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Baden, Lindsey - Unredacted CV 2019-03-27 AMDAC
… Women’s Hospital, Core Education Program 2000 Update on vancomycin-resistant Enterococcus West Roxbury VA Medical … (Lecturer) Framingham Union Hospital, Framingham, MA 1999 Vancomycin-Resistant Enterococcus (Speaker) Northeast Branch, … University Medical Center 2001 The Clinical Importance of Vancomycin- Resistant Enterococcus Grand Rounds, Roger …
RC Outsourcing LLC. Lowellville, OH. Amended 483 Issued 02/25/2016
… 400mcg/0.1, Phenylephrine 1.50%, Phe. hrine 2.5%, Vancomycin 1mg/0.1Inl, and Vancomycin 2mg/0.1Inl product is not calibrated as instmcted … - in Tb syringe Ceftazidime 4.5 mg/0.1 rnl - in Tb syringe Vancomycin 1 mg/0.1 rnl - Tb syringe Vancomycin 2 mg/0.1 rnl …
GHPUDP 2023 Curriculum Vitae William Jarvis
… for Outstanding Scientific Paper in 1999 (The Emergence of Vancomycin-Intermediate Resistant Staphylococcus aureus in … for Outstanding Scientific Paper in 2001 (Control of Vancomycin-resistant Enterococcus in 32 Healthcare Facilities … Scientific Publication in 2002 (Prevention for Control of Vancomycin- resistant Enterococcus in 32 Healthcare …
C.diff PLS Summary Draft 05102024
… The first episode of C. diff is treated with either vancomycin or fidaxomicin. rCDI can be treated with … main treatment for C. diff is antibiotics, specifically vancomycin or fidaxomicin. Vancomycin is a broad spectrum antibiotic and is more …
California Pharmacy & Compounding Center, Newport Beach, CA. 483 Issued 08/31/2016
… test was conducted for the following drug products: 1) Vancomycin Ophthalmic (lntravitreal) I mg/0.1 mL Syringe. 2) … SDV Bevacizumab/Dexamethasone 1.25mgllmg/O/lml Injection Vancomycin PF lmg/O.lml (SDV) Sol. Progesterone 1 OOmg Canola … lml PF Lidocaine 1% Phenylephrine 1.5% P-F lml SDV Vancomycin lmg/O.lml Inj in NaCl 0.9% • The lot or batch …
California Pharmacy & Compounding Center, Newport Beach, CA, 483 Issued 8/25/2014
… OBSt: R VATIONS PAGE 9 OF 1.1 I'AGF.S (b) (4) "' Vancomycin Sterile to sterile opthalmic l4mg/ml lot B718067 … Sterile to sterile opthalmic 1Omg/ml lot B721598 Vancomycin Sterile to sterile opthalmic l4mg/ml lot 8718067 … ODSot.E.l f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACF.S Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot …
Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Briefing Document- Sponsor- Rebiotix- RBX2660
… coli US United States UTI Urinary tract infection VRE Vancomycin-resistant Enterococci VRE Vancomycin-resistant Enterococcus Rebiotix Inc A Ferring …
RC Outsourcing LLC, Lowellville, OH. 483 Issued 02/08/2019
… to follow the formula worksheet for the compounding of Vancomycin HCI USP l mg/0.1 ml loL no.03092018. Per the … these complaints attributed the observed cloudiness to vancomycin precipitating out of solution from the high pH … at your facility: -Cefuruxi me I mg -Moxilloxacin 1.5mg -Vancomycin I mg -Ynncomyc in 2mg t------~---EMPLOYEE(S) - …
Curriculum Vitae: Michael Green
… 10. Vincent S, Knight RG, Green M, Sahm D, Shlaes DM. Vancomycin susceptibility and identification of motile … 11. Green M, Barbadora K, Michaels M. Recovery of vancomycin-resistant gram-positive cocci from pediatric liver … Edmund M, Barbadora K, Kusne S, Shlaes DM. Constitutively vancomycin -resistant Enterococcus faecium resistant to …
Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Presentation- Sponsor
… (first recurrence) Third episode (second recurrence) Vancomycin Fidaxomicin Vancomycin taper-pulse Fidaxomicin Vancomycin taper-pulse + bezlotoxumab Antibiotic ➡ Microbiota …
Wellcare Rx Investments LLC dba Denson’s Specialty Pharmacy, Wheaton, IL, 483 Issued 11/19/2015
… lot# 13-071615, prepared 7116/15 and expires 10/16/15. b) Vancomycin 25 mg/ml Ophthabnic, finn lot# 23-081115, prepared …
Paul M. Beringer, Pharm.D. CV
