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CEFIDEROCOL sulfate tosylate, 1g, concentrate, vial

https://unicat.msf.org/cat/product/94002
NST DINJCEFD1V-

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
6.2.3 - Reserve group antibiotics
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J01DI04
Anatomical Therapeutic Chemical Classification according to WHOCC
PMFE
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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CEFIDEROCOL

Full Name

Fetcroja®

Therapeutic Action

Anti-infective for systemic use

Fifth-generation siderophore cephalosporin antibiotic

Active against aerobic Gram-negative bacteria (incl. Carbapenem-resistant Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii and Stenotrophomonas maltophilia).

Indications

Last resort option in the treatment of severe Gram-negative infections in adults, caused by:

  • Carbapenem-Resistant Enterobacterales (CRE) in severe infections when resistant to ceftazidime/avibactam or confirmed/suspected metallo-beta-lactamase producer; or in non-severe infections with limited treatment options.
  • Difficult-to-treat Pseudomonas aeruginosa (DTR-P) in severe infections when resistant to ceftazidime/avibactam, or in non-severe infections with limited treatment options.
  • Stenotrophomonas maltophilia when resistant to other drugs (third-line treatment).
  • Carbapenem-Resistant Acinetobacter baumannii (CRAB), and other Carba-R Acinetobacter baumannii spp when resistant or non-responsive to polymyxins, or non-severe infections with limited treatment options. En combination with a second antibiotic (ideally ampicillin/sulbactam).
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Instructions for use

Reconstitute the powder vial as follows:

  • Using a syringe, withdraw 10 ml from a 100 ml bottle of 0.9% NaCl.
  • Add this volume to the powder vial of cefiderocol and shake gently the vial until complete dissolution of the contents. Allow the vial to stand until the foaming generated on the surface has disappeared (generally within 2 minutes).
  • Withdraw the required volume of reconstituted solution and transfer it to the remainder of the 100 ml bottle of 0.9% NaCl.

Administer the 100 ml bottle containing the diluted cefiderocol by slow IV infusion (over 3 hrs). The solution must be clear and free of visible particles.

Dosage should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.

The antibiotic treatment will be started only once culture and antibiotic susceptibility testing (AST) results are available (in case of an outbreak in hospital settings, discuss with specialist).

Only to be used in health settings where validated microbiology laboratory is available to confirm antimicrobial susceptibility (particularly for Enterobacterales) and detection of carbapenemases

Precautions for Use

Do not administer in children.

Storage

  • Keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • After reconstitution and dilution, use the solution immediately.
  • Discard any unused solution.