IMOCOLIBOV

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Inactivated e.coli serotype 09; Inactivated e.coli serotype 08; Inactivated e.coli serotype 015; Inactivated e.coli serotype 078; Inactivated e.coli serotype 0101; Inactivated e.coli serotype 00117; Inactivated e.coli (antigen k99); Inactivated e.coli (antigen y); Inactivated e.coli (antigen 31a)

Pieejams no:

Boehringer Ingelheim Vetmedica GmbH

ATĶ kods:

QI02AC; QI04AC

SNN (starptautisko nepatentēto nosaukumu):

Inactivated e.coli serotype 09; Inactivated e.coli serotype 08; Inactivated e.coli serotype 015; Inactivated e.coli serotype 078; Inactivated e.coli serotype 0101; Inactivated e.coli serotype 00117; Inactivated e.coli (antigen k99); Inactivated e.coli (antigen y); Inactivated e.coli (antigen 31a)

Deva:

.

Zāļu forma:

Suspension for injection

Receptes veids:

LM: Licensed Merchant as defined in relevant national legislation

Ārstniecības joma:

Inactivated bacterial vaccines and antisera; Inactivated bacterial vaccines and antisera

Autorizācija statuss:

Authorised

Autorizācija datums:

2003-08-06

Produkta apraksts

Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
IMOCOLIBOV
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of vaccine contains _E. coli _somatic serotypes 09, 08, 015,
078, 0101, 0117, expressing virulence factors:
Active substances:
Antigen K99 of _E. coli_
>1.22 SA.U*
Antigen Y of _E. coli_
>1.80 SA.U*
Antigen 31A of _E. coli_
>1.27 SA.U*
E coli serotype 078
>1.14 OD Units **
Adjuvants:
Saponin
Aluminium hydroxide (expressed in A1
+++
)
0.3 mg
0.7 mg
Formaldehyde, at most
1.5 mg
Excipient, q.s
1 ml
* 1 SA.U: q.s. to obtain an agglutinating antibody titre of 1 log 10
in guinea-pigs after two administrations of vaccine.
** OD – Optical Density
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pregnant cows or pregnant ewes
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pregnant cows or pregnant ewes.
Passive immunisation against neonatal _Escherichia coli _infections by
administration of the vaccine to pregnant cows or
ewes. Reduction of diarrhoea and mortality caused by enterotoxic _E.
coli_ strains in both lambs and calves.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the label to the physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The vaccine may cause the formation of a transient nodule at the site
of injection (at most 2 cm) disappearing three to four
weeks after vaccination.
Hypersensitivity reactions may occur. In such cases, symptomatic
treatment should be provided.
The vaccination may c