CANIXIN Pi/L lyophilisate and suspension for suspension for injection for dogs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated

MAH:

Virbac S.A.

ATC_code:

QI07AI08

INN:

Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated

dosage:

.

pharmaceutical_form:

Lyophilisate and suspension for suspension for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

live canine parainfluenza virus + inactivated leptospira

therapeutic_indication:

Immunological

authorization_status:

Authorised

authorization_date:

2017-04-13

SPC

Health Products Regulatory Authority
31 January 2022
CRN00CHWY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIXIN Pi/L lyophilisate and suspension for suspension for injection
for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Lyophilisate:
Live attenuated canine parainfluenza virus (CPiV), Manhattan strain
10
4.8
-
10
6.9
CCID
50
*
* Cell culture infectious dose 50%
Suspension:
Inactivated _Leptospira interrogans_:
- serogroup Canicola serovar Canicola, strain 601903 4350 - 7330 U**
- serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain
601895 4250 - 6910 U**
** Antigenic mass ELISA units
EXCIPIENTS
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Lyophilisate: White lyophilisate.
Suspension: Translucent liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs from 8 weeks of age to:
- reduce respiratory clinical signs and viral excretion caused by
canine parainfluenza virus;
- prevent mortality and reduce infection, clinical signs, kidney
colonisation, renal lesions and urine shedding of _Leptospira _
Canicola;
- reduce infection, clinical signs, kidney colonisation and urine
shedding of _Leptospira_ Icterohaemorrhagiae;
Onset of immunity:
The onset of immunity has been demonstrated from 4 weeks after the
primary vaccination for CPiV, 5 weeks for _Leptospira_
Canicola and 2 weeks for _Leptospira_ Icterohaemorrhagiae_._
Duration of immunity:
The duration of immunity lasts for one year after the primary
vaccination for all components.
In the one-year duration of immunity studies there was no significant
difference between vaccinated and control dogs in viral
excretion for CPiV, in reduction of kidney colonisation for
_Leptospira_ Canicola and _Leptospira_ Icterohaemorrhagiae, nor in
renal
lesions and urine shedding for _Leptospira_ Canicola.
4.3