DOCSLIB.ORG

Center Study to Evaluate the Efficacy, Safety, and Tolerability

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Center Study to Evaluate the Efficacy, Safety, and Tolerability A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi- Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) PLUS ISN/Protocol 178-MA-1008 ClinicalTrials.gov Identifier: NCT02757768 Date of Protocol Version 5.2: 22 Jan 2018 Sponsor: Astellas Pharma Global Development, Inc. Medical Affairs, Americas 1 Astellas Way Northbrook, IL 60062, USA Sponsor: APGD, Medical Affairs, Americas ISN/Protocol 178-MA-1008 EudraCT 2015-004036-36 - CONFIDENTIAL - A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi- Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) PLUS ISN/Protocol 178-MA-1008 Version 5.2 Incorporating Substantial Amendment 4 [See Attachment 1] 22 January 2018 IND 69,416 EudraCT 2015-004036-36 Sponsor: Astellas Pharma Global Development, Inc. Medical Affairs, Americas 1 Astellas Way Northbrook, IL 60062 Investigator information is on file at Astellas. -------------------------------------------------------------------------------------------------------------------------------------- This confidential document is the property of the Sponsor. No unpublished information contained in this document may be disclosed without prior written approval of the Sponsor. 22 Jan 2018 Astellas Page 1 of 87 Sponsor: APGD, Medical Affairs, Americas ISN/Protocol 178-MA-1008 EudraCT 2015-004036-36 - CONFIDENTIAL - Table of Contents I. SIGNATURES ······················································································ 8 II. CONTACT DETAILS OF KEY SPONSOR’S PERSONNEL····························10 III. LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS ··················12 IV. SYNOPSIS··························································································17 V. FLOW CHART AND SCHEDULE OF ASSESSMENTS ·································24 1 INTRODUCTION·················································································28 1.1 Background ····················································································28 1.2 Summary of Non-clinical and Clinical Data ···············································29 1.2.1 Mirabegron (YM178) ···································································29 1.2.1.1 Summary of Non-clinical Studies of Mirabegron······························29 1.2.1.2 Summary of the Pharmacokinetics of Mirabegron ····························30 1.2.1.3 Summary of Clinical Data with Mirabegron ···································30 1.2.2 Tamsulosin Hydrochloride ·····························································32 1.2.2.1 Summary of Non-clinical Studies of Tamsulosin Hydrochloride············32 1.2.2.2 Summary of the Pharmacokinetics of Tamsulosin Hydrochloride···········33 1.2.2.3 Summary of Clinical Data with Tamsulosin Hydrochloride··················33 1.3 Summary of Key Safety Information for Study Drugs ···································34 1.3.1 Summary of Key Safety Information for Mirabegron ······························34 1.3.2 Summary of Key Safety Information for Tamsulosin Hydrochloride·············35 1.3.3 Summary of Key Safety Information for Combination of Mirabegron and Tamsulosin Hydrochloride ·····························································35 1.4 Risk-Benefit Assessment·····································································36 2 STUDY OBJECTIVE(S), DESIGN, AND ENDPOINTS ··································36 2.1 Study Objectives ··············································································36 2.2 Study Design and Dose Rationale···························································37 2.2.1 Study Design·············································································37 2.2.2 Dose Rationale···········································································38 2.3 Endpoints·······················································································38 2.3.1 Primary Endpoints·······································································38 2.3.2 Secondary Endpoints····································································38 2.3.3 Exploratory Endpoint ···································································39 2.3.4 Safety Variables ·········································································39 22 Jan 2018 Astellas Page 2 of 87 Sponsor: APGD, Medical Affairs, Americas ISN/Protocol 178-MA-1008 EudraCT 2015-004036-36 - CONFIDENTIAL - 3 STUDY POPULATION··········································································39 3.1 Selection of Study Population ·······························································39 3.2 Inclusion Criteria··············································································39 3.3 Exclusion Criteria ·············································································40 4 TREATMENT(S)··················································································42 4.1 Identification of Investigational Product(s) ················································42 4.1.1 Test Drug(s)··············································································42 4.1.2 Concomitant Medication ·······························································43 4.1.3 Placebo····················································································43 4.2 Packaging and Labeling ······································································43 4.3 Study Drug Handling ·········································································43 4.4 Blinding ························································································44 4.4.1 Blinding Method·········································································44 4.4.2 Confirmation of the Indistinguishability of the Study Drugs ······················44 4.4.3 Retention of the Assignment Schedule and Procedures for Treatment Code Breaking ··················································································45 4.4.4 Breaking the Treatment Code for Emergency ·······································45 4.4.5 Breaking the Treatment Code by the Sponsor ·······································45 4.5 Assignment and Allocation ··································································45 5 TREATMENTS AND EVALUATION························································46 5.1 Dosing and Administration of Study Drug(s) and Other Medication(s)················46 5.1.1 Dose/Dose Regimen and Administration Period ····································46 5.1.2 Increase or Reduction in Dose of the Study Drug(s) ································46 5.1.3 Previous and Concomitant Treatment (Medication and Non-Medication Therapy) ··················································································46 5.1.3.1 Previous Medication (Drugs and Therapies) ···································46 5.1.3.2 Concomitant Medication (Drugs and Therapies) ······························47 5.1.4 Treatment Compliance··································································47 5.2 Demographics and Baseline Characteristics ···············································48 5.2.1 Demographics············································································48 5.2.2 Medical History··········································································48 5.2.3 Diagnosis of the Target Disease, Severity, and Duration of Disease··············48 5.3 Efficacy Assessment··········································································48 5.3.1 Patient Diary – Micturition and Incontinence········································48 22 Jan 2018 Astellas Page 3 of 87 Sponsor: APGD, Medical Affairs, Americas ISN/Protocol 178-MA-1008 EudraCT 2015-004036-36 - CONFIDENTIAL - 5.3.2 Patient Perception of Intensity of Urgency Scale (PPIUS) ·························49 5.3.3 Total Urgency and Frequency Score (TUFS) ········································50 5.3.4 International Prostate Symptom Score (IPSS) ·······································50 5.3.5 OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit ·······50 5.3.5.1 Overactive Bladder-questionnaire (OAB-q)····································50 5.3.5.2 Patient Perception of Bladder Condition (PPBC)······························51 5.3.5.3 EQ-5D-5L ··········································································51 5.3.5.4 Treatment Satisfaction – Visual Analog Scale (TS-VAS) ····················51 5.4 Safety Assessment ············································································51 5.4.1 Vital Signs················································································51 5.4.2 Patient Diary – Subject Measurement Vital Signs···································52 5.4.3 Adverse Events ··········································································53 5.4.3.1 Adverse Events of Possible Hepatic Origin ····································53 1.1.1.1 Adverse Events of Special Interest ··············································53 5.4.4 Laboratory Assessments································································53 5.4.5 Physical Examination ···································································55
Load more

Recommended publications
  • Appendix A: Potentially Inappropriate Prescriptions (Pips) for Older People (Modified from ‘STOPP/START 2’ O’Mahony Et Al 2014)
    Appendix A: Potentially Inappropriate Prescriptions (PIPs) for older people (modified from ‘STOPP/START 2’ O’Mahony et al 2014) Consider holding (or deprescribing - consult with patient): 1. Any drug prescribed without an evidence-based clinical indication 2. Any drug prescribed beyond the recommended duration, where well-defined 3. Any duplicate drug class (optimise monotherapy) Avoid hazardous combinations e.g.: 1. The Triple Whammy: NSAID + ACE/ARB + diuretic in all ≥ 65 year olds (NHS Scotland 2015) 2. Sick Day Rules drugs: Metformin or ACEi/ARB or a diuretic or NSAID in ≥ 65 year olds presenting with dehydration and/or acute kidney injury (AKI) (NHS Scotland 2015) 3. Anticholinergic Burden (ACB): Any additional medicine with anticholinergic properties when already on an Anticholinergic/antimuscarinic (listed overleaf) in > 65 year olds (risk of falls, increased anticholinergic toxicity: confusion, agitation, acute glaucoma, urinary retention, constipation). The following are known to contribute to the ACB: Amantadine Antidepressants, tricyclic: Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Nortriptyline, Trimipramine and SSRIs: Fluoxetine, Paroxetine Antihistamines, first generation (sedating): Clemastine, Chlorphenamine, Cyproheptadine, Diphenhydramine/-hydrinate, Hydroxyzine, Promethazine; also Cetirizine, Loratidine Antipsychotics: especially Clozapine, Fluphenazine, Haloperidol, Olanzepine, and phenothiazines e.g. Prochlorperazine, Trifluoperazine Baclofen Carbamazepine Disopyramide Loperamide Oxcarbazepine Pethidine
    [Show full text]
  • Pharmacology in MS Advanced Practice Management
    Pharmacology in MS Advanced Practice Management Heidi Maloni APRN, BC [email protected] Objectives • Discuss basic principles of pharmacology, pharmacokinetics and pharmacodynamics. • Describe the pharmacotherapeutics of drugs used in MS • Identify the role of advanced practice nurse in MS pharmacological management. Advanced Practice Pharmacology Background • Pharmacology: study of a drug’s effects within a living system • Each drug is identified by 3 names: chemical, generic, trade or marketing name N-4-(hydroxyphenyl) acetamide; acetaminophen; Tylenol sodium hypochlorite; bleach; Clorox 4-(diethylamino)-2-butynl ester hydrochloride; oxybutynin chloride; Ditropan • Drugs are derived from: plants, humans, animals, minerals, and chemical substances • Drugs are classified by clinical indication or body system APN Role Safe drug administration Nurses are professionally, legally, morally, and personally responsible for every dose of medication they prescribe or administer Know the usual dose Know usual route of administration Know significant side effects Know major drug interactions Know major contraindication Use the nursing process Pregnancy Safety • Teratogenicity: ability to produce an abnormality in the fetus (thalidomide) • Mutogenicity: ability to produce a genetic mutation (diethylstilbestrol, methotrexate) Pregnancy Safety Categories • A: studies indicate no risk to the fetus (levothyroxan; low dose vitamins, insulin) • B: studies indicate no risk to animal fetus; information in humans is not available (naproxen;acetaminophen; glatiramer
    [Show full text]
  • The Effects of Oral Administration of the Novel Muscarinic Receptor
    Choi et al. BMC Urology (2020) 20:41 https://doi.org/10.1186/s12894-020-00611-8 RESEARCH ARTICLE Open Access The effects of oral administration of the novel muscarinic receptor antagonist DA- 8010 on overactive bladder in rat with bladder outlet obstruction Jin Bong Choi1, Seung Hwan Jeon2, Eun Bi Kwon3, Woong Jin Bae4, Hyuk Jin Cho2, U-Syn Ha2, Sung-Hoo Hong2, Ji Youl Lee2 and Sae Woong Kim4* Abstract Background: DA-8010 is a novel compound developed for the treatment of overactive bladder (OAB) and urinary incontinence. The aims of this study were to investigate the effects of DA-8010 on OAB in a rat model. Methods: Study animals were divided into the following five groups of seven animals each: a sham-operated control group, a control group with partial bladder outlet obstruction (BOO) (OAB group), and three DA-8010 (doses of 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day, respectively) with partial BOO groups. Oral administration of the drugs was continued for 14 days after 2 weeks of partial BOO. After 4 weeks of partial BOO, cystometrography was performed in all groups. Additionally, pro-inflammatory cytokines, Rho-kinases, and histology of the bladder were analyzed. Results: There was a significant increase in the contraction interval and a decrease in contraction pressure in the 3 mg/kg/day DA-8010 group versus those in the OAB group. Rho kinase was also significantly decreased in the DA- 8010 3 mg/kg/day dosage treatment group. The increased ratio of collagen to smooth muscle after partial BOO was significantly attenuated in the DA-8010 3 mg/kg/day dosage group.
    [Show full text]
  • Long Term Follow up of Mirabegron - a Real Life- Pragmatic Experience
    Central Journal of Urology and Research Bringing Excellence in Open Access Research Article *Corresponding author Haitham Abdelmoteleb, Bristol Urological Institute, Southmead Hospital, Bristol, BS10 5NB, UK, Tel: 440-7884- Long Term Follow Up of 827995; Email: Submitted: 04 June 2016 Mirabegron - A Real Life- Accepted: 22 August 2016 Published: 24 August 2016 ISSN: 2379-951X Pragmatic Experience Copyright Haitham Abdelmoteleb*, Musaab Yassin, and Hashim Hashim © 2016 Abdelmoteleb et al. Bristol Urological Institute, South mead Hospital, UK OPEN ACCESS Abstract Keywords • Mirabegron Objectives: To evaluate the efficacy and tolerability of Mirabegron for the • Beta-3 agonist treatment of overactive bladder symptoms in a real life, long term follow up study • Overactive bladder syndrome conducted in a tertiary referral centre. • Long term Methods: A structured telephone questionnaire of patients was conducted in order to evaluate the efficacy and tolerability of Mirabegron. Patients who were initially prescribed and responded to Mirabegron 50mg once daily between 6/2013 and 9/2013, were interviewed to see if they were compliant with treatment, continue to respond to treatment and if they discontinued treatment. Results: Follow-up was for a mean of 11.7 months. At short-term follow-up, 20/39 patients responded to treatment. In the long term follow-up, 18/20 patients were still using Mirabegron. 2/20 patients discontinued because of lack of efficacy. Overall, the main reasons for discontinuation of Mirabegron after trying it for a mean of 5.3 months, was lack of efficacy and adverse events. The majority of AEs were mild in severity and few were serious. Other reasons include the lack of further prescription from general practitioners.
    [Show full text]
  • Betmiga, INN-Mirabegron
    EMA/591015/2015 EMEA/H/C/002388 EPAR summary for the public Betmiga mirabegron This is a summary of the European public assessment report (EPAR) for Betmiga. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Betmiga. What is Betmiga? Betmiga is a medicine containing the active substance mirabegron. It is available as prolonged-release tablets (25 mg, 50 mg). ‘Prolonged-release’ means that mirabegron is released slowly from the tablet over a few hours. What is Betmiga used for? Betmiga is used in adults with overactive bladder syndrome. It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt). The medicine can only be obtained with a prescription. How is Betmiga used? The recommended dose of Betmiga is 50 mg once a day. In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines. For full details, see the package leaflet (also part of the EPAR). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2015.
    [Show full text]
  • Frailty & Cognihon: Management of OAB in Elderly & Frail Pahents
    Frailty & Cogni.on: Management of OAB in Elderly & Frail Pa.ents MR. RAHUL MISTRY CONSULTANT UROLOGICAL SURGEON POGP CONFERENCE NOVEMBER 2016 Topics • What are LUTS? • Symptom definiDons • The impact of OAB on paents • Management of OAB • The challenge of treang OAB • The Ancholinergic burden • Novel treatment of OAB Change of Terminology • LUTS = Lower urinary tract symptoms • LUTS instead of “prostasm” • Storage instead of “irritave” • Voiding instead of “obstrucDve” What are LUTS Post-micturion Storage symptoms Voiding symptoms symptoms DayDme frequency Slow stream Post-micturiDon Nocturia Spraying dribbling Incomplete Urgency IntermiUency emptying Urinary Hesitancy inconnence Straining Terminal dribbling Definions • Urgency - sudden compelling desire to pass urine which is difficult to defer • Urinary inconnence • any involuntary leakage of urine (urge / stress) • may need to be disDnguished from sweang or vaginal discharge • Increased dayme frequency - the complaint by the paent who considers that he/she voids too o]en by day • Nocturia - individual has to wake at night one or more Dmes to void • ICS DefiniDons, Abrams P et al. Neurourol Urodyn; 21:167-178 (2002) Defini.on of Overac.ve Bladder (OAB) (Internaonal Connence Society) 1. Abrams P et al. Neurourol Urodyn 2002;21:167-178 Mrs W. E. Terrible, your classic pa.ent? Age: 64 year old woman Occupaon: Recently reDred from an office job Symptoms: • Urinary frequency (14−15 Dmes a day) • Urge inconDnence (daily) • Nocturia (3 Dmes a night) THe impact of OAB on pa.ents How do OAB symptoms affect pa.ents? haven’t slept depressing like a baby negave lose control locked in embarrassing exhausted no control terrible so red I keep it xxx secret Quotes from a video of real-life OAB paents talking about how OAB has affected their lives.
