FVAX-MG®

FOR ANIMAL USE ONLY

Mycoplasma gallisepticum Vaccine, Live Culture

Reg. No. G4295 (Act 36/1947)

INDICATIONS

FVAX-MG® is recommended for use in healthy chickens 9 weeks of age or older by spray administration to aid in prevention of clinical signs associated with Mycoplasma gallisepticum infection.

COMPOSITION

FVAX-MG® vaccine is a live vaccine containing the F-strain of Mycoplasma gallisepticum ≥106,0 CCU50 per dose, in a freeze-dried preparation sealed under vacuum in a stabiliser.

Preservative: Penicillin.

Contains lactose.

STORAGE

  • Store between 2 °C and 7 °C.
  • Do not freeze.
  • Protect from direct sunlight.

WARNINGS

  • Withdrawal Period: Do not vaccinate within 21 days of slaughter.
  • The F-strain can be transmitted through the eggs. It is advised to vaccinate chickens before the onset of egg production.
  • Vaccinate only healthy chickens.
  • To avoid interference with development of protection, chickens to be vaccinated should not be given any antibiotic and/or sulphonamide medication for 3 days before and 7 days after vaccination.
  • Do not administer within 3 days before to 7 days after treatment with oxytetracycline or chlortetracycline.
  • FVAX-MG® should not be administered within 1 week before or after vaccination with live Newcastle disease, bronchitis or laryngotracheitis vaccines.
  • Do not dilute the vaccine or otherwise stretch the dosage.
  • All chickens within a flock should be vaccinated on the same day.
  • Isolate other susceptible chickens on the premises from the chickens being vaccinated.
  • Mycoplasma gallisepticum F-Strain is known to produce clinical disease in turkeys. DO NOT ALLOW TURKEYS TO COME IN CONTACT WITH VACCINE OR VACCINATED CHICKENS.
  • Do not spill or spatter the vaccine.
  • Use entire contents of vial once opened.
  • Dispose of empty bottles, caps and all unused vaccine and accessories according to local waste disposal regulations.
  • Wear protective clothing.
  • Wash hands thoroughly after using the vaccine.
  • 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

It is advised to vaccinate chickens before the onset on egg production.

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 1 hour.
  • Remove the tear-off aluminium seal from the vaccine vial without disturbing the rubber stopper.
  • Use cool, clean, potable, non-chlorinated drinking water.
  • Holding the vial submerged in water, lift the lip of the rubber stopper so that the water is sucked into the vial.
  • Reseal the stopper and shake to thoroughly dissolve the vaccine. The vaccine is now ready for use.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

  • Spray administration only.
  • Use 100 mℓ cool, clean non-chlorinated drinking water per 1 000 doses.
  • Place vaccine in sprayer container.
  • Spray coarse droplets. Droplets of 40 to 50 microns average size are desirable.
  • Apply vaccine over all chickens at the rate of 9 doses/m2 or 1 dose per chicken, whichever is greater.
  • Use rehydrated vaccine within 1 hour.

ADVICE ON CORRECT ADMINISTRATION

  • Proper spray application of this vaccine is accomplished only through use of a clean sprayer emitting a coarse spray.
  • Use the spray method only in houses that can be closed during vaccination and for at least 15 minutes thereafter.
  • Cross winds, drafts or operating ventilation fans may prevent effective application.

PRESENTATION

The vaccine is filled in sterile clear Type I glass vial, containing 1 000 or 5 000 doses. The vial is closed with sterile Type I grey chlorobutyl rubber stopper and sealed with a silver aluminium seal.

The vaccine is presented in carton boxes containing 10 vials of the same dose presentation.

Not all pack sizes may be marketed.

REGISTRATION HOLDER                               MANUFACTURER

Intervet South Africa (Pty) Ltd.                           Merck Animal Health

20 Spartan Road, Spartan                                 21401 West Center Road

1619, RSA                                                          Elkhorn

Tel: +27 (0) 11 923 9300                                   Nebraska 68022, USA

Fax: +27 (0) 11 392 3158

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT

10 October 2018

SLEGS VIR DIEREGEBRUIK

FVAX-MG®

Mycoplasma gallisepticum Entstof, Lewende Kultuur

Reg. Nr. G4295 (Wet 36/1947)

INDIKASIES

FVAX-MG® word aanbeveel vir gebruik in gesonde hoenders van 9 weke oud of ouer deur sproeitoediening vir die voorkoming van die kliniese tekens wat gepaard gaan met Mycoplasma gallisepticum infeksie.

SAMESTELLING

FVAX-MG® entstof is ‘n lewende entstof wat die F-stam van Mycoplasma gallisepticum bevat ≥ 106,0 CCU50 per dosis, in ‘n gevriesdroogde vorm verseël onder vakuum in ‘n stabiliseerder.

