Patient leaflet - Zulvac BTV
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Zulvac BTV suspension for injection for sheep and cattle
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodon, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac BTV suspension for injection for sheep and cattle
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
| Active substances: One of the following inactivated bluetongue virus strains | Amount per 2 ml dose (BTV-1, BTV-4, BTV-8 in sheep; BTV-1, BTV-8 in cattle) | Amount per 4 ml dose (BTV-4 in cattle) |
| Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 | RP* > 1 | n.a. |
| Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 | RP* > 1 | n.a. |
| Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 | RP* > 0.8 | RP* > 0.8 |
| Adjuvants: Al3+ (as hydroxide) | 4 mg | 8 mg |
| Quil-A (Quillaja saponaria saponin extract) | 0.4 mg | 0.8 mg |
| Excipients: Thiomersal | 0.2 mg | 0.4 mg |
n.a.: not applicable
Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and/or cattle.
The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label. The target species will also be shown on the label.
Off-white or pink liquid.
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4. INDICATION(S)
Sheep:
Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
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*Below the level of detection of <3.9 log10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome.
Onset of immunity: 21 days after completion of the primary vaccination scheme.
Duration of immunity: 12 months after completion of the primary vaccination scheme.
Cattle:
Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1, serotype 4 or serotype 8.
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**Below the level of detection of <3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
Onset of immunity: Bluetongue virus, serotype 1: 15 days after completion of the primary
vaccination scheme.
Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Bluetongue virus, serotype 4: 14 days after completion of the primary vaccination scheme.
Duration of immunity: Bluetongue virus, serotype 1: 12 months after completion of the primary
vaccination scheme.
Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Bluetongue virus, serotype 4: 6 months after completion of the primary vaccination scheme.
There is evidence of BTV-1 seroneutralising antibodies indicative of protection for up to 21 months after primary vaccination.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
Sheep:
A transient increase in rectal temperature, not exceeding 1.6 °C, may very commonly occur during the 48 hours following vaccination.
A local reaction at the injection site may occur very commonly after vaccination. These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Cattle administered a 2 ml dose:
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.
Cattle administered a 4 ml dose :
A transient increase in rectal temperature, not exceeding 2.7°C, was very commonly observed within 48 hours following vaccination in the lab and field safety study conducted. The pyrexia observed had a maximum duration of 2 days. Local reactions at the injection site of up to 6 cm in diameter, which resolved in a maximum of 8 days, also very commonly appeared in the lab safety study conducted.
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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Sheep and cattle.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Sheep:
Subcutaneous use.
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme:
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– 1st injection: from 6 weeks of age.
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– 2nd injection: after 3 weeks.
Revaccination:
For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Cattle:
Intramuscular use.
For protection against serotype 1 and serotype 8 :
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme:
1st injection: from 12 weeks of age.
2nd injection: after 3 weeks.
Revaccination:
For protection against serotype 1, administer one dose of 2 ml, every 12 months.
For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
For protection against serotype 4 :
Primary vaccination:
Administer a dose of 4 ml according to the following vaccination scheme:
1st injection: from 12 weeks of age.
2nd injection: after 3 weeks.
Revaccination:
Administer two doses of 4 ml three weeks apart, every 6 months
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9. ADVICE ON CORRECT ADMINISTRATION
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.
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 broaching.
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WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life after first opening the container: use immediately.
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12. SPECIAL WARNINGS
Special warnings for each target species :
Vaccinate healthy animals only.
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 sheep and cattle.
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Special precautions for use in animals :
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Not applicable.
Pregnancy:
Can be used during pregnancy in sheep and cattle.
Lactation:
The safety of the vaccine has not been established during lactation in sheep. It can be used during lactation in cattle.
Fertility :
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).
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.
Overdose (symptoms, emergency procedures, antidotes) :
Sheep:
After administration with a two-fold overdose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Cattle:
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.
Incompatibilities :
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED