Versican Plus Pi
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
16-05-2019
Produktets egenskaber
(SPC)
16-05-2019
Offentlige vurderingsrapport
(PAR)
20-10-2014
Aktiv bestanddel:
canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated)
Tilgængelig fra:
Zoetis Belgium SA
ATC-kode:
QI07AD08
INN (International Name):
canine parainfluenza virus
Terapeutisk gruppe:
Dogs
Terapeutisk område:
Immunologicals for canidae, Live viral vaccines
Terapeutiske indikationer:
Active immunisation of dogs from six weeks of age to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Produkt oversigt:
Revision: 5
Autorisation status:
Authorised
Autorisation dato:
2014-07-03
Indlægsseddel
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
VERSICAN PLUS PI LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION
FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Bioveta, a.s.,
Komenského 212,
683 23 Ivanovice na Hané,
CZECH REPUBLIC
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Pi lyophilisate and solvent for suspension for injection
for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
LYOPHILISATE (LIVE ATTENUATED):
MINIMUM
MAXIMUM_ _
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
10
3.1
TCID
50
*
10
5.1
TCID
50
*
SOLVENT:
Water for injections (
_Aqua ad iniectabilia_
)
1ml
*
Tissue culture infectious dose 50%
Lyophilisate: spongy matter of white colour.
Solvent: clear colourless liquid.
4.
INDICATION(S)
Active immunisation of dogs from 6 weeks of age:
−
to prevent clinical signs (nasal and ocular discharge) and reduce
viral excretion caused by
canine parainfluenza virus.
Onset of immunity:
3 weeks after completion of the primary course.
17
Duration of immunity:
At least one year following the primary vaccination course.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient swelling (up to 5 cm) may commonly be observed at the
injection site following
subcutaneous administration in dogs. This can be painful, warm or
reddened. Any such swelling will
either have spontaneously resolved or be greatly diminished by 14 days
after vaccination.
Anorexia and decreased activity are rarely observed.
Hypersensitivity reactions (e.g. gastrointestinal signs such as
diarrhoea and vomiting, anaphylaxis,
angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
If such a reaction occurs,
appropriate treatment should be administered without delay. Such
reactions may evolve to
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Pi lyophilisate and solvent for suspension for injection
for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
LYOPHILISATE (LIVE ATTENUATED):
MINIMUM
MAXIMUM_ _
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
10
3.1
TCID
50
*
10
5.1
TCID
50
*
SOLVENT:
Water for injections (
_Aqua ad iniectabilia_
)
1 ml
*
Tissue culture infectious dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
The visual appearance is as follows:
Lyophilisate: spongy matter of white colour.
Solvent: clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of dogs from 6 weeks of age:
−
to prevent clinical signs (nasal and ocular discharge) and reduce
viral excretion caused by
canine parainfluenza virus.
Onset of immunity:
3 weeks after completion of the primary course.
Duration of immunity:
At least one year following the primary vaccination course.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A good immune response is reliant on a fully competent immune system.
Immunocompetence of the
animal may be compromised by a variety of factors including poor
health, nutritional status, genetic
factors, concurrent drug therapy and stress.
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The live attenuated virus vaccine strain CPiV may be shed by
vaccinated animals following
vaccination. However, due to the low pathogenicity of this strain, it
is not necessary to keep
vaccinated dogs separated from non-vaccinated dogs.
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
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