Nobilis® MG 6/85

FOR ANIMAL USE ONLY

NOBILIS^® MG 6/85
Reg. No. G2598 (Act 36/1947)
Ethiopia INT/NET/006
Namibia Reg. No. V05/24.3/191 NS0

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
The vaccine contains the live, attenuated, freeze-dried strain 6/85 of Mycoplasma gallisepticum. The content of each vial is lyophilised and vacuum packed.
Each vial contains at least 10^7,0 CFU¹ per dose of live Mycoplasma gallisepticum strain Intervet 6/85 in stabiliser.
1. Colony forming units.

STORAGE

• Store in the dark between 2 ºC and 8 ºC.
• 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 expiry date stated on the label.

WARNINGS

• Withdrawal period: Do not vaccinate within 21 days before slaughter.
• 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 vaccination.
• 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 the vaccine or otherwise stretch the dosage.
• Nobilis^® MG 6/85 does not contain any preservatives.
• Do not store partially used containers for future use, and use entire contents once opened and/or reconstituted.
• Destroy any unused vaccine, empty vaccine containers and vaccination equipment in accordance with local waste disposal regulations.
• 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

• Vaccinate healthy chickens only.
• All susceptible chickens on the same premises should be vaccinated at the same time.
• Observe aseptic precautions. Ensure that vaccination equipment (needles, syringes, etc.) is clean and sterile before use.
• Do not contaminate with disinfectant or spirits.
• Do not use any disinfectants or skimmed milk in the spray apparatus.
• 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.

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. Allow it to reach room temperature (20 ºC to
  25 ºC) before use.

VACCINATION PROGRAMME
Many factors must be considered in 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 program of periodic revaccination may be necessary.

PREPARATION OF VACCINE FOR FINE SPRAY USE

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

1.    SPRAY ADMINISTRATION
For chickens 6 weeks of age or older.

Preparation of vaccine

1. After dissolving the vaccine in water it has to be used within 2 hours.
2. Use clean, cool, non-chlorinated water, preferably distilled.
3. Open the vaccine vial under water by removing the tear-off seal and stopper from the vial.
4. Allow water to fill the vaccine vial.
5. Replace the rubber stopper and shake moderately until all material is dissolved and add this mixture back to the water.
6. 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 of fine spray of less than 20 microns.
2. Do not use any disinfectants or skimmed milk in 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.
7. Use only clean, cool, non-chlorinated water, preferably distilled.
8. Individual(s) spraying chickens should wear face mask and goggles.

2.    EYE DROP ADMINISTRATION
For chickens 6 weeks of age or older.

Preparation of vaccine
After dissolving the vaccine in solvent it has to be used within 2 hours.

1. Open the vaccine and the Diluent Oculo-Nasal vial.
2. Connect them, 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(s) and affix the dropper.

Administrationof the eye drops

1. Instil 1 drop into an eye of each bird. Allow the drop to spread across the surface of the eye. Do not release the chicken until a swallowing motion is noticed.
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 stopper and sealed with an orange aluminium tear-off cap. Each vial contains 1 000 or 2 000 doses in a freeze-dried form. There are 10 vials in a cardboard box.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International B.V.
35 Wim de Körverstraat
Boxmeer, The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 May 2015

Zimbabwe Reg. No. E98/80.23.17/9476
Pharmacological classification: 802317
Distribution category: VMGD