Fragmin 5000 IE - Fertigspritzen

Was Fragmin enthält

• Der Wirkstoff ist Dalteparin-Natrium. 1 Fertigspritze zu 0,2 ml enthält:

5000 IE Anti-Faktor Xa* (ca. 2500 IE aPTT)

(mittleres Molekulargewicht 5600 - 6400)

• Der sonstige Bestandteil ist: Wasser für Injektionszwecke.

*) Die aPTT ist ein Maß für die gerinnungshemmende Wirkung, während die Anti-Xa-Aktivität die antithrombotische Wirkung widerspiegelt.

Wie Fragmin aussieht und Inhalt der Packung

Fertigspritzen ohne Nadelschutzklemme

Injektionslösung in einer Einzeldosis Fertigspritze (Typ I Glas) mit einer latexfreien Nadelschutzkappe, einem Gummistopfen und einem Kolben.

2, 5, 10 Fertigspritzen zu 0,2 ml

Fertigspritzen mit Nadelschutzklemme

Injektionslösung in einer Einzeldosis Fertigspritze (Typ I Glas) mit einer latexfreien Nadelschutzkappe, einem Gummistopfen, einem Kolben und einer Nadelschutzklemme.

2, 5, 10 Fertigspritzen zu 0,2 ml mit Sicherheitssystem (Nadelschutzklemme)

Spritzanleitung

Die Fertigspritze ist mit einem Sicherheitssystem (Nadelschutzklemme) ausgestattet, das nach der Injektion aktiviert werden muss. So kann das Risiko von Nadelstichverletzungen reduziert werden. Die Nadelschutzklemme (orange) ist am Glaszylinder der Fertigspritze befestigt.

Die Fertigspritze vor Injektion.

1. Nadelschutzkappe (grau)
2. Nadelschutzklemme (orange)
3. Glaszylinder

Den Kolben nicht vor Injektion betätigen. Die vorhandene Luftblase dient zur vollständigen

Entleerung der Spritze und sollte daher nicht entfernt werden.

1. Deckfolie vollständig abziehen. Fertigspritze nicht durch die Deckfolie drücken.

2. Fertigspritze vorsichtig entnehmen.

3. Nadelschutzklemme weit genug (ca. 60 bis 80 Grad) wegklappen.

4. Graue Nadelschutzkappe gerade abziehen. Eventuell vorhandene Tropfen an der Nadelspitze vorsichtig abschütteln (nicht abstreifen).

5. Hautfalte bilden: Dazu die vorgesehene Einstichstelle mit Daumen und Zeigefinger anheben (nicht pressen). Fertigspritze senkrecht zur Hautfalte ansetzen, die Nadel vollständig einstechen. Gesamten Inhalt der Fertigspritze langsam injizieren. Nadel vorsichtig herausziehen. Ein Pflaster ist in der Regel nicht erforderlich. An der Einstichstelle kann sich später eventuell ein kleiner Bluterguss bilden.

Nadel aktiv sichern: Nadelschutzklemme mit einer Hand gegen eine feste Oberfläche drücken. Um mehr als 45 Grad biegen, bis ein „Klick“ zu hören ist.

ACHTUNG: Nadelschutzklemme niemals mit dem Finger umbiegen!

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer: Pfizer Corporation Austria Ges.m.b.H., Wien

Hersteller: Catalent France Limoges S.A.S., Limoges, Frankreich

Pfizer Manufacturing Belgium NV, Puurs, Belgien

Z.Nr.: 1-18733

Diese Packungsbeilage wurde zuletzt überarbeitet im Mai 2014.

Reisethrombose – vermeidbar mit rechtzeitiger Prophylaxe

Die Gefahr einer Reisethrombose bei Langstreckenflügen oder bei langen Busfahrten kann durch einfache Vorsichtsmaßnahmen minimiert werden.

Das Sitzen mit abgewinkelten Beinen, ohne Bewegung, führt, auch bei Menschen mit gesunden Venen, nach einigen Stunden zu einer Beinschwellung. Der Grund ist ein Versacken des Blutes in den Beinen und darauffolgend eine Drucksteigerung in den Venen, welche sich erweitern.

Als besondere Risikofaktoren für eine Reisethrombose gelten:

• langes Sitzen (länger als fünf Stunden)
• Alter über 40
• Venenerkrankungen, Herzschwäche, Schwangerschaft, Pille, Übergewicht
• vorangegangene Thrombosen oder Embolien, Gipsverband an den unteren Extremitäten, nach größeren Operationen (vor allem orthopädischen), Gerinnungsstörung, Krebserkrankungen
• Beim Fliegen wird das Risiko, an einer Reisethrombose zu erkranken, durch die extrem trockene Luft (führt zum Eindicken des Blutes) und durch das Konsumieren von alkoholischen Getränken (Gefäße erweitern sich) und eventuelle Einnahme von Schlafmitteln erhöht.

Wenn Sie zu den Patienten mit niedrigem oder mäßigem Risiko gehören, können Sie mit folgenden Vorsichtsmaßnahmen die Gefahr einer Reisethrombose weitgehend reduzieren:

• die Beine regelmäßig bewegen
• die Schuhe ausziehen und einmal pro Stunde die Zehen bewegen, die Füße kreisen lassen oder im Sprunggelenk wippen
• immer wieder aufstehen und herumzugehen
• die Rückenlehne jede Stunde zurückstellen, damit man sich durchstrecken kann
• reichlich Flüssigkeit zu sich nehmen (kein Alkohol)
• Zurückhaltung bei der Einnahme von Schlaf- und Beruhigungsmitteln
• bei schmerzenden und geschwollenen Beinen erfrischt ein nasses Tuch oder ein kühlender Spray
• Personen mit mittlerem Risiko sollten während Langstreckenflügen Stützstrümpfe der Kompressionsklasse 1 bis 2 tragen.

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Die folgenden Informationen sind für Ärzte bzw. medizinisches Fachpersonal bestimmt:

Spezielle Dosierungshinweise

Patienten mit Niereninsuffizienz

In klinischen Studien, die mit Fragmin durchgeführt wurden, ist als Grenze für schwer niereninsuffiziente Patienten ein Serum-Kreatinin von >dem 3fachen des oberen Normwertes festgelegt worden. Aus diesen Studien ging hervor, dass die Fragmin-Dosis bei diesen Patienten so angepasst werden soll, dass eine therapeutische Anti-Faktor Xa-Konzentration von 1 IE/ml (zwischen 0,5 und 1,5 IE/ml) 4 bis 6 Stunden nach Verabreichung erreicht wird. Wenn der Anti-Faktor Xa-Spiegel unter oder über dem therapeutischen Bereich liegt, sollte die Fragmin-Dosis entsprechend nach oben oder unten korrigiert werden. Die Messung des Anti-Faktors Xa sollte nach 3 - 4 Dosierungen erneut vorgenommen und die Dosisanpassung so lange wiederholt werden, bis der therapeutische Bereich erreicht wird.

Patienten mit Leberinsuffizienz

Eine Dosisanpassung ist nicht erforderlich.

Ältere Patienten

Bei älteren Patienten ist keine Dosisanpassung erforderlich, sofern die Nierenfunktion nicht eingeschränkt ist. (siehe Abschnitt 4.4)

Kinder und Jugendliche

Bei Kindern wurden die Sicherheit und Wirksamkeit von Dalteparin-Natrium nicht nachgewiesen. In den Abschnitten 5.1 und 5.2 sind die derzeit vorliegenden Daten aufgeführt. Es können jedoch keine Dosierungsangaben gemacht werden.

Kontrolle des Plasma-Anti-Faktor Xa-Spiegels bei Kindern

Bei bestimmten Patientenpopulationen, wie z.B. bei Kindern, sollte bei Anwendung von Fragmin ca. 4 Stunden nach der Applikation eine Bestimmung des maximalen Plasma-Anti-Faktor Xa-Spiegels erwogen werden. Bei therapeutischer Anwendung mit Einmalgabe sollten die ca. 4 Stunden nach der Applikation gemessenen maximalen Plasma-Anti-Faktor Xa-Spiegel üblicherweise zwischen 0,5 und 1,0 IE/ml liegen. Bei eingeschränkter und instabiler physiologischer Nierenfunktion, wie etwa bei Neugeborenen, wird eine engmaschige Kontrolle der Plasma-Anti-Faktor Xa-Spiegel empfohlen. Bei prophylaktischer Anwendung sollten sich die Plasma-Anti-Faktor Xa-Spiegel üblicherweise zwischen 0,2 und 0,4 IE/ml bewegen.

Wie bei allen Antikoagulanzien besteht auch bei Anwendung von Fragmin die Gefahr systemischer Blutungen. Bei frisch operierten Patienten sollte die Anwendung von Fragmin in hohen Dosen mit erhöhter Vorsicht erfolgen. Nach Behandlungsbeginn sollten die Patienten engmaschig auf Blutungskomplikationen kontrolliert werden. Das kann durch die üblichen Kontrolluntersuchungen bei den Patienten, sorgfältige Beobachtung der Wunddrainage und regelmäßige Bestimmung von Hämoglobin sowie des Plasma-Anti-Faktor Xa-Spiegels erfolgen.

Art der Anwendung

Nur zur subkutanen Injektion.

Die Luftblase in der Spritze nicht entfernen, sie gewährleistet eine vollständige Entleerung der Kanüle. Die Injektion sollte in eine von zwei Fingern geformte Hautfalte der vorderen oder seitlichen Bauchwand erfolgen. Die Nadel senkrecht bis zum Glaskolben in die Bauchfalte einführen. Langsam injizieren. Die Hautfalte darf während der Injektion nicht gelockert werden.

Bei Ausstattung mit einer Nadelschutzklemme als Schutzvorrichtung wird die Spritze nach der Injektion einhändig mit der orangefarbenen Nadelschutzklemme gegen eine feste Oberfläche gedrückt und solange gebogen (um mehr als 45°), bis die Nadel einrastet. Die Nadel ist nun dauerhaft unbrauchbar (siehe Abschnitte 6.5 und 6.6).

Durch diese Schutzvorrichtung wird das Risiko unbeabsichtigter Nadelstichverletzungen reduziert.

• Überdosierung

Inaktivierung von Fragmin im Notfall:

Die gerinnungshemmende Wirkung von Dalteparin kann durch Protamin (1 mg) neutralisiert werden. Während die induzierte Verlängerung der Gerinnungszeit vollständig normalisiert wird, wird die Anti- Faktor Xa-Aktivität nur zu etwa 25 - 50% aufgehoben: 1 mg Protamin hebt die Wirkung von 100 IE (Anti-Faktor Xa) Dalteparin auf.

Protamin sollte jedoch nur in Notfällen eingesetzt werden und eine Überdosierung von Protamin sollte vermieden werden, da Protamin selbst einen gerinnungshemmenden Effekt ausübt.