Porcilis Coli Clos Suspension for injection for pigs 50ml

Porcilis Coli Clos Suspension for injection for pigs 50ml, 25 Dose.

Qualitative and quantitative composition

Each dose of 2 ml contains:

Active substances:

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-alpha-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.

Contra-indications

None.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals. 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.

Adverse reactions

An increase in body temperature up to 2°C may be observed on the day of vaccination. Reduced activity and lack of appetite on the day of vaccination commonly occurs and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days may be observed at the site of injection.

Use during pregnancy, lactation or lay

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 injection of 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear.

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.

Before use allow the vaccine to reach room temperature. Shake vigorously before use and at intervals during use.

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 periods

Zero days.

Pharmacological particulars

Immunological properties

Pharmacotherapeutic group: inactivated bacterial vaccine. ATC vet 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 neutralizing activity against LT toxin.

Pharmaceutical particulars

Excipients

Sodium chloride, Potassium chloride, Disodium hydrogen phosphate, Potassium dihydrogenphosphate, Simethicone, Polysorbate 80 and 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 (between +2°C and + 8°C). Protect from light. Do not freeze.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.