CANIXIN DHPPI LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-10-2016
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Active ingredient:
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CANINE PARAINFLUENZA (MANHATTAN STRAIN)
Available from:
Virbac S.A.
ATC code:
QI07AD04
INN (International Name):
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CAN
Dosage:
Per Cent
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Canine distemper virus vaccine + Canine adenovirus vaccine + Canine parvovirus vaccine + Canine para
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2016-09-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIXIN DHPPi lyophilisate and solvent for suspension for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
LYOPHILISATE :
SOLVENT:
Water for injections
1 ml
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: White pellet.
Solvent: Colourless liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
Canine distemper virus (CDV) - Lederle strain
10
3.0 -
10
4.9
CCID
50
Canine adenovirus type 2 (CAV-2) - Manhattan strain
10
4.0
- 10
6.0
CCID
50
Canine parvovirus (CPV) - CPV780916 strain
10
5.0
- 10
6.8
CCID
50
Canine parainfluenza virus (CPIV) - Manhattan strain
10
5.0
- 10
6.9
CCID
50
Cell culture infectious dose 50 %
*
*
*
*
*
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/09/2016_
_CRN 7021356_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs from 8 weeks of age to:
-
prevent mortality and clinical signs caused by canine distemper virus;
-
prevent mortality and clinical signs caused by canine adenovirus type 1;
- prevent clinical signs and mortality and reduce excretion caused by canine parvovirus in challenge studies
performed with a CPV-2b strain;
- prevent clinical signs and reduce excretion caused by canine parvovirus in a challenge study performed with a
CPV-2c strain
- reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus and canine adenovirus
type 2;
Onset of immunity:
The onset of immunity has been demonstrated:
• From 3 weeks after the primary vaccination for CDV
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