For Animal Use Only

PACKAGE INSERT

For Animal Use Only

Nobilis ® AE+Pox

Reg. No. G2448 (Act 36/1947) Namibia Reg No. V05/24.3/57 S0

A live attenuated vaccine for the immunization of layer pullets and breeder replacement pullets against Avian Encephalomyelitis (AE) and Fowl pox.

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. - Diluent: Store at room temperature between 20 °C and 25 °C.

Composition Each dose of Nobilis® AE + Pox vaccine contains Avian Encephalomyelitis (AE) virus, strain Calnek 1143 and fowl pox virus, strain Gibbs.

Contents 2,5 Each dose of Nobilis® AE + Pox vaccine contains at least 10 EID50 Avian 2,58 Encephalomyelitis virus, strain Calnek 1143 and 10 EID50 fowl pox virus, strain Gibbs.

Warnings - Do not vaccinate during lay or within 28 days before the beginning of the laying period. - Do not vaccinate fowls younger than 8 weeks of age. - Do not vaccinate within 21 days of slaughter. - Do not freeze. - It is advisable to vaccinate all the susceptible fowls on the farm at the same time. If this is not feasible, strict separation of vaccinated and unvaccinated fowls should be done, to prevent the spread of the vaccine virus to the unvaccinated fowls. - Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc. for instance by burning after completion of the vaccination. - 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. - Protect the reconstituted vaccine from direct sunlight. - Do not mix the vaccine with other vaccines. - Do not administer simultaneously with or within 14 days after vaccination with other live vaccines. - Use according to the number of doses as indicated on the label. - Do not use less than one dose per fowl. - - Keep out of reach of children and uninformed persons. 2.

- 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 fowls only. - Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc) are clean and sterile before use. - Ensure that all equipment is kept clean and sterile during use. - Each vial should be used immediately after opening. - Avoid touching the feathers with the applicator. - Avoid touching the bone when applying the vaccine. - Dip the applicator into the reconstituted vaccine before every application. - 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.

Vaccination Programme - The vaccine is recommended for the active immunization of layer and breeder replacement pullets. - Vaccinate at the age of 8 to 16 weeks. - Revaccinate during the moulting period. - Vaccinate healthy fowls only.

Dosage and Administration - By the Wing-Web method. - The vaccine is supplied with diluent and double needle. - Do not open and reconstitute the vaccine until ready to start the vaccination. - Use the vaccine immediately after reconstitution. - Dip the wing-web needle (double needle) into the reconstituted vaccine solution making sure that both grooves are filled. - The needle is inserted through the wing-web taking care to avoid feathered parts of the web. Avoid touching the bone when applying the vaccine. - Dip the wing-web needle into the re-constituted vaccine solution before every application. - A few fowls should be examined for vaccination success (as indicated by swelling and scab formation at the injection site) approximately 7 to 10 days after vaccination. The minor swellings and small scabs will disappear within two or three weeks.

Immunity - Vaccinated fowls are protected against decreased egg production due to both diseases during lay and their progeny are protected against AE for the first few weeks of life via maternally transmitted immunity. - Full immunity will develop within two to three weeks after vaccination. 3.

- Vaccination will normally cause no visible reaction.

Presentation Vial containing 1000 doses supplied with diluent and wing-web needle 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

Date of Publication of this Package Insert: 20.01.1998

VOUBILJET Slegs vir Dieregebruik

Nobilis ® AE + Pox

Reg. No. G2448 (Wet 36/1947) Namibië Reg Nr. V05/24.3/57 S0

‘ n Lewende geattenueerde entstof vir die immunisasie van lê-hennetjies en teel- vervangings hennetjes teen bewerasiesiekte (AE) en hoender pokke.

Berging - Berg in die donker tussen 2 °C en 8 °C. Moenie vries nie. - Vermy langdurige en herhaalde blootstelling aan hoë omgewings temperature. - Beskerm teen blootstelling aan direkte sonlig. - Oplosmiddel: Berg teen kamertemperatuur tussen 20 °C en 25 °C.

Samestelling Elke dosis van die gevriesdroogde Nobilis ® AE + Pox entstof bevat Bewerasiesiekte (AE) virus, stam Calnek 1143 en hoender pokke virus, stam Gibbs.

Inhoud 2,5 Elke dosis van Nobilis® AE + Pox entstof bevat ten minste 10 EID50 Bewerasiesiekte 2,58 virus, stam Calnek 1143 en 10 EID50 hoender pokke virus, stam Gibbs.

