Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Mycoplasma hyopneumoniae
Ceva Animal Health Ltd
QI09AB13
Mycoplasma hyopneumoniae
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2015-06-11
Revised: October 2022 AN: 01665/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hyogen emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCE: Inactivated _Mycoplasma hyopneumoniae _2940 strain: min. 5.5 EU * ADJUVANTS: Light liquid paraffin 187 μl _Escherichia coli_ J5 LPS max. 38000 Endotoxin unit EXCIPIENT: Thiomersal 50 µg * Mean antibody titre – expressed in _M. hyopneumoniae_ ELISA Unit – obtained 28 days after the immunisation of rabbits with half of pig vaccine dose (1ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection Off-white, homogeneous emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs for fattening 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of fattening pigs from 3 weeks of age to reduce the occurrence and severity of lung lesions caused by _ Mycoplasma hyopneumoniae _ infection. Onset of immunity: 3 weeks after the vaccination Duration of immunity: 26 weeks after vaccination Revised: October 2022 AN: 01665/2022 Page 2 of 6 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. 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. 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 Read the complete document