PORCILIS® PCV ID

Inactivated vaccine emulsion for intradermal injection for pigs.

FOR ANIMAL USE ONLY

PORCILIS® PCV ID
Inactivated vaccine emulsion for intradermal injection for pigs.
Reg. No. G4354 (Act 36/1947)

INDICATIONS

For the active immunisation of pigs to reduce viremia, virus load in lungs and lymphoid tissues and virus shedding, caused by PCV2 infection. In addition, to reduce loss of daily weight gain and mortality associated with PCV2 infection.

IMMUNITY

Onset of immunity: 2 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.

COMPOSITION

Each dose of 0,2 mℓ contains:

Porcine circovirus type 2 ORF2 subunit antigen             ≥1 436 AU1

dl-α-tocopheryl acetate                                                     0,6 mg

Light liquid paraffin                                                           8,3 mg

1Antigenic units as determined in the in vitro antigenic mass assay.

STORAGE

  • Store between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.
  • Do not use after the expiry date which is stated on the label.
  • In-use shelf life after opening the vial: 8 hours when stored between 2 °C and 8 °C.

WARNINGS

  • Withdrawal period: 21 days.
  • Vaccinate healthy animals only.
  • Do not mix with any other vaccine
  • or veterinary medicinal product, except for those as described under
  • INTERACTIONS”.
  • Transient local reactions, mostly consisting of hard non-painful swellings of a diameter of up to 2 cm are very common. A biphasic pattern of the local reactions, consisting of an increase and decrease, followed by another increase and decrease of the size, is commonly observed. In individual pigs the size may increase to 4 cm and redness may be observed. The local reactions disappear completely within approximately 5 weeks after vaccination.
  • Do not store partially used vaccine vials for future use.
  • Destroy any unused vaccine,
  • empty vaccine vials, needles etc. in accordance with local waste disposal regulations after completion of vaccination.
  • 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.

PRECAUTIONS

Special precautions to be taken by the person administering Porcilis® PCV ID to animals

To the user

  • Observe aseptic precautions. Ensure that vaccination equipment is clean and sterile before and during use.
    • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
    • Do not use vaccination equipment with rubber parts, as the excipient may damage certain types of rubber.
    • Porcilis® PCV ID contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected 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 accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected 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® PCV ID contains mineral oil. Even if small amounts have been administered, accidental administration with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the administration area, especially where there is involvement of a finger pulp or tendon.

INTERACTIONS

Safety and efficacy data are available which demonstrate that Porcilis® PCV ID can be given with Porcilis® M Hyo ID Once at different injection sites on the same day from 3 weeks of age.
The product literature of Porcilis® M Hyo ID Once should be consulted. In the case both vaccines are used at the same day, the size of the local reactions may increase up to 6 cm in individual pigs and may last 5 weeks. Moreover, a transient increase in body temperature on the day of vaccination of about 0,2 °C is common. In individual pigs this temperature may increase up to 2 °C. The animal’s temperature returns to normal within 1 to 2 days after the peak temperature is observed.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product must be made on an individual basis.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage and administration

  • Intradermal administration of 0,2 mℓ per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg using a multi-dose needle-free injection device for intradermal application of liquids, suitable to deliver a “jet-stream” volume of vaccine (0,2 mℓ ± 10 %) through the epidermal layers of the skin.
  • Safety and efficacy of Porcilis® PCV ID have been demonstrated using the device IDAL (a revolutionary needle-free vaccination device, that allows intradermal application of swine vaccines).

Vaccination scheme

  • Vaccinate once from an age of 3 weeks onwards.
  • Allow the vaccine to reach room temperature before use. Shake well before use.
  • Avoid multiple broaching of the 10 mℓ vial.

IDENTIFICATION

Homogenous, white to nearly white emulsion after shaking.

PRESENTATION

Glass vial (type I) of 10 mℓ closed with a grey, nitryl-based rubber stopper and sealed with an olive brown aluminium cap.
Clear, PET (polyethylene terephthalate) vial of 20 mℓ, closed with a nitryl-based rubber stopper and sealed with an olive brown aluminium cap.
Pack size:
Cardboard box with 1 or 10 glass vials. Cardboard box with 1 or 10 PET vials.
Not all pack sizes may be marketed.

MANUFACTURER
Intervet International B.V.
35 Wim de Körverstraat
5831 AN Boxmeer
The Netherlands

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

DATE OF PUBLICATION OF PACKAGE INSERT

29 July 2019

SLEGS VIR DIEREGEBRUIK

Porcilis® PCV ID
Geïnaktiveerde entstofemulsie vir intradermale inspuiting vir varke.
Reg. Nr. G4354 (Wet 36/1947)

INDIKASIES

Vir die aktiewe immunisering van varke om viremie, viruslading in longe en limfoïedweefsel en virusafwerping, veroorsaak deur PCV2 infeksie te verminder. Daarbenewens om die verlies van daaglikse gewigstoename en mortaliteit geassosieer met PCV2-infeksie, te verminder.
Aanvang van immuniteit: 2 weke na inenting.
Duur van immuniteit: 23 weke na inenting.

SAMESTELLING

Elke dosis van 0,2 mℓ bevat:
Vark Circo Virus tipe 2 ORF2 subeenheid antigeen        ≥1 436 AE1
dl-α-tokoferolasetaat                                                         0,6 mg
Ligte vloeibare paraffien                                                   8,3 mg

1Antigeniese eenhede soos bepaal in die in vitro antigeniese massatoets.

BERGING

  • Berg in die donker tussen 2 ºC en 8 ºC.
  • Moenie vries nie.
  • Beskerm teen lig.
  • Moenie gebruik na die vervaldatum soos op die etiket aangedui nie.
  • In-gebruik rakleeftyd nadat die flessie oopgemaak is: 8 ure indien dit geberg word tussen 2 ºC en 8 ºC.

WAARSKUWINGS

  • Onttrekkingsperiode: Geen.
  • Slegs gesonde varke mag ingeënt word.
  • Moenie met enige ander veterinêre medisinale produk meng nie, behalwe dit wat onder “INTERAKSIES” beskryf word.
  • Tydelike lokale reaksies meestal bestaande uit harde nie-pynlike swelsels, met ‘n deursnee van tot 2 cm is baie algemeen. ‘n Twee-fase patroon van lokale reaksies, wat bestaan uit ‘n toename en afname gevolg deur nog ‘n verhoging en verlaging van die grootte, word algemeen waargeneem. In individuele varke kan die grootte verhoog tot 4 cm en rooiheid kan waargeneem word. Die lokale reaksies verdwyn heeltemal binne ongeveer 5 weke na inenting.
  • Gedeeltelik gebruikte entstofhouers moet nie vir latere gebruik bewaar word nie.
  • Vernietig alle ongebruikte entstof, leë entstofhouers, naalde ens. soos voorgeskryf deur plaaslike afvalbestuursregulasies, na voltooiing van inenting.
  • HOU BUITE DIE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof 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.

VOORSORGMAATREëLS

Spesiale voorsorgmaatreëls wat geneem moet word deur die persoon wat Porcilis® PCV ID vir diere toedien.

Aan die gebruiker

  • Aseptiese voorsorgmaatreëls moet nagekom word. Daar moet verseker word dat alle entstoftoerusting skoon en steriel is voor en tydens gebruik.
  • Dit is goeie inentingspraktyk wanneer entstowwe hanteer word, om kontak met die oë, hande en klere te vermy.
  • Moenie entstoftoerusting gebruik met enige rubber dele nie aangesien die hulpstowwe sekere tipes rubber kan beskadig.
  • Porcilis® PCV ID bevat mineraalolie. Toevallige inspuiting/selfinspuiting kan lei tot erge pyn en swelling, veral as dit ingespuit word in ‘n gewrig of vinger, en in rare gevalle kan dit lei tot die verlies van die geaffekteerde vinger, as daar nie vinnige mediese aandag gekry word nie. Indien selfinspuiting plaasgevind het met hierdie produk, moet mediese advies dadelik verkry word, selfs al is dit net ‘n baie klein hoeveelheid wat ingespuit is. Neem die voubiljet saam na die geneesheer. As pyn voortduur vir meer as 12 uur na mediese ondersoek, kry weer mediese hulp.

