Respiporc Flu3 - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Respiporc FLU3 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

Ceva Santé Animale

10 av. de La Ballastière

33500 Libourne

France

Manufacturer responsible for batch release:

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

Germany

Ceva-Phylaxia Veterinary Biologicals Co. Ltd.

Szallas u. 5.

1107 Budapest

Hungary

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Respiporc FLU3 suspension for injection for pigs

• 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Each dose of 2 ml contains:

Active substances:

Strains of inactivated Influenza A virus/swine/

Bakum/IDT1769/2003 (H3N2) > 10.53 log2 GMNU1

Haselunne/IDT2617/2003 (H1N1) > 10.22 log2 GMNU1

Bakum/1832/2000 (H1N2) > 12.34 log2GMNU1

1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine

Adjuvant:

Carbomer 971 P NF

Excipient:

Thiomersal

Clear, yellowish orange to pink coloured suspension for injection.

• 4. INDICATION(S)

Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.

Onset of immunity: 7 days after primary vaccination

Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and

6 months in pigs vaccinated for the first time at 96 days and above.

Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days. On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals treated, including isolated reports).

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For intramuscular use.

Piglets:

Primary vaccination: 2 injections of one dose (2 ml)

• – From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.

or

• – Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.

Gilts and sows:

Primary vaccination: see above

A booster is possible at each stage of pregnancy and lactation. When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth.

Maternally-derived immunity in the piglets interacts with antibody induction. Generally, maternally-derived antibodies induced by vaccination last for approx. 5–8 weeks after birth. In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life. In the latter case piglets should be vaccinated after the age of 96 days.

• 9. ADVICE ON CORRECT ADMINISTRATION

None.

• 10. WITHDRAWAL PERIOD(S)

Zero days

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.

Shelf-life after first opening the container: 10 hours.

• 12. SPECIAL WARNING(S)

Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection only a minor injection site reaction is expected.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

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.

Incompatibili­ties:

Do not mix with any other medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

{MM/YYYY}

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION