The National Drugs List
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Appendix 1 Table of Contents
@ECHA EUROPEAN CHEMICALS AGENCY Appendix 1 Table of Contents: Supplementary Table C:Substances on Annex II of the Cosmetic Products Regulation ... 1 Supplementary Table D: Substances proposed to be restricted due their use restriction in CPR Annex IV column 9..,,.. 119 Supplementary Table E: Substances allowed in tattoo inks subject to the conditions specified in CPR Annex IV columns h and i ......r29 Annankatu 18. P.O. Box 400, FI-00121 Helsinki, Finland I Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV RESTRICTION REPORT - SUBSTANCES IN TATTOO INKS AND PERMANENT MAKE UP Su lemen Table C:Substances on Annex II of the Cosmetic Products Re ulationl Substance EC# cAs # Substance EC# cAs # R T T T A- s c R I T Name Name e b b b II s M 7 c I s I I I #4 5 6 D 9 2 1 2 3 a 3 3 3 N-(s- Chlorobenzoxa zol-2- 35783- vl)acetamide 57-4 1 (2- Acetoxyethyl)t rimethylammo (2- nium acetoxyethyl hydroxide )trimethyla 200- (Acetylcholine) 200- mmonium 124-9 5 1-84-3 and its salts t2a-9 51-84-3 2 Deanol Deanol 222- 3342- aceglumate 222- 3342- aceqlumate 085-5 61-8 (INN) 085-5 61-8 3 Spironolacto 200- Spironolactone 200- ne 133-6 52-O1-7 rINN) 133-6 52-0L-7 4 14-(4- Hydroxy-3- iodophenoxy)- 3,5- diiodophenylla cetic acid (Tiratricol 200- (INN)) and its 200- Tiratricol 086- 1 5r-24-7 salts 086- 1 5l-24-7 5 Methotrexat 200- Methotrexate 200- e 413-8 59-05-2 (INN) 413-8 59-05-2 6 Aminocaproic Aminocaproi 200- acid (INN) and 200- c acid 469-3 60-32-2 its salts 469-3 60-32-2 7 Cinchophen (rNN), its salts, derivatives and salts of 205- 132-60- these 205- 132-60- Cinchophen 067-r 5 derivatives 067-l 5 Thyropropic acid (INN) and its salts 5L-26-3 9 Trichloroacet 200- Trichloroacetic 200- ic acid 927-2 75-03-9 acid 927-2 76-03-9 l0 Aconitum napellus L. -
Amidotrizoic Acid/Barium Sulfate 1477 Imbalance Should Be Corrected Before Contrast Media Are Given
Amidotrizoic Acid/Barium Sulfate 1477 imbalance should be corrected before contrast media are given. management of adhesive small bowel obstruction;2 they allow pyloric stenosis or lesions that may predispose to obstruction. Particular care is needed in patients with multiple myeloma since identification of patients who require surgery and, although they Adequate hydration should be ensured after the procedure to pre- dehydration resulting from use of contrast media may cause pre- have not been shown to relieve obstruction, they may reduce vent severe constipation. cipitation of protein in the renal tubules, leading to anuria and length of hospital stay in patients treated without surgery. It is contra-indicated in patients with gastrointestinal perforation, fatal renal failure. 1. Murshed R, et al. Meconium ileus: a ten-year review of thirty-six and should be avoided, particularly when given rectally, in those Caution is also necessary in patients with severe hypertension, patients. Eur J Pediatr Surg 1997; 7: 275–7. at risk of perforation, such as patients with acute ulcerative colitis advanced cardiac disease, phaeochromocytoma, sickle-cell dis- 2. Abbas S, et al. Oral water soluble contrast for the management or diverticulitis and after rectal or colonic biopsy, sigmoidosco- of adhesive small bowel obstruction. Available in The Cochrane ease, or hyperthyroidism or epilepsy, and in debilitated, severely Database of Systematic Reviews; Issue 3. Chichester: John Wi- py, or radiotherapy. ill, very old, or very young patients. ley; 2007 (accessed 14/07/08). Uses and Administration Amidotrizoates and other hypertonic contrast media are neuro- Preparations Barium sulfate is used as a radiographic contrast medium toxic and should not be given intrathecally; patients with sub- (p.1474) for X-ray examination of the gastrointestinal tract in- arachnoid haemorrhage may be at risk with any intravascular BP 2008: Meglumine Amidotrizoate Injection; Sodium Amidotrizoate In- jection; volving single- or double-contrast techniques or computed tom- use. -
Antiseptics and Disinfectants for the Treatment Of
Verstraelen et al. BMC Infectious Diseases 2012, 12:148 http://www.biomedcentral.com/1471-2334/12/148 RESEARCH ARTICLE Open Access Antiseptics and disinfectants for the treatment of bacterial vaginosis: A systematic review Hans Verstraelen1*, Rita Verhelst2, Kristien Roelens1 and Marleen Temmerman1,2 Abstract Background: The study objective was to assess the available data on efficacy and tolerability of antiseptics and disinfectants in treating bacterial vaginosis (BV). Methods: A systematic search was conducted by consulting PubMed (1966-2010), CINAHL (1982-2010), IPA (1970- 2010), and the Cochrane CENTRAL databases. Clinical trials were searched for by the generic names of all antiseptics and disinfectants listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A. Clinical trials were considered eligible if the efficacy of antiseptics and disinfectants in the treatment of BV was assessed in comparison to placebo or standard antibiotic treatment with metronidazole or clindamycin and if diagnosis of BV relied on standard criteria such as Amsel’s and Nugent’s criteria. Results: A total of 262 articles were found, of which 15 reports on clinical trials were assessed. Of these, four randomised controlled trials (RCTs) were withheld from analysis. Reasons for exclusion were primarily the lack of standard criteria to diagnose BV or to assess cure, and control treatment not involving placebo or standard antibiotic treatment. Risk of bias for the included studies was assessed with the Cochrane Collaboration’s tool for assessing risk of bias. Three studies showed non-inferiority of chlorhexidine and polyhexamethylene biguanide compared to metronidazole or clindamycin. One RCT found that a single vaginal douche with hydrogen peroxide was slightly, though significantly less effective than a single oral dose of metronidazole. -
Commission Decision of 8 February 2010 Concerning The
L 36/36 EN Official Journal of the European Union 9.2.2010 COMMISSION DECISION of 8 February 2010 concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (notified under document C(2010) 751) (Text with EEA relevance) (2010/72/EU) THE EUROPEAN COMMISSION, concerned should therefore not be included in Annex I, IA or IB to Directive 98/8/EC. Having regard to the Treaty on the Functioning of the European Union, (6) In the interest of legal certainty, biocidal products Having regard to Directive 98/8/EC of the European Parliament containing active substances for the product-types and of the Council of 16 February 1998 concerning the placing indicated in the Annex to this Decision should no of biocidal products on the market ( 1), and in particular the longer be placed on the market, with effect from a second subparagraph of Article 16(2) thereof, specific date. Whereas: (7) The measures provided for in this Decision are in accordance with the opinion of the Standing (1) Commission Regulation (EC) No 1451/2007 of Committee on Biocidal Products, 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive HAS ADOPTED THIS DECISION: 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the Article 1 market ( 2) establishes a list of active substances to be assessed, with a view to their possible inclusion in The substances indicated in the Annex to this Decision shall not Annex I, IA or IB to Directive 98/8/EC. -
Hygroscopicity of Pharmaceutical Crystals
