LT-IVAX®

Modified live virus vaccine for use in chickens 4 weeks of age or older, as an aid in the prevention of chicken laryngotracheitis through vaccination by the eye drop method.

FOR ANIMAL USE ONLY

LT-IVAX®
Reg. No. G3603 (Act 36 /1947)
Namibia Reg. No. V03/24.3/742 NS0

INDICATIONS
Modified live virus vaccine for use in chickens 4 weeks of age or older, as an aid in the prevention of chicken laryngotracheitis through vaccination by the eye drop method.

COMPOSITION
LT-IVAX® vaccine contains a live virus of chicken tissue culture origin.
Preservative: Gentamycin sulphate

CONTENTS
Each dose contains: 102,9 TCID50 chicken laryngotracheitis virus.

STORAGE
Store between 2 °C and 7 °C.

WARNINGS

  • Withdrawal period: Do not vaccinate within 21 days before slaughter.
  • Vaccinate healthy chickens only.
  • An eye reaction may be noticed if chickens are incubating coryza or other infectious organisms, or if there is excess ammonia or dust in the air of the housing facilities.
  • Dispose of any unused vaccine as well as all 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

  • Avoid contact with eyes, hands and clothing when handling/administering the vaccine.
  • Do not dilute the vaccine or otherwise stretch the dosage.
  • Do not spill or spatter the vaccine.
  • Use entire contents of each vial when first opened.
  • Wash hands after vaccination.

CONTRA-INDICATIONS

The application of Newcastle Disease- or Bronchitis vaccine, either singly or in combination should be avoided for a period of 3 days prior to and after the application of LT-IVAX®.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED.
In outbreak situations, vaccinate healthy chickens first, progressing toward outbreak areas in order to vaccinate diseased chickens last.
Vaccinate by the eye drop method according to the following schedule:

1.         When to vaccinate

Initial vaccinationRevaccination
4 weeks of age10 weeks of age or older

2.         Vaccination programme
The development of a durable strong protection depends upon the use of an effective vaccination program as well as many circumstances such as administration techniques, environment and flock health at time of vaccination.
Although disease may not be evident, coccidiosis, chronic respiratory disease,
Mycoplasma infection, lymphoid leucosis, infectious bursal disease, Marek’s disease, or other disease conditions may cause serious complications or reduce protection.
The immune response to 1 vaccination under field conditions is seldom complete for all chickens within a given flock. Even when vaccination is successful, the protection stimulated in individual chickens against different diseases may not be lifelong.
If necessary, the vaccine may be used to aid in limiting the spread of an outbreak; however, only chickens not yet infected with the virulent outbreak virus can be protected.
Examination of chickens for vaccination “takes” is unnecessary and so-called “takes” are not to be expected.
As with all live virus vaccines, a mild transitory reaction may occur in a small portion of the flock, and with LT-IVAX®, this is generally limited to a mild, localised eye reaction of short duration.

3.         Preparation of the vaccine

  • Do not open and mix the vaccine until ready for use.
  • Mix only 1 vial at a time and use entire contents within 2 hours.
  • Remove the tear-off aluminium seal and stopper from vial containing the dried vaccine.
  • Do the same for the diluent bottle and insert the long end of the adapter into the diluent bottle.
  • Hold the diluent bottle firmly in an upright position and insert the vaccine vial on the adapter of the diluent bottle. The neck of the vaccine vial should snap into position and should be seated securely on the adapter on the diluent bottle.
  • Invert the 2 containers so that the vaccine vial is on the bottom and allow the diluent to flow into the vaccine vial. If the diluent does not flow freely, squeeze the diluent bottle gently and the diluent will flow into the vaccine vial. The vaccine vial should be completely filled with diluent to prevent excess foaming.
  • Hold the joined containers by the ends; shake vigorously until the vaccine plug has been completely dissolved.
  • Return the joined containers to its original position (diluent bottle on the bottom).
  • Allow the vaccine to flow into the diluent bottle. If the vaccine does not flow into the diluent bottle, tap or squeeze the diluent bottle gently and release to draw the vaccine into the diluent bottle. Ensure that the entire contents are removed from the vaccine vial.
  • Remove the vaccine vial and adapter from the neck of the diluent bottle and insert dropper applicator into plastic diluent bottle.
  • The vaccine is now ready for use.
  • Wash hands thoroughly after mixing the vaccine.

4.         How to vaccinate
Hold dropper bottle in vertical position throughout vaccination to avoid wasting vaccine.
Instill 1 full drop of rehydrated vaccine into the open eye of the chicken and hold until a swallowing motion is observed.

PRESENTATION
1 000 dose vials with 30 mℓ diluent.

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
Merck Animal Health
21401 West Center Road
Elkhorn, Nebraska

DATE OF PUBLICATION OF THIS PACKAGE INSERT
18 February 2010

SLEGS VIR DIEREBEGRUIK

LT-IVAX®
Reg. Nr. G3603 (Wet 36/1947)
Namibië Reg. Nr. V03/24.3/742 NS0

INDIKASIES
Gemodifiseerde lewende virusentstof vir gebruik in hoenders 4 weke of ouer, as ‘n hulpmiddel in die voorkoming van hoender laringotrageïtis deur enting deur middel van die oogdruppelmetode.

SAMESTELLING
LT-IVAX® entstof bevat ‘n lewende virus van hoenderweefselkultuur oorsprong. Preserveermiddel: Gentamisiensulfaat

INHOUD
Elke dosis bevat: 102,9 TCID50 hoender laringotrageïtis virus.

BERGING
Berg tussen 2 °C en 7 °C.

