NOBIVAC® RL

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.

Nobivac® RL is an inactivated vaccine for the active immunisation of healthy dogs against rabies and canine leptospirosis.

FOR ANIMAL USE ONLY
NOBIVAC® RL
Reg.No. G2199 (Act 36/1947)
Namibia Reg. No. V97/24.1/891 NS0

Only for use by or under the supervision of persons registered or authorized in terms of section 23(1)(c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982)

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, as measured in the mouse potency test, of Rabies virus strain Pasteur RIV, grown on cell culture and inactivated with BPL, as well as BPL-inactivated Leptospira interrogans serogroups Canicola, strain Ca-12-000 ≥ 40 hamster PD80 and Icterohaemorrhagiae, strain 820K ≥ 40 hamster PD80 with aluminium phosphate as an adjuvant and thiomersal as a preservative.

STORAGE

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

WARNINGS

  • 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.
  • Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc., according to local waste disposal regulations, after the completion of vaccination.
  • Use the entire contents of the multi dose vial within one working day. Do not store partially used vaccine containers for future use.
  • Nobivac® RL can be used to reconstitute the 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).
  • KEEP OUT OF REACH OF CHILDREN AND UNIFORMED PERSONS.
  • 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

  • Vaccinate healthy dogs only.
  • Adequate clinical examination 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 (needles, syringes, etc.) are clean and sterile prior to use.
  • Ensure that all the vaccination equipment remains clean and sterile during the vaccination process
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Allow the vaccine to gradually reach room temperature between 20 °C and 25 °C before use.
  • Shake well before use.
  • Give 1 mℓ subcutaneously in the neck or chest region.
  • Nobivac® RL may be mixed or may be used as a diluent for Nobivac® DHP or Nobivac® DHPPi.

Vaccination programme
The primary vaccination against rabies is a single administration not given before 12 weeks of age. The primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at approximately 12 weeks, 2 to 4 weeks after the first vaccination.
The primary vaccination against leptospirosis should consist of two vaccinations, 2 to 4 weeks apart. Puppies should be at least 8 weeks of age before they receive the first vaccination against leptospirosis.

Therefore Nobivac® RL can be used under the following circumstances:

In healthy dogs this programme will provide full protection against all components included.

Revaccination
Revaccination against rabies should be given every 3 years but local regulations may require earlier revaccination.
Revaccination against leptospirosis is needed every year. It is advocated to revaccinate against leptospirosis in the spring because infections with Leptospirae occur most frequently during late summer, and to give dogs that are often in natural water a third leptospirosis vaccination 6 months after the basic vaccination.

PRESENTATION
Polyethylene terephthalate (PET) tray containing 10 single dose vials.
Multi dose vials containing 10 doses.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 September 2006