Equilis West Nile
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-10-2018
Charakterystyka produktu
(SPC)
15-10-2018
Sprawozdanie z oceny publicznego
(PAR)
21-07-2013
Składnik aktywny:
inactivated chimaeric flavivirus strain YF-WN
Dostępny od:
Intervet International BV
Kod ATC:
QI05AA10
INN (International Nazwa):
inactivated chimaeric flavivirus strain YF-WN
Grupa terapeutyczna:
Horses
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia. Onset of immunity: 2 weeks after primary vaccination course of two injections. Duration of immunity: 12 months.,
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Authorised
Data autoryzacji:
2013-06-06
Ulotka dla pacjenta
B. PACKAGE LEAFLET
13
PACKAGE LEAFLET:
EQUILIS WEST NILE SUSPENSION FOR INJECTION FOR HORSES
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 responsible for batch
release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis West Nile suspension for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
Inactivated chimeric flavivirus strain YF-WN
≥ 492 AU
1
Iscom-Matrix containing:
Purified saponin
250 micrograms
Cholesterol
83 micrograms
Phosphatidylcholine
42 micrograms
1
Antigenic units
Opalescent suspension.
4.
INDICATION(S)
Active immunisation of horses against West Nile virus (WNV) to reduce
clinical signs of disease and
lesions in the brain and to reduce viraemia.
Onset of immunity
: 2 weeks after primary vaccination course of two injections.
Duration of immunity: 12 months
.
_ _
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In laboratory studies and field trials:
After vaccination a mild transient swelling may very commonly develop
at the injection site (max.
3 cm in diameter). This swelling normally resolves within 1 to 5 days.
A mild body temperature
increase (max. 1.5
°
C) may very commonly occur for 1 to 2 days.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
14
- common (more than 1 but less than 10 animals in 100 animals treated
)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please in
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis West Nile suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Inactivated chimeric flavivirus strain YF-WN
≥ 492 AU
1
ADJUVANT:
Iscom-Matrix containing:
Purified saponin
250 micrograms
Cholesterol
83 micrograms
Phosphatidylcholine
42 micrograms
1
Antigenic units determined by ELISA.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of horses against West Nile virus (WNV) to reduce
clinical signs of disease and
lesions in the brain and to reduce viraemia.
Onset of immunity
: 2 weeks after primary vaccination course of two injections.
Duration of immunity: 12 months
.
_ _
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
2
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:
After vaccination a mild transient swelling may very commonly develop
at the injection site (max.
3 cm in diameter). This swelling normally resolves within 1 to 5 days.
A mild body temperature
increase (max. 1.5
°
C) may very commonly occur for 1 to 2 days.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than
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