Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
genetically modified recombinant Shiga-toxin-2e antigen
CEVA Santé Animale
QI09AB02
genetically modified Shiga-toxin-2e antigen
Pigs
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by Shiga toxin 2e produced by Escherichia coli (STEC). Onset of immunity: 21 days after vaccination. Duration of immunity: 105 days after vaccination.,
Revision: 4
Authorised
2013-04-10
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: ECOPORC SHIGA SUSPENSION FOR INJECTION FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France Manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany Ceva-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5. 1107 Budapest Hungary 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: ACTIVE SUBSTANCES: Genetically modified recombinant Stx2e antigen: ≥ 3.2 x 10 6 ELISA units _ _ ADJUVANT: Aluminium (as hydroxide) max. 3.5 mg EXCIPIENT: Thiomersal max. 0.115 mg Appearance after shaking: yellowish to brownish, homogenous suspension. 4. INDICATION(S) Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by _E. coli_ (STEC). Onset of immunity: 21 days after vaccination Duration of immunity: 105 days after vaccination 17 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 6. ADVERSE REACTIONS Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment. Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection. But these reactions subside within a short time (maximum of two days) without treatment. Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treate Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Genetically modified recombinant Stx2e antigen: ≥ 3.2 x 10 6 ELISA units ADJUVANT: Aluminium (as hydroxide) max. 3.5 mg EXCIPIENT: Thiomersal max. 0.115 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Appearance after shaking: yellowish to brownish, homogenous suspension. _ _ _ _ 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by _E. coli_ (STEC). Onset of immunity: 21 days after vaccination Duration of immunity: 105 days after vaccination 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 3 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 product to animals In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment. Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection. However, these reactions subside within a short time (maximum of two days) without treatment. Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecopor Olvassa el a teljes dokumentumot