Iscador P 1 mg

Hauptinformation

  • Handelsname:
  • Iscador P 1 mg Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • Auszug aquosum flüssigen Teig 5 mg ex viscum album (pini) frisch 1 mg, natrii chloridum, aqua q.s. zu einer Lösung anstelle von 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Iscador P 1 mg Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Anthroposophische Arzneimittel
  • Therapiebereich:
  • Zusatzbehandlung bei benignen und malignen Geschwulstkrankheiten

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 56831
  • Berechtigungsdatum:
  • 14-10-1953
  • Letzte Änderung:
  • 25-10-2018

Packungsbeilage

Patienteninformation

13,16

Iscador® Injektionslösung

Iscador AG

Anthroposophisches Arzneimittel

Wann wird Iscador angewendet?

Gemäss der anthroposophischen Menschen- und Naturerkenntnis kann Iscador auf Verschreibung

Ihres Arztes oder Ihrer Ärztin als Zusatzbehandlung zur Verbesserung der Lebensqualität und

eventuell des Krankheitsverlaufes bei bösartigen Geschwulstkrankheiten, auch mit begleitenden

Störungen der blutbildenden Organe, bei gutartigen Geschwulstkrankheiten und nach Operationen

von bösartigen Geschwülsten angewendet werden.

Was sollte dazu beachtet werden?

Zu Wechselwirkungen mit anderen Substanzen liegen keine Untersuchungen vor. Wenn Ihnen Ihr

Arzt oder Ihre Ärztin andere Arzneimittel verordnet hat, fragen Sie Ihren Arzt oder Apotheker bzw.

Ihre Ärztin oder Apothekerin, ob Iscador gleichzeitig angewendet werden darf.

Wann darf Iscador nicht oder nur mit Vorsicht angewendet werden?

Iscador darf nicht angewendet werden bei:

·bekannter Unverträglichkeit (Allergie) auf Mistelzubereitungen;

·chronischen granulomatösen (knötchenartigen) Erkrankungen und Autoimmunerkrankungen mit

stark ausgeprägten Krankheitszeichen sowie bei einer die Immunreaktion unterdrückenden

Behandlung;

·Schilddrüsenüberfunktion.

Iscador darf nur mit Vorsicht angewendet werden bei:

·akut entzündlichen bzw. fieberhaften Erkrankungen (Körpertemperatur über 38 °C, evt. mit

Abgeschlagenheit, Frösteln, allgemeinem Krankheitsgefühl, Kopfschmerzen, Schwindelgefühlen):

die Behandlung sollte dann bis zum Abklingen der Symptome abgebrochen werden und

gegebenenfalls wieder aufgenommen werden;

·Hirn- und Rückenmarkstumoren;

·Hirnmetastasen mit Gefahr einer Hirndruckerhöhung.

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

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbst gekaufte!) einnehmen.

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

Über die Anwendung von Iscador während der Schwangerschaft entscheidet Ihr Arzt oder Ihre

Ärztin. Bei der Anwendung in der Schwangerschaft und Stillzeit ist Vorsicht geboten.

Wie verwenden Sie Iscador?

Die Dosierung und die Häufigkeit der Anwendung werden von Ihrem Arzt oder Ihrer Ärztin

individuell festgelegt. Bei den Serienpackungen ist pro Faltschachtel für die Anwendung der

Ampullen die Reihenfolge 1 bis 7 angegeben. Bitte befolgen Sie bei Ihren Injektionen diese

Reihenfolge der Nummerierung, da verschiedene Stärken enthalten sind (siehe Tabelle 2).

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.

Iscador wird mittels einer Spritze unter die Haut verabreicht. Diese subcutane Injektion sollte nach

Möglichkeit in Tumor- oder Metastasennähe, ansonsten an stets wechselnden Injektionsorten (z.B.

Bauchhaut, Oberschenkel oder eventuell Oberarm [nicht bei Brustkrebs]) erfolgen. Entzündete

Hautbezirke oder Bestrahlungsfelder sind in jedem Fall zu meiden. Ihr Arzt bzw. Ihre Ärztin wird

Sie bezüglich Vorbereiten der Spritzen und Injektionstechnik genau informieren. Halten Sie sich

genau an diese Anweisungen.

Vorsichtshalber wird empfohlen, Iscador nicht mit anderen Arzneimitteln zusammen in einer Spritze

aufzuziehen.

Bei länger als 3 Tage anhaltenden erhöhten Temperaturen, Fieber über 38 °C (evtl. mit

Abgeschlagenheit, Frösteln, allgemeinem Krankheitsgefühl, Kopfschmerzen und kurzzeitigen

Schwindelgefühlen) oder bei örtlichen Reaktionen an der Einstichstelle über 5cm, informieren Sie

Ihren Arzt bzw. Ihre Ärztin.

Die Anwendungsdauer ist prinzipiell nicht begrenzt. Sie wird vom Arzt oder der Ärztin festgelegt.

Die Dosierung sollte in regelmässigen Abständen von Ihrem Arzt oder Ihrer Ärztin überprüft

werden.

Welche Nebenwirkungen kann Iscador haben?

Eine Steigerung der Körpertemperatur bis hin zu Fieber und örtlich begrenzte entzündliche

Reaktionen um die Einstichstelle können insbesondere zu Beginn der Therapie auftreten. Auch

können sich leichte Schwellungen regionaler Lymphknoten zeigen.

Es können örtliche oder allgemeine allergische oder allergieähnliche Reaktionen in Form von

generalisiertem Juckreiz, Nesselsucht, Hautausschlägen oder als akut entzündliche Erkrankung der

Haut oder Schleimhaut sowie auch allergische Schwellungen in Mund und Hals, Schüttelfrost,

Atemnot und Verkrampfung der Atemwege und Schock (anaphylaktische Reaktion) auftreten, die

das Absetzen des Präparates und bei anaphylaktischer Reaktion dringend eine ärztliche Behandlung

erfordern.