Waarskuwings - Moenie inent gedurende die lê-periode of binne 28 dae voor die begin van die lê- periode nie. - Moenie hoenders jonger as 8 weke van ouderdom inent nie. - Moenie binne 21 dae voor slag inent nie. - Moenie vries nie. - Dit word aanbeveel dat alle hoenders op die plaas gelyktydig ingeënt word. As dit nie moontlik is nie, moet die geënte hoenders streng apart van die nie-geënte hoenders gehou word. Dit sal die verspreiding van die entstofvirus, na nie- geënte hoender verhoed. - Vernietig alle ongebruikte, hersaamgestelde entstof, leë entstofhouers, naalde ens. deur bv. verbranding na die inenting voltooi is. - Moenie die entstof oopmaak of hersaamstel voordat daar nie gereed is om met die inenting te begin nie. - Die hersaamgestelde entstof moet onmiddelik na hersamestelling gebruik word. - Moenie gedeeltelik gebruikte houers vir toekomstige gebruik bêre nie. - Beskerm die hersaamgestelde entstof teen direkte sonlig. - Moenie die entstof met ander entstowwe meng nie. - Die entstof moet nie saam met of binne 14 dae na inenting met enige ander lewendige entstof toegedien word nie. - Gebruik volgens die aantal dosisse soos op die etiket aangedui. - Moenie minder as een dosis per hoender gebruik nie. - Hou buite bereik van kinders en oningeligte persone. 2.

- 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 - Net gesonde hoenders mag ingeënt word. Aseptiese voorsorgmatreëls moet nagekom word. Daar moet verseker word dat alle inentingstoerusting (naalde, spuite, ens.) skoon en steriel is voor gebruik. - Sorg dat alle toerusting skoon en steriel is gedurende gebruik. - Elke flessie moet onmiddelik nadat oopgemaak is gebruik word. - Verhoed dat die vere met die aanwender aangeraak word. - Verhoed dat die been tydens aanwending getref word. - Die aanwender moet in die hersaamgestelde entstof voor elke aanwending gedoop word. - Dit is goeie inentings gebruik om kontak met die oë, hande en klere te vermy wanneer die entstof gehanteer word.

Gebruiksaanwysings - Gebruik alleenlik soos aanbeveel.

Inentingsprogram - Die entstof word aanbeveel vir die aktiewe immunisasie van lê-hennetjies en teel-vervangings hennetjies. - Ent vanaf 8 tot 16 weke van ouderdom. - Herinenting gedurende die ververings periode word aanbeveel. - Net gesonde hoenders mag ingeënt word.

Dosering en Aanwending - Deur die Vlerk-web metode. - Die entstof word saam met oplosmiddel en dubbel naald voorsien. - Moenie die entstof oopmaak of hersaamstel voordat daar nie gereed is om met die inenting te begin nie. - Gebruik die entstof onmiddelik na hersamestelling. - Die vlerk-web naald (dubbel naald) word in die hersaamgestelde entstofoplossing gedoop. Daar moet seker gemaak word dat beide groefies gevul is. - Die naald word deur die vlerk-web gedruk terwyl seker gemaak word dat die geveerde dele van die web vermy word. Vermy ook die aanraking van been wanneer die entstof aangewend word. - Die vlerk-web naald moet in die hersaamgestelde entstof voor elke aanwending gedoop word. - ‘ n Aantal hoenders moet vir inentingssukses (soos deur vel swelling en korsvorming by die plek van inspuiting aangedui) ongeveer 7 tot 10 dae na inenting, ondersoek te word. Die ligte swelling en klein korsies sal binne twee tot drie weke verdwyn. 3.

Immuniteit - Ingeënte hoenders word teen eierproduksie verlies (egg drop) wat tewyte is aan beide siektes gedurende lê, beskerm. Hulle nageslag word gedurende die eerste paar weke van lewe via die eiers oorgedraagde immuniteit teen AE beskerm. - Volle immuniteit sal binne twee tot drie weke na inenting ontwikkel. - Inenting sal normalweg geen ooglopende reaksie veroorsaak nie.

Aanbieding Flessies wat 1000 dosisse bevat en wat voorsien word met die oplosmiddel en vlerk-web naald en verpak word in ‘n karton houer.

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

Datum van Publikasie van hierdie Voubiljet: 20.01.1998