Calciparine 12'500 U.I.

Hauptinformation

  • Handelsname:
  • Calciparine 12'500 U.I. solution injectable en.c.
  • Darreichungsform:
  • solution injectable en.c.
  • Zusammensetzung:
  • heparinum calcicum 12500 U. I., Wasser iniectabilia q.s. zu einer Lösung anstelle von 0,5 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Calciparine 12'500 U.I. solution injectable en.c.
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Biotechnologika
  • Therapiebereich:
  • Gerinnungshemmer

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 38212
  • Berechtigungsdatum:
  • 05-09-1973
  • Letzte Änderung:
  • 27-01-2018

Packungsbeilage

Patienteninformation

Calciparine®

SANOFI-AVENTIS

Was ist Calciparine und wann wird es angewendet?

Calciparine ist ein Medikament, das aus der Darmschleimhaut des Schweines gewonnen wird. Es

handelt sich um ein Heparin, d.h. eine Substanz, die das Blut verflüssigt, indem es seine

Gerinnungsfähigkeit herabsetzt.

Calciparine wird auf ärztliche Verordnung eingesetzt, um thromboembolischen Ereignissen – also

der Bildung von Blutgerinnseln, die den Blutkreislauf blockieren können – vorzubeugen und diese zu

behandeln.

Wann darf Calciparine nicht angewendet werden?

Calciparine darf in folgenden Fällen nicht angewendet werden:

frühere Blutveränderungen wie eine Abnahme der Thrombozytenzahl unter Heparin,

Blutungen oder Blutungsrisiko (Gerinnungsstörungen, Gefässerkrankungen, gastrointestinale

Erkrankungen mit Blutungen),

Störungen der Nieren- oder Leberfunktion,

zu hoher Blutdruck,

Heparinallergie,

nach einem chirurgischen Eingriff am Gehirn, dem Rückenmark oder den Augen,

Hirnschlaganfall.

Im Zweifelsfall ist es unerlässlich, dass Sie Ihren Arzt befragen.

Wann ist bei der Anwendung von Calciparine Vorsicht geboten?

Falls Sie an einer Erkrankung der Nieren oder der Leber oder zu hohem Blutdruck leiden, bereits

früher ein Darmgeschwür hatten oder andere organische Läsionen aufweisen, die bluten können, ist

Vorsicht geboten.

Calciparine setzt die Gerinnungsfähigkeit des Blutes herab. Sie müssen daher bei Verletzungen

wegen des Blutungsrisikos sehr vorsichtig sein und sofort Ihren Arzt bzw. Ihre Ärztin aufsuchen,

wenn Sie eine Blutung feststellen.

Um Calciparine gut einsetzen zu können, wird Ihr Arzt bzw. Ihre Ärztin häufige Kontrollen

durchführen, bei denen er Ihnen Blut abnehmen muss, um die Effekte des Medikamentes zu

beobachten.

Bei gleichzeitiger Verabreichung anderer Medikamente können deren Wirkungen und/oder die von

Calciparine sich verändern.

Wenn Sie Schmerz- oder Rheumamedikamente (Antiphlogistika), Medikamente zur

Blutverflüssigung (Antikoagulantien) oder cortisonhaltige Medikamente einnehmen, müssen Sie dies

Ihrem Arzt bzw. Ihre Ärztin mitteilen, bevor Sie mit einer Calciparine-Behandlung beginnen.

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

Krankheiten leiden, Allergien haben oder andere Medikamente (auch selbstgekaufte!) einnehmen.

Darf Calciparine während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Ihr Arzt bzw. Ihre Ärztin wird entscheiden, ob Sie Calciparine während der Schwangerschaft oder

Stillzeit anwenden dürfen.

Wie verwenden Sie Calciparine?

Die tägliche Calciparine-Dosis hängt von der Art der Erkrankung, dem Körpergewicht und dem

Alter des Patienten ab. Ihr Arzt bzw. Ihre Ärztin wird die für Ihren Fall geeignete Dosis anhand von

Blutuntersuchungen bestimmen.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Medikament

wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. Ihre Ärztin

oder Apothekerin.

Calciparine wird subkutan (unter die Haut) in die untere Bauchwand einmal rechts, einmal links

injiziert.

Bitte verwenden Sie für die Calciparine-Injektion die in der Packung enthaltene Spritze.

Calciparine 0,2 ml in Fertigspritzen

Die Calciparine-Spritzen sind bereits gefüllt und gebrauchsfertig.

Vor der Injektion nehmen Sie bitte die Kappe von der Nadel ab. Um Stichverletzungen zu

vermeiden, wird die Kappe nach der Injektion wieder aufgesetzt.

