Equilis Prequenza
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
16-12-2020
Produktets egenskaber
(SPC)
16-12-2020
Offentlige vurderingsrapport
(PAR)
23-05-2013
Aktiv bestanddel:
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93
Tilgængelig fra:
Intervet International BV
ATC-kode:
QI05AA01
INN (International Name):
vaccine against equine influenza in horses
Terapeutisk gruppe:
Horses
Terapeutisk område:
equine influenza virus
Terapeutiske indikationer:
Active immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Produkt oversigt:
Revision: 9
Autorisation status:
Authorised
Autorisation dato:
2005-07-08
Indlægsseddel
14
B.
PACKAGE LEAFLET
15
PACKAGE LEAFLET:
Equilis Prequenza 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
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Prequenza suspension for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Equine influenza virus strains:
A/equine-2/ South Africa/4/03
50 AU
1
A/equine-2/ Newmarket/2/93
50 AU
1
Antigenic ELISA units
ADJUVANT:
Iscom-Matrix containing:
Purified saponin
375 micrograms
Cholesterol
125 micrograms
Phosphatidylcholine
62.5 micrograms
Clear opalescent suspension.
4.
INDICATION(S)
Active immunisation of horses from 6 months of age against equine
influenza to reduce clinical signs and virus
excretion after infection.
Influenza
Onset of immunity:
2 weeks after the primary vaccination course
Duration of immunity:
5 months after the primary vaccination course
12 months after the first revaccination
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
16
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur
at the injection site, regressing within 2
days. Pain at the injection site can occur in rare cases, which may
result in temporary functional discomfort
(stiffness). A local reaction exceeding 5 cm and possibly persisting
longer than 2 days may occur in very rare
cases. Fever, sometimes accompanied by lethargy and inappetence, may
in very rare cases occur for 1 day, and
up to 3 days in exceptional circumstances.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Prequenza suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Equine influenza virus strains:
A/equine-2/ South Africa/4/03
50 AU
1
A/equine-2/ Newmarket/2/93
50 AU
1
Antigenic units
ADJUVANT:
Iscom-Matrix containing:
Purified Saponin
375 micrograms
Cholesterol
125 micrograms
Phosphatidylcholine
62.5 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of horses from 6 months of age against equine
influenza to reduce clinical signs and virus
excretion after infection.
Influenza
Onset of immunity:
2 weeks after the primary vaccination course
Duration of immunity:
5 months after the primary vaccination course
12 months after the first revaccination
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
3
Foals should not be vaccinated before the age of 6 months, especially
when born to mares that were
revaccinated in the last two months of gestation, because of possible
interference by maternally derived
antibodies.
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
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 diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur
at the injection site, regressing within 2
days. Pain at the injection site can occur in rare cases, which may
result in temporary functional discomfort
(stiffness). A local reaction exceeding 5 cm and possibly persisting
longer than 2 days ma
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