Patient leaflet - Suvaxyn CSF Marker
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
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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 and manufacturer responsible for batch release :
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
Lyophilisate
Live recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)
104.8* to 106.5 TCID**50
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* min 100 PD50
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* * Tissue culture infectious dose
Solvent:
Sodium chloride 9 mg/ml
Water for injections q.s.p. 1 ml
Lyophilisate: Off-white pellet
Solvent: Clear colourless liquid
After reconstitution, the suspension should be slightly pink clear liquid.
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4. INDICATION(S)
For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus.
Onset of immunity: 14 days after vaccination
Duration of immunity: at least 6 months after vaccination
For active immunisation of breeding females to reduce transplacental infection caused by CSFV.
Onset of immunity: 21 days after vaccination
Duration of immunity has not been demonstrated.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
In laboratory safety studies in pregnant animals, the following adverse reactions were observed:
A local and transient tissue reaction in the form of swelling of up to 5 mm in diameter at the injection site was very common and lasted for up to 1 day. A transient increase in body temperature of 2.9 °C was observed commonly 4 hours after vaccination. This resolved spontaneously within 1 day after vaccination.
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).
If you notice any side effects, whether or not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Pigs
KU
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Basic vaccination
A single 1 ml dose should be administered to pigs from 7 weeks of age and breeding females.
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9. ADVICE ON CORRECT ADMINISTRATION
Reconstitute the lyophilisate aseptically with the solvent to obtain a suspension for injection.
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10. 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 and carton after EXP {month/year}.
Shelf life after reconstitution according to directions: use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones.
Protection against transplacental transmission of CSFV was shown 21 days after vaccination when challenge was applied in 6 pregnant sows with a moderately virulent CSFV strain. Partial protection against transplacental transmission of CSFV was observed when challenge was applied in 6 pregnant sows with a highly virulent CSFV strain.
Birth of persistently infected immunotolerant piglets represent a very high risk since they are shedding field virus and they cannot be identified serologically due to their seronegative status. Vaccination of breeding animals may be included in risk-based control strategies in case of outbreak and considering the above information.
The vaccine has shown reduced protection in studies of piglets with maternally derived antibodies compared to studies of piglets without maternally derived antibodies.
Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted. Use of the vaccine in experimental studies in breeding boars has not revealed safety concerns. Therefore, the decision to vaccinate breeding boars and piglets with maternally derived antibodies should be taken based on the actual outbreak case and associated control zones.
RT-PCR tools could be used in outbreak situations to differentiate between the vaccine virus genome and those of field strains based on sequences unique to the CP7_E2alf.
Special precautions for use in animals:
Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination. Transplacental transmission of the vaccine virus has not been detected in the limited studies performed but cannot be excluded.
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.
Pregnancy:
The vaccine can be used in sows during pregnancy.
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.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
DIVA tests:
The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals). Diagnostic tools targeted to detection of antibody responses could enable DIVA strategies. Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses after solely herd vaccination with CP7_E2alf from responses after natural field CSFV infection.
DIVA efficiency depends on the performance of tests related to fitness for purpose in outbreak situations. Serological DIVA concept has been shown in principle, while actual DIVA tools remain to be tested on large panels of samples from emergency vaccination in outbreak situations.
Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union. Specific derogation is required to use this vaccine in an outbreak situation.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
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