Porcilis® PCV M Hyo

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.

FOR ANIMAL USE ONLY

Porcilis® PCV M Hyo
Reg. No. G4354 (Act 36/1947)
Emulsion for injection for pigs.

INDICATIONS

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection. To reduce the loss of daily weight gain during the finishing period in face of infections with Mycoplasma hyopneumoniae and/or PCV2 (as observed in field studies). 

IMMUNITY

Onset of immunity with single dose vaccination:
PCV2: 2 weeks after vaccination. 
M. hyopneumoniae: 4 weeks after vaccination.
Onset of immunity with repeated dose vaccination:
PCV2: 18 days after first vaccination.
M. hyopneumoniae: 3 weeks after second vaccination.

Duration of immunity both vaccination schedules:
PCV2: 22 days after the last vaccination.
M. hyopneumoniae: 21 weeks after the last vaccination.

COMPOSITION

Each 2 mℓ dose of inactivated emulsion vaccine contains:

Porcine circovirus type 2 ORF2 subunit antigen        ≥ 2,828 AU1

M. hyopneumoniae J strain inactivated                       ≥ 2,69 RPU2

Adjuvants:

Light mineral oil                                                           0,268 mℓ

Aluminium (as hydroxide)                                            2,0 mg

1 Antigenic units as determined in the in vitro potency test (ELISA).

2 Relative potency units defined against a reference vaccine.

STORAGE

WARNINGS

  • Withdrawal period: Pigs – meat and offal, 21 days.
  • Vaccinate healthy animals only.
  • No information is available on the safety and efficacy of Porcilis® PCV M Hyo when used with any other veterinary medicinal product. A decision to use Porcilis® PCV M Hyo before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
  • Do not mix Porcilis® PCV M Hyo with any other veterinary medicinal product.
  • A transient increase in body temperature very commonly occurs on the day of vaccination (mean increase of + 1 °C, in individual pigs up to 2 °C). The animals return to normal from 1 to 2 days after the peak temperature is observed.
  • 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

  • Do not store partially used vials for future use and dispose of empty vials and unused vaccine in accordance with local waste disposal regulations.
  • In very rare cases anaphylactic-type reactions can occur, which may be life-threatening. In the event of such reactions, treatment may be needed.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

DOSAGE

Before using the vaccine allow it to reach room temperature (15 °C to 25 °C).
Shake well before use.
Avoid introduction of contaminants.
Vaccinate pigs via intramuscular injection in the neck.

Single dose vaccination schedule
A single dose of 2 mℓ in pigs starting at 3 weeks of age.
Two dose vaccination schedule

Two 1 mℓ doses administered to pigs starting at 3 days of age, with a second dose at least 18 days later.

Needle length and diameter should be adapted to the age of the animal.

When PCV2 and/or M. hyopneumoniae infections occur early, the two-dose vaccination schedule is recommended.

SPECIAL WARNINGS

To the user

Porcilis® PCV M Hyo 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 veterinary medicinal 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 M Hyo contains mineral oil. Even if small amounts have been injected, accidental injection 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 injected area, especially where there is involvement of finger pulp or tendon.

OVERDOSAGE

No data available.

PRESENTATION

Polyethylene terephthalate (PET) vials of 20, 50, 100, 200 or 500 mℓ, closed with nitrile rubber stoppers and sealed with aluminium caps.

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.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT

29 July 2019

SLEGS VIR DIEREGEBRUIK

Porcilis® PCV M Hyo
Reg. Nr. G4354 (Wet 36/1947)

INDIKASIES

Vir die aktiewe inenting van varke om viremie, viruslading in longe en limfoïede weefsel te verminder, virusstorting veroorsaak deur infeksie van varksirkovirus tipe 2 (PCV2) en die erns van die longletsels veroorsaak deur Mycoplasma hyopneumoniae infeksie. Verder, om daaglikse gewigsverlies en sterftes wat verband hou met PCV2 en/of M. hyopneumoniae infeksie te verminder (soos in veldstudies waargeneem).

IMMUNITEIT

Aanvang van immuniteit met enkeldosis inenting:
PCV2: 2 weke na inenting.
M. hyopneumoniae: 4 weke na inenting.

Aanvang van immuniteit met inenting teen herhaalde dosisse:
PCV2: 18 dae na eerste inenting.
M. hyopneumoniae: 3 weke na tweede inenting.

Duur van immuniteit met beide inentingskedules:
PCV2: 22 dae na laaste inenting.
M. hyopneumoniae: 21 weke na laaste inenting.

SAMESTELLING

Elke 2 mℓ dosis van geïnaktiveerde enstofemulsie bevat:

Vark sirkovirus tipe 2 ORF2 subeenheid antigeen    ≥ 2,828 AU1

M. hyopneumoniae J stam geïnaktiveer                     ≥ 2,69 RPU2

Adjuvante:

Ligte mineraalolie                                                         0,268 mℓ

Aluminium (as hidroksied)                                           2,0 mg

1 Antigeniese eenhede soos bepaal in die in vitro-sterktetoets (ELISA).

2 Relatiewe sterkte-eenhede gedefinieer teen ‘n verwysingsentstof.

BERGING

WAARSKUWINGS

  • Varke – vleis en afval, 21 dae.

VOORSORGMAATREëLS

  • Moenie gedeeltelik gebruikte flessies vir toekomstige gebruik berg nie en doen weg met leë flessies en ongebruikte entstof in ooreenstemming met plaaslike afvalbestuursregulasies.
  • In baie seldsame gevalle kan anafilaktiese reaksies voorkom, wat lewensgevaarlik kan wees. In die geval van sulke reaksies, mag behandeling nodig wees.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

DOSIS

Voor gebruik, moet die entstof kamertemperatuur bereik (15 °C tot 25 °C).
Skud goed voor gebruik.
Vermy blootstelling aan kontaminasie.
Ent varke deur binnespierse toediening in die nek.
Inentingskedule vir enkeldosis
‘n Enkele 2 mℓ dosis in varke vanaf 3 weke oud.
Inentingskedule vir twee dosisse.
Twee inspuitings van 1 mℓ  elk wat op varke van 3 dae oud begin, met ‘n interval van minstens 18 dae.
Naaldlengte en deursnee moet aangepas word by die ouderdom van die dier.
Wanneer PCV2 en/of M. hyopneumoniae infeksies vroeg voorkom, word die inentingskedule vir twee dosisse aanbeveel.

SPESIALE WAARSKUWINGS

Aan die gebruiker

Porcilis® PCV M Hyo bevat mineraalolie. Toevallige inspuiting/selfinspuiting kan ernstige pyn en swelling tot gevolg hê, veral as dit in ‘n gewrig of vinger ingespuit word, in seldsame gevalle kan dit lei tot die verlies van die geaffekteerde vinger, as daar nie vinnige mediese aandag verkry word nie. Indien selfinspuiting plaasgevind het met hierdie produk, moet mediese advise 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 M Hyo 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 inspuitingsplek mag nodig wees, veral waar daar ‘n vingerlitweefsel of sening betrokke is.

OORDOSERING

Geen data beskikbaar nie.

AANBIEDING

Poliëtileentereftalaat (PET) flessies van 20, 50, 100, 200 of 500 mℓ, geseël met nitrielrubberstoppers en verseël met aluminiumdoppies.

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

DATUM VAN PUBLIKASIE VAN DIE VOUBILJET

29 Julie 201