CattleMarker IBR Inactivated Emulsion for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bovine rhinotraceitis virus

Available from:

Zoetis UK Limited

ATC code:

QI02AH

INN (International Name):

Infectious bovine rhinotraceitis virus

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Expired

Authorization date:

2016-07-21

Summary of Product characteristics

Issued: July 2016
AN: 01640/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CattleMarker IBR Inactivated emulsion for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains the following:
ACTIVE SUBSTANCE:
Inactivated gE negative Bovine Herpes Virus type 1 (BoHV-1), strain
Difivac, to
induce a geometric mean seroneutralizing titre of at least 5.5 log
2
ADJUVANT:
Procision A
TM
: 0.164 ml/dose of vaccine
Composition of the adjuvant (per ml)
Quil A: 3.05 mg
Cholesterol: 3.05 mg
Amphigen Base (liquid paraffin + soya lecithin): 0.076 ml
Drakeol 5 (liquid paraffin): 0.228 ml.
EXCIPIENTS
Thiomersal
max 0.2mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection. Off-white, translucent oil-in-water emulsion,
with an oily phase
which is easily dispersed by shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
FOR ACTIVE IMMUNISATION OF SERONEGATIVE CATTLE FROM 2 WEEKS OF AGE:
- to reduce the clinical signs (pyrexia and depression) of infectious
bovine
rhinotracheitis (IBR) and duration of virus shedding caused by BoHV-1
infection
Onset of protection: 2 weeks after completion of the primary
vaccination course.
Duration of protection: 6 months after completion of the primary
vaccination course.
Issued July 2016
AN: 01640/2014
Page 2 of 6
FOR ACTIVE IMMUNISATION OF FEMALE CATTLE FROM 6 MONTHS OF AGE:
-to reduce the clinical signs (pyrexia and duration of dyspnoea) of
infectious bovine
rhinotracheitis (IBR) and virus shedding caused by BoHV-1 infection
Onset of protection: 2 weeks after completion of the primary
vaccination course.
Duration of protection: 12 months after completion of the primary
vaccination course.
-to reduce the incidence of abortions associated with BoHV-1
infections as
demonstrated during the second trimester of gestation following
challenge.
Onset of protection: completion of the primary course of vaccination
at least 19