Chirosyn

Hauptinformation

  • Handelsname:
  • Chirosyn Händedesinfektion
  • Darreichungsform:
  • Lösung zur Anwendung auf der Haut
  • Zusammensetzung:
  • Ethanol 96% 57.6g; 1-Propanol (Ph.Eur.) 10.g
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Chirosyn Händedesinfektion
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 86110.00.00
  • Letzte Änderung:
  • 09-12-2017

Packungsbeilage

Beschriftungsentwurf für Vorder- und Rückseite des Behältnisses

Chirosyn Händedesinfektion 10 g/57,6 g pro 100 g Lösung zur Anwendung auf der Haut

1-Propanol/Ethanol 96 % (v/v)

Chirosyn Händedesinfektion ist ein alkoholisches Einreibepräparat für die hygienische und

chirurgische Händedesinfektion. Chirosyn Händedesinfektion enthält hautpflegende und fettende

Substanzen.

Anwendungsgebiete: Hygienische und chirurgische Händedesinfektion.

Wirkungsspektrum: Bakterizid

, tuberkulozid

, levurozid

, viruzid

(behüllte Viren inkl. HBV,

HCV, HIV

sowie unbehüllte Viren wie Adeno-Viren, Polyoma-Viren SV 40, Noro-Viren, Polio-

Viren). VAH-Liste, ÖGHMP-Expertisenverzeichnis.  RKI-Liste A/B. 

Prüfung in in-vitro- und in-vivo-Prüfungen gemäß VAH-Methoden, EN 1500, EN 12791, EN 13727,

EN 13624, EN 14348, EN 14476 sowie DVV/RKI-Leitlinie.

Gemäß RKI-Stellungnahme (Bundesgesundheitsbl. 60, 353 - 363, 2017).

Zusammensetzung: 100 g Lösung enthalten als Wirkstoffe 10 g 1-Propanol und 57,6 g Ethanol 96 %.

Sonstige Bestandteile: Gereinigtes Wasser, Butan-1,3-diol, Propylenglycol, Glycerol 85 %,

2-Butanon, Phosphorsäure 85 %, Lanolin-poly(oxyethylen)-75, Parfum Fresh.

Darreichungsform und Inhalt: 150 ml, 500 ml, 1000 ml, 5000 ml Lösung zur Anwendung auf der

Haut.

Art der Anwendung: Zur Anwendung auf der intakten Haut.

Vorsichtsmaßnahmen/Warnhinweise:  Flüssigkeit und Dampf leicht entzündbar. Verursacht

schwere Augenreizung. Von Hitze, heißen Oberflächen, Funken, offenen Flammen sowie anderen

Zündquellen fernhalten. Nicht rauchen. Flammpunkt 22 °C. Nur äußerlich anwenden. Kontakt mit den

Augen vermeiden. Ein etwaiges Umfüllen darf nur unter aseptischen Bedingungen (Sterilbank)

erfolgen.

Aufbewahrungshinweise: Das Arzneimittel soll nach Ablauf des Verfalldatums nicht mehr

angewendet werden. Arzneimittel für Kinder unzugänglich aufbewahren.

Stand der Information: 12.2017

Ch.-B./verwendbar bis: siehe Aufdruck

Zul.-Nr.: 86110.00.00

Pharmazeutischer Unternehmer und Hersteller: orochemie GmbH + Co. KG, Max-Planck-Straße

27, 70806 Kornwestheim

Tel.: +49 7154 1308-0

www.orochemie.de

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Beschriftungsentwurf für die Rückseite des Behältnisses (Inhalt des Leporello)

Gebrauchsinformation

Chirosyn Händedesinfektion 10 g/57,6 g pro 100 g Lösung zur Anwendung auf der Haut

1-Propanol/Ethanol 96 % (v/v)

Indikationsgruppe: Händedesinfektion

Anwendungsgebiete: Hygienische und chirurgische Händedesinfektion.

Wirkungsspektrum: Bakterizid

, tuberkulozid

, levurozid

, viruzid

(behüllte Viren inkl. HBV,

HCV, HIV

sowie unbehüllte Viren wie Adeno-Viren, Polyoma-Viren SV 40, Noro-Viren, Polio-

Viren). VAH-Liste, ÖGHMP-Expertisenverzeichnis.  RKI-Liste A/B. 

Prüfung in in-vitro- und in-vivo-Prüfungen gemäß VAH-Methoden, EN 1500, EN 12791, EN 13727,

EN 13624, EN 14348, EN 14476 sowie DVV/RKI-Leitlinie.

Gemäß RKI-Stellungnahme (Bundesgesundheitsbl. 60, 353 - 363, 2017).

Chirosyn Händedesinfektion darf nicht angewendet werden, wenn Sie allergisch gegen

1-Propanol, Ethanol oder einen der sonstigen Bestandteile sind. Nicht auf Schleimhäuten und offenen

Wunden anwenden.

Warnhinweise und Vorsichtsmaßnahmen: Propylenglycol kann Hautreizungen hervorrufen.

Wollwachs (Lanolin-poly(oxyethylen)-75) kann örtlich begrenzte Hautreizungen (z. B.

Kontaktdermatitis) auslösen. Chirosyn Händedesinfektion ist alkoholhaltig und brennbar. Vor

Anwendung elektrischer Geräte die mit Chirosyn Händedesinfektion eingeriebene Haut gut trocknen

lassen. Nicht verschlucken oder in den Blutkreislauf gelangen lassen. Verursacht schwere

Augenreizung.

