Neocolipor
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
16-06-2020
Vara einkenni
(SPC)
16-06-2020
Opinber matsskýrsla
(PAR)
17-02-2021
Virkt innihaldsefni:
E. coli adhesin F4 (F4ab, F4ac, F4ad), E. coli adhesin F5, E. coli adhesin F6, E. coli adhesin F41
Fáanlegur frá:
Boehringer Ingelheim Vetmedica GmbH
ATC númer:
QI09AB02
INN (Alþjóðlegt nafn):
Neonatal piglet colibacillosis vaccine (inactivated)
Meðferðarhópur:
Sows; Sows (nullipar)
Lækningarsvæði:
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Ábendingar:
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.
Vörulýsing:
Revision: 14
Leyfisstaða:
Authorised
Leyfisdagur:
1998-04-14
Upplýsingar fylgiseðill
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
NEOCOLIPOR
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
MANUFACTURER FOR THE BATCH RELEASE
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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.
INDICATION(S)
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.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
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.
17
7.
TARGET SPECIES
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.
Revaccination:
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 vigo
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Neocolipor suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 log10 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.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
-
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.
3
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 la
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