Hiprabovis IBR Marker Live

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50

Available from:

Laboratorios Hipra S.A

ATC code:

QI02AD01

INN (International Name):

live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

Therapeutic group:

Cattle

Therapeutic area:

Immunologicals

Therapeutic indications:

For the active immunisation of cattle from three months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.Onset of immunity: 21 days after completion of the basic vaccination scheme.Duration of immunity: 6 months after completion of the basic vaccination scheme

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2011-01-27

Patient Information leaflet

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET:
HIPRABOVIS IBR MARKER LIVE
lyophilisate and solvent for suspension for injection for cattle.
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
LABORATORIOS HIPRA, S.A.
Avda la Selva, 135
17170 Amer (Girona)
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for
injection for cattle.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Lyophilisate:
Each dose of 2 ml contains: Live gE
-
tk
-
double-gene deleted bovine herpes virus type 1 (BoHV-1),
strain CEDDEL: 10
6.3
– 10
7.3
CCID
50.
_Abbreviations: _
_gE_
_-_
_: deleted glycoprotein E; tk_
_-_
_: deleted thymidine kinase; CCID: cell culture infectious dose _
Solvent:
Phosphate buffer solution.
Suspension after reconstitution: transparent pinkish liquid.
Lyophilisate: white to yellowish powder.
Solvent: transparent homogenous liquid.
4.
INDICATION(S)
For the active immunisation of cattle from 3 months of age against
bovine herpes virus type 1
(BoHV-1) to reduce the clinical signs of Infectious bovine
rhinotracheitis (IBR) and field virus
excretion.
Vaccinated animals can be differentiated from field virus infected
animals due to the marker deletion
(gE
-
) by means of commercial diagnostic kits, unless the animals were
previously vaccinated with a
conventional vaccine or infected with field virus.
Onset of immunity: 21 days after completion of the basic vaccination
scheme.
Duration of immunity: 6 months after completion of the basic
vaccination.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
21
6.
ADVERSE REACTIONS
Common adverse reactions:
A slight increase in body temperature up to 1 °C is common within 4
days following vaccination.
Commonly, an increase in rectal temperature up to 1.63 ºC in adult
c

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for
injection for cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Live gE
-
tk
-
double-gene deleted bovine herpes virus type 1 (BoHV-1), strain
CEDDEL: 10
6.3
– 10
7.3
CCID
50.
_ _
_Abbreviations: _
_gE_
_-_
_: deleted glycoprotein E; tk_
_-_
_: deleted thymidine kinase; CCID: cell culture infectious dose _
Solvent:
Phosphate buffer solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Suspension after reconstitution: transparent pinkish liquid.
Lyophilisate: white to yellowish powder.
Solvent: transparent homogenous liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves and adult cows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of cattle from 3 months of age against
bovine herpes virus type 1 (BoHV-
1) to reduce the clinical signs of Infectious bovine rhinotracheitis
(IBR) and field virus excretion.
Onset of immunity: 21 days after completion of the basic vaccination
scheme.
Duration of immunity: 6 months after completion of the basic
vaccination scheme.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Common adverse reactions:
A slight increase in body temperature up to 1 °C is common within 4
days following vaccination.
Commonly, an increase in rectal temperature up to 1.63 ºC in adult
cows and up to 2.18 ºC in calves
may be observed. This transient rise in temperature