ACLOTINE

Information principale

  • Nom commercial:
  • ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable
  • Dosage:
  • 100 UI
  • forme pharmaceutique:
  • poudre
  • Composition:
  • composition pour 1 ml de solution reconstituée > antithrombine humaine : 100 UI solvant composition > Pas de substance active. :
  • Mode d'administration:
  • intraveineuse
  • Unités en paquet:
  • 1 flacon(s) en verre de poudre - 1 flacon(s) en verre de solvant de 5 ml avec aiguille(s) avec dispositif de transfert
  • classe:
  • Liste I
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • sang et organes hématopoïétiques, (Antithrombine)
  • Descriptif du produit:
  • 561 937-1 ou 4009 561 937 1 4 - 1 flacon(s) en verre de poudre - 1 flacon(s) en verre de solvant de 5 ml avec aiguille(s) avec dispositif de transfert - Déclaration de commercialisation:22/02/1999;561 938-8 ou 4009 561 938 8 2 - 1 flacon(s) en verre de poudre - 1 flacon(s) en verre de solvant de 10 ml avec aiguille(s) avec dispositif de transfert - Déclaration de commercialisation:22/02/1999;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Valide
  • Numéro d'autorisation:
  • 60991573
  • Date de l'autorisation:
  • 30-12-1998
  • Dernière mise à jour:
  • 22-06-2018

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 13/02/2017

Dénomination du médicament

ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable.

Antithrombine humaine

Encadré

Veuillez lire attentivement cette notice avant d’utiliser ce médicament car elle contient des informations importantes pour

vous.

Gardez cette notice. Vous pourriez avoir besoin de la relire.

Si vous avez d’autres questions, interrogez votre médecin, votre pharmacien ou votre infirmier/ère.

Ce médicament vous a été personnellement prescrit. Ne le donnez pas à d’autres personnes. Il pourrait leur être nocif,

même si les signes de leur maladie sont identiques aux vôtres.

Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, votre pharmacien ou votre infirmier/ère. Ceci

s’applique aussi à tout effet indésirable qui ne serait pas mentionné dans cette notice. Voir rubrique 4

Que contient cette notice ?

1. Qu'est-ce que ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable et dans quel cas est-il utilisé ?

2. Quelles sont les informations à connaître avant d'utiliser ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable

3. Comment utiliser ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable ?

4. Quels sont les effets indésirables éventuels ?

5. Comment conserver ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable ?

6. Contenu de l’emballage et autres informations.

1. QU’EST-CE QUE ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable ET DANS QUELS CAS EST-IL

UTILISE ?

Classe pharmacothérapeutique - code ATC : B01AB02

ACLOTINE est un médicament antithrombotique.

ACLOTINE est indiqué pour traiter :

Les déficits constitutionnels en antithrombine :

dans les traitements des accidents thrombo-emboliques, en association avec l'héparine, lorsque l'héparine, utilisée seule,

est inefficace ;

dans la prévention des thromboses veineuses, en cas de situation à risque élevé (notamment lors d'une chirurgie ou d'une

grossesse) lorsque le risque hémorragique ne permet pas d'utiliser des doses suffisantes d'héparine.

Le déficit acquis sévère (< 60 %) en antithrombine, dans les CIVD (coagulation intravasculaire disséminée) graves,

évolutives, notamment associées à un état septique.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT D’UTILISER ACLOTINE 100 UI/mL, poudre et solvant

pour solution injectable ?

N’utilisez jamais ACLOTINE :

si vous êtes allergique (hypersensible) à la substance active ou à l’un des autres composants contenus dans ce

médicament, mentionnés dans la rubrique 6.

Avertissements et précautions

Adressez-vous à votre médecin, votre pharmacien ou votre infirmier/ère avant d’utiliser ACLOTINE.

Le traitement substitutif du déficit en antithrombine implique votre prise en charge par un spécialiste de l'hémostase.

La surveillance clinique et biologique comprendra une surveillance étroite des paramètres de la coagulation afin d'éviter une

hypocoagulabilité excessive.

Lorsque l'antithrombine humaine est associée à un traitement anticoagulant, des contrôles itératifs, réguliers et rapprochés

du TCA, de l'héparinémie, ou de l'activité anti-Xa doivent être réalisés, en particulier, dans les minutes ou les heures qui

suivent la perfusion d'antithrombine humaine afin d'adapter la posologie de l'héparine. Il existe en effet un risque de

surdosage en héparine non fractionnée ou de bas poids moléculaire au début du traitement par l'antithrombine humaine

chez les patients recevant de l'héparine.

Une mesure quotidienne des taux d'antithrombine doit être effectuée afin d'adapter les posologies, les traitements prolongés

par l'héparine non fractionnée pouvant entraîner une diminution du taux d'antithrombine circulante.

L'association d'un traitement par l'antithrombine humaine avec un autre anticoagulant utilisé à dose curative peut faire courir

un risque hémorragique au patient lorsqu'il existe des circonstances favorisantes telles que : mise en place ou présence de

voies d'abord vasculaires profondes, chirurgie récente, ponction lombaire ou analgésie rachidienne, association avec

d'autres troubles de l'hémostase en particulier thrombopénie (diminution du taux de cellules sanguines ayant un rôle dans la

coagulation) sévère ou hypofibrinogénémie (diminution du taux de fibrinogène dans le sang).

Lorsque des médicaments sont préparés à partir de sang ou de plasma humain, des mesures de prévention de la

transmission d'agents infectieux sont mises en place. Celles-ci comprennent une sélection soigneuse des donneurs de sang

et de plasma de façon à exclure les donneurs risquant d'être porteurs d'infections, et le contrôle de chaque don et des

mélanges de plasma pour la présence de virus/d'infection.

Les fabricants de ces médicaments mettent également en œuvre dans leur procédé de fabrication des étapes capables

d'éliminer ou d'inactiver les virus.

Cependant, lorsque des médicaments préparés à partir de sang ou de plasma humain sont administrés, le risque de

transmission de maladies infectieuses ne peut être totalement exclu. Ceci s'applique également à tous les virus inconnus ou

émergents ou autres types d'agents infectieux.

Les mesures prises sont considérées comme efficaces pour lutter contre le risque d'infection par le virus de

l'immunodéficience humaine (VIH), le virus de l'hépatite B, le virus de l'hépatite C, le virus de l'hépatite A et le parvovirus

B19.

Il est recommandé que les patients recevant régulièrement ACLOTINE soient correctement vaccinés contre l'hépatite A et

l'hépatite B.

Enfants

Sans objet.

Autres médicaments et ACLOTINE

Le traitement substitutif par ACLOTINE potentialise l'effet anticoagulant d'un traitement par l'héparine. Le risque

d'hypocoagulabilité lié à la première administration d'ACLOTINE, chez un patient traité par héparine et à risque

hémorragique, doit être évalué avec soin, de manière à prévenir la survenue d'une hémorragie. Les effets sur la coagulation

devront être très attentivement surveillés sur le plan clinique et biologique.

L'héparine non fractionnée pouvant entraîner une diminution du taux d'antithrombine circulante, les posologies d'ACLOTINE

seront adaptées aux dosages quotidiens d'antithrombine (voir la rubrique "Mises en garde et précautions d’emploi").

Informez votre médecin ou votre pharmacien si vous utilisez, avez récemment utilisé ou pourriez utiliser tout autre

médicament.

ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable avec des aliments, boissons et de l’alcool

Sans objet.

Grossesse et allaitement

L'innocuité d'ACLOTINE au cours de la grossesse et de l'allaitement n'a pas été évaluée par des essais cliniques contrôlés.

L'expérimentation animale est insuffisante pour établir la sécurité vis-à-vis de la reproduction, du déroulement de la

grossesse, du développement de l'embryon ou du fœtus et du développement péri- et postnatal. Par conséquent, ACLOTINE

ne sera prescrit au cours de la grossesse ou de l'allaitement qu'en cas de nécessité bien établie.

Si vous êtes enceinte ou que vous allaitez, si vous pensez être enceinte ou planifiez une grossesse, demandez conseil à

votre médecin ou pharmacien avant de prendre ce médicament.

Sportifs

Sans objet.

Conduite de véhicules et utilisation de machines

Rien ne suggère qu'ACLOTINE diminue l'aptitude à conduire des véhicules et à utiliser des machines.

ACLOTINE contient du sodium

Ce médicament contient environ 0,28mg de sodium par mL de produit (2,8 mg de sodium par flacon de 10 mL, 1,4 mg de

sodium par flacon de 5 mL). Aux doses habituelles d’ACLOTINE, la quantité apportée de sodium est inférieure à 23 mg (1

mmol de sodium), c’est-à-dire « sans sodium ».