HYGROSCOPICITY OF PHARMACEUTICAL CRYSTALS A DISSERTATION SUBMITTED TO THE FACULTY OF GRADUATE SCHOOL OF THE UNIVERSITY OF MINNESOTA BY DABING CHEN IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY RAJ SURYANARAYANAN (ADVISER) JANUARY, 2009 © Dabing Chen, January / 2009 ACKNOWLEDGEMENTS I am very grateful to my thesis advisor, Prof. Raj Suryanarayanan, for his constant guidance, support, and encouragement throughout my research. Without his help, the completion of this thesis would be impossible. His friendship and advices are precious to my professional and personal growth and will help me overcome many difficulties in my future career. I would like to take the opportunity to thank Prof. David J.W. Grant, who was my advisor during the first three years in graduate school and led me into the research area of physical pharmacy. It was my great honor to have worked for him, and he will always live as a role model in my life. Many thanks to Dr. Zheng Jane Li at Boehringer Ingelheim Pharmaceuticals (BI) for her invaluable advice as an industrial mentor and also for agreeing to serve on my committee. I sincerely appreciate her helpful discussions, revision of the manuscripts, and supervision of my research. I also want to thank her for providing me the internship opportunity at BI. I thank Dr. Timothy S. Wiedmann and Dr. Theodore P. Labuza for serving on my committee and for critically reviewing my thesis. I also want to thank Dr. Timothy S. Wiedmann for allowing me the use of the HPLC instruments in his lab and also for his advice as the Director of Graduate Studies. -
The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection
The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Country Reports Japan International Corporation of Welfare Services (JICWELS) Contents 1. Cambodia 1 2. Indonesia 70 3. Malaysia 91 4. Philippines 116 5. Sri Lanka 141 6. Thailand 161 The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Cambodia -1- KINGDOM OF CAMBODIA Nation Religion King Ministry of Health Department of Drugs and Food Country Report The Study Program on Quality Management of Essential Medicines Good Manufacturing Practice (GMP) and Inspection November 4, 2012 – November 30, 2012 Sponsored by : The Government of Japan Japan International Cooperation Agency (JICA) Department of Drugs and Food Ministry of Health, Cambodia. -2- I- COUNTRY PROFILE -3- A-Geography Cambodia is an agricultural country located in South East Asia which bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. Its approximate geographical coordinates are 13°N 105°E. Its 2,572 km border is split among Vietnam (1,228 km), Thailand (803 km) and Laos (541 km), as well as 443 km of coastline. Cambodia covers 181,035 square kilometers in the southwestern part of the Indochina, Cambodia lies completely within the tropics; its southernmost points are only slightly more than 10° above the equator. The country is bounded on the north by Thailand and by Laos, on the east and southeast by Vietnam, and on the west by the Gulf of Thailand and by Thailand. It consists of the Tonle Sap Basin and the Mekong Lowlands. To the southeast of this great basin is the Mekong Delta, which extends through Vietnam to the South China Sea. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Theophylline-7-Acetic Acid
