Human Albumin "Octapharma"

Hauptinformation

  • Handelsname:
  • Human Albumin "Octapharma" 25 % - Infusionsflasche
  • Einheiten im Paket:
  • 50 ml, Laufzeit: 36 Monate,100 ml, Laufzeit: 36 Monate
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Human Albumin "Octapharma" 25 % - Infusionsflasche
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Blood substitutes and pla
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 2-00276
  • Berechtigungsdatum:
  • 19-09-2002
  • Letzte Änderung:
  • 07-03-2018

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

Seite 1/7

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

HUMAN ALBUMIN „OCTAPHARMA“ 25 %-INFUSIONSFLASCHE

Wirkstoff: Humanalbumin aus menschlichem Plasma

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der

Anwendung dieses Arzneimittels beginnen, denn sie enthält wichtige

Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals

lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an

Dritte weiter. Es kann anderen Menschen schaden, auch wenn diese die gleichen

Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder

Apotheker. Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage

angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

1. Was ist Human Albumin „Octapharma“ 25 % - Infusionsflasche und wofür wird es

angewendet?

2. Was sollten Sie vor der Anwendung von Human Albumin „Octapharma“ 25 % -

Infusionsflasche beachten?

3. Wie ist Human Albumin „Octapharma“ 25 % - Infusionsflasche anzuwenden?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist Human Albumin „Octapharma“ 25 % - Infusionsflasche aufzubewahren?

6. Inhalt der Packgung und weitere Informationen

1.

Was ist Human Albumin „Octapharma“ 25 % - Infusionsflasche und wofür

wird es angewendet?

Human

Albumin

"Octapharma"

Infusionsflasche

gehört

pharmako-

therapeutischen Gruppe der Plasmasubstitute und Plasmaproteinfraktionen. Das

Produkt

wird

Patienten

verabreicht,

zirkulierende

Blutvolumen

wieder

herzustellen bzw. zu erhalten, wenn ein Mangel an Volumen festgestellt wurde.

Seite 2/7

2.

Was müssen Sie vor der Anwendung von Human Albumin „Octapharma“

25 % - Infusionsflasche beachten?

Human Albumin „Octapharma“ 25 % - Infusionsflasche darf nicht angewendet

werden,

wenn

eine

Überempfindlichkeit

gegen

Albuminpräparate

oder

einen

anderen Inhaltsstoffe des Produktes haben.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Human Albumin

„Octapharma“ 25 % - Infusionsflasche anwenden.

Besondere Vorsicht bei der Anwendung von Human Albumin „Octapharma“ 25 % -

Infusionsflasche ist erforderlich,

Falls Sie auf diese Albuminbehandlung allergisch reagieren, wird die Infusion

abgebrochen und Ihr Arzt wird Ihnen eine alternative Behandlung vorschlagen.

wenn Sie ein erhöhtes Risiko eines hohen Blutvolumens haben, z.B. bei einigen

Herzkrankheiten, oder an hohem Blutdruck, Erweiterung der Speiseröhrenvenen

Flüssigkeit in der Lunge, Gerinnungsstörungen, verminderter Anzahl an roten

Blutkörperchen oder eingeschränkter Harnproduktion leiden.

bei Anzeichen eines erhöhten Blutvolumens (Kopfschmerzen, Atembeschwerden,

Blutstauung in den Halsvenen) oder erhöhtem Blutdruck. Die Infusion sollte sofort

abgebrochen werden.

Dieses Produkt enthält Natrium und Kalium und könnte für Personen mit einer

natrium- bzw. kaliumarmen Diät schädlich sein. Bitte informieren Sie Ihren Arzt,

falls dies auf Sie zutrifft.

Wenn konzentriertes Albumin verabreicht wird, ist besondere Vorsicht geboten, um

eine

ausgeglichene

Flüssigkeitsbilanz

Patienten

sicherzustellen.

Patienten

sollten

sorgfältig

überwacht

werden,

Kreislaufüberlastung

durch

einen

Flüssigkeitsüberschuss zu vermeiden.

Darüber

hinaus

sollten

Elektrolytwerte

Patienten

überwacht

entsprechende

Maßnahmen

gesetzt

werden,

Elektrolytgleichgewicht

wiederherzustellen bzw. zu erhalten.

Albuminlösungen dürfen nicht mit Wasser für Injektionszwecke verdünnt werden, da

dies zu Veränderungen im Blutbild beim Patienten führen kann.

Wenn

relativ

große

Mengen

Albumin

verabreicht

werden

sollen,

eine

Überwachung der Gerinnung und des Hämatokrit erforderlich. Sorgfalt ist geboten,

eine

ausreichende

Versorgung

anderen

Blutbestandteilen

(Gerinnungsfaktoren,

Elektrolyte,

Blutplättchen

rote

Blutkörperchen)

sicherzustellen.

erhöhtes

zirkulierendes

Blutvolumen

kann

auftreten,

wenn

Dosis

Infusionsgeschwindigkeit nicht an die Kreislaufsituation des Patienten angepasst

werden.

ersten

Anzeichen

einer

Überlastung

Gefäßsystems

Herzens (Kopfschmerzen, Atemnot, Halsvenen-Stauung), eines erhöhten Blutdrucks

Seite 3/7

oder eines erhöhten Venendrucks und eines Lungenödems muss die Infusion sofort

abgesetzt werden.

Standardmaßnahmen

Verhinderung

Infektionen

infolge

Verwendung von aus menschlichem Blut oder Plasma hergestellten Arzneimitteln

zählen

Auswahl

Spender,

Untersuchung

einzelnen

Spenden

Plasmapools auf spezifische Infektionsmarker sowie wirksame Produktionsschritte

zur Inaktivierung/Entfernung von Viren. Dennoch kann bei der Verabreichung von

Arzneimitteln,

menschlichem

Blut

oder

Plasma

hergestellt

wurden,

Möglichkeit von Infektionskrankheiten durch die Übertragung vor allem von noch

unbekannten oder neuen Erregern nicht völlig ausgeschlossen werden.

gibt

keine

Berichte

über

Virenübertragung

durch

Albumin,

gemäß

Spezifikationen des europäischen Arzneibuches in etablierten Verfahren hergestellt

wurde.

Anwendung von Human Albumin „Octapharma“ 25 % - Infusionsflasche mit

anderen Arzneimitteln

Bisher

sind

keine

Wechselwirkungen

zwischen

Humanalbumin

anderen

Medikamenten bekannt. Allerdings sollte Human Albumin „Octapharma“ 25 % -

Infusionsflasche

Lösung nicht mit anderen Medikamenten oder Blutkonserven in

einer Injektion gemischt werden

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen

anwenden,

kürzlich eingenommen / angewendet haben, oder beachsichtigen

andere Arzneimittel einzunehmen/anzuwenden.

Schwangerschaft und Stillzeit

Humanalbumin ist ein normaler Bestandteil des menschlichen Bluts. Es sind keine

schädlichen

Auswirkungen

Verwendung

dieses

Produkts

während

Schwangerschaft und Stillzeit bekannt.

Bei der Einstellung des Blutvolumens bei Schwangeren ist besondere Vorsicht

angebracht.

Verkehrstüchtigkeit und das Bedienen von Maschinen

Es gibt keine Hinweise darauf, dass Humanalbumin die Fähigkeit beeinträchtigt, ein

Fahrzeug zu lenken oder Maschinen zu bedienen.

3.

Wie

ist

Human

Albumin

„Octapharma“

25

%

-

Infusionsflasche

anzuwenden?

Human Albumin „Octapharma“ 25 % - Infusionsflasche Lösung ist fertig zur Infusion

(„Tropf“) in eine Vene. Vor der Anwendung sollte das Produkt auf Zimmer- oder

Körpertemperatur erwärmt werden. Die Dosierung und Infusionsrate (wie rasch

Albumin in die Vene infundiert wird) hängt von Ihrem Krankheitsbild ab. Ihr Arzt wird

entscheiden, welche Behandlung für Sie am besten ist.

Das Produkt kann an Frühgeborene und Dialysepatienten verabreicht werden.

Seite 4/7

Wenn

Sie

eine

größere

Menge

Human

Albumin

„Octapharma“

25

%

angewendet haben als Sie sollten:

Bei zu hoher Dosierung oder Infusionsrate könnten Kopfschmerzen, hoher Blutdruck

Atembeschwerden

auftreten.

diesem

Fall

sollte

Infusion

sofort

abgebrochen werden und Ihr Arzt wird entscheiden, ob eine andere Behandlung

erforderlich ist.

4.

Welche Nebenwirkungen sind möglich?

alle

Arzneimittel

kann

auch

Human

Albumin

„Octapharma“

Infusionsflasche Nebenwirkungen haben, die aber nicht bei jedem auftreten müssen.

Nebenwirkungen nach einer Infusion mit Humanalbumin sind selten.

Seltene Nebenwirkungen (Vorkommen bei mehr als 1 von 10000, aber weniger als 1

von 1000 Transfusionen):

allergische Reaktion oder Senkung des Blutdrucks

Sehr

seltene

Nebenwirkungen

(Vorkommen

weniger

10000

Transfusionen, einschließlich vereinzelter Berichte):

allergischer Schock, Verwirrtheit , Kopfschmerzen, beschleunigte oder verlangsamte

Herzfrequenz,

erhöhter

Blutdruck,

Hitzegefühl,

Atemnot,

Übelkeit,

Nesselsucht,

Schwellung

Bereich

Augen,

Mund

Nase,

Ausschlag,

vermehrtes

Schwitzen, Fieber, Schüttelfrost

Diese Symptome verschwinden jedoch meistens, wenn die Infusionsrate gesenkt

wird oder die Infusion abgebrochen wird.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt, Apotheker

oder das medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in

dieser Packungsbeilage angegeben sind. Sie können Nebenwirkungen auch direkt

anzeigen (siehe Details unten). Indem Sie Nebenwirkungen melden, können Sie

dazu beitragen, dass mehr Informationen über die Sicherheit dieses Arzneimittels zur

Verfügung gestellt werden.

