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Porcilis AR-T DF - Patient leaflet, side effects, dosage

Contains active substance :

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Porcilis AR-T DF

B. PACKAGE LEAFLET

PACKAGE LEAFLET

Porcilis AR-T DF suspension for injection for pigs

  • 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 Korverstraat 35

5831 AN Boxmeer

The Netherlands

  • 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis AR-T DF suspension for injection for pigs

  • 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 2 ml contains:

Active substances:

  • – Protein dO (non-toxic deletion derivative of Pasteurella >6.2 log2 TN titre1

multocida dermonecrotic toxin)

  • – 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

  • 4. INDICATION(S)

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.

  • 5. CONTRAINDI­CATIONS

None.

  • 6. 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.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

  • 7. TARGET SPECIES

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.

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.

  • 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.

  • 10. WITHDRAWAL PERIOD

Zero days

  • 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.

  • 12. SPECIAL WARNING(S)

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.

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.

Incompatibilities

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.

  • 15. OTHER INFORMATION

Sources: Original PDF (ema.europa.eu)

Frequently Asked Questions

What is Porcilis AR-T DF used for?

Porcilis AR-T DF is a vaccine for piglets that protects against porcine reproductive and respiratory syndrome (PRRS). It helps to boost immunity in young pigs.

How does Porcilis AR-T DF work?

The vaccine works by stimulating the pig's immune system to recognize and fight against the PRRS virus, helping to prevent infection.

Is Porcilis AR-T DF safe for my pigs?

Yes, Porcilis AR-T DF is extensively tested for safety and effectiveness. It is designed specifically for use in healthy piglets.

At what age can I vaccinate my piglets with Porcilis AR-T DF?

Piglets can typically be vaccinated with Porcilis AR-T DF from 3 weeks of age onwards.

How should Porcilis AR-T DF be stored?

Porcilis AR-T DF should be stored in a cool place between 2°C and 8°C, and protected from light. Do not freeze.

Can I use Porcilis AR-T DF in pregnant sows?

No, Porcilis AR-T DF is meant only for piglets. Consult your veterinarian for appropriate vaccines for breeding sows.

What are the common side effects of Porcilis AR-T DF?

Some piglets may experience mild swelling at the injection site or a temporary decrease in appetite. Most recover quickly.

How often do piglets need to be vaccinated with Porcilis AR-T DF?

Typically, piglets require a single dose, but your veterinarian may recommend additional doses based on herd health needs.

Is there a withdrawal period after using Porcilis AR-T DF?

There is no withdrawal period required after vaccination with Porcilis AR-T DF before slaughter.

Can I mix Porcilis AR-T DF with other vaccines?

Mixing vaccines should only be done under the guidance of a veterinarian. Do not mix without professional advice.

What if I miss a vaccination date for my piglets?

If you miss a vaccination date, consult your veterinarian for advice on whether to administer the vaccine late or adjust your schedule.

How should I administer Porcilis AR-T DF?

Porcilis AR-T DF is administered via intramuscular injection. Follow your veterinarian's instructions for proper technique.

Can I vaccinate stressed or sick piglets with Porcilis AR-T DF?

It's best to wait until piglets are healthy and unstressed before vaccination. Consult your veterinarian if you have concerns.

Does Porcilis AR-T DF require refrigeration during transport?

Yes, it must remain refrigerated during transport to ensure its effectiveness upon arrival at the farm.

What happens if my piglet shows signs of illness after vaccination with Porcilis AR-T DF?

Monitor the piglet closely and consult your vet if any concerning symptoms arise after vaccination.

Can I buy Porcilis AR-T DF without a prescription?

Porcilis AR-T DF is typically available through veterinary practices, and you may need a prescription or guidance from your vet.

Are there any long-term effects of using Porcilis AR-T DF on herd health?

Using vaccines like Porcilis AR-T DF can significantly improve overall herd health by reducing PRRS outbreaks.

Will using Porcilis AR-T DF prevent all diseases in my pigs?

While it protects against PRRS, other diseases may still affect your pigs. A comprehensive health management plan is essential.

What should I do if the vaccine seems damaged upon opening?

If you notice any damage or abnormalities in the vaccine vial, do not use it. Contact your veterinarian or supplier immediately.

Where can I learn more about managing PRRS in my herd alongside using Porcilis AR-T DF?

Consult your veterinarian or look for resources provided by agricultural extension services or veterinary associations regarding PRRS management strategies.