    [Show full text]
  • Pain Management 101
    PAIN MANAGEMENT 101 By: Vicki McCulloch RN, NP & DeAnna Looper RN, CHPN, CHPCA Expect more from us. We do. Objectives • Identify a step-wise approach to pain management. • Identify the WHO Pain Ladder. • Identify non-pharmacological pain control measures. • Identify adjuvant treatment measures. • Identify common myths and truths • Identify common side effects and treatment options. Expect more from us. We do. Pain Management Principles • Use Multi-Treatment and Multi-Discipline Approach • Combine opioids with non-opioid medications • Non-pharmaceutical approaches • Include family and caregiver in planning • Include the patient! • Coordinate with facility • Coordinate with all providers- • Primary Care Provider • Nursing Home Physician • Hospice IDG Members Expect more from us. We do. Utilize the WHO Ladder World Health Organization • (WHO) “analgesic ladder” • Follow the steps as indicated. • Determine if adjuvants are necessary. Expect more from us. We do. WHO Pain Ladder STEP 3 “Strong” opioid for severe pain +/- non-opioid +/- adjuvant STEP 2 “Mild” opioid for mild- moderate pain +/- non- opioid +/- adjuvant STEP 1 Non-opioid + / - adjuvant Expect more from us. We do. Step 1-Mild Pain NON-OPIOID MEDICATION OPTIONS • Acetaminophen (Tylenol)-(Paracetamol)-(Panadol) • Non-steroidal anti-inflammatory drugs (NSAIDs) Traditional NSAIDS Ibuprofen-(Motrin) Aspirin-(Bayer) Naproxen- (Aleve) Nabumetone-(Relafen) Cox-2 Inhibitors Celecoxib-(Celebrex) Rofecoxib-(Vioxx) Valdecoxib-(Bextra) Expect more from us. We do. Adjuvants • Antidepressants
    [Show full text]
  • Study Protocol
    CLINICAL STUDY PROTOCOL Study Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder Protocol Number: RVT-901-3003 Compound Name and/or Vibegron Number: Indication Treatment of Overactive Bladder Sponsor: Urovant Sciences GmbH Viaduktstrasse 8 4051 Basel Switzerland Development Phase: 3 Regulatory Identifier(s): IND# 106,410 EudraCT# 2017-003293-14 Current Version and Version 3.0; 15 NOV 2018 Effective Date: Previous Version(s) and Version 2.1; 12 FEB 2018 Effective Date(s): Version 2.0; 30 JAN 2018 Version 1.2; 01 NOV 2017 Version 1.1; 05 OCT 2017 Version 1.0; 29 SEP 2017 Study Director: , , Clinical Development Confidentiality Statement The information contained in this document, particularly unpublished data, is the property or under control of Urovant Sciences GmbH, and is provided to you in confidence as an investigator, potential investigator or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from Urovant Sciences GmbH. except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Confidential Page | 1 NCT Number: NCT03492281 This NCT number has been applied to the document for purposes of posting on clinicaltrials.gov Clinical Study Protocol RVT-901-3003 Urovant Sciences GmbH Effective: 15 NOV 2018 SUMMARY OF CHANGES Version Location Description of Change 3.0 Global Minor typographical/formatting errors were corrected.
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
    [Show full text]
  • Department of Health
    DEPARTMENT OF HEALTH National Drug Policy - Pharmaceutical Management Unit 50 National Formulary Committee Philippine National Drug Formulary EssentialEssential MedicinesMedicines ListList Volume I, 7th Edition ( 2008 ) Published by: The National Formulary Committee National Drug Policy ‐ Pharmaceutical Management Unit 50 DEPARTMENT OF HEALTH Manila, Philippines All rights reserved 2008 The National Formulary Committee National Drug Policy‐Pharmaceutical Management Unit 50 (NDP‐PMU 50) Department of Health San Lazaro Cmpd., Rizal Ave., Sta. Cruz, Manila, Philippines 1003 ISBN 978‐971‐91620‐7‐0 Any part or the whole book may be reproduced or transmitted without any alteration, in any form or by any means, with permission from DOH provided it is not sold commercially. ii PHILIPPINE NATIONAL DRUG FORMULARY Volume I, 7th Edition 2 0 0 8 Francisco T. Duque III, MD, MSc Secretary of Health Alexander A. Padilla Undersecretary of Health, Office for External Affairs Robert Louie P. So, MD Program Manager, NDP-PMU 50 Dennis S. Quiambao, MD Proj. Mgmt. Operating Officer & Coordinator (PMOOC) NDP-PMU 50 NATIONAL FORMULARY COMMITTEE Estrella B. Paje-Villar, MD, DTM & H Chairperson Jose M. Acuin, MD, MSc Alma L. Jimenez, MD Alejandro C. Baroque II, MD Marieta B. de Luna, MD Bu C. Castro, MD Nelia P. Cortes-Maramba, MD Dina V. Diaz, MD Yolanda R. Robles, PhD Pharm Mario R. Festin, MD, MS, MHPEd Isidro C. Sia, MD BFAD Representative SECRETARIAT Luzviminda O. Marquez, RPh, RMT Mary Love C. Victoria, RPh Michael D. Junsay, RPh Ermalyn M. Magturo iii Republic of the Philippines DEPARTMENT OF HEALTH OFFICE OF THE SECRETARY 2/F Bldg. 1, San Lazaro Cmpd., Rizal Avenue, Sta.
    [Show full text]
  • Pcf5 Palliative Care Formulary
    PCF5 PALLIATIVE CARE FORMULARY Published by palliativedrugs.com Ltd. Palliativedrugs.com Ltd Hayward House Study Centre Nottingham University Hospitals NHS Trust, City Campus Nottingham NG5 1PB United Kingdom www.palliativedrugs.com # palliativedrugs.com Ltd 2014 The moral rights of the editors have been asserted. PCF4þ ePDF 2013 PCF4þ ePDF 2012 PCF4 2011, reprinted 2012 (twice), 2013 PCF3 2007, reprinted 2008, 2009 PCF2 2002, reprinted 2003 PCF1 1998 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission in writing of palliativedrugs.com Ltd or as expressly permitted by law, or under terms agreed with the appropriate reprographics rights organization. Enquiries concerning reproduction outside the scope of the above should be sent to [email protected] or by ordinary mail to the above address. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library. ISBN 978-0-9552547-9-6 Typeset by OKS Prepress Services Private Ltd, Chennai, India Printed by Halstan Printing Group, Amersham, UK DISCLAIMER Every effort has been made to ensure the accuracy of this text, and that the best information available has been used. However, palliativedrugs.com Ltd neither represents nor guarantees that the practices described herein will, if followed, ensure safe and effective patient care. The recommendations contained in this book reflect the editors’ judgement regarding the state of general knowledge and practice in the field as of the date of publication. Information in a book of this type can never be all-inclusive, and therefore will not cover every eventuality.
    [Show full text]