Theophylline-7-acetic acid sc-237085 Material Safety Data Sheet Hazard Alert Code Key: EXTREME HIGH MODERATE LOW Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME Theophylline-7-acetic acid STATEMENT OF HAZARDOUS NATURE CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO OSHA 29 CFR 1910.1200. NFPA FLAMMABILITY1 HEALTH2 HAZARD INSTABILITY0 SUPPLIER Santa Cruz Biotechnology, Inc. 2145 Delaware Avenue Santa Cruz, California 95060 800.457.3801 or 831.457.3800 EMERGENCY ChemWatch Within the US & Canada: 877-715-9305 Outside the US & Canada: +800 2436 2255 (1-800-CHEMCALL) or call +613 9573 3112 SYNONYMS C9-H10-N4-O4, "purine-7-acetic acid, 1, 2, 3, 6-tetrahydro-1, 3-dimethyl-2, 6-dioxo-", acefylline, acephylline, 7-(carboxymethyl)theophylline, "1, 2, 3, 6-tetrahydro-1, 3-dimethyl-2, 6-dioxopurine-7-acetic acid", "7-theophyllineacetic acid", "7-theophyllinylacetic acid", alkaloid Section 2 - HAZARDS IDENTIFICATION CHEMWATCH HAZARD RATINGS Min Max Flammability: 1 Toxicity: 2 Body Contact: 2 Min/Nil=0 Low=1 Reactivity: 1 Moderate=2 High=3 Chronic: 2 Extreme=4 1 of 8 CANADIAN WHMIS SYMBOLS EMERGENCY OVERVIEW RISK Harmful if swallowed. Irritating to eyes, respiratory system and skin. POTENTIAL HEALTH EFFECTS ACUTE HEALTH EFFECTS SWALLOWED ! Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual. ! Xanthine derivatives may produce nausea, vomiting, anorexia, stomach pain, vomiting of blood and diarrhea. Protein in the urine, increased amounts of urine output, and increased excretion of renal tubular cells and red blood cells may also occur. -
Updatirg the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults
Updatirg the BeersCriteria for Potentially InappropriateMedication Use in Older Adults Resultsof a US ConsensusPanel of Experts DonnaM.Fich,PhD,RN;lamesW.Cooper,PhD,RPh;WilliamE.Wade,PhannD,FASHP,FCCP; JenniJerL. Waller, PhD;J, RossMaclean, MD; Marh H. Beers,MD Bcckground: Medication toxic effectsand drug- Reruhr: This study identified 48 individual medica- relatedproblems can have profound medical and safety tions or classeso[ medicationsto avoid in older adults consequencesfor older adults and economically affect the and their potential concernsand 20 diseases/conditions health caresystem. The purpose of this initiative was to and medicationsto be avoidedin older adultswith these reviseand update the Beerscriteria for potentially inap- conditions.Of thesepotentially inappropriate drugs, 66 propriate medicationuse in adults 65 yearsand older in wereconsidered by the panelto haveadverse outcomes the United States. of high severity. lYlcthcdr: This study used a modified Delphi method, a Concludonr: This study is an importantupdate of pre- setof proceduresand methodsfor formulating a groupjudg- viously establishedcriteria that have been widely used ment for a subject matter in which precise information is and cited. The application of the Beerscriteria and other Iacking. The criteria reviewed covered 2 types of state- tools for identifying potentially inapproprlate medica- ments: (l) medicationsor medicationclasses that should tion use will continue to enableproviders to plan inter- grnerally be avoidedin persons 65 years or older because -
Ep 1931310 B1
(19) & (11) EP 1 931 310 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/12 (2006.01) A61K 9/06 (2006.01) 06.06.2012 Bulletin 2012/23 A61K 9/70 (2006.01) A61K 47/32 (2006.01) A61K 47/24 (2006.01) A61K 47/10 (2006.01) (21) Application number: 06779420.6 (86) International application number: (22) Date of filing: 14.09.2006 PCT/GB2006/003408 (87) International publication number: WO 2007/031753 (22.03.2007 Gazette 2007/12) (54) Monophasic film-forming composition for topical administration Monophasische filmbildende Zusammensetzung zum topischen Auftrag Composition monophase formant un film pour l’administration à voie topique (84) Designated Contracting States: • JONES, Stuart, Allen AT BE BG CH CY CZ DE DK EE ES FI FR GB GR London SE3 0XA (GB) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR (74) Representative: Lord, Hilton David Marks & Clerk LLP (30) Priority: 14.09.2005 GB 0518769 90 Long Acre London (43) Date of publication of application: WC2E 9RA (GB) 18.06.2008 Bulletin 2008/25 (56) References cited: (73) Proprietor: Medpharm Limited WO-A2-01/43722 US-A- 4 752 466 Charlbury, US-A- 4 863 721 US-A1- 2004 184 994 Oxfordshire OX7 3RR (GB) US-A1- 2004 213 744 (72) Inventors: • BROWN, Marc, Barry Hertfordshire WD19 4QQ (GB) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
