Summary of medicine characteristics - Zulvac SBV
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
| Active substance: Inactivated Schmallenberg virus, strain BH80/11–4 | Amount per 2 ml dose (cattle) RP* > 1 | Amount per 1 ml dose (sheep) RP* > 1 |
| Adjuvants: | ||
| Aluminium hydroxide | 385.2 mg (4 mg Al3+) | 192.6 mg (2 mg Al3+) |
| Quil-A (Quillaja saponaria saponin extract) | 0.4 mg | 0.2 mg |
| Excipient: | ||
| Thiomersal | 0.2 mg | 0.1 mg |
*Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Off-white or pink liquid.
4. CLINICAL PARTICULARS4.1 Target species
Cattle and sheep.
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4.2 Indications for use, specifying the target species
Cattle:
For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Onset of immunity: 2 weeks after completion of the primary vaccination course.
Duration of immunity: 1 year after completion of the primary vaccination course.
Sheep:
For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months after vaccination.
Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
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*Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
Vaccinate healthy animals only.
No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies.
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4.5 Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
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4.6 Adverse reactions (frequency and seriousness)
Cattle:
A transient increase in rectal temperature, not exceeding 1.5 °C, was very commonly observed during the first 48 hours after vaccination. Local reactions at the injection site in the form of small intramuscular granulomas up to 0.7 cm in diameter which resolve in a maximum of 10 days, also very commonly appeared in the safety studies conducted.
Sheep:
A transient increase in rectal temperature, not exceeding 1.5 °C, was very commonly observed during the first 24 hours after vaccination. Local reactions at the injection site in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm also very commonly appeared in the safety studies conducted. The reactions were observed for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.
Pregnant ewe:
A transient increase in rectal temperature, not exceeding 0.8 °C, was very commonly observed during the first 4 hours after vaccination. Local reactions at the injection site in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm also very commonly appeared in the safety studies conducted. The reactions were observed for at least 97 days in the form of small granulomas of less than 0.5 cm in diameter.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Pregnancy:
Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep. Can be used at 2 months of pregnancy and onwards.
Cattle: The safety and efficacy of the vaccine have not been established in pregnant cattle.
Lactation:
The safety and the efficacy of the vaccine have not been established in lactating animals.
Fertility:
The safety and the efficacy of the vaccine have not been established in breeding males.
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
Shake the vial before use.
Cattle:
Intramuscular use (in the neck).
Primary vaccination:
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– For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Booster vaccination :
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– Administer two doses of 2 ml three weeks apart, every twelve months.
Sheep:
Subcutaneous use (in the axillar region behind the elbow).
Primary vaccination:
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– For sheep from 3.5 months of age: administer one dose of 1 ml.
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– For female sheep at breeding age: administer one dose of 1 ml at least 14 days prior to breeding.
Booster vaccination :
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– For non-breeding sheep: administer one dose of 1 ml, every 6 months.
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– For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
ATC vet code: QI02AA.
To stimulate active immunity against Schmallenberg virus in cattle and sheep.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Aluminium hydroxide
Quil-A (Quillaja saponaria saponin extract)
Thiomersal
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Sodium chloride
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Shelf life after first opening the immediate packaging: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze. Protect from light.
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6.5 Nature and composition of immediate packaging
Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Cattle: Cardboard box with 1 vial of 50 ml (25 doses).
Sheep: Cardboard box with 1 vial of 50 ml (50 doses).
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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
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/14/178/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 06/02/2015.
Date of last renewal: