ISMP's List of Products with Drug Name Suffixes
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Lipid-Based Depots: Manufacturing, Administration and Interactions of Protein Drugs with Lipid Formulations
Dissertation zur Erlangung des Doktorgrades der Fakultät für Chemie und Pharmazie der Ludwig-Maximilians-Universität München Lipid-based depots: manufacturing, administration and interactions of protein drugs with lipid formulations Michaela Maria Breitsamer aus Starnberg, Deutschland 2019 II ERKLÄRUNG Diese Dissertation wurde im Sinne von § 7 der Promotionsordnung vom 28. November 2011 von Herrn Prof. Dr. Gerhard Winter betreut. EIDESSTATTLICHE VERSICHERUNG Diese Dissertation wurde eigenständig und ohne unerlaubte Hilfe erarbeitet. Wolfratshausen, den 20.05.2019 ________________________________ (Michaela Breitsamer) Dissertation eingereicht am: 20.05.2019 1. Gutachter: Prof. Dr. Gerhard Winter 2. Gutachter: Prof. Dr. Wolfgang Frieß Mündliche Prüfung am: 25.06.2019 III IV FOR MY FAMILY “The way to get started is to quit talking and begin doing” Walt Disney (1901 – 1966) V VI ACKNOWLEDGEMENTS The present thesis was prepared between March 2015 and December 2018 at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics at the Ludwig-Maximilians Universität (LMU) in Munich under the supervision of Prof. Dr. Gerhard Winter. First of all, I would like to express my deepest gratitude to my supervisor Prof. Dr. Gerhard Winter for giving me the opportunity to join his research group and to work on this extremely interesting and interdisciplinary project. I really appreciated his scientific input throughout all phases of this work, his elaborate advice and his guidance, which also contributed to my personal development over the last years. Furthermore, I would like to thank him for the outstanding working and team atmosphere, which he created at the chair, for supporting my participation in scientific conferences and for initiating and motivating me to the numerous collaborations which contributed to a successful thesis. -
Confusing Brand Names: Nightmare of Medical Profession
Original Article www.jpgmonline.com Confusing brand names: Nightmare of medical profession Rataboli PV, Garg A Department of Pharma- ABSTRACT cology and Therapeutics, Objective: India has more than 20,000 registered pharmaceutical manufacturers. Consequently, there is a Goa Medical College, Bambolim, Goa 403202, flood of brand names to choose from. We conducted this study to analyse and sort out the multitudinous India brand names thronging the Indian market, and identified those that could create a possible confusion. Materials and Methods: Recent issues of drug formularies like Indian Drug Review, Drug Index, and Monthly Correspondence: Index of Medical Specialities-India were checked and all the brand names given were included. Some other Amit Garg, MD brand names that are available with the pharmacists but are not included in these indexes were also included E-mail: [email protected] in the study for analysis. Observations: Potentially confusing brand names were sorted out and categorised according to the severity of damage they can cause if misinterpreted by the pharmacist or the patient. Subgroups were made according to the brand name, the generic name, and the manufacturers of the drug. Conclusion: Several brand names are strikingly identical, similar looking (orthographic), or similar sounding (phonological). Preventing this possible confusion is not the work of any one person involved. We describe the Received : 09-08-04 role of prescribing doctors, dispensing pharmacists, consumer patients, and the manufacturing companies to Review completed : 30-09-04 prevent “wrong prescribing” due to similarities in brand names. Accepted : 22-12-04 PubMed ID : 15793332 J Postgrad Med 2005;51:13-6 KEY WORDS: Identical; look-alike; sound-alike; confusing; brand names rescribing drugs with their brand name is an essential the patients, doctors, pharmacists, and the drug manufacturers were P part of medical practice. -
Food and Drugs Regulations
LAWS OF TRINIDAD AND TOBAGO 22 Chap. 30:01 Food and Drugs SUBSIDIARY LEGISLATION FOOD AND DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation. 2. Requirements prescribed by regulation. 3. Interpretation. 4. Request to Director. 5. Functions, duties, responsibilities of Inspectors. 6. Certificate of appointment. 7. Taking of photographs. 8. Taking samples and detention pending further examination. 9. Violation of Act or Regulations and relabelling or recondition ing of food, drug, cosmetic or device. 10. Issue of certificate. 11. Taking a sample, notification of intention and division of sample. 12. Division an interference and objection to procedure by owner or person. 13. Certificate of Analysis. 14. Definition of terms in Part II. 15. Offence to sell unlabelled food. 16. Labelling of package. 17. Declaration of net contents not required on certain labels. 18. List of ingredients not required on certain labels. 19. Declaration not required. 20. Declaration not required to indicate presence of flavouring. 21. Dried or dehydrated products. 22. Food from vending machine. 23. Non application of regulation 16. 24. Standard for a food. 25. Name of designation given to standard, grade or definition. 26. Adulteration of food. 27. Non-adulteration. 28. Contents of package. 29. Display of information on label. 30. First Schedule. 31. Offence. 32. Definition of terms in Part III. 33. Labelling of drug. 34. Contents of label. 35. Label on bulk package. 36. Drug sold on prescription. 37. Packing cases. LAWS OF TRINIDAD AND TOBAGO Food and Drugs Chap. 30:01 23 Food and Drugs Regulations [Subsidiary} REGULATION 38. Name and proportion of drug to be stated on label. -
Product Monograph
PRODUCT MONOGRAPH PrFLUANXOL® Flupentixol Tablets (as flupentixol dihydrochloride) 0.5 mg, 3 mg, and 5 mg PrFLUANXOL® DEPOT Flupentixol Decanoate Intramuscular Injection 2% and 10% flupentixol decanoate Antipsychotic Agent Lundbeck Canada Inc. Date of Revision: 2600 Alfred-Nobel December 12th, 2017 Suite 400 St-Laurent, QC H4S 0A9 Submission Control No : 209135 Page 1 of 35 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 -
Depot Antipsychotic Injections
Mental Health Services Good Practice Statement For The Use Of DEPOT & LONG ACTING ANTIPSYCHOTIC INJECTIONS Date of Revision: February 2020 Approved by: Mental Health Prescribing Management Group Review Date: CONSULTATION The document was sent to Community Mental Health teams, Pharmacy and the Psychiatric Advisory Committee for comments prior to completion. KEY DOCUMENTS When reading this policy please consult the NHS Consent Policy when considering any aspect of consent National Institute for Clinical Excellence CG178 (2014), Psychosis and schizophrenia in adults: prevention and management NHS Lothian (2011), Depot Antipsychotic Guidance, Maudsley (2015), Prescribing Guidelines in Psychiatry 12th edition. UKPPG (2009) Guidance on the Administration to Adults of Oil based Depot and other Long Acting Intramuscular Antipsychotic Injections Summary of Product Characteristics for: Clopixol (Zuclopethixol Decanoate) Flupenthixol Decanoate Haldol (Haloperidol Decanoate) Risperdal Consta Xeplion (Paliperidone Palmitate) ZypAdhera (Olanzapine Embonate) Abilify Maintena (Aripiprazole) 1 CONTENTS REFERENCES/KEY DOCUMENTS …………………………………………………………… 1 INTRODUCTION …………………………………………………………………………………. 3 SCOPE …………………………………………………………………………………………….. 3 DEFINITIONS ……………………………………………………………………………………... 3 CHOICE OF DRUG AND DOSAGE SELECTION ……………………………………………. 3 SIDE EFFECTS ……………………………………………………………….………………….. 5 PRESCRIBING …………………………………………………………………………………… 5 ADMINISTRATION ………………………………………………………………………………. 7 RECORDING ADMINISTRATION ……………………………………………………………… 7 -
022450Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022450Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) CLINICAL PHARMACOLOGY REVIEW NDA 22-450 Submission Dates 05/13/2009 Brand Name - Generic Name IV acetaminophen Reviewer Ping Ji, Ph.D. Team Leader Suresh Doddapaneni, Ph.D. PM Primary Reviewers Ping Ji. Ph.D. PM Team Leader Yaning Wang, Ph.D. OCP Division Division of Clinical Pharmacology-II OND Division Division of Anesthesia, Analgesia, and Rheumatology Products Sponsor Cadence Pharmaceuticals, Inc. Relevant IND(s) 58,362 Submission Type; Code 505 (b) (2) P Formulation; Strength(s) Sterile solution for intravenous infusion, 1000 mg/vial Indication Treatment of acute pain and fever Proposed Dosing Regimen Single or repeated dose via a 15-minute intravenous infusion. The dose administered varied depending on age and body weight. Table of Contents Table of Contents.................................................................................................................1 1. Executive Summary.....................................................................................................2 1.1. Recommendations............................................................................................ 2 1.2. Phase IV Commitments................................................................................... 2 2. Question-Based Review...............................................................................................9 2.1. General Attributes........................................................................................... -
