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Date: Monday, May 6, 2024 17:18

Description: MSD-AH
Release 2.65
Porcilis® Ery suspension for injection
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® Ery
Product index: Porcilis® Ery
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (2ml) contains:
Active substance:
Inactivated lysed antigen concentrate of Erysipelothrix rhusiopathiae strain M2 (serotype 2): ≥ 1 pig protective dose (ppd)*
*as measured in the Ph. Eur.Potency test.
Adjuvent
dl-α-tocopherol acetate: 150 mg
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Suspension for injection.
Aqueous white or nearly white liquid.
Clinical particulars
Target species
Pigs.
Indications for use
For active immunisation of pigs to prevent clinical signs of Erysipelas disease caused by all relevant Erysipelothrix rhusiopathiae serotypes (serotype 1 and 2).
Onset of immunity: 3 weeks
Duration of immunity: 6 months
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Sick and weak animals should not be vaccinated.
Operator Warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
In laboratory studies and field trials:
Transient increases in body temperature (0.5 °C) within 24 hours may very commonly occur. Mild transient local swelling (Ø 1-10 mm) until 8 days after vaccination may very commonly occur. Transient reluctance to move may commonly occur.
In post marketing experience:
In very rare cases, a hypersensitivity reaction may occur.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
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 except Porcilis Parvo vaccine. 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
Administer one dose of 2 ml by deep intramuscular injection behind the ear.
Initial vaccination:
A single dose of vaccine in pigs from an age of 10 weeks onwards.
Repeat vaccination 4 weeks later.
Booster vaccination:
Revaccinations should be twice a year.
Before using vaccine allow it to reach room temperature (15 °C – 25 °C)
Shake vial before and regularly during use.
Use sterile syringe and needles. Avoid introduction of contamination by multiple broaching.
Overdose
Reactions observed after administration of a double dose are not different from those observed after administration of a single dose.
Withdrawal period(s)
Zero days.
Pharmacological particulars
Immunological properties
Pharmacotherapeutic group: Erysipelas vaccine.
ATCvet code: QI09AB03.
The active substance is a lysate of E. rhusiopathiae strain M2 (serotype 2).
For active immunisation of pigs, as an aid in the control of swine erysipelas. The antigen is incorporated in an aqueous tocopherol based adjuvant in order to enhance a prolonged stimulation of immunity.
Pharmaceutical particulars
Excipients
dl-α-tocopherol acetate
Polysorbate 80
Simethicone
Sodium chloride
Tris (hydrocymethyl) aminomethane
Hydrochloric acid
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Immediate packaging
PET vial closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes:
1 vial of 20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses) packed in a cardboard box.
Not all pack sizes may be marketed.
Disposal
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 Number
UK: Vm 01708/4355
Significant changes
Date of the first authorisation or date of renewal
7 July 1997.
Date of revision of the text
December 2022
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Porcilis Ery 1x50ml:
GTIN:08713184023377
GTIN description:Porcilis Ery 1x100ml:
GTIN:08713184026903