CHF 2570.45

1-24 hours

Delivery is possible through one of our partner pharmacies after consultation.

Swissmedic Nr.: 61254001
Index: 07.16.20

Pharmacode: 5433229
GTIN/EAN: 7680612540014
Markteintritt: 02.11.2012

Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.


Signifor® (0.3 mg/ml)

Pasireotid (H01CB05)

30x1 ml

(0/5 , 392)

Um Signifor® (0.3 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 Signifor® (0.3 mg/ml)'s gegen Unterschrift (24h) oder dem Medikamenten-Taxi nach einer Online Sprechstunde, falls gewünscht.

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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 Signifor und wann wird es angewendet?

Auf Verschreibung des Arztes oder der Ärztin.

Signifor ist ein Arzneimittel, das zur Behandlung der Cushing-Krankheit angewendet wird, wenn alle nicht medikamentösen Therapien ausgeschöpft sind.

Die Cushing-Krankheit wird durch eine Vergrösserung der Hypophyse (Hirnanhangdrüse) verursacht, die als Adenom der Hypophyse bezeichnet wird. Dieses veranlasst den Körper zu einer Überproduktion eines Hormons mit Namen Adrenocorticotropes Hormon (ACTH), welches seinerseits in einer Überproduktion eines weiteren Hormons, des Cortisols, resultiert.

Signifor kann die Produktion von ACTH durch das Adenom der Hirnanhangdrüse blockieren und damit eine Kontrolle der Überproduktion von Cortisol und der Symptome der Cushing-Krankheit herbeiführen.

Wenn Sie Fragen zur Wirkungsweise von Signifor haben oder warum Ihnen dieses Arzneimittel verschrieben worden ist, wenden Sie sich an Ihren Arzt/Ihre Ärztin.

+-Was sollte dazu beachtet werden?

Befolgen Sie sorgfältig alle Anweisungen Ihres Arztes bzw. Ihrer Ärztin. Diese können von den allgemeinen Informationen in dieser Gebrauchsinformation abweichen.

Signifor enthält weniger als 1 mmol (23 mg) Natrium je Dosis und wird als salzfrei angesehen.

+-Wann darf Signifor nicht angewendet werden?

Sie dürfen Signifor nicht anwenden wenn Sie

  • überempfindlich (allergisch) sind gegen Pasireotid oder einen der sonstigen Bestandteile von Signifor.
  • Bei schwer beeinträchtigter Leberfunktion.
+-Wann ist bei der Anwendung von Signifor Vorsicht geboten?

Signifor hat keine bekannte Wirkung auf die Verkehrstüchtigkeit und die Fähigkeit zum Bedienen von Maschinen.

Bevor Sie mir der Behandlung mit Signifor beginnen, teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, wenn bei Ihnen eines der folgenden Probleme besteht oder jemals bestanden hat:

  • Probleme mit Ihrem Blutzuckerspiegel, ob zu hoch (Diabetes) oder zu niedrig (Unterzuckerung),
  • eine Herzerkrankung oder Störungen des Herzrhythmus wie beispielsweise ein unregelmässiger Herzschlag oder ein abnormes elektrisches Signal, das als «Verlängerung des QT-Intervalls» oder «QT-Verlängerung» bezeichnet wird,
  • Gallensteine,
  • Leberfunktionseinschränkung.

Während Ihrer Behandlung mit Signifor

  • können bei Ihnen Anzeichen oder Symptome eines Cortisolmangels wie extreme Schwäche, Ermüdung, Appetitlosigkeit, Gewichtsverlust, Übelkeit, Erbrechen oder niedriger Blutdruck auftreten. In einem solchen Fall wenden Sie sich sofort an Ihren Arzt bzw. Ihre Ärztin.
  • kann Signifor einen Anstieg Ihres Blutzuckers verursachen. Ihr Arzt bzw. Ihre Ärztin möchte vielleicht Ihren Blutzucker überwachen und kann Ihnen Medikamente verschreiben, die den Blutzucker senken.
  • möchte Ihr Arzt bzw. Ihre Ärztin vielleicht Ihre Herzfrequenz mit einem Gerät überwachen, welches die elektrische Aktivität des Herzens misst («EKG» oder Elektrokardiogramm). Wenn Sie Arzneimittel zur Behandlung von Störungen des Herzens einnehmen, muss Ihr Arzt bzw. Ihre Ärztin vielleicht auch deren Dosis anpassen.
  • möchte Ihr Arzt bzw. Ihre Ärztin vielleicht Ihre Gallenblase, die Leberenzyme und die Hormone der Hirnanhangdrüse in regelmässigen Abständen überprüfen.

Einnahme von anderen Arzneimitteln

Teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, wenn Sie eines der folgenden Arzneimittel einnehmen oder jemals eingenommen haben:

  • Arzneimittel zur Kontrolle Ihres Herzschlages (bekannt als antiarrhythmische Arzneimittel) wie Amiodarone, Sotalol.
  • Arzneimittel, die eine unerwünschte Wirkung auf die Funktion Ihres Herzens (QT-Verlängerung) haben können wie Ketoconazole, Chloroquine, Halofantrine, Clathromycin, Haloperidol, Methadon, Pimozide.
  • Bestimmte andere Arzneimittel:
  • Arzneimittel welche bei Transplantationen zur Unterdrückung des Immunsystems verwendet werden (Cyclosporin)
  • Arzneimittel zur Behandlung von Heuschnupfen und anderen Allergien (Terfenadine)
  • Arzneimittel zur Reduzierung der Laktation (Bromocriptine)

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

  • an anderen Krankheiten leiden,
  • Allergien haben oder
  • andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden.

Essen und Trinken hat keinen Einfluss auf die Wirkungen von Signifor.

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

Ihr Arzt bzw. ihre Ärztin wird mit Ihnen die potentiellen Risiken der Anwendung von Signifor während der Schwangerschaft besprechen.

Die Anwendung von Signifor während der Schwangerschaft wird nicht empfohlen, sofern nicht eindeutig erforderlich. Wenn Sie schwanger sind oder dies vermuten, oder schwanger werden möchten, ist es wichtig, dies Ihrem Arzt bzw. Ihrer Ärztin mitzuteilen. Er bzw. sie wird mit Ihnen besprechen, ob Sie Signifor während Ihrer Schwangerschaft anwenden können.

Während der Behandlung mit Signifor sollten Sie nicht stillen. Es ist nicht bekannt, ob Signifor in die Muttermilch übertritt.

+-Wie verwenden Sie Signifor?

Wenden Sie Signifor immer genau nach Anweisung des Arztes bzw. der Ärztin an. Bitte fragen Sie bei Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin oder Apothekerin nach, wenn Sie sich nicht ganz sicher sind.

Signifor Injektionslösung wird als klare farblose Lösung in einer Ampulle geliefert (siehe weiter unten: «Gebrauchsanweisung»).

Die empfohlene Dosis beträgt 0.6 mg zweimal täglich (ungefähr alle 12 Stunden). Die Anwendung von Signifor an jedem Tag zur selben Zeit hilft Ihnen, an die Anwendung Ihres Arzneimittels zu denken.

Ihr Arzt bzw. Ihre Ärztin wird beobachten, wie Sie auf die Behandlung ansprechen, und die beste Dosis für Sie feststellen. Eine Selbstüberwachung der Blutglukosewerte sollte während der ersten zwei bis drei Behandlungsmonate wöchentlich und danach periodisch nach Anweisung des Arztes erfolgen. Nach einer Dosiserhöhung sollte eine wöchentliche Selbstüberwachung der Blutglukosewerte nach Anweisung des Arztes über die ersten zwei bis vier Wochen erfolgen.

Ihr Arzt bzw. Ihre Ärztin oder das Pflegepersonal wird sie anleiten, wie Sie sich Signifor selbst injizieren. Sie sollten ausserdem die Gebrauchsanweisung lesen (siehe weiter unten). Wenn Sie Fragen haben, wenden Sie sich an Ihren Arzt bzw. Ihre Ärztin, Ihren Apotheker bzw. Ihre Apothekerin oder das Pflegepersonal.

Signifor ist zur subkutanen Anwendung bestimmt. Dies bedeutet, dass es durch eine kurze Nadel in das Fettgewebe direkt unter der Haut injiziert wird. Geeignete Bereiche für eine subkutane Injektion sind die Oberschenkel und der Bauch. Wählen Sie für jede Injektion eine neue Injektionsstelle aus, damit es an der Injektionsstelle nicht zu einer Entzündung oder Reizung kommt.

Sie sollten mit der Anwendung von Signifor so lange fortfahren, wie Ihr Arzt bzw. Ihre Ärztin Ihnen sagt.

Wenn Sie versehentlich eine grössere Menge Signifor angewendet haben, als Ihnen Ihr Arzt bzw. Ihre Ärztin verschrieben hat, wenden Sie sich unverzüglich an Ihren Arzt bzw. Ihre Ärztin, oder an Ihren Apotheker bzw. Ihre Apothekerin oder an das Pflegepersonal.

Wenn Sie die vorherige Injektion vergessen haben, injizieren Sie nicht die doppelte Dosis Signifor. Injizieren Sie einfach die nächste Dosis zum vorgesehenen Zeitpunkt.

