Summary of medicine characteristics - Gripovac 3
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
1. NAME OF THE VETERINARY MEDICINAL PRODUCTGripovac 3 suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach dose of 2 ml contains:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2)
Haselünne/IDT2617/2003 (H1N1)
> 10.53 log2 G]
> 10.22 log2 G]
> 12.34 log2 G
Bakum/1832/2000 (H1N2) 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Carbomer 971 P NF
0 mg
3. PHARMACEUTICAL FORM
Clear, yellowish orange to pink colored suspension for injection.
4. CLINICAL PARTICULARS4.1. Target species
4. CLINICAL PARTICULARS4.1. Target speciesPigs
4.2.
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.
4.3.
None.
4.4. Special warnings for the target species
None.
4.5. Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medi
animals
In case of accidental self-injection only a minor injection site reaction is expected.
4.6. 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 occur after vaccination.
ectal temperature increase might
The frequency of adverse reactions is defined using the following convention:
-
– very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of
one treatment)
common (more than 1 but less than 10 animals in 100 animals) uncommon (more than 1 but less than 10 animals in 1,000 animals )
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports)
4.7. Use during pregnancy,lactati
4.7. Use during pregnancy,lactatiay
Can be used during pregnancy and lactation.
4.8. Interaction with other medicinal products and other forms of interaction
4.8. Interaction with other medicinal products and other forms of interactionNo 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
4.9. Amounts to be administered and administration routeFor intramuscular use.
Piglets:
-
– 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.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessaryAfter administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.
4.11. Withdrawal period
Zero days
5. IMMUNOLOGICAL PROPERTIES
5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: Immunologicals,
ATC vet 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.
6. PHARMACEUTICAL PARTICULARS6.1. List of excipients
Carbomer 971 P NF
Thiomersal
Sodium chloride solution (0.9 %)
6.2. Incompatibilities
6.2. IncompatibilitiesDo not mix with any other veterinary medicinal product.
6.3. Shelf-life
6.3. Shelf-lifeShelf 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
6.4. Special precautions for storageStore in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
6.5. Nature and composition of immediate packaging
Glass vials: 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
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.
Not all pack sizes may be marketed.
6.6. Special precautions for the disposal of unused veterinary medicinals product or waste materials derived from the use of such products
6.6. Special precautions for the disposal of unused veterinary medicinals product or waste materials derived from the use of such productsAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE