FOR ANIMAL USE ONLY
FOR ANIMAL USE ONLY
Reg. No. G4482 (Act 36/1947)
Suspension for injection for dogs
Only for use by or under the supervision of persons registered in terms of, or authorised in terms of, Section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).
For active immunisation of dogs against leptospirosis.
To stimulate active immunity in dogs against Leptospira interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang.
In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
Each 1 mℓ dose contains:
|Inactivated Leptospira strains:||Minimum titres:|
|L. interrogans serogroup Canicola serovar Portland-vere|
|≥ 3 550 U1|
|L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni|
|≥ 290 U1|
|L. interrogans serogroup Australis serovar Bratislava|
|≥ 500 U1|
|L. kirschneri serogroup Grippotyphosa serovar Dadas|
|≥ 650 U1|
• Store between 2 °C – 8 °C in a refrigerator.
• Do not freeze.
• Protect from light.
• Do not use after the expiry date stated on the label.
• Shelf-life after reconstitution with Nobivac® vaccines: 45 minutes.
• Vaccinate only healthy dogs.
• Do not use within 2 weeks of antimicrobial treatment.
• Do not inject intravenously.
• Accidental self-injection could lead to a severe allergic reaction, seek medical advice immediately and show this package leaflet to the physician.
• Nobivac® L6 can be used during pregnancy.
• Do not mix Nobivac® L6 with any other vaccine or medication other than described below.
• Safety and efficacy data are available which demonstrate that Nobivac® L6 can be mixed with vaccines of the Nobivac® series containing canine distemper virus, canine adenovirus type 2 and/or canine parvovirus (strain 154) and/or canine parainfluenza virus components (Nobivac® DHPPi G2377), for subcutaneous administration. When Nobivac® L6 is mixed with these Nobivac® vaccines, the demonstrated safety and efficacy claims for Nobivac® L6 are the same, as when it is administered alone.
• Safety and efficacy data are available which demonstrate that Nobivac® L6 can be administered on the same day, but not mixed with vaccines of the Nobivac® series containing Bordetella bronchiseptica and/or parainfluenza virus components (Nobivac® KC G2604) for intranasal administration.
• Safety data are available which demonstrate that Nobivac® L6 can be administered at the same time, but not mixed with the inactivated vaccine of the Nobivac® series against Bordetella bronchiseptica (Nobivac® Respira Bb G4506). When Nobivac® L6 is administered in association with Nobivac® Respira Bb (G4506), the demonstrated antibody response data and other immunity data of Nobivac® L6 are the same, as when it is administered alone.
• No information is available on the safety and efficacy of Nobivac® L6 when used with any other veterinary medicinal product except the products mentioned above. A decision to use Nobivac® L6 before or after any other veterinary medicinal product, therefore needs to be made on a case by case basis by your veterinarian.
• As with all vaccines, hypersensitivity or anaphylactic reactions may occur.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
• Observe aseptic precautions. Ensure that the vaccination equipment (containers, syringes and needles) is clean and sterile prior to use.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• Use entire contents when vials are first opened and do not store unused contents and vials for future use.
• Adhere to the vaccination programme to obtain optimum results.
• It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing. In case of ocular irritation, seek medical advice immediately and show this package leaflet to the physician.
• Destroy any unused vaccine and dispose of all empty vaccine containers and disposable vaccination equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Before use, allow the vaccine to reach room temperature (between 15 ºC – 25 ºC).
Administer two vaccinations of 1 dose (1 mℓ) each, with an interval of 4 weeks, to dogs from 6 weeks of age onwards.
Basic vaccination: The first vaccination can be administered from 6 to 9* weeks of age and the second vaccination from 10 to 13 weeks of age.
Revaccination: Dogs should be revaccinated annually with 1 dose (1 mℓ) of vaccine.
For simultaneous use, 1 dose of a Nobivac® vaccine containing canine distemper virus, canine adenovirus type 2 and/or canine parvovirus (strain 154) and/or canine parainfluenza virus components (Nobivac® DHPPi G2377) should be reconstituted with 1 dose (1 mℓ) of Nobivac® L6. The mixed vaccines must be administered by subcutaneous injection.
- In case of high levels of maternally derived antibodies (MDA), first vaccination is recommended at 9 weeks of age.
A mild and transient increase in body temperature (≤ 1 °C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either disappear or will be clearly diminished by 14 days post-vaccination. No adverse reactions other than those mentioned above were observed after the administration of a double dose of vaccine. However, these reactions may be more severe and/or last longer. For example, local swelling, which can be up to 5 cm in diameter, and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
In very rare cases, clinical signs of immune-mediated haemolytic anaemia (IMHA), immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported.
In very rare cases a transient, acute hypersensitivity reaction may occur. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. If such reactions occur appropriate treatment is recommended.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian.
Colourless suspension, in a Type I glass vial of 1 mℓ (1 dose), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes: Box with 5, 10, 25 or 50 vials of 1 mℓ (1 dose).
Not all pack sizes may necessarily be marketed.
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
Tel: +27 (0) 11 923 9300
DATE OF PUBLICATION OF THIS PACKAGE INSERT
10 March 2023