Wechselwirkungen mit anderen Arzneimitteln: Nicht bekannt.

Schwangerschaft und Stillzeit: Bei sachgemäßem Gebrauch kann Chirosyn Händedesinfektion

während Schwangerschaft und Stillzeit angewendet werden.

Dosierung und Art der Anwendung: Zur hygienischen Händedesinfektion Chirosyn

Händedesinfektion unverdünnt in die Hände einreiben, diese während 30 Sekunden feucht halten. Zur

chirurgischen Händedesinfektion unverdünnt die Hände und Unterarme einreiben, diese während

1,5 Minuten feucht halten. Zur Virusinaktivierung Chirosyn Händedesinfektion unverdünnt in die

Hände einreiben, diese während 1,5 Minuten feucht halten.

Zur Anwendung auf der intakten Haut.

Anwendungsfehler und Überdosierung: Nach bestimmungswidriger oraler Aufnahme größerer

Mengen von Chirosyn Händedesinfektion (ab ca. 0,5 ml/kg Körpergewicht) ist mit

Intoxikationserscheinungen durch die enthaltenden Alkohole zu rechnen. Das klinische Bild einer

kombinierten Intoxikation dürfte dem in Fachkreisen bekannten der reinen Ethanol-Intoxikation

entsprechen. Die Notfallbehandlung hat zunächst den allgemeinen Prinzipien der

Vergiftungsbehandlung (z. B. möglichst vollständige primäre Giftelimination und Verhinderung

weiterer Resorption) zu folgen. Neben symptomatischen Maßnahmen ist (im Unterschied zur

kombinierten Methanol/Ethanol-Intoxikation) vordringlich eine rasche Senkung des Ethanol-

Blutspiegels (z. B. mittels Glucose- oder Lävulose-Infusionen, ggf. Dialyse) anzustreben, da der hohe

Ethanolspiegel den enzymatischen Abbau des 1-Propanols verzögern kann.

Nebenwirkungen: Insbesondere bei mehrfacher Anwendung kann es zu Irritationserscheinungen der

Haut (z. B. Austrocknung, Schuppung, Rötung, Spannung, Juckreiz) und bei hochfrequenter

Anwendung auch zu weiter gehenden Hautreizungen mit oberflächlichen Defekten kommen. Das

Ausmaß und der Schweregrad dieser Erscheinungen hängen direkt mit der Häufigkeit der Anwendung

und der Durchführung angemessener Hautpflegemaßnahmen zusammen. Bei dem ersten Auftreten

von Irritationserscheinungen sind die Hautpflegemaßnahmen zu intensivieren. Informieren Sie Ihren

Arzt oder Apotheker, wenn Sie Nebenwirkungen bemerken, die nicht in dieser Gebrauchsinformation

aufgeführt sind.

Meldung von Nebenwirkungen: Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren

Arzt, Apotheker oder das medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in

dieser Packungsbeilage angegeben sind. Sie können Nebenwirkungen auch direkt dem Bundesinstitut

für Arzneimittel und Medizinprodukte, Abt. Pharmakovigilanz, Kurt-Georg-Kiesinger-Allee 3, D-

53175 Bonn, Website: www.bfarm.de anzeigen. Indem Sie Nebenwirkungen melden, können Sie dazu

beitragen, dass mehr Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt

werden.

Angaben zur Aufbewahrung, Haltbarkeit und Beseitigung: Bewahren Sie dieses Arzneimittel für

Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Behältnis angegebenen Verfalldatum nicht mehr

verwenden. Das Verfalldatum bezieht sich auf den letzten Tag des Monats. Haltbarkeit nach Öffnen

des Behältnisses 6 Monate.

Flüssigkeit und Dampf leicht entzündbar. Von Hitze, heißen Oberflächen, Funken, offenen Flammen

sowie anderen Zündquellen fernhalten. Nicht rauchen. Flammpunkt 22 °C. Anwendungshinweise und

Sicherheitsregeln für alkoholische Desinfektionsmittel beachten. Kontakt mit den Augen vermeiden.

Eindringen größerer Mengen der Flüssigkeit in Kanalisation verhindern. Mit flüssigkeitsbindendem

Material aufnehmen. Bei höheren Temperaturen Explosionsgefahr. Vor Anwendung elektrischer

Geräte gut trocknen lassen. Nicht mit dem Hausmüll, sondern unter Beachtung der lokalen

Anforderungen entsorgen.

Ein etwaiges Umfüllen darf nur unter aseptischen Bedingungen (Sterilbank) erfolgen.

Zusammensetzung: Wirkstoffe: 100 g Lösung enthalten 10 g 1-Propanol und 57,6 g Ethanol 96 %.

Sonstige Bestandteile: Gereinigtes Wasser, Butan-1,3-diol, Propylenglycol, Glycerol 85 %,

2-Butanon, Phosphorsäure 85 %, Lanolin-poly(oxyethylen)-75, Parfum Fresh.

Darreichungsform und Inhalt: Lösung zur Anwendung auf der Haut. 150 ml, 500 ml, 1000 ml,

5000 ml

Pharmazeutischer Unternehmer und Hersteller: orochemie GmbH + Co. KG, Max-Planck-Straße

27, 70806 Kornwestheim

Stand der Information: 12.2017

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14-9-2018

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13-9-2018

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