Swissmedic Nr.: 56120004
Index: 02.07.10

Pharmacode: 5311259
GTIN/EAN: 7680561200045
Markteintritt: 26.11.2004

Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.


Remodulin® (5 mg/ml)

Treprostinil (B01AC21)

20 ml

(0/5 , 388)

Um Remodulin® (5 mg/ml) kaufen zu können, benötigen Sie zunächst ein Rezept. Bei Deindoktor.ch können Sie im Rahmen einer Online-Sprechstunde per Webcam, mit dem Artz Ihrer Wahl, ein elektronische Rezept erhalten.

Das mit DeinDoktor.ch erhaltene Rezept kann in einer der 1400 Schweizer Apotheken verwendet werden. Wir organisieren mit einer unserer Partner-Apotheken eine Sendung Ihres Remodulin® (5 mg/ml)'s gegen Unterschrift (24h) oder dem Medikamenten-Taxi nach einer Online Sprechstunde, falls gewünscht.

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Dr. Tim Schäufele, Bern (BE)
Cardiologist
Generalist
Internist


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+-Medicaments
Your received prescription through DeinDoktor.ch is usable to get your medicaments in any of the 1400 Swiss pharmacies or in the Swiss online pharmacies. We can arrange with one of our pharmacy-partners a delivery against signature (24h) or medicament-taxi after an online-consultation.
+-Was ist Remodulin und wann wird es angewendet?

Remodulin enthält den Wirkstoff Treprostinil (als Natrium-Treprostinil) und wird zur Behandlung bestimmter Formen der pulmonalen arteriellen Hypertonie eingesetzt (Bluthochdruck in den Arterien zwischen Herz und Lunge).

Remodulin darf nur auf Verschreibung des Arztes oder der Ärztin angewendet werden.

+-Wann darf Remodulin nicht angewendet werden?

Remodulin darf bei Allergie gegenüber einem Bestandteil von Remodulin oder ähnlichen Arzneimitteln nicht angewendet werden.

+-Wann ist bei der Anwendung von Remodulin Vorsicht geboten?

Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Maschinen zu bedienen, beeinträchtigen.

Remodulin darf nur mit Vorsicht angewendet werden, wenn Sie an Leber- oder Nierenfunktionsstörungen leiden.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere (auch selbstgekaufte) Arzneimittel einnehmen oder anwenden.

Dies betrifft insbesondere die folgenden Arzneimittel: Antigerinnungsmittel (Antikoagulantien oder Thrombozyten-Aggregationshemmer), Mittel zur Behandlung von zu hohem Blutdruck, gefässerweiternde Mittel, harntreibende Arzneimittel, gewisse Arzneimittel, welche die Wirkung von Remodulin vermindern oder verstärken können (z.B. Arzneimittel mit den Wirkstoffen Gemfibrozil, Trimethoprim, Deferasirox, Rifampicin, Phenytoin, Carbamazepin, Phenobarbital oder Johanniskraut).

+-Darf Remodulin während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Remodulin darf nur nach Absprache mit dem Arzt bzw. der Ärztin während der Schwangerschaft angewendet werden. Wenn Sie während der Behandlung mit Remodulin schwanger werden, suchen Sie rasch möglichst Ihren Arzt bzw. Ihre Ärztin auf.

Während der Behandlung mit Remodulin sollte nicht gestillt werden.

+-Wie verwenden Sie Remodulin?

Die Behandlung mit Remodulin wird im Spital unter ärztlicher Überwachung begonnen. Remodulin wird als subkutane oder intravenöse Dauerinfusion appliziert.

Subkutane Dauerinfusion:

Die Kanüle wird unter Haut auf dem Bauch oder auf dem Oberschenkel platziert und befestigt. Remodulin wird über eine kleine Pumpe, die am Gurt, an der Wade, am Oberschenkel oder Bauch befestigt wird, dauernd mit konstantem Fluss freigesetzt. Die Remodulin Glasflasche ist Teil der Pumpe, und die Lösung wird über einen feinen Polyvinyl-Schlauch zur Nadel transportiert.

Intravenöse Dauerinfusion:

Im Spital wird Ihnen ein zentraler Venenkatheder gesetzt. Über diesen wird die verdünnte Remodulin-Lösung mittels einer Pumpe dauernd infundiert. Die Lösung von 50 oder 100 ml wird über maximal 48 Stunden verabreicht werden. Danach wird die Lösung durch eine frische Verdünnung ersetzt.

Anwendung:

Im Spital wird Ihnen vom Personal der Gebrauch der Pumpe, das Einsetzen des Infusionsbestecks, der Ersatz von Remodulin und der Einsatz der Dauerinfusion genau erklärt.

Die Durchflussrate von Remodulin wird jede Woche neu eingestellt.

Meistens wird die Dosierung in Abhängigkeit der Symptome der pulmonalen Hypertonie leicht erhöht. Falls unerträgliche Nebenwirkungen auftreten, wird die Dosierung nach Anweisung Ihres Arztes bzw. Ihrer Ärztin angepasst.

