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Revised References to Heavy Metals <231> Targeted Official Date for Omission of References: 01-January-2018 Title File Type <3> Topical And Transdermal Drug Products--Product Quality Tests General Chapter <661> Containers--Plastics General Chapter <1059> Excipient Performance General Chapter <1086> Impurities In Drug Substances And Drug Products General Chapter <1151> Pharmaceutical Dosage Forms USP Acarbose USP Acebutolol Hydrochloride USP Acesulfame Potassium NF Acetaminophen USP Acetazolamide USP Acetic Acid NF Diluted Acetic Acid NF Glacial Acetic Acid USP & NF Acetohexamide USP Acetohydroxamic Acid USP Acetylcysteine USP & NF Acetyltributyl Citrate NF Acetyltriethyl Citrate NF Acetyltyrosine DS Acitretin USP Adapalene USP Adenine USP Adenosine USP S-Adenosyl-L-methionine Disulfate Tosylate DS Adipic Acid NF Agar NF Alanine USP & DS Alclometasone Dipropionate USP Alcohol in Dextrose Injection USP Alendronate Sodium USP Alfadex NF Alginic Acid NF Alprazolam USP Altretamine USP Ammonium Alum USP Potassium Alum USP Alumina and Magnesia Oral Suspension USP Alumina, Magnesia, and Calcium Carbonate Oral Suspension USP Aluminum Acetate Topical Solution USP Aluminum Chloride USP Aluminum Chlorohydrate USP Aluminum Chlorohydrate Solution USP Aluminum Chlorohydrex Polyethylene Glycol USP Aluminum Chlorohydrex Propylene Glycol USP Aluminum Dichlorohydrate USP Aluminum Dichlorohydrate Solution USP Aluminum Dichlorohydrex Polyethylene Glycol USP Aluminum Dichlorohydrex Propylene Glycol USP Aluminum Hydroxide Gel USP Dried Aluminum Hydroxide Gel USP Aluminum Monostearate NF Aluminum Oxide NF Aluminum Phosphate Gel USP Aluminum Sesquichlorohydrate USP Aluminum Sesquichlorohydrate Solution USP Aluminum Sesquichlorohydrex Polyethylene Glycol USP Aluminum Sesquichlorohydrex Propylene Glycol USP Aluminum Sulfate USP Aluminum Zirconium Octachlorohydrate USP Aluminum Zirconium Octachlorohydrate Solution USP Aluminum Zirconium Octachlorohydrex Gly USP Aluminum Zirconium Octachlorohydrex Gly Solution USP Aluminum Zirconium Pentachlorohydrate USP Aluminum Zirconium Pentachlorohydrate Solution USP Aluminum Zirconium Pentachlorohydrex Gly USP Aluminum Zirconium Pentachlorohydrex Gly Solution USP Aluminum Zirconium Tetrachlorohydrate USP Aluminum Zirconium Tetrachlorohydrate Solution USP Aluminum Zirconium Tetrachlorohydrex Gly USP Aluminum Zirconium Tetrachlorohydrex Gly Solution USP Aluminum Zirconium Trichlorohydrate USP Aluminum Zirconium Trichlorohydrate Solution USP Aluminum Zirconium Trichlorohydrex Gly USP Aluminum Zirconium Trichlorohydrex Gly Solution USP Amantadine Hydrochloride USP Amcinonide USP Powdered American Ginseng Extract DS Amifostine USP Amiloride Hydrochloride USP Aminobenzoate Potassium USP Aminobenzoate Sodium USP Aminobenzoic Acid USP Aminocaproic Acid USP Aminoglutethimide USP Aminohippuric Acid USP Aminosalicylate Sodium USP Aminosalicylic Acid USP Amiodarone Hydrochloride USP Amitriptyline Hydrochloride USP Amlodipine Besylate USP Strong Ammonia Solution NF Ammonio Methacrylate Copolymer NF Ammonium Carbonate NF Ammonium Chloride USP Ammonium Molybdate USP Ammonium Phosphate NF Amobarbital Sodium USP Amobarbital Sodium For Injection USP Amylene Hydrate NF Anagrelide Hydrochloride USP Anastrozole USP Powdered Andrographis Extract DS Anethole NF Anise Oil NF Antipyrine USP Apraclonidine Hydrochloride USP Arginine USP & DS & NF Arginine Hydrochloride USP & DS Aripiprazole USP Articaine Hydrochloride USP Ascorbic Acid USP & DS & NF Ascorbyl Palmitate NF Powdered Ashwagandha Root Extract DS Powdered Asian Ginseng Extract DS Aspartame NF Aspartame Acesulfame NF Aspartic Acid USP & DS Aspirin USP Astemizole USP Atomoxetine Hydrochloride USP Atorvastatin Calcium USP Atovaquone USP Atracurium Besylate USP Azelastine Hydrochloride USP Azithromycin USP Aztreonam USP Bacitracin for Injection USP Baclofen USP Powdered Bacopa Extract DS Balsalazide Disodium USP Barium Sulfate USP Behenoyl Polyoxylglycerides NF Benazepril Hydrochloride USP Bendroflumethiazide USP Benzocaine USP Benzoic Acid USP & NF Benzonatate USP Beta Carotene USP & DS Beta Carotene Preparation DS Betadex NF Betadex Sulfobutyl Ether Sodium NF Betaine Hydrochloride USP Betaxolol Hydrochloride USP Bethanechol Chloride USP Bicalutamide USP Powdered Bilberry Extract DS Bisacodyl USP Bisoctrizole USP Bisoprolol Fumarate USP Black Cohosh Fluidextract DS Powdered Black Cohosh Extract DS Powdered Black Pepper Extract DS Borage Seed Oil DS Boric Acid NF Boswellia serrata Extract DS Bretylium Tosylate USP Brinzolamide USP Bromocriptine Mesylate USP Bumetanide USP Bupivacaine Hydrochloride USP Buspirone Hydrochloride USP Butabarbital Sodium USP Butalbital USP Butamben USP Butorphanol Tartrate USP Butylated Hydroxyanisole NF Butylated Hydroxytoluene NF Cabergoline NF & DS Caffeine USP Calcitonin Salmon USP Calcium Acetate USP Calcium Ascorbate USP & DS & NF Calcium Carbonate USP & DS & NF Calcium Carbonate Oral Suspension USP & DS Calcium Chloride USP & NF Calcium Citrate USP Calcium Gluceptate USP & DS Calcium Gluconate USP & DS Calcium Glycerophosphate USP & DS Calcium Hydroxide USP Calcium Lactate USP & DS Calcium Lactobionate USP & DS Calcium Levulinate USP & DS Calcium Pantothenate USP & DS Racemic Calcium Pantothenate USP & DS Anhydrous Dibasic Calcium Phosphate USP & DS & NF Tribasic Calcium Phosphate NF Dibasic Calcium Phosphate Dihydrate USP & DS & NF Calcium Saccharate USP & NF Calcium Silicate NF Calcium Stearate NF Calcium Sulfate NF Candelilla Wax NF Canola Oil NF Capecitabine USP Capreomycin Sulfate USP Capreomycin for Injection USP Caprylic Acid NF Caprylocaproyl Polyoxylglycerides NF Captopril USP Caraway Oil NF Carbamazepine USP Carbidopa USP Carbomer Copolymer NF Carbomer Homopolymer NF Carbomer Interpolymer NF Carbomer 1342 NF Carbomer 934 NF Carbomer 934P NF Carbomer 940 NF Carbomer 941 NF Urea C 13 USP Carboxymethylcellulose Calcium NF Carboxymethylcellulose Sodium USP & NF Carboxymethylcellulose Sodium Paste USP & NF Carboxymethylcellulose Sodium 12 NF Cardamom Oil NF Carisoprodol USP Carmellose NF Carmustine USP Carprofen USP Carrageenan NF Carteolol Hydrochloride USP Carvedilol USP Casanthranol USP Castor Oil USP & NF Hydrogenated Castor Oil NF Powdered Cat's Claw Extract DS Cefazolin USP Cefdinir USP Cefepime Hydrochloride USP Cefoxitin Sodium USP Cefpodoxime Proxetil USP Celecoxib USP Cellaburate NF Cellacefate NF Microcrystalline Cellulose and Carboxymethylcellulose Sodium NF Microcrystalline Cellulose NF Silicified Microcrystalline Cellulose NF Powdered Cellulose NF Cellulose Acetate NF Cellulose Sodium Phosphate USP Centella asiatica Triterpenes DS Powdered Centella asiatica Extract DS Cetirizine Hydrochloride USP Cetyl Palmitate NF Cetylpyridinium Chloride USP & NF Activated Charcoal USP & NF Powdered Chaste Tree Extract DS Powdered Horse Chestnut Extract DS Chitosan NF Chlordiazepoxide USP Chlordiazepoxide Hydrochloride USP Chlordiazepoxide Hydrochloride for Injection USP Chlorothiazide USP Chlorpropamide USP Chlorthalidone USP Chlorzoxazone USP Cholestyramine Resin USP Choline Bitartrate DS Choline Chloride DS Chondroitin Sulfate Sodium DS Ciclopirox USP Ciclopirox Olamine USP Cilastatin Sodium USP Cilostazol USP Cimetidine USP Cimetidine Hydrochloride USP Ciprofloxacin USP Ciprofloxacin Hydrochloride USP Citalopram Hydrobromide USP Anhydrous Citric Acid USP & NF Citric Acid Monohydrate USP & NF Cladribine USP Clarithromycin USP Clemastine Fumarate USP Clenbuterol Hydrochloride USP Clidinium Bromide USP Clobetasol Propionate USP Clomiphene Citrate USP Clomipramine Hydrochloride USP Clonazepam USP Clonidine USP Clorazepate Dipotassium USP Clorsulon USP Clotrimazole USP Clove Oil NF Clozapine USP Hydrogenated Coconut Oil NF Colestipol Hydrochloride USP Colistimethate Sodium USP Colistimethate for Injection USP Copovidone NF Coriander Oil NF Corn Oil NF Cottonseed Oil NF Creatinine NF Cromolyn Sodium USP Croscarmellose Sodium NF Crospovidone NF Curcuminoids DS Cyclandelate USP Cyclobenzaprine Hydrochloride USP Gamma Cyclodextrin NF Cyclophosphamide USP Cyclosporine USP Cyproheptadine Hydrochloride USP Cysteine Hydrochloride USP & DS Cysteine Hydrochloride Injection USP Cystine DS Cytarabine USP Dantrolene Sodium USP Deferoxamine Mesylate USP Dehydroacetic Acid NF Dehydrocholic Acid USP Demecarium Bromide USP Desipramine Hydrochloride USP Desloratadine USP Desoximetasone USP Dexamethasone Acetate USP Dexmedetomidine Hydrochloride USP Dextran 1 USP Dextran 40 USP Dextran 40 in Dextrose Injection USP Dextran 40 in Sodium Chloride Injection USP Dextran 70 USP Dextran 70 in Dextrose Injection USP Dextran 70 in Sodium Chloride Injection USP Dextrates NF Dextrin NF Dextromethorphan USP Dextrose USP & NF Dextrose Excipient NF Diacetylated Monoglycerides NF Diatrizoate Meglumine USP Diatrizoate Meglumine Injection USP Diatrizoate Meglumine and Diatrizoate Sodium Injection USP Diatrizoate Sodium USP Diatrizoate Sodium Injection USP Diatrizoic Acid USP & NF Diazepam USP Dichloralphenazone USP Dichlorphenamide USP Diclofenac Potassium USP Diclofenac Sodium USP Didanosine USP Diethylcarbamazine Citrate USP Diethyl Sebacate NF Diflunisal USP Dihydroxyacetone USP Diltiazem Hydrochloride USP Dimethicone NF Diosmin DS Dipivefrin Hydrochloride USP Dipyridamole USP Dirithromycin USP Disopyramide Phosphate USP Divalproex Sodium USP Dobutamine Hydrochloride USP Docetaxel USP Docusate Calcium USP Docusate Potassium USP Docusate Sodium USP & NF Dofetilide USP Donepezil Hydrochloride USP Dopamine Hydrochloride USP Dorzolamide Hydrochloride USP Doxapram Hydrochloride
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    PHARMACY REENGINEERING (PRE) Version 0.5 Pre-Release Implementation Guide PSS*1*129 & PSS*1*147 February 2010 Department of Veterans Affairs Office of Enterprise Development Revision History Date Revised Patch Description Pages Number 02/2010 All PSS*1*147 Added Revision History page. Updated patch references to include PSS*1*147. Described files, fields, options and routines added/modified as part of this patch. Added Chapter 5, Additive Frequency for IV Additives, to describe the steps needed to ensure correct data is in the new IV Additive REDACTED 01/2009 All PSS*1*129 Original version REDACTED February 2010 Pharmacy Reengineering (PRE) V. 0.5 Pre-Release i Implementation Guide PSS*1*129 & PSS*1*147 Revision History (This page included for two-sided copying.) ii Pharmacy Reengineering (PRE) V. 0.5 Pre-Release February 2010 Implementation Guide PSS*1*129 & PSS*1*147 Table of Contents Introduction ................................................................................................................................. 1 Purpose ....................................................................................................................................1 Project Description ....................................................................................................................1 Scope ........................................................................................................................................3 Menu Changes ..........................................................................................................................4
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    071_078_00_Thomsen:Thomsen 13-02-2008 9:32 Pagina 71 MDCT and Contrast Media: What are the Risks? Henrik S. Thomsen Department of Diagnostic Radiology, Copenhagen University Hospital Herlev, Herlev Department of Diagnostic Sciences, Faculty of Health Sciences, University of Copenhagen, Denmark Introduction Renal Adverse Reactions With the advent of multi-detector computed to- Contrast-material-induced kidney damage is imme- mography (MDCT) technology, the number of pa- diate, starting as soon as the first CM molecule reach- tients undergoing contrast-enhanced CT (CECT) es the kidney; however, it takes several hours or days studies has steadily grown in the last 6 years. In for a deterioration of renal function to be detected. 2005, approximately 22 million CECT examinations Despite more than 30 years of research, the patho- were carried out in the European Union, and 32 mil- physiology of CM-induced nephropathy (CIN) is lion in the United States (The Imaging Market Guide poorly elucidated. Nonetheless, several risk factors 2005. Arlington Medical Resources, Inc., Philadel- are well-known and can be divided into CM- and pa- phia, PA). Unfortunately, post-contrast-material-re- tient-related factors. lated adverse events, i.e., all those unintended and unfavorable signs, symptoms, or diseases temporally associated with the use of an iodinated contrast ma- Contrast-Medium-Related Factors terial (CM), are a common occurrence in radiology departments. Most adverse events occur within the More than 25 years ago, Barrett and Carlisle [1] first 60 min following CM administration (“imme- showed that the incidence of CIN is significantly diate” or “acute” adverse events), with the greatest higher after the administration of high-osmolarity risk in the first 20 min.
  • Package Insert TECHNETIUM Tc99m GENERATOR for the Production of Sodium Pertechnetate Tc99m Injection Diagnostic Radiopharmaceuti

    Package Insert TECHNETIUM Tc99m GENERATOR for the Production of Sodium Pertechnetate Tc99m Injection Diagnostic Radiopharmaceuti

    NDA 17693/S-025 Page 3 Package Insert TECHNETIUM Tc99m GENERATOR For the Production of Sodium Pertechnetate Tc99m Injection Diagnostic Radiopharmaceutical For intravenous use only Rx ONLY DESCRIPTION The technetium Tc99m generator is prepared with fission-produced molybdenum Mo99 adsorbed on alumina in a lead-shielded column and provides a means for obtaining sterile pyrogen-free solutions of sodium pertechnetate Tc99m injection in sodium chloride. The eluate should be crystal clear. With a pH of 4.5-7.5, hydrochloric acid and/or sodium hydroxide may have been used for Mo99 solution pH adjustment. Over the life of the generator, each elution will provide a yield of > 80% of the theoretical amount of technetium Tc99m available from the molybdenum Mo99 on the generator column. Each eluate of the generator should not contain more than 0.0056 MBq (0.15 µCi) of molybdenum Mo99 per 37 MBq, (1 mCi) of technetium Tc99m per administered dose at the time of administration, and not more than 10 µg of aluminum per mL of the generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used after twelve hours from the time of generator elution. PHYSICAL CHARACTERISTICS Technetium Tc99m decays by an isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 1. Table 1. Principal Radiation Emission Data1 Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 1Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC-11026, p.