NOBIVAC® RABIES

For the active immunisation of healthy dogs, cats, cattle, sheep, goats and horses against rabies.

NOBIVAC® RABIES

Reg. No. G2207 (Act 36/1947)

Namibia Reg. No. V97/24.1/828 NS0

NAFDAC Reg. No. 04-3251

Only for use by or under the supervision of persons registered 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

For the active immunisation of healthy dogs, cats, cattle, sheep, goats, ferrets, foxes and horses, and in principle all healthy mammals against rabies. Nobivac® Rabies may be used to reconstitute the freeze-dried canine vaccines, Nobivac® DHP (G2201) and Nobivac® DHPPi (G2377) and may be administered in combination with Nobivac® Lepto (G2200) or Nobivac® L6 (G4482). Vaccination leads to a high peak level within 3 weeks, followed by a more or less constant level, sufficiently high to provide protection.

IMMUNITY

In dogs, peak antibody titres have been demonstrated to occur by 3 weeks after vaccination.

COMPOSITION

Nobivac® Rabies is an inactivated culture of rabies virus, cloned out of strain Pasteur RIV. The virus is grown on the BHK-21 clone CT cell-line and inactivated with β-Propiolactone. It is presented as an aqueous aluminium phosphate suspension.

Each 1 dose of 1 mℓ contains: Inactivated rabies antigen suspension with a potency per dose of ≥ 2,0 i.u. (Ph. Eur. method) with 0,3 % aluminium phosphate as adjuvant, glycine as a buffer and 0,1 % thiomersal as preservative.

STORAGE INSTRUCTIONS

  • Store in the dark between 2 °C and 8 °C.
  • Do not freeze.
  • Allow the vaccine to reach room temperature (15 °C to 25 °C) before use.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
  • Protect from direct sunlight.
  • In-use shelf-life: For the multi-dose (10 mℓ) vials, broached vials should be used within 1 working day.

WARNINGS

  • Avoid intravenous injection.
  • After subcutaneous administration, occasionally a transient palpable nodule may occur at the site of injection.
  • In case of accidental self-injection may lead to severe allergic reactions. Seek medical advice immediately and show the 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 inform the registration holder.

PRECAUTIONS

  • Vaccinate healthy animals only.
  • As with all vaccines, hypersensitivity or anaphylactic reactions may occur.
  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Dispose of any unused vaccine and all the vaccine containers after vaccination according to National Environmental Management Waste Act, 2008 (Act No. 59 of 2008) after completion of 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 and during use.

•    1 mℓ is administered by subcutaneous (SC) or intramuscular (IM) injection.

Vaccination scheme

Dogs/CatsCattle/Sheep/Goats/HorsesFerrets
*     Primary vaccination at an       age of more than3 months6 months3 months
* *  Revaccination every3 years2 years1 year
      Route of administrationIM or SCIMSC
  • Primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at the age of 3 months.

* *   Recommended vaccination interval is based upon regulations in force may require

       earlier revaccinations.

  • Vaccination leads to a high peak level within 3 weeks followed by a more or less constant level, sufficiently high to provide protection.
  • Results from serological investigations indicate that vaccination of sheep, goats and foxes provide protection for at least 1 year.
  • Do not store partially used containers for future use.
  • Use the entire contents of the multi-dose vial when first opened.

USE DURING PREGNANCY AND LACTATION

Can be used during pregnancy in dogs.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Nobivac® Rabies can be used to reconstitute the freeze-dried canine vaccines of the Nobivac® series (Nobivac® DHP (G2201), Nobivac® DHPPi (G2377). Nobivac® Rabies can be administered with the Nobivac® leptospirosis vaccines (Nobivac® Lepto (G2200) or Nobivac® L6 (G4482)) at the same time but at a different administration site.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

PRESENTATION

The vials are of hydrolytical Type I glass (Ph.Eur.) and closed with halogenated butyl rubber stoppers (Ph.Eur.) and sealed with coded aluminium caps.

Vials are packed in in polyethylene terephthalate (PET) trays containing 10 or 50 single dose or 10 vials of 10 doses.

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 PACKAGE INSERT

12 August 2021

Zimbabwe Reg. No.: 91/80.23.10/9287
Pharmacological classification: 802310
Distribution category: VMGD