Für die korrekte Handhabung der Infusionspumpe halten Sie sich bitte an die Gebrauchsanweisung der Pumpe.

Vergewissern Sie sich, dass Sie die richtige Remodulin-Konzentration und das richtige Infusionsbesteck anwenden und wechseln Sie alle 48 bis 72 Stunden das Infusionsbesteck und das entsprechende Arzneimittelreservoir. Beachten Sie die hygienische Handhabung.

Ein schlechtes Funktionieren der Pumpe oder eine Verstopfung des Infusionsbestecks können zu einer Verschlechterung der Symptome der pulmonalen arteriellen Hypertonie führen. Im Falle eines Unterbruchs des Flusses von Remodulin halten Sie sich an die Anweisungen der Bedienungsanleitung der Pumpe und verständigen Sie ? falls nötig ? Ihren Arzt bzw. Ihre Ärztin oder die Klinik. Halten Sie immer eine Infusionspumpe, Infusionsbesteck und Remodulin in Reserve.

Die Anwendung und Sicherheit von Remodulin bei Kindern und Jugendlichen ist bisher nicht auseichend geprüft worden.

Ihr Arzt bzw. Ihre Ärztin wird die Dosierung und Behandlungsdauer an Ihre persönliche Situation anpassen.

Befolgen Sie die Anweisung des Arztes bzw. der Ärztin genau und ändern Sie nicht von sich aus die vorgeschriebene Dosierung.

Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.

Überdosierung

Im Falle einer Überdosierung könnten folgende Symptome auftreten: Fieberhitze, Kopfschmerzen, Übelkeit, Erbrechen, Durchfall und eine Senkung des Blutdrucks. Es wird empfohlen, unter Anleitung Ihres Arztes bzw. Ihrer Ärztin die Durchflussrate zu senken oder zu unterbrechen bis die Symptome wieder verschwunden sind. Danach kann wieder mit der vom Arzt bzw. der Ärztin verschriebenen Dosierung weitergefahren werden.

+-Welche Nebenwirkungen kann Remodulin haben?

Die meisten unerwünschten Wirkungen treten an der Einstichstelle der Kanüle auf (85%). Schmerzen, Röte, Hitze, Schwellung und Blutungen zeigen sich oft zu Beginn der Behandlung, im Verlaufe der Behandlung aber weniger häufig. Ihr Arzt bzw. Ihre Ärztin kann die Dosierung von Remodulin senken, wenn Ihre Nebenwirkungen sehr ernsthaft sind.

Eine Interpretation der übrigen Nebenwirkungen ist dadurch erschwert, dass einzelne klinische Symptome der pulmonalen arteriellen Hypertonie (z.B. Schwindel, Ohnmacht) ähnlich sind. Unerwünschte Wirkungen, die wahrscheinlich auf die zugrunde liegende Krankheit zurückzuführen sind, schliessen Atemnot, Müdigkeit, Brustschmerzen und Blässe ein.

Einige unerwünschte Wirkungen können eindeutig Remodulin zugeschrieben werden: Kopfschmerzen (30%), Durchfall (22%), Übelkeit (19%), Blutungen oder blaue Flecken an der Infusionsstelle (21%), Gefässerweiterung (10%), Kieferschmerzen (13%), Hautausschlag (12%), Schmerzen (10%), Schwellungen (Ödeme).

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

+-Was ist ferner zu beachten?

Das ungeöffnete Arzneimittel bei Raumtemperatur (15 bis 25 °C) und ausserhalb der Reichweite von Kindern lagern.

Einmal angestochene Vials dürfen nicht länger als 30 Tage verwendet werden.

Die verdünnte Lösung für die intravenöse Infusion darf maximal über 48 Stunden verabreicht werden. Danach sind allfällige Reste zu vernichten und eine neue Verdünnung zu verwenden.

Es darf nur bis zu dem auf der Packung bezeichneten Datum verwendet werden.

Weitere Auskünfte erteilt Ihnen gern Ihr Arzt oder Apotheker bzw. Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.

+-Was ist in Remodulin enthalten?

Remodulin enthält den Wirkstoff Treprostinil (als Natrium-Treprostinil) in folgenden Konzentrationen: 1 mg/ml, 2.5 mg/ml, 5 mg/ml und 10 mg/ml.

Hilfsstoffe: Natriumcitrat, Natriumchlorid, Wasser für Injektionszwecke; Konserv.: Metakresol 3 mg/ml.

+-Zulassungsnummer

56'120 (Swissmedic)

+-Wo erhalten Sie Remodulin? Welche Packungen sind erhältlich?

Remodulin ist in Apotheken nur gegen ärztliche Verschreibung erhältlich.

Remodulin 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml: Einzelpackungen mit 1 Glasflasche (Vial) zu 20 ml

+-Zulassungsinhaberin

OrPha Swiss GmbH, 8700 Küsnacht

Diese Packungsbeilage wurde im September 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.

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