Porcilis® AR-T

FOR ANIMAL USE ONLY

PORCILIS^® AR-T DF

Reg. No. G2873 Act 36/1947

Namibia Reg. No. V05/24.5/457 NS0

INDICATION

Porcilis^® AR-T DF is an inactivated vaccine for the vaccination of pigs (sows and gilts) for the reduction of clinical signs of progressive Atrophic Rhinitis (AR) in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.

COMPOSITION

Porcilis^® AR-T DF is an inactivated vaccine containing a non-toxic recombinant derivative of the P. multocida toxin (Protein dO) and inactivated B. bronchiseptica cells.

CONTENTS

Each dose of 2 mℓ Porcilis^® AR-T DF contains at least 2 ESRD* of Protein dO (a non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) and at least 2 ESRD of inactivated Bordetella bronchiseptica cells.

The antigens are incorporated in a dl-α-tocopherol based adjuvant. Formalin is included as a preservative.

* ESRD – effective sero-response dose in final product potency test (0,5 dose induces mean toxin neutralising titre of ≥ 6,2 (log₂) against P. multocida toxin and mean agglutination titre of ≥ 5,5 (log₂) against B. bronchiseptica in rabbits).

STORAGE

• Store in the dark between 2 ºC and 8 ºC.
• Do not freeze.
• Allow the vaccine to reach room temperature (20 ºC to 25 ºC) gradually before use.
• Avoid prolonged and repetitive exposure to high ambient temperatures.
• Protect from direct sunlight.
• Use within 10 hours after opening.

WARNINGS

• Withdrawal period: 21 days.
• Shake the bottle prior to and regularly during application.
• Do not mix Porcilis^® AR-T DF with other vaccines.
• After vaccination, a transient raise in body temperature may occur and a transient swelling may arise at the injection site.
• Accidental self-injection may lead to a local allergic reaction. Consult a physician immediately informing him/her that the vaccine contains a mineral oil.
• Do not store partially used containers for future use, and use the entire contents once opened.
• Opened bottles, must be used within 10 hours. If the contents are not used within 10 hours, it should be discarded.
• Discard any unused vaccine, empty vaccine containers and vaccination equipment after vaccination as per local waste disposal regulations.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

• Vaccinate healthy pigs only.
• Do not administer Porcilis^® AR-T DF in conjunction with other medicinal products.
• Observe aseptic conditions. Ensure that the vaccination equipment (needles, syringes, etc.) is clean and sterile prior to use.
• Avoid intravenous injection.
• It is good vaccination practice when handling the vaccine, to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake vigorously before use.

Vaccination Programme

Breeding stock, that has not been vaccinated before should be given a primary, followed by a secondary vaccination. The interval between these vaccinations should be 6 weeks. Pregnant sows should be revaccinated 2 to 3 weeks before subsequent farrowing.

Revaccination

A single vaccination of one dose should be carried out prior to each subsequent farrowing. Generally, this means every 5 to 6 months. It is preferable to vaccinate sows and gilts during the second half of the pregnancy, but not within two weeks before the expected date of farrowing.

DOSAGE AND ADMINISTRATION

Intramuscular injection of 2 mℓ per animal. The vaccine should preferably be administered just behind the ear.

Note: Allow the vaccine to reach room temperature (20 ºC to 25 ºC) and shake vigorously before use. Ensure the vaccination equipment is clean and sterile before use.

IMMUNITY AND VACCINATION REACTION

After vaccination a transient raise in body temperature may occur and a transient swelling may arise at the site of injection.

PRESENTATION

Hydrolytical class Type I glass or polyethylene terephthalate (PET) vials of 50 mℓ (25 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

DATE OF PUBLICATION OF THIS PACKAGE INSERT

06 February 2020