Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7)
SteriMax Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
CEFOTAXIME- CEFOTAXIME INJECTION POWDER, FOR SOLUTION STERIMAX INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- IMPORTANT PRESCRIBING INFORMATION January 13, 2023 TEMPORARY IMPORTATION OF CEFOTAXIME FOR INJECTION TO ADDRESS DRUG SHORTAGE Dear Healthcare Professional: Due to the current critical shortage of Cefotaxime for Injection products in the United States (U.S.) market, SteriMax Inc. (SteriMax), in conjunction with Provepharm, Inc. (Provepharm) and Direct Success, Inc. (Direct Success) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. SteriMax has initiated temporary importation of non-FDA approved Cefotaxime for Injection (1 g/vial, and 2 g/vial) into the U.S. market. The Cefotaxime for Injection from SteriMax is marketed in Canada and is manufactured at an FDA-inspected facility that complies with current Good Manufacturing Practice requirements. At this time, no other entity except Provepharm or its distributor Direct Success is authorized by the FDA to import or distribute SteriMax’s Cefotaxime for Injection in the United States. FDA has not approved SteriMax’s Cefotaxime for Injection in the United States. Effective immediately, Provepharm will distribute the following presentations of SteriMax’s Cefotaxime for Injection to address the critical shortage: Note: DIN refers to Drug Identification Number for products approved by Health Canada STERIMAX CEFOTAXIME FOR INJECTION 1 g/vial (as cefotaxime sodium) DIN: 02434091 (Canada) NDC 21586-011-2 2 g/vial (as cefotaxime sodium) DIN: 02434105 (Canada) NDC 21586-012-2 THE BARCODE ON THE IMPORTED PRODUCT LABEL MAY NOT REGISTER ACCURATELY ON THE U.S. SCANNING SYSTEMS. Institutions should manually input the imported product information into their systems and confirm that the barcode, if scanned, provides correct information. Alternative procedures s Lue koko asiakirja