Nobilis® ND Clone 30

A live freeze-dried vaccine to prevent Newcastle Disease in chickens. It is administered via coarse spray or eye drop method.

FOR ANIMAL USE ONLY

NOBILIS® ND CLONE 30
Reg. No. G2466 (Act 36/1947)
Namibia Reg. No. V98/24.3/672 NS0

Newcastle disease is a notifiable disease in terms of the Animal Diseases Act (Act35/1984). The occurrence of suspicion of this disease has to be reported to the responsible state Veterinarian.

INDICATIONS
A live freeze-dried vaccine to prevent Newcastle Disease in chickens. It is administered via coarse spray or eye drop method.

COMPOSITION
Nobilis® ND Clone 30 contains a live freeze-dried vaccine virus strain Clone 30.

CONTENTS
Each dose contains at least 106 EID50 of the Newcastle Disease vaccine virus strain Clone 30. The vaccine pellet contains stabilisers and gentamycin.

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 direct sunlight.

WARNINGS

  • Withdrawal period: Do not vaccinate within 21 days of slaughter.
  • Do not administer the vaccine simultaneously with or within 7 days after the vaccination with any other live vaccine.
  • It is advisable to vaccinate all the susceptible chickens on the farm at the same time.
  • If this is not feasible, strict separation of vaccinated and non-vaccinated chickens should be done to prevent the spread of the vaccine virus to the non-vaccinated chickens.
  • Protect the reconstituted vaccine from direct sunlight.
  • Do not mix Nobilis® ND Clone 30 with other vaccines.
  • Wash and disinfect hands and equipment after vaccinating.
  • Use according to the number of doses as indicated on the label.
  • Do not store partially used vaccine containers for future use.
  • Dispose of any unused, reconstituted vaccine, empty vaccine containers and vaccination equipment according to 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.
  • If the spray method is used for the administration of the vaccine, ensure that there is no chlorine, iron or disinfectants in the water.
  • If the spray method is used ensure that the spray apparatus is free from sediments, corrosion and traces of disinfectants.
  • Each vial should be used immediately after opening.
  • It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

ADMINISTRATION
The vaccine may be administered by coarse spray or eye drop installation. (For eye drop application, the Intervet Diluent Oculo-Nasal may be used.)

Spray Method

  • Nobilis® ND Clone 30 should be dissolved in cool, clean, non-chlorinated water which is free from iron and chlorine.
  • The freeze-dried vaccine vials should be opened under water.
  • The spray apparatus should be free from sediments, corrosion and traces of disinfectants (preferably to be used for vaccination purposes only).
  • The vaccine medicated water should be spread evenly over the correct number of chickens, at a distance of 30 to 40 cm, preferably when the chickens are sitting together in dim light.
  • Dissolve 1 000 doses in 1 ℓ of water and set the nozzle to produce fine droplets falling like fine rain. (Aerosol generators should be used only when this is known to be safe in chickens).

Eye Drop Application

  • Dissolve the vaccine in physiological saline solution or the Intervet Diluent Oculo-Nasal may be used.
  • Administer by means of a standardised dropper (usually 30 mℓ per 1 000 doses).
  • A single drop should be applied from a height of a few centimetres onto 1 eye. The eye drop should be allowed to spread across the surface of the eye.
  • The diluent contains a dye (patent blue) which allows an easy check on the correct vaccination.
  • Do not release the chickens until a swallowing motion is noticed.

VACCINATION PROGRAMME
The optimum time and method of administration depends largely upon the local situation. Therefore, the advice of a veterinary surgeon should be sought. The vaccine is safe to use from day 1 of age onwards.

IMMUNITY AND VACCINATION REACTION
Duration and intensity of the vaccination reaction and the establishment of a solid immunity are generally dependent on the health and condition of the chickens. Hygiene and management are also important in the post vaccination period.
An adequate immunity against Newcastle Disease will last for approximately 6 weeks. In areas where Newcastle Disease is endemic (high risk areas) a secondvaccination with Nobilis® ND Clone 30 should be given within approximately 2 to 4 weeks after the first. Consult your veterinarian. Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.

PRESENTATION
Vials containing 1 000, 2 500 or 5 000 doses packed in cardboard boxes containing 1, 2 or 10 vials.

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
26 February 1998

Zimbabwe Reg. No. E94/80.23.10/9363 Veterinary Classification: 802310 Distribution Category: V.M.G.D

SLEGS VIR DIEREGEBRUIK
NOBILIS® ND CLONE 30
Reg. Nr. G2466 (Wet 36/1947)
Namibië Reg. Nr. V98/24.3/672 NS0

INDIKASIES
‘n Lewende, gevriesdroogde entstof wat aangedui word vir die inenting van hoenders teen Newcastlesiekte. Dit word deur growwe sproei- of oogdruppelmetode toegedien.

SAMESTELLING
Nobilis® ND Clone 30 bevat ‘n gevriesdroogde entstofvirusstam Clone 30.

INHOUD
Elke dosis bevat ten minste 106 EID50 van die Newcastlesiekte entstofvirusstam Clone 30. Die entstofpilletjie bevat stabiliseerders en gentamisien.

BERGING

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

WAARSKUWINGS

  • Onttrekkingsperiode: Moenie binne 21 dae voor slagting inent nie.
  • Die entstof moet nie gelyktydig met, of binne 7 dae na inenting met enige ander lewendige entstowwe toegedien word nie.
  • Dit word aanbeveel dat alle hoenders op die plaas terselfdertyd ingeënt word.
  • As dit nie moontlik is nie, moet die ingeënte hoenders streng apart gehou word van die nie-ingeënte hoenders. Sodoende sal die verspreiding van die entstofvirus na die nie-ingeënte hoenders verhoed word.
  • Beskerm hersaamgestelde entstof teen direkte sonlig.
  • Moenie Nobilis® ND Clone 30 met ander entstowwe meng nie.
  • Was en ontsmet die hande en toerusting na inenting.
  • Gebruik volgens die aantal dosisse soos op die etiket aangedui.
  • Gedeeltelike gebruikte entstofhouers moet nie vir toekomstige gebruik bewaar word nie.
  • Vernietig alle leë enstofhouers, ongebruikte produk asook weggooibare inentingstoestelle in ooreenstemming met plaaslike afvalbestuursregulasies.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof 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.
  • As die sproeimetode gebruik word vir die toediening van die entstof, moet seker gemaak word dat daar geen chloor, yster of ontsmettingsmiddels in die water is nie.
  • As die sproei metode gebruik word, moet seker gemaak word dat die sproeitoestel vry is van afsaksels, roes en spore van ontsmettingsmiddels.
  • Elke flessie moet onmiddellik nadat dit oopgemaak is, gebruik word.
  • Dit is goeie inentingspraktyk om kontak met die oë, hande en klere te vermy wanneer die entstof hanteer word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

TOEDIENING
Die entstof mag deur sproei- of oogdruppelaanwending toegedien word. (Vir oogdruppeltoediening mag die Intervet Diluent Oculo-Nasal as oplosmiddel gebruik word.)

Sproeimetode

  • Nobilis® ND Clone 30 moet in koel, skoon, nie-gechlorineerde water wat vry van yster en chloor is, opgelos word.
  • Die gevriesdroogde entstofflessies moet onder die water oopgemaak word.
  • Die sproeitoerusting moet vry wees van afsaksels, roes en spore van ontsmettingsmiddels (verkieslik moet dit alleenlik vir inentingsdoeleindes gebruik word).
  • Die entstofbehandelde water moet eweredig oor die korrekte aantal hoenders, teen ‘n afstand van 30 tot 40 cm gespuit word. Die hoenders moet verkieslik in dowwe lig bymekaar sit.
  • Los 1 000 dosisse in 1 ℓ water op en stel die sproeikop om fyn druppeltjies, wat soos fyn reën sal val, te gee. (Aërosolgenereerders moet alleenlik gebruik word as dit bekend is dat dit veilig vir die hoenders is.)

Oogdruppeltoediening

  • Los die entstof in fisiologiese soutoplossing op, of die Intervet Diluent Oculo-Nasal oplosmiddel mag gebruik word.
  • Toediening deur middel van ‘n gestandaariseerde drupper (gewoonlik 30 mℓ per 1 000 dosisse).
  • ‘n Enklele druppel moet op ‘n hoogte van ‘n paar sentimeter op 1 oog toegedien word. Die oogdruppel moet toegelaat word om oor die hele oppervlakte van die oog te versprei.
  • Die oplosmiddel bevat ‘n kleurstof (patent blue) wat die kontrolering van korrekte inenting vergemaklik.
  • Moenie die hoender loslaat voordat daar nie ‘n slukbeweging waargeneem is nie.

INENTINGSPROGRAM
Die optimale tyd en metode van toediening hang grootliks af van die plaaslike toestande. Dit is dus nodig om die advies van ‘n veearts te bekom. Die entstof is veilig vir gebruik vanaf 1 dag oud en ouer.

IMMUNITEIT EN INENTINGSREAKSIE
Die duur en intensiteit van die inentingsreaksie, asook die vestiging van ‘n vaste immuniteit, hang af van die immuniteit verkry van die algemene gesondheid en kondisie van die hoenders. Higiëne en bestuur in die na-inentingsperiode is ook belangrik.
‘n Bevredigende immuniteit teen Newcastle siekte sal vir ongeveer 6 weke hou. In omgewings waar Newcastle siekte endemies is (hoë risiko areas), behoort ‘n tweede inenting met Nobilis® ND Clone 30 binne ongeveer 2 tot 4 weke na die eerste inenting gegee te word. Raadpleeg ‘n veearts. Noodinenting gedurende die lê-periode mag met ‘n verbygaande vermindering in eierproduksie gepaard gaan.

AANBIEDING
Flessies wat onderskeidelik 1 000, 2 500 of 5 000 dosisse bevat en in kartonhouers met 1, 2 of 10 flessies verpak.

REGISTRASIEHOUER 
Intervet South Africa (Pty) Ltd.
Spartanweg 20, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Faks: +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

26 Februarie 1998

Zimbabwe Reg. No. E94/80.23.10/9363 Veterinary Classification: 802310 Distribution Category: V.M.G.D