Bovilis® S

An aid in the control of cattle salmonellosis and calf paratyphoid caused by Salmonella dublin and Salmonella typhimurium.

FOR ANIMAL USE ONLY

BOVILIS® S

Reg. No. G3763 (Act 36/1947)

Namibia Reg. No. V07/24.4/375 [NS0]

INDICATIONS

An aid in the control of cattle salmonellosis and calf paratyphoid caused by Salmonella dublin and Salmonella typhimurium.

COMPOSITION

Bovilis® S is a bivalent, inactivated, whole cell vaccine containing Salmonella dublin and Salmonella typhimurium antigens. Each dose (2 mℓ) contains a minimum of 5 x 108 organisms of inactivated Salmonella dublin and 5 x 108 organisms of inactivated Salmonella typhimurium with 0,2 mg thiomersal as a preservative.

STORAGE

  • Store between 2 °C and 8 °C.
  • Do not freeze. Discard if previously frozen.
  • Protect from light.

WARNINGS

  • Withdrawal period: Do not vaccinate within 21 days of slaughter.
  • For subcutaneous injection only.
  • Avoid vaccination of animals during wet weather or under dusty conditions.
  • Accidental self-injection may lead to severe local allergic reactions. Clean the affected area with a suitable disinfectant and seek medical advice.
  • Partly used containers should be disposed of at the end of each day’s operation since under field conditions, it may be difficult to avoid accidental contamination of the vaccine.
  • Do not over- or under-dose the vaccine.
  • 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.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use by boiling for at least 20 minutes.
  • Do not use disinfectants or antiseptics to sterilise any equipment. Ensure that all equipment is kept clean and sterile during vaccination.
  • It is good vaccination practice when handling vaccines to avoid contact with the eyes, hands, skin and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • Use entire contents when container is first opened and do not store partially used containers for future use.
  • Adhere to the vaccination programme to obtain optimum results.
  • Do not contaminate rivers, dams or any water sources with containers or waste.
  • Repeated exposure may cause allergic disorders. Wash hands after 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).

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake well before and during use.

  • Before vaccination, the site of vaccination may be cleansed by swabbing with cotton wool dipped in antiseptic.
  • Use needles of appropriate length and gauge i.e. 16-gauge 15 mm.

Dosage

Administer 2 mℓ subcutaneously. The recommended site of injection is that used for routine injection in cattle i.e. under the skin in the neck.

Vaccination Programme

  • It is recommended that cows should be vaccinated twice with a 2 mℓ subcutaneous injection 3 to 4 weeks apart.
  • A booster dose is given every 12 months.
  • For colostrum protection, vaccinate pregnant cows approximately 8 and 3 weeks before calving.
  • Calves should be fed colostrum from vaccinated dams for at least 5 days after birth.

Herd Management

In addition to vaccination with Bovilis® S, the following management techniques should be employed:

  • Calves should be fed colostrum from vaccinated dams mixed at a rate of 10 % diluted with milk replacer for up to 5 days after birth.
  • Maintain adequate levels of hygiene throughout the farm and minimise stressful situations.
  • Good calf rearing practices are essential.
  • After natural challenge with Salmonella, vaccinated animals may develop mild disease but do not shed the organisms.

PRESENTATION

Polyethylene terephthalate (PET) vials of 20 mℓ and 100 mℓ, with nitryl rubber stopper and aluminium cap. One vial per carton. Not all pack sizes may be marketed.

REGISTRATION HOLDER                                              

Intervet South Africa (Pty) Ltd.                                    

20 Spartan Road, Spartan                                              

1619, R.S.A                                                                            

Tel: +27 (0) 11 923 9300                                                   

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

MANUFACTURER

Intervet Australia (Pty) Ltd.

91 – 105 Harpin Street

Bendigo East, Victoria 3550

Australia

DATE OF PUBLICATION OF PACKAGE INSERT

1 September 2022

SLEGS VIR DIEREGEBRUIK

BOVILIS® S

Reg. Nr. G3763 (Wet 36/1947)

Namibië Reg. Nr. V07/24.4/375 [NS0]

INDIKASIES

‘n Hulpmiddel in die beheer van beessalmonellose en paratifus in kalwers veroorsaak deur Salmonella dublin en Salmonella typhimurium.

SAMESTELLING

Bovilis® S is ‘n bivalente, geïnaktiveerde, heelsel entstof wat Salmonella dublin en Salmonella typhimurium antigene bevat. Elke dosis (2 mℓ) bevat ʼn minimum van 5 x 108 organismes van geïnaktiveerde Salmonella dublin en 5 x 108 organismes van geïnaktiveerde Salmonella typhimurium met 0,2 mg tiomersal as ‘n preserveermiddel.

BERGING

  • Berg tussen 2 °C en 8 °C.
  • Moenie vries nie. Gooi weg indien dit voorheen gevries het.
  • Beskerm teen lig.

WAARSKUWINGS

  • Onttrekkingsperiode: Moenie slag binne 21 dae na inenting nie.
  • Slegs vir onderhuidse inenting.
  • Vermy inenting van diere gedurende nat weer of onder stowwerige toestande.
  • Toevallige self-inspuiting kan ‘n ernstige plaaslike allergiese reaksie tot gevolg hê. Maak die area skoon met ‘n geskikte ontsmettingsmiddel en raadpleeg ‘n geneesheer.
  • Houers wat gedeeltelik gebruik is, moet aan die einde van die dag na gebruik vernietig word, aangesien dit onder veldtoestande moeilik is om te verhoed dat die entstof besmet word.
  • Moenie die entstof oor- of onderdosseer nie.
  • Moenie binneaars ingespuit word nie.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • 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.

VOORSORGMAATREëLS

  • Aseptiese voorsorgmaatreëls moet nagekom word. Daar moet verseker word dat alle inentingstoerusting (naalde, spuite ens.) skoon en steriel is voor gebruik deur dit te kook vir ten minste 20 minute.
  • Moenie ontsmettingsmiddels of antiseptikums gebruik om enige toerusting te steriliseer nie. Sorg dat alle toerusting skoon en steriel gehou word gedurende inenting.
  • Dit is goeie inentingspraktyk wanneer die entstof hanteer word, om kontak met die oë, hande, vel en klere te vermy.
  • Moenie eet, drink of rook gedurende hantering van die produk nie.
  • Gebruik die volledige inhoud van die houer, wanneer dit vir die eerste keer oopgemaak word. Moenie gedeeltelik gebruikte houers stoor vir latere gebruik nie.
  • Om optimale resultate te verkry, moet daar voldoen word aan die inentingsprogram.
  • Moenie riviere, damme of enige waterbronne kontamineer met houers of afval nie
  • Herhaalde blootstelling mag allergiese toestande veroorsaak. Was hande na gebruik.
  • Vernietig enige ongebruikte entstof en verwyder alle entstofhouers en weggooibare toerusting na gebruik in ooreenstemming met Nasionale Omgewingsbestuur: Afval Bestuur Wet, 2008 (Wet Nr. 59 van 2008).

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Skud goed voor en gedurende gebruik.

  • Voor inenting, mag die inentingsarea skoongemaak word met watte wat in antiseptikum gedoop is.
  • Gebruik naalde van geskikte lengte en maat d.w.s.16-maat 15 mm.

Dosis

Dien 2 mℓ onderhuids toe. Die aanbevole plek van inspuiting, is dié wat gebruik word vir roetine inspuiting van beeste d.w.s. onder die vel van die nek.

Inentingsprogram

  • Dit word aanbeveel dat beeste twee keer met 2 mℓ onderhuidse inspuiting ingeënt moet word met ‘n 3 tot 4 weke tussenpose.
  • ‘n Skraagdosis moet elke 12 maande gegee word.
  •  Vir kolostrumbeskerming, ent dragtige koeie omtrent 8 en 3 weke voor kalwing.
  • Kalwers moet kolostrum gevoer word van ingeënte koeie vir ten minste 5 dae na geboorte.

Kuddebestuur

Buiten inenting met Bovilis® S, moet die volgende bestuurstegnieke gevolg word:

  • Kalwers moet kolostrum gevoer word van ingeënte koeie, wat gemeng is teen ‘n dosis van 10 % verdun met melkvervanger vir ten minste 5 dae na geboorte.
  • Handhaaf goeie standaarde van higiëne op die plaas en verminder toestande wat stres veroorsaak.
  • Goeie kalwergrootmaakpraktyke is noodsaaklik.
  • Na natuurlike uitdaging met Salmonella, mag ingeënte diere ligte siekte ontwikkel maar sal nie die organismes afwerp nie.

AANBIEDING

Poliëtileentereftalaat (PET) bottels, van 20 mℓ en 100 mℓ, met nitrielrubberprop en aluminiumdop. Een flessie per kartonhouer. Nie alle verpakingsgroottes word dalk bemark nie.

REGISTRASIEHOUER                                                      

Intervet South Africa (Pty) Ltd.                                    

Spartanweg 20, Spartan                                                 

1619, RSA                                                                              

Tel: +27 (0) 11 923 9300                                                   

E-pos: msdahza@msd.com

www.msd-animal-health.co.za

VERVAARDIGER

Intervet Australia (Pty) Ltd.

91 – 105 Harpin Street

Bendigo East, Victoria 3550

Australia

DATUM VAN PUBLIKASIE VAN VOUBILJET

1 September 2022