Nobilis® CAV P4

FOR ANIMAL USE ONLY

NOBILIS^® CAV P4
Reg. No. G2467 (Act 36/1947)
Namibia Reg No. V98/24.3/673 NS0

INDICATIONS
This is a live attenuated freeze-dried vaccine containing chicken anaemia vaccine virus.

Nobilis^® CAV P4 is intended for the immunisation of healthy future breeding chickens against chicken anaemia.

COMPOSITION
Each 1 mℓ dose contains at least 2,3 log₁₀ TCID₅₀ of chicken anaemia vaccine virus propagated on embryonated eggs. The freeze-dried pellet contains stabilisers.

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.
• The diluent may be stored at room temperature (20 ºC to 25 ºC) prior to use.

WARNINGS

• The vaccine must not be administered to chickens under 6 weeks of age.
• Breeding chickens have to be vaccinated at least 6 weeks before the onset of lay.
• 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.
• Wash and disinfect hands and equipment after vaccinating.
• Do not open and reconstitute the vaccine until ready to start vaccination.
• Use the vaccine immediately after reconstitution.
• Do not store partially used containers for future use.
• Use according to the number of doses as indicated on the label.
• Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc. according to local waste disposal regulations after completion of the vaccination.
• 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

• Only healthy chickens should be vaccinated.
• Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) are clean and sterile before use.
• The vaccination equipment used should be free from traces of disinfectant or spirit.
• Ensure that all equipment is kept clean and sterile during use.
• Each vial should be used immediately after opening.
• Avoid intravenous injection.
• 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

Intramuscular and Subcutaneous Injection
Reconstitute the vaccine with Intervet’s diluent, Dilavia.
Add some of the diluent to the vaccine vial, using a sterile syringe and needle, and shake. Withdraw the rehydrated vaccine into the syringe and add the rest of the diluent. Gently shake to mix. Withdraw a portion of the diluent to flush the vial and inject the fluid back into the diluent bottle. Remove the syringe. Fill the automatic syringe according to the manufacturer’s recommendation and set the dose to 0,2 mℓ.
Dosage: 0,2 mℓ contains 1 chicken dose (The amount of diluent to be used depends on the number of doses per vial). Administer the vaccine by intramuscular or subcutaneous route.

Application by the Wing web method
Reconstitute the vaccine with the appropriate amount of diluent.
The vaccine is supplied with 200 mℓ diluent and a double needle.
After reconstitution of the vaccine with the diluent the wing web needle is dipped into the vaccine solution, before the vaccination of each chicken, so that both grooves are filled. The needle is inserted through the wing web from beneath, taking care to avoid the feathered parts of the web. After 7 to 10 days of vaccination, the reaction should be examined in a certain number of chickens. The vaccination site should show minor swelling and small scabs which will disappear within 2 to 3 weeks.

VACCINATION PROGRAM
The optimum time and method of administration depend largely upon the local situation. Therefore, the advice of a veterinarian should be sought. Under no circumstances should the vaccine be administered under 6 weeks of age. To make sure that adequate antibody levels are built up at the onset of lay, breeding chickens have to be vaccinated at least 6 weeks before this onset.
Vaccination against CAV can be combined with vaccination against Reo (intramuscular or subcutaneous route) or with vaccination against Chicken Pox (wing web route)

IMMUNITY
The induction of high neutralising antibody levels is generally dependent on the health and condition of the chickens. Hygiene and management are also important in the post-vaccination period. Breeding chickens must be vaccinated at least 6 weeks before the onset of lay.

PRESENTATION
Boxes containing 10 vials of 1 000 dose each with diluent and wing web needle.

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

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
26 February 1998

Slegs vir Dieregebruik

Nobilis^® CAV P4
Reg. Nr. G2467 (Wet 36/1947)
Namibia Reg. Nr. V98/24.3/673
Nobilis^® CAV P4 word aangedui vir die immunisasie van gesonde toekomstige teelhoenders teen hoenderanemie.

BERGING
Berg in die donker tussen 2 ºC en 8 ºC. Moenie vries nie.
Vermy langdurige en herhaalde blootstelling aan hoë omgewingstemperature nadat dit uit die yskas is voo gebruik.
Beskerm teen direkte sonlig.
Die oplosmiddel mag teen kamertemperatuur (20 ºC tot 25 ºC) geberg word voor gebruik.

INDIKASIES
Dit is ‘n lewende gevriesdroogde entstof wat hoender anemie entstofvirus bevat.

SAMESTELLING
Elke 1 mℓ dosis bevat ten minste 2,3 log TCID ₅₀ van hoender anemie entstofvirus wat op bebroeide eiers gekweek is. Die gevriesdroogde pilletjie bevat stabiliseerders.