Aan die dokter

  • Porcilis® PCV ID bevat mineraalolie. Selfs al is ‘n klein hoeveelheid toegedien, kan selfinspuiting met hierdie produk intense swelling veroorsaak, wat byvoorbeeld kan lei tot iskemiese nekrose en selfs die verlies van ‘n vingerlit. Kundige, VINNIGE, chirurgiese aandag mag vereis word en vroegtydige insnyding en irrigasie van die toedieningsarea mag nodig wees, veral waar daar ‘n vingerlitweefsel of sening betrokke is.

INTERAKSIES

Veiligheids- en effektiwiteitsdata is beskikbaar wat aandui dat Porcilis® PCV ID op dieselfde dag, saam met Porcilis® M Hyo ID ONCE op verskillende toedieningsplekke, vanaf 3 weke oud toegedien kan word. Die produkliteratuur van Porcilis® M Hyo ID ONCE moet geraadpleeg word.
In die geval waar beide entstowwe gebruik word op dieselfde dag, mag die grootte van die plaaslike reaksies verhoog tot 6 cm in individuele varke en kan tot 5 weke duur. Daarbenewens is ‘n verbygaande toename in liggaamstemperatuur van ongeveer 0,2 °C op die dag van inenting, algemeen. In individuele varke kan hierdie temperatuur verhoog tot 2 °C. Die diere se temperatuur keer terug na normaal binne 1 tot 2 dae na die piektemperatuur waargeneem is.
Geen inligting oor die veiligheid en doeltreffendheid van Porcilis® PCV ID wanneer dit saam met enige ander veterinêre medisinale produk gebruik word, is beskikbaar nie. ‘n Besluit om Porcilis® PCV ID te gebruik voor of na enige ander veterinêre medisinale produk moet dus op ‘n individuele basis gemaak word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Dosis en toediening

  • Intradermale toediening van 0,2 mℓ per dier, verkieslik aan die kante van die nek, langs die spiere van die rug of in die agterbeen, met behulp van ‘n multidosis naaldvrye inspuitingstoestel vir intradermale toediening van vloeistowwe, geskik om ‘n “straalstroom” volume van entstof te lewer (0,2 mℓ ± 10 %) deur die epidermale lae van die vel.
  • Die veiligheid en doeltreffendheid van Porcilis® PCV ID is gedemonstreer met behulp van die toestel IDAL (‘n revolusionêre naaldvrye doseerspuit, wat intradermale toediening van varkentstowwe moontlik maak).

Inentingsprogram

  • Eenmalige inenting vanaf die ouderdom van 3 weke.
  • Laat die entstof toe om kamertemperatuur te bereik voor gebruik. Skud goed voor gebruik.
  • Vermy veelvuldige penetrasie van die 10 mℓ flessie.

IDENTIFIKASIE

Homogene, wit tot byna wit emulsie na geskud is.

AANBIEDING

Glasflessie (tipe I) van 10 mℓ geseël met ‘n grys, nitriel gebaseerde rubberprop en verseël met ‘n olyf-bruin aluminiumdoppie.
Deursigtige, PET (poliëtileentereftalaat) flessie van 20 mℓ geseël met ‘n nitriel gebaseerde rubberprop en verseël met ‘n olyf-bruin aluminiumdoppie.
Verpakkingsgrootte:
Kartonhouer met 1 of 10 glasflessies. Kartonhouer met 1 of 10 PET flessies.
Nie alle verpakkingsgroottes word noodwendig bemark nie.

VERVAARDIGER
Intervet International B.V.
35 Wim de Körverstraat
5831 AN Boxmeer
The Netherlands

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