Nobilis® MG 6/85

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.

FOR ANIMAL USE ONLY

NOBILIS® MG 6/85
Reg. No. G2598 (Act 36/1947)
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 107,0 CFU1 per dose of live Mycoplasma gallisepticum strain Intervet 6/85 in stabiliser.

1. Colony forming units.

STORAGE

  • Store in the dark between 2 °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.
  • 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 °C to 25 °C) 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.

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.

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.

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 stopper and sealed with an orange aluminium tear-off cap. Each vial contains 1 000 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  

SLEGS VIR DIEREGEBRUIK

NOBILIS® MG 6/85
Reg. Nr. G2598 (Wet 36/1947)
Namibië Reg. Nr. V05/24.3/191 NS0

INDIKASIES
’n Lewende, verswakte entstof vir die immunisering van gesonde hoenders (teel- en lêhoenders) via die sproei- of oogdruppelmetode vir beskerming teen die kliniese tekens wat met Mycoplasma gallisepticum (Mg) infeksie gepaard gaan.

SAMESTELLING
Nobilis® MG 6/85 bevat die lewende, verswakte gevriesdroogde stam 6/85 van Mycoplasma gallisepticum. Die inhoud van elke flessie word gevriesdroog en vakuumverpak.
Elke flessie bevat ten minste 107,0 CFU1 per dosis van lewende Mycoplasma gallisepticum stam Intervet 6/85 in stabiliseerder.
1. Kolonievormende eenhede.

BERGING

  • Berg in die donker tussen 2 ºC en 8 ºC.
  • Moenie vries nie.
  • Vermy langdurige en herhaalde blootstelling aan hoë omgewingstemperature nadat die entstof uit die yskas gehaal is voor gebruik.
  • Beskerm teen blootstelling aan direkte sonlig.
  • Moenie gebruik na vervaldatum wat op die etiket verskyn nie.

WAARSKUWINGS

  • Onttrekkingperiode: Moenie binne 21 dae voor slagting inent nie.
  • Moenie Nobilis® MG 6/85 binne 4 weke voor die begin van eierproduksie of nadat eierproduksie begin het, toedien nie.
  • Nobilis® MG 6/85 mag nie binne 2 weke vandat enige Newcastlesiekte, aansteeklike brongitis- of larynotrageïtisentstof toegedien is, toegedien word nie.
  • Hoenders moenie met antibakteriële medisyne, soos chloortetrasikliene, oksitetrasikliene en sulfoonamiedes behandel word 5 dae voor of na inenting nie.
  • Voorsorg moet getref word om spanningstoestande tydens die inenting en gedurende die reaksietyd te verminder.
  • Nobilis® MG 6/85 moenie gemors, gespat of met enige ander bymiddel of entstof gemeng word nie.
  • Nobilis® MG 6/85 moenie verdun of op enige ander manier gepoog word om die dosis te rek nie.
  • Nobilis® MG 6/85 bevat geen preserveermiddels nie.
  • Moenie gedeeltelik gebruikte houers vir latere gebruik bêre nie en die totale inhoud moet, nadat dit oopgemaak is, en/of hersaamgestel is, gebruik word.
  • Vernietig enige ongebruikte entstof, leë entstofhouers en entstoftoerusting in ooreenstemming met plaaslike afvalbestuursregulasies.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

VOORSORGMAATREËLS

  • Slegs gesonde hoenders mag ingeënt word.
  • Alle vatbare hoenders op dieselfde perseel moet gelyktydig ingeënt word.
  • Aseptiese voorsorgmaatreëls moet nagekom word. Daar moet verseker word dat al die inentingstoerusting (naalde, spuite, ens.) skoon en steriel is voor gebruik.
  • Moenie met ontsmettingsmiddels of spiritus besoedel word nie.
  • Ontsmettingsmiddels en afgeroomde melk mag nie in die sproeitoerusting gebruik word nie.
  • Dit is goeie inentingsgebruik, om kontak met die oë, hande, vel en klere te vermy wanneer die entstof hanteer word. ‘n Masker en oogbeskerming moet deur die operateurs gebruik word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

  • Nobilis® MG 6/85 word aanbeveel vir die inenting van gesonde hoenders van 6 weke oud en ouer.
  • Die gevriesdroogde pilletjie moet in skoon, koel, chloorvrye, verkieslik gedistilleerde water, opgelos word. Laat dit toe om kamertemperatuur (20 ºC tot 25 ºC) te bereik, voor gebruik.

