List Item Cetrimide: Summary Report
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Quaternary Ammonium Compounds
FACT SHEET: Quaternary Ammonium Compounds Quaternary ammonium compounds, also known as “quats” or “QACs,” include a number of chemicals used as sanitizers and disinfectants, including benzalkonium chloride, benzethonium chloride, cetalkonium chloride, cetrimide, cetrimonium bromide, cetylpyridinium chloride, glycidyl trimethyl, ammonium chloride, and stearalkonium chloride.[i] In general, quats cause toxic effects through all Mutagenicity routes of exposure including inhalation, Some quats have shown to be mutagenic and to ingestion, dermal application, and irrigation of damage animal DNA and DNA in human body cavities. Exposure to diluted solutions may lymphocytes at much lower levels than are result in mild irritation, while concentrated present in cleaning chemicals.[6] solutions are corrosive, causing burns to the skin and mucous Membranes. They can produce Antimicrobial Resistance systemic toxicity and can also cause allergic Genes have been discovered that mediate reactions.[2] resistance to quats. There has been an association of some of these genes with beta lactamase genes, Asthma and Allergies raising concern for a relationship between Of particular interest with regard to use as disinfectant resistance and antibiotic resistance.[7] disinfectants in the COVID-19 pandemic, quats increase the risk for asthma and allergic Reproductive Toxicity sensitization. Evidence from occupational Mice whose cages were cleaned with QACs had exposures shows increased risk of rhinitis and very low fertility rates. [8] Exposure to a common asthma -
Antimicrobial Activity of Cationic
ANTIMICROBIAL ACTIVITY OF CATIONIC ANTISEPTICS IN LAYER-BY-LAYER THIN FILM ASSEMBLIES A Thesis by CHARLENE MYRIAH DVORACEK Submitted to the Office of Graduate Studies of Texas A&M University in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE May 2009 Major Subject: Mechanical Engineering ANTIMICROBIAL ACTIVITY OF CATIONIC ANTISEPTICS IN LAYER-BY-LAYER THIN FILM ASSEMBLIES A Thesis by CHARLENE MYRIAH DVORACEK Submitted to the Office of Graduate Studies of Texas A&M University in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Approved by: Chair of Committee, Jaime Grunlan Committee Members, Michael Benedik Xinghang Zhang Head of Department, Dennis O'Neal May 2009 Major Subject: Mechanical Engineering iii ABSTRACT Antimicrobial Activity of Cationic Antiseptics in Layer-by-Layer Thin Film Assemblies. (May 2009) Charlene Myriah Dvoracek, B.S., Rose-Hulman Institute of Technology Chair of Advisory Committee: Dr. Jaime Grunlan Layer-by-layer (LbL) assembly has proven to be a powerful technique for assembling thin films with a variety of properties including electrochromic, molecular sensing, oxygen barrier, and antimicrobial. LbL involves the deposition of alternating cationic and anionic ingredients from solution, utilizing the electrostatic charges to develop multilayer films. The present work incorporates cationic antimicrobial agents into the positively-charged layers of LbL assemblies. When these thin films are exposed to a humid environment, the antimicrobial molecules readily diffuse out and prevent bacterial growth. The influence of exposure time, testing temperature, secondary ingredients and number of bilayers on antimicrobial efficacy is evaluated here. Additionally, film growth and microstructure are analyzed to better understand the behavior of these films. -
Reseptregisteret 2013–2017 the Norwegian Prescription Database
LEGEMIDDELSTATISTIKK 2018:2 Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Christian Berg Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Utgitt av Folkehelseinstituttet/Published by Norwegian Institute of Public Health Område for Helsedata og digitalisering Avdeling for Legemiddelstatistikk Juni 2018 Tittel/Title: Legemiddelstatistikk 2018:2 Reseptregisteret 2013–2017 / The Norwegian Prescription Database 2013–2017 Forfattere/Authors: Christian Berg, redaktør/editor Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Acknowledgement: Julie D. W. Johansen (English text) Bestilling/Order: Rapporten kan lastes ned som pdf på Folkehelseinstituttets nettsider: www.fhi.no The report can be downloaded from www.fhi.no Grafisk design omslag: Fete Typer Ombrekking: Houston911 Kontaktinformasjon/Contact information: Folkehelseinstituttet/Norwegian Institute of Public Health Postboks 222 Skøyen N-0213 Oslo Tel: +47 21 07 70 00 ISSN: 1890-9647 ISBN: 978-82-8082-926-9 Sitering/Citation: Berg, C (red), Reseptregisteret 2013–2017 [The Norwegian Prescription Database 2013–2017] Legemiddelstatistikk 2018:2, Oslo, Norge: Folkehelseinstituttet, 2018. Tidligere utgaver / Previous editions: 2008: Reseptregisteret 2004–2007 / The Norwegian Prescription Database 2004–2007 2009: Legemiddelstatistikk 2009:2: Reseptregisteret 2004–2008 / The Norwegian Prescription Database 2004–2008 2010: Legemiddelstatistikk 2010:2: Reseptregisteret 2005–2009. Tema: Vanedannende legemidler / The Norwegian Prescription Database 2005–2009. -
Being Aware of Chlorhexidine Allergy
Being aware of chlorhexidine allergy If you have an immediate allergic reaction to chlorhexidine you may experience symptoms such as: x itching x skin rash (hives) x swelling x anaphylaxis. People who develop anaphylaxis to chlorhexidine may have experienced mild reactions, such as skin rash, to chlorhexidine before. Irritant contact dermatitis or allergic contact dermatitis Chlorhexidine can also cause irritant dermatitis. This is not a true allergic reaction. It is caused by chlorhexidine directly irritating skin and results in rough, dry and scaly Chlorhexidine is an antiseptic. Allergic reactions to skin, sometimes with weeping sores. chlorhexidine are rare but are becoming more common. Chlorhexidine is used in many products both in Chlorhexidine can also cause allergic contact hospitals and in the community. dermatitis. Symptoms look like irritant dermatitis, but the cause of the symptoms is delayed by 12-48 hours Why have I been given this factsheet? after contact with chlorhexidine. You have been given this brochure because you have had a reaction to a medication, a medical dressing Both irritant dermatitis and allergic contact dermatitis or antiseptic. This may or may not be caused by a caused by chlorhexidine are annoying but not chlorhexidine allergy. dangerous. It is important that you are aware of the possibility of an It is recommended that you avoid chlorhexidine if you allergy. experience these responses as some people have gone on to develop immediate allergic reaction to chlorhexidine. Allergic reactions to chlorhexidine Severe allergic reactions to chlorhexidine are rare, but How do I know which products contain they can be serious. Immediate allergic reactions can chlorhexidine? cause anaphlaxis (a very severe allergic reaction which can be life-threatening). -
Quaternary Ammonium Compounds
FT-619502 Quaternary ammonium compounds Products Description Name : BenzyldimethylhexadecylAmmoniu m Chloride Catalog Number : 619502, 100g 16-BAC ; Cetalkonium chloride; N-hexadecyl-N,N-dimethyl Benzenemethaminium, Chloride; cloruro de Structure : CAS: [122-18-9]; cetalconio; Chlorure de cetalkonium Benzyldimethylhexadecylammonium chloride; Benzyl n-hexadecyl Molecular Weight : MW= 396.1 dimethylammonium chloride; Cetol; Benzyldimethylhexadecylammonium chloride, hydrate; N-Hexadecyl- N,N-dimethylbenzenemethanaminium chloride; Alkyl C-16 Properties: Freely soluble benzyldimethyl ammonium chloride; pH : 6.0 - 8.5 (10% sol.) Corrosive Avoid shock and frictions S26-45-60-61 Storage: Room temperature (Z) Technical and Scientific Information General description and applications Quaternary ammonium compounds are any of a group of ammonium salts in which organic radicals have been substituted for all four hydrogens of the