Nobivac® Respira Bb

Nobivac® Respira Bb is a vaccine for active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection

FOR ANIMAL USE ONLY

Nobivac® Respira Bb

Reg. No. G4506 (Act 36/1947)

Suspension for Injection

INDICATIONS

For active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection.

Onset of immunity: 2 weeks.

Duration of immunity: 7 months after primary vaccination. 1 year after re-vaccination.

COMPOSITION

Each dose (1 mℓ) contains:

Active substance

Bordetella bronchiseptica fimbriae1: 88 – 399 U2

1 Purified from strain Bb7 92932

2 Antigenic mass ELISA units

Adjuvant

dl-α-tocopheryl acetate: 74,7 mg

Excipient

Thiomersal: 0,15 mg

STORAGE

  • Store in a refrigerator between 2 °C and 8 °C.
  • Do not freeze.
  • Once broached, the multi-dose vial should be stored between 2 °C and 25 °C and used within 4 weeks.
  • Store in the original package in order to protect from light.

WARNINGS

  • Vaccinate healthy animals only.
  • Do NOT mix with any other veterinary medicinal product, except those specifically mentioned under the section ‘INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION’.
  • Do not over- or under-dose the vaccine.
  • This vaccine is safe for use during pregnancy, however the safety has not been investigated during the first 20 days of gestation.
  • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the package insert to the physician.
  • 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 all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • 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).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Inject subcutaneously with 1 mℓ per dose.

Dogs can be vaccinated from the age of 6 weeks onwards.

Allow the vaccine to reach room temperature (15 °C to 25 °C) before use.

For the multi-dose vial – Shake well before each administered dose. Avoid introduction of contamination by using a clean needle for each administered dose.

Primary vaccination:

Two vaccinations with an interval of 4 weeks.

Re-vaccination:

A single vaccination, administered 7 months after the primary vaccination, is sufficient to maintain protection against Bordetella bronchiseptica for another year. Thereafter, a single vaccination should be administered, annually. In case re-vaccination at 7 months is missed, a single vaccination within 12 months after primary vaccination is sufficient to extend protection against Bordetella bronchiseptica for another year.

Nobivac® Respira Bb can also be used for re-vaccination in a schedule where Nobivac® KC has been used for primary vaccination. A single vaccination, administered 1 year after primary vaccination with Nobivac® KC, is sufficient to prolong immunity against Bordetella bronchiseptica for another year.

Re-vaccination after primary vaccination with Nobivac® KC:

One vaccination, annually.

For associated use:

When Nobivac® Respira Bb is administered in associated use (i.e., not mixed) with another vaccine of the Nobivac® series, as indicated under ‘INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION’, the vaccines should be given subcutaneously at the same time, at a different site. Dogs should not be younger than the minimum age recommended for the other Nobivac® vaccines, as stated in their respective product information leaflets.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Safety and efficacy data are available which demonstrate that Nobivac® Respira Bb vaccine can be administered at the same time, but not mixed, with Nobivac® DHPPi,
Nobivac® L6 and Nobivac® Rabies.

When this vaccine is administered in association with the relevant Nobivac® vaccines, the demonstrated safety and efficacy claims of Nobivac® Respira Bb are the same as when this vaccine is administered alone.

The product information of the relevant Nobivac® vaccines used in association with Nobivac® Respira Bb should be consulted with the assistance of a veterinarian before administration.

No information is available on the safety and efficacy of Nobivac® Respira Bb when used with any other veterinary medicinal products except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.

SIDE EFFECTS

A transient swelling at the site of injection (≤ 2 cm), which can occasionally be firm, may commonly be present for up to 25 days post-vaccination. A medium size transient swelling at the site of injection (≤ 3,5 cm) may occur in common cases and can be painful. The swelling may uncommonly last for up to 35 days post-vaccination.

PRESENTATION

An aqueous, white to nearly white suspension presented in a polyethylene terephthalate (PET) multi-dose vial closed with a halogenobutyl rubber stopper and aluminium cap, containing 10 mℓ (10 doses) of vaccine.

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.

35 Wim de Körverstraat

Boxmeer

The Netherlands

DATE OF PUBLICATION OF PACKAGE INSERT

21 July 2022

SLEGS VIR DIEREGEBRUIK

Nobivac® Respira Bb

Reg. Nr. G4506 (Wet 36/1947)

Suspensie vir Inspuiting

INDIKASIES

Vir die aktiewe immunisering van honde teen Bordetella bronchiseptica om kliniese tekens van boonste lugweginfeksie te verminder, asook om bakteriële uitskeiding ná infeksie te verminder.

Aanvang van immuniteit: 2 weke.

Duur van immuniteit: 7 maande na primêre inenting. 1 jaar na herinenting.

SAMESTELLING

Elke dosis (1 mℓ) bevat:

Aktiewe bestanddeel

Bordetella bronchiseptica fimbriae1: 88 – 399 U2

1Gesuiwer vanaf stam Bb7 92932

2Antigeen massa ELISA eenhede

Bymiddel

dl-α-tokoferielasetaat: 74,7 mg

Hulpmiddel

Tiomersal: 0,15 mg

BERGING

  • Berg in ‘n yskas tussen 2 °C en 8 °C.
  • Moenie vries nie.
  • Sodra die seël geperforeer is, moet die multidosisflessie geberg word tussen 2 °C en 25 °C en binne 4 weke gebruik word.
  • Berg in die oorspronklike verpakking om dit sodoende teen lig te beskerm.

WAARSKUWINGS

  • Slegs gesonde diere moet ingeënt word.
  • MOENIE met enige ander veterinêre medisinale produkte gemeng word NIE, behalwe die produkte wat spesifiek genoem word onder die afdeling ‘INTERAKSIE MET ANDER MEDISINALE PRODUKTE EN ANDER VORMS VAN INTERAKSIE’.
  • Moenie die entstof oor- of onderdoseer nie.
  • Hierdie entstof is veilig om te gebruik tydens dragtigheid, maar die veiligheid van die entstof is nie tydens die eerste 20 dae van dragtigheid ondersoek nie.
  • In die geval van toevallige self-inspuiting, raadpleeg dadelik ‘n geneesheer en verskaf aan hom/haar hierdie voubiljet.
  • Moenie binneaars ingespuit word nie
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie entstof deeglik onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van ‘n wye verskeidenheid redes. Indien dit vermoed word, raadpleeg ‘n veearts en stel die registrasiehouer in kennis.

VOORSORGMAATREëLS

  • Aseptiese voorsorgmaatreëls moet gehandhaaf word. Verseker dat alle inentingstoerusting (houers, spuite en naalde) skoon en steriel is voor en gedurende gebruik. Gebruik steriele toerusting tydens die toediening van die entstof.
  • Moenie ontsmettingsmiddels of antiseptikums gebruik om enige toerusting te steriliseer nie.
  • Dit is goeie inentingspraktyk wanneer die entstof hanteer word om kontak met die oë, hande en klere te vermy.
  • Moenie eet, drink of rook gedurende hantering van die produk nie.
  • Vernietig enige ongebruikte entstof en verwyder alle leë entstofhouers en weggooibare inentingstoerusting na gebruik, in ooreenstemming met Nasionale Omgewingsbestuur: Afval Bestuur Wet, 2008 (Wet Nr. 59 van 2008).
  • Moenie riviere, damme of enige waterbronne kontamineer met houers of afval nie.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Dien onderhuids toe teen 1 mℓ per dosis.

Honde kan ingeënt word vanaf ‘n ouderdom van 6 weke.

Laat die entstof kamertemperatuur bereik (15 °C tot 25 °C) voor gebruik.

