Eurican L4 Suspension for Injection

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae

Fáanlegur frá:

Boehringer Ingelheim Vetmedica GmbH

INN (Alþjóðlegt nafn):

Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Dogs

Lækningarsvæði:

Inactivated Bacterial Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

2023-06-02

Vara einkenni

Amended Pages: August 2023
AN: 01518/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican L4 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* (*)
Inactivated _Leptospira interrogans _serogroup Australis and serovar_
_Bratislava
strain
16785......................................................................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 from 7 weeks of age to prevent or reduce
mortality, clinical signs, infection, bacterial excretion, renal
carriage and renal
lesions caused by:
- Leptospira interrogans serogroup Canicola serovar Canicola,
- Leptospira interrogans serogroup Icterohaemorrhagiae serovar
Icterohaemorrhagiae,
- Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa,
and
- Leptospira interrogans serogroup Australis serovar Bratislava.
Amended Pages: August 2023
AN: 01518/2021
Page 2 of 5
INDICATION
SEROGROUP / SEROVAR
MORTALITY
CLINICAL
SIGNS
INFECTION
BACTERIAL
EXCRETION
RENAL
CARRIAGE
RENAL
LESIONS
Canicola / Canicola
Prevention*
Prevention*
Reduction
Reduction
Reduction
Reduction
Icterohaemorrhagiae
/
Ictero