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Date: Saturday, May 18, 2024 14:01

Release 2.119
Respiporc® FLU3 suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Respiporc® FLU3 suspension for injection for pigs
Product index: Respiporc® FLU3
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 2 ml contains:
Active substances:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU1
Haselünne/IDT2617/2003 (H1N1) ≥ 10.22 log2 GMNU1
Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU1
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 2.0 mg
Excipient:
Thiomersal 0.21 mg
For the full list of excipients, see Pharmaceutical particulars
Pharmaceutical form
Clear, yellowish orange to pink coloured suspension for injection
Clinical particulars
Target Species
Pigs
Indication for use, specifying the target species
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.
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Not applicable.
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.
Adverse reactions (frequency and seriousness)
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.
Use during pregnancy, lactation or lay
Can be used 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.
Amounts to be administered and administration route
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of a double dose (4 ml), no adverse reactions other than those described in Adverse events were observed.
Withdrawal period
Zero days
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals, inactivated viral vaccines. ATCvet code: QI09AA03
The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2. It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes. When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Pharmaceutical particulars
List of excipients
Carbomer 971 P NF, Thiomersal, Sodium chloride solution (0.9%)
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the vial: 10 hours.
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.
Nature and composition of immediate packaging
Glass vial:
20 ml vials, glass type I
50 ml vials, glass type II
100 ml vials, glass type II
PET vials:
20 ml Polyethylene terephthalate (PET) vials, clear
50 ml PET vials, clear
100 ml PET vials, clear
500 ml PET vials, clear
Stoppers: Bromobutyl rubber stoppers
Caps: Flanged caps
Package sizes:
Cardboard box with 1 glass vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Cardboard box with 1 PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Cardboard box with 8 PET vials of 250 doses (500 ml) with a rubber stopper and flanged cap. Not all pack sizes may be marketed.
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 the local requirements.
Marketing Authorisation Holder (if different from distributor)
Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France
Marketing Authorisation Number
UK(GB): Vm 15052/5016
UK(NI): EU/2/09/103/001-007
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 14/01/2010
Date of last renewal: 04/12/2014
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/).
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Respiporc FLU3 50 ml
GTIN:03411113039691