Nobilis Gumboro inac ad us. vet.

Hauptinformation

  • Handelsname:
  • Nobilis® Gumboro inac ad us. vet.
  • Darreichungsform:
  • Nobilis® Gumboro inac ad us. vet.
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Nobilis® Gumboro inac ad us. vet.
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Inaktivierter Impfstoff gegen Infektiöse Bursitis; für Hühner.

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • IVI Nr. 1144
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Nobilis

Gumboro inac ad us. vet.

MSD Animal Health GmbH

Inaktivierter Impfstoff gegen Infektiöse Bursitis; für Hühner.

ATCvet: QI01AA01

Zusammensetzung

1 Dosis enthält:

Gumboro Virusstamm D78

(inaktiviert)

≥ 14.5 log2 VN Einheiten

öliges-Adjuvans

215 mg

Fachinformationen Wirkstoffe (CliniPharm)

Aviäres Infektiöses Bursitisvirus

Zielspezies

Huhn

Eigenschaften / Wirkungen

Der inaktivierte Impfstoff Nobilis

Gumboro inac enthält einen immunogenen Stamm des

Infektiösen Bursitis-Virus, welcher mit Formalin inaktiviert und anschliessend in der

wässrigen Phase einer Oel-Adjuvans Emulsion suspendiert wurde. Nach der aktiven

Immunisierung von Zucht- und Elterntieren sind die Nachkommen mindestens in den

ersten vier Lebenswochen durch maternale Antikörper gegen Infektiöse Bursitis geschützt.

Indikationen

Aktive Immunisierung der Muttertiere zur passiven Immunisierung der Nachkommen

gegen Infektiöse Bursitis.

Dosierung / Anwendung

Impfschema

Verabreichung um die 16. - 20. Lebenswoche, jedoch nicht weniger als 3 Wochen vor dem

voraussichtlichen Legebeginn.

Vor der Verabreichung des Impfstoffes sollten die Tiere entweder in der 3. - 4.

Lebenswoche mit einem Gumboro-Lebendimpfstoff grundimmunisiert, oder einer

natürlichen Gumboro-Feldinfektion ausgesetzt werden. Im zweiten Fall muss dies durch

eine serologische Untersuchung vor der Anwendung des inaktivierten Impfstoffes

nachgewiesen werden.

Falls die Herde keiner Feldinfektion ausgesetzt war (was in der Praxis nicht oft der Fall

ist), sollten die Tiere spätestens vier Wochen vor der Verabreichung des inaktivierten

Impfstoffes mit einem Gumboro-Lebendimpfstoff grundimmunisiert werden.

Dosierung / Anwendung

Jedem Huhn wird 0,5 ml Impfstoff intramuskulär in die Oberschenkel- oder

Brustmuskulatur injiziert. Eine Kanüle der Grösse 0.9 × 13 mm sollte verwendet werden.

Nobilis

Gumboro inac kann zusammen mit Nobilis

CAV P4 in derselben Spritze und als

1 Injektion verabreicht werden, ohne dass die Immunitätsbildung beeinträchtigt wird. Das

gesamte Injektionsvolumen darf dabei 1 ml nicht übersteigen.

Zu beachten:

-Vor Gebrauch Impfstoff auf Raumtemperatur bringen (15° bis 25°C).

-Vor und während der Applikation Flasche regelmässig schütteln.

Sterile Spritzen und Kanülen verwenden. Um Kontaminationen zu verhindern sollte die

Kanüle öfters ersetzt werden.

-Angebrochene Flaschen innerhalb 24 Stunden aufbrauchen.

Immunität

Wenn die Impfung korrekt durchgeführt worden ist, sind die Nachkommen von geimpften

Elterntieren mindestens in den ersten 4 Lebenswochen durch maternale Antikörper vor

Infektionen durch Gumboro geschützt. Küken von Elterntieren, die sich dem Ende der

Legeperiode nähern, sind ebenso geschützt.

Anwendungseinschränkungen

Kontraindikationen

Kranke Tiere sollen nicht geimpft werden.

Unerwünschte Wirkungen

VetVigilance: Vaccinovigilance-Meldung erstatten

Bei gesunden Hühnern sind in der Regel keine klinisch sichtbaren Reaktionen zu

beobachten. Während einigen Wochen kann möglicherweise eine leichte Schwellung an

der Injektionsstelle festgestellt werden. Dies zieht keine dauerhafte Schädigung des

Gewebes nach sich, vorausgesetzt die Impfung wurde aseptisch durchgeführt.

Keine

Sonstige Hinweise

Warnung

Dieses Tierarzneimittel enthält Mineralöl. Eine versehentliche (Selbst-)Injektion kann zu

starken Schmerzen und Schwellungen führen, insbesondere bei einer Injektion in ein

Gelenk oder den Finger. In seltenen Fällen kann dies zum Verlust des betroffenen Fingers

führen, wenn er nicht umgehend ärztlich versorgt wird.

Im Falle einer versehentlichen (Selbst-)Injektion ziehen Sie sofort einen Arzt zu Rate,

selbst wenn nur geringe Mengen injiziert wurden, und zeigen Sie dem Arzt die

Packungsbeilage. Sollten die Schmerzen länger als 12 Stunden nach der ärztlichen

Untersuchung andauern, ziehen Sie erneut einen Arzt zu Rate.

Lagerung

Im Kühlschrank (2°C - 8°C) lagern. Vor Licht und Frost schützen.

Arzneimittel, für Kinder unerreichbar aufbewahren.

Packungen

Flasche zu 500 ml (1000 Impfstoff-Dosen)

Abgabekategorie: B

IVI Nr. 1144

Informationsstand: 01/2008

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10-12-2018

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more:  https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

. @US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDA pic.twitter.com/HiJbgPnsPt

FDA - U.S. Food and Drug Administration

7-12-2018


Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated),  06/12/2018,  Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Europe - EMA - European Medicines Agency

1-12-2018

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation.  https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

. @US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre  pic.twitter.com/XiTbPfEkcj

FDA - U.S. Food and Drug Administration

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall:  https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

FDA - U.S. Food and Drug Administration

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split influenza virus, inactivated containing antigens equivalent to the B-like strain, decision type: , therapeutic area: , PIP number: P/0155/2018

Europe - EMA - European Medicines Agency

26-11-2018

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do:  https://go.usa.gov/xPHtk   #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

26-11-2018

Ixiaro (Valneva Austria GmbH)

Ixiaro (Valneva Austria GmbH)

Ixiaro (Active substance: Japanese Encephalitis vaccine (inactivated, adsorbed)) - Centralised - Renewal - Commission Decision (2018)7979 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/963/R/91

Europe -DG Health and Food Safety

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more:  https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

. @US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevice pic.twitter.com/pv0k2yaNfj

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more:  https://go.usa.gov/xPAzD  #MedicalDevice

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

. @US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

13-11-2018

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA  encourages patients and caregivers to beware of illegally markets  diabetes treatments. Check out our Consumer Update on this issue  http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w

FDA - U.S. Food and Drug Administration