Product Details - NOBIVAC® RABIES

Reg. No. G2207 Act 36/1947
Indications:
For the active immunisation of healthy dogs against Rabies. Nobivac® Rabies may be used to reconstitute the freeze-dried canine vaccines and may be administered in combination with Nobivac® D.
Vaccination leads to a high peak level within 3 weeks, followed by a more or less constant level sufficiently high to provide protection.
Storage Instructions:
- Store in the dark between 2 °C and 8 °C.
- Allow the vaccine to reach room temperature (20 °C and 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.
Composition:
The vaccine is an inactivated culture of Rabies virus, cloned out
of strain Pasteur RIV with a potency of > 2,0 i.u. The virus is grown on the BHK-21 Clone CT cell line and inactivated with beta-propiolactone. It is presented as an aqueous aluminium phosphate suspension.
Contents:
Each vial of 10 doses 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 mg per dose of Thiomersal as a preservative.
Warnings:
- Do not freeze.
- Avoid intravenous injection.
- After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection.
- Accidental self injection may lead to a severe allergic reaction. Consult a physician.
- Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
- 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 animals only.
- Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc) are clean and sterile prior to use.
- Destroy any unused vaccine, by for example, burning and dispose of all the vaccine containers after 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.
- 1 ml is administered by subcutaneous injection.
VaccinationScheme - Dogs:
* Primary vaccination at an age of more than - 3 months
** Re-vaccination every - 3 years
Vaccination leads to a high peak level within 3 weeks followed by a more or less constant level sufficiently high to provide protection.
* Primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at the age of 3 months.
** Recommended re-vaccination interval is based upon results from challenge experiments. Local regulations in force may require earlier re-vaccinations.
Do not store partially used containers for future use.
Use the entire contents of multi-dose vials when first opened.
Presentation:
Cardboard boxes containing 5 vials of 10 doses each.
Registration holder
Intervet S.A. (Pty) Ltd
Co. Reg. No. 1991/006580/07
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