Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Mycoplasma hyopneumoniae
Boehringer Ingelheim Limited
QI09AB13
Mycoplasma hyopneumoniae
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2009-08-04
Revised: February 2016 AN: 01030/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac MycoFLEX suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated _Mycoplasma hyopneumoniae_, J Strain Isolate B-3745. Each dose ( 1 ml) of inactivated vaccine contains: ACTIVE SUBSTANCE: _Mycoplasma hyopneumoniae_: > 1 RP* *Relative potency (ELISA test) by comparison with a reference vaccine. ADJUVANT: Carbomer: 1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear to slightly opalescent, pink to brown suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (fattening pigs or future breeders until first reproductive service). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with _Mycoplasma hyopneumoniae_. Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Page 1 of 5 Revised: February 2016 AN: 01030/2015 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy animals only In case of anaphylactic-type reactions, the administration of epinephrine is recommended. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Adverse reactions are very rare (less than 1 animal in 10,000 animals, including isolated reports): - anaphylactic-type reactions may occur and should be treated symptomatically (e.g. epinephrine) - transient swelling up to four centimetres in diameter, sometimes associated with redness of the skin, may be observed at the injection site. These swellings may last up to five days. - a transient mean increase in rectal body temperature of about 0.8 °C lasting up to 20 hours after vaccination may be observed. The freq Read the complete document