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Gudair®

Description

  • Gudair® is Australia's only vaccine for the control of ovine Johne’s disease (OJD).
  • It contains inactivated (killed) Mycobacterium paratuberculosis strain 316F and when combined with the adjuvant offers protection against the development of clinical OJD and a reduction in faecal shedding of the organism in sheep.

Key Benefits

A single 1 mL dose provides protection for life.
Following whole flock vaccination, producers should see:
  • Significant decrease in the number of clinically affected animals over time
  • Decrease in the number of mortalities associated with OJD
  • Gradual decrease in the prevalence of infection within the flock
  • Notable decrease in faecal M.paratuberculosis shedding.
Inactivated (killed) vaccine and will not introduce the disease into the flock.

Recommendations for Use

  • Active immunisation for the control of ovine Johne's disease and reduction of faecal Mycobacterium paratuberculosis shedding in sheep.
  • Active immunisation as an aid in the control of Johne's disease in goats.
  • It’s strongly recommended to use the Gudair Sekurus® 1mL Safety vaccinator when administering Gudair and use a 6mm, ¼ inch needle.

  • Its safety features reduce the risk of accidental self-injection.

The Zoetis Advantage

Gudair is a highly effective tool to prevent and control Ovine Johne’s disease

  • A single 1mL Gudair dose is effective for life.
  • Gudair will decrease OJD shedding by more than 90% in high disease sheep flocks.
  • Gudair will decrease OJD mortalities by greater than 90% in high disease sheep flocks.
  • Gudair delays shedding and onset of clinical signs by more than 12 months.
  • Vaccinate lambs at 4-16 weeks of age will be classified as an ‘Approved Vaccinate’.
  • Safe for use in older sheep and during all stages of pregnancy.

Dosage

Dose rate: Single 1 mL for sheep and goats.
  • Single 1mL dose for life
  • Vaccinate lambs at 4-16 weeks of age will be classified as an ‘Approved Vaccinate’.
  • Safe for use in older sheep and during all stages of pregnancy.
It’s strongly recommended to use the Gudair Sekurus®  1ml Safety vaccinator when administering Gudair as it is a reactive, oil based vaccine.
  • The Gudair Sekurus 1mL Safety vaccinator has a protective shroud and a two-stage locking mechanism to reduce self-administration risk.
  • Its safety features reduce the risk of accidental self-injection. Ask your retailer for more information on the Gudair Sekurus 1mL Safety vaccinator
  • Gently agitate before use and keep thoroughly mixed during use.

Injection site:
  • GUDAIR® vaccine should be administered subcutaneously using a GUDAIR Safety Vaccinator and a 6mm (¼ inch) 18 gauge needle on a 45mm degree angle on the side of the neck midway between the ear and the front of the shoulder.
  •  Do not inject at any other site.
  • Ensure animals are adequately restrained in an appropriate sheep handling device (e.g. lambs in a cradle) during the injection process.
  • Ensure that the vaccine does not enter your body (self-injection, needle scratch, etc).
  • Unscrew the delivery tube from the vaccine pack after use by following the directions below
Directions for Resealing Gudair
A partially used pack can be stored and used for up to 30 days after first opening of the following steps are taken:
  1. Unscrew the delivery tube from the vaccine pack.
  2. Empty the deilvery tub and vaccinator by depressing the plunger several times
  3. Disinfect the stopper with Methylated spirits
  4. Store the vaccine in the original cardboard carton and place in the refrigerator  (2oC-8oC) DO NOT FREEZE
  5. Use the remaining vacine within 30 days
  6. Clean the delivery tube and draw off cap and sterilise by boiling water for  10 minutes
  7. Before reuse, disinfect the stopper with Methylated spirits 

Applicator Recommendations 

  • Clean and maintain the vaccinator as outlined by the manufacturer daily.
  • DO NOT use disinfectants at the site of vaccination or to clean the vaccinator or needle.
  • Ensure the needle is sharp and not burred, replace often.
  • This product must be injected ONLY under the skin
  • Further vaccine (booster) doses are not required.

