PORCILIS® M HYO ID ONCE

Porcilis® M Hyo ID Once is indicated for the active immunisation of grower pigs to reduce pulmonary lesions due to infection caused by Mycoplasma hyopneumoniae.

FOR ANIMAL USE ONLY

PORCILIS® M HYO ID ONCE
Emulsion for injection
Reg. No. G4299 (Act 36/1947)

Only for use by or under the supervision of persons registered in terms of, or authorised in terms of, Section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS
Porcilis® M Hyo ID Once is indicated for the active immunisation of grower pigs to reduce pulmonary lesions due to infection caused by Mycoplasma hyopneumoniae.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 22 weeks for pigs.

COMPOSITION
Each dose of 0,2 mℓ contains inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: 1,0 PCVU1 inducing ≥ 6,5 log2 Ab titre.*
34,6 mg light liquid paraffin
2,5 mg dl-α-tocopherol acetate
        1 packed cell volume units
*mean antibody titre (Ab) in mice.

STORAGE

  • Store between 2 °C to 8 °C.
  • Do not freeze.
  • Protect from direct sunlight.
  • Once the vial has been broached, the vaccine must be used within 3 hours.

WARNINGS

  • Withdrawal period: Do not slaughter animals for human consumption for at least 21 days
  • after vaccination.
  • Vaccinate healthy animals only.
  • Do not use during pregnancy and lactation. Vaccinate at least 21 days before breeding.
  • 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.
  • Do not store partially used containers for future use, and use the entire contents once opened.
  • 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.

SPECIAL WARNINGS
To the user:
Porcilis® M Hyo ID Once contains a mineral oil. Accidental self-injection may result in severe pain and swelling, particularly if administered into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidently injected with this product, seek prompt medical advice even if only a very small amount is administered and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:
Porcilis® M Hyo ID Once contains a mineral oil. Accidental self-injection may result in severe pain and swelling, particularly if administered into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidently injected with this product, seek prompt medical advice even if only a very small amount is administered and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (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 first opened and do not store unused contents and containers for future use.
  • Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Adhere to the vaccination programme to obtain optimum results.

SIDE EFFECTS
The following side effects may be noticed, but will subside:
A transient increase in body temperature may occur on the day of vaccination. The animals return to normal 1 to 2 days after the peak temperature is observed. Transient local reactions mostly consisting of hard non-painful button-like swellings and can be observed in the majority of the animals for up to 21 days.
Consult a veterinarian if symptoms persist.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Shake well before use and at regular intervals during the vaccination process.
  • Route of administration is via intradermal vaccination.
  • Ensure that all animals are vaccinated.
  • For the vaccination of grower pigs.
  • Safety and efficacy data are available which demonstrate that Porcilis® M Hyo ID Once can be given with Porcilis® PCV ID at different sites on the same day from 3 weeks of age.
  • The possible side effects are as presented above. If any symptoms appear abnormal or do not subside, a veterinarian should be consulted.
  • Do not mix with any other veterinary medicinal product, except Porcilis® PCV ID as stated above.
  • Before using the vaccine allow it to reach room temperature of 15 °C to 25 °C by placing the vial in a suitable container containing 500 mℓ of water at 25 °C for 10 minutes just before use.
  • Remove the aluminium overseal just before the vaccine is ready for use.

DOSAGE (AND ADMINISTRATION)
Once the vial has been broached, the vaccine must be used within 3 hours.
Intradermal administration of 0,2 mℓ per animal preferably at the sides of the neck along the muscles of the back using a suitable intradermal device.
Vaccination scheme: Vaccinate once from an age of 2 weeks onwards.
Porcilis® M Hyo ID Once is efficacious in the presence of maternally derived antibodies (MDA).
The container is not opened for use but inserted into the intradermal device. Using the intradermal device, the vaccine is administered using pressure (i.e. without a needle).

