Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
mycoplasma hyopneumoniae inactivated 3 ELISAU
Merial
QI09AB13
Suspension for injection
Mycoplasma
Pigs
2012-02-24
D90_TM Page 1 of 5 September 2007 SUMMARY OF PRODUCT CHARACTERISTICS _ _ D90_TM Page 2 of 5 September 2007 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HYORESP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per one dose of 2 ml: ACTIVE SUBSTANCE: . Inactivated whole cell _Mycoplasma hyopneumoniae _antigen, at least ...................... 3.0 ELISA.U * ADJUVANT: . Al +++ (as hydroxide) ......................................................................................................... 4.2 mg EXCIPIENTS: . Thiomersal ....................................................................................................................... 0.2 mg * ELISA.U: Unit of RP (relative potency) compared to reference vaccine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Milky color 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES - Suckling piglets from the age of 5 days - Post weaning piglets - Fattening pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs to reduce infection and lung lesions caused by _Mycoplasma _ _hyopneumoniae_. 4.3 CONTRAINDICATIONS None. See 4.7 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS . Apply usual procedures for the handling of the animals. . Vaccinate only healthy animals. . Shake prior to use. . Apply usual aseptic procedures. Hyoresp Page 3 of 5 September2007 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 Read the complete document