PORCILIS® GLäSSER

For the active immunisation of pigs, as an aid in protection against clinical signs of Glässer’s disease caused by Haemophilus parasuis serotype 5.

FOR ANIMAL USE ONLY

PORCILIS® GLäSSER

Reg. No. G4402 (Act 36/1947)

INDICATIONS

Porcilis® Glässer is indicated for the active immunisation of pigs, as an aid in protection against clinical signs of Glässer’s disease caused by Haemophilus parasuis serotype 5.

For passive immunisation of the progeny of vaccinated sows and gilts to reduce clinical signs and mortality caused by Haemophilus parasuis serotypes 4 and 5.

IMMUNITY

Onset of immunity: 2 weeks after booster injection.

Duration of immunity: until an age of at least 23 weeks.

COMPOSITION

Each 2 mℓ dose contains 200 mg inactivated whole cell concentrate of Haemophilus parasuis serotype 5, strain 4800 containing 0,05 mg TN with 150 mg dl-α-tocopherol acetate as adjuvant.

STORAGE INSTRUCTIONS

  • Store between 2 °C and 8 °C (in a refrigerator, in the original package).
  • Do not freeze.
  • Use broached vials immediately.

WARNINGS

  • Withdrawal period: 21 days. 
  • Ensure that marketed animals do not have local reactions (swellings) at the site of vaccine administration, or elevated temperature reactions (fever) as this may result in the condemnation of the carcasses.
  • Vaccinate healthy animals only.
  • Do NOT mix with any other vaccine or immunological product.
  • Do not use within 2 weeks of antimicrobial treatment.
  • No information is available on the compatibility of Porcilis® Glässer with any other vaccine or medication. Therefore, the safety and efficacy of Porcilis® Glässer when used with any other product (either when used on the same day or at different times) has not been demonstrated.
  • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
  • Do not inject intravenously.
  • 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.

PREGNANCY AND LACTATION

Can be used during pregnancy.

PRECAUTIONS

  • Wear protective clothing, masks, gloves etc. according to hazard standards.
  • Avoid contact of the vaccine with skin, eyes and mouth.
  • Do not eat, drink or smoke whilst handling the vaccine.
  • Observe aseptic precautions. Ensure that all vaccination equipment (e.g. containers, syringes and needles) are clean and sterile prior to and during use.
  • Do not use disinfectants or antiseptics to sterilise any equipment or drinking water equipment.
  • Use entire contents when container is first opened and do not store unused containers for future use.
  • Adhere to the vaccination programme to obtain optimum results.
  • Dispose of any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with local waste disposal regulations.
  • Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake well before and at regular intervals during use.

For the vaccination of pigs of at least 5 weeks of age.

Allow vaccine to gradually reach room temperature (20 °C to 25 °C) prior to use.

Remove the aluminium over-seal just before the vaccine is ready for use.

Administer 2 mℓ (1 dose) of the vaccine intramuscularly in the neck of the pig.

Ensure that all animals are vaccinated.

Vaccination scheme for pigs

Vaccinate pigs, of at least 5 weeks of age, twice with an interval of 2 weeks.

Vaccination scheme for sows

Vaccinate sows, at 6 to 8 weeks before expected time of farrowing, twice with an interval of

4 weeks.

Revaccination scheme for sows

For sows vaccinated during the previous pregnancy, a single revaccination at 4 to 2 weeks before farrowing is recommended.

It is advisable to vaccinate pigs if the infection of Haemophilus parasuis takes place in animals older than the age animals are protected by passive immunity. In case of earlier infections, sows should be vaccinated.

ADVERSE REACTIONS

An increase in body temperature in combination with signs of general discomfort may be observed up to 1 to 3 days after vaccination.

Local reactions disappear or clearly diminish 14 days after vaccination.

Systemic anaphylactic reactions may occur in very rare cases.

PRESENTATION

Clear vials of polyethylene terephthalate (PET) containing 20 mℓ, 50 mℓ (25 doses) or 100 mℓ (50 doses), closed with a light grey halogenbutyl rubber stopper and sealed with a coded aluminium cap.

Not all pack sizes may necessarily 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 28 January 2020