Porcilis AR-T DF
Active substance
ATC code
Species
Pigs (sows and gilts).
Indications
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.
Dose 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.
Adverse reactions
Pigs (sows and gilts):
|
Very common (>1 animal / 10 animals treated): |
Elevated temperature1, Decreased activity2, Appetite loss2; Injection site swelling3. |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hypersensitivity reaction4 |
1 Transient; mean increase of 1.5 °C, in some pigs up to 3°C, could lead to an abortion, and can generally be measured on the day of vaccination or the following day.
2 On the day of vaccination.
3 Transient (max diameter: 10 cm) for up to two weeks.
4 e.g. vomiting, dyspnoea and shock, may occur.
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 AR-T DF suspension for injection for pigs
2. 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 rabbitsAdjuvant:
|
dl-α-tocopherol acetate Excipient: |
150 mg |
|
Formaldehyde |
≤1 mg |
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Pigs (sows and gilts).
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications None.
4.4 Special warnings
None.
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate only healthy animals
Special precautions to be taken by the person administering the 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.
4.6 Adverse reactions (frequency and seriousness)
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.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy (see details under section 4.9).
4.8 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 by case basis.
4.9 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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 4.6 can be expected following the administration of a double dose of vaccine.
4.11 Withdrawal period
Zero days
5. 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 Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis. Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica. The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells. The immunogens are incorporated in an adjuvant based on dl-α-tocopherol. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Phosphate buffer
Simethicone
Polysorbate 80
Formaldehyde
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life after first opening the vial: 10 hours.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Protect from light Do not freeze.
6.5 Nature and composition of 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.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5052
9. DATE OF THE FIRST AUTHORISATION
16 November 2000
10. DATE OF REVISION OF THE TEXT
April 2022
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Porcilis AR-T DF is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Porcilis AR-T DF must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Approved: 06 April 2022