original ammonium cation. They has a central nitrogen atom which is joined to four organic radicals and one acid radical. The organic radicals may be alkyl, aryl, or aralkyl, and the nitrogen can be part of a ring system. They are prepared by treatment of an amine with an alkylating agent. They show a variety of physical, chemical, and biological properties and most compounds are soluble in water and strong electrolytes. Such compounds include: Benzalkonium Chloride ( CAS RN: 8001-54-5) Benzethonium Chloride CAS 121-54-0 Cetalkonium Chloride( CAS 122-18-9) Cetrimide ( CAS 8044-71-1) Cetrimonium Bromide ( CAS 57-09-0) Cetylpyridinium -
National OTC Medicines List
National OTC Medicines List ‐ DraŌ 01 DRAFT National OTC Medicines List Draft 01 Ministry of Public Health of Lebanon This list was prepared under the guidance of His Excellency Minister Waêl Abou Faour andDRAFT the supervision of the Director General Dr. Walid Ammar. Editors Rita KARAM, Pharm D. PhD. Myriam WATFA, Pharm D Ghassan HAMADEH, MD.CPE FOREWORD According to the French National Agency for Medicines and Health Products Safety (ANSM), Over-the-counter (OTC) drugs are medicines that are accessible to patients in pharmacies, based on criteria set to safeguard patients’ safety. Due to their therapeutic class, these medicines could be dispensed without physician’s intervention for diagnostic, treatment initiation or maintenance purposes. Moreover, their dosage, treatment period and Package Insert Leaflet should be suitable for OTC classification. The packaging size should be in accordance with the dosage and treatment period. According to ArticleDRAFT 43 of the Law No.367 issued in 1994 related to the pharmacy practice, and the amendment of Articles 46 and 47 by Law No.91 issued in 2010, pharmacists do not have the right to dispense any medicine that is not requested by a unified prescription, unless the medicine is mentioned in a list which is established by pharmacists and physicians’ syndicates. In this regard, the Ministry of Public Health (MoPH) developed the National OTC Medicines List, and presentedit in a scientific, objective, reliable, and accessible listing. The OTC List was developed by a team of pharmacists and physicians from the Ministry of Public Health (MoPH). In order to ensure a safe and effective self- medicationat the pharmacy level, several pharmaceutical categories (e.g. -
Of 8 August 2014 Amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on Cosmetic Products
9.8.2014 EN Official Journal of the European Union L 238/3 COMMISSION REGULATION (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(2) thereof, Whereas: (1) The substances identified by the denominations alkyl (C12-22) trimethyl ammonium bromide and chloride are regu lated as preservatives under entry 44 of Annex V to Regulation (EC) No 1223/2009 with a maximum concentra tion of 0,1 %. (2) The Scientific Committee on Consumer Products (‘SCCP’), subsequently replaced by the Scientific Committee on Consumer Safety (‘SCCS’) pursuant to Commission Decision 2008/721/EC (2), evaluated the safety of alkyl (C16, C18, C22) trimethylammonium chloride (cetrimonium chloride, steartrimonium chloride and behentrimonium chloride) for other uses than as preservatives in 2005, 2007 and 2009. (3) The SCCS concluded in its opinion of 8 December 2009 (3) that, apart from the fact that quaternary ammonium derivative formulations have the potential to be skin irritants, especially when combinations of the concerned compounds are used, the use of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride does not pose a risk to the health of the consumer in concentrations below certain limits, which are explicitly set out in the SCCS opinion. -
Legemiddelforbruket I Norge 2012–2016 Drug Consumption in Norway 2012–2016
