DOCSLIB.ORG

Product Information Sheet

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Product Information Sheet September 17, 2015 productISOVACTIN information AA PLUS Nutrients 8.5 fl oz (250mL) per 100mL SKU 37002 Calories 186 74 Calories From Fat 57 23 NET WEIGHT 2 GAL (7.5 L) Protein Equivalent, g 20 8 Free Amino Acids, g 22 9 SERVING SIZE 8.5 fl oz (250mL) Carbohydrates, g 13 5 Sugar, g 5 2 SERVINGS PER PACKAGE 30 Sugar Alcohols, g 0 0 Dietary Fiber, g 2.8 1 Fat, g 6 2.4 24359-0702-03 REIMBURSEMENT CODE Saturated Fat, g 0.5 0.2 (for USA only) Trans Fat, g 0.0 0.0 DHA, mg 150.0 60.0 Cholesterol, mg 0.4 0 MEDICAL FOOD PRODUCT Vitamin A, IU 1100.0 440.0 For the dietary management of Isovaleric Acidemia. Dispensed by prescription. Vitamin C, mg 40.0 16.0 Isovactin AA Plus is a ready-to-drink metabolic formula product for Isovaleric Acidemia Vitamin D, IU 620.0 248.0 patients, over 1 year of age. Isovactin contains an advanced fortification blend. Product Vitamin E, IU 10.0 4.0 Vitamin K1, mcg 20.0 8.0 comes in a 250 mL carton. Vitamin K2 (MK-7), mcg 20.0 8.0 Thiamin (B1), mg 0.5 0.2 Riboflavin (B2), mg 0.5 0.2 Niacin (B3), mg 6.6 2.6 PRECAUTIONS For the dietary management of Isovaleric Acidemia (IVA) and Vitamin B6, mg 0.5 0.2 other disorders of leucine metabolism. Use as directed by physician. Must be Folic acid, mcg 186.0 74.4 administered under medical supervision only. Vitamin B12, mcg 1.0 0.4 Pantothenic Acid (B5), mg 2.4 1.0 NOT FOR PARENTERAL USE • USE AS DIRECTED BY PHYSICIAN Biotin, mcg 10.6 4.2 Choline, mg 209.0 83.6 INGREDIENTS Calcium, mg 677.0 270.8 Water, amino acid blend (L-alanine, glycine, L-proline, L-arginine, L-lysine, L-tyrosine, L- Chromium, mcg 17.3 6.9 Copper, mg 0.2 0.1 phenylalanine, L-serine, L-carnitine, L-aspartic acid, L-threonine, L-valine, L-isoleucine, L- Iodine, mcg 76.0 30.4 histidine, L-menthionine, L-tryptophan, L-cystine, taurine), vitamins and minerals (calcium Iron, mg 8.0 3.2 lactate, monosodium phosphate, monopotassium phosphate, choline bitartrate, Magnesium, mg 143.0 57.2 magnesium amino acid chelate, sodium ascorbate, ascorbic acid, dl-alpha-tocopheryl Manganese, mg 1.0 0.4 acetate, Fe amino acid chelate, niacinamide, zinc amino acid chelate, calcium d- Molybdenum, mcg 20.0 8.0 pantothenate, manganese sulfate, riboflavin, B6 Pyridoxal 5’ Phosphate, thiamin HCl, Phosphorus, mg 664.0 265.6 Selenium, mcg 26.6 10.6 copper gluconate, L-methylfolate, vitamin A palmitate, potassium iodide, sodium selenite, Zinc, mg 5.0 2.0 cholecalciferol, K1 phytonadione, K2 MK-7, sodium molybdate, cholecalciferol, chromium Potassium, mg 573.0 229.2 chloride, biotin, B12 methylcobalamin), canola oil, sugar, natural flavors (propylene glycol, Sodium, mg 287.0 114.8 water, potassium sorbate), inulin, cellulose gel and carboxymethylcellulose sodium, food Chloride, mg 358.0 143.2 starch modified, sodium hexametaphosphate, DHA algal oil, acesulfame potassium, Inositol, mg 0.0 0.0 carrageenan, sucralose. L-alanine, mg 4340.0 1736.0 Contains corn and soy. L-arginine, mg 1900.0 760.0 L-asparagine, mg 0.0 0.0 L-aspartate, mg 1110.0 444.0 L-carnitine, mg 1130.0 452.0 L-cysteine, mg 161.9 64.8 L-glutamate, mg 0.0 0.0 L-glycine, mg 2180.0 872.0 L-histidine, mg 600.0 240.0 L-isoleucine, mg 630.0 252.0 PREPARATION L-leucine, mg 0.0 0.0 Ready to drink. Shake well. L-lysine, mg 1440.0 576.0 L-methionine, mg 431.0 172.4 L-phenylalanine, mg 1230.0 492.0 L-proline, mg 2150.0 860.0 L-serine, mg 1160.0 464.0 STORAGE TO REQUEST A SAMPLE L-taurine, mg 43.0 17.2 Store in cool, dry place. Refrigerate after Call 866 456 9776, opt 2 or complete form: L-threonine, mg 1050.0 420.0 opening. Do not freeze. www.samples.cambrooke.com L-tryptophan, mg 229.0 91.6 L-tyrosine, mg 994.6 397.8 L-valine, mg 717.0 286.8 MLT37002D.
Load more

Recommended publications
  • Brochure-Product-Range.Pdf
    PRODUCT RANGE 2015 edition ANSI Standard 60 NSF® CERTIFIED HALAL M ISLAMIC FOOD AND NUTRITION ® COUNCIL OF AMERICA Rue Joseph Wauters, 144 ISO 9001:2008 (Quality) / OHSAS 18001:2007 (Health/ B-4480 Engis Safety) / ISO 14001:2004 (Environment) / ISO 22000:2005 www.globulebleu.com (Food Safety) / FSSC 22000:2013 (Food Safety). Tel. +32 (0) 4 273 93 58 Our food grade phosphates are allergen free, GMO free, Fax. +32 (0) 4 275 68 36 BSE/TSE free. www.prayon.com mail. [email protected] Design by www.prayon.com PRODUCT RANGE | 11 TABLE OF CONTENTS HORTICULTURE APPLICATIONS HORTIPRAY® RANGE FOR HORTICULTURE* FOOD AND INDUSTRIAL APPLICATIONS PRODUCT NAME Bulk density P O pH N-NH Made 2 5 4 MONOAMMONIUM PHOSPHATE - NH4H2PO4 in 3 3 % 1% % Sodium orthophosphates ................................................................................... 03 g/cm lbs/ft indicative indicative indicative Water-soluble fertilisers. Sodium pyrophosphates .................................................................................... 04 HORTIPRAY® MAP Horticultural Grade 0.9 56 61 4.5 12 Sodium tripolyphosphates ................................................................................. 05 HORTIPRAY® MAP 12.60 Horticultural Grade 0.9 56 60 5 12.1 Water-soluble fertilisers; Sodium polyphosphates ..................................................................................... 06 HORTIPRAY® MAP anticalc Horticultural Grade 0.9 56 61 4.5 12 preventive action against clogging. Potassium orthophosphates .............................................................................
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0143022 A1 Wicker Et Al
    US 20170143022A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0143022 A1 Wicker et al. (43) Pub. Date: May 25, 2017 (54) COMPOSITIONS INCORPORATING AN (52) U.S. Cl. UMLAM FLAVORAGENT CPC ............... A2.3L 27/20 (2016.08); A23L 27/88 (2016.08); A23L 2/56 (2013.01); A23L 2780 (71) Applicant: Senomyx, Inc., San Diego, CA (US) (2016.08); A23L 27/30 (2016.08); A23K 20/10 (2016.05); A23K 50/40 (2016.05); A61K 47/22 (72) Inventors: Sharon Wicker, Carlsbad, CA (US); (2013.01) Tanya Ditschun, San Diego, CA (US) (21) Appl. No.: 14/948,101 (57) ABSTRACT The present invention relates to compositions containing (22) Filed: Nov. 20, 2015 flavor or taste modifiers, such as a flavoring or flavoring agents and flavor or taste enhancers, more particularly, Publication Classification savory (“umami”) taste modifiers, savory flavoring agents (51) Int. Cl. and savory flavor enhancers, for foods, beverages, and other AOIN 25/00 (2006.01) comestible compositions. Compositions comprising an A23K2O/It (2006.01) umami flavor agent or umami taste-enhancing agent in A6 IK 47/22 (2006.01) combination with one or more other food additives, prefer A2.3L 2/56 (2006.01) ably including a flavorant, herb, Spice, fat, or oil, are A23K 50/40 (2006.01) disclosed. US 2017/O 143022 A1 May 25, 2017 COMPOSITIONS INCORPORATING AN tions WO 02/06254, WO 00/63166 art, WO 02/064631, and UMAM FLAVORAGENT WO 03/001876, and U.S. Patent publication US 2003 0232407 A1. The entire disclosures of the articles, patent BACKGROUND OF THE INVENTION applications,
    [Show full text]
  • Long-Term Calcium-Phosphorus Studies in Confined Dairy Cows
    Long-Term Calcium-Phosphorus Studies in Confined Dairy Cows George Ward, Ph.D. E. P. Call, Ph.D. Dept. of Animal Sciences and Insdustry Kansas State University Manhattan, Kansas 66506 Modern dairy cows are under considerable stress ~tudy (Figures 1 and 2). Comparison of Figures 3 and consuming and metabolizing large quantities of feed 4 shows the influence of supplemental vitamin D on and synthesizing large quantities of milk. The calcium utilization. Cows producing more than 15 kg nutrient requirement for peak production in a cow's milk without vitamin D supplement had negative lactation usually exceeds her capacity for feed. The calcium balances with intakes to 250 g/day. We es­ combination of deficit consumption and obligatory timated the calcium requirement from the balances nutrient balance required for milk synthesis com­ with cows supplemented with vitamin Da and produc­ pounds that stress. Attempts to satisfy energy re­ ing in excess of 15 kg milk in Figure 4. We drew the quirements result in inordinate skewing of the ration requirement line where it included negative balances toward a large proportion of concentrate. above the line equal in number to positive balances Combination of extreme variation among rations below the line (10). This estimate was nearly twice and the vast requirement for nutrients to support the NRC requirement (11). Some of our contem­ heavy lactation emphasizes the need for adequate in­ poraries ascribe the deviation to short-time balances formation concerning nutrient requirements, but few longer ones are being reported. Graphic treatment of data from Forbes, et al. (3), availabilities, and interactions.
    [Show full text]
  • Monosodium Phosphate 1 of 9 Anhydrous
    SAFETY DATA SHEET Monosodium Phosphate 1 of 9 Anhydrous Complying with 1907/2006/EEC Regulation of 18 December 2006 Section 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING REACH Product name: Monosodium Phosphate Anhydrous Trade names: Monosodium Phosphate Anhydrous; MSP-Gr; MSP-Pw; Hi-C-510; Hi-C-511; Hi-C-512; Hi-C-516. Synonyms: Sodium Phosphate, Monobasic; Monosodium Dihydrogen Phosphate; Phosphoric acid, monosodium salt; MSP Chemical formula: NaH2PO4 Fertilizer formula: Not applicable Product type: Solid (powder or granular) Cas number: 7558-80-7 Use of the substance/preparation: Food processing-buffer, emulsifier. Pharmacopoeia - nutrient, buffer. Industries – water treatment, metal treatment, corrosion control, drilling mud, ceramics, acid-base cleaners. Company/undertaking identification Supplier/Manufacturer: Haifa Chemicals Ltd. P.O.B 10809, Haifa Bay 26120, Israel Tel: +972-4-8469961 Fax: +972-4-8469955 E-mail address of person responsible for this SDS: [email protected] Emergency telephone number: +972-4-8469603/4 (with hours of operation) Section 2. HAZARDS IDENTIFICATION Classification: The substance is not classified as dangerous according to Directive 67/548/EEC and its amendments. Most important hazards: CAUTION! Dust in high concentration may cause eye, skin and respiratory tract irritation. See section 11 for more detailed information on health effects and symptoms. SAFETY DATA SHEET Monosodium Phosphate 2 of 9 Anhydrous Section 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance/preparation: Ingredient name CAS % EC number Classification number Monosodium Phosphate 7558-80-7 100% 231-449-2 - Anhydrous See section 16 for the full text of the R-phrases declared above There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
    [Show full text]
  • Section 13. Disposal Considerations Disposal Methods : the Generation of Waste Should Be Avoided Or Minimized Wherever Possible
    SAFETY DATA SHEET Sodium Phosphate, Monobasic, Monohydrate Section 1. Identification GHS product identifier : Sodium Phosphate, Monobasic, Monohydrate Code : 20233 Other means of : Sodium dihydrogenorthophosphate monohydrate; Monosodium phosphate, identification monohydrate; Monosodium dihydrogen phosphate Supplier/Manufacturer : 3420 Central Expressway, Santa Clara CA 95051 3420 Central Expressway, Santa Clara CA 95051 In case of emergency : Chemtrec: 1 800 424 9300 Outside USA & Canada: +1 703 527 3887 Section 2. Hazards identification OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the safe handling and proper use of the product. This MSDS should be retained and available for employees and other users of this product. Classification of the : Not classified. substance or mixture GHS label elements Signal word : No signal word. Hazard statements : No known significant effects or critical hazards. Precautionary statements Prevention : Not applicable. Response : Not applicable. Storage : Not applicable. Disposal : Not applicable. Hazards not otherwise : None known. classified Section 3. Composition/information on ingredients Substance/mixture : Substance Ingredient name % CAS number Phosphoric acid, monosodium salt, monohydrate 99.99 - 100 10049-21-5 Any concentration shown as a range is to protect confidentiality or is due to batch variation. There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section. Occupational exposure limits, if available, are listed in Section 8. Section 4. First aid measures Description of necessary first aid measures Eye contact : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids.
    [Show full text]
  • 488 Part 184—Direct Food
    § 182.8217 21 CFR Ch. I (4–1–19 Edition) § 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic).
    [Show full text]
  • Phosphates and Phosphoric Acid in Everyday Life
    Detergents Metal treatment Fertilisers Water treatment Phosphates and phosphoric acid in everyday life Products to meet everyday needs PRAYON, a long tradition in the chemical industry Prayon was founded in 1982, but its roots reach back more than 100 years to the Liège region of Belgium. It is the parent company of the Prayon Group, a world leader in producing phosphate chemicals (fertilisers, detergents, food additives and technical applications) and developing inorganic chemical specialities. The Group’s expertise in the wet process production of phosphoric acid is acknowledged and utilised worldwide, including by its competitors. Currently, some 50% of phosphoric acid production sites use Prayon technology and 70% use Prayon equipment. Jointly owned by Office Chérifien des Phosphates (OCP) and Société Régionale d’Investissement de Wallonie (SRIW), the Group consists of over 20 companies located in more than 10 countries. It employs 1,450 people and generates a turnover of €500 million. Prayon boasts worldwide coverage via its production sites in Europe (Belgium and France), the Americas (USA, Brazil) and Africa (Morocco). The Group markets its products in more than 70 countries on five continents, an international presence that reinforces its position as a global player. PRAYON AND TECHNICAL PHOSPHATES Prayon markets the following major groups of phosphate products used in technical applications: • PURIFIED PHOSPHORIC ACID: produced using Prayon’s own solvent extraction process. Available in different grades and concentrations, this acid is used in a wide range of technical and food applications. Production sites: • Engis and Puurs (Belgium): 250,000 tonnes of P2O5 per year • Jorf-Lasfar (Morocco), via Emaphos, a joint venture between Prayon (33%), OCP (33%) and CFB (Chemische Fabrik Budenheim) (33%): 150,000 tonnes of P2O5 per year • Phosphate salts: sodium, potassium, calcium, ammonium and aluminium phosphates, and a wide variety of special blends based on these products.
    [Show full text]
  • Fertilizer Materials
    THIS ARTICLE begins with a brief survey of the eßect of the World War in stimulating the fertilizer industry in the United States, and then outlines the situation today» First the sources of nitrogen, phosphorus, potassium, and some elements not commonly used in fertilizers are broadly discussed. Then certain eßects of fertilizer materials are considered, A detailed appendix, arranged for ready reference, describes the commercial materials now available and their uses, together with some materials still in the ex- perimental stage. Fertilizer Materials By OSWALD SCHUEINER, ALBERT K. MERZ, and B. E. BROWN ^ THE use of fertilizer materials as a means of supplementing the natural food supplies of the soil is of considerable importance among the various factors involved in tlie economical production of crops as well as in W\% proper maintenance of soil fertility. With- out certain elements, such as nitrogen, phospliorus, potassium, calcium, magnesium, and some others, plants cannot live. With inadequate amounts of these elements plants are undernourished and fail to grow and produce normally. Undernourished plants, in turn, are likely to meau imdernourished men and aiiimals. It is to suppl}^ deficiencies in these essential elements that fertilizer materials must be added to the soil.- Because fertilizer materials increase the production and improve the quality of crops, they have become an. essential elemcTit in farming in all countries practicing modern agricultural methods. It is probably true that there has never been a greater need than now of aiding farmers to secure maximum returns from fertilizer materials. Thej^ represent a considerable share of crop-pro(hiction costs and should therefore be bought and used with care.
    [Show full text]
  • Third Supplement, FCC 11 Index / All-Trans-Lycopene / I-1
    Third Supplement, FCC 11 Index / All-trans-Lycopene / I-1 Index Titles of monographs are shown in the boldface type. A 2-Acetylpyridine, 20 Alcohol, 80%, 1524 3-Acetylpyridine, 21 Alcohol, 90%, 1524 Abbreviations, 6, 1726, 1776, 1826 2-Acetylpyrrole, 21 Alcohol, Absolute, 1524 Absolute Alcohol (Reagent), 5, 1725, 2-Acetyl Thiazole, 18 Alcohol, Aldehyde-Free, 1524 1775, 1825 Acetyl Valeryl, 562 Alcohol C-6, 579 Acacia, 556 Acetyl Value, 1400 Alcohol C-8, 863 ªAccuracyº, Defined, 1538 Achilleic Acid, 24 Alcohol C-9, 854 Acesulfame K, 9 Acid (Reagent), 5, 1725, 1775, 1825 Alcohol C-10, 362 Acesulfame Potassium, 9 Acid-Hydrolyzed Milk Protein, 22 Alcohol C-11, 1231 Acetal, 10 Acid-Hydrolyzed Proteins, 22 Alcohol C-12, 681 Acetaldehyde, 10 Acid Calcium Phosphate, 219, 1838 Alcohol C-16, 569 Acetaldehyde Diethyl Acetal, 10 Acid Hydrolysates of Proteins, 22 Alcohol Content of Ethyl Oxyhydrate Acetaldehyde Test Paper, 1535 Acidic Sodium Aluminum Phosphate, Flavor Chemicals (Other than Acetals (Essential Oils and Flavors), 1065 Essential Oils), 1437 1395 Acidified Sodium Chlorite Alcohol, Diluted, 1524 Acetanisole, 11 Solutions, 23 Alcoholic Potassium Hydroxide TS, Acetate C-10, 361 Acidity Determination by Iodometric 1524 Acetate Identification Test, 1321 Method, 1437 Alcoholometric Table, 1644 Aceteugenol, 464 Acid Magnesium Phosphate, 730 Aldehyde C-6, 571 Acetic Acid Furfurylester, 504 Acid Number (Rosins and Related Aldehyde C-7, 561 Acetic Acid, Glacial, 12 Substances), 1418 Aldehyde C-8, 857 Acetic Acid TS, Diluted, 1524 Acid Phosphatase
    [Show full text]
  • SODIUM PHOSPHATE MONOBASIC, Monohydrate
