Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Inactivated whole cell concentrate of m. hyopneumoniae strain 11
Intervet Ireland Limited
QI09AB13
Inactivated whole cell concentrate of m. hyopneumoniae strain 11
.
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
mycoplasma
Immunological - Inactivated Vaccine
Authorised
2012-01-20
M SUMMARY OF PRODUCT CHARACTERISTICS M 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis M Hyo ID ONCE emulsion for injection for pigs IT: Porsilis M Hyo ID ONCE HU: Porcilis M Hyo ID ONCE vakcina A.U.V. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains: ACTIVE SUBSTANCE: _Mycoplasma hyopneumoniae_ inactivated _, _ strain 11: 6.5 log 2 Ab titre* * Mean antibody titre (Ab) obtained after inoculation of mice with a 1/1,000 pig dose. ADJUVANTS: light liquid paraffin 34.6 mg dl- -tocopheryl acetate 2.5 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ Polysorbate 80 Simethicone Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Water for injections Emulsion for injection. White to nearly white emulsion with creamy appearance after shaking. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the active immunisation of 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. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS M Vaccinate healthy animals only. 3.5 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, Soma hati kamili