CANIXIN DHPPI/L LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-09-2016
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Active ingredient:
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CANINE PARAINFLUENZA (MANHATTAN STRAIN), BUFFERED ISOTONIC SOLUTION, L.CANICOLA, L.ICTEROHAEMORRHAGIAE
Available from:
Virbac S.A.
ATC code:
QI07AI02
INN (International Name):
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CAN
Dosage:
Unknown
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Live Canine distemper virus vaccine + live Canine adenovirus vaccine + live Canine parainfluenza vi
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2015-12-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIXIN DHPPi/L lyophilisate and suspension for suspension for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES
LYOPHILISATE
SUSPENSION
*According to Eur. pharmacopeia monograph 447, Hamster potency test
EXCIPIENTS
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Lyophilisate: White pellet
Suspension: Translucent 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%
Inactivated _Leptospira interrogans _serogroup canicola serovar canicola - strain 601903
conferring > 80 % protection*
Inactivated _Leptospira interrogans _serogroup icterohaemorrhagiae serovar icterohaemorrhagiae
- strain 601895
conferring > 80 % protection*
*
*
*
*
*
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 25/08/2016_
_CRN 7024089_
_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
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