WAARSKUWINGS
Die entstof moet nie aan hoenders jonger as 6 weke van ouderom toegedien word nie.
Teelhoenders moet ten minste 6 weke voor die aanvang van die lê-periode ingeënt word.
Moenie vries 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-ingeënte hoenders versprei.
Vernietig alle ongebruikte, hersaamgestelde entstof, leë entstofhouers, naalde ens. deur bv. verbranding na voltooïng van die inenting.
Die hande en toerusting moet gewas en ontsmet word na inenting.
Moenie oopmaak en hersaamstel voordat daar gereed is om met die inenting te begin nie.
Gebruik die entstof onmiddelik na hersamestelling.
Moenie gedeeltelik gebruikte houers berg vir latere gebruik nie.
Gebruik volgens die aantal dosisse soos op die etiket aangedui.
HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid van 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 voorsorgmaatreëls moet gehandhaaf word. Daar moet verseker word dat die inentingstoerusting (naalde, spuite ens.) skoon en steriel is voor gebruik.
Die inentingstoerusting, wat gebruik word, moet vry van spore van ontsmettingsmiddels en spiritus wees.
Sorg dat alle toerusting skoon en steriel gehou word gedurende gebruik.
Elke flessie moet onmiddelik nadat dit oopgemaak is, gebruik word.
Vermy binneaarse inspuiting.
Dit is goeie inentingspraktyk wanneer entstowwe hanteer word om kontak met die oë, hande en klere te vermy.

GEBRUIKSAANWYSINGS
Gebruik alleenlik soos aangedui.
Binnespierse en Onderhuidse Inspuiting
Die entstof moet met Intervet se oplosmiddel, Diluent 251258, hersaamgestel word.
Voeg van die oplosmiddel by die flessie met die entstof deur gebruik te maak van ‘n steriele spuit en naalde en skud. Trek van die gerehidreerde entstof in die spuit op en voeg die res van die oplosmiddel by. Skud liggies om te meng. Trek ‘n gedeelte van die oplosmiddel op om die flessie uit te spoel en spuit die vloeistof terug in die oplosmiddelbottel. Verwyder die spuit. Die automatiese spuit word gevul volgens die vervaardiger se aanbevelings en die dosis op 0,2 mℓ gestel.
Dosering: 0,2 mℓ bevat 1 hoender dosis (Die hoeveelheid oplosmiddel wat gebruik word sal afhang van die aantal dosisse per flessie). Die entstof word binnespiers toegedien.

Aanwending deur die Vlerk-webmetode
Die entstof word hersaamgestel met die toepaslike hoeveelheid van die oplosmiddel.
Die entstof word met 200 mℓ oplosmiddel en ‘n dubbel naald voorsien.
Na hersaamstelling van die entstof met die oplosmiddel, word die vlerk-web naald in die entstof oplossing gedoop, voor die inenting van elke hoender, sodat beide groefies gevul is. Die naald word deur die vlerk-web van onder af gedruk terwyl gesorg gedra word dat die veergedeeltes van die web vermy word. 7 tot 10 dae na inenting moet die reaksie ondersoek word by ‘n sekere aantal hoenders. Die plek van inenting behoort ‘n geringe swelling en klein korsies te toon, wat binne 2 tot 3 weke sal verdwyn.

INENTINGSPROGRAM
Die optimum tyd en metode van toediening sal afhang van plaaslike omstandighede. Dit is daarom nodig om die advies van ‘n veearts in te win.
Onder geen omstandighede moet die entstof onder 6 weke van ouderdom toegedien word nie. Om te verseker dat genoegsame teenliggampie vlakke by die begin van die lê-periode opgebou is, moet teelhoenders ten minste 6 weke voor die begin van die lê-periode ingeënt word.
Inenting teen CAV kan met inenting teen Reo (binnespiers of onderhuidsse roete) of inenting teen Hoenderpokke (vlerk-web roete) gekombineer word.

IMMUNITEIT
Die induksie van hoë neutraliserende teenliggaampie vlakke is in die algemeen afhanklik van die gesondheid en toestand van die hoenders. Higiëne en bestuur is ook belangrik in die na-inentings periode. Teel hoenders moet ten minste 6 weke voor die begin van die lê-periode ingeënt word.

AANBIEDING
Kartonhouers bevattende 10 flessies van 1 000 dosisse met Diluent 251258 en vlerk-webnaald.

REGISTRASIEHOUER
Intervet South Africa (Pty) Ltd.
Spartanweg 20
Spartan, 1619
RSA
Tel: +27 (0) 11 923 9300
Faks: +27 (0) 392 3158
www.msd-animal-health.co.za

VERVAARDIGER
Intervet International B.V.
Boxmeer, Nederland
Datum van Publikasie: 26 Februarie 1998