Argatroban Accord 1 mg/ml Infusionslösung

Hauptinformation

  • Handelsname:
  • Argatroban Accord 1 mg/ml Infusionslösung
  • Darreichungsform:
  • Infusionslösung
  • Zusammensetzung:
  • Argatroban 0.966mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Argatroban Accord 1 mg/ml Infusionslösung
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 96950.00.00
  • Letzte Änderung:
  • 22-11-2018

Packungsbeilage

Wortlaut der für die Packungsbeilage vorgesehenen Angaben

Gebrauchsinformation: Information für Anwender

Argatroban Accord 1 mg/ml Infusionslösung

Argatroban

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder oder das

medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser

Packungsbeilage angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht:

Was ist Argatroban Accord und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Argatroban Accord beachten?

Wie ist Argatroban Accord anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Argatroban Accord aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Argatroban Accord und wofür wird es angewendet?

Argatroban Accord ist ein Antikoagulans (ein Arzneimittel, das die Bildung von Blutgerinnseln in

Ihrem Blutkreislauf zu verhindern hilft). Seine Wirkung beruht auf der Unterdrückung der Wirkung

von Thrombin, einer Substanz in Ihrem Blut, die für die Blutgerinnung wichtig ist.

Argatroban Accord wird angewendet, wenn Sie an einer Erkrankung namens heparininduzierter

Thrombozytopenie Typ II (HIT-II) leiden. Wenn Sie an HIT-II erkrankt sind, besteht für Sie das

Risiko der Bildung von Blutgerinnseln in Ihrem Blutkreislauf, was zu Herzanfällen, Schlaganfällen,

Atemproblemen und zu Durchblutungsstörungen in Ihren Gliedmaßen führen kann. Argatroban

Accord kann diese Probleme verhindern bzw. vermeiden, dass sie sich verschlimmern.

2.

Was sollten Sie vor der Anwendung von Argatroban Accord beachten?

Argatroban Accord darf nicht angewendet werden:

Argatroban Accord wird Ihnen nicht verabreicht,

wenn bei Ihnen eine unkontrollierbare Blutung vorliegt;

wenn Sie allergisch gegen Argatroban oder einen der in Abschnit 6. genannten sonstigen

Bestandteile dieses Arzneimittels sind;

wenn Sie eine schwere Leberfunktionsstörung haben.

Warnhinweise und Vorsichtsmaßnahmen

Argatroban Accord wird Ihnen mit besonderer Vorsicht verabreicht:

wenn ein erhöhtes Risiko einer Blutung besteht;

wenn Ihnen kürzlich andere Gerinnungshemmer, wie etwa Heparin, injiziert oder infundiert wurden;

wenn Sie eine leichte bis mäßige Störung der Leberfunktion aufweisen.

Anwendung von Argatroban Accord zusammen mit anderen Arzneimitteln

Bitte informieren Sie Ihren Arzt, wenn Sie andere Arzneimittel einnehmen/anwenden, kürzlich

andere Arzneimittel eingenommen/angewendet haben oder beabsichtigen andere Arzneimittel

einzunehmen/anzuwenden, auch wenn es sich um nicht verschreibungspflichtige Arzneimittel

handelt.

Die Anwendung von Argatroban Accord zusammen mit anderen Blutverdünnern oder Arzneimitteln,

die Blutgerinnsel auflösen, kann das Blutungsrisiko erhöhen.

Schwangerschaft, Stillzeit und Fortpflanzungsfähigkeit

Wenn Sie schwanger sind, wird Ihr Arzt Ihnen Argatroban Accord nur verabreichen, wenn es absolut

notwendig ist.

Sie dürfen während der Anwendung von Argatroban Accord nicht stillen.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Die Auswirkungen von Argatroban Accord auf die Verkehrstüchtigkeit und die Fähigkeit zum

Bedienen von Maschinen wurden nicht untersucht.

Argatroban Accord enthält Sorbitol

Dieses Arzneimittel enthält Sorbitol. Wenn Ihr Arzt Ihnen mitgeteilt hat, dass Sie bestimmte

Zuckerarten nicht vertragen, müssen Sie vor der Anwendung dieses Arzneimittels mit Ihrem Arzt

sprechen.

Argatroban Accord enthält Natrium

Dieses Arzneimittel enthält 3,54 mg Natrium pro ml Lösung.

Dies ist besonders bei Patienten unter einer kontrollierten Natriumdiät zu beachten.

3.

Wie ist Argatroban Accord anzuwenden?

Argatroban Accord wird Ihnen stets durch eine medizinische Fachkraft verabreicht. Argatroban

Accord wird Ihnen als Dauerinfusion intravenös (in eine Vene) verabreicht. Der Arzt entscheidet

über die Dosis und die Dauer der Behandlung.

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Blutungen stellen die häufigsten Nebenwirkungen dar.

Schwere Blutungen können bei etwa 5 %

und leichte Blutungen bei etwa 39 % der Patienten auftreten. Wenn Sie eines der folgenden

Symptome bei sich feststellen,

müssen Sie sich umgehend an Ihren Arzt wenden.

● Blutung oder Blutergüsse

● Blut im Harn oder Stuhl

● Erbrechen von Blut oder Bluthusten

● schwarz gefärbter Stuhl

● Atembeschwerden

● klamme Haut

● Mundtrockenheit

● erweiterte Pupillen und/oder schwacher, rasender Puls.

Diese Symptome könnten ein Hinweis auf Blutungsprobleme sein.

Häufige Nebenwirkungen (können mehr als 1 von 100 Behandelten betreffen):

● Anämie (Blutarmut)

● Blutgerinnsel

● Blutung, einschließlich punktförmiger Blutergüsse (mit Fleckenbildung) in der Haut und in den

Schleimhäuten (Purpura)

● Übelkeit.

Gelegentliche Nebenwirkungen (können mehr als 1 von 1.000 Behandelten betreffen):

● Infektionen wie Harnwegsinfekte

● Blutbildveränderungen

● Blutgerinnsel

● Appetitlosigkeit

● niedrige Blutzuckerspiegel

● niedrige Natriumspiegel im Blut

● Verwirrtheit

● Schwindel

● Ohnmacht

● Kopfschmerzen

● Schlaganfall

● Muskelerkrankungen

● Sprachstörungen

● Sehstörungen

● Taubheit

● Herzinfarkt

● Flüssigkeit im Herzbeutel

● Herzrhythmusstörungen

● Herzrasen

● niedriger Blutdruck

● hoher Blutdruck

● Venenentzündung

● Schock

● herabgesetzte Versorgung von Geweben mit Sauerstoff

● Atembeschwerden

● Flüssigkeitsansammlung im Lungenbereich

● Schluckauf

● Blut im Hustenauswurf, Erbrochenem oder Stuhl

● Verstopfung

● Durchfall

● Magenentzündung

● Schluckbeschwerden

● Zungenerkrankungen

● Leberfunktionsstörung

● Gelbsucht (Gelbfärbung von Haut und Augen)

● veränderte Werte bei Blutuntersuchungen zur Leberfunktion

● Ausschlag, einschließlich Nesselsucht

● Juckreiz

● vermehrtes Schwitzen

● Haarausfall

● Muskelschwäche

● Muskelschmerzen

● Nierenversagen

● Fieber

● Schmerzen

● Müdigkeit

● Reaktionen an der Injektionsstelle

● Anschwellen der Beine

● verstärkte Wundsekretion

● abnorme Laborwerte

Informieren Sie bitte Ihren Arzt oder Apotheker, wenn eine der Nebenwirkungen Sie erheblich

beeinträchtigt oder Sie Nebenwirkungen bemerken, die nicht in dieser Gebrauchsinformation

angegeben sind.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich bitte 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.

5.

Wie ist Argatroban Accord aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Nicht einfrieren. Die Durchstechflasche im Umkarton aufbewahren, um den Inhalt vor Licht zu

schützen.

Die Lösung muss nach dem Öffnen sofort verbraucht werden.

Lösungen, die trüb sind oder Partikel enthalten, dürfen nicht verwendet werden.

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

verwenden. Das Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

6.

Inhalt der Packung und weitere Informationen n

Was Argatroban Accord enthält

Der Wirkstoff ist Argatroban. Die sonstigen Bestandteile sind Sorbitol (Ph.Eur.), Natriumchlorid und

Wasser für Injektionszwecke.

1 ml Infusionslösung enthält 0,966 mg Argatroban entsprechend 1 mg Argatroban 1 H

1 Durchstechflasche mit 50 ml Infusionslösung enthält 48,30 mg Argatroban entsprechend 50 mg

Argatroban 1 H

Wie Argatroban Accord aussieht und Inhalt der Packung

Dieses Arzneimittel ist eine klare, farblose bis blassgelbe Infusionslösung in einer Durchstechflasche

aus klarem Glas mit Gummistopfen und einem Aluminiumbördelverschluss mit Flip-off-

Schnappdeckel. Jede Durchstechflasche enthält 50 ml Lösung. Die Durchstechflaschen sind in

Faltschachteln mit 1, 5 oder 6 Durchstechflaschen abgepackt. Es werden möglicherweise nicht alle

Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer:

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Vereinigtes Königreich

Hersteller:

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Vereinigtes Königreich

oder

Wessling Hungary Kft

Fòti ùt 56., Budapest 1047,

Ungarn

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR)

unter den folgenden Bezeichnungen zugelassen:

Name des

Mitgliedsstaates

Bezeichnung des Arzneimittels

Vereinigtes

Königreich

Argatroban 1 mg/ml Solution for Infusion

Österreich

Argatroban Accord 1 mg/ml Infusionslösung

Deutschland

Argatroban Accord 1 mg/ml Infusionslösung

Frankreich

Argatroban Accord 1 mg/ml solution pour perfusion

Diese Gebrauchsinformation wurde zuletzt überarbeitet im November 2017.

-----------------------------------------------------------------------------------------------------------------------

Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt

Hinweise für die Anwendung, Handhabung und Entsorgung

Argatroban Accord 1 mg/ml Infusionslösung ist als gebrauchsfertige Lösung mit einer Konzentration

von 1 mg/ml (50 mg/50 ml) erhältlich.

Die Durchstechflasche ist nur zur einmaligen Anwendung bestimmt. Der pH-Wert der Lösung zur

intravenösen Infusion beträgt 3,2-7,5.

Lichtschutzmaßnahmen wie Abdecken der intravenösen Schläuche mit Folie sind nicht erforderlich.

Es traten keine signifikanten Aktivitätsverluste durch intravenöse Schläuche bei simulierten

Infusionen der Lösung auf.

Nicht verwendetes Arzneimittel oder Abfallmaterial ist entsprechend den nationalen Anforderungen

zu beseitigen.

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Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Brevibloc 10 mg/ml Infusionslösung

Rote - Liste

12-11-2018

Venofundin® 60 mg/ml Infusionslösung

Rote - Liste

12-11-2018

Tetraspan® 6 % Infusionslösung

Rote - Liste

12-11-2018

Tetraspan® 10 % Infusionslösung

Rote - Liste

8-11-2018

Voluven 10 % Infusionslösung

Rote - Liste

6-11-2018

Hospasol 145 mmol/l Infusionslösung

Rote - Liste

11-10-2018

Vimpat® 10 mg/ml Infusionslösung

Rote - Liste

11-10-2018

Avalox® 400 mg/250 ml Infusionslösung

Rote - Liste

2-10-2018

Ig Vena 50 g/l Infusionslösung

Rote - Liste

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety