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Date: Tuesday, April 23, 2024 8:55

Release 5.91
ERYSENG suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:ERYSENG suspension for injection for pigs.
Product index: Eryseng
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each 2ml dose contains:
Active substances:
Inactivated Erysipelothrix rhusiopathiae, strain R32E11, > 3.34 log2 IE50%*
* IE50% – Inhibition ELISA 50%.
Adjuvants:
Aluminium hydroxide 5.29 mg (aluminium)
DEAE-Dextran
Ginseng.
Excipients:
Qualitative composition of excipients and other constituents
Disodium phosphate dodecahydrate
Potassium chloride
Potassium dihydrogen phosphate
Simethicone
Sodium chloride
Sodium hydroxide
Water for injection
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
Vaccinate healthy animals only.
Special precautions for each target species
Special precautions for use in animals:
None.
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Pigs:
Very common
(> 1 animal / 10 animals treated):
Injection site inflammation1
Common
(1 to 10 animals / 100 animals treated):
Elevated temperature2
Very rare
(< 1 animal / 10 000 animals treated, including isolated reports):
Anaphylactic-type reaction3
1 Mild to moderate inflammation at the injection site that typically resolves within 4 days but in some cases may persist for up to 12 days post-vaccination.
2 A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours.
3 An appropriate symptomatic treatment is recommended.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
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).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse reactions other than those mentioned in “Adverse reactions” were observed after the administration of a 2-fold vaccine dose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance.
Not applicable.
Withdrawal periods
Zero days.
Pharmacological particulars
Immunological properties
ATCvet code: QI09AB03.
To stimulate the development of active immunity in pigs against E. rhusiopathiae.
Pharmaceutical particulars
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. The vials are closed with a rubber stopper and aluminium cap
Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
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 derived from the use of such products
Medicines should not be disposed of via wastewater or household waste. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
LABORATORIOS HIPRA, S.A.
Marketing Authorisation Number
UK(GB): Vm 17533/5002
UK(NI): 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