Vir die multidosisfles – Skud goed voor elke dosis toegedien word. Vermy kontaminasie deur ‘n skoon naald te gebruik met elke toediening van ‘n dosis.

Primêre inenting:

Twee inentings, 4 weke uitmekaar.

Herinenting:

‘n Enkele inenting, toegedien 7 maande na die primêre inenting, is voldoende om beskerming teen Bordetella bronchiseptica vir nog ‘n jaar te bied. Daarna moet ‘n enkele inenting jaarliks toegedien word. Indien die herinenting op 7 maande gemis word, sal ‘n enkele inenting binne ‘n tydperk van 12 maande voldoende wees om beskerming teen Bordetella bronchiseptica vir nog ‘n jaar te verleng.

Nobivac® Respira Bb kan ook gebruik word vir herinenting in ‘n skedule waar Nobivac® KC gebruik is as primêre inenting.  ‘n Enkele inenting, wat 1 jaar na die basiese inenting met Nobivac® KC, toegedien word, sal voldoende wees om beskerming teen Bordetella bronchiseptica vir nog ‘n jaar te verleng.

Herinenting na primêre inenting met Nobivac® KC:

Een inenting,  jaarliks.

Vir gepaardgaande gebruik:

Wanneer Nobivac® Respira Bb terselfdertyd toegedien word (nie gemeng nie) met ‘n ander entstof van die Nobivac® reeks, soos beskryf word onder die afdeling ‘INTERAKSIE MET ANDER MEDISINALE PRODUKTE EN ANDER VORMS VAN INTERAKSIE’, moet die entstowwe onderhuids toegedien word op verskillende areas op die liggaam. Honde moenie jonger wees as die voorgestelde minimum ouderdom soos aangedui in die onderskeie produkte se produkinformasievoubiljette vir die ander Nobivac® entstowwe nie.

INTERAKSIE MET ANDER MEDISINALE PRODUKTE EN ANDER VORMS VAN INTERAKSIE

Veiligheids- en effektiwiteitsdata is beskikbaar wat demonstreer dat Nobivac® Respira Bb entstof toegedien kan word, maar nie gemeng nie, met Nobivac® DHPPi, Nobivac® L6 en
Nobivac® Rabies.

Wanneer Nobivac® Respira Bb toegedien word terselfdertyd as die geskikte Nobivac® entstof, is die veiligheids- en effektiwiteitsindikasies van Nobivac® Respira Bb dieselfde as wanneer die entstof alleen toegedien sou word.

Die produkinformasie van die geskikte Nobivac® entstof wat terselfdertyd as Nobivac® Respira Bb toegedien word, moet nagegaan word voor toediening.

Geen informasie is beskikbaar oor die veiligheid en effektiwiteit van Nobivac® Respira Bb  indien dit gebruik word met enige ander veterinêre medisinale produkte, behalwe die produkte soos hierbo genoem nie. Die besluit om hierdie entstof voor of na enige ander veterinêre produk te gebruik, moet evalueer word met behulp van ‘n veeaarts op ‘n geval-tot-geval basis.

NEWE-EFFEKTE

‘n Verbygaande swelling (≤ 2 cm), wat af en toe ferm kan wees tydens aanraking, kan algemeen op die inspuitingsplek waargeneem word tot en met 25 dae na inenting. ‘n Medium grootte, verbygaande swelling (≤ 3,5 cm), wat af en toe pynlik kan wees tydens aanraking, kan gereeld op die inspuitingsplek waargeneem word. Die swelling kan moontlik duur vir 35 dae na inenting, maar dit is onwaarskynlik.

AANBIEDING

‘n Waterige, wit tot naaswit suspensie aangebied in ‘n poliëtileentereftalaat (PET) multidosisflessie, toegemaak met ‘n halogeenbutielrubberproppie en aluminiumdoppie, wat 10 mℓ (10 dosisse) van die entstof bevat.

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.

35 Wim de Körverstraat,

Boxmeer

The Netherlands

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

21 Julie 2022