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.
  • Shelf-life after first opening the vial: 3 hours.

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 (eg. 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
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za           

MANUFACTURER
Intervet International B.V.
35 Wim de Körverstraat
Boxmeer, The Netherlands

DATE OF PUBLICATION OF PACKAGE INSERT

28 January 2020

SLEGS VIR DIEREGEBRUIK

PORCILIS® GLäSSER
Reg. No. G4402 (Act 36/1947)

INDIKASIES
Porcilis® Glässer is aangedui vir die aktiewe immunisering van varke, as ‘n hulpmiddel in beskerming teen die kliniese tekens van Glässer se siekte, wat veroorsaak word deur Haemophilus parasuis serotipe 5.
Vir die passiewe immunisering van die nageslag van geënte sôe en jong sôe om kliniese tekens en sterftes, wat veroorsaak word deur Haemophilus parasuis serotipe 4 en 5 te verminder.
Aanvang van immuniteit: 2 weke na die skraagdosis.
Duur van immuniteit: tot en met ‘n ouderdom van ten minste 23 weke.

SAMESTELLING
Elke 2 mℓ dosis bevat onaktiewe heelselkonsentraat van Haemophilus parasuis serotipe 5, stam 4800 met 0,05 mg TN en 150 mg dl-α-tokoferolasetaat as adjuvant.

BERGING

  • Berg tussen 2 °C en 8 °C.
  • Moenie vries nie.
  • Rakleeftyd na eerste oopmaak van flessie: 3 ure.

WAARSKUWINGS

  • Ontrekkingsperiode: Diere moet vir ten minste 21 dae na inenting nie vir menslike gebruilk geslag word nie*.
  • Verseker dat bemarkte diere geen lokale reaksies (swelling) by die inentingsplek, of verhoogde temperatuur reaksies (koors) het nie, omdat dit veroordeling van die karkaste kan veroorsaak
  • Ent slegs gesonde diere
  • Moet NIE met enige ander entstof of immunologiese produk meng nie.
  • Moenie binne 2 weke na antimikrobiese behandling gebruik nie.
  • Geen inligting oor die verenigbaarheid van Porcilis® Glässer met enige ander entstof is beskikbaar nie. Daarom is die veiligheid en effektiwiteit van Porcilis® Glässer, wanneer dit saam met enige ander produk gebruik word (of dit op dieselfde dag of op verskillende tye gebruik word), nie bepaal nie.
  • In die geval van toevallige self-inspuiting, verkry dadelik mediese advies en toon hierdie voubiljet aan die geneesheer.
  • Moenie binneaars inspuit nie.
  • Moenie ongebruikte houers vir toekomende gebruik hou nie en gebruik die hele inhoud as die houer eers oopgemaak is.
  • Doen weg met enige ongebruikte entstof asook alle leë entstofhouers en wegdoenbare enstoftoerusting volgens die Nasionale Omgewingsbestuur: Afval Bestuur Wet, 2008 (Wet 59 van 2008).
  • Moenie waterbronne besoedel nie.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof breedvoerig onder ʼn wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ʼn veearts en verwittig die registrasiehouer.

DRAGTIGHEID EN LAKTASIE
Kan gedurende dragtigheid gebruik word.

*21 dae is ‘n standaard onttrekkingsperiode vasgestel volgens Suid-Afrikaanse wetgewing vir alle entstowwe. lndien voorgeskryf deur nasionale wetgewing, mag ‘n ander onttrekkingsperiode ook gelisensieerd wees, bv. 0 dae.

VOORSORGMAATREëLS

  • Aseptiese voorsorgmaatreëls moet nagekom word. Daar moet verseker word dat alle entstoftoerusting (bv. naalde, spuite ens.) skoon en steriel is voor en tydens gebruik.
  • Moenie ontsmettingsmiddels of antiseptiese middels op toerusting gebruik nie.
  • Voldoen aan n ineëntings program om optimum resultate kry.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Skud goed voor en gereeld tussen gebruik.
Vir die inenting van varke ten minste 5 weke oud.
Laat toe dat die entstof omgewingstemperatuur (20 °C tot 25 °C) bereik voor gebruik.
Haal die aluminium oor-seël af net voor die enstof reg is om te gebruik.
Dien 2 mℓ (1 dosis) van die entstof, binnespiers in die vark se nek toe.
Inentingskema vir varke
Ent varke teen ‘n ouderdom van ten minstens 5 weke, twee keer met ‘n tussenpose van 2 weke.
Inentingskema vir sôe Ent sôe op 6 tot 8 weke voor die verwagte tyd van jonging, twee keer met ‘n tussenpose van 4 weke.
Herinentingskema vir sôe
Vir sôe wat gedurende ‘n vorige dragtigheid ingeënt was, word ‘n enkele herinenting teen 4 tot 2 weke voor jonging aanbeveel.
Daar word aanbeveel dat varke ingeënt word indien infeksie met Haemophilus parasuis, plaasvind in diere wat ouer is as die ouderdom van diere wat deur passiewe immuniteit beskerm word. In die geval van vroeër infeksies, moet sôe ingeënt word.

ONGEWENSTE REAKSIES
‘n Styging in liggaamstemperatuur, in kombinasie met tekens van algemene ongemak kan vir 1 tot 3 dae na immunisering waargeneem word.
Lokale reaksies verdwyn of verminder duidelik 14 dae na inenting. Sistemiese anafilaktiese reaksies mag in baie seldsame gevalle voorkom.

AANBIEDING
Flessies van poliëtileenteraftelaat (PET) of Tipe I (Ph. Eur) helder glasflessies wat 50 mℓ (25 dosisse) of 100 mℓ (50 dosisse) bevat. Dit word toegemaak met ‘n ligtegrys halogeenbutiel-rubberstopper en geseël met ‘n gekodeerde aluminiumdoppie.

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

VERVAARDIGER    
Intervet International B.V.
35 Wim de Körverstraat
Boxmeer, The Netherlands

DATUM OF PUBLIKASIE VAN HIERDIE VOUBILJET

TBA