NOBIVAC® RABIES

NOBIVAC^® RABIES

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 vaccine Nobivac^® DHPPi (G2377) and may be administered in combination with 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 0,01 % thiomersal as preservative.

STORAGE INSTRUCTIONS

• Store between 2 °C  and 8 °C in a refrigerator.
• Do not freeze.
• Protect from light.
• 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.
• In-use shelf-life: For the multi-dose (10 mℓ) vials, broached vials should be used within
  1 working day.

WARNINGS

• Vaccinate healthy animals only.
• Avoid intravenous injection.
• After subcutaneous administration, occasionally, a transient palpable nodule may occur at the site of injection.
• 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

• 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.
• As with all vaccines, hypersensitivity or anaphylactic reactions may occur.
• It is good vaccination practice when handling the vaccine, to avoid contact with the eyes, hands and clothing.
• Dispose of any containers, disposable equipment and any other waster after use, in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008) and do not reuse for any other purpose.
• Do not contaminate rivers, dams or any water sources with containers or waste.

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/Cats	Cattle/Horses	Ferrets	Sheep/Goats/Foxes
*Primary vaccination at an age of more than	3 months	6 months	3 months	3 – 6 months
**Revaccination every	3 years	2 years	1 year	1 year***
Route of administration	IM or SC	IM	SC	Sheep SC Goats & Foxes IM

• 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 results from challenge experiments.  

         Local regulations in force may require earlier revaccinations.

***  Results from serological investigations indicate that vaccination of sheep, goats and 

         foxes provide protection for at least a year.

• Vaccination leads to a high peak level within 3 weeks followed by a more or less constant level, sufficiently high to provide protection.
• 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 vaccine Nobivac^® DHPPi (G2377). Nobivac^® Rabies can be administered at the same time with the Nobivac^® leptospirosis vaccine Nobivac^® L6 (G4482), 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

Light yellow/orange to slightly red/purple aqueous suspension with a whitish sediment packed in vials of hydrolytical Type I glass and closed with halogenated butyl rubber stoppers and sealed with coded aluminium caps. Vials are packed in polyethylene terephthalate (PET) trays containing 10 or 50 single dose vials, or 10 vials of 10 doses.

Not all pack sizes may necessarily be marketed.

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