Patient leaflet - Eryseng
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
ERYSENG 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 :
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG suspension for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each does of 2 ml contains:
Inactivated Erysipelothrix rhusiopathiae , strain R32E11,.................... ELISA > 3.34 log2 IE50%
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IE50% – Inhibition ELISA 50%.
Aluminium hydroxide.....................................................................................5.29 mg (aluminium)
DEAE-Dextran
Ginseng.
Whitish suspension for injection.
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4. INDICATION(S)
For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae , serotype 1 and serotype 2.
Onset of immunity : three weeks after completion of the basic vaccination scheme.
Duration of immunity : six months.
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5. CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
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6. ADVERSE REACTIONS
Very common adverse reactions :
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– Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Common adverse reactions :
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– A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies.
Very rare adverse reactions:
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– Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
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, 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
Pigs.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Basic vaccination:
Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3–4 weeks. The second injection should be administered 3–4 weeks before mating.
Revaccination :
A single injection should be given 2–3 weeks prior to each subsequent mating (approximately every 6 months).
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9. ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach room temperature (15–25 °C) before administration.
Shake well before use.
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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 after EXP.
Shelf life after first opening the container: use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate only healthy animals.
Special precautions for use in animals :
None.
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 and lactation :
Can be used during pregnancy and lactation.
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) :
No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
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
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon or pharmacist 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
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION