Maltofer

Hauptinformation

  • Handelsname:
  • Maltofer Sirup
  • Darreichungsform:
  • Sirup
  • Zusammensetzung:
  • Eisen(III) 50 mg als Eisen-oxidum polymaltosatum, arom.: vanillinum und andere, conserv.: E 216, E 218, excipiens ad-Lösung für 5 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Maltofer Sirup
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Eisenmangelanämie bei nachgewiesenem Eisenmangel

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 30124
  • Berechtigungsdatum:
  • 02-09-1971
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Patienteninformation

Maltofer® Sirup

Vifor (International) AG

Was ist Maltofer Sirup und wann wird er angewendet?

Maltofer Sirup ist ein Eisenpräparat, welches zur Behandlung des Eisenmangels ohne Anämie

(latenten Eisenmangels) und des Eisenmangels mit Anämie (manifesten Eisenmangels) angewendet

wird.

Eisen ist ein unentbehrlicher Baustein des roten Blutfarbstoffes, des roten Muskelfarbstoffes und der

eisenhaltigen Enzyme. Eisenmangel kann zu folgenden allgemeinen Beschwerden führen: vermehrte

Müdigkeit, verminderte geistige Leistungsfähigkeit, Reizbarkeit, Unruhe, Kopfschmerzen,

Appetitlosigkeit, Schwächung der Abwehrkräfte, auffallende Blässe, Mundwinkelrisse, trockene

Haut, brüchige Haare und Nägel.

Was sollte dazu beachtet werden?

Bevor Sie mit der Einnahme von Maltofer Sirup beginnen, sollte der Gehalt des Blutes an Eisen und

Blutfarbstoff (Hämoglobin) vom Arzt oder der Ärztin durch geeignete Untersuchungen abgeklärt

worden sein. Wenn die Symptome nicht durch Eisenmangel bedingt sind, ist Maltofer Sirup nicht

wirksam.

Ihr Arzt bzw. Ihre Ärztin möchte durch regelmässige Untersuchungen die Fortschritte Ihrer

Behandlung feststellen und vielleicht auch Blutuntersuchungen vornehmen. Das ist normal und sollte

Sie nicht weiter beunruhigen. Wenn sich Ihre Beschwerden innerhalb von 3 Wochen nicht bessern,

suchen Sie Ihren Arzt bzw. Ihre Ärztin auf.

Wann darf Maltofer Sirup nicht angewendet werden?

·Bei bekannter Überempfindlichkeit (Allergie) oder Unverträglichkeit gegenüber dem Wirkstoff

Eisen(III)-hydroxid Polymaltose Komplex oder einem der Hilfsstoffe (siehe «Was ist in Maltofer

Sirup enthalten?»)

·Bei Eisenüberschuss im Körper (z.B. bedingt durch selten vorkommende Eisenspeicherkrankheiten,

welche zu Eisenablagerungen in den Geweben führen)

·Bei sogenannten Eisenverwertungsstörungen (wenn die Blutarmut z.B. auf einer mangelhaften

Verwertung des Eisens beruht)

·Bei Blutarmut, die nicht auf einem Eisenmangel beruht (z.B. bedingt durch erhöhten

Hämoglobinabbau oder Mangel an Vitamin B12).

Wann ist bei der Einnahme von Maltofer Sirup Vorsicht geboten?

Informieren Sie vor der Einnahme von Maltofer Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder

Apothekerin, wenn Sie eine Infektion oder einen Tumor haben.

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

injizierbaren Eisenpräparaten behandelt worden sind oder mit diesen behandelt werden könnten.

Solche Eisenpräparate sollten nicht gleichzeitig mit Maltofer angewendet werden.

Informieren Sie auch Ihren Arzt resp. Ärztin, wenn Sie Bluttransfusionen erhalten haben, denn dann

besteht ein Risiko von Eisenüberladung bei zusätzlicher Eisengabe.

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

·An anderen Krankheiten leiden

·Allergien haben

·Andere Arzneimittel (auch selbstgekaufte!) einnehmen.

Darf Maltofer Sirup während einer Schwangerschaft oder in der Stillzeit eingenommen werden?

Wenn Sie schwanger sind, es werden möchten oder stillen, dürfen Sie Maltofer nur nach

Rücksprache mit Ihrem Arzt resp. Ihrer Ärztin einnehmen..

Wie verwenden Sie Maltofer Sirup?

Maltofer Sirup soll während oder direkt nach dem Essen eingenommen werden. Er kann mit Frucht-

oder Gemüsesäften, bzw. mit Flaschennahrung gemischt werden. Die leichte Färbung beeinträchtigt

weder Wirkung noch Geschmack. Zur genauen Dosierung wird der beigelegte Messbecher

verwendet.

Ein Messbecher entspricht einem Volumen von 15 ml, corresp. 150 mg Eisen.

Die Tagesdosis kann auf einmal oder in mehrere einzelne Dosen aufgeteilt eingenommen werden.

Eisenmangel mit Anämie:

Kleinkinder bis 1 Jahr: 2,5-5 ml täglich.

Kinder (1-12 Jahre): 5-10 ml täglich.

Jugendliche ab 12 Jahren und Erwachsene: 10-30 ml täglich.

