Ovilis® Enzovax - MSD Animal Health South Africa
For the active immunisation of susceptible breeding female sheep as an aid in the prevention of abortion and stillbirth caused by Chlamydia abortus infection.
Reg. No. G2758 (Act 36/1947)
Namibia Reg No. V03/24.4/249 NS0
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.
Ovilis® Enzovax is a live, attenuated vaccine, containing ≥ 105,0 IFU of Chlamydophila abortus, strain ts 1B, per dose.
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.
Withdrawal period: Animals should not be slaughtered for human consumption within 7 days after vaccination.
Do not vaccinate animals less than 4 weeks before mating.
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.
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.
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.
Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
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.
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.
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.
Reg. Nr. G2758 (Act 36/1947)
Namibia Reg Nr. V03/24.4/249 NS0
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.
Ovilis® Enzovax is ŉ lewende, verswakte entstof, wat ≥ 105.0 IVE van Chlamydia abortus, stam ts 1B, per dosis bevat.
Berg in die yskas tussen 2 °C – 8 °C. Moenie vries nie.
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.
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.
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.
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.
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.
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.