WAARSKUWINGS

  • Onttrekkingsperiode: Moenie hoenders binne as 21 dae voor slagting, ent nie.
  • Slegs gesonde hoenders mag geënt word.
  • ‘n Oogreaksie mag opgemerk word in hoenders wat koryza of ander aansteeklike organismes inkubeer, of as daar ‘n oormaat ammoniak of stof in die lug van die hokke is.
  • Doen weg met enige ongebruikte entstof asook alle leë enstofhouers en entstoftoerusting volgens plaaslike afvalbestuursregulasies.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof deeglik getoets is onder ‘n groot verskeidenheid toestande, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

VOORSORGMAATREëLS

  • Verhoed kontak met die oë, hande en klere wanneer die entstof hanteer/toegedien word.
  • Moenie die entstof verdun of die dosis aanpas nie.
  • Moet nie die entstof spat of mors nie.
  • Gebruik die totale inhoud van elke fles wanneer dit eers oopgemaak is.
  • Was hande na enting.

KONTRA-INDIKASIES
Die toediening van Newcastlesiekte- of Brongitisentstof, alleen of in kombinasie moet vermy word vir ‘n periode van 3 dae voor en na die toediening van LT-IVAX®.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI.

Ingeval van ‘n uitbreeksituasie, moet die gesonde hoenders eerste geënt word en dan deur die uitbreekareas beweeg word, sodat die siekste hoenders heel laaste geënt word.

Ent deur middel van die oogdruppelmetode volgens die volgende skedule:

1.         Wanneer om te ent.

Eerste entingHerenting
4 weke ouderdom10 weke ouderdom of ouer

2.         Inentingsprogram

Die ontwikkeling van ‘n deeglike, sterk beskerming hang af van ‘n effektiewe entingsprogram sowel as verskeie omstandighede soos b.v. toedieningsmetodes, omgewing en trop gesondheid ten tye van die enting.
Alhoewel daar nie indikasie van siektes is nie, kan koksidiose, kroniese respiratoriese siektes, mikoplasma infeksie, limfoïede leukose, aansteeklike bursasiekte, Marek se siekte, of ander siektes, ernstige komplikasies veroorsaak of beskerming verlaag.
Die immuunrespons na 1 enting is selde volledig vir alle hoenders in ‘n trop onder veldtoestande. Selfs wanneer inenting suksesvol was, is die beskerming wat tot stand gebring word, in individuele hoenders teen verskillende siektes nie noodwendig lewenslank nie.
Indien nodig, kan die entstof gebruik word as ‘n hulpmiddel in die beperking van die verspreiding van ‘n uitbreek. Slegs die hoenders wat nie reeds besmet is met die virulente uitbreek virus nie,kan beskerm word.
Ondersoek van hoenders vir entstof “reaksie” is onnodig en sogenaamde “reaksies” word nie verwag nie.
Soos met alle lewende virus entstowwe, mag ‘n geringe verbygaande reaksie voorkom in ‘n klein gedeelte van die trop. Met LT-IVAX®, is dit gewoonlik beperk tot ‘n geringe, gelokaliseerde oogreaksie van korte duur.

3.         Voorbereiding van die entstof

  • Moenie die entstof oopmaak en meng voor gereed is om gebruik te word nie.
  • Meng slegs 1 fles op ‘n slag en gebruik die totale inhoud binne 2 ure.
  • Verwyder die afskeur-aluminiumseël en prop van die fles wat die gedroogde entstof bevat.
  • Doen dieselfde vir die bottel wat die verdunningsmiddel bevat en steek dan die lang punt van die koppelstuk in die verdunningsmiddelbottel.
  • Hou die verdunningsmiddelbottel stewig en in ‘n regop posisie vas, druk dan die fles wat die gedroogde entstof bevat op die ander kant van die koppelstuk. Die nek van die entstoffles sal in posisie knip en stewig op die koppelstuk van die verdunningsmiddelbottel pas.
  • Draai die 2 houers om, sodat die entstoffles onder is en laat die verdunningsmiddel in die entstoffles vloei. As die verdunningsmiddel nie vrylik vloei nie, druk die verdunningsmiddelbottel liggies, dan sal die verdunningsmiddel in die entstoffles invloei. Die entstoffles moet heeltemal gevul word met die verdunningsmiddel om oormatige skuiming te voorkom.
  • Hou die saamgevoegde houers aan die ente vas; skud kragtig tot die entstofklont heeltemal opgelos is.
  • Draai die saamgevoegde houers na die oorspronklike posisie (verdunningsmiddelbottel onder).
  • Laat die entstof in die verdunningsmiddelbottel invloei. As die entstof nie in die verdunningsmiddelbottel vloei nie, tik of druk die verdunningsmiddelbottel liggies en los weer, om die entstof in die verdunningsmiddelbottel in te trek. Sorg dat die volle inhoud verwyder is uit die entstoffles.
  • Vewyder die entstoffles en koppelstuk van die nek van die verdunningsmiddelbottel en steek die druppeltoediener in die plastiek verdunningsmiddelbottel.
  • Die entstof is nou gereed vir gebruik.
  • Was hande deeglik nadat entstof gemeng is.

4.         Hoe om te ent
Hou die drupper bottel in ‘n vertikale posisie gedurende enting om vermorsing van die entstof te voorkom.
Dien 1 volle druppel hersaamgestelde entstof toe in die oop oog van die hoender en hou die hoender vas totdat ‘n slukbeweging waargeneem word.

AANBIEDING
10 x 1 000 dosis flessies met verdunningsmiddel (15 mℓ of 30 mℓ).

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

VERVAARDIGER
Schering-Plough Animal Health Corp.
21401 West Center Road
Elkhorn, Nebraska

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
18 Februarie 2010