2017:1 LEGEMIDDELSTATISTIKK EVT STIKKTITTEL INN HER Legemiddelforbruket i Norge 2012–2016 Drug Consumption in Norway 2012–2016 ISSN 1890-9647 Legemiddelforbruket i Norge 2012–2016 Drug Consumption in Norway 2012–2016 Solveig Sakshaug Hanne Strøm Christian Berg Hege Salvesen Blix Irene Litleskare Tove Granum Utgitt av Folkehelseinstituttet / Published by Norwegian Institute of Public Health Området for Psykisk og fysisk helse Avdeling for Legemiddelepidemiologi Mars 2017 Tittel/Title: Legemiddelstatistikk 2017:1 Legemiddelforbruket i Norge 2012-2016/Drug Consumption in Norway 2012-2016 Forfattere/Authors: Solveig Sakshaug (redaktør) Hanne Strøm Christian Berg Hege Salvesen Blix Irene Litleskare Tove Granum Bestilling/Order: Rapporten kan lastes ned som pdf på Folkehelseinstituttets nettsider: www.fhi.no/ The report is available as pdf format only and can be downloaded from the www.fhi.no Layout omslag: www.fetetyper.no Kontaktinformasjon/Contact information Folkehelseinstituttet/Norwegian Institute of Public Health P.O.Box 4404 Nydalen N-0403 Oslo Tel: +47 21 07 70 00 ISSN: 1890-9647 ISBN 978-82-8082-826-2 elektronisk utgave Sitering/Citation: Sakshaug, S (red), Legemiddelforbruket i Norge 2012-2016 [Drug Consumption in Norway 2012-2016], Legemiddelstatistikk 2017:1, Oslo: Folkehelseinstituttet, 2017. Tidligere utgaver/Previous editions: 1977: Legemiddelforbruket i Norge 1974 - 1976 1978: Legemiddelforbruket i Norge 1975 - 1977 1980: Legemiddelforbruket i Norge 1975 - 1979 1981: Legemiddelforbruket i Norge 1980 1982: Legemiddelforbruket -
Federal Communications Commission
FEDERAL REGISTER VOLUME 34 • NUM BER 189 Thursday, October 2,1969 • Washington, D.C. Pages 15331-15405 Agencies in this issue— The President Agency for International Development Atomic Energy Commission Civil Aeronautics Board Consumer and Marketing Service Customs Bureau Emergency Preparedness Office Federal Aviation Administration Federal Communications Commission Federal Home Loälh Bank Board Federal Maritime Commission Federal Power Commission Federal Trade Commission Fish and Wildlife Service Food and Drug Administration General Services Administration Indian Aifairs Bureau Internal Revenue Service Interstate Commerce Commission Land Management Bureau Public Health Service Securities and Exchange Commission _ _ Small Business Administration Treasury Department Detailed list of Contents appears inside. MICROFILM EDITION FEDERAL REGISTER 35mm MICROFILM Complete Set 19 3 6 -6 7,16 7 Rolls $1,162 \ Vol. Year Price Vol. Year Price Vol. Year Price 1 1936 $8 12 1947 $26 23 1958 $36 2 1937 10 13 1948 27 24 1959 40 3 1938 9 14 1949 22 25 1960 49 4 1939 14 15 1950 26 26 1961 46 5 1940 15 16 1951 43 27 1962 50 6 1941 20 17 1952 35 28 1963 49 7 1942 35 18 1953 32 29 1964 57 8 1943 52 19 1954 39 30 1965 58 9 1944 42 20 1955 36 31 1966 61 10 1945 43 21 1956 38 32 1967 64 11 1946 42 22 1957 38 Order Microfilm Edition from Publications Sales Branch National Archives and Records Service Washington, D.C. 20408 rr<nr<n ■ w n m C T m Published daily, Tuesday through Saturday (no publication on Sundays, Mondays» rrllrll/ll jMllFd1 K r III NI I* K on the day aiter an official Federal holiday), by the Office of the Federal Register, Na ■ ArchivesA«.Msa> nnrtand RaanrHsRecords Service.Service, General Services Administration.Administration, Washington, D.C. -
Povidone-Iodine (Topical)
PATIENT & CAREGIVER EDUCATION Povidone-Iodine (Topical) This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Brand Names: US Aplicare Povidone-Iodine Scrub [OTC] [DSC]; Aplicare Povidone-Iodine [OTC] [DSC]; Betadine Antiseptic Dry Powder [OTC]; Betadine Antiseptic Gargle [OTC]; Betadine Antiseptic Rinse [OTC]; Betadine Antiseptic [OTC]; Betadine Skin Cleanser [OTC] [DSC]; Betadine Surgical Scrub [OTC]; Betadine Swabsticks [OTC]; Betadine [OTC]; Clorox Nasal Antiseptic [OTC] [DSC]; ExCel AP [OTC] [DSC]; First Aid Antiseptic [OTC]; NuPrep 5% Povidone-Iodine [OTC] [DSC]; PVP Prep [OTC] [DSC]; PVP Scrub [OTC] [DSC]; Scrub Care Povidone-iodine [OTC]; Summers Eve Disp Medicated [OTC] What is this drug used for? All