Nobilis® IB MA5

Nobilis® IB Ma5 is a live attenuated vaccine to prevent Infectious Bronchitis (Massachusetts type) in chickens (via eye drop application or spray administration).

FOR ANIMAL USE ONLY

NOBILIS® IB Ma5
Reg. No. G2300 (Act 36/1947)
Namibia Reg. No. V97/24.3/822 NS0

INDICATIONS
Nobilis® IB Ma5 is a live attenuated vaccine to prevent Infectious Bronchitis (Massachusetts type) in chickens (via eye drop application or spray administration).

COMPOSITION
Each dose of freeze-dried Nobilis® IB Ma5 contains at least 103,5 EID50 Infectious Bronchitis virus strain Ma5 (serotype Massachusetts). The vaccine pellet contains stabilisers and gentamycin.

STORAGE

  • Store in the dark between 2 °C and 8 °C.
  • Do not freeze.
  • Avoid prolonged or repetitive exposure to high ambient temperatures.
  • Protect from exposure to direct sunlight.
  • The diluent may be stored at room temperature between 20 °C and 25 °C.

WARNINGS

  • Withdrawal period: Do not vaccinate within 21 days of slaughter.
  • 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 unvaccinated chickens should be done to prevent the spread of the vaccine virus to the unvaccinated chickens.
  • Do not mix Nobilis® IB Ma5 with other vaccines.
  • Do not administer simultaneously with other live vaccines.
  • Do not open and reconstitute until ready to start vaccination.
  • Use the vaccine immediately after reconstitution.
  • Use according to the number of doses as indicated on the label.
  • The vaccine is safe for use from day 1 of age onwards. After the first vaccination an adequate immunity against Massachusetts type IB will last approximately 6 weeks, provided the vaccine is properly administered.
  • Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.
  • Do not store partially used containers for future use.
  • Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc. 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 iron, chlorine or disinfectants in the water.
  • The spray apparatus should be free from sediments, corrosion and traces of disinfectants. It should preferably be used for vaccination purposes only.
  • Avoid contamination with traces of disinfectant and/or spirits.
  • Wash and disinfect hands and equipment after vaccination.
  • 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

Spray Method

  1. The vaccine should be dissolved in distilled water. The vial of freeze-dried vaccine should be opened under water. The spray apparatus should be free from sediments, corrosion and traces of disinfectants (it should preferably be used for vaccination purposes only).
  2. 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.
  3. For 1-day-old chicks use 0,25 ℓ of water per 1 000 birds and set nozzle to produce fine droplets, falling like a fine rain. For older chickens, dissolve 1 000 doses/ℓ of water and set the nozzle to produce fine droplets (Aerosol generators should be used only when this is known to be safe to chickens).

Eye Drop Application

  • Dissolve the vaccine in Intervet Diluent Oculo Nasal and administer by means of a standardised dropper (usually 30 mℓ per 1 000 doses). One drop should be applied from a height of a few centimetres onto 1 eye. As an eye drop application, the drop should be allowed to spread evenly across the surface of the eye.
  • Do not release the chicken until a swallowing motion is noticed.
  • For numbers of birds between standard dosages, the next high dosage should be chosen.

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

Guidelines
Broilers: Vaccination at day old by coarse spray or eye drop route.
Layers and Breeders: Vaccination at day old by coarse spray or eye drop route.
Revaccination: At approximately 6 weeks of age by coarse spray or the eye drop methods.

Immunity and Vaccination Reaction
The 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.
After a first vaccination an adequate immunity against Massachusetts type of IB will last for approximately 6 weeks, provided that the vaccine is properly administered. Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.

PRESENTATION

10 Vials with each vial containing 1 000, 2 500 or 5 000 doses, packed 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

12 December 2014

Zimbabwe Reg. No. 2015/80.23.17/9724 Pharmacological classification: 802317 Distribution category: VMGD

SLEGS VIR DIEREGEBRUIK

NOBILIS® IB Ma5

Reg. Nr. G2300 (Wet 36/1947)
Namibië Reg. Nr. V97/24.3/822 NS0

INDIKASIES
Nobilis® IB Ma5 is ‘n lewende verswakte entstof om Aansteeklike Brongitis (Massachusetts tipe) in hoenders te voorkom (via oogdruppelmetode of sproeitoediening).

SAMESTELLING
Elke dosis Nobilis® IB Ma5 bevat ten minste 103,5 EID50 Aansteeklike Brongitis virus stam Ma5 (serotipe Massachusetts). 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 temperature.
  • Beskerm teen blootstelling aan direkte sonlig.
  • Die oplosmiddel mag teen kamertemperatuur tussen 20 ºC en 25 ºC geberg word.

WAARSKUWINGS

  • Onttrekkingsperiode: Moenie binne 21 dae voor slagting inent nie.
  • Dit word aanbeveel dat al die vatbare hoenders op die plaas gelyktydig ingeënt word. As dit nie moontlik is nie, moet die ingeënte en die nie-ingeënte hoenders streng apart gehou word om te verhoed dat die entstofvirus na die nie-geënte hoenders versprei.
  • Moenie oopmaak en hersaamstel voordat daar gereed is om met die inenting te begin nie.
  • Gebruik die entstof onmiddellik na hersamestelling.
  • Moenie Nobilis® IB Ma5 met ander entstowwe meng nie.
  • Moenie gelyktydig, of binne 7 dae na inenting, met ander lewende entstowwe toedien nie.
  • Gebruik volgens die aantal dosisse soos op die etiket aangedui.
  • Die entstof is veilig vir gebruik vanaf ’n ouderdom van 1-dag-oud en ouer. Na die eerste inenting sal ’n bevredigende immuniteit teen Massachusetts tipe Aansteeklike Brongitis vir ongeveer 6 weke verkry word, mits die entstof korrek toegedien was.
  • Nood-inenting gedurende die lê-periode mag gepaard gaan met ’n verbygaande afname in eierproduksie.
  • Moenie gedeeltelike gebruikte houers berg vir latere gebruik nie.
  • Vernietig alle ongebruikte, hersaamgestelde entstof, leë entstofhouers, naalde, ens., in ooreenkoms met plaaslike afval bestuursregulasies.
  • 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, moet gedistilleerde water gebruik word.
  • Die sproeitoerusting moet vry van afsaksels, roes en spore van ontsmettingsmiddels wees. Dit moet verkieslik vir inentingsdoeleindes alleenlik gebruik word.
  • Vermy besmetting met spore van ontsmettingsmiddels en/of spiritus.
  • Was en ontsmet hande en toerusting na inenting.
  • Dit is goeie inentingspraktyk wanneer entstowwe hanteer word om kontak met die oë, hande en klere te vermy.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Sproeimetode

  1. Die entstof moet in gedistilleerde water opgelos word. Die flessie met gevriesdroogde entstof moet onder water oopgemaak word. Die sproeitoerusting moet vry van afsaksels, roes en spore van ontsmettingsmiddels wees (dit moet verkieslik vir inentingsdoeleindes alleenlik gebruik word).
  2. Die entstofbehandelde water moet eweredig oor die korrekte aantal hoenders, teen ’n afstand van 30 tot 40 cm gespuit word, verkieslik wanneer die hoenders in dowwe lig bymekaar sit.
  3. Vir 1-dag-oue kuikens gebruik 0,25 ℓ water per 1 000 kuikens en stel die sproeikop om fyn druppeltjies, wat soos fyn reën val, te gee. Vir ouer hoenders los 1 000 dosisse/ℓ water op en stel die sproeikop om fyn druppels te gee (Aerosol genereerders moet alleenlik gebruik word as dit bekend is dat dit veilig is vir hoenders).

Oogdruppeltoediening

  • Die entstof word in Intervet Diluent Oculo Nasal opgelos en deur middel van ’n gestandaardiseerde drupper (gewoonlik 30 mℓ per 1 000 dosisse) toegedien. Een druppel moet op ’n hoogte van ’n paar sentimeter op 1 oog aangewend word. As ’n oogdruppel toegedien word, moet die druppel toegelaat word om oor die hele oppervlakte van die oog te sprei.
  • Die hoender moet nie losgelaat word voordat daar nie ’n slukbeweging waargeneem is nie.
  • Vir ’n aantal hoenders tussen standaard dosisse, moet die volgende hoër dosis gekies word.

INENTINGSPROGRAM
Die optimale tyd en metode van toediening sal grootliks afhang van die plaaslike toestande. Die advies van ’n veearts moet verkry word. Die entstof is veilig vanaf ’n ouderdom van 1-dag-oud en ouer.

Riglyne
Braaihoenders: Inenting op 1-dag-oud d.m.v. growwesproei of oogdruppeltoediening.
Lê- en teelhoenders: Inenting op 1-dag-oud d.m.v. growwesproei of oogdruppeltoediening.
Herinenting: Teen ’n ouderdom van ongeveer 6 weke deur growwesproei of oogdruppeltoediening.

Immuniteit en Inentingsreaksie
Die duur en intensiteit van die inentingsreaksie en die vestiging van ’n sterk immuniteit, is oor die algemeen afhanklik van die gesondheid en toestand van die hoenders. Higiëne en bestuur is ook belangrik in die na-inentingsperiode.
Na die eerste inenting sal ’n bevredigende immuniteit teen Massachusetts tipe van Aansteeklike Brongitis (IB) verkry word, mits die entstof korrek toegedien was.
Nood-inenting gedurende die lê-periode mag gepaard gaan met ’n verbygaande afname in eierproduksie.

AANBIEDING
10 Flessies, elk bevattende 1 000, 2 500 of 5 000 dosisse, verpak in ’n kartonhouer.

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
12 Desember 2014

Zimbabwe Reg. No. 2015/80.23.17/9724 Pharmacological classification: 802317 Distribution category: VMGD