देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Chlamydophila abortus strain A22 inactivated; Salmonella enterica subsp. enterica serovar Abortusovis strain Sao
Laboratorios Hipra S.A.
QI04AB
Chlamydophila abortus strain A22 inactivated; Salmonella enterica subsp. enterica serovar Abortusovis strain Sao
.
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Authorised
2019-06-14
Health Products Regulatory Authority 10 February 2022 CRN00CNWW Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT INMEVA, suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCES: Inactivated _Chlamydia abortus_ strain A22 RP* ≥ 1 Inactivated _Salmonella enterica_ subsp. _enterica_ serovar Abortusovis strain Sao RP* ≥ 1 *Relative Potency determined by ELISA, using a reference vaccine demonstrated to be efficacious. ADJUVANTS: Aluminium hydroxide(Aluminium) 5.29 mg DEAE Dextran 20 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Ivory-coloured suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep (ewe). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunization of animals to reduce clinical signs (abortion, stillbirth, early mortality and hyperthermia) caused by _Chlamydia abortus,_ abortions caused by _Salmonella _Abortusovis and to reduce shedding of both pathogens from infected animals. Vaccination covers the whole gestation period, when administered according to section 4.9. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances, to the adjuvants or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. In farms with recurring reproductive disorders caused by _Chlamydia abortus _and/or _Salmonella _Abortusovis, it would be advisable to maintain a high level of immunity within the flock. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Health Products Regulatory Authority 10 February 2022 CRN00CNWW Page 2 of 4 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 पूरा दस्तावेज़ पढ़ें