Rhinovac IBR Marker live Lyophilisate and solvent for suspension for injection or nasal spray for cattle.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bovine herpesvirus 1, strain bio-27 live

Available from:

Animal Health Distributors Limited

ATC code:

QI02AD01

INN (International Name):

Bovine herpesvirus 1, strain bio-27 live

Dosage:

.

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Therapeutic area:

bovine rhinotracheitis virus (IBR)

Authorization status:

Authorised

Authorization date:

2021-09-10

Summary of Product characteristics

Health Products Regulatory Authority
10 September 2021
CRN009WPL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rhinovac IBR Marker live Lyophilisate and solvent for suspension for
injection or nasal spray for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Eachdose of 2ml reconstituted vaccine contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Live attenuated bovine herpesvirus Type I (BHV-I), strain Bio-27: IBR
(gE negative), 10
5.7
– 10
7.5
TCID
50
*
​
​
​
*TCID
50
– medium tissue culture infectious dose (50%)
​
​
​
EXCIPIENTS:
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​
​
For the full list of excipients see Pharmaceutical Particulars
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​
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection or nasal spray.
The lyophilisate has a spongy consistency, a cream to yellowish
colour.
The solvent is a clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of cattle to reduce the severity and
duration of clinical signs and viral excretion caused by BHV-1
(infectious bovine rhinotracheitis; IBR) infections.
Onset of Immunity:
One week after intranasal vaccination of calves from 2 weeks of age
without maternally derived antibodies.
Two weeks after intramuscular vaccination of calves from 3 months of
age.
Duration of immunity:
Ten weeks after intranasal vaccination of calves from 2 weeks of age
without maternally derived antibodies.
Six months after intramuscular vaccination of calves from 3 months of
age.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Maternal antibodies have been shown to have a negative impact on the
efficacy of intranasal vaccination of calves from 2
weeks of age, therefore the efficacy of intranasal vaccination has
been demonstrated only in seronegative calves. The presence
of maternally derived antibodies in calves from 3 months of age do not
interfere with the response to intramuscular
vaccination.
Vaccinate hea