Eine Aktivierung schon bestehender Entzündungen sowie entzündliche Reizerscheinungen

oberflächlicher Venen im Injektionsbereich sind möglich. In diesen Fällen ist eine vorübergehende

Therapiepause bis zum Abklingen der Entzündungsreaktion erforderlich.

Es wurde über das Auftreten chronisch granulomatöser (knötchenartiger) Erkrankungen und von

Autoimmunerkrankungen während einer Misteltherapie berichtet. Auch Symptome einer

Hirndruckerhöhung bei Hirntumoren/-metastasen wie Kopfschmerzen und Sehstörungen während

einer Misteltherapie sind möglich.

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?

Iscador ist im Kühlschrank bei 2– 8 °C zu lagern. Die gekühlte Ampulle vor der Anwendung kurz in

der Hand erwärmen.

Ausser Reichweite von Kindern aufbewahren. Das Arzneimittel darf nur bis zu dem auf der Ampulle

mit «EXP» bezeichneten Datum verwendet werden.

Iscador Ampullen nach dem Öffnen sofort anwenden. Angebrochene Ampullen dürfen weder

aufbewahrt noch zu einem späteren Zeitpunkt verwendet werden.

Iscador darf nicht mit anderen Arzneimitteln in der Spritze vermischt werden.

Iscador ist eine klare und, je nach Stärke, farblose bis gelb gefärbte Injektionslösung.

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

Personen verfügen über die ausführliche Fachinformation.

Was ist in Iscador enthalten?

1 Ampulle à 1 ml Iscador enthält: fermentierter wässriger Auszug aus der frischen Mistel-Pflanze

von verschiedenen Wirtsbäumen im Verhältnis 1: 5 (Frischpflanze zu Auszug), gegebenenfalls mit

einer Metallsalzzugabe, welche je nach Iscador Sorte einen Gehalt von 10–8 g pro 100 mg

Frischpflanze aufweist.

Hilfsstoffe: Wasser für Injektionszwecke, Natriumchlorid.

Die Stärke in mg in der Arzneimittelbezeichnung gibt die Menge an frischem Pflanzenmaterial an,

welche zur Herstellung von einer Ampulle Iscador eingesetzt wurde. Beispiel: «Iscador M 1 mg»

enthält den Auszug aus 1 mg frischem Mistelkraut.

Iscador-Produkte mit dem Zusatz «spezifiziert» in der Präparatebezeichnung unterscheiden sich von

den anderen Produkten durch einen festgelegten sog. spezifizierten Lektingehalt (für Wirtsbäume,

Metallsalzzugaben und Sorten siehe Tabelle 1).

Zulassungsnummer

Iscador M: 56829 (Swissmedic).

Iscador A: 56830 (Swissmedic).

Iscador P: 56831 (Swissmedic).

Iscador U c. Hg: 56832 (Swissmedic).

Iscador Qu: 56833 (Swissmedic).

Wo erhalten Sie Iscador? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliche Verschreibung.

Es sind Einzelsorten à 7 Ampullen und Serien als Bündelpackungen à 2 x 7 Ampullen erhältlich

(siehe Tabelle 1).

Die Serienpackungen beinhalten 3 verschiedene Stärken (siehe Tabelle 2).

Zulassungsinhaberin

Iscador AG, Arlesheim, Schweiz

Diese Packungsbeilage wurde im Dezember 2017 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

Erhältliche Iscador Packungen/Inhalt der Serien-Packungen

Iscador Sortiment

Tabelle 1

Wirtsbaum

Iscador

Einzelsorten in den Stärken (1× 7 Ampullen)

Serien-Bündel (2×

7 Ampullen)

0,0001

0,001

0,01

Serie

Serie

Serie

Malus

(Apfelbaum)

M c.

Arg.1

M c. Cu2

M c.

M spez.4

Quercus

(Eiche)

Qu c.

Arg.1

Qu c.

Qu c.

spez.4

Pinus (Kiefer)

P c. Hg3

Abies (Tanne)

Ulmus (Ulme)

U c. Hg3

1 als Silbercarbonat

2 als Kupfercarbonat

3 als Quecksilbersulfat

4 spez. = spezifiziert

Inhalt der Serien-Packungen

Tabelle 2

IscadorSerien

Iscador

Stärken pro

Packung

Verteilung der Stärken in der Packung entsprechend der Nummer

erste Packung à 7 Ampullen

zweite Packung à 7 Ampullen

Serie 0

2× 0,01 mg

0.01

0.01

0.01

0.01

2× 0,1 mg

3× 1 mg

Serie I

2× 0,1 mg

2× 1 mg

3× 10 mg

Serie II

2× 1 mg

1 mg 1 mg

1 mg 1 mg

2× 10 mg

3× 20 mg

8-11-2018

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25-10-2018

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20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

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20-10-2018

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18-10-2018

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Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

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11-10-2018

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21-9-2018

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21-9-2018

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21-9-2018

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21-9-2018

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21-9-2018

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21-9-2018

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21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

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21-9-2018

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21-9-2018

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20-9-2018

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14-9-2018

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14-9-2018

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14-9-2018

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29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

27-7-2018

Pending EC decision:  Opdivo, nivolumab, Opinion date: 26-Jul-2018

Pending EC decision: Opdivo, nivolumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Pending EC decision: Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Pending EC decision: Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Pending EC decision: Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

12-9-2018

 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

Europe - EMA - European Medicines Agency

12-9-2018

Humanalbumin 200 g/l Kedrion

Rote - Liste

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

2-8-2018

Pinimenthol® Erkältungssalbe

Rote - Liste