Versican Plus DHPPi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
16-05-2019
Valmisteyhteenveto
(SPC)
16-05-2019
Julkisesta arviointikertomuksesta
(PAR)
27-04-2015
Aktiivinen ainesosa:
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated)
Saatavilla:
Zoetis Belgium SA
ATC-koodi:
QI07AD04
INN (Kansainvälinen yleisnimi):
canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Immunologicals for canidae, Live viral vaccines
Käyttöaiheet:
Active immunisation of dogs from six weeks of age.to prevent mortality and clinical signs caused by canine distemper virus,to prevent mortality and clinical signs caused by canine adenovirus type 1,to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,to prevent clinical signs, leukopenia and viral excretion caused by canine parvovirus,to prevent clinical signs and reduce viral excretion caused by canine parainfluenza virus.
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-07-03
Pakkausseloste
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
VERSICAN PLUS DHPPI 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 DHPPi 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 distemper virus, strain CDV Bio 11/A
10
3.1
TCID
50
*
10
5.1
TCID
50
Canine adenovirus Type 2, strain CAV-2 Bio 13
10
3.6
TCID
50
*
10
5.3
TCID
50
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
10
4.3
TCID
50
*
10
6.6
TCID
50
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%.
Lyophilisate: spongy matter of white colour.
Solvent: clear colourless liquid.
4.
INDICATION(S)
Active immunisation of dogs from 6 weeks of age:
−
to prevent mortality and clinical signs caused by canine distemper
virus,
−
to prevent mortality and clinical signs caused by canine adenovirus
type 1,
19
−
to prevent clinical signs and reduce viral excretion caused by canine
adenovirus type 2,
−
to prevent clinical signs, leucopoenia and viral excretion caused by
canine parvovirus, and
−
to prevent clinical signs (nasal and ocular discharge) and reduce
viral excretion caused by
canine parainfluenza virus.
Onset of immunity:
−
3 weeks after the first vaccination for CDV, CAV, CPV, and
−
3 weeks after completion of the primary course for CPiV.
Duration of immunity:
At least three years following the primary vaccination course
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus DHPPi 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 distemper virus, strain CDV Bio 11/A
10
3.1
TCID
50
*
10
5.1
TCID
50
Canine adenovirus Type 2, strain CAV-2 Bio 13
10
3.6
TCID
50
*
10
5.3
TCID
50
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
10
4.3
TCID
50
*
10
6.6
TCID
50
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 mortality and clinical signs caused by canine distemper
virus,
−
to prevent mortality and clinical signs caused by canine adenovirus
type 1,
−
to prevent clinical signs and reduce viral excretion caused by canine
adenovirus type 2,
−
to prevent clinical signs, leucopoenia and viral excretion caused by
canine parvovirus, and
−
to prevent clinical signs (nasal and ocular discharge) and reduce
viral excretion caused by
canine parainfluenza virus.
Onset of immunity:
−
3 weeks after the first vaccination for CDV, CAV, CPV, and
−
3 weeks after completion of the primary course for CPiV.
3
Duration of immunity:
At least three years following the primary vaccination course for
canine distemper virus, canine
adenovirus type 1, canine adenovirus type 2 and canine parvovirus. The
duration of immunity against
CAV-2 was not established by challenge. It was shown that 3 years
after the v
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