North of England Guidance for Long Acting Antipsychotic Injections July 17
Guidance on the Use of Antipsychotic Long-acting Injections in North of England (TEWV version) This guidance aims to inform and support prescribers within the three mental health service providers in the north of England in the cost-effective use of antipsychotic long-acting injections. Long-acting or “depot” injections are a useful and well-established form of administering antipsychotics in the management of schizophrenia and other psychoses. The introduction of long-acting formulations of second-generation (atypical) antipsychotics has created an additional pressure on drug budgets in mental health services, which may be justified if their use results in reduced hospital admissions, shortened length of stay and improved quality of life compared with the first generation (typical) agents. Advantages of long-acting / depot injections Assured compliance with antipsychotic treatment Increased bioavailability (less first-pass metabolism) Steady plasma levels compared to oral medication Reduction in relapse rate, severity of relapse and rehospitalisation Stable therapeutic effects Better downward titration to minimise side-effects There is some evidence that long-acting injections cause less brain tissue loss and deterioration (CATIE study1) Disadvantages of long-acting / depot injections Treatment cannot be stopped quickly if severe side-effects develop (dystonia, EPSE, NMS) Perception by the patient of “being controlled”, losing control over their treatment, or possibly being punished. Pain at the site of injection, lasting possibly 10 days Tissue necrosis - over time hard plaques may form, which will reduce the ease of administration and the efficacy of the injection as well as causing discomfort. Loss of dignity with the gluteal route Over and above these factors, NICE2 recommend that consideration should be given to offering a depot / long-acting injectable antipsychotic to people with psychosis or schizophrenia who express a preference for such treatment after an acute episode. -
Formulary Update
PEI Drug Programs Formulary Update Issue 06-04 October, 2006 The following changes and additions to the July 2006 edition of the PEI Drug Programs Formulary will be effective October 16th, 2006 unless otherwise noted within this update. If there are any questions regarding the information presented in this update please call the Drug Program office at 368-4947 or toll free at 1-877-577-3737. 1.0 Changes and Additions To The Formulary & MAC Pricing ALMOTRIPTAN (new addition) EDS Criteria: For the treatment of migraine headaches where other standard therapies, such as analgesics and/or ergotamine products have failed. Eligibility is restricted to persons over the age of 18 and under 65 years of age. Coverage is limited to 6 tablets per 30 day period. Persons requiring more than 6 doses per 30 day period should be considered for migraine prophylaxis therapy if they are not already receiving such therapy. 6.25mg tablet 02248128 AXERT (EDS) JAN FW 12.5mg tablet 02248129 AXERT (EDS) JAN FW DILTIAZEM HYDROCHLORIDE (new addition) 120mg capsule 02231150 TIAZAC BVL FNSW 180mg capsule 02231151 TIAZAC BVL FNSW 240mg capsule 02231152 TIAZAC BVL FNSW 300mg capsule 02231154 TIAZAC BVL FNSW 360mg capsule 02231155 TIAZAC BVL FNSW PEI Drug Programs Formulary Update Issue 06-04 October 2006 Page 1 DILTIAZEM HYDROCHLORIDE (new addition) 120mg extended release tablet 02256738 TIAZAC XC BVL FNSW 180mg extended release tablet 02256746 TIAZAC XC BVL FNSW 240mg extended release tablet 02256754 TIAZAC XC BVL FNSW 300mg extended release tablet 02256762 TIAZAC XC BVL FNSW 360mg extended release tablet 02256770 TIAZAC XC BVL FNSW ETHINYL ESTRADIOL/DROSPIRENONE (new addition) 3.0mg/0.03mg tablets 02261723 YASMIN 21 DAY BEX FW 02261731 YASMIN 28 DAY BEX FW ESPROSARTAN MESYLATE & HYDROCHLOROTHIAZIDE (new addition) 600mg & 12.5mg tablet 02253631 TEVETEN PLUS SLV FNSW GABAPENTIN (change) There is no longer an EDS restriction on this drug. -
Regencerx Preferred Medication List/Formulary Regencerx Preferred Effective February 1, 2008 ©2008
