Summary of medicine characteristics - Zulvac 1+8 Bovis
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1+8 Bovis suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
Active substance(s):
Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* > 1
Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* > 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Adjuvant(s):
4 mg (Al3+)
1 mg
0.2 mg
Aluminium hydroxide
Saponin
Excipient(s):
Thiomersal
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
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4.2 Indications for use, specifying the target species
For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
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*(Cycling value (Ct) > 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 21 days after completion of the primary vaccination course
Duration of immunity: 12 months after completion of the primary vaccination course.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in cattle.
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4.5 Special precautions for use
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
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4.6 Adverse reactions (frequency and seriousness)
A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies. These resolved within a maximum of 25 days. Local reactions may increase slightly following the second dose in this case lasting up to 15 days. Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
The frequency of adverse reactions is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reaction(s)) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated) – 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
Can be used during pregnancy and lactation.
The safety and the efficacy of the vaccine have not been established in breeding males. In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
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
Intramuscular use.
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
2nd injection: 3 weeks after 1st injection.
Apply usual aseptic procedures.
Shake gently immediately before use.
Avoid bubble formation, as this can be irritating at the site of injection.
The entire content of the bottle should be used immediately after broaching and during the same procedure.
Avoid multiple vial broaching.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used
Revaccination:
Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A transient increase in rectal temperature, not exceeding 2 C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated viral vaccines – Bluetongue virus
ATCvet code: QI02AA08.
To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Aluminium hydroxide
Saponin
Thiomersal
Potassium chloride
Potassium dihydrogen phosphate
Disodium hydrogen 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 after broaching.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
Do not freeze.
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6.5 Nature and composition of immediate packaging
High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Pack sizes
Pack of 1 bottle of 10 doses (20 ml).
Pack of 1 bottle of 50 doses (100 ml).
Pack of 1 bottle of 120 doses (240 ml).
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
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/12/139/001 (20 ml)
EU/2/12/139/002 (100 ml)
EU/2/12/139/003 (240 ml)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 08/03/2012.
Date of latest renewal: 13/12/2016