HIPRABOVIS SOMNI/LKT EMULSION FOR INJECTION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MANNHEIMIA HAEMOLYTICA BIOTYPE A, SEROTYPE A1, STRAIN 2806, LEUKOTOXOID, INACTIVATED HAEMOPHILUS SOMMUS BAILIE STRAIN

Available from:

Laboratorios Hipra S.A.

ATC code:

QI02AB

INN (International Name):

MANNHEIMIA HAEMOLYTICA BIOTYPE A, SEROTYPE A1, STRAIN 2806, LEUKOTOXOID, INACTIVATED HAEMOPHILUS SOMMUS BAILIE STRAIN

Dosage:

Unknown

Pharmaceutical form:

Emulsion for Injection

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia vaccines)

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 18/12/2014_
_CRN 7017628_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use in animals which are underweight for their age.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medic