Canixin L Suspension for Injection for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Leptospira canicola, Leptospira icterohaemorrhagiae

Saatavilla:

Virbac

ATC-koodi:

QI07AB01

INN (Kansainvälinen yleisnimi):

Leptospira canicola, Leptospira icterohaemorrhagiae

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Inactivated Bacterial Vaccine

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2017-04-03

Valmisteyhteenveto

Unlimited Renewal. Revised: February 2022
AN: 01010/2021 & 01011/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
OF
THE
VETERINARY
MEDICINAL
PRODUCT
CANIXIN L suspension for injection for dogs
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
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
Suspension for injection.
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:
-
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 5 weeks for
_Leptospira_ Canicola
and 2 weeks for _Leptospira_ Icterohaemorrhagiae_._
Unlimited Renewal. Revised: February 2022
AN: 01010/2021 & 01011/2021
Page 2 of 5
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 reduction of kidney
colonisation for
_Leptospira_ Canicola and _Leptospira_ Icterohaemorrhagiae, nor in
renal lesions and
urine shedding for _Leptospira_ Canicola.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
None.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals:
In case of accidental self-injection, seek medical ad