Biorganic Beta-Carotene 15 mg Gisand

Hauptinformation

  • Handelsname:
  • Biorganic Beta-Carotene 15 mg Gisand Kapseln
  • Darreichungsform:
  • Kapseln
  • Zusammensetzung:
  • betacarotenum 15 mg, excipiens pro capsula.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Biorganic Beta-Carotene 15 mg Gisand Kapseln
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika human
  • Therapiebereich:
  • Vitamin A-Präparat

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 45837
  • Berechtigungsdatum:
  • 21-09-1984
  • Letzte Änderung:
  • 05-02-2018

Packungsbeilage

Patienteninformation

Biorganic Beta-Carotene 15 mg Gisand

GISAND

Was ist Biorganic Beta-Carotene 15 mg Gisand und wann wird es angewendet?

Biorganic Beta-Carotene 15 mg Gisand wird bei Erwachsenen bei Vitamin A-Mangelerscheinungen

sowie unterstützend bei bestimmten Hautkrankheiten auf Verschreibung des Arztes oder der Ärztin

angewendet.

Es enthält reines Betacaroten, der Vorläufer von Vitamin A. Vitamin A ist für Wachstum und Schutz

von Haut und Schleimhaut unentbehrlich. Als Bestandteil des Sehpurpurs ist es am Sehvorgang

beteiligt. Ein Mangel an Vitamin A zeigt sich zum Beispiel in Form von Sehstörungen in der

Dämmerung.

Was sollte dazu beachtet werden?

Als Zeichen einer langandauernden, hochdosierten Einnahme kann es zu einer Gelbfärbung der Haut

kommen, vor allem an Händen, Füssen und im Gesicht.

Wann darf Biorganic Beta-Carotene 15 mg Gisand nicht angewendet werden?

Biorganic Beta-Carotene 15 mg Gisand darf nicht zusammen mit Präparaten eingenommen werden,

welche Vitamin A enthalten, sowie wenn schon eine Überversorgung des Körpers mit Vitamin A

besteht, bei schweren Nierenfunktionsstörungen und während einer Therapie mit Retinoiden (z.B.

gegen Akne).

Wann ist bei der Einnahme von Biorganic Beta-Carotene 15 mg Gisand Vorsicht geboten?

Bei plötzlich auftretenden Beschwerden soll das Präparat nicht mehr eingenommen werden und der

Arzt oder die Ärztin aufgesucht werden. Patienten bzw. Patientinnen mit chronischen

Nierenfunktionsstörungen müssen besonders aufpassen. In zwei wissenschaftlichen Studien wurde

festgestellt, dass bei langjährigen Rauchern, welche Betacaroten in einer Dosierung über 20 mg

täglich während mehreren Jahren eingenommen haben, das Risiko von Lungenkrebs oder von Herz-

Kreislauferkrankungen erhöht war.

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

Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbst gekaufte!) einnehmen

oder äusserlich anwenden.

Darf Biorganic Beta-Carotene 15 mg Gisand während einer Schwangerschaft oder in der Stillzeit

eingenommen werden?

Nein. Sprechen Sie mit Ihrem Arzt bzw. Ihrer Ärztin, wenn Sie schwanger sind, es werden möchten

oder stillen.

Wie verwenden Sie Biorganic Beta-Carotene 15 mg Gisand?

Falls nicht anders verordnet, nehmen Erwachsene 2 bis 3 mal 1 Kapsel pro Tag während einer

Mahlzeit mit etwas Flüssigkeit ein.

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.

Welche Nebenwirkungen kann Biorganic Beta-Carotene 15 mg Gisand haben?

Folgende Symptome sprechen für eine Vitamin A-Überdosierung: Kopfschmerzen, Mattigkeit,

Schwindel, Trägheit, Übererregbarkeit, Schlafstörungen, Appetitlosigkeit, Übelkeit, Erbrechen,

Doppelsehen; an der Haut: Schuppung, Juckreiz, Haarausfall, Spalten in den Mundwinkeln. Bei

Auftreten dieser Symptome ist das Präparat nicht mehr einzunehmen und der Arzt oder die Ärztin

aufzusuchen.

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?

Bewahren Sie das Arzneimittel ausser Reichweite von Kindern auf.

Bewahren Sie den Behälter gut verschlossen und bei Raumtemperatur (15–25 °C) auf.

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

Personen verfügen über die ausführliche Fachinformation.

Was ist in Biorganic Beta-Carotene 15 mg Gisand enthalten?

1 Kapsel enthält 15 mg Betacaroten sowie Hilfsstoffe.

Zulassungsnummer

45837 (Swissmedic).

Wo erhalten Sie Biorganic Beta-Carotene 15 mg Gisand? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliche Verschreibung.

Packungen zu 100 Kapseln.

Zulassungsinhaberin

Gisand AG, Bern.

Diese Packungsbeilage wurde im November 2008 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

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Health Canada

18-10-2018

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17-10-2018

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October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

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Europe - EFSA - European Food Safety Authority Publications

23-8-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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FDA - U.S. Food and Drug Administration

15-8-2018

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Europe -DG Health and Food Safety

22-10-2018

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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

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Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

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Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

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Riximyo (Sandoz GmbH)

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EU/3/16/1762 (Pharma Gateway AB)

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Europe -DG Health and Food Safety

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Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

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Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety