FVAX-MG®

FOR ANIMAL USE ONLY

FVAX-MG®

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 mix this vaccine with any other medication or vaccine.
  • 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, portable, 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                                      

Intervet South Africa (Pty) Ltd.                           

20 Spartan Road, Spartan                                      

1619, RSA                                                                      

Tel: +27 (0) 11 923 9300                                          

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT 10 October 2018