Nobivac L4

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Leptospira interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000), L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001), L. interrogans serogroup Australis serovar Bratislava (strain As-05-073), L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)

Available from:

Intervet International BV

ATC code:

QI07AB01

INN (International Name):

Vaccine to prevent Leptospira infections in dogs

Therapeutic group:

Dogs

Therapeutic area:

Immunologicals

Therapeutic indications:

For active immunisation of dogs against:Leptospira interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion;L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion;L. interrogans serogroup Australis serovar Bratislava to reduce infection;L. kirschneri serogroup Grippotyphosa serovar Bananal / Lianguang to reduce infection and urinary excretion.

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2012-07-16

Patient Information leaflet

13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL
VIAL OF 1 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac L4
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
See package leaflet.
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 ml
4.
ROUTE(S) OF ADMINISTRATION
SC
5.
WITHDRAWAL PERIOD(S)
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use immediately.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14
B.
PACKAGE LEAFLET
15
PACKAGE LEAFLET:
NOBIVAC L4
SUSPENSION FOR INJECTION FOR DOGS
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
Nobivac L4 suspension for injection for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Inactivated
_Leptospira _
strains:
-
_L. interrogans _
serogroup Canicola serovar Portland-vere (strain Ca-12-000)
3550–7100 U
1
-
_L. interrogans _
serogroup Icterohaemorrhagiae serovar Copenhageni
(strain Ic-02-001)
290–1000 U
1
-
_L. interrogans _
serogroup Australis serovar Bratislava (strain As-05-073)
500–1700 U
1
-
_L. kirschneri _
serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
650–1300 U
1
1
Antigenic mass ELISA units.
Colourless suspension.
4.
INDICATION(S)
For active immunisation of dogs against:
-
_L. interrogans_
serogroup Canicola serovar Canicola to reduce infection and urinary
excretion
-
_L. interrogans_
serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection
and urinary
excretion
-
_L._
_interrogans _
serogroup Australis serovar Bratislava to reduce infection
-
_L._
_kirschneri _
serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection
and urinary
excretion.
Onset of immunity

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac L4 suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Inactivated
_Leptospira _
strains:
-
_L. interrogans _
serogroup Canicola serovar Portland-vere (strain Ca-12-000)
3550–7100 U
1
-
_L. interrogans _
serogroup Icterohaemorrhagiae serovar Copenhageni
(strain Ic-02-001)
290–1000 U
1
-
_L. interrogans _
serogroup Australis serovar Bratislava (strain As-05-073)
500–1700 U
1
-
_L. kirschneri _
serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
650–1300 U
1
1
Antigenic mass ELISA units.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Colourless suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs against:
-
_L. interrogans_
serogroup Canicola serovar Canicola to reduce infection and urinary
excretion
-
_L. interrogans_
serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection
and urinary
excretion
-
_L._
_interrogans _
serogroup Australis serovar Bratislava to reduce infection
-
_L._
_kirschneri _
serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection
and urinary
excretion.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Avoid accidental self-injection or contact with the eyes. In case of
ocular irritation seek medical
advice immediately and show the package leaflet or the label to the
physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A mild and transient increase in body temperature (
≤
1 °C) has been observed very commonly in
clinical studies fo