Coliprotec F4/F18 Lyophilisate for Oral Suspension for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Escherichia coli

Available from:

Elanco Europe Ltd

ATC code:

QI09AE03

INN (International Name):

Escherichia coli

Pharmaceutical form:

Lyophilisate for Oral Suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Live Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2017-01-09

Summary of Product characteristics

Renewed Indefinitely March 2022
AN: 00507/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4/F18 lyophilisate for oral suspension for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
ACTIVE SUBSTANCES:
Live non-pathogenic _Escherichia coli_ O8:K87
*
(F4ac):.......................1.3x10
8
to
9.0x10
8
CFU
**
Live non-pathogenic _Escherichia coli_ O141:K94
*
(F18ac): ...............2.8x10
8
to
3.0x10
9
CFU
**
*
not attenuated
**
CFU – colony forming units
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
White or whitish powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 18 days of age against
enterotoxigenic F4-
positive and F18-positive _Escherichia coli_ in order to:
-
reduce the incidence of moderate to severe post-weaning _E. coli_
diarrhoea (PWD)
in infected pigs;
-
reduce the faecal shedding of enterotoxigenic F4-positive and
F18-positive _E. coli_
from infected pigs.
Onset of immunity: 7 days after vaccination
Duration of immunity: 21 days after vaccination
Renewed Indefinitely March 2022
AN: 00507/2021
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is not recommended to vaccinate animals undergoing
immunosuppressive
treatment or to vaccinate animals undergoing antibacterial treatment
effective against
_E. coli._
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals.
The vaccine strains may be excreted by vaccinated piglets for at least
14 days
following vaccination. The vaccine strains readily spread to other
pigs in contact to
vaccinated pigs. Unvaccinated pigs in contact with vaccinated pigs
will harbour and
shed the vaccine strains similarly to vaccinated pigs. During this
time, the contact of
immunosuppressed pigs with vaccinated pigs should be avoided.
Special