RegenceRx Preferred Medication List/Formulary Help to stretch your prescription dollar February1, 2008 ©2008. RegenceRx. All Rights Reserved. ©2008. RegenceRx. Effective February 1,2008 Effective 2 Your Preferred Medication List/Formulary 3 Common Questions and Answers Preferred/Formulary Medications 4-11 • By Category • A to Z Listing 12-17 – Generics 18-22 – Preferred/Formulary Brands Non-Preferred/Non-Formulary Brands 23-27 • Generic and Preferred Brand Alternatives Table of Contents Table Effective February 1, 2008 ©2008. RegenceRx. All Rights Reserved. RegenceRx is dedicated to provide the tools you need to understand your options and be a more informed consumer. This preferred medication list/formulary will help—with the answers you need to access affordable prescription benefits. Determining Cost Newly-introduced How much you pay for a prescription generic medications depends on whether it’s a: When a generic is introduced to the • Generic marketplace, it immediately becomes • Preferred/formulary brand name available at the lowest copay. After a • Non-preferred/non-formulary generic is available, the brand name brand name (brand name medication will only be available at the medication not on the list) non-preferred/non-formulary copay. Your cost is lowest for generic Preferred/formulary medications and highest for non- brand name medications preferred/non-formulary brand name Brand name medications on the medications. You can find specific preferred medication list (PML) coverage and copay information in have been chosen because our your summary of benefits. professional review has shown each Generic medications of them to be high-quality, effective, Generics provide the same and affordable. Preferred/formulary therapeutic benefits of their brand brand name medications are either name counterparts, without the more effective or equally effective—at brand name price. -
20 Official Journal of the European Union 23.9.2003
20EN Official Journal of the European Union 23.9.2003 Appendix referred to in Chapter 1 of Annex VII (*) List as provided by Cyprus in one language of pharmaceutical products for which a marketing authorisation issued under Cypriot law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 31 December 2005, whichever is the earlier. Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis. The attached lists A and B indicate the pharmaceutical products for human use and the veterinary medicinal products respectively, which are currently in circulation in Cyprus. These products were granted their initial marketing author- isation/licence based on the old, non-harmonised legislation. The marketing authorisations of all pharmaceutical products listed, will be renewed (if requested by the manufacturers and/or importers) during 2004 and 2005 in accordance with the provisions of the new, harmonised legislation and eventually, fully harmonised dossiers will be achieved by 31 December 2005. LIST A: MEDICINAL PRODUCTS FOR HUMAN USE Code No Product 9900231 4-WAY NASAL FAST ACTING SPRAY 1% 9800571 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 10ML 9800570 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 5ML 9700037 -5-FLUOROURACIL INJECTION 50MG/ML 9800572 5-FLUOROURACIL‘EBEWE’ VIALS 50MG/ML, 20ML 20050619 99F0165 HAIR & NAILCARE CAPSULES 97F0150 ABC SPEKTRUM TABLETS 9800252 ABERNIL TABLETS 50MG 9800252 ABERNIL TABLETS -
2019 Careoregon Advantage Plus Comprehensive Formulary
2019 CareOregon Advantage Customer Service CALL: 503-416-4279 or toll-free 888-712-3258 Drug List (Formulary) TTY/TDD: 711 HOURS OF OPERATION: every day, 8 a.m. to 8 p.m. CareOregon Advantage Plus (HMO-POS SNP) For Oregon counties: Clackamas, Columbia, Jackson, Multnomah, Tillamook and Washington facebook.com/careoregon twitter.com/careoregon careoregonadvantage.org H5859_PH2019_1085_C CMS ACCEPTED COA-18422.05-0820 CareOregon Advantage Plus HMO-POS SNP 2019 Formulary (List of Covered Drugs) PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN H5859_PH2019_1085_C FORMULARY ID 00019571, VERSION 27 This formulary was updated on December 1, 2019. For more recent information or other questions, please contact CareOregon Advantage Customer Service at 888-712-3258 or, for TTY/TDD users, 711, 8 a.m. to 8 p.m., daily, or visit careoregonadvantage.org Note to existing members: This formulary has changed since last year. Please review this document to make sure that it still contains the drugs you take. When this drug list (formulary) refers to “we,” “us”, or “our,” it means Health Plan of CareOregon, Inc. When it refers to “plan” or “our plan,” it means CareOregon Advantage Plus. This document includes a list of the drugs (formulary) for our plan which is current as of December 1, 2019. For an updated formulary, please contact us. Our contact information, along with the date we last updated the formulary, appears on the front and back cover pages. You must generally use network pharmacies to use your prescription drug benefit. Benefits, formulary, pharmacy network, and/or copayments/coinsurance may change on January 1, 2020, and from time to time during the year. -
Can I Drink Alcohol 24 Hours After Taking Tramadol
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