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:

Merial Animal Health Limited

ATC code:

QI07AB01

INN (International Name):

Inactivated leptospira interrogans serogroup canicola strain 16070, Inactivated leptospira interrogans serogroup icterohaemorrha

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

leptospira

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2015-11-27

Summary of Product characteristics

Health Products Regulatory Authority
06 February 2018
CRN000VS1
Page 1 of 5
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
strain 16069
.................................................................................
Activity acc. to Ph. Eur.447*
Inactivated _Leptospira interrogans _serogroup and serovar
Grippotyphosa
strain Grippo Mal
1540...............................................................
Activity acc. to Ph. Eur.447*
*³ 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.
Health Products Regulatory Authority
06 February 2018
CRN000VS1
Page 2 of 5

prevent mortality, clinical signs, renal infection, bacterial
excretion, renal
carriage and renal lesions caused by _Leptospirainterrogans_ serogroup
Icterohaemorrhagiae serovar Copenhageni.**
Onset of immunity: 2 weeks for al