Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
PENICILLIN G BENZATHINE (UNII: RIT82F58GK) (PENICILLIN G - UNII:Q42T66VG0C)
Provepharm Inc.
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
EXTENCILLINE- BENZATHINE BENZYLPENICILLIN EXTENCILLINE- BENZATHINE BENZYLPENICILLIN INJECTION, POWDER, FOR SUSPENSION PROVEPHARM 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._ ---------- EXTENCILLINE, (BENZATHINE BENZYLPENICILLIN) POWDER AND DILUENT FOR RECONSTITUTION FOR INJECTION HEALTH CARE PROVIDER LETTER March 7, 2024 Laboratoires DELBERT 49 Rue Rouelle 75015 Paris France Phone : +33(0)1 46 99 68 20 https://laboratoires-delbert.fr/en/ IMPORTANT PRESCRIBING INFORMATION SUBJECT: TEMPORARY IMPORTATION OF EXTENCILLINE, (BENZATHINE BENZYLPENICILLIN) POWDER AND DILUENT FOR RECONSTITUTION FOR INJECTION, 1,200,000 UNITS AND 2,400,000 UNITS WITH FOREIGN, NON-U.S. LABELING TO ADDRESS SUPPLY SHORTAGE Dear Healthcare Provider, To address the ongoing shortages of Bicillin® L-A (penicillin G benzathine injectable suspension) in the United States, Laboratoires Delbert in conjunction with Provepharm Inc. (Provepharm) and several distributors (McKesson Corporation, Cencora Global Procurement Ltd., Cardinal Health, Morris & Dickson and Direct Success Inc.) ("Distributors") coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units into the U.S. market. Delbert’s Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units marketed in France and manufactured in Italy for Delbert, is not FDA-approved. Benzathine benzylpenicillin is another name for Penicillin G benzathine. At this time, no other entity except Provepharm or its Distributors identified in the first paragraph are authorized by the FDA to import or distribute Extencilline powder and diluent for reconstitution for injection in the U.S. Effective immediately, Provepharm will distribute the follo Կարդացեք ամբողջական փաստաթուղթը