Hiprabovis IBR Marker Live

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-07-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
06-07-2017
Public Assessment Report Public Assessment Report (PAR)
07-02-2011

Active ingredient:

živi gE-tk- virus goveje herpes z grenivom, tip 1, seva CEDDEL: 106,3-107,3 ​​CCID50

Available from:

Laboratorios Hipra S.A

ATC code:

QI02AD01

INN (International Name):

live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

Therapeutic group:

Govedo

Therapeutic area:

Imunologija

Therapeutic indications:

Za aktivno imunizacijo goveda iz treh mesecih starosti proti goveja herpes virus tipa 1 (BoHV-1) za zmanjšanje kliničnih znakov kužnih goveja rhinotracheitis (IBR) in področje virus izločanje. Začetek imunosti: 21 dni po zaključku osnovnega programa cepljenja. Trajanje imunitete: 6 mesecev po zaključku osnovnega programa cepljenja.

Product summary:

Revision: 4

Authorization status:

Pooblaščeni

Authorization date:

2011-01-27

Patient Information leaflet

                                19
B. NAVODILO ZA UPORABO
20
NAVODILO ZA UPORABO
HIPRABOVIS IBR MARKER LIVE
liofilizat in vehikel za suspenzijo za injiciranje za govedo.
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za
sproščanje serij:
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
ŠPANIJA
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za
injiciranje za govedo.
3.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN
Liofilizat:
Vsak odmerek po 2 ml vsebuje:
Živ gE
-
tk
-
Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo
genov, sev CEDDEL: 10
6.3
– 10
7.3
CCID
50
_Okrajšave: _
_gE-: izbrisan glikoprotein E tk-: izbrisana timidin kinaza; CCID:
odmerek za infekcije celične kulture _
Vehikel:
Raztopina fosfatnega pufra
Suspenzija po rekonsituciji: Rožnata prozorna tekočina.
Liofilizat: bela do rumenkasta prašek
Vehikel: prozorna homogena tekočina
4.
INDIKACIJA(E)
Za aktivno imunizacijo goveda nad 3 mesece starosti proti Govejemu
Herpes Virusu vrste 1 (BoHV-
1) za zmanjšanje kliničnih znakov Infekcioznega bovinega
rinotraheitisa in izločanje divjega virusa
Cepljene živali je mogoče razlikovati od živali, ki so okužene z
divjim virusom, na osnovi izbrisa
markerja (gE
-
) s pomočjo komercialnih diagnostičnih kompletov, razen v primeru,
ko so živali
predhodno cepili z običajnim cepivom ali pa so okužene z divjim
virusom.
Nastop imunosti: 21 dni po zaključku osnovnega cepljenja.
Trajanje imunosti: 6 mesecev po zaključku osnovnega cepljenja.
5.
KONTRAINDIKACIJE
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali
na katero koli pomožno snov.
21
6.
NEŽELENI UČINKI
Pogosti neželeni učinki:
Rahel porast telesne temperature do 1°C je v obdobju 4 dni po
cepljenju običajen. Pogosto je mogoče
opaziti zvišanje rektalne temperature do 1,63 ºC pri odraslih kravah
in do 2,18 ºC
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za
injiciranje za govedo
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsak odmerek po 2 ml vsebuje:
Liofilizat:
ZDRAVILNA UČINKOVINA:
Živ gE
-
tk
-
Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev
CEDDEL: 10
6.3
– 10
7.3
CCID
50
_Okrajšave: _
_gE_
_-_
_: izbrisan glikoprotein E; tk_
_-_
_: izbrisana timidin kinaza; CCID: odmerek za infekcije celične
kulture_
Vehikel:
Raztopina fosfatnega pufra
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Liofilizat in vehikel za suspenzijo za injiciranje.
Suspenzija po rekonsituciji: Rožnata prozorna tekočina.
Liofilizat: bela do rumenkasta prašek
Vehikel: prozorna homogena tekočina
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Govedo (teleta in odrasle krave).
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Za aktivno imunizacijo goveda nad 3 mesece starosti proti Govejemu
Herpes Virusu vrste 1 (BoHV-1)
za zmanjšanje kliničnih znakov Infekcioznega bovinega rinotraheitisa
in izločanje divjega virusa
Nastop imunosti: 21 dni po zaključku osnovnega cepljenja.
Trajanje imunosti: 6 mesecev po zaključku osnovnega cepljenja.
4.3
KONTRAINDIKACIJE
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali
na katero koli pomožno snov.
4.4.
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Jih ni
3
4.5
POSEBNI PREVIDNOSTNI UKREPI
Posebni previdnostni ukrepi za uporabo pri živalih
Cepite le zdrave živali.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim
daje zdravilo
Ni smiselno.
4.6.
NEŽELENI UČINKI (POGOSTOST IN RESNOST)
Pogosti neželeni učinki:
Rahel porast telesne temperature do 1°C je v obdobju 4 dni po
cepljenju običajen. Pogosto je mogoče
opaziti zvišanje rektalne temperature do 1,63 ºC pri odraslih kravah
in do 2,18 ºC pri teletih. Ta
prehoden porast temperature samodejno izzveni v 48 urah brez
zdravljenja
                                
                                Read the complete document

Similar products

Active ingredient živi gE-tk- virus goveje herpes z grenivom, tip 1, seva CEDDEL: 106,3-107,3 ​​CCID50

živi gE-tk- virus goveje herpes z grenivom, tip 1, seva CEDDEL: 106,3-107,3 ​​CCID50

ATC code QI02AD01

QI02AD01

Marketed by Laboratorios Hipra S.A

Laboratorios Hipra S.A

INN (International Name) live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

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Hiprabovis IBR Marker Live