    SAFETY DATA SHEET: SODIUM PHOSPHATE MONOBASIC, Monohydrate 1. IDENTIFICATION Product Name: SODIUM PHOSPHATE MONOBASIC, Monohydrate Synonyms: Monosodium phosphate; Sodium biphosphate; Sodium acid phosphate; Sodium dihydrogen phosphate Formula and Formula Weight: NaH2PO4 H2O 137.99 Integra numbers beginning with: S518.10 Recommended Use: Commercial/industrial use Restrictions on Use: No information available INTEGRA Chemical Company 24 Hour Emergency Response: CHEMTREC 800-424-9300 (Outside USA 703-527-3887) 1216 6th Ave N Kent WA 98032 Phone: 253-479-7000 2. HAZARDS IDENTIFICATION OSHA Classification: Hazard Category: Hazard Statement: None identified Not applicable Not applicable Hazards Not Otherwise Classified: No information available 3. COMPOSITION/INFORMATION ON INGREDIENTS Component Synonyms CAS # % Weight Sodium phosphate monobasic, monohydrate Monosodium phosphate; Sodium biphosphate; 10049-21-5 100 Sodium acid phosphate; Sodium dihydrogen phosphate 4. FIRST AID MEASURES Inhalation: Remove person to fresh air and keep comfortable for breathing. If not breathing, give artificial respiration. If breathing is difficult administer oxygen. Seek medical attention. Eye Contact: Flush eyes with water for at least 15 minutes. Seek medical attention. Skin Contact: Wash with soap and water. Seek medical attention if irritation develops. Ingestion: Rinse mouth and give victim large quantities of water. Never give anything by mouth to an unconscious person. Seek immediate medical attention. Additional notes: Symptoms and effects include irritation. 5. FIRE-FIGHTING MEASURES Extinguishing Media: Material is not flammable. Use extinguishing media suitable to surrounding materials. Special Equipment and Precautions: Use water to cool nearby containers and structures. Wear full protective equipment, including suitable respiratory protection. Specific Hazards: None identified Hazardous combustion products: Oxides of phosphorous, oxides of sodium 6.
    [Show full text]
  • Ep 0618291 A2
    Europaisches Patentamt J European Patent Office Oy Publication number: 0 618 291 A2 Office europeen des brevets EUROPEAN PATENT APPLICATION © Application number: 94102757.5 © int. CIA C12N 15/12, C12P 21/02, A61K 37/02, C12P 21/08, © Date of filing: 24.02.94 C12N 15/62 The applicant has subsequently filed a sequence Inventor: Kitada, Chieko listing and declared, that it includes no new 2-8, Minamikoyocho 1-cho, matter. Saki Osaka 590 (JP) ® Priority: 26.02.93 JP 38755/93 Inventor: Ishibashi, Yoshihiro 05.04.93 JP 78290/93 8-3-2-102, Ninomiya 4-chome, 27.04.93 JP 100669/93 Tsukuba 17.05.93 JP 114446/93 Ibaraki 305 (JP) 24.06.93 JP 153963/93 Inventor: Hosoya, Masaki 10.11.93 JP 281413/93 13-19, Higashi 2-chome, 27.12.93 JP 333175/93 Tsukuba Ibaraki 305 (JP) © Date of publication of application: Inventor: Ogi, Kazuhiro 05.10.94 Bulletin 94/40 16-1-206, Umezono 2-chome, Tsukuba © Designated Contracting States: Ibaraki 305 (JP) AT BE CH DE DK ES FR GB GR IE IT LI LU NL Inventor: Miyamoto, Yasunori PTSE 8-3-7-403, Ninomiya 4-chome, Tsukuba © Applicant: TAKEDA CHEMICAL INDUSTRIES, Ibaraki 305 (JP) LTD. Inventor: Habata, Yugo 1-1, Doshomachi 4-chome 18-7-A201, Namiki 3-chome, Chuo-ku, Osaka 541 (JP) Tsukuba Ibaraki 305 (JP) @ Inventor: Onda, Haruo Inventor: Shimamoto, Norio 5-26, Shimotakatsu 4-chome, 10-1, Uzumoridai 4-chome, Tsuchiura Higashinada-ku Ibaraki 300 (JP) Kobe, Hyogo 658 (JP) Inventor: Ohtaki, Tetsuya 7-9-802, Kasuga 1-chome, Tsukuba Representative: von Kreisler, Alek, CM Ibaraki 305 (JP) Dipl.-Chem.
    [Show full text]
  • Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
    Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration.
    [Show full text]