Preserveermiddel: Penisillien.

Bevat laktose.

BERGING

  • Berg tussen 2 °C en 7 °C.
  • Moenie vries nie.
  • Beskerm teen direkte sonlig.

WAARSKUWINGS

  • Onttrekkingsperiode: Moenie binne 21 dae voor slagting inent nie.
  • Die F-stam kan oorgedra word deur die eiers. Dit word aanbeveel dat hoenders ingeënt word voor die aanvang van eierproduksie.
  • Ent slegs gesonde hoenders.
  • Om inmenging met die ontwikkeling van beskerming te vermy, moet hoenders wat ingeënt word, nie enige antibiotika en/of sulfoonamiedmedikasie gegee word vir 3 dae voor en 7 dae na inenting nie.
  • Moenie oksitetrasiklien of chloortetrasiklien binne 3 dae voor tot 7 dae na behandeling toedien nie.
  • FVAX-MG® moenie binne 1 week voor of na inenting, met lewende Newcastlesiekte-, brongitis- of laringotrageïtisentstowwe toegedien word nie.
  • Moenie die entstof verdun of andersins die dosis vermeerder nie.
  • Alle hoenders in ‘n trop moet op dieselfde dag ingeënt word.
  • lsoleer ander sensitiewe hoenders wat op dieselfde perseel is as die hoenders wat ingeënt word.
  • Mycoplasma gallisepticum F-stam is bekend daarvoor om kliniese siekte te veroorsaak in kalkoene. MOENIE TOELAAT DAT KALKOENE IN KONTAK KOM MET ENTSTOF OF GEëNTE HOENDERS NIE.
  • Moenie die entstof mors of spat nie.
  • Gebruik die totale inhoud van die flessie sodra dit die eerste keer oopgemaak word.
  • Doen weg met alle leë bottels, doppies, ongebruikte entstof en entstoftoerusting, volgens plaaslike afvalbestuursregulasies.
  • Dra beskermende klere.
  • Was hande deeglik na gebruik van die entstof.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie middel breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. lndien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Dit word aanbeveel dat hoenders voor die aanvang van eierproduksie ingeënt word.

Voorbereiding van die entstof

  • Moenie die entstof oopmaak en meng tot gereed vir gebruik nie.
  • Meng slegs 1 flessie op ‘n slag en gebruik die totale inhoud binne 1 uur.
  • Verwyder die aluminiumseël van die entstofflessie sonder om die rubberprop te beweeg.
  • Gebruik koel, skoon, drinkbare nie-gechlorineerde drinkwater.
  • Hou die flessie onder die water, lig die lip van die rubberprop op sodat die water ingesuig word in die flessie.
  • Herseël die prop en skud om die entstof deeglik op te los. Die entstof is nou gereed vir gebruik.

DOSIS, ROETE EN METODE VAN TOEDIENING

  • Slegs vir sproeitoediening.
  • Gebruik 100 mℓ koel, skoon nie-gechlorineerde drinkwater per 1 000 dosisse.
  • Plaas entstof in spuithouer.
  • Spuit growwe druppels. Druppels met ‘n gemiddelde grootte van 40 tot 50 mikron word aanbeveel.
  • Wend entstof oor al die hoenders aan teen ‘n tempo van 9 dosisse/m2 of 1 dosis per hoender, wat ook al groter is.
  • Gebruik gerehidreerde entstof binne 1 uur.

ADVIES VIR KORREKTE TOEDIENING

Behoorlike besproeiing van hierdie entstof word slegs bereik deur die gebruik van ‘n skoon sproeier wat ‘n growwe sproei uitstraal.

Gebruik die sproeitoediening net in huise wat gedurende inenting en vir ten minste 15 minute daarna toegemaak kan word.

Dwarswinde, trekke, en ventilasiewaaiers kan effektiewe toediening verhoed.

AANBIEDING

Die entstof is gevul in ‘n steriele deurskynende Tipe1 glasflessie, met 1 000 en 5 000 dosisse.

Die flessie word toegemaak met ‘n steriele Tipe 1 grys chlorobutiel-rubberstopper en verseël met ‘n silwer aluminiumseël.

Die entstof word aangebied in kartonhouers met 10 flessies van dieselfde dosis.

Nie alle verpakkingsgroottes word noodwendig bemark nie.

REGISTRASIEHOUER                                     VERVAARDIGER

Intervet South Africa (Pty) Ltd.                           Merck Animal Health

Spartanweg 20, Spartan                                    21401 West Center Road

1619, RSA                                                          Elkhorn

Tel: +27 (0) 11 923 9300                                   Nebraska 68022, USA

Faks: +27 (0) 11 392 3158

www.msd-animal-health.co.za

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

10 Oktober 2018