Bundesamt für Sicherheit im Gesundheitswesen

Traisengasse 5

1200 WIEN

ÖSTERREICH

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

Seite 5/7

5.

Wie

ist

Human

Albumin

„Octapharma“

25

%

-

Infusionsflasche

aufzubewahren?

Nicht über +25°C lagern. Das Behältnis in der Originalverpackung aufbewahren, um

den Inhalt vor Licht zu schützen. Nicht einfrieren.

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Haltbarkeitsdauer

Sie dürfen das Arzneimittel nach dem auf dem Etikett angegebenen Verfalldatum

nicht mehr anwenden.

Die Lösung sollte klar oder leicht opaleszierend sein. Keine Lösungen verwenden,

die trüb sind oder einen Satz haben.

Nach dem Öffnen des Behälters sollte der Inhalt sofort verbraucht werden.

Das Arzneimittel darf nicht im Abwasser oder Haushaltsabfall entsorgt werden.

Fragen Sie Ihren Apotheker wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht

mehr benötigen. Sie tragen damit zum Schutz der Umwelt bei..

6.

Inhalt der Packung und weitere Informationen

Was Human Albumin „Octapharma“ 25 % - Infusionsflasche enthält

Der Wirkstoff ist: 250 g/l Humanalbumin aus menschlichem Plasma.

Die sonstigen Bestandteile sind: Natrium (142,5-157,5 mmol/l), Kalium (max. 2,0

mmol/l), Stabilisatoren N-Acetyl-DL-Tryptophan und Caprylsäure sowie Wasser

für Injektionszwecke.

Wie Human Albumin „Octapharma“ 25% - Infusionsflasche aussieht und Inhalt

der Packung

Human

Albumin

„Octapharma“

eine

klare

oder

leicht

opaleszierende

Infusionslösung zur intravenösen Anwendung.

Die Infusionsflaschen sind in Abfüllgrößen von 50 ml bzw. 100 ml erhältlich.

1 Packung enthält:

Eine Infusionsflasche mit Lösung

Pharmazeutischer Unternehmer und Hersteller

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaerstr. 235

A-1100 Wien

Österreich

Zulassungsnummer: 2-00276

Seite 6/7

Diese Packungsbeilage wurde zuletzt überarbeitet im April 2015.

Seite 7/7

Die folgenden Informationen sind nur für Ärzte bzw. medizinisches

Fachpersonal bestimmt:

Dosierung und Art der Anwendung

Die Konzentration des Albuminpräparats, Dosierung und Infusionsgeschwindigkeit

sollten sich nach den individuellen Anforderungen des Patienten richten.

Dosierung

Die erforderliche Dosis hängt von der Körpermasse des Patienten, vom Schweregrad

des Traumas oder der Krankheit sowie vom Fortbestand des Flüssigkeits- und

Proteinverlusts ab. Die Dosis sollte anhand des Kreislaufvolumens und nicht anhand

des Plasma-Albuminspiegels bestimmt werden.

Bei der Verabreichung von Humanalbumin sollte die haemodynamische Leistung

regelmäßig überwacht werden; dazu gehört vor allem:

arterieller Blutdruck und Puls

zentraler Venendruck

Pulmonalkapillardruck

Harnproduktion

Elektrolyte

Hämatokrit/Hämoglobin

Dieses Produkt ist für Frühgeborene und Dialysepatienten geeignet.

Art der Anwendung

Humanalbumin kann direkt intravenös verabreicht werden.

Die Infusionsgeschwindigkeit muss den individuellen Umständen und der Indikation

angepasst werden.

Bei Austauschtransfusionen kann die Infusionsgeschwindigkeit höher sein und sollte

der Entnahmegeschwindigkeit angepasst werden.

Jede

Verabreichung

mittels

beigefügter

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

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

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

Xylitol and Your Dog: Danger, Paws Off

This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.

FDA - U.S. Food and Drug Administration

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)

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)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

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

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

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Active substance: Human apotransferrin) - Orphan designation - Commission Decision (2018)7803 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/109/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

6-11-2018

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Important information about potential impact of regulation changes that came in force on 1 July 2018

Therapeutic Goods Administration - Australia

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

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

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

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)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

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