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).

Learn more about Infectious Bronchitis in chickens by visiting our dedicated website here.

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.

IMMUNITY

After a first vaccination an adequate immunity against the Massachusetts type of IB will

last for approximately 6 weeks provided that the vaccine is properly administered.

COMPOSITION

Each dose of Nobilis® IB Ma5 contains at least 103,0 EID50 infectious bronchitis virus strain Ma5 (serotype Massachusetts). The vaccine contains stabilisers and gentamicin.

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 to 25 °C.
  • In-use shelf life after reconstitution: 2 hours.

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.
  • Use according to the number of doses as indicated on the label.
  • Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.
  • Nobilis® IB Ma5 with any other vaccine or medication other than Nobilis® IB Primo QX (G4211) or Nobilis® IB 4-91 (G4031).
  • Do not administer simultaneously with any other live vaccines.
  • Do not open and reconstitute until ready to start vaccination.
  • Use the vaccine immediately after reconstitution.
  • Do not store partially used containers for future use.
  • Dispose of any unused vaccine, empty vaccine containers and disposable vaccination equipment according to the National Environmental Management Waste Act, 2008 (Act 59 of 2008), after vaccination.
  • KEEP OUT OF REACH OF CHILDREN, ANIMALS AND UNINFORMED PERSONS.
  • 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.
  • Observe aseptic precautions and ensure that all vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use.
  • It is good vaccination practice when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis® IB Primo QX (G4211) or Nobilis® IB 4-91 (G4031) for spray or intranasal/ocular administration from 1-day-old onwards. Read the product information of Nobilis® IB Primo QX (G4211) or Nobilis® IB 4-91 (G4031) before use.
  • If the spray application 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.
  • Do not use disinfectants and/or spirits prior to vaccination.
  • Wash and disinfect hands and equipment before and after vaccination.
  • Nobilis® IB Ma5 may be administered as a lyophilised pellet in a glass vial or as lyophilised spheres in a cup. In the case of the aluminium cup presentation, the cups must contain at least 3 spheres. Do not use Nobilis® IB Ma5 if the contents are brownish and stick to the containers as this indicates that the integrity of the container has been breached.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  1. Spray Application
  2. should be dissolved in cool, clean, non-chlorinated water which is free from iron.
  3. The vial of freeze-dried vaccine should be opened under water or the content of the cup(s) should be poured into the water. In both cases mix the water containing the vaccine well before use. After reconstitution the suspension looks clear.
  4. The spray apparatus should be free from sediments, corrosion and traces of disinfectants. It should preferably be used for vaccination purposes only.
  5. 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.
  6. For 1-day-old chicks, use 0,25 ℓ water per 1 000 chicks 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).
  • Intranasal/Eye-drop Application
  • Dissolve Nobilis® IB Ma5 in physiological saline or 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.
  • The handler should ensure that the nasal drop is inhaled by the chick and a swallowing motion is noticed before the chicken is released.
  • l, is commercially available in South Africa and should be used instead of physiological saline solution.
  • Drinking water Application
  • The vials should be opened under water or the content of the cup(s) should be poured into the water. In both cases mix the water containing the vaccine well before use. After reconstitution the suspension looks clear.
  • Nobilis® IB Ma5 should be dissolved in cool, clean water which is free of iron and chlorine.
  • Ensure uptake of all the vaccine-medicated water within 2 hours. Depending on the weather conditions, it may be advisable to deprive the birds of water prior to vaccination. It is essential to have enough water containers to provide adequate drinking space. These water containers should be clean and free from traces of detergents and disinfectants.
  • Dissolve 1 000 doses in as many litres of water as the age of the chickens in days, to a maximum of 40 ℓ.
  • The vaccine should be given in the early morning as this is the main period of drinking or the cool period on a hot day. When vaccinating larger flocks, it is advisable to start by dissolving only part of the vaccine.
  • If vaccine is administered through a central water supply or a proportioner, great care should be taken.
  • For numbers of birds between standard dosages, the next higher dosage should be chosen.

Note:   Administration by coarse spray or the intranasal/eye-drop method gives the best response. These should be the methods of choice, especially when vaccinating young chicks. The vaccine can be administered through the drinking water. The vaccine should be dissolved in an amount of water which will be consumed by the chickens within approximately 2 hours.

VACCINATION PROGRAMME

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 in chicks from 1-day-old onwards.

Guidelines

Broilers:                        Vaccination at 1-day-old by coarse spray or intranasal/eye-drop method.

Layers and Breeders:   Vaccination at 1-day-old by coarse spray or intranasal/eye-drop method.

Revaccination:              At approximately 6 weeks of age by coarse spray, intranasal/eye-drop or drinking water administration.

Instructions on reconstitution when Nobilis® IB Ma5 is used together with Nobilis® IB Primo QX or Nobilis® IB 4-91:

  • Reconstitution and subsequent application of both lyophilisates are to be followed as outlined above for spray and intranasal/eye-drop administration.
  • The same volumes of water (spray administration) or Intervet Diluent Oculo-Nasal (intranasal/eye-drop administration) should be used as required for the single product.
  • The vaccines should be reconstituted individually into water (spray administration) or into Intervet Diluent Oculo-Nasal (intranasal/eye-drop administration) and subsequently mixed together before use.
  • Do not open and reconstitute until ready to start vaccination.
  • Each vial or cup should be used immediately after opening.
  • Use the vaccine within 2 hours after reconstitution.

Note: Do not use Nobilis® IB Ma5 simultaneouslytogether with Nobilis® IB Primo QX (G4211) and Nobilis® IB 4-91 (G4031). Nobilis® IB Ma5 can be used with either Nobilis® IB Primo QX (G4211) or Nobilis® IB 4-91 (G4031).

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 to minimise vaccine reaction.

Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.

PRESENTATION

Containers with 10 vials of hydrolytic glass Type I, which contains the freeze-dried pellet of

1 000, 2 500 or 5 000 doses. Closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.

Containers with 6 or 12 sealed aluminium laminate cups with a polypropylene cup and polypropylene/polyethylene lid contact layer containing 1 000, 2 500, 5 000 or 10 000 doses.

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

Fax: +27 (0) 11 392 3158

www.msd‑animal-health.co.za

MANUFACTURERS

Intervet International B.V.               Merck Sharp & Dohme

Wim de Körverstraat 35                  Animal Health S.L.

5831 AN Boxmeer                           C/Zeppelin 6,

The Netherlands                              Poligono El Montalvo,

                                                         Carbajosa de la Sagrada

                                                         Parcela 38

                                                         Salamanca, Spain

DATE OF PUBLICATION OF THIS PACKAGE INSERT

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.

IMMUNITEIT

Na ‘n eerste inenting sal ‘n voldoende immuniteit teen die Massachusetts tipe IB

duur vir ongeveer 6 weke mits die entstof behoorlik toegedien word.

SAMESTELLING

Elke dosis Nobilis® IB Ma5 bevat ten minste 103,0 EID50 aansteeklike brongitis virusstam Ma5 (serotipe Massachusetts). Die entstof bevat stabiliseerders en gentamisien.

BERGING

  • Berg in die donker tussen 2 °C en 8 °C.
  • Moenie vries nie.
  • Vermy lang en herhaalde blootstelling aan hoë omgewingstemperature.
  • Beskerm teen blootstelling aan direkte sonlig.
  • Die oplosmiddel mag teen kamertemperatuur tussen 20 °C en 25 °C geberg word.
  • In-gebruik rakleeftyd na hersamestelling: 2 ure.

