VIMCO emulsion for injection for ewes and female goats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Staphylococcus aureus SP140 CP8 strain, inactivated, expressing biofilm components

Available from:

Laboratorios Hipra S.A.

ATC code:

QI03AB

INN (International Name):

Staphylococcus aureus SP140 CP8 strain, inactivated, expressing biofilm components

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Goats, Sheep

Therapeutic area:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2017-09-29

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VIMCO emulsion for injection for ewes and female goats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCE:
Inactivated
_Staphylococcus aureus_
, SP140 CP**8 strain, expressing Biofilm components ≥ 8.98 SaCC*
*
_Staphylococcus aureus _
Cell Count in log
10
.
** CP: capsular polysaccharide
ADJUVANT:
Liquid
paraffin……………………...............................................................................
18.2 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Benzyl alcohol
21 mg
Sorbitan monooleate
Polysorbate 80
Sodium alginate
Calcium chloride, dihydrate
Simethicone
Sodium chloride
Potassium chloride
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Water for injections
Ivory-coloured homogeneous emulsion.
3. CLINICAL INFORMATION
3.1 TARGET SPECIES
Sheep (ewes) and goats (adult females).
3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of healthy ewes in flocks with recurring
mastitis problems, to reduce the
incidence of sub-clinical mastitis (reduction of udder lesions,
somatic cell count and
_S. aureus _
count)
caused by
_Staphylococcus aureus_
.
For active immunisation of healthy female goats in herds with
recurring mastitis problems, to reduce
the incidence of sub-clinical mastitis caused by
_Staphylococcus aureus _
and/or Coagulase-Negative
Staphylococci; when clinical mastitis caused by Coagulase-Negative
Staphylococci* however occurs,
the severity of clinical signs (udder and milk aspect) is reduced.
_(*Determination of the CNS species has not been performed)_
-
Onset of immunity:
Ewes: 6 weeks
Goats: has not been established (see section 4)
-
Duration of immunity: has not been established
3.3 CONTRAINDICATIONS
None.
3.4 SPECIAL WARNINGS
Vaccinate healthy animals only.
Immunisation has to be considered as one component in a complex