Mebhydrolin Napadisylate
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(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group R01 (Nasal preparations) Table of Contents Page INTRODUCTION 5 DISCLAIMER 7 GLOSSARY OF TERMS USED IN THIS DOCUMENT 8 ACTIVE SUBSTANCES Cyclopentamine (ATC: R01AA02) 10 Ephedrine (ATC: R01AA03) 11 Phenylephrine (ATC: R01AA04) 14 Oxymetazoline (ATC: R01AA05) 16 Tetryzoline (ATC: R01AA06) 19 Xylometazoline (ATC: R01AA07) 20 Naphazoline (ATC: R01AA08) 23 Tramazoline (ATC: R01AA09) 26 Metizoline (ATC: R01AA10) 29 Tuaminoheptane (ATC: R01AA11) 30 Fenoxazoline (ATC: R01AA12) 31 Tymazoline (ATC: R01AA13) 32 Epinephrine (ATC: R01AA14) 33 Indanazoline (ATC: R01AA15) 34 Phenylephrine (ATC: R01AB01) 35 Naphazoline (ATC: R01AB02) 37 Tetryzoline (ATC: R01AB03) 39 Ephedrine (ATC: R01AB05) 40 Xylometazoline (ATC: R01AB06) 41 Oxymetazoline (ATC: R01AB07) 45 Tuaminoheptane (ATC: R01AB08) 46 Cromoglicic Acid (ATC: R01AC01) 49 2 Levocabastine (ATC: R01AC02) 51 Azelastine (ATC: R01AC03) 53 Antazoline (ATC: R01AC04) 56 Spaglumic Acid (ATC: R01AC05) 57 Thonzylamine (ATC: R01AC06) 58 Nedocromil (ATC: R01AC07) 59 Olopatadine (ATC: R01AC08) 60 Cromoglicic Acid, Combinations (ATC: R01AC51) 61 Beclometasone (ATC: R01AD01) 62 Prednisolone (ATC: R01AD02) 66 Dexamethasone (ATC: R01AD03) 67 Flunisolide (ATC: R01AD04) 68 Budesonide (ATC: R01AD05) 69 Betamethasone (ATC: R01AD06) 72 Tixocortol (ATC: R01AD07) 73 Fluticasone (ATC: R01AD08) 74 Mometasone (ATC: R01AD09) 78 Triamcinolone (ATC: R01AD11) 82 -
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). -
Product Information
PRODUCT INFORMATION NAME OF THE MEDICINE POLARAMINE® (dexchlorpheniramine maleate) DESCRIPTION Polaramine (dexchlorpheniramine maleate) is the dextro-isomer of chlorpheniramine maleate. It is an antihistamine with anticholinergic properties Dexchlorpheniramine maleate (CAS no. 2438-32-6) is described chemically as (+)-2-[p- chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). It has the empirical formula of C16H19ClN2.C4H4O4 and the following structural formula: Dexchlorpheniramine maleate is a white, odourless, crystalline powder which in aqueous solution has a pH of between 4 and 5. It is freely soluble in water, soluble in alcohol and in chloroform, but only slightly soluble in benzene or ether. PHARMACOLOGY Pharmacodynamics Mechanism of Action: Dexchlorpheniramine, the d-isomer of the racemic compound chlorpheniramine, is two times more active than chlorpheniramine. Dexchlorpheniramine does not prevent the release of histamine, but rather, competes with free histamine for binding at the H1-receptor sites, and competitively antagonizes the effects of histamine on H1-receptors in the GI tract, uterus, large blood vessels, and bronchial muscle. Blockade of H1-receptors also suppresses the formation of oedema, flare, and pruritus that result from histaminic activity. Since dexchlorpheniramine binds to central and peripheral H1-receptors, sedative effects are likely to occur. H1-antagonists are structurally similar to anticholinergic agents and therefore possess the potential to exhibit anticholinergic properties of varying -
Report Update 1
Drug Class Review on Newer Antihistamines Final Report Update 1 April 2006 Original Report Date: November 2004 A literature scan of this topic is done periodically The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2006 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved. Note: A scan of the medical literature relating to the topic is done periodically (see http://www.ohsu.edu/ohsuedu/research/policycenter/DERP/about/methods.cfm for scanning process description). Upon review of the last scan, the Drug Effectiveness Review Project governance group elected not to proceed with another full update of this report. Some portions of the report may not be up to date. Prior version of this report can be accessed at the DERP website. Final Report Update #1 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.............................................................................................................................................................4 SCOPE AND KEY QUESTIONS.............................................................................................................................6 -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Download a Drug Interactions Card
