ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Neocolipor suspension for injection
2.
Active substances:
per dose of 2 ml:
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U*
E. coli adhesin F5, at least………………………1.7 SA.U*
E. coli adhesin F6, at least………………………1.4 SA.U*
E. coli adhesin F41, at least…………………….1.7 SA.U*
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log
10
in the guinea pig.
Adjuvant:
Aluminium (as hydroxide)
1.4 mg
Excipients:
Thiomersal
0.2 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection.
4.
Pigs (sows and gilts).
4.2 Indications for use specifying the target species
Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins
F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
None.
None.
-
Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a
sufficient quantity of colostrum within 6 hours of birth.
-
Vaccinate only healthy animals.
-
Do not administer in conjunction with other medicinal products.
2/18
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In the case of accidental self injection, seek medical advice immediately and show the package insert
or label to a physician.
Wash and disinfect hands after use.
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
No special precautions.
No information is available on the compatibility of this vaccine with any other. Therefore the safety
and efficacy of this product when used with any other (either when used on the same day or at
different times) has not been demonstrated
Shake the vial vigorously before use.
Use sterile syringe and needles. Administer using aseptic procedures.
One 2 ml dose intramuscularly in the neck in the area behind the ear, according to the following
schedule:
Primary vaccination
:
Second injection:
5 to 7 weeks before farrowing
Revaccination
:
1 injection 2 weeks before each subsequent farrowing.
No undesirable effects have been observed after the administration of twice the recommended dosage.
Zero days.
5.
ATC vet code: QI09AB02
The vaccine contains the inactivated strains of
E. coli
expressing the adhesins F4ab, F4ac, F4ad, F5,
F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant. In
sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are
passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
3/18
First injection:
2 weeks before farrowing.
6.
6.1 List of excipients
Thiomersal
Aluminium hydroxide
Sodium chloride
6.2 Incompatibilities
Do not mix with any other vaccine.
6.3 Shelf life
Shelf-life: 18 months at 2 - 8 °C.
Broached vial: 3 hours.
6.4 Special precautions for storage
Store and transport at 2°C - 8°C, protected from light. Do not freeze.
6.5 Nature and composition of immediate packaging
Box of 5-dose 10 ml vial (glass type I vial with butyl rubber stopper).
Box of 10-dose 20 ml vial (glass type I vial with butyl rubber stopper).
Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper).
Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper).
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/2/98/008/001-004
9.
DATE OF FIRST RENEWAL OF THE AUTHORISATION
03/2008
4/18
03/2008
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
http://www.emea.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5/18
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER(S) 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
6/18
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
MERIAL
Laboratoire de Toulouse
4 Chemin du Calquet
31300 TOULOUSE
FRANCE
Manufacturer responsible for batch release
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
FRANCE
Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à
la Santé, and the Ministère de l’Agriculture et de la Forêt on 31 March 1992.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
C. PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
D. STATEMENT OF THE MRLs WHICH ARE ACCEPTED IN ACCORDANCE WITH
COUNCIL REGULATION (EEC) No 2377/90
Annex II of Council Regulation (EEC) No 2377/90
Pharmacologically
active
Animal species
Other provisions
substance(s)
Aluminium hydroxide
1
All food producing species
Thiomersal
2
All food producing species
For use only as a preservative in
multidose
vaccines
at
a
concentration not exceeding 0.02%
Sodium hydroxide
3
All food producing species
Sodium chloride
4
All food producing species
Hydrochloric acid
5
All food producing species
For use as excipient
1
OJ No L 290 of 05.12.95
2
OJ No L 110 of 26.04.97
3
OJ No L 272 of 25.10.96
4
OJ No L 290 of 05.12.95
5
OJ No L 143 of 27.06.95
7/18
ANNEX III
LABELLING AND PACKAGE INSERT
8/18
A. LABELLING
9/18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Neocolipor suspension for injection
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
per dose of 2 ml:
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U*
E. coli adhesin F5, at least………………………1.7 SA.U*
E. coli adhesin F6, at least………………………1.4 SA.U*
E. coli adhesin F41, at least…………………….1.7 SA.U*
…
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log
10
in the guinea pig.
Adjuvant:
Aluminium (as hydroxide) ............................................................................................................. 1.4 mg
3.
Suspension for injection
4.
PACKAGE SIZE
5 doses = 10 ml vial.
10 doses = 20 ml vial.
25 doses = 50 ml vial.
50 doses =100 ml vial.
5.
Pigs (sows and gilts)
6.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular injection
8.
Withdrawal period: Zero days.
10/18
9.
SPECIAL WARNING(S), IF NECESSARY
Shake the vial vigorously prior to use.
10. EXPIRY DATE
EXP
11. SPECIAL STORAGE CONDITIONS
Store and transport between 2ºC and 8ºC, protected from light. Do not freeze.
Shelf-life of broached vial: 3 hours.
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
F-69007 LYON
FRANCE
EU/2/98/008/001
10 ml vial.
EU/2/98/008/002
20 ml vial.
EU/2/98/008/003
100 ml vial.
17. MANUFACTURER’S BATCH NUMBER
Lot
11/18
EU/2/98/008/004
50 ml vial.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{NATURE/TYPE}
1.
Neocolipor
Suspension for injection
Pigs (sows and gilts)
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41
Aluminium adjuvant
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
2 ml = 1 dose 5d
10 ml vial
2 ml = 1 dose 10 d
20 ml vial
2 ml = 1 dose 25 d
50 ml vial
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular injection
5.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP {month/year}>
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
Read the package leaflet before use.
12/18
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{NATURE/TYPE}
1.
Neocolipor
Suspension for injection
Pigs (sows and gilts)
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
per dose of 2 ml:
adhesins:
F4 (F4ab, F4ac, F4ad), at least .................................................................................................... 2.1 SA.U
*
F5, at least ................................................................................................................................... 1.7 SA.U
*
F6, at least ................................................................................................................................... 1.4 SA.U
*
F41, at least ................................................................................................................................. 1.7 SA.U
*
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log
10
in the guinea pig.
Adjuvant:
Aluminium (as hydroxide) ................................................................................................................ 1.4 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
50 dose
100 ml vial
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular injection
5.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP {month/year}>
13/18
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
Shake vigorously prior to use
Read the package leaflet before use.
14/18
B. PACKAGE LEAFLET
15/18
PACKAGE LEAFLET
Neocolipor
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
MANUFACTURER FOR THE BATCH RELEASE
MERIAL
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
FRANCE
2.
Neocolipor suspension for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
per dose of 2 ml:
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U*
E. coli adhesin F5, at least………………………1.7 SA.U*
E. coli adhesin F6, at least………………………1.4 SA.U*
E. coli adhesin F41, at least…………………….1.7 SA.U*
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log
10
in the guinea pig.
Adjuvant:
Aluminium (as hydroxide) ............................................................................................................. 1.4 mg
4.
Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E.
coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
5.
None.
6.
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
16/18
7.
Pigs (sows and gilts)
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One 2 ml dose according to the following schedule:
Primary vaccination:
First injection:
5 to 7 weeks before farrowing
Second injection:
2 weeks before farrowing.
1 injection 2 weeks before each subsequent farrowing.
9.
ADVICE ON CORRECT ADMINISTRATION
Intramuscular injection in the neck in the area behind the ear.
Shake the vial vigorously before use.
Use sterile syringe and needles. Administer using aseptic procedures.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Store and transport at 2°C - 8°C, protected from light. Do not freeze.
Shelf life of broached vial: 3 hours.
12. SPECIAL WARNING(S)
-
Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a
sufficient quantity of colostrum within 6 hours of birth.
-
Vaccinate only healthy animals.
-
Do not administer in conjunction with other medicinal products.
No information is available on the compatibility of this vaccine with any other. Therefore the safety
and efficacy of this product when used with any other (either when used on the same day or at
different times) has not been demonstrated
In the case of accidental self injection, seek medical advice immediately and show the package insert
or label to a physician.
Wash and disinfect hands after use.
No undesirable effects have been observed after the administration of twice the recommended dosage.
Do not mix with any other vaccine.
17/18
Revaccination:
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
03/2008
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA)
http://www.emea.europa.eu/
15. OTHER INFORMATION
The vaccine contains the inactivated strains of
E. coli
expressing the adhesins F4ab, F4ac, F4ad, F5,
F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant. In
sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are
passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Box of 5-dose 10 ml vial (glass type I vial with butyl rubber stopper).
Box of 10-dose 20 ml vial (glass type I vial with butyl rubber stopper).
Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper).
Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper).
Not all pack sizes may be marketed.
Veterinary medicinal product subject to prescription.
18/18
Source: European Medicines Agency
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