Patient leaflet - CircoMax Myco
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
CircoMax Myco Emulsion for injection for pigs
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
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CircoMax Myco emulsion for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 2 ml contains:
Active substances:
1.5 – 4.9 RP*
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (ORF2) protein
Inactivated recombinant chimeric porcine circovirus type 1 containing the 1.5 – 5.9 RP*
porcine circovirus type 2b ORF2 protein
Inactivated Mycoplasma hyopneumoniae, strain P-5722–3 1.5 – 4.7 RP*
Adjuvant:
Squalane 0.4% (v/v)
Poloxamer 401 0.2% (v/v)
Polysorbate 80 0.032% (v/v)
Excipients:
Thiomersal 0.2 mg *
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)
Active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with PCV2 infection.Protection was demonstrated against porcine circovirus types 2a, 2b and 2d.. Active immunisation of pigs against Mycoplasma hyopneumoniae to reduce the lung lesions associated with Mycoplasma hyopneumoniae infection.
Onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.
Duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.
In addition, vaccination has been shown to reduce body weight gain losses under field conditions.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A transient increase in body temperature, not exceeding 2.1°C, is very common after vaccination and resolves spontaneously within 24 hours without treatment. In a laboratory study, a post-mortem examination of the injection site, performed 2 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild lymphocytic-granulomatous inflammatory response. Local tissue reactions in the form of swelling at the injection site, below 2 cm in diameter, are common and may last for up to 10 days. Erythema may be uncommonly observed during the first 24 hours after vaccination. Hypersensitivity reactions, vomiting, incoordination, lethargy, and laboured breathing were uncommonly observed in field studies. The animals mostly recover within 24 hours.
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.
7.
TARGET SPECIES
Pigs (for fattening).
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use, in the neck behind the ear.
Single dose vaccination schedule
A single dose of 2 ml in pigs from 3 weeks of age.
Split dose vaccination schedule
Two injections each of 1 ml in pigs from 3 days of age with an interval of approximately 3 weeks.
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9. ADVICE ON CORRECT ADMINISTRATION
Choice of dosing regimen, including age of vaccination should take into account farm circumstances. In situations where the level of maternally-derived antibodies against PCV2 is expected to be moderately high or very high, it is recommended to use the split dose vaccination schedule or to delay the age of vaccination.
Shake well before administration and intermittently during the process of vaccination.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions. The vaccine is to be administered aseptically. During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
10.
WITHDRAWAL PERIOD(S)
Zero days.
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.
Once broached use immediately.
12.
SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
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: None.
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):
In supportive overdose studies, lethargy and polypnea have been observed. Transient mild injection site swellings can occur for up to 1 day. Transient fever (maximum 41.1°C) may occur for up to 12 hours.
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