Enteroporc AC

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Clostridium perfringens

Tilgængelig fra:

IDT BIOLOGIKA GMBH

ATC-kode:

QI09AB12

INN (International Name):

Clostridium perfringens

Lægemiddelform:

Lyophilisate and solvent for suspension for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Pigs

Terapeutisk område:

Inactivated Bacterial Vaccine

Autorisation status:

Expired

Autorisation dato:

2017-09-21

Produktets egenskaber

Issued: September 2017
AN: 00152/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENTEROPORC AC
Lyophilisate and solvent for suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml of the reconstituted vaccine) contains:
ACTIVE SUBSTANCES:
_Clostridium perfringens_ type A/C toxoids:
alpha toxoid
min. 125 rU/ml*
beta1 toxoid
min. 3354 rU/ml*
beta2 toxoid
min. 770 rU/ml*
*toxoid content in relative units per ml, determined in ELISA against
an internal
standard
ADJUVANT:
Montanide Gel
37.4 – 51.5 mmol/l titratable acrylate units
EXCIPIENTS:
Thiomersal
0.085 – 0.115 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Beige to brown lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pregnant sows and gilts)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of progeny by active immunisation of sows
and gilts to
reduce mortality and clinical signs during the first days of life
caused by _Clostridium _
_perfringens_
type
A
associated
enteritis
and
necrotising
enteritis
induced
by
_Clostridium perfringens_ type C.
Issued: September 2017
AN: 00152/2016
Page 2 of 6
Onset of immunity:
This protection was proven in a challenge test with toxins on suckling
piglets on the
first day of life.
Duration of immunity:
Serological data show that neutralising antibodies are present up to
the 2nd week
after birth. The presence of neutralising antibodies has been shown to
correlate to
protection.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Protection of piglets is achieved by colostrum intake. Therefore, care
should be taken
to ensure that each piglet ingests a sufficient quantity of colostrum.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
pr