ProteqFlu
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
23-11-2020
Valmisteyhteenveto
(SPC)
23-11-2020
Julkisesta arviointikertomuksesta
(PAR)
17-10-2014
Aktiivinen ainesosa:
Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus
Saatavilla:
Boehringer Ingelheim Vetmedica GmbH
ATC-koodi:
QI05AD02
INN (Kansainvälinen yleisnimi):
Equine influenza vaccine (live recombinant)
Terapeuttinen ryhmä:
Horses
Terapeuttinen alue:
Immunologicals, Live viral vaccines equine influenza virus
Käyttöaiheet:
Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Tuoteyhteenveto:
Revision: 14
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2003-03-06
Pakkausseloste
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET
PROTEQFLU SUSPENSION FOR INJECTION FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for the batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProteqFlu suspension for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 1 ml contains:
ACTIVE SUBSTANCES:
Influenza A/eq/Ohio/03 [H
3
N
8
] recombinant canarypox virus (vCP2242) ............. ≥ 5.3 log10
FAID
50
*
Influenza A/eq/Richmond/1/07 [H
3
N
8
] recombinant canarypox virus (vCP3011) .. ≥ 5.3 log10 FAID
50
*
* vCP content checked by global FAID
50
(fluorescent assay infectious dose 50%) and qPCR ratio
between vCP.
ADJUVANT:
Carbomer
...........................................................................................................................................
4 mg.
4.
INDICATION(S)
Active immunisation of horses of 4 months of age or older against
equine influenza to reduce clinical
signs and virus excretion after infection.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme: 5 months after
primary vaccination course
and 1 year after the third vaccination.
5.
CONTRAINDICATIONS
None.
15
6.
ADVERSE REACTIONS
A transient swelling which usually regresses within 4 days may appear
at the injection site. In rare
occasions, swelling can reach a diameter up to 15–20 cm, with
duration up to 2–3 weeks, that may
require symptomatic treatment.
Pain, local hyperthermia and muscle stiffness can occur in rare cases.
In very rare occasions, abscessation may be observed.
A slight increase in temperature (max. 1.5 °C) may occur for 1 day,
exceptionally 2 days.
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProteqFlu suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 1 ml contains:
ACTIVE SUBSTANCES:
Influenza A/eq/Ohio/03 [H
3
N
8
] recombinant canarypox virus (vCP2242) .............. ≥ 5.3 log10
FAID
50
*
Influenza A/eq/Richmond/1/07 [H
3
N
8
] recombinant canarypox virus (vCP3011). .. ≥ 5.3 log10 FAID
50
*
* vCP content checked by global FAID
50
(fluorescent assay infectious dose 50%) and qPCR ratio
between vCP.
ADJUVANT:
Carbomer
...........................................................................................................................................
4 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of horses of 4 months of age or older against
equine influenza to reduce clinical
signs and virus excretion after infection.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme: 5 months after
primary vaccination course
and 1 year after the third vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy animals should be vaccinated.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient swelling which usually regresses within 4 days may appear
at the injection site. In rare
occasions swelling can reach a diameter up to 15–20 cm, with
duration up to 2–3 weeks, that may
require symptomatic treatment.
Pain, local hyperthermia and muscle stiffness can occur in rare cases.
In very rare occasions, a
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