Eisenmangel ohne Anämie:

Für Kleinkinder bis 1 Jahr ist der Sirup nicht geeignet. Zur Behandlung dieser Kinder stehen

Maltofer Tropfen zur Verfügung.

Kinder (1-12 Jahre): 2,5-5 ml täglich.

Jugendliche ab 12 Jahren und Erwachsene: 5-10 ml täglich.

Die Dosierung und die Behandlungsdauer ist abhängig vom Ausmass des Eisenmangels. Bei

Eisenmangel mit Anämie dauert die Behandlung durchschnittlich 3-5 Monate bis die Bluttestwerte

wieder normal sind. Anschliessend wird die Behandlung mit der Dosierung wie für Eisenmangel

ohne Anämie beschrieben für mehrere Wochen fortgesetzt, um die Eisenspeicher aufzufüllen.

Für Eisenmangel ohne Anämie dauert die Behandlung etwa 1-2 Monate.

Über die genaue Behandlungsdauer entscheidet in jedem einzelnen Fall der Arzt bzw. die Ärztin.

Wenn Sie mehr Maltofer eingenommen haben als sie sollten, so sprechen Sie mit Ihrem Arzt oder

Apotheker bzw. mit Ihrer Ärztin oder Apothekerin. Wenn Sie vergessen haben Maltofer

einzunehmen, nehmen Sie einfach die nächste Dosis zur gewohnten Zeit. Nehmen Sie keine doppelte

Dosis, um die vergessene Dosis zu kompensieren.

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

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 Maltofer Sirup haben?

Folgende Nebenwirkungen können bei der Einnahme von Maltofer Sirup auftreten:

Eine sehr häufige Nebenwirkung ist eine Stuhlverfärbung bedingt durch die Eisenausscheidung,

diese ist aber harmlos.

Andere häufige Nebenwirkungen sind Durchfall, Übelkeit und Magen-Darm-Beschwerden.

Gelegentlich kommt es zu Erbrechen, Verstopfung, Bauchschmerzen, Zahnverfärbung oder

Kopfschmerzen sowie zu lokalen Hautreaktionen (Juckreiz, Ausschlag).

Diese Nebenwirkungen sind meist harmlos und vorübergehend.

Sehr selten kann es zu allergischen Reaktionen kommen. Es kann sich z.B. um Hautreaktionen,

Schwellungen (Ödeme) oder Atemnot handeln. In solchen Fällen sollten Sie das Arzneimittel nicht

mehr einnehmen und den Arzt aufsuchen .

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?

Arzneimittel nicht in Reichweite von Kindern aufbewahren.

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet

werden.

Bei Raumtemperatur (15-25°C) lagern.

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

Personen verfügen über die ausführliche Fachinformation.

Was ist in Maltofer Sirup enthalten?

5 ml Maltofer Sirup enthalten 50 mg Eisen in Form von Eisen(III)-hydroxid Polymaltose Komplex

als Wirkstoff, Konservierungsmittel (E218, E216), Zucker, Aromastoffe, Vanillin und weitere

Hilfsstoffe.

Zuckergehalt: 200 mg pro 1 ml Maltofer Sirup.

Alkoholgehalt: weniger als 0.33%.

Zulassungsnummer

30124 (Swissmedic).

Wo erhalten Sie Maltofer Sirup? Welche Packungen sind erhältlich?

Maltofer Sirup erhalten Sie in Apotheken ohne ärztliche Verschreibung.

In Packungen zu 150 ml (mit beigelegtem Messbecher).

Zulassungsinhaberin

Vifor (International) AG, 9001 St. Gallen.

Diese Packungsbeilage wurde im April 2015 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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Europe - EFSA - European Food Safety Authority EFSA Journal

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Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

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Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

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Antimicrobial resistance

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France - Agence Nationale du Médicament Vétérinaire

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

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21-12-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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14-12-2018

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Europe - EFSA - European Food Safety Authority Publications

14-12-2018

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Europe - EFSA - European Food Safety Authority Publications

13-12-2018

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Europe - EFSA - European Food Safety Authority Publications

28-11-2018

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Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

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Europe - EFSA - European Food Safety Authority Publications

22-11-2018

National Research Programme on Environmental and Occupational Health:  calls for research projects issued for 2019

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France - Agence Nationale du Médicament Vétérinaire

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

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Europe - EFSA - European Food Safety Authority Publications

22-11-2018

The text of the 2019 Call for Research Projects on Environmental and Occupational Health

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France - Agence Nationale du Médicament Vétérinaire

21-11-2018


Draft reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products

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Europe - EMA - European Medicines Agency

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

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...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the "Winning on Reducing Food Waste" initiative.

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

8-10-2018

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

2-10-2018

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

France - Agence Nationale du Médicament Vétérinaire

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.

France - Agence Nationale du Médicament Vétérinaire

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-12-2018

Metopiron® 250 mg Weichkapseln

Rote - Liste

26-11-2018

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.

FDA - U.S. Food and Drug Administration

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Europe - EMA - European Medicines Agency

20-11-2018

Faktor VIII SDH Intersero

Rote - Liste

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

9-10-2018

Testoviron®-Depot-250

Rote - Liste

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency