Porcilis AR-T DF
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
05-05-2014
Fachinformation
(SPC)
05-05-2014
Öffentlichen Beurteilungsberichts
(PAR)
20-12-2011
Wirkstoff:
protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin), inactivated Bordetella bronchiseptica cells
Verfügbar ab:
Intervet International BV
ATC-Code:
QI09AB04
INN (Internationale Bezeichnung):
adjuvanted vaccine against progressive atrophic rhinitis in piglets
Therapiegruppe:
Pigs (gilts and sows)
Therapiebereich:
Immunologicals for suidae
Anwendungsgebiete:
For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Produktbesonderheiten:
Revision: 6
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2000-11-16
Gebrauchsinformation
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
PORCILIS AR-T DF 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 and manufacturer:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis AR-T DF suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml contains:
Active substances:
- Protein dO (non-toxic deletion derivative of
_Pasteurella _
_multocida _
dermonecrotic toxin)
≥
6.2 log2 TN titre
1
- Inactivated
_Bordetella bronchiseptica_
cells.
≥
5.5 log2 Aggl. titre
2
1
Mean toxin neutralising titre obtained after repeated vaccination of a
half dose in rabbits.
2
Mean agglutination titre obtained after a single vaccination of a half
dose in rabbits
Adjuvant:
dl-α-tocopherol acetate
150 mg
Excipient:
Formaldehyde
≤1 mg
4.
INDICATION(S)
For the reduction of clinical signs of progressive atrophic rhinitis
in piglets by passive oral
immunisation with colostrum from dams actively immunised with the
vaccine.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A mean transient increase in body temperature of 1.5°C, in some pigs
up to 3 °C, which could lead to an
abortion, can generally be measured on the day of vaccination or the
following day. Reduced activity and
lack of appetite on the day of vaccination very commonly occurs and/or
a transient swelling (max
16
diameter: 10 cm) for up to two weeks may arise at the site of
injection. In very rare cases other immediate
hypersensitivity reactions, e.g. vomiting, dyspnoea and shock, may
occur.
If you notice any serious effects or other effects not mentioned in
this package leaflet, please inform
your veterinary surgeon.
7.
TARGET SPECIES
Pigs (sows and gilts).
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer one dose of 2 ml by intramuscular injectio
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Fachinformation
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis AR-T DF suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
- Protein dO (non-toxic deletion derivative of
_Pasteurella _
_multocida _
dermonecrotic toxin)
≥
6.2 log2 TN titre
1
- Inactivated
_Bordetella bronchiseptica_
cells
≥
5.5 log2 Aggl. titre
2
1
Mean toxin neutralising titre obtained after repeated vaccination of a
half dose in rabbits.
2
Mean agglutination titre obtained after a single vaccination of a half
dose in rabbits
ADJUVANT:
dl-α-tocopherol acetate
150 mg
EXCIPIENT:
Formaldehyde
≤1 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
For the reduction of clinical signs of progressive atrophic rhinitis
in piglets by passive oral immunisation
with colostrum from dams actively immunised with the vaccine.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the
2
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A mean transient increase in body temperature of 1.5 °C, in some pigs
up to 3 °C, which could lead to an
abortion, can generally be measured on the day of vaccination or the
following day. Reduced activity and
lack of appetite on the day of vaccination very commonly occurs and/or
a transient swelling (max
diameter: 10 cm) for up to two weeks may arise at the site of
injection. In very rare cases other immediate
hypersensitivity reactions, e.g. vomiting, dyspnoea and shock, may
occur.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be use
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