Information Pack
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Patch Development with New Drugs Versus Generic Development – Principles and Methods
Patch development with new drugs versus generic development – principles and methods Dr. Barbara Schug SocraTec R&D, Oberursel , Germany www.socratec-pharma.de AGAH Workshop, The new European modified Release Guideline- from cook book to interpretation, Bonn, June 15th –16th, 2015 Some basics Physico-chemical properties / conventional patches small molecule < 500kDa lipophilic potent therapeutic concept which requires low fluctuation Skin controls release rate drug substance dispersed in adhesive matrix Patch controls release rate rate controlling membrane between drug reservoir and skin Currently marketed patches Year Generic (Brand) Names Indication 1979 Scopolamine (Transderm Scop®) Motion sickness 1982 Nitroglycerine (Nitroderm TTS) Angina pectoris 1984 Clonidine (Catapress TTS®) Hypertension 1986 Estradiol (Estraderm®) Menopausal symptoms 1990 Fentanyl (Duragesic®) Chronic pain 1991 Nicotine (Nicoderm®, Habitrol®, Prostep®) Smoking cessation 1993 Testosterone (Androderm®) Testosterone deficiency 1995 Lidocaine/epinephrine (Iontocaine®) Local dermal analgesia 1998 Estradiol/norethindrone (Combipatch®) Menopausal symptoms 1999 Lidocaine (Lidoderm®) Post-herpetic neuralgia pain 2001 Ethinyl estradiol/norelgestromin (OrthoEvra®) Contraception 2003 Estradiol/levonorgestrel (Climara Pro®) Menopause 2003 Oxybutynin (Oxytrol®) Overactive bladder 2004 Lidocaine/ultrasound (SonoPrep®) Local dermal anesthesia Source: modified from Wilson EJ, Three Generations: The Past, Present, and Future of Transdermal Drug Delivery Systems, May 2014 -
F.8 Ethinylestradiol-Etonogestrel.Pdf
General Items 1. Summary statement of the proposal for inclusion, change or deletion. Here within, please find the evidence to support the inclusion Ethinylestradiol/Etonogestrel Vaginal Ring in the World Health Organization’s Essential Medicines List (EML). Unintended pregnancy is regarded as a serious public health issue both in developed and developing countries and has received growing research and policy attention during last few decades (1). It is a major global concern due to its association with adverse physical, mental, social and economic outcomes. Developing countries account for approximately 99% of the global maternal deaths in 2015, with sub-Saharan Africa alone accounting for roughly 66% (2). Even though the incidence of unintended pregnancy has declined globally in the past decade, the rate of unintended pregnancy remains high, particularly in developing regions. (3) Regarding the use of contraceptive vaginal rings, updated bibliography (4,5,6) states that contraceptive vaginal rings (CVR) offer an effective contraceptive option, expanding the available choices of hormonal contraception. Ethinylestradiol/Etonogestrel Vaginal Ring is a non-biodegradable, flexible, transparent with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Ethinylestradiol/Etonogestrel Vaginal Ring is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The main advantages of CVRs are their effectiveness (similar or slightly better than the pill), ease of use without the need of remembering a daily routine, user ability to control initiation and discontinuation, nearly constant release rate allowing for lower doses, greater bioavailability and good cycle control with the combined ring, in comparison with oral contraceptives. -
Wellness Benefits
Wellness Benefits University of South Alabama This schedule outlines services and items that the University of South Alabama considers a preventive service under this plan. These services must be performed by a physician in the University of South Alabama Health System provider network or by a dermatologist, endocrinologist, durable medical equipment provider, ancillary service provider, urologist, or rheumatologist provider (as applicable) in the entire VIVA HEALTH network. Many of these services are provided as part of an annual physical. This list does not apply to all VIVA HEALTH plans. Please refer to your Summary Plan Description to determine the terms of your health plan. PREVENTIVE SERVICE FREQUENCY/LIMITATIONS Well Baby Visits (Age 0-2) As recommended per guidelines1 Routine screenings, tests, and immunizations As recommended per guidelines Well Child Visits (Age 3-17) One per year at PCP2 Routine screenings, tests, & immunizations As recommended per guidelines HIV screening and counseling As recommended per guidelines Obesity screening As recommended per guidelines Hepatitis B virus screening As recommended per guidelines Sexually transmitted infection counseling Annually Skin cancer behavioral counseling (Beginning at age 10) As recommended per guidelines Routine Physical (Age 18+) One per year at PCP2 Alcohol misuse screening and counseling Annually Blood pressure screening Annually Cholesterol screening As recommended per guidelines Depression screening Annually Diabetes screening As recommended per -
Vaginal Administration of Contraceptives
Scientia Pharmaceutica Review Vaginal Administration of Contraceptives Esmat Jalalvandi 1,*, Hafez Jafari 2 , Christiani A. Amorim 3 , Denise Freitas Siqueira Petri 4 , Lei Nie 5,* and Amin Shavandi 2,* 1 School of Engineering and Physical Sciences, Heriot-Watt University, Edinburgh EH14 4AS, UK 2 BioMatter Unit, École Polytechnique de Bruxelles, Université Libre de Bruxelles, Avenue F.D. Roosevelt, 50-CP 165/61, 1050 Brussels, Belgium; [email protected] 3 Pôle de Recherche en Gynécologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, 1200 Brussels, Belgium; [email protected] 4 Fundamental Chemistry Department, Institute of Chemistry, University of São Paulo, Av. Prof. Lineu Prestes 748, São Paulo 05508-000, Brazil; [email protected] 5 College of Life Sciences, Xinyang Normal University, Xinyang 464000, China * Correspondence: [email protected] (E.J.); [email protected] (L.N.); [email protected] (A.S.); Tel.: +32-2-650-3681 (A.S.) Abstract: While contraceptive drugs have enabled many people to decide when they want to have a baby, more than 100 million unintended pregnancies each year in the world may indicate the contraceptive requirement of many people has not been well addressed yet. The vagina is a well- established and practical route for the delivery of various pharmacological molecules, including contraceptives. This review aims to present an overview of different contraceptive methods focusing on the vaginal route of delivery for contraceptives, including current developments, discussing the potentials and limitations of the modern methods, designs, and how well each method performs for delivering the contraceptives and preventing pregnancy. -
Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2Nd Edition
Morbidity and Mortality Weekly Report Early Release / Vol. 62 June 14, 2013 U.S. Selected Practice Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html. U.S. Department of Health and Human Services Centers for Disease Control and Prevention Early Release CONTENTS CONTENTS (Continued) Introduction ............................................................................................................1 Appendix A: Summary Chart of U.S. Medical Eligibility Criteria for Methods ....................................................................................................................2 Contraceptive Use, 2010 .................................................................................. 47 How To Use This Document ...............................................................................3 Appendix B: When To Start Using Specific Contraceptive Summary of Changes from WHO SPR ............................................................4 Methods .............................................................................................................. 55 Contraceptive Method Choice .........................................................................4 Appendix C: Examinations and Tests Needed Before Initiation of Maintaining Updated Guidance ......................................................................4 Contraceptive Methods -
Solpadeine Max Tabs 03
File title: 9034_SOMT01240812v1_Solpadeine Max tabs 20s-30s PIL v3F • If you take a painkiller for headaches for more than 3 days it can make Item No.: 11000000010649 PROSP SOLPADEINA MAX TABLETAS UK 1212 them worse. Last edit: 22nd November 2013 Do not take Solpadeine Max Tablets: Brand: Solpadeine Tablets Variant: MAX Tablets • If you have ever had an allergic reaction to paracetamol, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6) Component: Leaflet • If you are taking other medicines containing paracetamol or codeine • For pain relief in children and adolescents (0-18 years of age) after removal • This medicine is for the short term treatment of acute moderate pain Market/s: UK of their tonsils or adenoids due to obstructive sleep apnoea syndrome when other painkillers have not worked. • If you know that you metabolise very rapidly codeine into morphine • You should only take this product for a maximum of 3 days at a time. If Dimensions: 150 x 100mm (Drw No. L613D005) • If you are breastfeeding. you need to take it for longer than 3 days you should see your doctor or pharmacist for advice. Printer: Santiago Gonzalez • This medicine contains codeine which can cause addiction if you take it Ask your doctor before you take this medicine: continuously for more than 3 days. This can give you withdrawal Substrate: Paper symptoms from the medicine when you stop taking it. • If you have liver or kidney disease, including alcoholic liver disease Tablets EAN Code: N/A • If you take this medicine for headaches for more than 3 days it can make • If you have bowel problems including blockage of your bowel them worse. -
Biomedical Technology and Devices Handbook
1140_bookreps.fm Page 1 Tuesday, July 15, 2003 9:47 AM 29 Pharmaceutical Technical Background on Delivery Methods CONTENTS 29.1 Introduction 29.2 Central Nervous System: Drug Delivery Challenges to Delivery: The Blood Brain Barrier • Indirect Routes of Administration • Direct Routes of Administration 29.3 Cardiovascular System: Drug Delivery Chronotherapeutics • Grafts/Stents 29.4 Orthopedic: Drug Delivery Metabolic Bone Diseases 29.5 Muscular System: Drug Delivery 29.6 Sensory: Drug Delivery Ultrasound • Iontophoresis/Electroporation 29.7 Digestive System: Drug Delivery GI Stents • Colonic Drug Delivery 29.8 Pulmonary: Drug Delivery Indirect Routes of Administration • Direct Routes of Robert S. Litman Administration Nova Southeastern University 29.9 Ear, Nose, and Throat: Drug Delivery Maria de la Cova The Ear • The Nose • The Throat 29.10 Lymphatic System: Drug Delivery Icel Gonzalez 29.11 Reproductive System: Drug Delivery University of Memphis Contraceptive Implants • Contraceptive Patch • Male Contraceptive Eduardo Lopez References 29.1 Introduction In the evolution of drug development and manufacturing, drug delivery systems have risen to the forefront in the latest of pharmaceutical advances. There are many new pharmacological entities discov- ered each year, each with its own unique mechanism of action. Each drug will demonstrate its own pharmacokinetic profile. This profile may be changed by altering the drug delivery system to the target site. In order for a drug to demonstrate its pharmacological activity it must be absorbed, transported to the appropriate tissue or target organ, penetrate to the responding subcellular structure, and elicit a response or change an ongoing process. The drug may be simultaneously or sequentially distributed to a variety of tissues, bound or stored, further metabolized to active or inactive products, and eventually © 2004 by CRC Press LLC 1140_bookreps.fm Page 2 Tuesday, July 15, 2003 9:47 AM 29-2 Biomedical Technology and Devices Handbook excreted from the body. -
Glaxosmithkline Plc Annual Report for the Year Ended 31St December 2000
GlaxoSmithKline 01 GlaxoSmithKline plc Annual Report for the year ended 31st December 2000 Contents Report of the Directors 02 Financial summary 03 Joint statement by the Chairman and the Chief Executive Officer 05 Description of business 29 Corporate governance 37 Remuneration report 47 Operating and financial review and prospects 69 Financial statements 70 Directors’ statements of responsibility 71 Report by the auditors 72 Consolidated statement of profit and loss 72 Consolidated statement of total recognised gains and losses 74 Consolidated statement of cash flow 76 Consolidated balance sheet 76 Reconciliation of movements in equity