Letifend

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
22-02-2022
Public Assessment Report Public Assessment Report (PAR)
02-06-2016

Active ingredient:

Recombinant protein Q from Leishmania infantum MON-1

Available from:

LETI Pharma, S.L.U.

ATC code:

QI07A

INN (International Name):

Canine leishmaniasis vaccine (recombinant protein)

Therapeutic group:

Hunde

Therapeutic area:

Inaktiverede bakterielle vacciner (herunder mycoplasma, toxoid og chlamydia)

Therapeutic indications:

Til aktiv immunisering af hunde fra 6 måneder for at reducere risikoen for at udvikle et klinisk tilfælde af leishmaniasis.

Product summary:

Revision: 11

Authorization status:

autoriseret

Authorization date:

2016-04-20

Patient Information leaflet

                                15
B. INDLÆGSSEDDEL
16
INDLÆGSSEDDEL:
LETIFEND LYOFILISAT OG SOLVENT TIL INFUSIONSVÆSKE, OPLØSNING TIL
HUNDE
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for
batchfrigivelse:
LETI Pharma, S.L.U.
C/ Del Sol 5, Polígono Industrial Norte
Tres Cantos
28760 Madrid
SPANIEN
2.
VETERINÆRLÆGEMIDLETS NAVN
LETIFEND lyofilisat og solvent til infusionsvæske, opløsning til
hunde
3.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
Hver dosis på 0,5 ml indeholder:
LYOFILISAT
(hvidtlyofilisat)
Aktivt stof:
Rekombinant protein Q fra
_Leishmania infantum_
MON-1
≥
36,7 ELISA enheder (EE)
*
*
Antigen-indhold bestemmes i en ELISA i forhold til en intern standard.
Hjælpestoffer:
Natriumklorid
Argininhydroklorid
Borsyre.
SOLVENT
Vand til injektionsvæsker:q.s. (efter behov) 0,5 ml
4.
INDIKATIONER
Til aktiv immunisering af ikke-inficerede hunde fra 6 måneders
alderen med det formål at reducere
risikoen for udvikling af aktiv infektion og/eller klinisk sygdom
efter eksponering for
_Leishmania _
_infantum. _
Vaccinens effekt blev påvist i en feltundersøgelse, hvor hunde
naturligt blev eksponeret for
_Leishmania infantum_
i zoner med højt infektionstryk over en periode på to år.
I laboratorieundersøgelser, herunder eksperimentel belastning med
_Leishmania infantum_
, reducerede
vaccinen sygdommens sværhedsgrad, herunder kliniske tegn og
parasitbyrden i milt og lymfekirtler.
Start af immunitet: 4 uger efter vaccination.
Varighed af immunitet: 1 år efter vaccination.
17
5.
KONTRAINDIKATIONER
Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive
stof eller over for et eller flere af
hjælpestofferne.
6.
BIVIRKNINGER
Efter vaccination har det været meget almindeligt at se kradsen på
injektionsstedet hos hunde.Denne
reaktion blev observeret at forsvinde spontant inden for 4 timer.
Overfølsomhedsreakti
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
VETERINÆRLÆGEMIDLETS NAVN
LETIFEND lyofilisat og solvent til infusionsvæske, opløsning til
hunde
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver dosis på 0,5 ml indeholder:
LYOFILISAT
Aktivt stof:
Rekombinant protein Q fra
_Leishmania infantum_
MON-1
≥
36,7 ELISA enheder (EE)
*
*
Antigen-indhold bestemmes i en ELISA i forhold til en intern standard.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Lyofilisat og solvent til injektionsvæske, opløsning.
Hvidt lyofilisat.
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Hunde.
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Til aktiv immunisering af ikke-inficerede hunde fra 6 måneders
alderen med det formål at reducere
risikoen for udvikling af aktiv infektion og/eller klinisk sygdom
efter eksponering for
_Leishmania _
_infantum. _
Vaccinens effekt blev påvist i en feltundersøgelse, hvor hunde
naturligt blev eksponeret for
_Leishmania infantum_
i zoner med højt infektionstryk over en periode på to år.
I laboratorieundersøgelser, herunder eksperimentel belastning med
_Leishmania infantum_
, reducerede
vaccinen sygdommens sværhedsgrad, herunder kliniske tegn og
parasitbyrden i milt og lymfekirtler.
Indtræden af immunitet: 4 uger efter vaccination.
Varighed af immunitet: 1 år efter vaccination.
4.3
KONTRAINDIKATIONER
Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive
stof eller over for et eller flere af
hjælpestofferne.
3
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Kun raske, ikke-inficerede dyr må vaccineres.
Vaccinen er sikker til inficerede hunde. Revaccination af inficerede
hunde forværrede ikke
sygdommens forløb (i løbet af observationsperioden på 2 måneder).
Der er ikke blevet påvist nogen
effekt hos disse dyr.
En test til detektion af Leishmaniasis anbefales inden vaccination.
Indvirkningen af vaccinen på folkesundheden og kontrol af infektion
hos mennesker kan ikke
esti
                                
                                Read the complete document

Similar products

Active ingredient Recombinant protein Q from Leishmania infantum MON-1

Recombinant protein Q from Leishmania infantum MON-1

ATC code QI07A

QI07A

Marketed by LETI Pharma, S.L.U.

LETI Pharma, S.L.U.

INN (International Name) Canine leishmaniasis vaccine (recombinant protein)

Canine leishmaniasis vaccine (recombinant protein)

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Patient Information leaflet Patient Information leaflet Bulgarian 22-02-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 22-02-2022
Public Assessment Report Public Assessment Report Bulgarian 02-06-2016
Patient Information leaflet Patient Information leaflet Spanish 22-02-2022
Summary of Product characteristics Summary of Product characteristics Spanish 22-02-2022
Public Assessment Report Public Assessment Report Spanish 02-06-2016
Patient Information leaflet Patient Information leaflet Czech 22-02-2022
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Public Assessment Report Public Assessment Report Czech 02-06-2016
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Public Assessment Report Public Assessment Report German 02-06-2016
Patient Information leaflet Patient Information leaflet Estonian 22-02-2022
Summary of Product characteristics Summary of Product characteristics Estonian 22-02-2022
Public Assessment Report Public Assessment Report Estonian 02-06-2016
Patient Information leaflet Patient Information leaflet Greek 22-02-2022
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Public Assessment Report Public Assessment Report Greek 02-06-2016
Patient Information leaflet Patient Information leaflet English 22-02-2022
Summary of Product characteristics Summary of Product characteristics English 22-02-2022
Public Assessment Report Public Assessment Report English 02-06-2016
Patient Information leaflet Patient Information leaflet French 22-02-2022
Summary of Product characteristics Summary of Product characteristics French 22-02-2022
Public Assessment Report Public Assessment Report French 02-06-2016
Patient Information leaflet Patient Information leaflet Italian 22-02-2022
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Public Assessment Report Public Assessment Report Romanian 02-06-2016
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Summary of Product characteristics Summary of Product characteristics Slovak 22-02-2022
Public Assessment Report Public Assessment Report Slovak 02-06-2016
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Public Assessment Report Public Assessment Report Slovenian 02-06-2016
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Summary of Product characteristics Summary of Product characteristics Finnish 22-02-2022
Public Assessment Report Public Assessment Report Finnish 02-06-2016
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Public Assessment Report Public Assessment Report Croatian 02-06-2016

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