Aservo EquiHaler

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970

Active ingredient:

ciclesonide

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QR03BA08

INN (International Name):

ciclesonide

Therapeutic group:

Hestar

Therapeutic area:

Öndunarfærum, Önnur lyf fyrir veikindi öndunarvegi sjúkdómum, inhalants

Therapeutic indications:

Til að lina klínískum merki um alvarlega hrossum asma (áður þekktur sem Endurtekinn Öndunarvegi – (RAO), Sumar Haga Tengslum Endurtekin Öndunarvegi – (SPA-RAO)).

Authorization status:

Leyfilegt

Authorization date:

2020-01-28

Patient Information leaflet

                                16
B.
FYLGISEÐILL
17
FYLGISEÐILL:
ASERVO EQUIHALER 343 MÍKRÓG/AFMÆLDAN SKAMMT, INNÖNDUNARLAUSN FYRIR
HESTA
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
ÞÝSKALAND
Framleiðandi sem ber ábyrgð á lokasamþykkt:
Fareva Amboise
Zone Industrielle
29 Route des Industries
37530 Pocé-sur-Cisse
FRAKKLAND
2.
HEITI DÝRALYFS
Aservo EquiHaler 343 míkróg/afmældan skammt, innöndunarlausn fyrir
hesta
ciclesonid
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Hver afmældur skammtur inniheldur:
VIRK INNIHALDSEFNI:
Ciclesonid
343 míkróg
HJÁLPAREFNI:
Etanól:
8,4 mg
Tær, litlaus eða gulleit lausn.
4.
ÁBENDING(AR)
Til þess að draga úr klínískum einkennum svæsins hestaastma
(áður þekkt sem RAO (Recurrent
Airway Obstruction), SPA-RAO (Summer Pasture Associated Recurrent
Airway Obstruction)).
5.
FRÁBENDINGAR
Gefið ekki dýrum sem hafa ofnæmi fyrir virka efninu, barksterum
eða einhverju hjálparefnanna.
6.
AUKAVERKANIR
Algengt var að væg útferð úr nösum kæmi fram í rannsóknum á
öryggi og í klínískum rannsóknum.
Tíðni aukaverkana er skilgreind samkvæmt eftirfarandi:
-
Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10
dýrum sem fá meðferð)
-
Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100
dýrum sem fá meðferð)
-
Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum
1.000 dýrum sem fá meðferð)
18
-
Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af
hverjum 10.000 dýrum sem fá meðferð)
-
Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000
dýrum sem fá meðferð, þ.m.t.
einstök tilvik)
Gerið dýralækni viðvart ef vart verður einhverra aukaverkana,
jafnvel aukaverkana sem ekki eru
tilgreindar í fylgiseðlinum eða ef svo virðist sem lyfið hafi
ekki tilætluð áhrif.
7.
DÝRATEGUND(IR)
Hestar
8.
SKAMMTAR FYRIR HVERJA DÝRATEGUND, ÍKOM
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Aservo EquiHaler 343 míkróg/afmældan skammt, innöndunarlausn fyrir
hesta
2.
INNIHALDSLÝSING
Hver afmældur skammtur inniheldur:
VIRKT INNIHALDSEFNI:
Ciclesonid
343 míkróg
HJÁLPAREFNI:
Etanól:
8,4 mg
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Innöndunarlausn.
Tær, litlaus eða gulleit lausn.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hestar
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til þess að draga úr klínískum einkennum svæsins hestaastma
(áður þekkt sem RAO (Recurrent
Airway Obstruction), SPA-RAO (Summer Pasture Associated Recurrent
Airway Obstruction)).
4.3
FRÁBENDINGAR
Gefið ekki dýrum sem hafa ofnæmi fyrir virka efninu, barksterum
eða einhverju hjálparefnanna.
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Gæta skal sérstakrar varúðar þegar dýralyfið er gefið. Til
þess að tryggja árangursríka lyfjagjöf þarf að
fylgjast með öndunarvísinum sem er í vegg hólfsins á
nasamillistykkinu: þegar hesturinn andar að sér
sveigist himnan á öndunarvísinum inn á við. Við útöndun
sveigist himnan á öndunarvísinum út á við.
Losun á úðanum ætti að hefjast við upphaf innöndunar þ.e.
þegar öndunarvísirinn sveigist inn í hólfið.
Ef hreyfingar öndunarvísisins sjást ekki á að ganga úr skugga um
rétta staðsetningu nasamilli-
stykkisins.
Ef engin hreyfing er enn sjáanleg í innöndunartækinu eða ef
hreyfingin er of ör á ekki að gefa lyfið.
Verkun lyfsins hefur ekki verið staðfest hjá hestum með bráða
versnun (<14 dagar) klínískra einkenna.
4.5
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN
Sérstakar varúðarreglur við notkun hjá dýrum
Öryggi dýralyfsins hefur hvorki verið staðfest hjá hestum sem
vega minna en 200 kg né hjá folöldum.
Dýralæknirinn sem ávísar lyfinu á að meta hvort lundarfar
hestsins henti fyrir örugga og árangursríka
gjöf með Aservo EquiHaler í samræmi við góðar starfsvenjur við
dýralækningar.
3
Hafi
                                
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Similar products

Active ingredient ciclesonide

ciclesonide

ATC code QR03BA08

QR03BA08

Marketed by Boehringer Ingelheim Vetmedica GmbH

Boehringer Ingelheim Vetmedica GmbH

INN (International Name) ciclesonide

ciclesonide

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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
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Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
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Public Assessment Report Public Assessment Report English 01-01-1970
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