Nobilis IB multi ad us. vet.

Hauptinformation

  • Handelsname:
  • Nobilis® IB multi ad us. vet.
  • Darreichungsform:
  • Nobilis® IB multi 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® IB multi ad us. vet.
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Inaktivierter Kombinationsimpfstoff gegen aviäre Infektiöse Bronchitis (Serotypen M41 und D274); für Hühner

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • IVI Nr. 1145
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage

Nobilis

IB multi ad us. vet.

MSD Animal Health GmbH

Inaktivierter Kombinationsimpfstoff gegen aviäre Infektiöse Bronchitis (Serotypen

M41 und D274); für Hühner

ATCvet: QI01AA03

Zusammensetzung

Pro 1 Dosis (0.5 ml):

IB-Antigen vom Serotyp M41: induziert ≥ 5.5 log

VN Einheiten

IB-Antigen vom Serotyp D274: induziert ≥ 4.0 log

VN Einheiten

Öliges Adjuvans 215 mg

Formaldehyd ≤ 0.05%

Fachinformationen Wirkstoffe (CliniPharm)

Aviäres Infektiöses Bronchitisvirus - Aviäres Infektiöses Bronchitisvirus

Eigenschaften / Wirkungen

Nobilis

IB multi wird durch Vermehrung von IB-Virus der Serotypen M41 und D274 auf

embryonierten Hühnereiern hergestellt. Die Viren werden mit Formalin inaktiviert und

anschliessend in der wässrigen Phase einer Oel-Adjuvans Emulsion suspendiert. Das

ölige Adjuvans fördert eine längerdauernde immunogene Wirkung des Produktes.

Das Impfschema umfasst die Verwendung von IB-Lebendimpfstoffen als Priming und

mindestens 6 Wochen später die Nachimpfung mit Nobilis

IB multi. Wird diese

Grundimpfung korrekt durchgeführt, sind die Tiere vor einer Infektion mit den in den

Impfstoffen enthaltenen Antigenen bis mindestens zur 64. Lebenswoche geschützt.

Indikationen

Booster-Impfung von Hühnern gegen Infektionen, welche durch die IB-Serotypen M41 und

D274 sowie serologisch verwandte Typen verursacht werden.

Dosierung / Anwendung

Je 0.5 ml s.c. in den Nacken oder i.m. in die Brust- oder Schenkelmuskulatur injizieren.

Nobilis

IB multi kann mit folgenden Impfstoffen in derselben Spritze gemischt und in einer

Injektion verabreicht werden, ohne dass die Immunitätsbildung beeinträchtigt wird:

Nobilis

Gumboro inac, Nobilis

RT inac sowie Nobilis

CAV P4.

Das gesamte Injektionsvolumen darf dabei 1 ml nicht übersteigen.

Zu beachten:

-Vor Gebrauch den Impfstoff auf Raumtemperatur (15°C - 25°C) erwärmen.

-Vor und während der Applikation Flasche regelmässig schütteln.

-Sterile Spritzen und Kanülen verwenden.

Angebrochene Flaschen innerhalb von 3 Stunden aufbrauchen, um Verunreinigungen

und Wirksamkeitsverluste zu vermeiden.

Impfschema

Nach dem Priming mit IB-Lebendimpfstoffen sollte Nobilis

IB multi den Hühnern um die

16.- 20. Lebenswoche verabreicht werden, jedoch nicht später als 4 Wochen vor dem

erwarteten Legebeginn.

Priming:

Am 1. Lebenst

Nobilis

IB Ma5 (oculo-nasale Applikation oder Spray-Applikation)

5. - 14. Woche:

Nobilis

IB Ma5 oder IB 4-91 alternierend (oculo-nasale Applikation,

Spray- Applikation oder via Trinkwasser).

Booster:

16. - 20. Woch

Nobilis

®

IB multi

Die besten Resultate werden erzielt, wenn zwischen Priming und Boosterung ein Abstand

von mindestens 6 Wochen eingehalten wird. Der Abstand darf auf keinen Fall weniger als

4 Wochen betragen.

Anwendungseinschränkungen

Kontraindikationen

Verwendung während der Legephase.

Kranke Tiere dürfen nicht geimpft werden.

Unerwünschte Wirkungen

VetVigilance: Vaccinovigilance-Meldung erstatten

An der Injektionsstelle kann vorübergehend eine leichte Schwellung auftreten.

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.

Packungen

Flasche zu 500 ml (1000 Impfstoffdosen)

Abgabekategorie: B

IVI Nr. 1145

Informationsstand: 02/2011

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 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

4-9-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)5859 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4274/IB/02/G

Europe -DG Health and Food Safety

29-8-2018

Fulvestrant Mylan (Mylan S.A.S.)

Fulvestrant Mylan (Mylan S.A.S.)

Fulvestrant Mylan (Active substance: fulvestrant) - Centralised - 2-Monthly update - Commission Decision (2018)5774 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004649/IB/0001

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

31-7-2018

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children.  https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/ZP3ImzNw2T

FDA - U.S. Food and Drug Administration

31-7-2018

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here:  https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm  #Pediatrics #medicaldevice pic.twitter.com/c0cuVYtTLK

FDA - U.S. Food and Drug Administration

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration