البلد: إيطاليا
اللغة: الإنجليزية
المصدر: HMA (Heads of Medicines Agencies)
mycoplasma hyopneumoniae 1.47 RPU
Intervet
QI09AB13
Emulsion for injection
Mycoplasma vaccine
Pigs
2011-02-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 N AME OF THE V ETERINARY M EDICINAL P RODUCT M+PAC ThoroVAX (in DK, SE, EE, LT, LV) 2 Q UALITATIVE AND Q UANTITATIVE C OMPOS ITION ACTIVE INGREDIENTS: Quantity per 1 ml volume : _Mycoplasma hyopneumoniae,_ inactivated 1.47 RPU (*) Light mineral oil 0.134 ml Aluminium (as hydroxide) 1.0 mg Thiomersal 0.10 mg Excipients qs 1ml For full list of excipients, see section 6.1. (*) Relative Unit defined against a reference vaccine 3 P HARMACEUTICAL F ORM Emulsion for injection. [White liquid emulsion] 4 C LINICAL P ARTICULARS _ _ 4.1 TARGET SPECIES Pig (fattening pigs, from 7 days of age). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of pigs in order to reduce frequency and severity of lung lesions caused by _Mycoplasma hyopneumoniae. _ _ _ For vaccination with 2 doses of 1 ml given 2-4 weeks apart, protection has been demonstrated 35 days post initial dose and the duration of immunity is at least 6 months. In field studies, only seroconversion has been demonstrated in pigs receiving two 1 ml doses. For vaccination with 1 dose of 2 ml, protection has been shown 24 days after vaccination and duration of immunity is at least 6 months after vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS Piglets vaccinated from 7 days of age : Under laboratory conditions, piglets from 4 weeks of age after administration of 2 doses of 1 ml at 2-4 weeks interval produced a protective immune resp اقرأ الوثيقة كاملة