3. COMMENT UTILISER ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable ?

Une unité internationale (UI) d'antithrombine est équivalente à la quantité d'antithrombine présente dans 1 mL de plasma

humain normal. Le taux normal est en moyenne de 100 %. L'administration de 1 UI/kg d’ACLOTINE augmente le taux

circulant d'environ 2 % dans les déficits constitutionnels, en dehors d'une période de thrombose (formation d'un caillot qui

obstrue un vaisseau sanguin).

Posologie

La posologie et la durée du traitement dépendent de la sévérité des signes cliniques et de l'importance du déficit en

antithrombine. La dose administrée et la fréquence des injections doivent toujours être adaptées en fonction de l'efficacité

clinique et du taux d'antithrombine observé. Un taux circulant d'antithrombine d'au moins 70 % doit être maintenu pendant la

durée du traitement.

A titre indicatif, la posologie est :

dans le déficit constitutionnel :

en traitement prophylactique : 30 à 50 UI/kg, lors d'une situation à risque thrombo-embolique (grossesse, chirurgie). La

posologie et le rythme d'injection sont adaptés à l'évolution clinique et biologique,

en traitement curatif : 40 à 50 UI/kg tous les jours ou tous les 2 jours chez l'adulte selon l'évolution clinique et biologique.

dans le déficit acquis sévère :

en traitement curatif : dose initiale de 40 à 50 UI/kg voire 100 UI/kg. Les doses ultérieures, la fréquence des injections et la

durée du traitement seront adaptées à l'état clinique et au suivi biologique.

Si vous avez utilisé plus de ACLOTINE que vous n’auriez dû :

Aucun effet indésirable connu lié à un surdosage accidentel d'ACLOTINE n'a été rapporté.

Consultez immédiatement votre médecin ou votre pharmacien.

Si vous oubliez d’utiliser ACLOTINE :

Sans objet.

Si vous arrêtez d’utiliser ACLOTINE :

Sans objet.

Si vous avez d’autres questions sur l’utilisation de ce médicament, demandez plus d’informations à votre médecin, votre

pharmacien ou à votre infirmier/ère.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Comme tous les médicaments, ce médicament peut provoquer des effets indésirables, mais ils ne surviennent pas

systématiquement chez tout le monde.

Aucun effet indésirable grave n’a été rapporté à ce jour avec ACLOTINE. Néanmoins, il existe un risque théorique de

réactions allergiques de type rash cutané (éruption étendue), œdème, chute tensionnelle.

De rares cas de céphalées (maux de tête) et de fièvre modérée ont été signalés.

En revanche, en l'absence d'association avec un autre anticoagulant, aucun accident hémorragique n'a été rapporté après

perfusion d'antithrombine humaine, y compris lors de traitement ayant généré des taux d'antithrombine supérieurs à 200 %.

Déclaration des effets secondaires

Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, votre pharmacien ou à votre infirmier/ère. Ceci

s’applique aussi à tout effet indésirable qui ne serait pas mentionné dans cette notice. Vous pouvez également déclarer les

effets indésirables directement via le système national de déclaration : Agence nationale de sécurité du médicament et des

produits de santé (ANSM) et réseau des Centres Régionaux de Pharmacovigilance - Site internet: www.ansm.sante.fr

En signalant les effets indésirables, vous contribuez à fournir davantage d’informations sur la sécurité du médicament.

5. COMMENT CONSERVER ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable ?

Tenir ce médicament hors de la vue et de la portée des enfants.

N’utilisez pas ce médicament après la date de péremption indiquée sur le flacon. La date de péremption fait référence au

dernier jour de ce mois.

Après reconstitution, une utilisation immédiate est recommandée.

A conserver à une température ne dépassant pas 25°C et à l’abri de la lumière. Ne pas congeler.

N’utilisez pas ACLOTINE si vous constatez que la solution présente un aspect non homogène ou qu’elle contient un dépôt.

Ne jetez aucun médicament au tout-à-l’égout ni avec les ordures ménagères. Demandez à votre pharmacien ou votre

infirmier/ère d’éliminer les médicaments que vous n’utilisez plus. Ces mesures contribueront à protéger l’environnement.

