Ovilis® Enzovax

For the active immunisation of susceptible breeding female sheep as an aid in the prevention of abortion and stillbirth caused by Chlamydia abortus infection.

FOR ANIMAL USE ONLY

OVILIS® ENSOVAX
Reg. No. G2758 (Act 36/1947)
Namibia Reg No. V03/24.4/249 NS0

INDICATIONS

Ovilis® Enzovax is indicated for the active immunisation of susceptible breeding female sheep as an aid in the prevention of abortion and stillbirth caused by Chlamydophila abortus infection.

COMPOSITION

Ovilis® Enzovax is a live, attenuated vaccine, containing ≥ 105,0 IFU of Chlamydophila abortus, strain ts 1B, per dose.

STORAGE

  • Store between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

OPERATOR WARNINGS

  • Ovilis® Enzovax should not be handled by pregnant women or women of child bearing age as the vaccine may cause abortion.
  • The vaccine should not be handled by persons who are immunodeficient (e.g. people with AIDS, persons undergoing chemotherapy or taking immunosuppressive drugs). If in any doubt, seek medical advice.
  • Operators should wear gloves when handling the vaccines.
  • Care should be taken to avoid self-injection, but if this occurs, immediate medical advice should be sought, and the doctor informed that self-injection with a living chlamydial vaccine has occurred. Tetracycline therapy is the current recognized treatment for chlamydiosis in humans.

WARNINGS

  • Withdrawal period: Animals should not be slaughtered for human consumption within 7 days after vaccination.
  • Vaccinate healthy animals only.
  • Do not vaccinate animals less than 4 weeks before mating.
  • Do not vaccinate pregnant animals.
  • Do not vaccinate ewes which are being treated with antibiotics, particularly tetracyclines.
  • Do not administer any other vaccine 14 days before or after vaccination with this product.
  • Do not open and reconstitute the vaccine until ready to start vaccination.
  • After reconstitution the vaccine should be kept cool and must be used within 2 hours. Do not store partially used containers for future use. Vaccinators should be cleaned according to manufacturer’s recommendations prior to reuse.
  • Do not mix Ovilis® Enzovax with other vaccines or medications.
  • Other live vaccines should not be administered within 4 weeks of the administration of Ovilis® Enzovax.
  • Dispose of any unused vaccine as well as all empty vaccine containers and vaccination equipment (e.g. gloves, needles and syringes used for mixing) according to local waste disposal regulations.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this remedy has been extensively tested under a wide 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

Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.

It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

DOSAGE AND ADMINISTRATION

Ovilis® Enzovax should be reconstituted with Unisolve.
Remove approximately 5 mℓ of Unisolve from the vial with a syringe and needle. Inject into the vaccine vial and shake well until the powder plug is fully dissolved. Remove the solution from the vial, re-inject into the diluent vial and shake well. Take care not to generate an aerosol by ensuring that there are no air bubbles in the syringe before re-injecting into the vial.
The dose is a single injection of 2 mℓ of reconstituted vaccine by subcutaneous or intramuscular injection. Animals should be revaccinated after 2 years.
Ewe lambs, where it is intended to breed from, may be vaccinated from 5 months of age. Shearlings and older ewes should be vaccinated during the 4-month period prior to mating.

PRESENTATION

Vial of Type I Ph. Eur. glass containing 20 doses (10 mℓ), sealed with a halobutyl rubber stopper and a colour coded aluminium cap. Enclosed diluent (Unisolve): Type II glass or polyethylene terephthalate (PET) vial of 40 mℓ sealed with a rubber stopper and an aluminium cap.

Or
Vial of Type I Ph. Eur. glass containing 50 doses (10 mℓ), sealed with a halobutyl rubber stopper and a colour coded aluminium cap. Enclosed diluent (Unisolve): Type II glass or polyethylene terephthalate (PET) vial of 100 mℓ sealed with a rubber stopper and an aluminium cap.

1 vial of the freeze-dried vaccine and 1 vial diluent are packed in an outer carton box.

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

21 January 2010

SLEGS VIR DIEREGEBRUIK

OVILIS® ENZOVAX

Reg. Nr. G2758 (Act 36/1947)
Namibia Reg Nr. V03/24.4/249 NS0

INDIKASIES

Ovilis® Enzovax is aangedui vir die aktiewe immunisering van vatbare teel ooie as ʼn hulpmiddel in die voorkoming van aborsie en stilgeboortes veroorsaak deur Chlamydia abortus infeksie.

SAMESTELLING

Ovilis® Enzovax is ʼn lewende, verswakte entstof, wat ≥ 105.0 IVE van Chlamydia abortus, stam ts 1B, per dosis bevat.

BERGING

  • Berg in die yskas tussen 2 °C – 8 °C. Moenie vries nie.
  • Beskerm teen lig.
  • Vermy lang en herhaalde blootstelling aan hoë omgewingstemperature nadat die entstof uit die yskas gehaal is voor gebruik.

