Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
mycoplasma hyopneumoniae 0 %
BOEHRINGER INGELHEIM
QI09AB13
Suspension for injection
Mycoplasma
Pigs
2011-11-10
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 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 of 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 a 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 None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only healthy animals should be vaccinated. In case of anaphylactic reactions, the administration of epinephrine is recommended. 3 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Adverse reactions are uncommon: transient swelling up to four centimetres in diameter, sometimes associated with redness of the skin, Read the complete document