6. CONTENU DE L’EMBALLAGE ET AUTRES INFORMATIONS

Ce que contient ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable

La substance active est :

Antithrombine humaine (100 UI/mL de solution reconstituée). L’activité spécifique est ³ 3 UI/mg de protéines totales.

Un flacon de 5 mL contient 500 UI d’antithrombine humaine.

Un flacon de 10 mL contient 1000 UI d’antithrombine humaine.

Les autres composants sont :

Poudre : glycine et chlorure de sodium.

Solvant : eau pour préparations injectables.

Qu’est-ce que ACLOTINE 100 UI/mL, poudre et solvant pour solution injectable et contenu de l’emballage extérieur

Ce médicament se présente sous forme de poudre et de solvant pour solution injectable. Boîte de 1.

Flacon de 5 mL ou de 10 mL.

Titulaire de l’autorisation de mise sur le marché

LFB BIOMEDICAMENTS

3 AVENUE DES TROPIQUES

ZA DE COURTABOEUF

91940 LES ULIS

Exploitant de l’autorisation de mise sur le marché

LFB BIOMEDICAMENTS

3 AVENUE DES TROPIQUES

ZA DE COURTABOEUF

91940 LES ULIS

Fabricant

LFB BIOMEDICAMENTS

3 AVENUE DES TROPIQUES

ZA DE COURTABOEUF

91940 LES ULIS

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

La dernière date à laquelle cette notice a été révisée est :

[à compléter ultérieurement par le titulaire]

{MM/AAAA}

Autres

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’ANSM (www.ansm.sante.fr).

Les informations suivantes sont destinées exclusivement aux professionnels de santé :

Reconstitution :

Respecter les règles d'asepsie habituelles.

Si nécessaire, amener les deux flacons (poudre et solvant) à

température ambiante.

Retirer la capsule protectrice du flacon de solvant (eau pour

préparations injectables) et du flacon de poudre.

Désinfecter la surface de chaque bouchon.

Retirer le capuchon protecteur translucide du système de

transfert et insérer à fond le biseau, ainsi dégagé, au centre du

bouchon du flacon de solvant en opérant simultanément un

mouvement de rotation.

Retirer le deuxième capuchon protecteur de l'autre extrémité du

système de transfert.

Maintenir les deux flacons dans une position horizontale (évent

vers le haut) et enfoncer rapidement l’extrémité libre du biseau

au centre du bouchon du flacon de poudre.

Veiller à ce que le biseau soit toujours immergé dans le solvant

pour éviter un cassage précoce du vide.

Placer immédiatement l'ensemble dans une position verticale,

flacon de solvant bien au-dessus du flacon de poudre, de façon

à permettre le transfert du solvant vers la poudre.

Pendant le transfert, diriger le jet de solvant sur toute la surface

de la poudre. Veiller à ce que la totalité du solvant soit

transférée.

A la fin du transfert, le vide est automatiquement cassé (air

stérile).

Retirer le flacon vide (solvant) avec le système de transfert.

Agiter modérément par un mouvement de rotation doux pour

éviter la formation de mousse, jusqu'à dissolution complète de

la poudre.

La mise en solution est généralement instantanée et doit être totale en moins de 10 minutes.

La solution est légèrement opalescente. Ne pas utiliser de solution présentant un aspect non homogène ou contenant un

dépôt.

Administration :

Aspirer le produit dans une seringue stérile à l’aide de l’aiguille-filtre fournie.

Retirer l'aiguille-filtre de la seringue et la remplacer par une aiguille intraveineuse ou une aiguille épicrânienne.

Expulser l’air de la seringue et piquer la veine après désinfection.

Injecter exclusivement par voie intraveineuse ou en perfusion, en une seule fois, immédiatement après reconstitution, sans

dépasser un débit de 4 mL/minute.

Tout médicament non utilisé ou déchet doit être éliminé conformément à la réglementation en vigueur.

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21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Human IgM kit for use on SPAPLUS (2018-10-23)

Human IgM kit for use on SPAPLUS (2018-10-23)

Canadiens en santé

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

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

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/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (Active substance: Humanised Fc-engineered monoclonal antibody against CD19) - Transfer of orphan designation - Commission Decision (2018)7815 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/17/T/01

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Active substance: Anti-GD2 monoclonal antibody 3F8 humanised) - Orphan designation - Commission Decision (2018)7804 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/126/18

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