Melaleuka-Pur

Hauptinformation

  • Handelsname:
  • Melaleuka-Pur flüssig
  • Darreichungsform:
  • flüssig
  • Zusammensetzung:
  • melaleucae aetheroleum, um die Lösung pro 1 g.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Pflanzliches für Menschengebrauch

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Melaleuka-Pur flüssig
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Phytoarzneimittel
  • Therapiebereich:
  • Bei Entzündungen im Mund/Rachenbereich

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 50068
  • Berechtigungsdatum:
  • 10-11-1989
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Information für Patientinnen und Patienten

Lesen Sie diese Packungsbeilage sorgfältig, denn sie enthält wichtige Informationen. Dieses

Arzneimittel haben Sie entweder persönlich von Ihrem Arzt oder Ihrer Ärztin verschrieben erhalten

oder Sie haben es ohne ärztliche Verschreibung in der Apotheke oder Drogerie bezogen. Wenden Sie

das Arzneimittel gemäss Packungsbeilage beziehungsweise nach Anweisung des Arztes, des

Apothekers oder des Drogisten bzw. der Ärztin, der Apothekerin oder der Drogistin an, um den

grössten Nutzen zu haben. Bewahren Sie die Packungsbeilage auf, Sie wollen sie vielleicht später

nochmals lesen.

Melaleuka-Pur Heilöl

Pflanzliches Arzneimittel

Was ist Melaleuka-Pur Heilöl und wann wird es angewendet ?

Melaleuka-Pur Heilöl besteht aus dem ätherischen Öl, das aus den frischen Blättern und

Zweigspitzen der Melaleuca alternifolia (Tea Tree, Teebaum), eines im südlichen Australien

beheimateten Baumes, gewonnen wird. Das ätherische Öl besitzt leicht desinfizierende,

durchblutungsfördernde

Eigenschaften und wird bei Schnupfen und Husten zur Inhalation sowie bei Entzündungen im Mund-

Rachenbereich als Mundspülung eingesetzt.

Was sollte dabei beachtet werden ?

Bei hohem Fieber oder wenn innerhalb einer Woche keine Besserung eintritt, ist ein Arzt bzw. eine

Ärztin zu konsultieren.

Wann darf Melaleuka-Pur Heilöl nicht oder nur mit Vorsicht angewendet werden ?

Wenn Sie auf ätherische Öle überempfindlich reagieren, dürfen Sie Melaleuka-Pur Heilöl nicht

anwenden. Bei Kindern unter 4 Jahren darf Melaleuka-Pur Heilöl nicht angewendet werden.

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

wenn Sie

-an Krankheiten leiden,

-Allergien haben oder

-andere Arzneimittel (auch selbstgekaufte) einnehmen oder äusserlich anwenden.

Darf Melaleuka-Pur Heilöl während einer Schwangerschaft oder in der Stillzeit eingenommen

werden ?

Auf Grund der bisherigen Erfahrung ist bei bestimmungsgemässer Anwendung kein Risiko für das

Kind bekannt. Systematische wissenschaftliche Untersuchungen wurden aber nie durchgeführt.

Vorsichtshalber sollten

Sie während der Schwangerschaft und Stillzeit möglichst auf Arzneimittel verzichten oder den Arzt

oder den Apotheker bzw. die Ärztin oder die Apo- thekerin um Rat fragen.

Wie verwenden Sie Melaleuka-Pur Heilöl ?

Zur Inhalation gibt man 30 Tropfen Melaleuka-Pur Heilöl in eine Tasse (ca. 150 ml) heisses Wasser

und atmet die Dämpfe mehrere Minuten unter einem Tuch tief ein. Die Inhalation kann 3-4mal

täglich wiederholt

werden. Vorsicht: Kinder die Anwendung nicht unbeaufsichtigt durchführen lassen! Zur

Mundspülung nimmt man 20 Tropfen Melaleuka-Pur Heilöl auf ein Glas lauwarmes Wasser und

gurgelt mehrmals täglich.

Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt bzw. der Ärztin

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt, Apotheker oder Drogisten bzw. mit Ihrer Ärztin, Apothekerin oder

Drogistin.

Welche Nebenwirkungen kann Melaleuka-Pur Heilöl haben ?

Folgende Nebenwirkungen können bei der Anwendung von Melaleuka-Pur Heilöl auftreten:

Schmerzhafte, juckende und entzündliche Hautver- änderungen. Beim Auftreten dieser

Nebenwirkungen ist die Behandlung abzubrechen und es ist ein Arzt bzw. eine Ärztin aufzusuchen.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt,

Apotheker oder Drogisten bzw. Ihre Ärztin, Apothekerin oder Drogistin informieren.

Was ist ferner zu beachten ?

Melaleuka-Pur Heilöl soll ausserhalb der Reichweite von Kindern aufbewahrt werden. Das

Arzneimittel darf nur bis zu dem auf dem Behälter «EXP» bezeichneten Datum verwendet werden.

Bei Raumtemperatur (15-25°C) aufbewahren. Weitere Auskünfte erteilt Ihnen Ihr Arzt, Apotheker

oder Drogist bzw. Ihre Ärztin, Apothekerin oder Drogistin.

Was ist in Melaleuka-Pur Heilöl enthalten ?

1 ml Melaleuka-Pur Heilöl enthält:

Ätherisches Öl aus Melaleuca alternifolia (Tea Tree) (1 ml = ~ 20 Tropfen)

Zulassungsnummer

50068 (Swissmedic).

Wo erhalten Sie Melaleuka-Pur Heilöl ? Welche Packungen sind erhältlich ?

In Apotheken und Drogerien, ohne ärztliche Verschreibung. Packung zu 20 ml

Zulassungsinhaberin

Elixan Aromatica GmbH, CH-9533 Kirchberg (SG).

Diese Packungsbeilage wurde im Oktober 2008 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

FDA - U.S. Food and Drug Administration

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically, the child-resistant mechanism may not work properly.

Health Canada

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.

Europe - EFSA - European Food Safety Authority EFSA Journal

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

19-5-2018

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Health Canada is advising Canadians that it has seized an unauthorized “Botox” product and other unauthorized health products from Arshia Hair Salon and Spa (6062A Yonge Street) in Toronto, ON, because they may pose serious health risks. These products may have been administered as injectable treatments for cosmetic purposes.

Health Canada

2-5-2018

Danish-Japanese collaboration on better use of health data

Danish-Japanese collaboration on better use of health data

The Danish Medicines Agency met today with leading representatives from the Japanese Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency at the Danish Medicines Agency in Copenhagen. The purpose of the meeting was to exchange knowledge and experience regarding regulatory work in the pharmaceutical area, and to begin a broader collaboration between the agencies.

Danish Medicines Agency

8-3-2018

Puritan Bennett 980 Series Ventilator

Puritan Bennett 980 Series Ventilator

New suspension - Medtronic Puritan Bennett 980 Series Ventilator

Therapeutic Goods Administration - Australia

6-2-2018

Purevax Rabies ad us. vet.

Purevax Rabies ad us. vet.

● Änderung Text "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

30-7-2018

Puregon Injektionslösung in Patronen

Rote - Liste

10-7-2018

Puregon (Merck Sharp and Dohme B.V.)

Puregon (Merck Sharp and Dohme B.V.)

Puregon (Active substance: follitropin beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4479 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/86/T/97

Europe -DG Health and Food Safety

3-7-2018

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices  https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://go.usa.gov/xU2e8 

FDA - U.S. Food and Drug Administration

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety

25-5-2018

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23C of the Therapeutic Goods Act 1989, make the following instrument under paragraphs 23C(2)(a...

Therapeutic Goods Administration - Australia

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety