Hiprabovis Somni/Lkt Emulsion for Injection for Cattle

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Histophilus somni, Mannheimia haemolytica

MAH:

Laboratorios Hipra SA

ATC_code:

QI02AB

INN:

Histophilus somni, Mannheimia haemolytica

pharmaceutical_form:

Emulsion for injection

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Cattle

therapeutic_area:

Inactivated Bacterial Vaccine

authorization_status:

Authorized

authorization_date:

2007-05-15

SPC

Revised: November 2014
AN: 00037/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hiprabovis Somni/Lkt Emulsion for Injection for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
_Mannheimia haemolytica _Biotype A serotype_ _A1,
inactivated
cell
free
suspension
containing
leukotoxoid
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 the full list of excipients, see section 6.1.
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.
Revised: November 2014
AN: 00037/2014
Page 2 of 5
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.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Do not use in animals which are underweight for their age.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-injection
may
result
in
severe
pain
and
swelling,
particularly if injected into a joint or finger, and in rare cases
could
result in the loss of the affected finger if prompt medical attention
is
not
given.
If
you
are
accidentally
injected
w