Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Mycoplasma hyopneumoniae
MSD Animal Health UK Limited
QI09AB13
Mycoplasma hyopneumoniae
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2012-01-24
Revised: August 2020 AN: 00299/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis M Hyo ID ONCE emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.2 ml contains: ACTIVE SUBSTANCE: Inactivated whole cell concentrate of _ Mycoplasma hyopneumoniae_ strain 11: 6.5 log 2 Ab titre* * Mean antibody titre (Ab) obtained after inoculation of mice with a 1/1,000 pig dose. ADJUVANT: light liquid paraffin 34.6 mg dl- -tocopheryl acetate 2.5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. White to nearly white emulsion with creamy appearance after shaking. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (finishing pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by _Mycoplasma hyopneumoniae_. Onset of immunity: 3 weeks after vaccination. Duration of immunity: 22 weeks after vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Revised: August 2020 AN: 00299/2020 Page 2 of 5 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 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 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: Lestu allt skjalið