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.
  • Gebruik volgens die aantal dosisse soos op die etiket aangedui.
  • Noodinenting gedurende die lê-periode mag gepaard gaan met ’n verbygaande afname in eierproduksie.
  • Moenie Nobilis® IB Ma5 met enige ander entstof of medikasie behalwe Nobilis® IB Primo QX (G4211) of Nobilis® IB 4-91 (G4031) toedien nie.
  • Moenie gelyktydig met ander lewende entstowwe toedien nie.
  • Moenie oopmaak en hersaamstel voordat daar gereed is om met die inenting te begin nie.
  • Gebruik die entstof onmiddellik na hersamestelling.
  • Moenie gedeeltelike gebruikte houers vir latere gebruik bêre nie.
  • Doen weg met enige ongebruikte entstof, leë entstofhouers en weggooibare inentingstoerusting na gebruik, in ooreenstemming met die Nasionale Wet op Afvalbestuur, 2008 (Wet No. 59 van 2008).
  • 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.
  • Neem aseptiese voorsorgmaatreëls in ag en sorg dat alle toerusting (naalde, spuite, ens.) skoon en steriel is voor gebruik.
  • Dit is goeie inentingspraktyk om kontak met die oë, hande en klere te vermy tydens die hantering van die entstof. Dra beskermende klere en handskoene.
  • Veiligheids- en effektiwiteitsdata is beskikbaar wat toon dat hierdie entstof vanaf 1-dag-oud met Nobilis® IB Primo QX (G4211) of Nobilis® IB 4-91 (G4031) gemeng en toegedien kan word. Lees die produkinligting van Nobilis® IB Primo QX (G4211) of Nobilis® IB 4-91 (G4031) voor gebruik.
  • As die sproeimetode vir die toediening van die entstof gebruik word, maak seker dat daar geen yster, chloor of ontsmettingsmiddels in die water is nie.
  • Die sproeitoerusting moet vry van afsaksels, roes en spore van ontsmettingsmiddels wees. Dit moet verkieslik vir inentingsdoeleindes alleenlik gebruik word.
  • Moenie ontsmettingsmiddels en/of spiritus gebruik voor inenting nie.
  • Was en ontsmet hande en toerusting na inenting.
  • Nobilis® IB Ma5 kan toegedien word as ‘n gevriesdroogde pilletjie in ‘n glasflessie of as gevriesdroogde sfere in ‘n koppie. In die geval van die aluminiumkoppie aanbieding, moet die koppies ten minste 3 sfere bevat. Moenie Nobilis® IB Ma5 gebruik as die inhoud bruinerig is en aan die houers vasklou nie, aangesien dit aandui dat die integriteit van die houer geskend is.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

  1. Sproeitoediening
  2. Nobilis® IB Ma5 moet opgelos word in koel, skoon, nie-gechloreerde water wat sonder yster is.
  3. Die flessie met gevriesdroogde entstof moet onder water oopgemaak word of die inhoud van die koppie(s) moet in die water gegooi word. Meng in beide gevalle die water wat die entstof bevat goed voor gebruik. Na hersamestelling lyk die oplossing helder.
  4. Die sproeitoerusting moet vry van afsaksels, roes en spore van ontsmettingsmiddels wees. Dit moet verkieslik vir inentingsdoeleindes alleenlik gebruik word.
  5. Die entstofbehandelde water moet eweredig oor die korrekte aantal hoenders, op ’n afstand van 30 tot 40 cm gespuit word, verkieslik wanneer die hoenders in dowwe lig bymekaar sit.
  6. 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).
  • Intranasale-/Oogdruppeltoediening
  • Nobilis® IB Ma5 word in fisiologiese soutoplossing of Intervet Diluent Oculo-Nasal verdunningsmiddel opgelos en deur middel van ’n gestandardiseerde 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 oogdruppeltoediening, moet die druppel toegelaat word om oor die hele oppervlakte van die oog te sprei.
  • Die hanteerder moet verseker dat die neusdruppel deur die kuiken ingeasem word en ‘n slukbeweging word opgemerk voordat die hoender vrygelaat word.
  • Intervet se oplosmiddel, Diluent Oculo-Nasal, is kommersieël beskikbaar in Suid-Afrika en moet in die plek van fisiologiese soutoplossing gebruik word.
  • Drinkwatertoediening
  • Die flessie moet onder die water oopgemaak word of die inhoud van die koppie(s) moet in die water gegooi word. Meng in beide gevalle die water wat die entstof bevat goed voor gebruik. Na hersamestelling lyk die oplossing helder.
  • Nobilis® IB Ma5 moet opgelos word in koel, skoon water wat vry is van yster en chloor.
  • Verseker opname van al die entstof-gemedikeerde water binne 2 ure. Afhangende van die weerstoestande, kan dit raadsaam wees om die voëls van water te ontneem voor inenting. Dit is noodsaaklik om ‘n voldoende aantal waterhouers te hê om voldoende drinkplek te voorsien. Hierdie waterhouers moet skoon en vry van spore van skoonmaak- en ontsmettingsmiddels wees.
  • Los 1 000 dosisse op in soveel liter water as die ouderdom van die hoenders in dae, tot ‘n maksimum van 40 ℓ.
  • Die entstof moet vroegoggend toegedien word aangesien dit die hoofperiode van drink is of die koeler periode op ‘n warm dag. Wanneer groter troppe ingeënt word, is dit raadsaam om te begin deur slegs ‘n deel van die entstof op te los.
  • Indien entstof deur middel van ‘n sentrale watertoevoer of ‘n doseerder toegedien word, moet groot sorg gedra word.
  • Vir getalle hoenders tussen standaard dosisse, moet die volgende hoër dosis gekies word.

