Respiporc Flu 3

ECOPORC SHIGA suspension for injection for pigs Name of the veterinary medicinal product Suspension for injection for pigs Statement of the active substances and other ingredients Each dose of 1 ml contains: Active substances: Genetically modified recombinant...

ECOPORC SHIGA suspension for injection for pigs

 Name of the veterinary medicinal product

Suspension for injection for pigs

 Statement of the active substances and other ingredients

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
Excipient: Thiomersal max. 0.115 mg

 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

 Contraindications

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

 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. 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 veterinary surgeon.

 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).

 Withdrawal period

Zero days

 Special storage precautions

Keep out of the 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 warnings

Special precautions for use in animals:
Only vaccinate healthy animals.

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 section 6 have been observed.

 Special precautions for the disposal of unused product or waste materials, if any

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

 Date on which the package leaflet was last approved

04/2013

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/)

 Other information

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.

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