HIPRABOVIS SOMNI/LKT EMULSION FOR INJECTION FOR CATTLE

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

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

可用日期:

Laboratorios Hipra S.A.

ATC代码:

QI02AB

INN（国际名称）:

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

剂量:

Unknown

药物剂型:

Emulsion for Injection

处方类型:

POM

治疗组:

Bovine

治疗领域:

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

疗效迹象:

Immunological - Inactivated vaccine

授权状态:

Authorised

授权日期:

2005-10-27

产品特点

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