Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
NYXTHRACIS 100 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). NYXTHRACIS is a clear to opalescent, colourless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates (which will be removed by inline filtration) with a pH of 5.5 and an osmolality of 277–308 mOsm/kg. |
Each mL of concentrate contains 100 mg of obiltoxaximab. One vial of 6 mL contains 600 mg obiltoxaximab.
Obiltoxaximab is produced in murine GS-NS0 myeloma cells by recombinant DNA technology.
Excipient with known effect: Each mL of concentrate contains 36 mg sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Obiltoxaximab |
Obiltoxaximab is a monoclonal antibody that binds the protective antigen (PA) of B. anthracis. Obiltoxaximab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and oedema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. |
| List of Excipients |
|---|
|
Histidine |
600 mg/6 mL of concentrate in vial (type I glass) with rubber stopper and a polypropylene cap with aluminium seal.
Pack contains 1 vial.
SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
EU/1/20/1485/001
Date of first authorisation: 18 November 2020
| Drug | Countries | |
|---|---|---|
| NYXTHRACIS | Austria, Estonia, Croatia, Italy, Lithuania, Poland |
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