Valsts: Francija
Valoda: angļu
Klimata pārmaiņas: HMA (Heads of Medicines Agencies)
SCS Boehringer Ingelheim
QI09AB13
Emulsion for injection
Mycoplasma vaccine
Pigs Food
2011-11-24
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac M. hyo emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated whole culture of _Mycoplasma hyopneumoniae_, J Strain, Isolate B-3745 grown in liquid medium. One dose of 2 ml vaccine contains: ACTIVE SUBSTANCE: _Mycoplasma hyopneumoniae_: 1 : 80* *antibody titre elicited with ½ dose (rabbits/ELISA assay) ADJUVANT: Montanide ISA 708: 1.30 ml (65 %) EXCIPIENTS For a complete list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. White opaque emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening pigs. 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 two weeks post vaccination and lasts for at least 118 days. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 3 Vaccinate only clinically healthy animals. In case of anaphylactic reactions, the administration of epinephrine is recommended. The application of the vaccine should be performed according to the requirements of Good Veterinary Practice. Injections with Ingelvac M. hyo done improperly can cause injection site lesions, such as granulomas or abscesses. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Self inje Izlasiet visu dokumentu
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac M. hyo emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated whole culture of _Mycoplasma hyopneumoniae_, J Strain, Isolate B-3745 grown in liquid medium. One dose of 2 ml vaccine contains: ACTIVE SUBSTANCE: _Mycoplasma hyopneumoniae_: 1 : 80* *antibody titre elicited with ½ dose (rabbits/ELISA assay) ADJUVANT: Montanide ISA 708: 1.30 ml (65 %) EXCIPIENTS For a complete list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. White opaque emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening pigs. 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 two weeks post vaccination and lasts for at least 118 days. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 3 Vaccinate only clinically healthy animals. In case of anaphylactic reactions, the administration of epinephrine is recommended. The application of the vaccine should be performed according to the requirements of Good Veterinary Practice. Injections with Ingelvac M. hyo done improperly can cause injection site lesions, such as granulomas or abscesses. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Self inje Izlasiet visu dokumentu