Porcilis Pesti
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
06-10-2011
Charakterystyka produktu
(SPC)
06-10-2011
Sprawozdanie z oceny publicznego
(PAR)
26-02-2009
Składnik aktywny:
Classical Swine Fever Virus (CSFV) -E2 subunit antigen
Dostępny od:
Intervet International BV
Kod ATC:
QI09AD04
INN (International Nazwa):
Adjuvanted vaccine against classical swine fever
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals for suidae
Wskazania:
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.The onset of protection is 2 weeks.The duration of protection is 6 months.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-06-09
Ulotka dla pacjenta
B. PACKAGE LEAFLET
14/17
PACKAGE LEAFLET
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE
MANUFACTURING
AUTHORISATION
HOLDER
RESPONSIBLE
FOR
BATCH
RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Pesti emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml contains:
120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen
Liquid paraffin as adjuvant: 941.4 mg
4.
INDICATION(S)
_ _
Active immunisation of pigs from the age of 5 weeks onwards to prevent
mortality and to reduce clinical
signs of Classical Swine Fever, as well as to reduce infection with
and excretion of CSF field virus.
The onset of protection is 2 weeks.
The duration of protection is 6 months.
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
A local and in most cases transient swelling at the injection site may
occur up to 4 weeks after administration
of each dose of the vaccine. Transient hyperthermia may occur post the
second dose.
Abscesses may be observed at the injection site.
Since safety after giving both inoculations at the same site
has not been examined, it is advised to carry out the second
vaccination at a different site than the first
vaccination.
If you notice any serious side effects or other effects not mentioned
in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Pigs
15/17
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Administer one dose (2 ml) by deep intramuscular injection in the neck
area behind the ear.
Vaccination scheme:
Basic vaccination: Inject one dose per pig followed by a second
injection 4 weeks after the first injection.
Re-vaccination: Every 6 months, using a single dose.
9.
ADVICE ON CORRECT ADMINISTRATION
Shake well before use.
Before use, allow the vaccine to reach room temperature.
Use sterile syringes and needles.
It is recommended to use a closed multiject vaccination system.
10.
WIT
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1/17
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Pesti emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCE:
Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa
Units (EU)
ADJUVANT:
941.4 mg liquid paraffin
EXCIPIENTS:
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs from the age of 5 weeks onwards to prevent
mortality and to reduce clinical
signs of Classical Swine Fever, as well as to reduce infection with
and excretion of CSF field virus.
The onset of protection is 2 weeks.
The duration of protection is 6 months.
_ _
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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
VETERINARY
MEDICINAL PRODUCT TO
ANIMALS
To the user:
2/17
This product contains mineral oil. Accidental injection/self injection
may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare
cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt
medical advice even if only a very small
amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination,
seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been
injected, accidental injection with this
product can cause intense swelling, which may, for example, result in
ischaemic necrosis and even the loss
of a digit. Expert, PROMPT, surgical attention is required and may
necessitate early incision and irrigation
of the injected area, especially where the
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