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Date: Thursday, May 30, 2024 10:55

Release 2.224
Porcilis​® Ery+Parvo suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis​® Ery+Parvo suspension for injection for pigs
Product index: Porcilis​® Ery+Parvo
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (2ml) contains:
Active substances:
- Inactivated lysed antigen concentrate of Erysipelothrix rhusiopathiae strain M2 (serotype 2): ≥ 1 pig protective dose (ppd)*
- Inactivated porcine parvovirus (PPV) strain 014: ≥ 552 EU**
* as determined in the final product by antigenic mass ELISA
** as measured in the Ph. Eur. potency test
Adjuvant:
dl-α-tocopherol: 150mg
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 (Sows and Gilts).
Indications for use
For active immunisation of sows and gilts to prevent clinical signs of Erysipelas disease caused by all relevant Erysipelothrix rhusiopathiae serotypes (serotype 1 and 2) and for protection against embryonal and foetal death caused by porcine parvovirus (PPV) infection.
E. rhusiopathiae:
Onset of immunity: 3 weeks
Duration of immunity: 6 months
Porcine parvovirus:
Duration of immunity: 12 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 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 or lactation
Can be used during pregnancy and lactation.
Interaction
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
Administer one dose of 2 ml by deep intramuscular injection behind the ear.
Before use, allow the vaccine to reach room temperature. Shake well before use.
Use sterile syringe and needles. Avoid introduction of contamination by multiple broaching.
Primary vaccination course:
Protection against E. rhusiopathiae and PPV should be achieved in gilts before first mating.
To induce protection against erysipelas, a double vaccination as a primary vaccination course is advised. This can be achieved with the monovalent erysipelas vaccine (Porcilis Ery) either 4 weeks before or 4 weeks after use of this combined erysipelas and PPV vaccine.
A single injection not later than 2 weeks before mating is sufficient to protect the following pregnancy from damage due to PPV.
To avoid possible interference from maternal antibodies the pigs should be 6 months old before vaccination to ensure efficacy against PPV.
Revaccinations:
Revaccinations should be administered once a year, supplemented with the administration of the monovalent erysipelas vaccine (Porcilis Ery), 6 months after use of this combined erysipelas and PPV vaccine.
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
ATCvet code: QI09AL01
Pharmacotherapeutic group
Immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
The active substances are a lysate of E. rhusiopathiae strain M2 (serotype 2) and inactivated porcine parvo virus strain 014.
For the active immunization of sows and gilts, as an aid in the control of swine erysipelas and for the protection of their embryos and fetuses against porcine parvovirus infection.
The antigens are incorporated in an aqueous tocopherol based adjuvant in order to enhance a prolonged stimulation of immunity.
Pharmaceutical particulars
Excipients
dl-α-tocopherol
Polysorbate 80
Tris (hydroxymethyl) aminomethane
Sodium chloride
Simethicone
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 Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4334
Significant changes
Date of the first authorisation or date of renewal
16 July 1997
Date of revision of the text
February 2023.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
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