Calciparine 0,5 ml Ampullen

Die Injektionslösung Calciparine ist in der selbstbrechenden Ampulle enthalten. Öffnen Sie diese,

indem Sie den Ampullenhals an der mit einem weissen Strich markierten Stelle abbrechen. Nehmen

Sie die in der Packung enthaltene Spritze und entfernen Sie die Kappe von der Nadel. Um

Stichverletzungen zu vermeiden, wird die Kappe nach der Injektion wieder aufgesetzt.

Entnehmen Sie die erforderliche Menge der Lösung, indem Sie am Kolben ziehen. Sie können eine

eventuell zu viel entnommene Lösungsmenge entleeren, indem Sie bis zu der gewünschten

Masseinteilung auf den Kolben drücken.

Vor der Injektion müssen eventuelle Luftblasen aus der Spritze entfernt werden, indem Sie die

Spritze aufrecht halten und den vorderen Teil (nicht die Nadel) mit dem Fingernagel beklopfen.

Die Spritzen dürfen nur einmal verwendet werden.

Bereiten Sie den Hautbereich für die Injektion vor, indem Sie diesen mit Watte und Alkohol

desinfizieren. Nehmen Sie eine Hautfalte zwischen Daumen und Zeigefinger Ihrer linken Hand

(wenn Sie Rechtshänder sind) und nehmen Sie die Spritze in die rechte Hand. Führen Sie die Nadel

senkrecht in die Hautfalte ein und halten Sie die Hautfalte während der ganzen Injektionsdauer fest.

Drücken Sie leicht mit dem Daumen den Kolben bis zum Anschlag. Sobald die Injektion beendet ist,

ziehen Sie die Nadel senkrecht aus der Hautfalte. Wenn das Eindringen der Nadel einen heftigen

Schmerz verursacht, ist die Injektion abzubrechen (wahrscheinlich wurde ein Blutgefäss getroffen).

In diesem Fall ziehen Sie die Nadel zurück und führen die Injektion auf der anderen Körperseite

durch (nach Desinfektion der entsprechenden Stelle).

Welche Nebenwirkungen kann Calciparine haben?

Folgende Nebenwirkungen können bei der Anwendung von Calciparine auftreten:

Während der Behandlung mit Calciparine können leichte oder schwerere Blutungen auftreten. In

diesem Fall oder falls Sie das Auftreten lilafarbener Flecken an der Injektionsstelle und/oder eine

lokale oder allgemeine Allergie feststellen, nehmen Sie bitte sofort Kontakt mit Ihrem Arzt bzw. Ihre

Ärztin auf.

Es kann sein, dass sich die Thrombozytenzahl verringert (Thrombozytopenie). Ihr Arzt bzw. Ihre

Ärztin wird Blutkontrollen durchführen, um dies zu vermeiden.

An den Injektionsstellen kann es auch zu kleinen Blutergüssen sowie zu Knötchen kommen. Diese

verschwinden nach einigen Tagen, ohne dass eine Behandlungsunterbrechung erforderlich ist.

Wenn Sie solche Symptome feststellen oder Nebenwirkungen bemerken, die hier nicht beschrieben

sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Calciparine soll ausserhalb der Reichweite von Kindern und bei einer Raumtemperatur (15–25 °C)

aufbewahrt werden.

Es darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet werden.

Falls Sie Packungen besitzen, deren Verfalldatum abgelaufen ist, geben Sie diese bitte Ihrem

Apotheker bzw. Ihre Apothekerin zurück.

Nach dem öffnen der Ampulle oder der Spritze, muss das Arzneimittel sofort angewendet werden.

Die Ampulle oder die Spritze dürfen nur einmal verwendet werden.

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

die ausführliche Fachinformation verfügt.

Was ist in Calciparine enthalten?

Der Wirkstoff von Calciparine ist Heparin-Calcium.

1 Fertigspritze Calciparine 0,2 ml enthält 5’000 U.I. Heparin-Calcium in wässeriger Lösung.

1 Ampulle Calciparine 0,5 ml enthält 12’500 U.I. Heparin-Calcium in wässeriger Lösung.

Zulassungsnummer

38212 (Swissmedic).

Wo erhalten Sie Calciparine? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliches Rezept.

Es gibt folgende Packungsgrössen:

Fertigspritzen zu 0,2 ml: Packung mit 10 Spritzen.

Ampullen zu 0,5 ml mit graduierten Einmalspritzen: Packung mit 2 und 10 Ampullen.

Zulassungsinhaberin

sanofi-aventis (schweiz) ag, 1214 Vernier/GE.

Diese Packungsbeilage wurde im Dezember 2010 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

14-9-2018

Fentanyl AWD® Matrix 12 Mikrogramm/h

Rote - Liste

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety