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Date: Tuesday, October 27, 2020 4:13

Description: HIPRA_LOGO BLAU.jpg
Release 5.16
Eryseng
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Eryseng
Product index: Eryseng
Pig - meat: Zero days
Qualitative and quantitative composition
Each 2ml dose contains:
Active substances:
Inactivated Erysipelothrix rhusiopathiae, strain R32E11,ELISA > 3.34 log2 IE50%*
* IE50% – Inhibition ELISA 50%.
Adjuvants:
Aluminium hydroxide5.29 mg (aluminium)
DEAE-Dextran
Ginseng.
Pharmaceutical form
Suspension for injection
Whitish suspension
Clinical particulars
Target species
Pigs.
Indications for use
For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Onset of immunity: three weeks after completion of the basic vaccination scheme.
Duration of immunity: six months.
Contra-indications
Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Very common adverse reactions:
- Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Common adverse reactions:
- A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours.
Very rare adverse reactions:
Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatictreatment is recommended
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions 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).
Use during pregnancy, lactation or lay
Can be used during pregnancy and lacatation.
Interactions
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
Intramuscular use.
Allow the vaccine to reach room temperature (15–25 °C) before administration.
Shake well before use.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Basic vaccination:
Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3–4 weeks. The second injection should be administered 3–4 weeks before mating.
Revaccination:
A single injection should be given 2–3 weeks prior to each subsequent mating (approximately every 6 months).
Overdose
No adverse reactions other than those mentioned in “Adverse reactions” were observed after the administration of a 2-fold vaccine dose.
Withdrawal periods
Zero days.
Pharmacological particulars
Immunological properties
Pharmacotherapeutic group: Inactivated bacterial vaccines for pigs, erysipelothrix.
ATCvet code: QI09AB03.
 
To stimulate active immunisation against swine erysipelas.
 
Pharmaceutical particulars
List of excipients
Aluminium hydroxide
DEAE-dextran
Disodium phosphate dodecahydrate
Ginseng
Potassium chloride
Potassium dihydrogen phosphate
Simethicone
Sodium chloride
Sodium hydroxide
Water for injections
Major incompatibilities
Do not mix with any other veterinary medical product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Do not freeze.
Protect from light.
Immediate packaging
Type I colourless glass vials of 20, 50 and 100 ml.
Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
The vials are closed with a rubber stopper and aluminium cap.
Pack sizes:
Cardboard box with 1 glass vial of 10 doses (20 ml).
Cardboard box with 1 glass vial of 25 doses (50 ml).
Cardboard box with 1 glass vial of 50 doses (100 ml).
Cardboard box with 1 PET bottle of 10 doses (20 ml).
Cardboard box with 1 PET bottle of 25 doses (50 ml).
Cardboard box with 1 PET bottle of 50 doses (100 ml).
Cardboard box with 1 PET bottle of 125 doses (250 ml).
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials
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)
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona) SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
Marketing Authorisation Number
EU/2/14/166/001-007
Significant changes
Date of the first authorisation or date of renewal
4.07.2014
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:ERYSENG 10ds
GTIN:8427711144793
GTIN description:ERYSENG 25ds
GTIN:84277111448209
GTIN description:ERYSENG 50ds
GTIN:8427711144816