Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Clostridium perfringens
IDT BIOLOGIKA GMBH
QI09AB12
Clostridium perfringens
Lyophilisate and solvent for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Expired
2017-09-21
Issued: September 2017 AN: 00152/2016 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENTEROPORC AC Lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml of the reconstituted vaccine) contains: ACTIVE SUBSTANCES: _Clostridium perfringens_ type A/C toxoids: alpha toxoid min. 125 rU/ml* beta1 toxoid min. 3354 rU/ml* beta2 toxoid min. 770 rU/ml* *toxoid content in relative units per ml, determined in ELISA against an internal standard ADJUVANT: Montanide Gel 37.4 – 51.5 mmol/l titratable acrylate units EXCIPIENTS: Thiomersal 0.085 – 0.115 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Beige to brown lyophilisate. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (pregnant sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life caused by _Clostridium _ _perfringens_ type A associated enteritis and necrotising enteritis induced by _Clostridium perfringens_ type C. Issued: September 2017 AN: 00152/2016 Page 2 of 6 Onset of immunity: This protection was proven in a challenge test with toxins on suckling piglets on the first day of life. Duration of immunity: Serological data show that neutralising antibodies are present up to the 2nd week after birth. The presence of neutralising antibodies has been shown to correlate to protection. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal pr Read the complete document