Nobivac RL is an inactivated vaccine for the active immunisation of healthy dogs against rabies and canine leptospirosis caused by L. interrogans serogroup canicola and icterohaemorrhagiae.

Storage Instructions:

• Store in the dark between 2 °C and 8 °C. Do not freeze.
• Allow the vaccine to reach room temperature (20 °C and 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.

Composition:
Nobivac RL is an inactivated vaccine containing rabies virus strain Pasteur RIV and BPL-inactivated Leptospirainteroggans serogroup canicola strain Ca-12-000 and icterohaemorrhagiae strain 820K.

Contents:
Each 1 ml dose of Nobivac RL contains rabies virus strain Pasteur RIV, grown on cell culture and inactivated with BPL, at least 3 i.u. as measured in the mouse potency test and BPL-inactivated Leptospira interrogans serogroup canicola strain Ca-12-000 ³ 40 hamster PD80 and icterohaemorrhagiae strain 820K ³ 40 hamster PD80 with a 2% aluminium phosphate adjuvant.

Warnings:

• Do not freeze.
• Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc., for example, burning, after the completion of the vaccination.
• Do not store partially used vaccine containers for future use.
• Do not mix the vaccines with other than freeze-dried live Nobivac canine vaccines, or any other medications. (No information is available on the effects of concurrent use with any other vaccine. 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 uninformed 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 made 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 remain clean and sterile during the vaccination.
• 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.
• Shake well before use.
• The contents of one vial is given subcutaneously in the neck or chest region.
• Nobivac RL may be mixed or used as a diluent for Nobivac DH, Nobivac Parvo-C, Nobivac DHP, Nobivac DHPPi or Nobivac Corona.

Vaccination Programme:

The primary vaccination against rabies is a single administration given not before 12 weeks of age. The primary vaccination can be administered at an earlier age, but then a repeat vaccination must be given at approximately 12 weeks, 2 - 4 weeks after the first vaccination.

The primary vaccination against leptospirosis should consist of two vaccinations 2 - 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:

Puppies [early start]:

• Age 8/9 weeks: Nobivac Lepto or Nobivac RL (in case of possible early exposure to rabies).
• Age 12 weeks: Nobivac RL (repeat vaccination with rabies to ensure protection of puppies with maternal immunity against rabies)

Primary vaccination at any age ³ 12 weeks:

• Age 12 weeks: Nobivac RL.
• Age 14/15 weeks: Nobivac Lepto

Proposed Vaccination Schedule:

Depending on the local situation and the maternal immunity status of the animal, a choice can be made from the following vaccination programmes:

1. No direct infection risk:
2. • Age 9 weeks: Nobivac L
   • Age 12 weeks: Nobivac DHPPi, Parvo-C + RL
   • In healthy dogs this programme will provide full protection against all components included.
3. Risk of parvovirus infection in weaned puppies:
4. • Age 9 weeks: Nobivac Parvo-C + L
   • Age 12 weeks: Nobivac DHPPi, Parvo-C + RL
   • The first vaccination at 9 weeks will protect 90% of the pups against parvovirus disease. The second vaccination will provide full protection against all components included.
5. Risk of parvovirus and distemper infection in non-weaned puppies:
6. • Age 6 weeks: Nobivac Puppy DP
   • Age 9 weeks: Nobivac Parvo-C + L
   • Age 12 weeks: Nobivac DHPPi, Parvo-C + RL
   • The first vaccination at 6 weeks will provide protection against parvovirus disease in 75% of the pups, the second one will increase this percentage to 95%, and the third vaccination will provide full protection against all components.

Re-vaccination:
Re-vaccination against rabies should be given every 3 years but local regulations may require earlier re-vaccination.

Re-vaccination against leptospirosis is needed every year. It is advocated to [re]vaccinate 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.

Revaccinations:
Yearly against leptospirosis: Nobivac Lepto

Every three years against rabies: Nobivac RL [or sooner to comply with local regulations].

Vaccination Reactions:
Occasionally a mild hypersensitivity reaction may occur after vaccination as is possible after administration of any foreign protein. Such type of reactions are in most cases self-limiting. A local reaction of limited size may arise during the first few days after vaccination.

Presentation:
Cardboard boxes containing 10 dose x 1 ml glass vials.

Registration holder 
Intervet S.A. (Pty) Ltd
Co. Reg. No. 1991/006580/07