1. NAME OF THE VETERINARY MEDICINAL PRODUCT
RESPIPORC FLUpan H1N1 suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly turbid, reddish to pale-pink coloured suspension.
4. CLINICAL PARTICULARS
4.1 Target species : Pigs.
4.2 Indication for use, specifying the target species
Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion.
Onset of immunity: 7 days after primary vaccination.
Duration of immunity: 3 months after primary vaccination.
4.3 Contraindications None.
4.4 Special warnings for each target species Vaccinate healthy animals only.
4.5 Special precautions for use Not applicable.
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.
4.6 Adverse reactions (frequency and seriousness)
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).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy up to three weeks before expected farrowing and during lactation.
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 : For intramuscular use.
2 injections of one dose (1 ml) from the age of 56 days, with an interval of 3 weeks between injections.
The efficacy of revaccinations 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 active immunisation at 12 weeks of age. In such cases the piglets should be vaccinated after the age of 12 weeks.
Gilts and sows:
Primary vaccination: 2 injections of one dose (1 ml) with an interval of 3 weeks between injections and up to 3 weeks before expected farrowing or during lactation.
The efficacy of single dose revaccination has not been investigated and therefore no single dose revaccination schedule is proposed for further pregnancies.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary : None known.
4.11 Withdrawal period(s) Zero days.
5. IMMUNOLOGICAL PROPERTIES : Pharmacotherapeutic group: Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus.
ATCvet code: QI09AA03.
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 15–100% 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).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
- Carbomer 971P NF
- Sodium chloride solution (0.9%)
6.2 Major 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: 2 years.
- Shelf life after first opening the vial: 10 hours.
6.4 Special precautions for storage
Store in a refrigerator (2 ºC−8 ºC). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
PET vials: 25 ml polyethylene terephthalate (PET) vials
50 ml PET vials
Stoppers: Bromobutyl rubber stoppers
Caps: Aluminium flanged caps
Cardboard box with 1 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.
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
Ceva Santé Animale
10 av. de La Ballastière
8. MARKETING AUTHORISATION NUMBER(S) EU/2/17/209/001–002
9. DATE OF FIRST AUTHORISATION Date of first authorisation: 17/05/2017
10. DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE