Embocept S DSM 50 um

Nom de l'organisation

Magle Chemoswed AB

SRN

SE-MF-000003569

Statut du fabricant

Actif

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• CW999

  Pains in the region of the target organ caused by vessel occlusion (usually subsides after about 30 – 60 minutes and disappears after approximately 1 hour. Ischemic pain (epigastric discomfort, chest pains) Transient functional impairment in the target organ (e.g. elevated liver enzymes) Dyspnoea Caused by the combination with cytostatic drugs: nausea, vomiting, diarrhoea, mucosal inflammation, fever, shivers, cough, ulcers in the upper gastrointestinal tract (not possible to attribute directly to the embolisation)

Marché principal en Allemagne ; disponible dans 14 pays au total.

Dénomination commerciale

Embocept S DSM 50 um

Code d'UDI-DI

07350108050012

Basic UDI-DI

B-07350108050012

Numéro de référence/catalogue

493094

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

EmboCept® S DSM 50 μm is a suspension of degradable starch microspheres (DSM) for injection intended as adjuvant for the intra-arterial therapy of liver and lung tumours in combination with cytostatic agents. These microspheres are produced from partially hydrolysed starch. EmboCept® S DSM 50 μm particles have a size of 20 to 90 μm, 95% of the particles are within this size range and have a mean diameter of 50+7 μm. They are degraded by serum alpha-amylase, but due to a higher degree of crosslinking at the periphery, DSMs maintain their size until they finally degraded and disappear. The total time of occlusion is therefore indirectly proportionate to the amount of alpha-amylase present in the plasma. The half-life in vitro at 37 °C is approximately 30-40 minutes. Thus, these microspheres induce a short-lasting temporary vascular occlusion, in contrast to non-degradable particles that induce permanent chemoembolisation. Consequently, treatment sessions using DSM- induced vascular occlusion and can be repeated. EmboCept® S DSM 50 μm occludes liver and lung vessels to induce by ischaemia and by optimisation of the intra- tumoural drug accumulation tumour necrosis.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 50 MU128

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• C010402020303EMBOLISATION PARTICLES AND MICROSPHERES