Let wel: Toediening deur growwe bespuiting of die intranasale-/oogdruppeltoediening roete gee die beste reaksie. Dit moet die metodes van keuse wees, veral wanneer jong voëls ingeënt word. Die entstof kan deur die drinkwater toegedien word. Die entstof moet opgelos word in ‘n hoeveelheid water wat binne ongeveer 2 ure deur die hoenders verbruik sal 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. growwe sproei- of intranasale-/oogdruppeltoediening.

Lê- en teelhoenders: Inenting op 1-dag-oud d.m.v. growwe sproei- of intranasale-/oogdruppeltoediening.

Herinenting:                Teen ’n ouderdom van ongeveer 6 weke deur growwe sproei-,  intranasale-/oogdruppel-, of drinkwatertoediening.

Instruksies oor hersamestelling wanneer Nobilis® IB Ma5 saam met Nobilis® IB Primo QX of Nobilis® IB 4-91 gebruik word:

  • Hersamestelling en daaropvolgende toediening van beide liofilisate moet gevolg word soos hierbo uiteengesit vir sproei- of intranasale-/oogdruppeltoediening.
  • Dieselfde volumes water (sproeitoediening) of Intervet Diluent Oculo-Nasal verdunningsmiddel (intranasale-/oogdruppeltoediening) moet gebruik word soos benodig vir die enkele produk.
  • Die entstowwe moet individueel in water (sproeitoediening) of in Intervet Diluent Oculo-Nasal verdunningsmiddel (intranasale-/oogdruppeltoediening) hersaamgestel word en daarna saam gemeng word voor gebruik.
  • Moenie oopmaak en hersaamstel totdat gereed is om inenting te begin nie.
  • Elke flessie of koppie moet onmiddellik na oopmaak gebruik word.
  • Gebruik die entstof binne 2 uur na hersamestelling.

Let wel: Moenie Nobilis® IB Ma5 gelyktydig saam met Nobilis® IB Primo QX (G4211) en Nobilis® IB 4-91 (G4031) gebruik nie. Nobilis® IB Ma5 kan óf met Nobilis® IB Primo QX (G4211) óf met Nobilis® IB 4-91 (G4031) gebruik word.

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.

Noodinenting gedurende die lê-periode mag gepaard gaan met ’n verbygaande afname in eierproduksie.

AANBIEDING

Houers met 10 flessies hidrolitiese glas Tipe I, wat gevriesdroogte pilletjies van 1 000, 2 500 of 5 000 dosisse bevat. Toegemaak met ‘n halogeenbutielrubberprop en verseël met ‘n gekodeerde aluminiumdop.

Houers met 6 of 12 verseëlde aluminium gelamineerde koppies met ‘n polipropileen koppie en polipropileen/poliëtileen deksel kontaklaag wat 1 000, 2 500, 5 000 of 10 000 dosisse bevat.

Nie alle verpakkingsgroottes word noodwendig bemark nie.

REGISTRASIHOUER

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

VERVAARDIGERS

Intervet International B.V.               Merck Sharp & Dohme

Wim de Körverstraat 35                  Animal Health S.L.

5831 AN Boxmeer                           C/Zeppelin 6,

The Netherlands                              Poligono El Montalvo,

                                                         Carbajosa de la Sagrada

                                                         Parcela 38

                                                         Salamanca, Spain

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

10 Junie 2021