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Date: Wednesday, April 30, 2025 9:23

Description: MSD-AH
Release 2.76
Porcilis® ColiClos suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® ColiClos suspension for injection for pigs
Product index: Porcilis® ColiClos
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 2 ml contains:
Active substances:
Escherichia coli components:
- F4ab fimbrial adhesin
9.7 log2 Ab titre1
- F4ac fimbrial adhesin
8.1 log2 Ab titre1
- F5 fimbrial adhesin
8.4 log2 Ab titre1
- F6 fimbrial adhesin
7.8 log2 Ab titre1
- LT toxoid
10.9 log2 Ab titre1
Clostridium perfringens component:
- Type C (strain 578) beta toxoid
20 IU2
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/20 sow dose.
2 International units of beta antitoxin according to Ph.Eur.
Adjuvant:
dl-α-tocopheryl acetate: 150 mg
For full list of excipients, see section "Pharmaceutical Particulars".
Pharmaceutical form
Suspension for injection.
Aqueous, white to nearly white.
Clinical particulars
Target species
Pigs (sows and gilts).
Indications for use
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those E. coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by C. perfringens type C.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only
Special precautions for use
Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum.
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
Pigs (sows and gilts).
Very Common (> 1 animal / 10 animals treated):
Elevated temperature1, Injection site swelling2.
Common (1 to 10 animals in 100 animals):
Decreased activity3, Appetite loss3.
Very rare (< 1 animal / 10,000 animals treated, including isolated reports):
1. Up to 2 °C on the day of vaccination.
2. Sometimes painful and hard up to 10 cm in diameter for up to 25 days.
3. On the day of vaccination.
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 the national competent authority via the national reporting system. See also section “Contact details” of the package leaflet.
Use during pregnancy or lactation
Can be used during pregnancy.
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.
Administer 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear.
Before use, allow the vaccine to reach room temperature.
Shake vigorously before use and at intervals during use.
Vaccination scheme:
Primary vaccination: Sows/gilts which have not yet been vaccinated with the product are given a primary injection 6 to 8 weeks before the expected date of farrowing and a second injection 4 weeks later.
Revaccination: A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing.
Overdose
A slight redness and/or roughness may transiently occur after a double dose vaccination. No adverse reactions other than those mentioned in section “Adverse reactions” have been observed.
Withdrawal period
Zero days.
Pharmacological particulars
ATC vet code: QI09AB08.
Pharmacotherapeutic group
Immunologicals for Suidae, inactivated bacterial vaccine.
To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C. Vaccination results in an antibody response with neutralising activity against LT toxin.
Pharmaceutical particulars
Excipients
Polysorbate 80
Simethicone
Sodium chloride
Potassium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
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 vial: 10 hours.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Immediate packaging
Cardboard box with PET vial of 20 ml, 50 ml, 100 ml, 200 ml or 250 ml.
Cardboard box with type I glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
The vials are closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
Disposal
UK(GB): Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
UK(NI): 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)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB): Vm 01708/5053
UK(NI): EU/2/12/141/001-009
Significant changes
Date of the first authorisation or date of renewal
29 March 2017.
Date of revision of the text
July 2023
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Porcilis ColiClos 1x50ml:
GTIN:08713184122735