PRESENTATION
Porcilis® M Hyo ID Once is presented in 10 and 20 mℓ glass vials closed with a rubber
stopper and sealed with a coded aluminium cap.
Porcilis® M Hyo ID Once is presented in 20 mℓ polyethylene vials closed with a rubber stopper and sealed with a coded aluminium cap.
Pack sizes: 50 or 100 doses filled in 10 or 20 mℓ vials may be packed single or in packs of 5 or 10 vials. 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
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT
6 December 2018

SLEGS VIR DIEREGEBRUIK

PORCILIS® M HYO ID ONCE
Emulsie vir inspuiting
Reg. No. G4299 (Act 36/1947)

Slegs vir gebruik deur of onder die toesig van persone geregistreer in terme van, of daartoe gemagtig in terme van, Artikel 23 (1) (c) van die Wet op Veterinêre en Para-Veterinêre Beroepe, 1982 (Wet Nr. 19 van 1982).

INDIKASIES
Porcilis® M Hyo ID Once word aangedui vir die aktiewe immunisering van groeivarke om pulmonale letsels te verminder weens infeksie wat veroorsaak word deur Mycoplasma hyopneumoniae.
Aanvang van immuniteit: 3 weke na inenting.
Duur van immuniteit: 22 weke vir varke.

SAMESTELLING
Elke 0,2 mℓ dosis bevat geïnaktiveerde heel selkonsentraat van Mycoplasma hyopneumoniae stam 11: 1,0 PCVU1 wat ≥ 6,5 log2 Ab titer* induseer.
34,6mg ligte vloeibare paraffien
2,5 mg dl-α-tokoferolasetaat
     1verpakte sel volume eenhede
*gemiddelde teenliggaamtiter (Ab) in muise.

BERGING
WAARSKUWINGS

  • Onttrekkingsperiode: Diere moet vir ten minste 21 dae ná enting nie vir menslike verbruik geslag word nie.
  • Maak seker dat bemarkte diere nie plaaslike reaksies (swellings) het op die plek van entstoftoediening, of verhoogde temperatuurreaksies (koors) het nie, aangesien dit kan lei tot die afkeuring van die karkasse.
  • Slegs gesonde diere mag geënt word.
  • Moenie binne 2 weke van antimikrobiese behandeling gebruik nie.
  • Moenie binneaars toedien nie.
  • Moenie gedeeltelik gebruikte flessies bêre vir latere gebruik nie en gebruik die totale inhoud wanneer oopgemaak.
  • Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

SPESIALE WAARSKUWINGS
Vir die gebruiker:
Porcilis® M Hyo ID Once bevat ‘n mineraalolie. Toevallige selfinspuiting mag lei tot erge pyn en swelling, veral wanneer dit in ‘n gewrig of ‘n vinger toegedien word, en in seldsame gevalle kan dit lei tot die verlies van die aangetaste vinger indien onmiddellike mediese aandag nie verkry word nie. As u per ongeluk met hierdie produk ingespuit word, verkry onmiddelik mediese advies, selfs as slegs ‘n baie klein hoeveelheid toegedien is en neem hierdie voubiljet saam met u. As pyn vir meer as 12 uur na die mediese ondersoek voortduur, moet u weer mediese advies aanvra.

Vir die dokter:
Porcilis® M Hyo ID Once bevat ‘n mineraalolie. Selfs as ‘n klein hoeveelheid per ongeluk ingespuit is, kan dit intense swelling veroorsaak, wat byvoorbeeld kan lei tot iskemiese nekrose en selfs die verlies van ‘n vinger veroorsaak. Kundige, VINNIGE, chirurgiese aandag word benodig en kan vroeë insnyding en irrigasie van die ingespuite gebied noodsaak, veral waar daar vingerpulp of -ligament betrokke is.

