Porcilis ColiClos
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-06-2020
Charakterystyka produktu
(SPC)
26-06-2020
Sprawozdanie z oceny publicznego
(PAR)
13-06-2013
Składnik aktywny:
Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT
Dostępny od:
Intervet International BV
Kod ATC:
QI09AB08
INN (International Nazwa):
vaccine to provide passive immunity to the progeny against Escherichia coli and Clostridium perfringens in pigs
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those Escherichia coli strains which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by Clostridium perfringens type C.,
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Authorised
Data autoryzacji:
2012-06-14
Ulotka dla pacjenta
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
PORCILIS COLICLOS SUSPENSION FOR INJECTION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer(s) responsible for batch release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
MSD Animal Health UK Ltd
Walton Manor, Walton, Milton Keynes
Buckinghamshire, MK7 7AJ, UK
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ColiClos suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
_Escherichia coli _
components:
- F4ab fimbrial adhesin
9.7 log
2
Ab titre
1
- F4ac fimbrial adhesin
8.1 log
2
Ab titre
1
- F5 fimbrial adhesin
8.4 log
2
Ab titre
1
- F6 fimbrial adhesin
7.8 log
2
Ab titre
1
- LT toxoid
10.9 log
2
Ab titre
1
_Clostridium perfringens_
component:
- Type C (strain 578) beta toxoid
≥20 IU
2
1
Mean antibody titre (Ab) obtained after vaccination of mice with a
1/20 or 1/40 sow dose
2
International units of beta antitoxin according to Ph. Eur.
ADJUVANT:
dl-
-tocopheryl acetate
150 mg
Aqueous, white to nearly white suspension for injection.
4.
INDICATION(S)
18
For the passive immunisation of progeny by active immunisation of sows
and gilts to reduce mortality
and clinical signs during the first days of life, caused by those
_E. coli_
strains, which express the
adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused
by
_C. perfringens_
type C.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
_In laboratory studies and field trials: _
An increase in body temperature up to 2°C was very commonly observed
on the day of vaccination.
Reduced activity and lack of appetite on the day of vaccination
commonly occurred and/or a
sometimes painful and hard swelling up to 10 cm diameter for up
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ColiClos suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
_Escherichia coli _
components:
- F4ab fimbrial adhesin
9.7 log
2
Ab titre
1
- F4ac fimbrial adhesin
8.1 log
2
Ab titre
1
- F5 fimbrial adhesin
8.4 log
2
Ab titre
1
- F6 fimbrial adhesin
7.8 log
2
Ab titre
1
- LT toxoid
10.9 log
2
Ab titre
1
_Clostridium perfringens_
component:
- Type C (strain 578) beta toxoid
≥20 IU
2
1
Mean antibody titre (Ab) obtained after vaccination of mice with a
1/20 or 1/40 sow dose
2
International units of beta antitoxin according to Ph. Eur.
ADJUVANT:
dl-
-tocopheryl acetate
150 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
Aqueous, white to nearly white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of progeny by active immunisation of sows
and gilts to reduce mortality
and clinical signs during the first days of life, caused by those
_E. coli_
strains, which express the
adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused
by
_C. perfringens_
type C.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Protection of piglets is achieved by colostrum intake. Therefore, care
should be taken to ensure that
each piglet ingests a sufficient quantity of colostrum.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
_In laboratory studies and field trials: _
An increase in body temperature up to 2°C was very commo
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