Pack Size

Plastic packs: 100 mL, 250 mL.

Storage

Store at 2°C to 8°C (Refrigerate. Do not freeze.) Protect from light.
Gudair can be stored and used for up to 30 days after first opening if the following steps are taken:
DO NOT leave vaccine in the draw off tube or vaccinator after work day.
Additional Information
Withholding period: Nil.
Schedule: Nil.
NOTE: Sheep and goats treated with this vaccine are likely to give positive results when tested for tuberculosis or Johne's disease.
Registered Label Warnings
Side Effects:
  • After vaccination a firm swelling usually develops at the site of injection. 2 months after vaccination most swellings will have decreased in size, and they usually continue to decrease over time. It is not unusual for an injection site nodule to appear 7-15 days after vaccination, which in a small proportion of animals may become larger than 5 cm in diameter, however the majority if site reactions will be less than 2 cm diameter when the recommended vaccination technique is followed.  When this vaccine is administered to animals already infected with or sensitised to M. paratuberculosis, a more intense focal reaction (secondary immune response) can occur.
  • In a small proportion (5%) of animals the swelling may develop into an abscess and burst. This may attract flies. Accordingly, vaccinated animals should be checked regularly for fly strike and be treated where necessary. Alternatively, preventative fly strike treatments should be given. Vaccinated animals, if sent for slaughter soon after vaccination, may be subject to additional trimming due to vaccination injection site reactions.
User Safety Information:

Ensure that the vaccine does not enter your body through contact with the needle (self-injection, needle scratch, etc) or entry through an open wound. Be especially careful that it doesn't enter your body through contact with eyes, mouth and skin, because the vaccine is an irritant. Wash your hands thoroughly with soap and water after use, especially if the vaccine comes into contact with your skin.

GUDAIR Vaccine contains mineral oil. Even when a small amount is accidentally injected into a human, intense swelling and a persistent granulomatous inflammatory reaction can occur. If injected into a finger joint or tendon sheath, the product may track along the tendon. The swelling and inflammation post injection may compromise blood supply and result in necrosis. In rare cases this can lead to the loss of a digit. Given the potential for serious side effects, all persons should seek prompt medical attention. Every case is different and the correct medical advice is a matter for the treating physician.

  

1. In the case of superficial skin exposure, eye exposure and oral ingestion:

• Skin contact: wash the contaminated area with warm soapy water.

• Eye splash: remove contact lens if worn and rinse eyes thoroughly with cool water from a running tap or a cup/jug and continue to flush for at least 15 minutes.

• Oral ingestion: rinse mouth with cool water.

2. In the case of needle-stick injuries without known injection of vaccine:

• Allow the wound to bleed freely and do not squeeze or otherwise interfere with the wound or injection site. Then wash the wound thoroughly with warm water and keep clean and dry.

3. In the case of actual injection of vaccine:

• Acute pain and inflammation are usually still evident 24 hours after the suspected injection occurred.

• In cases of self-injection, surgical attention is required.

Contact a doctor as soon as possible, even if only a very small amount is injected, and take this package leaflet/carton with you.

Further information on the treatment of accidental human exposure is available from the Poisons Information Centre 13 11 26 or Zoetis Product Services  1800 814 883.

Information for healthcare professionals about human accidental self-injection and exposure to Gudair® vaccine

 

What is Gudair vaccine used for?

Gudair vaccine is used in sheep and goats to protect them from a wasting disease known as Johne’s disease. Johne’s disease is caused by Mycobacterium paratuberculosis. 

What is contained in Gudair vaccine?

Each dose of Gudair vaccine contains:

  • Killed Mycobacterium paratuberculosis organisms (heat inactivated)
  • Mineral Oil
  • Thiomersal (preservative)

The oil typically forms a depot at the injection site to act as a potent adjuvant in stimulating a cell-mediated immune response to the mycobacteria. The action of the adjuvant and antigen

combination in this vaccine produces a reaction similar to that elicited by Freund’s complete adjuvant. 

Accidental self-injection

Gudair vaccine contains mineral oil. Even when a small amount is accidentally injected into a human, intense swelling and a persistent granulomatous inflammatory reaction can occur. If injected into a finger joint or tendon sheath, the product may track along the tendon. The swelling and inflammation post injection may compromise blood supply and result in necrosis. In rare cases this can lead to the loss of

a digit. Given the potential for serious side effects, all persons should seek prompt medical attention. Every case is different and the correct medical advice is a matter for the treating physician. 

Some common strategies recommended by healthcare professionals

We are aware of the following treatment strategies being frequently recommended by physicians in the past:

  1. In the case of superficial skin exposure, eye exposure and oral ingestion:
  • Skin contact: doctors have recommended washing the contaminated area with warm soapy water.
  • Eye splash: doctors have recommended that any contact lens be removed, and eyes be rinsed thoroughly with cool water from a running tap or a cup/jug and continue to flush for at least 15 minutes.
  • Oral ingestion: doctors have recommended the mouth be rinsed out with cool water.
  1. In the case of needle-stick injuries without known injection of vaccine:
  • Doctors have recommended that the wound be allowed to bleed freely and that the wound or injection site not be squeezed or otherwise interfered with. Doctors have recommended that the wound then be cleaned thoroughly with warm water and then kept clean and dry.
  • Doctors have also considered that, following appropriate immediate local cleansing, corticosteroids may decrease the severity of any local reaction.
  • Doctors have frequently determined the patient’s tetanus immunisation status and administered booster or primary series, as appropriate.
  • Commonly, if there is no pain or swelling 24 hours post exposure, doctors have continued to monitor for at least a month and treat any clinical symptoms accordingly. If pain and swelling is present after 24  hours,  doctors  have  considered  that  it  is  a  case  of  accidental  injection and have treated the injury as described below.
  1. In the case of actual injection of Gudair vaccine:
      • Doctors have observed that acute pain and inflammation is usually still evident 24 hours after the suspected injection occurred.
      • In cases of self-injection, doctors have considered that prompt surgical attention has been required and, in those case, the doctors have:
        • incised the wound to remove the vaccine, especially where there is involvement of finger pulp or tendon;
        • in the case of a lesion that has progressed to necrosis or granulomatous ulceration,physicians have performed surgical debridement to remove residual vaccine material.
      • Doctors have stated that meticulous technique has been required to stop inadvertent spread of the product during surgery.

          Given the nature of this Freund’s like vaccine, Zoetis recommends that any healthcare professional speak with a surgeon who has experience with the treatment of cases of accidental self-injection of Gudair to ensure the appropriate treatment is advised.

          Relevant published information:

          If you would like further information, we are happy to provide copies of the following published materials:

          1. Richardson GD, Links II, Windsor PA. Gudair (OJD) vaccine self-inoculation: a case for early debridement. MJA, 183, 3, 1 August 2005.
          2. Windsor PA, Bush R, Links I and Eppleston G. Injury caused by self-inoculation with a vaccine of a Freund’s complete adjuvant nature (Gudair TM) used for control of ovine paratuberculosis. Aust Vet J, 83:216-220, 2005.
          3. Jones DPG: Accidental self-inoculation with oil based veterinary vaccines. NZ Med J, 109: 363-365, 1996.
          4. Patterson CJ et al.,: Accidental self-inoculation with Mycobacterium paratuberculosis bacteria by veterinarians in Wisconsin. JAVMA, 192, 9, 1197-9, 1988.
          5. Bjornsson A et al.,: Paratuberculosis of the hand: Case Report. Scand J Plast Reconstr Surg, 5: 156- 160, 1971.

          Click here to download this information.

          Zoetis’ contact details

          If presented with a case of accidental self-injection or possible self-injection, medical professionals are advised to contact Zoetis on 1800 814 883. Zoetis can assist in providing further information.

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