Patient leaflet - Respiporc FLUpan H1N1
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.
Szâllâs u. 5.
1107 Budapest
Hungary
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
RESPIPORC FLUpan H1N1 suspension for injection for pigs
3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each dose of 1 ml contains:
Active substance:
Inactivated Influenza A virus/human
Strain: A/Jena/VI5258/2009(H1N1)pdm09 > 16 HU1
1 HU - haemagglutinating units.
Adjuvant:
Carbomer 971P NF 2 mg
Excipient:
Thiomersal 0.1 mg
Clear to slightly turbid, reddish to pale-pink coloured suspension.
4. INDICATION(S)
Active immunisation of pigs from the age of 8weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and virus excretion.
Onset of immunity: 7 days after primary vaccination.
Duration of immunity: 3 months after primary vaccination.
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 2 °C, is common after vaccination and this does not persist for more than one day.
A transient swelling up to 2 cm3 may occur at the site of injection, these reactions are common but resolve within 5 days.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- 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 serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For intramuscular use.
Vaccination: 2 injections of one dose (1 ml) from the age of 56 days, with an interval of 3 weeks between injections.
The efficacy of revaccination has not been investigated and therefore no revaccination schedule is proposed.
Maternally-derived antibodies in piglets interfere with the RESPIPORC FLUpan H1N1 mediated immunity. Generally, maternally-derived antibodies induced by vaccination last for approximately 5-8 weeks after birth.
In cases of exposure of the sows to antigens (from either field infections and/or vaccination) the antibodies transmitted to the piglets can interfere with their active vaccination at 12 weeks of age. In such cases the piglets should therefore be vaccinated after the age of 12 weeks.
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 vial: 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, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
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 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 {DD/MM/YYYY}
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
OTHER INFORMATION
The vaccine stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009 (H1N1)pandemic09-like virus. It induces neutralising and haemagglutination- inhibiting antibodies against this subtype. The antibody responses mentioned in the following have been documented in pigs without maternally-derived immunity. Neutralising antibodies in serum have been detected in more than 75% of the immunised pigs on day 7 after primary immunisation, lasting in more than 75% of the pigs for over 3 months. Haemagglutination inhibiting antibodies have been detected in 15100% of the immunised pigs on day 7 after primary immunisation which disappeared in the majority of animals within 1 to 4 weeks thereafter.
Efficacy of the vaccine was examined in laboratory challenge studies in pigs without maternally-derived antibodies and was demonstrated against the following strains;
FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin), FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).
Package sizes:
Cardboard box with 1 polyethylene terephthalate (PET) vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.
Not all pack sizes may be marketed.
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