Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
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)
Intervet International BV
QI07AB01
Vaccine to prevent Leptospira infections in dogs
Dogs
Immunologicals
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.
Revision: 6
Authorised
2012-07-16
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 Lestu allt skjalið
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 Lestu allt skjalið