transplant.bc.ca/medications Please discuss with your healthcare professionals BEFORE starting or stopping any medications, herbal or non-prescription products. Contact your Transplant Clinic nurse or pharmacist to let them know if there are any changes to your medications. Transplant Clinic Phone: _____________________________________ BC PHN (CareCard #) __________________________________ (2017v3) Please call your transplant clinic before starting any new medications to avoid possible drug interactions, especially those with CAUTION (see below) next to its name: Cyclosporine (Neoral), Tacrolimus (Prograf/Sandoz tac, Advagraf), Sirolimus (Rapamune): Seizure: phenytoin, carbamazepine, phenobarbital, primidone Infection: erythromycin, clarithromycin – CAUTION ( OK- azithromycin) fluconazole, ketoconzazole, posaconazole voriconazole - CAUTION rifampin – CAUTION Cyclosporine (Neoral), Tacrolimus (Prograf/Sandoz tac, d Advagraf), Sirolimus (Rapamune) cont’d Depression: fluoxetine, fluvoxamine ( OK- paroxetine, citalopram, escitalopram, sertraline, venlafaxine, mirtazapine) Heart/Blood pressure: diltiazem, verapamil, amiodarone, digoxin Cholesterol: lovastatin, simvastatin, atorvastatin ( OK- rosuvastatin, pravastatin, fluvastatin) Pain: anti-inflammatories can affect kidney function: ibuprofen, naproxen, diclofenac, indomethacin, celecoxib ( OK- acetaminophen) Mycophenolate mofetil/sodium (MMF, Cellcept/Myfortic): Antacids: space taking antacid and MMF by 2 hours Cholestyramine: AVOID if possible Azathioprine (Imuran): Gout: allopurinol – -
Wo 2010/075090 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 July 2010 (01.07.2010) WO 2010/075090 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 409/14 (2006.01) A61K 31/7028 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 409/12 (2006.01) A61P 11/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2009/068073 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 15 December 2009 (15.12.2009) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (26) Publication Language: English TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/122,478 15 December 2008 (15.12.2008) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): AUS- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, PEX PHARMACEUTICALS, INC. -
PACKAGE LEAFLET: INFORMATION for the PATIENT Desloratadine 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Desloratadine 5 mg tablets Read all of this leaflet carefully before you start taking/using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Desloratadine 5 mg Tablets are and what they are used for 2. What you need to know before you take Desloratadine 5 mg Tablets 3. How to take Desloratadine 5 mg Tablets 4. Possible side effects 5. How to store Desloratadine 5 mg Tablets 6. Contents of the pack and other information 1. What Desloratadine 5 mg Tablets are and what they are used for What Desloratadine 5 mg Tablets is Desloratadine 5 mg Tablets contain desloratadine which is an antihistamine. How Desloratadine 5 mg Tablets works Desloratadine 5 mg Tablets is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. When Desloratadine 5 mg Tablets should be used Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. -
Transdermal Drug Delivery Device Including An
(19) TZZ_ZZ¥¥_T (11) EP 1 807 033 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61F 13/02 (2006.01) A61L 15/16 (2006.01) 20.07.2016 Bulletin 2016/29 (86) International application number: (21) Application number: 05815555.7 PCT/US2005/035806 (22) Date of filing: 07.10.2005 (87) International publication number: WO 2006/044206 (27.04.2006 Gazette 2006/17) (54) TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING VORRICHTUNG ZUR TRANSDERMALEN VERABREICHUNG VON ARZNEIMITTELN EINSCHLIESSLICH EINER VERSTOPFUNGSSICHERUNG DISPOSITIF D’ADMINISTRATION TRANSDERMIQUE DE MEDICAMENTS AVEC COUCHE SUPPORT OCCLUSIVE (84) Designated Contracting States: • MANTELLE, Juan AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Miami, FL 33186 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • NGUYEN, Viet SK TR Miami, FL 33176 (US) (30) Priority: 08.10.2004 US 616861 P (74) Representative: Awapatent AB P.O. Box 5117 (43) Date of publication of application: 200 71 Malmö (SE) 18.07.2007 Bulletin 2007/29 (56) References cited: (73) Proprietor: NOVEN PHARMACEUTICALS, INC. WO-A-02/36103 WO-A-97/23205 Miami, FL 33186 (US) WO-A-2005/046600 WO-A-2006/028863 US-A- 4 994 278 US-A- 4 994 278 (72) Inventors: US-A- 5 246 705 US-A- 5 474 783 • KANIOS, David US-A- 5 474 783 US-A1- 2001 051 180 Miami, FL 33196 (US) US-A1- 2002 128 345 US-A1- 2006 034 905 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. -
Prohibited Substances List
Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR). Neither the List nor the EADCM Regulations are in current usage. Both come into effect on 1 January 2010. The current list of FEI prohibited substances remains in effect until 31 December 2009 and can be found at Annex II Vet Regs (11th edition) Changes in this List : Shaded row means that either removed or allowed at certain limits only SUBSTANCE ACTIVITY Banned Substances 1 Acebutolol Beta blocker 2 Acefylline Bronchodilator 3 Acemetacin NSAID 4 Acenocoumarol Anticoagulant 5 Acetanilid Analgesic/anti-pyretic 6 Acetohexamide Pancreatic stimulant 7 Acetominophen (Paracetamol) Analgesic/anti-pyretic 8 Acetophenazine Antipsychotic 9 Acetylmorphine Narcotic 10 Adinazolam Anxiolytic 11 Adiphenine Anti-spasmodic 12 Adrafinil Stimulant 13 Adrenaline Stimulant 14 Adrenochrome Haemostatic 15 Alclofenac NSAID 16 Alcuronium Muscle relaxant 17 Aldosterone Hormone 18 Alfentanil Narcotic 19 Allopurinol Xanthine oxidase inhibitor (anti-hyperuricaemia) 20 Almotriptan 5 HT agonist (anti-migraine) 21 Alphadolone acetate Neurosteriod 22 Alphaprodine Opiod analgesic 23 Alpidem Anxiolytic 24 Alprazolam Anxiolytic 25 Alprenolol Beta blocker 26 Althesin IV anaesthetic 27 Althiazide Diuretic 28 Altrenogest (in males and gelidngs) Oestrus suppression 29 Alverine Antispasmodic 30 Amantadine Dopaminergic 31 Ambenonium Cholinesterase inhibition 32 Ambucetamide Antispasmodic 33 Amethocaine Local anaesthetic 34 Amfepramone Stimulant 35 Amfetaminil Stimulant 36 Amidephrine Vasoconstrictor 37 Amiloride Diuretic 1 Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR). -
Alternative Forms of Oral Drug Delivery for Pediatric Patients Marcia L
PEDIATRIC PHARMACOTHERAPY A Monthly Newsletter for Health Care Professionals from the University of Virginia Children’s Hospital Volume 19 Number 3 March 2013 Alternative Forms of Oral Drug Delivery for Pediatric Patients Marcia L. Buck, Pharm.D., FCCP, FPPAG he lack of an appropriate dosage form the concentration versus time curve (AUC) of T limits the use of many medications that 45% for lopinavir and 47% for ritonavir (p = may potentially benefit children. While this has 0.003 and 0.006, respectively). been a long-standing problem for pediatric healthcare providers, little attention has been Cutting tablets, another common practice, may paid to remedying it until recently. In 2005 the be acceptable for some drugs, however this Eunice Kennedy Shriver National Institute for practice can introduce considerable variability Child Health and Human Development, joined between doses. In drugs with a narrow by representatives from the Food and Drug therapeutic index, such as levothyroxine, this Administration (FDA), academic medicine, and variability may be enough to produce clinically the pharmaceutical industry, formed the United significant changes in clinical response.7 When States (US) Pediatric Formulations Initiative in cutting a tablet is necessary, family members an effort to stimulate research in pediatric should receive specific instructions on the formulation technology.1 Similar work by the process, including the proper use of a tablet European Medication Agency (EMA) led to the splitter. Family members involved in dose development of the European Pediatric preparation should also understand how to Formulation Initiative.2 In addition, the World dispose of unused drug and the need to avoid Health Organization launched a global initiative repeated exposure to drugs that have in 2007 entitled “Make Medicines Child Size” to carcinogenic or teratogenic properties. -
NVA237 / Glycopyrronium Bromide Multinational, Multi-Database Drug
Quantitative Safety & Epidemiology NVA237 / Glycopyrronium bromide Non-interventional Final Study Report NVA237A2401T Multinational, multi-database drug utilization study of inhaled NVA237 in Europe Author Document Status Final Date of final version 28 April 2016 of the study report EU PAS register ENCEPP/SDPP/4845 number Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis NIS Report Template Version 2.0 August-13-2014 Novartis Confidential Page 2 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T PASS information Title Multinational, multi-database drug utilization study of inhaled NVA237 in Europe –Final Study Report Version identifier of the Version 1.0 final study report Date of last version of 28 April 2016 the final study report EU PAS register number ENCEPP/SDPP/4845 Active substance Glycopyrronium bromide (R03BB06) Medicinal product Seebri®Breezhaler® / Tovanor®Breezhaler® / Enurev®Breezhaler® Product reference NVA237 Procedure number SeebriBreezhaler: EMEA/H/C/0002430 TovanorBreezhaler: EMEA/H/C/0002690 EnurevBreezhaler: EMEA/H/C0002691 Marketing authorization Novartis Europharm Ltd holder Frimley Business Park Camberley GU16 7SR United Kingdom Joint PASS No Research question and In the context of the NVA237 marketing authorization objectives application, the Committee for Medicinal Products for Human Use (CHMP) recommended conditions for marketing authorization and product information and suggested to conduct a post-authorization