Company name: HIPRA UK Ltd
Address: Bio City
Pennyfoot Street
Nottingham
NG1 1GF
Telephone: 0115 812 0499
Fax: 0115 812 0498
Email: uk@hipra.com
Website: www.hipra.com
Hiprabovis IBR Marker Live
Company name: HIPRA UK Ltd
Address: Bio City
Pennyfoot Street
Nottingham
NG1 1GF
Telephone: 0115 812 0499
Fax: 0115 812 0498
Email: uk@hipra.com
Website: www.hipra.com
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: 106.3 – 107.3 CCID50.
Abbreviations:
gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose
Solvent:
Phosphate buffer solution.
Lyophilisate and solvent for suspension for injection.
Lyophilisate: white to yellowish tablet.
Solvent: transparent homogenous liquid.
Target species
Species: cattle
Sub-category: calves and adult cows
Age: From 3 months
Indications for use
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
Contra-indications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None
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
None.
Adverse reactions
A slight increase in body temperature up to 1° C is common within 4 days following vaccination. Occasionally, an increase in rectal temperature up to 1.63º C in adult cows and up to 2.18º C in calves may be observed. This transient rise in temperature is spontaneously resolved within 48 hours without treatment and it is not related to a febrile process.
A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination. This slight swelling lasts for less than 24 hours in most cases.
Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interactions
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Cattle: from the age of 3 months onwards.
Reconstitute the lyophilised tablet with the entire contents of the enclosed solvent to obtain a suspension for injection.
Recommended vaccination programme:
The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. The animal should be revaccinated 3 weeks later with the same dose.
Thereafter a single booster dose of 2 ml should be administered every six months.
The method of administration is by intramuscular route, in the neck muscles. The injections should be preferably administered on the alternate sides of the neck. The solvent should be allowed to warm to a temperature between 15 ºC to 20ºC before reconstitution of the lyophilised tablet. Shake well before use. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a 10-fold vaccine dose.
Withdrawal periods
Zero Days
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: live bovine vaccines against IBR, ATCvet code: QI02AD01.
To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle. The vaccine contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE surface protein and the tk enzyme. The tk deletion is related to reduced viral neurotropism andreduced establishment of latency. The absence of the gene coding for the gE surface protein entails that the vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine). This enables discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines. Diagnostic tools designed to detect gE antibodies should be suitable for this purpose. Animals exposed to gE surface protein will test positive (eg cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (ie non-infected animals, including those vaccinated with Hiprabovis IBR Marker Live). Animals vaccinated with Hiprabovis IBR Marker live will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens.
Excipients
Lyophilisate:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Gelatine
Povidone
Monosodium glutamate
Sodium chloride
Potassium chloride
Sucrose
Water for injections
Solvent:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium chloride
Potassium chloride
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the lyophilisate as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 2 years.
Shelf life after reconstitution: 6 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light
Immediate packaging
Lyophilisate: Colourless Type I glass bottle closed with a bromobutyl rubber closure and an aluminium cap.
Solvent: Colourless Type I glass bottle (10 ml) or Type II glass bottle (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
Package sizes:
Cardboard box containing 1 bottle with 5 doses of lyophilised tablet and 1 bottle with 10 ml of solvent.
Cardboard box containing 1 bottle with 25 doses lyophilised tablet and 1 bottle with 50 ml of solvent.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona) SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
27/01/2011
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Any person intending to import, sell, supply and/or use of HIPRABOVIS® IBR MARKER LIVE must consult the relevant Member State’s Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.
HIPRABOVIS IBR MARKER LIVE 25ds
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HIPRABOVIS IBR MARKER LIVE 5ds
08427711130727