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Date: Monday, June 16, 2025 5:35

Release 2.31
Cirbloc ® M Hyo emulsion for injection for pigs (NI)
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Cirbloc ® M Hyo emulsion for injection for pigs
Product index: Cirbloc ® M Hyo emulsion for injection for pigs
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each 2 ml dose contains:
Active substances:
Mycoplasma hyopneumoniae, strain 2940, inactivated min. 184 AU* Porcine circovirus type 2d, ORF2 capsid protein min. 19.6 mcg *AU: Antigen units as measured in potency test (ELISA)
Adjuvant: Light liquid paraffin 277 μl
Excipients:
Qualitative composition of excipients and other constituents
Sorbitan trioleate
Polysorbate 80
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Pharmaceutical form
Off-white emulsion. Greyish creaming and sedimentation may occur. Homogeneous emulsion after shaking.
Clinical particulars
Target species
Pigs (for fattening)
Indications for use for each target species
For the active immunisation of pigs to reduce:
- viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection,
- severity of lung lesions caused by Mycoplasma hyopneumoniae infection,
- the loss in body weight gain.
Onset of immunity:
PCV2: 2 weeks after vaccination
M. hyopneumoniae: 3 weeks after vaccination
Duration of immunity:
PCV2: 23 weeks after vaccination
M. hyopneumoniae: 23 weeks after vaccination
Contraindications
None.
Special warnings
Vaccinate healthy animals only. In farms where PCV2 and M. hyopneumoniae vaccination of sows and gilts is performed during their late pregnancy and the high levels of MDA can be expected, the use of Cirbloc M Hyo may be delayed.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Pigs (for fattening):
Very common (>1 animal / 10 animals treated):
Injection site swelling1
Very common (>1 animal / 10 animals treated):
Elevated temperature2
Lethargy2
1 Swellings of 0.2 cm to 2 cm diameter might occur when administration is performed with mass injector; they disappear spontaneously within nine days.
2 Lethargy and increase in body temperature can occur four hours after vaccination, with a maximum of 1.7 °C at individual level and 0.5-0.78 °C as an average, resolving spontaneously by the next day.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing 4 authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or 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.
Administration routes and dosage Intramuscular use.
Vaccinate pigs in the neck. A single dose of 2 ml is given to pigs from 3 weeks of age onwards.
Allow it to reach room temperature (15 °C – 25 °C). Shake well before use. Apply usual aseptic procedures.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No data available.
Withdrawal periods
Zero days
Pharmacological particulars
ATCvet code: QI09AL08.
The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs. The recombinant porcine circovirus type 2d antigen (ORF2 capsid protein) auto-assembles into viruslike-particles (VLPs). The vaccine is able to reduce the loss in body weight gain in those farms where the level of PCV2 infection is high and the duration is long.
Pharmaceutical particulars
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Store in the original container. Protect from light.
Nature and composition of immediate packaging
Low density polyethylene (LDPE) bottles of 50, 100, 250 or 500 ml sealed with rubber stopper and aluminium cap.
Pack sizes:
Cardboard box of 1 x 50 ml (1 x 25 doses)
Cardboard box of 10 x 50 ml (10 x 25 doses)
Cardboard box of 1 x 100 ml (1 x 50 doses)
Cardboard box of 10 x 100 ml (10 x 50 doses)
Cardboard box of 48 x 100 ml (48 x 50 doses)
Cardboard box of 1 x 250 ml (1 x 125 doses)
Cardboard box of 6 x 250 ml (6 x 125 doses)
Cardboard box of 1 x 500 ml (1 x 250 doses)
Cardboard box of 6 x 500 ml (6 x 250 doses)
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Ceva-Phylaxia Co. Ltd.
Marketing Authorisation Number
EU/2/24/322/001-009
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 24/10/2024
Date of revision of the text
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:CIRBLOC MHYO 100ML
GTIN:03411113147686
GTIN description:CIRBLOC MHYO 250ML
GTIN:03411113161088