Summary of medicine characteristics - Hiprabovis IBR Marker Live
SUMMARY OF PRODUCT CHARACTERISTICS
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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: 106.3 – 107.3
CCID50.
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 PARTICULARS4.1 Target species
Cattle (calves and adult cows).
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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.
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4.4 Special warnings for each target species
None.
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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.
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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 °C in adult cows and up to 2.18 °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.
Very rare adverse reactions:
Vaccination might very rarely cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
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– common (more than 1 but less than 10 animals in 100 animals)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals)
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– rare (more than 1 but less than 10 animals in 10,000 animals)
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– very rare (less than 1 animal in 10,000 animals, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
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.
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4.9 Amounts to be administered and administration route
Cattle: from the age of 3 months onwards.
Administer one dose of 2 ml by intramuscular injection in the neck muscles.
Reconstitute the lyophilisate with the entire contents of the supplied 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 °C and 20 °C before reconstitution of the lyophilisate. Shake well before use. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration.
4.10 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.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Live viral vaccines, bovine rhinotracheitis virus (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 and reduced 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 (i.e. cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (i.e. 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.
6. PHARMACEUTICAL PARTICULARS6.1 List of 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
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
6.3 Shelf life
Shelf life of the lyophilisate as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 5 years.
Shelf life after reconstitution according to directions: 6 hours.
6.4. Special precautions for storage
Lyophilisate: Store and transport refrigerated (2 °C – 8 °C).
Solvent of 5 and 25 doses: Store and transport refrigerated (2 °C – 8 °C).
Solvent of 30 doses: Do not store and transport above 25 °C.
Do not freeze.
Keep the bottles in the box in order to protect from light.
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6.5 Nature and composition of 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 or 100 ml containing 60 ml of solvent) or PET bottles (10, 50 or 100 ml containing 60 ml of solvent) closed with a bromobutyl rubber closure and an aluminium cap.
Package sizes:
Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent.
Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent.
Cardboard box containing 1 bottle with 30 doses of lyophilisate.
Cardboard box containing 1 bottle with 60 ml of solvent.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
LABORATORIOS HIPRA, S.A.
Avda la Selva, 135
17170 Amer (Girona)
SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail:
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/10/114/001
EU/2/10/114/002
EU/2/10/114/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27/01/2011
Date of last renewal: 06/11/2015