Equilis StrepE

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

live deletion-mutant Streptococcus equi strain TW928

Available from:

Intervet International BV

ATC code:

QI05AE

INN (International Name):

live vaccine against Streptococcus equi

Therapeutic group:

Horses

Therapeutic area:

Immunologicals for equidae

Therapeutic indications:

For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph-node abscesses.Onset of immunity: The onset of immunity is established as two weeks after basic vaccination.Duration of immunity: The duration of immunity is up to three months.The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows or competitions in such areas, or stables that obtain or have livery horses from such areas.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2004-05-07

Patient Information leaflet

19
_ _
MINIMUM PARTICULARS ON IMMEDIATE PACKAGING OF THE SOLVENT
SOLVENT VIAL
1.
NAME OF THE DILUENT
Equilis StrepE – solvent
2.
CONTENTS BY WEIGHT, BY VOLUME OR BYNUMBER OF DOSES
1 dose
3.
ROUTE OF ADMINISTRATION
See package leaflet.
4.
STORAGE CONDITIONS
5.
BATCH NUMBER
Lot {number}
6.
EXPIRY DATE
Exp {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET FOR:
Equilis StrepE, lyophilisate and solvent for 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 authorization holder and manufacturer responsible for batch
release:
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis StrepE, lyophilisate and solvent for suspension for injection,
for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Per dose of 0.2 ml vaccine:
Live deletion mutant
_Streptococcus equi_
strain TW928 10
9.0
to 10
9.4
cfu
1
1
colony forming units
Lyophilisate: off-white or cream coloured pellet
Solvent: clear colourless solution
4.
INDICATION(S)
For immunisation of horses against
_Streptococcus equi_
to reduce clinical signs and occurrence of
lymph node abscesses.
The onset of immunity is established as two weeks after vaccination.
The duration of immunity is up
to 3 months.
The vaccine is intended for use in horses for which a risk of
_Streptococcus equi_
infection has been
clearly identified, due to contact with horses from areas where this
pathogen is known to be present,
e.g. stables with horses that travel to shows and/or competitions in
such areas, or stables that obtain or
have livery horses from such areas.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
After vaccination a diffusely swollen reaction, which may be warm or
painful, develops at the
injection site within 4 hours. The reaction is maximal at 2–3 days
pos

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis StrepE, lyophilisate and solvent for suspension for injection,
for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.2 ml vaccine:
ACTIVE SUBSTANCE:
Live deletion mutant
_Streptococcus equi_
strain TW928 10
9.0
to 10
9.4
cfu
1
1
colony forming units
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Lyophilisate: off-white or cream-coloured pellet
Solvent: clear colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For immunisation of horses against
_Streptococcus equi_
to reduce clinical signs and occurrence of
lymph node abscesses.
Onset of immunity
: 2 weeks after basic vaccination.
Duration of immunity
: up to 3 months.
The vaccine is intended for use in horses for which a risk of
_Streptococcus equi_
infection has been
clearly identified, due to contact with horses from areas where this
pathogen is known to be present,
e.g. stables with horses that travel to shows and/or competitions in
such areas, or stables that obtain or
have livery horses from such areas.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
Shedding of the vaccine strain from the injection site can be observed
for a period of four days after
vaccination.
3
From literature, it is known that a very low number of horses may
develop purpura haemorrhagica if
they are vaccinated shortly after infection. Purpura haemorrhagica has
not been observed in any of the
safety studies performed during development of Equilis StrepE. As the
incidence of purpura
haemorrhagica is very low, its occurrence cannot be ruled out
completely.
In the challenge studies performed by the company, insufficient
protection was seen in approximately
one quarter of horses vaccinated with the recommended dose.
Do not use antibiotics within one week after vaccination.
The vaccine strain is sensitive to penicill