
4.1
INDICAŢII TERAPEUTICE
Budesonidă/Formoterol Teva Pharma B.V. este indicat doar la adulţi
cu vârsta de 18 ani şi peste.
Astm bronşic
_ _
Budesonidă/Formoterol Teva Pharma B.V. este indicat în tratamentul
cronic al astmului bronşic, în
cazurile în care este adecvată utilizarea unei asocieri
(corticosteroid şi agonist β
2
-adrenergic cu durată
lungă de acţiune, cu administrare inhalatorie):
-
la pacienţii care nu sunt controlaţi în mod adecvat cu
corticosteroizi administraţi inhalator şi cu
agonişti β
2
-adrenergici cu durată scurtă de acţiune administraţi inhalator
sau
-
la pacienţii care sunt deja controlaţi adecvat prin utilizarea atât
a corticosteroizilor administraţi
inhalator, cât şi a agoniştilor β
2
-adrenergici cu durată lungă de acţiune administraţi inhalator.
4.2
DOZE ŞI MOD DE ADMINISTRARE
Budesonidă/Formoterol Teva Pharma B.V. este indicat doar la adulţi
cu vârsta de 18 ani şi peste.
Budesonidă/Formoterol Teva Pharma B.V. nu este indicat pentru
utilizare la copii cu vârsta de 12 ani
sau mai mici sau la adolescenţi cu vârsta cuprins
                                
                                Read the complete document

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Active ingredient Budesonide, formoterol

Budesonide, formoterol

ATC code R03AK07

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Marketed by Teva Pharma B.V.

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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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