Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
30-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
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:

Lyf til veikindi öndunarvegi sjúkdómum,

Therapeutic area:

Astma

Therapeutic indications:

Budesonid / Formoterol Teva Pharma B. er ætlað fullorðnum 18 ára og eldri. AsthmaBudesonide/Formóteróli Sjá 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:

Aftakað

Authorization date:

2014-11-19

Patient Information leaflet

                                40
B. FYLGISEÐILL
Lyfið er ekki lengur með markaðsleyfi
41
FYLGISEÐILL: UPPLÝSINGAR FYRIR SJÚKLING
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. 160 MÍKRÓGRÖMM/4,5
MÍKRÓGRÖMM, INNÖNDUNARDUFT
(búdesóníð/ formóterólfúmarat tvíhýdrat)
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins
ef þörf er á frekari upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn, lyfjafræðing eða hjúkrunarfræðinginn vita um
allar aukaverkanir. Þetta gildir
einnig um aukaverkanir sem ekki er minnst á í þessum fylgiseðli.
Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR:
1.
Upplýsingar um Budesonide/Formoterol Teva Pharma B.V. og við hverju
það er notað (bls. 3)
2.
Áður en byrjað er að nota Budesonide/Formoterol Teva Pharma B.V.
(bls. 5)
3.
Hvernig nota á Budesonide/Formoterol Teva Pharma B.V. (bls. 9)
4.
Hugsanlegar aukaverkanir (bls. 18)
5.
Hvernig geyma á Budesonide/Formoterol Teva Pharma B.V. (bls. 21)
6.
Pakkningar og aðrar upplýsingar (bls. 22)
1.
UPPLÝSINGAR UM BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. OG VIÐ HVERJU
ÞAÐ ER NOTAÐ
Budesonide/Formoterol Teva Pharma B.V. inniheldur tvö mismunandi virk
efni: búdesóníð og
formóterólfúmarat tvíhýdrat.

Búdesóníð tilheyrir hópi lyfja sem kallast barksterar, einnig
kallaðir sterar. Það hefur áhrif með
því að draga úr og koma í veg fyrir bólgu og þrota í lungunum
og hjálpar þér að anda.

Formóterólfúmarat tvíhýdrat tilheyrir hópi lyfja sem kallast
langverkandi
β
2
-adrenviðtakaörvar
eða berkjuvíkkandi lyf. Það hefur áhrif með því að slaka á
vöðvum í öndunarvegi. Það opnar
öndunarveginn og hjálpar þér að anda.

                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
Lyfið er ekki lengur með markaðsleyfi
2
1.
HEITI LYFS
Budesonide/Formoterol Teva Pharma B.V. 160 míkrógrömm / 4,5
míkrógrömm, innöndunarduft
2.
INNIHALDSLÝSING
Hver gefinn skammtur (skammturinn sem fer út um munnstykki Spiromax)
inniheldur
160 míkrógrömm af búdesóníði og 4,5 míkrógrömm af
formóterólfúmarat tvíhýdrati.
Þetta samsvarar mældum skammti sem nemur 200 míkrógrömmum af
búdesóníði og
6 míkrógrömmum af formóterólfúmarat tvíhýdrati.
Hjálparefni með þekkta verkun:
Hver skammtur inniheldur um það bil 5 milligrömm af laktósa (sem
einhýdrat).
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Innöndunarduft.
Hvítt duft.
Hvítt innöndunartæki með hálfgegnsæju vínrauðu loki á
munnstykki.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Budesonide/Formoterol Teva Pharma B.V. er eingöngu ætlað
fullorðnum, 18 ára og eldri.
Astmi
Budesonide/Formoterol Teva Pharma B.V. er ætlað til reglubundinnar
meðferðar á astma, þar sem
notkun á samsettu lyfi (barksteri til innöndunar og
β
2
-adrenviðtakaörvi með langtímavirkni) hentar:
-
hjá sjúklingum þar sem ekki næst fullnægjandi stjórn á
sjúkdómnum með innöndun á
barksterum og innöndun á
β
2
-adrenviðtakaörvum með skammtímavirkni eftir þörfum.
eða
-
hjá sjúklingum þar sem fullnægjandi stjórn hefur náðst á
sjúkdómnum með bæði innöndun
barkstera og innöndun
β
2
-adrenviðtakaörvum með langtímavirkni.
4.2
SKAMMTAR OG LYFJAGJÖF
Budesonide/Formoterol Teva Pharma B.V. er eingöngu ætlað
fullorðnum, 18 ára og eldri.
Budesonide/Formoterol Teva Pharma B.V. er ekki ætlað börnum, 12
ára og yngri eða unglingum á
aldrinum 13 til 17 ára.
Skammtar
_Astmi _
_ _
Budesonide/Formoterol Teva Pharma B.V. er ekki ætlað til fyrstu
meðferðar á astma.
Lyfið er ekki lengur með markaðsleyfi
3
Budesonide/Formoterol Teva Pharma B.V. er ekki viðeigandi meðferð
fyrir fullorðna sjúklinga sem
eru einungis með mildan a
                                
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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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