Equip WNV (previously Duvaxyn WNV)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

inactivated West Nile virus, strain VM-2

Saatavilla:

Zoetis Belgium SA

ATC-koodi:

QI05AA10

INN (Kansainvälinen yleisnimi):

vaccine to aid in prevention of West Nile virus

Terapeuttinen ryhmä:

Horses

Terapeuttinen alue:

Immunologicals for equidae

Käyttöaiheet:

For the active immunisation of horses of six months of age or older against West-Nile-virus disease by reducing the number of viraemic horses.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2008-11-21

Pakkausseloste

13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET FOR:
EQUIP WNV EMULSION 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:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip WNV emulsion for injection for horses
3.
STATEMENT
OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
Active substance:
Inactivated West Nile virus, strain VM-2
RP* 1.0–2.2
* Relative potency by in vitro method, compared to a reference vaccine
that was shown efficacious in
horses.
Adjuvant:
SP oil
4.0% – 5.5% (v/v).
4.
INDICATION(S)
For the active immunisation of horses of 6 months of age or older
against West Nile virus (WNV)
disease by reducing the number of viraemic horses after infection with
WNV lineage 1 or 2 strains and
to reduce duration and severity of clinical signs against WNV of
lineage 2 strains.
Onset of immunity: 3 weeks after primary vaccination course.
Duration of immunity: 12 months after primary vaccination course for
WNV lineage 1 strains. For
WNV lineage 2 strains the duration of immunity has not been
established.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Transient local reactions in the form of a mild, local swelling at the
injection site post vaccination
(maximum 1 cm in diameter) that resolve spontaneously within 1 to 2
days and that are sometimes
associated with pain and mild depression were reported in very rare
cases. In very rare cases transient
hyperthermia may occur for up to 2 days.
15
As with any vaccine rare, occasional hypersensitivity reactions may
occur. If such a reaction occurs,
appropriate treatment should be administered without delay.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals displaying adverse
reaction(s) during the course of one
tre

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip
WNV emulsion for injection for horses
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE
:
Inactivated West Nile virus, strain VM-2
RP* 1.0–2.2
*Relative potency by in vitro method, compared to a reference vaccine
that was shown efficacious in
horses.
ADJUVANT
:
SP oil
4.0% – 5.5% (v/v)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_ _
For the active immunisation of horses of 6 months of age or older
against West Nile virus (WNV)
disease by reducing the number of viraemic horses after infection with
WNV lineage 1 or 2 strains and
to reduce duration and severity of clinical signs against WNV of
lineage 2 strains.
Onset of immunity: 3 weeks after primary vaccination course.
Duration of immunity: 12 months after primary vaccination course for
WNV lineage 1 strains. For
WNV lineage 2 strains the duration of immunity has not been
established.
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 healthy animals only.
3
Vaccination may interfere with existing sero-epidemiological surveys.
However, since the IgM
response following vaccination is infrequent, a positive IgM-ELISA
test result is a strong indicator of
natural infection with West Nile virus. If infection is suspected as a
result of a positive IgM response,
additional testing would need to be conducted to conclusively
determine whether the animal was
infected or vaccinated.
No specific studies have been conducted to demonstrate absence of
interferences from maternally
derived antibodies on vaccine take. It is therefore recommended not to
vaccinate foals of less than 6
months of age.
Special precautions to be taken by the person administering the
veterinary medicina