WAARSKUWINGS VIR OPERATEURS

  • Ovilis® Enzovax moet nie deur swanger vrouens of vrouens oud genoeg om kinders te hê hanteer word nie omdat die entstof aborsie kan veroorsaak.
  • Die entstof moet nie deur persone wat immuuntekort het gebruik word nie (bv. persone met Vigs, persone wat chemoterapie ondergaan of wat immuunonderdrukkende medikasie neem). Raadpleeg ʼn dokter as u onseker is.
  • Operateurs moet handskoene dra wanneer hulle die entstof hanteer.
  • Vermy self-inenting, maar as dit gebeur, raadpleeg ʼn dokter onmiddellik en verwittig hom/haar dat self-inenting met ʼn lewende chlamydia entstof plaasgevind het. Tetrasiklien behandeling word huidiglik aanvaar as die behandeling van keuse vir chlamydia infeksie in mense.

WAARSKUWINGS

  • Diere moenie geslag word vir menslike verbruik voor 7 dae na inenting nie.
  • Ent slegs gesonde diere in.
  • Moenie diere minder as 4 weke voor dekking inent nie.
  • Moenie dragtige diere inent nie.
  • Moenie ooie wat met antibiotika, veral tetrasikliene behandel word, inent nie.
  • Na verdunning moet die entstof koel gehou word en binne 2 ure gebruik word. Moenie gedeeltelik gebruikte houers vir verdere gebruik bêre nie.
  • Moenie met andere entstowwe of medikasie meng nie.
  • Ander lewende entstowwe moet nie binne 4 weke van die gebruik van Ovilis Enzovax gegee word nie.
  • Vernietig alle ongebruikte entstof, maak entstof houers leeg, en plaas alle gebruikte toerusting (handskoene, spuite en inspuitingsnaalde gebruik vir die samestelling van die entstof ens.) in ontsmettingsmiddel. Weggooi items moet verbrand word en inentingstoerusting moet skoongemaak word volgens die aanbevelings van die vervaardiger voordat dit weer gebruik word.
  • Moenie die entstofhouer oopmaak en die entstof saamstel alvorens inenting begin nie.
  • Hou buite die bereik van kinders en oningeligte persone.
  • Alhoewel hierdie entstof 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.

VOORSORGMAATREëLS

  • Gebruik aseptiese voorsorgmaatreëls. Sorg dat alle inentingstoerusting (inspuitingsnaalde, spuite) skoon en steriel voor gebruik is.
  • Verseker dat alle inentingstoerusting skoon en steriel bly gedurende die inenting.
  • Dit is goeie inentingspraktyk om kontak met die oë, hande en klere te vermy wanneer die entstof hanteer word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

DOSIS EN TOEDIENING

  • Ovilis® Enzovax moet met Unisolve hersaamgestel word.
  • Gebruik ʼn spuit en naald om ongeveer 5 mℓ Unisolve van die glashouer te onttrek. Spuit die Unisolve in die entstofhouer en skud goed totdat die poeier proppie heeltemal opgelos is. Ontttrek die inhoud van die entstof oplossing uit die entstofhouer, en spuit terug in die verdunningsmiddelhouer. Skud goed. Wees versigtig om nie ʼn aerosol te laat ontstaan nie deur seker te maak dat daar geen lugborrels in die spuit is, voor inspuiting nie.
  • Die dosis is ʼn enkele inspuiting van 2 mℓ van hersaamgestelde entstof onderhuids of binnespiers. Diere moet na 2 jaar heringeënt word.
  • Ooilammers wat vir teeldoeleindes gebruik gaan word, mag vanaf 5 maande ouderdom ingeënt word. Skeerskape en ouer ooie moet gedurende die 4 maande periode voor dekking ingeënt word.

AANBIEDING

Flessie van Tipe I Ph. Eur. glas met 20 dosisse (10 mℓ), geseël met ‘n halobutielrubberprop en ‘n kleurgekodeerde aluminiumdoppie. Ingeslote verdunningsmiddel (Unisolve): Tipe II glas of poliëtileentereftalaat (PET) flessie van 40 mℓ geseël met ’n rubberprop en ‘n aluminium doppie.

of

Flessie van Tipe I Ph. Eur. glas met 50 dosisse (10 mℓ), geseël met ‘n halobutielrubberprop en ‘n kleurgekodeerde aluminiumdoppie. Ingeslote verdunningsmiddel (Unisolve): Tipe II glas of poliëtileentereftalaat (PET) flessie van 100 mℓ geseël met ‘n rubberprop en ‘n aluminium doppie.

1 flessie met die gevriesdroogde entstof en 1 flessie verdunningsmiddel word saam in ‘n buitenste kartonhouer gepak.

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 HIERDIE VOUBILJET
21 Januarie 2010