EURICAN LMULTI SUSPENSION FOR INJECTION

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP CANICOLA STRAIN 16070, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP ICTEROHAEMORRHAGIAE STRAIN 16069, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP GRIPPOTYPHOSA STRAIN MAL 1540

Tillgänglig från:

Merial Animal Health Limited

ATC-kod:

QI07AB01

INN (International namn):

INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP CANICOLA STRAIN 16070, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP ICTEROHAEMORRHA

Dos:

Unknown

Läkemedelsform:

Suspension for Injection

Receptbelagda typ:

POM

Terapeutisk grupp:

Canine

Terapiområde:

Leptospira vaccine

Terapeutiska indikationer:

Immunological - Inactivated vaccine

Bemyndigande status:

Authorised

Tillstånd datum:

2015-11-27

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican Lmulti 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 Grippo Mal
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.
Onset of immunity : 2 weeks 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 Grippotyphosa, no mortality occurred
during the duration of immunity challenge.
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