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OFLOXACIN, powder, 1 g

https://unicat.msf.org/cat/product/18824
STD SASTAPWDOFX1

Valid Article

Former Code(s): SLASOFLO1P-
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
W0104010699 - Media for mycobacteria cultures - manual & automated (for ast drugs , supplements) - other
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
P
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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OFLOXACIN

Reserved for TB culture programmes.

Definition

Antimycobacterial used for drug susceptibility testing of M. tuberculosis complex.

Specifications

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Technical specifications

  • Powder
  • Off-white to pale yellow crystalline
  • Soluble in aqueous solutions with pH between 2 and 5 and above 9
  • Formula: C18H20FN3O4
  • Purity: ≥ 750µg per mg or ≥ 98%

Packaging & Labelling

1 g in glass vial

Transport not regulated

Instructions for use

  • For the procedure of stock solution and working solution preparations, refer to Tuberculosis Culture Laboratory, MSF-ITM, 2014.
  • The drug working solution is added to the medium during preparation (agar or LJ) or prior to inoculation (MGIT broth tubes).

Storage

  • Keep refrigerated between 2º C and 8º C
  • Do not freeze
  • Keep container tightly closed in a dry and well-ventilated place.
  • Avoid formation of dust and aerosols
  • Provide appropriate exhaust ventilation at places where dust is formed.

(Cf Introduction: Thermosensitive products)

MSF requirements

Ofloxacin is a key antibiotic of the second line drugs used against M. tuberculosis complex. The test is performed to investigate resistance of the mycobacteria to this antibiotic. It can be used for liquid and solid cultures.

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