ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Gripovac 3 suspension for injection for pigs
2.
Each dose of 2 ml contains:
Active substances:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log
2
GMNU
1
Haselünne/IDT2617/2003 (H1N1) ≥ 10.22 log
2
GMNU
1
Bakum/1832/2000 (H1N2) ≥ 12.34 log
2
GMNU
1
1
GMNU = 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 a full list of excipients, see section 6.1.
3.
Suspension for injection.
4.
Pigs
4.2. 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.
4.3.
None.
2
4.4. Specialwarningsfor the target species
None.
4.5. Specialprecautionsforuse
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.
4.6. Adversereactions
A transient slight swelling may occur after vaccination at the site of injection in a small number of
pigs, regressing within 2 days. On occasions, a slight transient rectal temperature increase might occur
after vaccination.
4.7. Use during pregnancy and lactation
The vaccine can be used during pregnancy and lactation.
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.
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.
3
4.10. Overdose
After 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
Pharmacotherpaeutic 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.
6.1. List of excipients
Carbomer 971 P NF
Thiomersal
Sodium chloride solution (0.9 %)
6.2. 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. Specialprecautionsforstorage
Store in a refrigerator (2 ºC − 8 ºC). Do not freeze.
Store in the original package in order to protect from light.
6.5. Nature and composition of immediate packaging
Glass bottles: 20 ml bottles, glass type I
100 ml bottles, glass type II
PET bottles: 20 ml Polyethylene terephthalate (PET) bottles, clear
50 ml PET bottles, clear
100 ml PET bottles, clear
4
50 ml bottles, glass type II
Stoppers: Bromobutyl rubber stoppers
Caps:
Flanged caps
Package sizes:
Cardboard box with 1 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 medicinal product
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.
7.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
8.
EU/2/09/102/001-006
9.
14.01.2010
10.
14.01.2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.ema.europa.eu/
PROHIBITION OF SALE; SUPPLY AND/OR USE
Not applicable.
5
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
6
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
Name and address of the manufacturer(s) responsible for batch release
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLs
The following substances are included in Annex II of Council Regulation (EEC) No 2377/90 in
accordance with the following table:
Pharmacologically active substances
Animal species
Other provisions
Thiomersal
Annex II, all food
producing species
Commission Regulation
No 749/97, for use only
as preservatives in
multidose vaccines at a
concentration not
exceeding 0,02 %
Sodium chloride solution (0.9%)
Annex II, all food
producing species
Commission Regulation
No 2796/95
Carbomer 971 PNF is considered as not falling within the scope of Council Regulation (EC) 470/09.
7
ANNEX III
LABELLING AND PACKAGE LEAFLET
8
LABELLING
9
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard box for 20ml, 50 ml, 100 ml
1.
Gripovac 3 suspension for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 2 ml contains:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log
2
GMNU*,
Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log
2
GMNU*,
Bakum/1832/2000 (H1N2) ≥ 12.34 log
2
GMNU*
*See package leaflet
Adjuvant: Carbomer 971 P NF 2.0 mg
Excipient: Thiomersal 0.21 mg
3.
Suspension for injection
4.
PACKAGE SIZE
20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses)
5.
Pigs
6.
Vaccine against swine influenza
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period: zero days
10
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once opened, use within 10 hours.
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2 ºC − 8 ºC). Do not freeze. Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
EU/2/09/102/001-006
17. MANUFACTURER’S BATCH NUMBER
Lot:
11
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Bottle of 100 ml
1.
Gripovac 3 suspension for injection for pigs
2.
STATEMENT OF ACTIVE SUBSTANCES
Each dose of 2 ml contains:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log
2
GMNU*,
Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log
2
GMNU*,
Bakum/1832/2000 (H1N2) ≥ 12.34 log
2
GMNU*
*See package leaflet
Adjuvant: Carbomer 971 P NF 2.0 mg
Excipient: Thiomersal 0.21 mg
3.
Suspension for injection
4.
PACKAGE SIZE
100 ml (50 doses)
5.
Pigs
6.
Vaccine against swine influenza
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period: zero days
12
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once opened, use within 10 hours.
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2 ºC − 8 ºC). Do not freeze. Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
EU/2/09/102/003
EU/2/09/102/006
17. MANUFACTURER’S BATCH NUMBER
Lot:
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle of 20 ml and 50 ml
1.
Gripovac 3 suspension for injection for pigs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Strains of inactivated Influenza A virus/swine
(H3N2) ≥ 10.53 log
2
GMNU, (H1N1) ≥ 10.22 log
2
GMNU, (H1N2) ≥ 12.34 log
2
GMNU
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml (10 doses), 50 ml (25 doses)
4.
ROUTE(S) OF ADMINISTRATION
i.m.
5.
Withdrawal period: zero days
6.
BATCH NUMBER
Lot:
7.
EXPIRY DATE
EXP {month/year}
Once opened, use within 10 hours.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
Gripovac 3
Suspension for injection for pigs
1.
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL
29 avenue Tony Garnier
69007 Lyon,
France
Manufacturer for the batch release
:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
2.
Gripovac 3 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 log
2
GMNU
1
Haselünne/IDT2617/2003 (H1N1)
≥ 10.22 log
2
GMNU
1
Bakum/1832/2000 (H1N
2
)
≥ 12.34 log
2
GMNU
1
1
GMNU = 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
Excipients:
Thiomersal
0.21 mg
16
4.
INDICATION
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.
None.
6.
A transient slight swelling may occur after vaccination at the site of injection in a small number of
pigs, regressing within 2 days. On occasions, a slight transient rectal temperature increase might occur
after vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Pigs
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.
17
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
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2 ºC − 8 ºC). Do not freeze.
Store in the original package in order to protect from light.
Shelf-life after first opening the container: 10 hours.
Do not use after the expiry date stated on the label or carton.
12. SPECIAL WARNINGS
In case of accidental self-injection only a minor injection site reaction is expected.
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.
Do not mix with any other medicinal product.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with the local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
14.01.2010
18
15. OTHER INFORMATION
The vaccine can be used during pregnancy and lactation.
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.
Package sizes:
Cardboard box with 1 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.
19
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/gripovac_3_veterinary.html
Copyright © 1995-2021 ITA all rights reserved.