Porcilis AR-T DF (protein dO (non-toxic deletion derivative...) – Package leaflet - QI09AB04
Updated on site: 09-Feb-2018
|Medication name:||Porcilis AR-T DF|
|Substance:||protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin) / inactivated Bordetella bronchiseptica cells|
|Manufacturer:||Intervet International BV|
- 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
- 2. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
- 4. INDICATION(S)
- 5. CONTRAINDICATIONS
- 6. ADVERSE REACTIONS
- 7. TARGET SPECIES
- 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
- 9. ADVICE ON CORRECT ADMINISTRATION
- 10. WITHDRAWAL PERIOD
- 11. SPECIAL STORAGE PRECAUTIONS
- 12. SPECIAL WARNING(S)
- 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
- 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
- 15. OTHER INFORMATION
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer: Intervet International B.V.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
2.NAME OF THE VETERINARY MEDICINAL PRODUCT
3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml contains:
- Protein dO
≥6.2 log2 TN titre1
multocida dermonecrotic toxin)
- Inactivated Bordetella bronchiseptica cells.
≥5.5 log2 Aggl. titre2
1Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.
2Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
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.
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.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
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Pigs (sows and gilts).
8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
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.
9.ADVICE ON CORRECT ADMINISTRATION
Before use, allow the vaccine to reach room temperature.
Shake vigorously before use and at intervals during use.
Avoid introduction of contamination.
11.SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use after the expiry date stated on the label.
Shelf life after first opening the vial: 10 hours.
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Prescription drugs listed. ATC Code: "QI09AB04"
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
Use during pregnancy, lactation or lay
Can be used during pregnancy
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.
Do not mix with any other veterinary medicinal products.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
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
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.
Not all pack sizes may be marketed.