Nobivac Rabies - Summary of Product Characteristics

Name of the IVMP:

Nobivac Rabies

Composition:

Per dose:
Active ingredient:
1 ml Rabies virus strain Pasteur RIV grown on tissue culture, inactivated with BPL and inducing at least 2 IU as measured in the potency test.

Pharmaceutical form:

Aqueous suspension

Pharmacological properties:

Inactivated aluminium phosphate adsorbed vaccine.

Clinical particulars

Target species:

Dogs, cats, cattle, sheep, goats, foxes, ferrets and horses.

Indications for use:

For the active immunisation of healthy dogs, cats, cattle, sheep, goats, foxes, ferrets and horses, and in principle all healthy mammals against Rabies.

Contra-indications:

When used according to instructions: None

Undesirable effects:

After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection.

Special precautions for use:

Before using the vaccine allow it to reach ambient temperature (15-25°C). Use sterile syringes and needles.

Use during pregnancy:

The vaccine may be used during pregnancy

Interactions:

In dogs: Nobivac Rabies can be used to reconstitute freeze dried Nobivac Canine vaccines and can be administered in combination withNobivac L.

In cats: Nobivac Rabies can be used to reconstitute freeze dried Nobivac Tricat vaccine.

Posology and method of administration:

	Dogs/Cats	Cattle/Horses	Ferrets
Primary vaccination at an age of more than	3 months*	6 months*	3 months*
Revaccination every	3 years**	2 years**	1 year**
Route of adminstration	i.m. or s.c.	i.m.	s.c.

* Primary vaccination can be administered at an earlier age, but then a repeat vaccination must be given at the age of 3 or 6 months depending on the species

** Recommended revaccination interval is based upon results from challenge experiments. Local regulations in force may require earlier revaccination.

Results from serological investigations indicate that vaccination of sheep, goats and foxes provides protection for at least one year.

Overdose:

After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection.

Special warnings for each target species:

None

Withdrawal periods:

None

Special safety precautions to be taken by persons administering the product:

None

Pharmaceutical particulars

Incompatibilities (major):

Not known

Shelf-life:

At least 4 years at 2-8°C. Do not freeze.
For the 10 dose presentation, broached vials should be used within 3 hours.

Special precautions for strorage:

Store refrigerated at 2-8°C. Do not freeze.

Nature and contents of the container:

Vial of glass, hydrolytical class type II (Ph.Eur), closed with a halogenbutyl rubber stopper and sealed with a coded aluminium cap.

Special precautions for disposal of unused product or waste material:

No special precautions are required. Dispose by appropriate channels.