NOBILIS® RT+IB MULTI+G+ND

FOR ANIMAL USE ONLY

NOBILIS® RT+IB MULTI+G+ND

Reg. No. G4428 (Act 36/1947)

Emulsion for Injection

Newcastle disease is a controlled disease in terms of the Animal Diseases Act

(Act 35/1984). The occurrence or suspicion of this disease must be reported to the responsible state veterinarian immediately.

INDICATIONS

Active immunisation of future breeder and layer chickens for:

  • Reduction of infection and prevention of egg drop caused by the Massachusetts M41 serotype of Infectious Bronchitis virus;
  • reduction of egg drop and eggshell defects caused by the serotype 249G (D274/D207) of Infectious Bronchitis virus (IBV);
  • reduction of infection caused by Newcastle Disease virus (NDV);
  • prevention of respiratory signs and reduction of egg drop, and eggshell defects related to Avian Rhinotracheitis virus (ART);
  • passive immunisation of the progeny of the vaccinated birds against Infectious Bursal Disease (IBDV) for at least the first 4 weeks of life.

IMMUNITY

For Infectious Bronchitis, Newcastle and Avian Rhinotracheitis virus:

Onset of immunity: 4 weeks after vaccination.

Duration of immunity: 1 laying period.

COMPOSITION

Each0,5 mℓ dose contains:

  • Inactivated ART strain BUT 1#8544: inducing ≥ 9,5 log2 ELISA units*
  • Inactivated IBV strain M41 (Massachusetts): inducing ≥ 5,5 log2 VN units*
  • Inactivated IBV strain 249G (D274/D207): inducing ≥ 4,0 log2 VN units*
  • Inactivated IBDV strain D78: inducing ≥ 14,5 log2 VN units*
  • Inactivated NDV strain Clone 30: inducing ≥ 4,0 log2 HI units per 1/50th dose*

or containing ≥ 50 PD50 units.

* Serological response in chickens

   Adjuvant: Light liquid paraffin

STORAGE INSTRUCTIONS

  • Store in the original package between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Protect from light.
  • Do not use after the expiry date which is stated on the label.
  • Once broached, use within 3 hours.

WARNINGS

  • Withdrawal period: Do not slaughter chickens for human consumption within 21 days of vaccination.
  • Vaccinate healthy chickens only.
  • Do not use during lay or within 4 weeks before the onset of the laying period.
  • Do not administer simultaneously with other veterinary medication.
  • Do not over- or under-dose the vaccine.
  • Do not inject intravenously.
  • A mild transient swelling may be observed at the injection site for 2 to 3 weeks.
  • After administration of a double dose, the reactions are not different from those observed after a single dose.
  • If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
  • In case of accidental self-injection, seek medical advice immediately and show the package insert 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 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.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • Do not use vaccination equipment with rubber parts as the excipient may damage certain types of rubber.
  • Adhere to the vaccination programme to obtain optimum results.
  • Use the entire contents of the container when first opened and do not store the vaccine for future use.
  • 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.

Special precautions to be taken by the person administering Nobilis® RT+IB Multi+G+ND to chickens

To the user

Nobilis® RT+IB Multi+G+ND contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with Nobilis® RT+IB Multi+G+ND, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician

Nobilis®  RT+IB Multi+G+ND contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

For intramuscular administration.

Advice on correct administration

  • Allow vaccine to reach ambient temperature, between 15 °C and 25 °C, before use.
  • Shake the bottle vigorously before use and periodically during use.

Dosage and administration

  • Administer one dose of 0,5 mℓ vaccine per chicken via intramuscular injection in the thigh or chest muscle.
  • Nobilis® RT+IB Multi+G+ND should be given to chickens around 14 to 20 weeks of age but not later than 4 weeks before the expected onset of lay.
  • In the event that live vaccines were used to prime chickens against Infectious Bronchitis,

Rhinotracheitis, Newcastle Disease and Infectious Bursal Disease, Nobilis® RT+IB Multi+G+ND should be given at least 4 weeks after the administration of the live vaccines.

CONTRAINDICATIONS

None.

PRESENTATION

A white to nearly white oily emulsion presented in polyethylene terephthalate (PET) vials of 250 mℓ (500 doses) or 500 mℓ (1 000 doses) closed with a nitryl rubber stopper and sealed with a colour coded aluminium cap.

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 THIS PACKAGE INSERT 11 June 2020