Eurican L multi Suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated leptospira interrogans serogroup canicola strain 16070; Inactivated leptospira interrogans serogroup icterohaemorrhagiae strain 16069; Inactivated leptospira interrogans serogroup grippotyphosa strain mal 1540

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI07AB01

INN (International Name):

Inactivated leptospira interrogans serogroup canicola strain 16070; Inactivated leptospira interrogans serogroup icterohaemorrhagiae strain 16069; Inactivated leptospira interrogans serogroup grippotyphosa strain mal 1540

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

leptospira

Authorization status:

Authorised

Authorization date:

2015-11-27

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2020
CRN009KQW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican L multi Suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1 ml) of suspension contains:
​
ACTIVE SUBSTANCES:
​
​
Inactivated _Leptospira interrogans _serogroup and serovar Canicola
strain 16070
​
Activity acc. to Ph. Eur.447*
​
Inactivated _Leptospira interrogans _serogroup and serovar
Icterohaemorrhagiae strain16069
​
Activity acc. to Ph. Eur.447*
​
Inactivated _Leptospira interrogans _serogroup and serovar
Grippotyphosa strain GrippoMal 1540
​
Activity acc. to Ph. Eur.447*
​
*≥80 % protection in hamsters
​
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Opalescent and homogenous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of dogs to:
- prevent mortality, clinical signs, infection, bacterial excretion,
renal carriage and renal lesions caused by _Leptospira_ interrogans
serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
- prevent mortality* and clinical signs, reduce infection, bacterial
excretion, renal carriage and renal lesions caused by
_Leptospira_ interrogans serogroup Canicola serovar Canicola.
- prevent mortality*, and reduce clinical signs, infection, bacterial
excretion renal carriage and renal lesions caused by
_Leptospira_ kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
- prevent mortality, clinical signs, renal infection, bacterial
excretion, renal carriage and renal lesions caused by _Leptospira _
_interrogans_ serogroup Icterohaemorrhagiae serovar Copenhageni.**
Onset of immunity: 2 weeks after the second injection of the primary
vaccination course for all strains.
Duration of immunity: at least one year after the second injection of
the primary vaccination course for all strains.
* For _Leptospira_ Canicola and Grippotyphos