VOORSORGMAATREëLS

  • Aseptiese voorsorgmaatreëls moet nagekom word. Verseker dat alle entstoftoerusting (entstofflessies, inspuitings en naalde) skoon en steriel is voor en gedurende gebruik.
  • Moenie ontsmettings- of antiseptiese middels gebruik om toerusting of drinkwatertoerusting te steriliseer nie.
  • Gebruik die totale inhoud sodra oopgemaak en moenie ongebruikte entstof en flessies bêre vir latere gebruik nie.
  • Doen weg met alle ongebruikte entstof asook alle leë entstofflessies en entstoftoerusting in ooreenstemming met die Nasionale Omgewingsbestuur: Afval Bestuur Wet, 2008 (Wet Nr. 59 van 2008).
  • Volg die inentingsprogram om optimale resultate te verkry.

KONTRA-INDIKASIES
Geen.

NEWE-EFFEKTE
‘n Verbygaande toename in liggaamstemperatuur mag op die dag van inenting plaasvind. Die diere sal binne 1 tot 2 dae, nadat die piek temperature waargeneem is, weer terugkeer na normaal. Verbygaande plaaslike reaksies, wat meestal uit harde, nie-pynlike, knoppieagtige swellings bestaan kan by die meerderheid van die diere opgemerk word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

  • Skud goed voor gebruik en met gereelde tussenposes tydens gebruik.
  • Vir immunisering van groeivarke.
  • Veiligheids- en effektiwiteitsdata is beskikbaar wat bewys dat Porcilis® M Hyo ID Once saam met Porcilis® PCV ID, by verskillende inspuitingsplekke, op dieselfde dag gegee kan word, vanaf ‘n ouderdom van 3 weke. Enige moontlike newe-effekte word onder NEWE-EFFEKTE genoem. Porcilis® PCV ID se produkliteratuur moet geraadpleeg word.
  • Moenie met enige ander veterinêre medisinale produk gemeng word nie.
  • Voor gebruik, laat die entstof kamertemperatuur van tussen 15 °C en 25 °C bereik, deur die flessie vir 10 minute in ‘n geskikte houer te plaas wat 500 mℓ water teen 25 °C bevat.
  • Verwyder die aluminiumseël net voor gebruik en die entstof is gereed vir gebruik.
  • Toedieningsroete deur middel van intradermale inenting.
  • Verseker dat alle diere ingeëent is.
  • Waterbehandeling of -bespuiting: verseker dat skoon, drinkbare, ongeklorineerde water gebruik word. Die water en toerusting moet geen spore van skoonmaakmiddels of ontsmettingsmiddels bevat nie.

DOSIS EN TOEDIENING
Die entstof moet binne 3 ure, nadat die flessie die eerste keer oopgemaak is, gebruik word.
Intradermale toediening van 0,2 mℓ per dier, verkieslik aan die kante van die nek, langs die spiere van die rug, met behulp van ‘n geskikte intradermale apparaat.
Inentingskema: Eenmalig vanaf 2 weke oud.
Porcilis® M Hyo ID Once is doeltreffend in die teenwoordigheid van moederteenliggaampies.
Die flessie word nie oopgemaak vir gebruik nie, maar in die intradermale toestel geplaas. Met behulp van die intradermale apparaat word die entstof toegedien met behulp van druk (d.w.s. sonder ‘n naald).

AANBIEDING
Porcilis® M Hyo ID Once word aangebied in 10 en 20 mℓ glasflessies toegemaak met ‘n rubberstopper en verseël met ‘n gekodeerde aluminiumproppie.
Porcilis® M Hyo ID Once word aangebied in 20 mℓ poliëtileenflessies toegemaak met ‘n rubberstopper en verseël met ‘n gekodeerde aluminiumproppie.
Verpakkingsgroottes: 50 of 100 dosisse gevul in 10 mℓ of 20 mℓ flessies wat enkel, of in pakke van 5 of 10 flessies verpak word.
Nie alle verpakkingsgroottes word noodwendig bemark nie.

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 BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
6 December 2018