Ecoporc Shiga
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-09-2020
Valmisteyhteenveto
(SPC)
18-09-2020
Julkisesta arviointikertomuksesta
(PAR)
16-05-2013
Aktiivinen ainesosa:
genetically modified recombinant Shiga-toxin-2e antigen
Saatavilla:
CEVA Santé Animale
ATC-koodi:
QI09AB02
INN (Kansainvälinen yleisnimi):
genetically modified Shiga-toxin-2e antigen
Terapeuttinen ryhmä:
Pigs
Terapeuttinen alue:
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Käyttöaiheet:
Active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by Shiga toxin 2e produced by Escherichia coli (STEC). Onset of immunity: 21 days after vaccination. Duration of immunity: 105 days after vaccination.,
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-04-10
Pakkausseloste
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
ECOPORC SHIGA 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:
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Szállás u. 5.
1107 Budapest
Hungary
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecoporc SHIGA suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Genetically modified recombinant Stx2e antigen:
≥ 3.2 x 10
6
ELISA units
_ _
ADJUVANT:
Aluminium (as hydroxide)
max. 3.5 mg
EXCIPIENT:
Thiomersal
max. 0.115 mg
Appearance after shaking: yellowish to brownish, homogenous
suspension.
4.
INDICATION(S)
Active immunisation of piglets from the age of 4 days, to reduce the
mortality and clinical signs of
oedema disease caused by Stx2e toxin produced by
_E. coli_
(STEC).
Onset of immunity:
21 days after vaccination
Duration of immunity:
105 days after vaccination
17
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvant or to any of the
excipients.
6.
ADVERSE REACTIONS
Commonly very small local reactions such as mild swelling at the
injection site (maximum of 5 mm)
may be observed, but these reactions are transient and subside within
a short time (up to seven days)
without treatment.
Commonly a slight rise in body temperature (maximum of 1.7 °C) may
occur after injection. But these
reactions subside within a short time (maximum of two days) without
treatment.
Clinical signs such as temporary mild behavioural disturbances can
uncommonly be observed after
application of Ecoporc SHIGA.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treate
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecoporc SHIGA suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Genetically modified recombinant Stx2e antigen:
≥ 3.2 x 10
6
ELISA units
ADJUVANT:
Aluminium (as hydroxide)
max. 3.5 mg
EXCIPIENT:
Thiomersal
max. 0.115 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Appearance after shaking: yellowish to brownish, homogenous
suspension.
_ _
_ _
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of piglets from the age of 4 days, to reduce the
mortality and clinical signs of
oedema disease caused by Stx2e toxin produced by
_E. coli_
(STEC).
Onset of immunity:
21 days after vaccination
Duration of immunity:
105 days after vaccination
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvant or to any of the
excipients.
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
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection or ingestion, seek medical advice
immediately and show the
package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Commonly very small local reactions such as mild swelling at the
injection site (maximum of 5 mm)
may be observed, but these reactions are transient and subside within
a short time (up to seven days)
without treatment.
Commonly a slight rise in body temperature (maximum of 1.7 °C) may
occur after injection. However,
these reactions subside within a short time (maximum of two days)
without treatment.
Clinical signs such as temporary mild behavioural disturbances can
uncommonly be observed after
application of Ecopor
Lue koko asiakirja
