NOBIVAC® RL

FOR ANIMAL USE ONLY

Nobivac® RL
Reg. No. G2199 (Act 36/1947)
Namibia Reg. No. V97/24.1/891 [NS0]

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).

Rabies is a controlled disease in terms of the Animal Diseases Act (Act 35 of 1984). The occurrence or suspicion of this disease must be reported to the responsible state veterinarian immediately.

INDICATIONS
Nobivac® RL is an inactivated vaccine for the active immunisation of healthy dogs against rabies and canine leptospirosis, caused by Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae.

COMPOSITION
Each 1 mℓ dose of Nobivac® RL contains at least 3 IU of rabies virus strain Pasteur RIV, as measured in the mouse potency test, grown on cell culture and inactivated with BPL, as well as BPL-inactivated Leptospira interrogans serogroup Canicola, strain Ca-12-000 ≥ 40 hamster PD80 and serogroup Icterohaemorrhagiae, strain 820K ≥ 40 hamster PD80 with
2 % aluminium phosphate as an adjuvant.

STORAGE INSTRUCTIONS
• Store between 2 °C and 8 °C in a refrigerator.
• Do not freeze.
• Protect from direct sunlight.
• Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) before use.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

WARNINGS
• Vaccinate healthy dogs only.
• Do not over- or under-dose the vaccine.
• Occasionally, a mild hypersensitivity reaction may occur after vaccination as is possible after administration of any foreign protein. Such reactions are in most cases, self-limiting. A local reaction of limited size may arise during the first few days after vaccination.
• Nobivac® RL can be used to reconstitute freeze-dried live Nobivac® canine vaccines.
• No information is available on the effects of the concurrent use with any other vaccines. It is therefore recommended that vaccines other than the live Nobivac® canine vaccines, are not administered within 14 days before or after vaccination with Nobivac® RL.
• In case of accidental self-injection, seek medical advice immediately and show this package leaflet to the physician.
• 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.

PRECAUTIONS
• Adequate clinical examinations should be done prior to inoculation.
• Following vaccination, contact with potential sources of infection should be avoided until 14 days after inoculation.
• Observe aseptic precautions. Ensure that the vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
• Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable 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
Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) before use.
Shake well before use.
Administer 1 mℓ subcutaneously in the neck or chest region.
Nobivac® RL may be mixed and used as a diluent for Nobivac® DHPPi.

Vaccination programme
The primary vaccination against rabies is a single administration and should not be administered before 12 weeks of age. The primary vaccination may be administered at an earlier age, but a repeat vaccination must be given at approximately 12 weeks, 2 to 4 weeks after the first vaccination. Local regulations should be adhered to.

The primary vaccination against leptospirosis should consist of 2 vaccinations, 2 to 4 weeks apart. Puppies should be at least 8 weeks of age before they receive the first vaccination against leptospirosis.

Revaccination
Revaccination against rabies should be given every 3 years but local regulations may require earlier revaccination.

Revaccination against leptospirosis is needed every year.

PRESENTATION
Hydrolytical class Type I glass vial, containing 1 mℓ dose, closed with a halogenobutyl stopper and sealed with a coded aluminium cap. Packed in a polyethylene terephthalate (PET) tray containing 10 single dose vials.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
E-mail: msdahza@msd.com
www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
28 September 2023