HIPRABOVIS SOMNI/LktEmulsion for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mannheimia haemolytica biotype a, serotype a1 leukotoxoid; Haemophilus somnus bailie strain, inactivated

Available from:

Laboratorios Hipra S.A.

ATC code:

QI02AB

INN (International Name):

Mannheimia haemolytica biotype a, serotype a1 leukotoxoid; Haemophilus somnus bailie strain, inactivated

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2005-10-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS SOMNI/Lkt
Emulsion for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
Ivory-coloured homogeneous emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle from 2 months of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To reduce the clinical signs and lung lesions caused by_ Mannheimia
haemolytica_ serotype A1 and_ Histophilus somni_
in calves from 2 months of age.
ONSET OF IMMUNITY:
3 weeks.
DURATION OF PROTECTION:
Not demonstrated.
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy animals.
Do not use in case of hypersensitivity to the active substances, to
the adjuvant or to any of the excipients.
ACTIVE SUBSTANCES:
_Mannheimia haemolytica_ Biotype A serotype A1,
inactivated cell free suspension containing leukoxid Ph. Eur.
-
ELISA > 2.8 (*)/dose
Inactivated_ Histophilus somni_ Bailie strain
-
MAT > 3.3 (**)/dose
(*) A minimum of 80% of vaccinated rabbits show ELISA value of > 2.0;
the mean ELISA is > 2.8
(**) A minimum of 80% of vaccinated rabbits show a log
2
MAT value of
3.0;
the mean log
2
MAT > 3.3
ADJUVANT:
Liquid paraffin
18.2 mg/dose
EXCIPIENTS:
Thiomersal
0.2 mg/dose
For a full list of excipients, see section 6.1.
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4.4 SPECI