Wenn Sie Ihre Behandlung mit Signifor unterbrechen, kann Ihr Cortisolspiegel erneut ansteigen und Ihre Symptome können wiederkehren. Brechen Sie deshalb die Anwendung von Signifor nicht ab, sofern Ihr Arzt bzw. Ihre Ärztin Ihnen dies nicht gesagt hat.

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

Wenn Sie weitere Fragen zur Anwendung des Arzneimittels haben, fragen Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin oder das Pflegepersonal.

Ändern Sie nicht von sich aus die verschriebene 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.

Gebrauchsanweisung

Signifor ist mit einer sterilen Einwegspritze mit Injektionsnadel zu verwenden. Ihr Arzt oder Ihre Ärztin wird Ihnen erklären, wie Sie die Signifor Injektionslösung aus den Ampullen korrekt anwenden.

Bevor Sie die Ampullen verwenden, lesen Sie die folgende Anleitung sorgfältig durch. Wenn Sie Fragen haben, wenden Sie sich an Ihren Arzt bzw. Ihre Ärztin, Ihren Apotheker bzw. Ihre Apothekerin oder das Pflegepersonal.

Vorbereitung

Um die Injektion von Signifor selbständig vorzunehmen benötigen Sie folgende Sachen:

  • eine Ampulle Signifor Injektionslösung
  • Alkoholtupfer oder ähnlich
  • eine sterile Spritze
  • eine lange, dicke und stumpfe Nadel zum Aufziehen der Lösung (optional)
  • eine kurze, feine Nadel für die subkutane Injektion
  • zur Entsorgung von Spritze und Nadel einen Spritzenbehälter oder einen anderen starren geschlossenen Behälter.

Injektionsstelle

Signifor ist zur subkutanen Anwendung bestimmt. Dies bedeutet, dass es durch eine kurze Nadel in das Fettgewebe direkt unter der Haut injiziert wird. Geeignete Bereiche für eine subkutane Injektion sind die Oberschenkel und der Bauch. Wählen Sie für jede Injektion eine neue Injektionsstelle aus, damit es an der Injektionsstelle nicht zu Entzündungen oder Reizungen kommt.

Vorbereitung zur Injektion

Wenn Sie alle Vorbereitungen getroffen haben, befolgen Sie schrittweise die folgenden Punkte:

  • waschen Sie Ihre Hände gründlich mit Seife und Wasser.
  • benutzen Sie frische Einwegspritzen und Nadeln und teilen Sie nie Spritzen oder Nadeln mit anderen Personen.
  • nehmen Sie eine Signifor Ampulle aus der Packung.
  • kontrollieren Sie sorgfältig, ob die Ampulle unversehrt ist. Benutzen Sie die Ampulle nicht, wenn das Glas beschädigt ist, oder wenn die Lösung trüb ist oder Partikel enthält. Bringen Sie in diesen Fällen die gesamte Packung zurück zu Ihrem Arzt, Ihrer Ärztin oder zur Apotheke.

Vergewissern Sie sich, dass das Ablaufdatum «EXP» auf der Ampulle nicht überschritten wird und die Dosis der von Ihrem Arzt oder Ihrer Ärztin verschriebenen Dosis entspricht. Benutzen Sie Signifor nicht, wenn das Ablaufdatum überschritten ist oder die Dosis nicht stimmt. In diesen Fällen bringen Sie die gesamte Packung zurück zu Ihrem Arzt, Ihrer Ärztin oder zur Apotheke.

Injektion von Signifor Lösung

Schritt 1: Die Signifor Lösung wird in einer Ampulle zum Aufbrechen geliefert. Tippen Sie die Ampulle an und stellen Sie sicher, dass sich vor dem Öffnen keine Lösung im Deckel befindet.

Schritt 2: Brechen Sie die Spitze der Ampulle an der mit einer Linie markierten Stelle ab.

Achten Sie darauf, dass Sie die Ampulle nach dem Öffnen aufrecht auf eine saubere und ebene Fläche stellen.

Schritt 3: Nehmen Sie eine neue sterile Spritze und befestigen Sie eine neue sterile Nadel. Falls Sie zwei Nadeln verwenden, befestigen Sie zum Aufziehen der Flüssigkeit zuerst die lange, dicke Nadel. Entfernen Sie danach den Schutzdeckel von der Nadel.

Bevor Sie mit Schritt 4 beginnen: Reinigen Sie die Injektionsstelle mit einem Alkoholtupfer.

Schritt 4: Stecken Sie die Nadel in die Ampulle saugen Sie die gesamte Injektionslösung durch aufziehen des Kolbens in die Spritze. Falls Sie zwei Nadeln verwenden, entfernen Sie jetzt die lange Nadel und setzen Sie die kurze Nadel zur Injektion auf.
Schritt 5: Halten Sie die Spritze in einer Hand wie abgebildet zwischen ihren Fingern, mit dem Daumen auf dem Kolben. Versichern sie sich, dass sich keine Luftblasen in der Spritze befinden: drücken sie den Kolben langsam in die Spritze, bis sich ein erster Flüssigkeitstropfen an der Nadelspitze bildet. Berühren Sie keine Gegenstände mit der Nadelspitze. Sie sind nun bereit zur Injektion.
Schritt 6: Reinigen Sie die Injektionsstelle mit einem Alkohol-Tupfer. Drücken Sie danach an der Injektionsstelle mit zwei Fingern sanft eine Hautfalte zusammen und führen Sie die Nadel in einem Winkel von etwa 45 Grad (wie abgebildet) an der Injektionsstelle ein.
Schritt 7: Behalten Sie die Hautfalte zwischen den Fingern und drücken Sie den Kolben langsam bis zum Anschlag hinunter bis die ganze Lösung injiziert ist. Halten Sie den Kolben weitere 5 Sekunden gedrückt.
Schritt 8: Lassen Sie die Hautfalte langsam los und ziehen Sie die Nadel langsam und gerade aus der Injektionsstelle. Setzten Sie den Schutzdeckel wieder auf die Nadel.

Schritt 9: Werfen Sie die gebrauchten Spritzen und Nadeln sofort nach Gebrauch in einen Spritzenbehälter oder einen anderen starren, geschlossenen Entsorgungsbehälter.

Entsorgen Sie allfällig ungebrauchtes Produkt- und Abfallmaterial gemäss den lokalen Vorschriften.

+-Welche Nebenwirkungen kann Signifor haben?

Wie alle Arzneimittel kann Signifor Nebenwirkungen haben, die aber nicht bei jedem auftreten müssen.

Folgende Nebenwirkungen können bei der Anwendung von Signifor auftreten:

Sehr häufig treten auf: Hoher Blutzuckerspiegel (es können übermässiger Durst, erhöhte Urinausscheidung, gesteigerter Appetit mit Gewichtsverlust sowie Müdigkeit auftreten), Gallensteine (es können plötzliche Rückenschmerzen oder Schmerzen in der rechten Bauchseite auftreten), Durchfall, Übelkeit, Bauchschmerzen, Erschöpfung, Lokale Schmerzen an der Injektionsstelle, Veränderung des Blutzuckerspiegels.

Häufig sind: Niedriger Cortisolspiegel (es können extreme Schwäche, Gewichtsverlust, Übelkeit, Erbrechen sowie niedriger Blutdruck auftreten), Langsamer Herzschlag, Verlängertes QT-Intervall, Appetitverlust, Erbrechen, Kopfschmerzen, Haarausfall, Abweichende Ergebnisse der Leberfunktionstests, Abweichende Ergebnisse der Funktionstests der Bauchspeicheldrüse, Abweichungen der Blutgerinnungsparameter.

Gelegentlich: Niedrige Anzahl an roten Blutkörperchen

Informieren Sie bitte Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn eine der aufgeführten Nebenwirkungen Sie erheblich beeinträchtigt. 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?

Arzneimittel sind für Kinder unerreichbar aufzubewahren.

In der Originalpackung, vor Licht geschützt und nicht über 30 °C lagern.

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet werden. Das Verfalldatum bezieht sich auf den letzten Tag des Monats.

Verwenden Sie Signifor nicht, wenn Sie bemerken, dass die Lösung nicht klar ist oder Partikel enthält. Die Lösung soll frei von sichtbaren Partikeln, klar und farblos sein.

Arzneimittel dürfen nicht im Abwasser oder Haushaltsabfall entsorgt werden. Fragen Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr benötigen.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin.

+-Was ist in Signifor enthalten?

Signifor enthält den Wirkstoff Pasireotid.

1 Ampulle enthält 1 ml Injektionslösung mit Pasireotid in einer Menge von 0.3 mg, 0.6 mg oder 0.9 mg, als Hilfsstoffe Mannitol, Weinsäure und Wasser für Injektionszwecke.

+-Zulassungsnummer

61254 (Swissmedic).

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

In Apotheken nur gegen ärztliche Verschreibung.

Ampullen zu 0.3 mg, Packung mit 30 Ampullen.

Ampullen zu 0.6 mg, Packung mit 30 Ampullen.

Ampullen zu 0.9 mg, Packung mit 30 Ampullen.

+-Zulassungsinhaberin

Novartis Pharma Schweiz AG, Risch; Domizil: 6343 Rotkreuz.

Diese Packungsbeilage wurde im Juli 2014 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.

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