FOR ANIMAL USE ONLY

NOBILIS^® MG 6/85

Reg. No. G2598 (Act 36/1947)

Namibia Reg. No. V05/24.3/191 [NS0]

NAFDAC Reg. No. A6-100085, A6-100086

INDICATIONS

A live, attenuated vaccine for the immunisation of healthy chickens (breeders & layers) via the spray method or eye drop administration for the protection against clinical signs associated by Mycoplasma gallisepticum (MG) infection.

COMPOSITION

Nobilis^® MG 6/85 contains the live, attenuated, freeze-dried strain Intervet 6/85 of Mycoplasma gallisepticum. The content of each vial is lyophilised and vacuum packed.

Each vial contains at least 10^6.9 CFU¹ per dose of live Mycoplasma gallisepticum strain Intervet 6/85 in a stabiliser.

¹ Colony forming units.

STORAGE INSTRUCTIONS

• Store between 2 °C and 8 °C in a refrigerator.
• 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.
• Do not use after the expiry date stated on the label.
• Shelf-life after reconstitution: 2 hours.

WARNINGS

• Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
• Vaccinate healthy chickens only.
• Do not administer Nobilis^® MG 6/85 within 4 weeks prior to the onset of production or after egg production has begun.
• Nobilis^® MG 6/85 should not be administered within 2 weeks of any live Newcastle disease, infectious bronchitis or laryngotracheitis vaccine.
• Do not medicate chickens with antibacterial drugs, especially chlortetracycline, oxytetracycline and sulphonamides, 5 days prior to, or after vaccination.
• Efforts should be taken to reduce stress conditions at the time of vaccination and during the reaction period.
• Do not spill, splash or mix Nobilis^® MG 6/85 with any substance or other vaccines.
• Do not dilute Nobilis^® MG 6/85 or otherwise stretch the dosage.
• Nobilis^® MG 6/85 does not contain any preservatives.
• 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

• All susceptible chickens on the same premises should be vaccinated at the same time.
• 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.
• Do not use any disinfectants or skimmed milk in the spray apparatus.
• Do not store partially used containers for future use and use entire contents once opened and/or reconstituted.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands, skin and clothing. A mask and eye protection should be used by the operators.
• 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).

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Nobilis^® MG 6/85 is recommended for the vaccination of healthy chickens 6 weeks of age or older.
• Dissolve the freeze-dried pellet in clean, cool, non-chlorinated water, preferably distilled or in the solvent. Allow it to reach room temperature (20 °C to 25 °C) before use.

VACCINATION PROGRAMME

Many factors must be considered when determining a sound vaccination programme for a particular farm or poultry complex. To be fully effective, the vaccine must be administered properly to healthy, receptive chickens maintained in a proper environment under good management. In addition, the response will be influenced by the age of the chickens and their immune status. The level of immunity required will vary with operational practices and the degree of exposure. A programme of periodic revaccination may be necessary.

Do not open and mix the vaccine until ready to begin vaccination. Use the vaccine immediately after mixing.

1. SPRAY ADMINISTRATION

For chickens 6 weeks of age or older.

After dissolving the vaccine in water, use within 2 hours.

Preparation of vaccine

1. Use clean, cool, non-chlorinated water, preferably distilled.
2. Open the vaccine vial under water by removing the tear-off seal and stopper from the vial.
3. Allow water to fill the vaccine vial until the vial is approximately two-thirds full.
4. Replace the rubber stopper and shake moderately until all material is dissolved and add this mixture back to the water.
5. The vaccine is now ready for spray use in accordance with directions below. For best results, be sure to follow directions carefully.

Administration of fine spray

1. Spray vaccination should be a fine spray of less than 20 microns.
2. Do not use any disinfectants or skimmed milk in the sprayer.
3. Use sprayer only for administration of vaccines. Clean thoroughly after use.
4. Shut off all fans while spray vaccinating. Also, close air-inlets. Turn on fans immediately after spraying. Be careful in hot weather.
5. Spray chickens by walking slowly through the house.
6. Follow the recommendations of the manufacturer of the sprayer regarding water volume.

• EYE DROP ADMINISTRATION

For chickens 6 weeks of age or older.

After dissolving the vaccine in solvent, use within 2 hours.

Preparation of vaccine

1. Open the vaccine and the Diluent Oculo-Nasal vial.
2. Connect the vials, using the plastic connector tube.
3. Shake the connected vials until the vaccine is dissolved.
4. Remove the small vial, transfer the liquid into the plastic vial and affix the dropper.

Administration of the eye drops

1. Instil 1 drop into an eye of each chicken.
2. Keep the dropper bottle inverted, in a vertical position, to assure correct droplet size and to avoid loss of vaccine.

PRESENTATION

Nobilis^® MG 6/85 is filled into glass vials and closed with grey rubber stoppers and sealed with orange aluminium tear-off caps. Each vial contains 1 000 or 2 000 doses in a freeze-dried form and are packed as a single vial in a carton box.

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 May 2015