Equilis Prequenza Te
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
10-12-2020
Produktets egenskaber
(SPC)
10-12-2020
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, tetanus toxoid
Tilgængelig fra:
Intervet International BV
ATC-kode:
QI05AL01
INN (International Name):
vaccine against equine influenza and tetanus in horses
Terapeutisk gruppe:
Horses
Terapeutisk område:
equine influenza virus + clostridium
Terapeutiske indikationer:
Active immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Produkt oversigt:
Revision: 10
Autorisation status:
Authorised
Autorisation dato:
2005-07-08
Indlægsseddel
14
B.
PACKAGE LEAFLET
15
PACKAGE LEAFLET:
Equilis Prequenza Te 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 Te 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
Tetanus toxoid
40 Lf
2
1
Antigenic ELISA units
2
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig
serum in the Ph.Eur. potency test
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, and active immunisation against tetanus to
prevent mortality.
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
Tetanus
Onset of immunity:
2 weeks after the primary vaccination course
16
Duration of immunity:
17 months after the primary vaccination course
24 months after the first revaccination
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
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 exceptio
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Prequenza Te 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
Tetanus toxoid
40 Lf
2
1
Antigenic units
2
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig
serum in the Ph.Eur. potency test
ADJUVANTS:
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, and active immunisation against tetanus to
prevent mortality.
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
Tetanus
Onset of immunity:
2 weeks after the primary vaccination course
Duration of immunity:
17 months after the primary vaccination course
24 months after the first revaccination
4.3
CONTRAINDICATIONS
3
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 ph
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