INENTINGSPROGRAM
Baie faktore moet in aanmerking geneem word om ‘n gesonde inentingsprogram vir ‘n spesifieke plaas of hoenderkompleks te bepaal. Om ten volle effektief te wees moet die entstof toegedien word aan gesonde, vatbare hoenders wat in ‘n goeie omgewing onder goeie bestuur aangehou word. Daarbenewens sal die resultate beïnvloed word deur die ouderdom van die hoenders en hulle immuunstatus. Die vlak van immuniteit benodig sal wissel met die operasionele praktyke en die graad van blootstelling. ‘n Program vir periodieke herinenting mag nodig wees.

DIE VOORBEREIDING VAN DIE ENTSTOF VIR FYNSPROEI GEBRUIK
Moenie die entstof oopmaak of meng voordat daar nie gereed is om met inenting te begin nie. Die entstof moet onmiddellik nadat dit gemeng is toegedien word.

SPROEITOEDIENING
Vir hoenders 6 weke oud of ouer.

Voorbereiding van die entstof

  1. Nadat die entstof in water opgelos is, moet dit binne 2 ure gebruik word.
  2. Gebruik skoon, koel, chloorvrye water, verkieslik gedistilleerde water.
  3. Maak die bottel onder die water oop.
  4. Verwyder die afskeurbare aluminiumdoppie en rubberproppie van die entstofflessie.
  5. Voeg water in die entstofflessie totdat die flessie ongeveer twee-derdes vol is.
  6. Plaas die rubberproppie terug en skud matig tot alles opgelos is.
  7. Die entstof is nou gereed vir die sproei in ooreenstemming met aanwysings soos hieronder genoem. Vir die beste resultate, moet die aanwysings noukeurig nagekom word.

Fyn sproeitoediening

  1. Sproei-inenting behoort ‘n fyn sproei van 20 mikron of minder te wees.
  2. Moenie ontsmettingsmiddels of afgeroomde melk in die sproeiers gebruik nie.
  3. Gebruik spuit net vir die toediening van entstowwe. Maak deeglik skoon na gebruik.
  4. Alle waaiers moet afgeskakel word tydens die toediening van die entstof. Maak ook alle luggate toe. Die waaiers moet onmiddellik weer na besproeiing aangeskakel word. Wees versigtig in warm weer.
  5. Sproei hoenders deur stadig deur die hoenderhok te loop.
  6. Volg die aanbevelings van die sproeier se vervaardiger ten opsigte van die volume water.
  7. Gebruik slegs skoon, koel, chloorvrye, verkieslik gedistilleerde water.
  8. Persoon(e) moet ‘n masker met skermbril dra tydens die sproei van die hoenders.

OOGDRUPPELTOEDIENING
Vir hoenders 6 weke oud of ouer.

Voorbereiding van die entstof
Die enstof moet binne 2 ure nadat dit in die oplosmiddel opgelos is, gebruik word.

  1. Maak die entstof en die Diluent Oculo Nasal flessie oop.
  2. Verbind hulle, met behulp van die plastiek verbindingsbuis.
  3. Skud die verbinde flessies totdat die entstof oplos is.
  4. Verwyder die klein flessie en dra die vloeistof oor na die plastiekflessie en plaas die drupper op.

Toediening van die oogdruppels

  1. Plaas 1 druppel in ‘n oog van elke hoender.
  2. Hou die drupperbottel omgekeer, in ‘n vertikale posisie om die korekte druppelgrootte te verseker en die verlies van die entstof te vermy.

AANBIEDING
Nobilis® MG 6/85 is gevul in glasflessies wat met grys rubberproppies toegemaak word en met oranje afskeurbare aluminiumdoppies verseël is. Elke flessie bevat 1 000 dosisse in ‘n gevriesdroogde vorm. Daar is 10 flessies in ‘n kartonhouer.

REGISTRASIEHOUER 
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          

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

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
11 May 2015

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