… to facilitate early identification of nephrotoxicity in vancomycin-treated patients. Antimicrob Agents Chemother. … Wong-Beringer, A., Joo J, Tse E, Beringer P.Vancomycin-associated nephrotoxicity: a critical appraisal of … PM, Wong-Beringer A, Rho JP. Predictive performance of a vancomycin- aminoglycoside population model. Ann Pharmacother …
GRAS Notice 946 with amendments
… to most antimicrobial agents with the exception of vancomycin. Resistance to vancomycin is intrinsic to many Lactobacillus spp. including … was tested for resistance to nine antibiotics (ampicillin, vancomycin, gentamycin, kanamycin, streptomycin, …
Final_OPOE_List_June2021_pdf
… TRYPAN BLUE N021670 SOLUTION TRYPAN BLUE N022278 SOLUTION VANCOMYCIN HYDROCHLORIDE N050671 INJECTABLE VANCOMYCIN HYDROCHLORIDE N209481 POWDER …
Final_OPOEList_June_2021_pdf
… TRYPAN BLUE N021670 SOLUTION TRYPAN BLUE N022278 SOLUTION VANCOMYCIN HYDROCHLORIDE N050671 INJECTABLE VANCOMYCIN HYDROCHLORIDE N209481 POWDER …
Final RX OPOE List for posting June 2022
… TRYPAN BLUE N021670 SOLUTION TRYPAN BLUE N022278 SOLUTION VANCOMYCIN HYDROCHLORIDE N050671 INJECTABLE VANCOMYCIN HYDROCHLORIDE N209481 POWDER VASOPRESSIN N212593 …
LEESAR, INC, Fort Myers, FL. 483 Issued 10/29/2021
… an out of specification potency test result for Vancomycin 1.5g Lot l (15) (4) 1- On 10/26/2020, your … to identify and investigate an OOS potency test result for Vancomycin 1.25g Lot l (b) (4) lwith a result of 89.8% on … Succinylcholine I 00 mg/5 mL in 10 mL syringe (20 mg/mL) • Vancomycin 1.25 g added to NaCl 0.9% 250 mL (5 mg/mL) • …
N201699_fidaxomicin_Orig_WR
… NDA 201699 Page 3 to vancomycin), stratified by age at enrollment (from 6 months … (i.e., a minimum of 14 randomized to fidaxomicin and 7 to vancomycin). Representation of Ethnic and Racial … in all subjects receiving fidaxomicin oral suspension and vancomycin oral liquid should be recorded. Efficacy …
Final RX OPOE List for posting December 2022 PDF
… TROMETHAMINE N013025 SOLUTION TRYPAN BLUE N021670 SOLUTION VANCOMYCIN HYDROCHLORIDE N050671 INJECTABLE VANCOMYCIN HYDROCHLORIDE N209481 POWDER VASOPRESSIN N212593 …
2023 Science Forum Poster-The impact of various routes of administered phages on host microbial community
… were chosen for the cocktail. All five phages target vancomycin-resistant enterococcus strain SF28057, which was …
GRAS Notice 762
… 0 Tetracycline 30 33 .0 33.9 34.0 33.7 36.0 30.5 29.4 33.3 Vancomycin 5 21.3 18.4 19.5 17.2 17.4 21.8 23.0 20.1 … 21 .0 22.0 21 .0 22 .0 19.6 Vancomvcin 5 0 0 0 0 0 0 0 Vancomycin 30 0 0 0 0 0 0 0 Based solely on the presence of … acidilactici appeared to be resistant to methicillin and vancomycin and somewhat resistant to gentamycin Table 4: …
N21-130S009 Linezolid Clinpharm BPCA
… as follows: Study 4: Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children. …
Gopinath, R. Drug Z-2 for Prevention of C. difficile Infection by Minimizing Disruption of the Gut Microbiome
… (n=15). – Reduction of colonization with C. difficile and Vancomycin-resistant Enterococci [VRE] (5% vs. 9% at 72 …
Merck Presentations for the June 9, 2016 Meeting of the Antimicrobial Drugs Advisory Committee
… treatment of CDI includes: – Oral/IV metronidazole – Oral vancomycin – Oral fidaxomicin Antibiotic treatment of CDI … disease – Antibiotic treatment with metronidazole or vancomycin disrupts normal gut microbiota, which facilitates … (carrier state) SoC therapy: Metronidazole Vancomycin Fidaxomicin No recurrent C. difficile infection …
PharMEDium Services LLC, Edison, NJ, 483 Issued 2/28/2013
… Chloride Injection USP (Lot l305 1036E Exp sn/2013); and Vancomycin HCL l.25g added to 250mL 0.9% Sodium Chloride … for Nicardipine HCL (Preservative Free) and 30 days for Vancomycin, is not based on site specific, processing … AdditionaJly, some ofthe finn's drug products, such as Vancomycin, have not been re-evaluated since 1999. MATERIALS …