Other products
Porcilis ColiClos
Active substance
ATC code
Species
Pigs (sows and gilts).
Indications
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.
Dose 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.
Adverse reactions
Pigs (sows and gilts):
|
Very common (>1 animal / 10 animals treated): |
|
|
Common (1 to 10 animals / 100 animals): |
Decreased activity3, Appetite loss3. |
|
Very rare (<1 animal / 10 000 animals treated, including isolated reports): |
Hypersensitivity reaction. |
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 the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ColiClos suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Active substances: components:
- Escherichia coli fimbrial adhesin F4ab ≥ 9.7 log2 Ab titre1
- Escherichia coli fimbrial adhesin F4ac ≥ 8.1 log2 Ab titre1
- Escherichia coli fimbrial adhesin F5 ≥ 8.4 log2 Ab titre1
- Escherichia coli fimbrial adhesin F6 ≥ 7.8 log2 Ab titre1 - Escherichia coli LT toxoid ≥ 10.9 log2 Ab titre1
Clostridium perfringens component:
- Clostridium perfringens type C (strain CN 883) beta toxoid ≥ 20 IU2
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose
2 International units of beta antitoxin according to Ph. Eur.
Adjuvant: dl-α-tocopheryl acetate 150 mg
Excipients:
|
Qualitative composition of excipients and other constituents |
|
Polysorbate 80 |
|
Simethicone |
|
Sodium chloride |
|
Potassium chloride |
|
Potassium dihydrogen phosphate |
|
Disodium hydrogen phosphate |
|
Water for injections |
Aqueous, white to nearly white suspension.
3. CLINICAL INFORMATION
3.1 Target species
Pigs (sows and gilts).
3.2 Indications for use for each target species
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.
3.3 Contraindications None.
3.4 Special warnings
Vaccinate healthy animals only.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum.
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.
3.6 Adverse events
Pigs (sows and gilts):
|
Very common (>1 animal / 10 animals treated): |
|
|
Common (1 to 10 animals / 100 animals): |
Decreased activity3, Appetite loss3. |
|
Very rare (<1 animal / 10 000 animals treated, including isolated reports): |
Hypersensitivity reaction. |
either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
3.8 Interaction with other medicinal products and other forms of 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-bycase basis.
3.9 Administration routes and dosage
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.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
A slight redness and/or roughness may transiently occur after a double dose vaccination. No adverse reactions other than those mentioned in section 3.6 have been observed.
3.11 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.
3.12 Withdrawal periods
Zero days.
4. IMMUNOLOGICAL INFORMATION
4.1 ATCvet code: QI09AB08.
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.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
Do not mix with any other veterinary medicinal product.
5.2 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.
5.3 Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
5.4 Nature and composition of 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.
5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
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.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
7. MARKETING AUTHORISATION NUMBER
Vm 01708/5053
8. DATE OF FIRST AUTHORISATION
14 June 2012
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
April 2025
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk. Gavin Hall Approved: 16 June 2025
[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