F 009 035 Benzocaine 20%, Lidocaine Hydrochoride 7
MEDISCA® NETWORK INC. TECHNICAL SUPPORT SERVICES FORMULATION CHEMISTRY DEPARTMENT TOLL-FREE: 866-333-7811 TELEPHONE: 514-905-5096 FAX: 514-905-5097 [email protected] 1/4/2021; Page 1 Suggested Benzocaine 20%, Lidocaine Hydrochloride 7%, Tetracaine Hydrochloride 7% FIN F 009 035 Formula Topical Gel (Suspension, 30 g) SUGGESTED FORMULATION Lot Expiry Ingredient Listing Qty. Unit NDC # Supplier Number Date Benzocaine, USP 6.000 g Lidocaine Hydrochloride, USP TBD Tetracaine Hydrochloride, USP 2.100 g Polysorbate 80, NF 0.5 mL Ethoxy Diglycol, NF 0.5 mL Medisca VersaPro™ Anhydrous Base 1.50 g Medisca VersaPro™ Anhydrous Base TBD MEDISCA® NETWORK INC. TECHNICAL SUPPORT SERVICES FORMULATION CHEMISTRY DEPARTMENT TOLL-FREE: 866-333-7811 TELEPHONE: 514-905-5096 FAX: 514-905-5097 [email protected] 1/4/2021; Page 2 Suggested Benzocaine 20%, Lidocaine Hydrochloride 7%, Tetracaine Hydrochloride 7% FIN F 009 035 Formula Topical Gel (Suspension, 30 g) SPECIAL PREPARATORY CONSIDERATIONS Ingredient-Specific Information Benzocaine, Tetracaine Hydrochloride, Polysorbate Light Sensitive (protect from light whenever possible): 80 Tetracaine Hydrochloride, Polysorbate 80, Ethoxy Hygroscopic (protect from moisture whenever possible): Diglycol Oxygen Sensitive (protect from air whenever possible): Polysorbate 80 Narrow Therapeutic Index Lidocaine Hydrochloride Suggested Preparatory Guidelines ■ Non-Sterile Preparation □ Sterile Preparation Processing Error / To account for processing error considerations during preparation, it is suggested to Testing Considerations: measure an additional 12 to 15% of the required quantities of ingredients. Special Instruction: This formula may contain one or more Active Pharmaceutical Ingredients (APIs) that may be classified as hazardous, please refer & verify the current NIOSH list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. -
Vaginal Yeast Infections Yeast Are Caused Byinfection an Overgrowth of Yeast in the Vagina
•Vaginal Yeast infections Yeast are caused byInfection an overgrowth of yeast in the vagina. • Yeast infections can be treated with over-the-counter medications. • Many yeast infections can be treated without seeing a medical provider. Symptoms: • Vaginal Itching, burning, swelling • Vaginal discharge (thick white vaginal discharge that looks like cottage cheese and does not have a bad smell) • May have pain during sex • May be worse the week before your period Self-care measures: • Use an over-the-counter medication for vaginal yeast infections. These antifungal medications should contain butoconazole, clotrimazole, miconazole, or tioconazole and should be used for 3-7 days. Follow directions on medication insert. Note: Over-the-counter medications are available at the University Health Center Pharmacy (first floor of Student Success Center), local pharmacies, grocery stores and superstores (examples - Walmart or Target). • Change tampons, pads and panty liners often • Do wear underwear with a cotton crotch • Apply a cool compress to labia for comfort • Do not douche or use vaginal sprays • Do not wear tight underwear and do not wear underwear to sleep • Avoid hot tubs Limit spread to others: • It is possible to spread yeast infections to your partner(s) during vaginal, oral or anal sex. • If your partner is a male, the risk is low. Some men get an itchy rash on their penis. • If this happens have your partner see a medical provider. • If your partner is a female, you may spread the yeast infection to her. • She should be treated if she