CATTLEMARKER IBR INACTIVATED EMULSION FOR INJECTION FOR CATTLE

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BOHV TYPE I, STRAIN DIFIVAC, GE-DELETION MUTANT INACTIVATED

Dostępny od:

Zoetis Belgium S.A.

Kod ATC:

QI02AH

INN (International Nazwa):

BOHV TYPE I, STRAIN DIFIVAC, GE-DELETION MUTANT INACTIVATED

Forma farmaceutyczna:

Emulsion for Injection

Typ recepty:

POM

Grupa terapeutyczna:

Bovine

Dziedzina terapeutyczna:

Live and inactivated viral vaccines

Wskazania:

Immunological - Inactivated vaccine

Status autoryzacji:

Authorised

Data autoryzacji:

2017-03-01

Charakterystyka produktu

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.
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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 prima