Porcilis AR -T DF Suspension for injection for pigs 50ml

Porcilis AR -T DF Suspension for injection for pigs 50ml, 25 Dose.

Qualitative and quantitative composition

Each dose of 2 ml contains:

Active substances:

- Protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) =6.2 log2 TN titre1

- Inactivated Bordetella bronchiseptica cells =5.5 log2 Aggl. Titre2

1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.

2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits.

Adjuvant: dl-a-tocopherol acetate 150 mg.

Excipient: Formaldehyde =1 mg.

For a full list of excipients, see section "Pharmaceutical Particulars".

Pharmaceutical form

Suspension for injection.

Clinical particulars

Target species

Pigs (sows and gilts).

Indications for use

For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.

Contra-indications

None.

Special warnings for each target species

None.

Special precautions for use

Vaccinate only healthy animals.

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

A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C, which could lead to an abortion, can generally be measured on the day of vaccination or the following day. Reduced activity and lack of appetite on the day of vaccination very commonly occurs and/or a transient swelling (max diameter: 10 cm) for up to two weeks may arise at the site of injection. In very rare cases other immediate hypersensitivity reactions, e.g. vomiting, dyspnoea and shock may occur.

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

Before use, allow the vaccine to reach room temperature. Shake vigorously before and at intervals during use. Avoid introduction of contamination. Administer one dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older. The vaccine should preferably be administered just behind the ear.

Vaccination scheme:

Primary vaccination: inject one dose (2 ml) per pig, followed by a second injection 4 weeks after the first injection. The first injection should be administered 6 weeks before the expected date of farrowing.

Revaccination: a single injection of one dose (2 ml) should be carried out 2 to 4 weeks prior to each subsequent farrowing.

Overdose

Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than those mentioned under section "Adverse reactions" can be expected following the administration of a double dose of vaccine.

Withdrawal periods

Zero days.

Pharmacological particulars

Immunological Properties

Pharmacotherapeutic group: inactivated bacterial vaccine.

ATCvet code: QI09AB04.

To stimulate active immunity in order to provide passive immunity to the progeny against progressive atrophic rhinitis. Dermonecrotic toxin producing P. multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis. Colonisation of the surface of the nasal mucosa by P. multocida is most often promoted by B. bronchiseptica. The vaccine contains a non-toxic recombinant derivative of the P. multocida toxin and inactivated B. bronchiseptica cells. The immunogens are incorporated in an adjuvant based on dl-a-tocopherol. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.

Pharmaceutical particulars

Excipients

Sodium chloride, Phosphate buffer, Simethicone, Polysorbate 80, Formaldehyde 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: 5 years.

Shelf life after first opening the vial: 10 hours.

Special precautions for storage

Store in a refrigerator (+2°C and +8°C). Protect from light. Do not freeze.

Immediate packaging

Cardboard box containing one glass vial (Hydrolytic Type I) of 20 ml or 50 ml.

Cardboard box containing one PET vial of 20 ml, 50 ml, 100 ml or 250 ml.

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 products should be disposed of in accordance with local requirements.