Indigocarmin 4mg/ml Amino

Hauptinformation

  • Handelsname:
  • Indigocarmin 4mg/ml Amino Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • indigocarminum 4 mg, natrii indigotinodisulfonas, Glukose anhydricum, mannitolum, aqua ad iniectabilia q.s. zu einer Lösung anstelle von 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

  • für die Allgemeinheit:
  • 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.


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Lokalisierung

  • Erhältlich in:
  • Indigocarmin 4mg/ml Amino Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Diagnostikum

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 56500
  • Berechtigungsdatum:
  • 05-10-2010
  • Letzte Änderung:
  • 25-10-2018

Zusammenfassung der Merkmale des Arzneimittels

Fachinformation

Indigocarmin Amino

AMINO

Zusammensetzung

Wirkstoff: Indigocarminum ut natrii indigotinodisulfonas.

Hilfsstoffe: Glucosum, Mannitolum, Aqua ad injectabilia.

Galenische Form und Wirkstoffmenge pro Einheit

1 Ampulle zu 5 ml enthält: 20 mg Indigocarmin.

Indikationen/Anwendungsmöglichkeiten

Darstellung der Uretermündungen bei cystoskopischer und bei uretaler Katheterisierung sowie

Darstellung von Ureterfisteln.

Dosierung/Anwendung

Normalerweise werden 5 ml einer 0,4%-igen Indigocarmin Injektionslösung entweder i.v. oder i.m.

appliziert. Bei normaler Nierenfunktion färbt sich der Urin innerhalb von ca. 10 Minuten blau.

Ausserdem wird die Funktionsfähigkeit zweier Nieren verglichen, indem man direkt bei der

Uretermündung mit Hilfe eines Cystoskops auf die Ankunft des Farbstoffs wartet. Die intravenöse

Methode wird bevorzugt. Eine Verminderung der Dosis bei Kindern und untergewichtigen Patienten

verhindert eine Hautfärbung.

Kontraindikationen

Indigocarmin ist kontraindiziert bei:

bekannter Überempfindlichkeit gegenüber Indigocarmin oder einem der Hilfsstoffe gemäss

Zusammensetzung;

arterieller Hypertonie;

schwerer Herzinsuffizienz.

Warnhinweise und Vorsichtsmassnahmen

Durch hohe parenterale Dosen können Hautverfärbungen verursacht werden. Deshalb sollte vor

allem bei Kindern und untergewichtigen Patienten auf eine Verminderung der Dosis geachtet

werden.

Indigocarmin Amino enthält Glucose und sollte bei Diabetes-Patienten nur mit Vorsicht verwendet

werden.

Interaktionen

Es liegen keine Daten vor.

Schwangerschaft/Stillzeit

Es liegen keine tierexperimentellen Studien zur Auswirkung von Indigocarmin auf Schwangerschaft,

Embryonalentwicklung, Entwicklung des Föten und/oder die postnatale Entwicklung vor. Das

potentielle Risiko für den Menschen ist nicht bekannt. Aufgrund dieser Tatsache darf das

Arzneimittel während der Schwangerschaft nicht verabreicht werden, es sei denn, dies ist eindeutig

erforderlich.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Nicht zutreffend.

Unerwünschte Wirkungen

Störungen des Immunsystems

Hypersensibilisierungsreaktionen (z.B. Pruritus, Erythem, Bronchienkonstriktion).

Störungen von Herz und Gefässen

Bluthochdruck, Bradykardie.

Gastrointestinale Störungen

Übelkeit, Erbrechen.

Funktionsstörungen der Haut

Hautverfärbungen können durch hohe parenterale Dosen verursacht werden.

Überdosierung

Aufgrund der sehr schnellen Halbwertszeit von 4–5 Minuten sind keine Fälle von Überdosierung

bekannt.

Eigenschaften/Wirkungen

ATC-Code: V04CH02

Die Anwendung von Indigocarmin basiert auf dessen Elimination aus dem Körper. Indigocarmin

wird kaum metabolisiert, bleibt blau und wird hauptsächlich durch die Nieren ausgeschieden.

Pharmakokinetik

Metabolisation/Elimination

Bei Patienten mit normaler Nierenfunktion wird Indigocarmin nach i.v.-Administration sehr schnell

aus dem Blutkreislauf entfernt. Die Plasmahalbwertszeit beträgt 4–5 Minuten. Indigocarmin wird

hauptsächlich über die Nieren ausgeschieden. Es wird dabei kaum metabolisiert und bleibt blau. Die

Elimination beginnt kurz nach der Injektion. Man findet Indigocarmin durchschnittlich nach ca. 10

Minuten im Urin und ca. 10% der Dosis werden in der ersten Stunde nach Administration eliminiert.

Bei i.m.-Injektion ist die Halbwertszeit verlängert, die Elimination etwas verzögert, und es müssen

grössere Mengen injiziert werden.

Präklinische Daten

Reproduktionstoxizität

Im Tierversuch (Mäuse) wurden chromosomale Aberrationen nach langfristiger Aufnahme von

Indigocarmin mit der Nahrung festgestellt.

Kanzerogenität

Nach wöchentlicher Injektion während 2 Jahren entwickelten 14 von 80 Ratten Sarkome an der

Injektionsstelle. Bei oraler Gabe gibt es keine Hinweise auf Kanzerogenität.

Sonstige Hinweise

Inkompatibilität

Indigocarmin ist sehr empfindlich gegen oxydierende Substanzen.

Beeinflussung diagnostischer Methoden

Indigocarmin kann aufgrund der Blaufärbung Urinanalysen beeinflussen.

Hinweis

Bei Raumtemperatur (15–25 °C) vor Licht geschützt in der Originalpackung, sowie ausser

Reichweite von Kindern aufbewahren. Nicht einfrieren.

Haltbarkeit

Das Medikament darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden.

Indigocarmin Amino enthält keine Konservierungsmittel. Nach Anbruch der Ampulle ist die Lösung

unmittelbar zu verwenden. Restmengen sind zu vernichten.

Zulassungsnummer

56500 (Swissmedic).

Packungen

Indigocarmin Amino Inj Lös 20 mg Amp 10 × 5 ml. (B)

Indigocarmin Amino Inj Lös 20 mg Amp 100 × 5 ml. (B)

Zulassungsinhaberin

Amino AG, Gebenstorf.

Stand der Information

März 2010.

  • 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 das Informationsblatt für die Öffentlichkeit.



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EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Active substance: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/17/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Active substance: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester) - Transfer of orphan designation - Commission Decision (2018)1826 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/299/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety