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Date: Thursday, April 25, 2024 10:13

Release 2.149
Ecoporc® SHIGA suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Ecoporc® SHIGA suspension for injection for pigs
Product index: Ecoporc SHIGA
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 1 ml contains:
Active substance:
Genetically modified recombinant Stx2e antigen: ≥ 3.2 x 106 ELISA units
Adjuvant: Aluminium (as hydroxide) max. 3.5 mg
Excipient: Thiomersal max. 0.115 mg
For the full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Suspension for injection.
Appearance after shaking: yellowish to brownish, homogenous suspension.
Clinical particulars
Target species
Pigs.
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
Contraindications
Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special warnings for each target species
Vaccinate healthy animals only.
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.
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 Ecoporc SHIGA.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Pregnancy and lactation: The use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
For intramuscular use.
The preferred application site is the neck muscle behind the ear. It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Prior to administration, shake the vaccine carefully.
A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose of vaccine no adverse reactions other than those described in the Adverse events section have been observed.
Withdrawal period
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines. ATCvet code: QI09AB02.
The vaccine consisting of genetically modified recombinant Stx2e stimulates an active immunity against Shiga toxin 2e produced by the causative agent of oedema disease in pigs.
Pharmaceutical particulars
List of excipients
Aluminium hydroxide (Al(OH)3), Thiomersal, Water for injections, Glutaraldehyde.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 24 hours
Between the withdrawals, the vaccine should be stored at 2 °C – 8 °C.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Protect from light.
Nature and composition of immediate packaging
PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml). Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France
Marketing Authorisation Number
UK (GB) VM: 15052/5006
UK (NI): EU/2/13/149/001-002
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation 10/04/2013
Date of revision of the text
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Ecoporc SHIGA 50 ml
GTIN:03411113038984