Ecoporc SHIGA (Canada)This page contains information on Ecoporc SHIGA for veterinary use.
The information provided typically includes the following:
- Ecoporc SHIGA Indications
- Warnings and cautions for Ecoporc SHIGA
- Direction and dosage information for Ecoporc SHIGA
Ecoporc SHIGAThis treatment applies to the following species:
Escherichia coli Subunit Vaccine
MARKETING AUTHORISATION HOLDER AND MANUFACTURER RESPONSIBLE FOR SERIAL RELEASE:
IDT Biologika GmbH • Am Pharmapark
06861 Dessau-Rosslau • Germany
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Escherichia coli Subunit Vaccine
Suspension for injection for pigs
Appearance after shaking: yellowish to brownish, homogenous suspension
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 106 ELISA units
Adjuvant: Aluminium hydroxide
max. 3.5 mg
max. 0.115 mg
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
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
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. Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA.
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian.
TARGET SPECIES: Pigs
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION:
Prior to administration, shake the vaccine carefully. A single intramuscular injection (1 ml) to pigs from the age of 4 days. The preferred application site is the neck muscle behind the ear.
ADVICE ON CORRECT ADMINISTRATION:
It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm (5/8 inches)).
WITHDRAWAL PERIOD: 21 days
SPECIAL STORAGE PRECAUTIONS:
Keep out of sight and reach of children.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze. Protect from light.
Shelf life after first opening the container: 24 hours (store at 2 °C - 8 °C).
Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.
Special precautions for use in animals: Only vaccinate healthy animals. In case of anaphylactic reaction use epinephrine as symptomatic treatment.
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.
Pregnancy: The safety of the veterinary medicinal product has not been established 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 about using this vaccine before or after any other veterinary medicinal product therefore needs to be made by the responsible veterinarian on a case by case basis. Do not mix with any other veterinary medicinal product.
Overdose (symptoms, emergency procedures, antidotes):
Following the administration of a double dose of vaccine no adverse reactions other than those described in the adverse reactions section have been observed.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY:
Ask your veterinarian how to dispose of medicines no longer required. These measures should help to protect the environment.
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.
IDT Biologika GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany
Manufacturing Authorization No.: DE 15 001 ZEB 02-2012
Distributed by Gallant Custom Laboratories Inc.
1425 BISHOP STREET N., UNITS 10-13, CAMBRIDGE, ON, N1R 6J9
|Every effort has been made to ensure the accuracy of the Ecoporc SHIGA information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
Copyright © 2018 North American Compendiums. Updated: 2018-09-03