Patient leaflet - Suvaxyn Circo+MH RTU
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Suvaxyn Circo+MH RTU emulsion 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 authorization 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 Circo+MH RTU emulsion for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml) contains:
Active substances:
2.3 – 12.4 RP*
1.5 – 3.8 RP*
0.4% (v/v)
0.2% (v/v) 0.032% (v/v)
0.2 mg
Inactivated recombinant chimeric porcine circovirus type 1 containing the
porcine circovirus type 2 ORF2 protein
Inactivated Mycoplasma hyopneumoniae, strain P-5722–3
Adjuvant:
Squalane
Poloxamer 401
Polysorbate 80
Excipients:
Thiomersal *
Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
White homogenous emulsion.
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4. INDICATION(S)
For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
For active immunization of pigs from 3 weeks of age against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A transient increase in body temperature (on average 1 °C) was very commonly observed during the first 24 hours after vaccination in laboratory and field trials. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. This resolves spontaneously within 48 hours without treatment.
Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies). The area of local tissue reactions is in general below 2 cm in diameter. In a laboratory study, a post-mortem examination of the injection site, performed 4 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
Immediate mild hypersensitivity-like reactions were uncommonly observed after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression, in field efficacy studies. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rare cases. In case of such reactions, appropriate treatment is recommended.
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)
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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 (for fattening).
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
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9. ADVICE ON CORRECT ADMINISTRATION
Shake well before administration and intermittently during the process of vaccination.
The vaccine is to be administered aseptically.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions.
A slight black deposit may appear and the emulsion may separate into two distinct phases during storage. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
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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 carton and the vial after EXP. The expiry date refers to the last day of that month.
Once broached 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:
No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
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 :
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Do not use 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):
A transient increase in body temperature (on average 0.8 °C) was observed 4 hours after administration of a 2-fold overdose. This resolved spontaneously within 24 hours without treatment.
Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
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 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