Nobilis® SG 9R

A live, freeze-dried vaccine for the active immunisation of healthy layers as an aid in the control of Salmonella gallinarum (chicken typhoid).

FOR ANIMAL USE ONLY

NOBILIS® SG 9R

Reg. No. G2523 (Act 36/1947)

Namibia Reg. No. V05/24.3/454 [NS0]

NAFDAC Reg. No. A6-100087

Salmonella Gallinarum is a controlled disease in terms of the Animal Diseases Act (Act 35/1984). The occurence or suspicion of this disease must be reported to the responsible state veterinarian immediately.

INDICATIONS

A live, freeze-dried vaccine for the active immunisation of healthy layers as an aid in the control of Salmonella Gallinarum (chicken typhoid).

COMPOSITION

Nobilis® SG 9R is a live freeze-dried vaccine based on the Salmonella Gallinarum strain 9R. Each 0,2 mℓ dose contains at least 2 x 107 CFU of Salmonella Gallinarumstrain 9R. The freeze-dried pellet contains a stabiliser.

STORAGE INSTRUCTIONS

  • Store in the dark between 2 °C and 8 °C.
  • Do not freeze.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
  • Protect from exposure to direct sunlight.
  • Nobilis® Diluent FD: Store at room temperature between 20 °C and 25 °C prior to use.
  • After reconstitution, use within 2 hours.

WARNINGS

  • Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
  • Vaccinate healthy chickens only.
  • The use of antibiotics or other substances with a systemic action should be avoided from 7 days before vaccination until 14 days after vaccination.
  • It is advisable to vaccinate all the susceptible chickens on the farm at the same time. If this is not feasible, strict separation of the vaccinated and the unvaccinated chickens should be done to prevent the spread of the vaccine organisms to the unvaccinated chickens.
  • Rough pathogenic field strains, where isolated, can interfere with diagnostic tools for differentiation of S. Gallinarum field strains from the vaccine strain.
  • The vaccine strain may be isolated for a prolonged period of time from post-mortem material depending on the health status of the chickens.
  • For optimal development of immunity, it is recommended not to introduce chickens to an infected environment until 14 days after primary vaccination.
  • Do not open and reconstitute the vaccine until ready to start vaccination.
  • Do not over- or under-dose the vaccine.
  • Use according to the number of doses as indicated on the label.
  • Accidental self-injection may lead to severe local reaction. Seek medical advice immediately and make this package insert available to the doctor.
  • Wash and disinfect hands and equipment after vaccination.
  • 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 notify 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.
  • The vaccination equipment should be free from traces of disinfectant and spirits.
  • Initial vaccination should be carried out at 6 weeks of age.
  • Avoid intravenous injection.
  • It is good vaccination practice when handling the vaccine to avoid contact with eyes, hands and clothes.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage and Administration

  • Shake the vaccine before use and at regular intervals during the vaccination process.
  • Reconstitute the vaccine with Nobilis® Diluent FD.
  • Each chicken should receive 0,2 mℓ of the reconstituted vaccine, subcutaneously into the lower part of the back of the neck.
  • Vaccinate all the chickens in the flock.

Vaccination Programme

Initial vaccination should be carried out at 6 weeks of age.

Revaccination at intervals of 12 weeks is recommended.

PRESENTATION

A white to off-white freeze-dried lyophilised pellet in Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

Packed in cardboard boxes containing 10 vials of 1 000 doses each.

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

10 March 2010

Zimbabwe Reg. No. E97/80.23.17/9456
Veterinary Classification: 802317
Distribution Category: V.M.G.D