skin products: It is used to treat or prevent bacterial infections. It may be given to your child for other reasons. Talk with the doctor. All vaginal products: It is used to treat vaginal irritation, itching, and soreness. Throat gargle: It is used to treat a sore throat. Povidone-Iodine (Topical) 1/7 What do I need to tell the doctor BEFORE my child takes this drug? All products: If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had. If your child is pregnant or breast-feeding a baby: If your child is pregnant or may be pregnant. Some forms of this drug are not for use during pregnancy. Talk with the doctor if your child is breast-feeding a baby or plans to breast- feed a baby. -
Antiseptics in the Era of Bacterial Resistance: a Focus on Povidone Iodine
Therapeutic Perspective Antiseptics in the era of bacterial resistance: a focus on povidone iodine Jean-Marie Lachapelle*1, Olivier Castel2, Alejandro Fueyo Casado3, Bernard Leroy1, Giuseppe Micali4, Dominique Tennstedt1 & Julien Lambert5 Practice Points Increasing bacterial resistance to antibiotics makes the management of superficial skin infections a major medical challenge. Antiseptics have broader spectrums of antimicrobial activity and a reduced potential for selection of bacterial resistance, relative to antibiotics. Consequently, antiseptics are appropriate alternatives to antibiotics for the prevention and treatment of superficial skin infections. Of four widely used antiseptics (povidone iodine, polihexanide, chlorhexidine and octenidine), povidone iodine has a particularly broad spectrum of antimicrobial activity that includes Gram-positive and Gram-negative bacteria, bacterial spores, fungi, protozoa and viruses. Widespread and extended use of povidone iodine is not associated with the selection of resistant bacterial strains. In contrast, bacterial resistance to chlorhexidine, quaternary ammonium salts, silver and triclosan has been documented. Regarding duration of effect on healthy skin, chlorhexidine is active for 1–4 h, whereas solutions of povidone iodine are active for 12–14 h. Aqueous and hydroalcoholic formulations of povidone iodine have good skin tolerance. Povidone iodine scrub has better skin tolerance than soap formulations of chlorhexidine and quaternary ammonium compounds (e.g., benzalkonium chloride and -
Guidance Document
Decentralised Procedure Public Assessment Report Levendex 1 mg/ml + 5 mg/ml Augentropfen, Lösung Ducressa 1 mg/ml + 5 mg/ml Augentropfen, Lösung Sevendoc 1 mg/ml + 5 mg/ml Augentropfen, Lösung Dexamethasone/Levofloxacin DE/H/6215-6217/001/DC Applicants: NTC S.r.l., Santen Oy, Doc Generici S.r.l. Date: 20th January 2021 This module reflects the scientific discussion for the approval of the above-mentioned products. The procedure was finalised on 28th May 2020. TABLE OF CONTENTS I INTRODUCTION ......................................................................................................................... 4 II EXECUTIVE SUMMARY .......................................................................................................... 4 II.1 Problem statement..................................................................................................................... 4 II.2 About the product ..................................................................................................................... 4 II.3 General comments on the submitted dossier .......................................................................... 5 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles .. 5 III SCIENTIFIC OVERVIEW AND DISCUSSION .................................................................... 6 III.1 Quality aspects ......................................................................................................................... 6 III.2 Non clinical aspects .................................................................................................................