shareholders’ funds 77 Company balance sheet 78 Notes to the financial statements 136 Group companies 142 Principal financial statements in US$ 144 Financial record 153 Investor information 154 Shareholder return 156 Taxation information for shareholders 157 Shareholder information 158 Share capital 160 Cross reference to Form 20-F 162 Glossary of terms The Annual Report was approved by the Board 163 Index of Directors on 22nd March 2001 and published on 12th April 2001. Contact details 02 GlaxoSmithKline Financial summary 2000 1999 Increase Business performance £m £m CER % £ % Sales 18,079 16,164 9 12 Trading profit 5,026 4,378 12 15 Profit before taxation 5,327 4,708 11 13 Earnings/Net income 3,697 3,222 13 15 Earnings per Ordinary Share 61.0p 52.7p 14 16 Total results Profit before taxation 6,029 4,236 Earnings/Net income 4,154 2,859 Earnings per Ordinary Share 68.5p 46.7p Business performance: results exclude merger items and restructuring costs; 1999 sales and trading profit exclude the Healthcare Services businesses which were disposed of in 1999. -
Malta Medicines List April 08
Defined Daily Doses Pharmacological Dispensing Active Ingredients Trade Name Dosage strength Dosage form ATC Code Comments (WHO) Classification Class Glucobay 50 50mg Alpha Glucosidase Inhibitor - Blood Acarbose Tablet 300mg A10BF01 PoM Glucose Lowering Glucobay 100 100mg Medicine Rantudil® Forte 60mg Capsule hard Anti-inflammatory and Acemetacine 0.12g anti rheumatic, non M01AB11 PoM steroidal Rantudil® Retard 90mg Slow release capsule Carbonic Anhydrase Inhibitor - Acetazolamide Diamox 250mg Tablet 750mg S01EC01 PoM Antiglaucoma Preparation Parasympatho- Powder and solvent for solution for mimetic - Acetylcholine Chloride Miovisin® 10mg/ml Refer to PIL S01EB09 PoM eye irrigation Antiglaucoma Preparation Acetylcysteine 200mg/ml Concentrate for solution for Acetylcysteine 200mg/ml Refer to PIL Antidote PoM Injection injection V03AB23 Zovirax™ Suspension 200mg/5ml Oral suspension Aciclovir Medovir 200 200mg Tablet Virucid 200 Zovirax® 200mg Dispersible film-coated tablets 4g Antiviral J05AB01 PoM Zovirax® 800mg Aciclovir Medovir 800 800mg Tablet Aciclovir Virucid 800 Virucid 400 400mg Tablet Aciclovir Merck 250mg Powder for solution for inj Immunovir® Zovirax® Cream PoM PoM Numark Cold Sore Cream 5% w/w (5g/100g)Cream Refer to PIL Antiviral D06BB03 Vitasorb Cold Sore OTC Cream Medovir PoM Neotigason® 10mg Acitretin Capsule 35mg Retinoid - Antipsoriatic D05BB02 PoM Neotigason® 25mg Acrivastine Benadryl® Allergy Relief 8mg Capsule 24mg Antihistamine R06AX18 OTC Carbomix 81.3%w/w Granules for oral suspension Antidiarrhoeal and Activated Charcoal -
VTE Prophylaxis in Gynecologic Surgery
ClinicalProviding Information Evidence-based for 25 Years AHC Media LLC Home Page—www.ahcmedia.com CME for Physicians—www.cmeweb.com EDITOR VTE Prophylaxis in Gynecologic Jeffrey T. Jensen, MD, MPH Leon Speroff Professor and Vice Chair for Research Surgery: Quo Vadis? Department of Obstetrics and Gynecology ABSTRACT & COMMENTARY Oregon Health & Science University InsIde Portland Oligohydram- By Robert L. Coleman, MD ASSOCIATE EDITORS nios: A reason Sarah L. Berga, MD Professor and Chair to deliver? Professor, University of Texas; M.D. Anderson Cancer Center, Houston Department of Obstetrics and page 59 Gynecology Vice President for Women’s Dr. Coleman reports no financial relationships relevant to this field of study. Health Services Wake Forest Baptist Health, Winston-Salem, NC Which is Synopsis: Venous thromboembolism (VTE) prophylaxis better: Open, Robert L. Coleman, MD interventions in gynecologic surgery are meritorious, supported Professor, University of laparoscopic, by Level 1 evidence and the subject of multiple guidelines, including Texas; M.D. Anderson Cancer Center, Houston or robotic? those published by the American College of Obstetricians and Gynecologists. However, new evidence suggests nearly Alison Edelman, MD, MPH page 60 Associate Professor, one-third of women undergoing hysterectomy in this country Assistant Director of the still receive no VTE prophylaxis, placing thousands of women at Family Planning Fellowship Special Department of Obstetrics & unnecessary risk for preventable morbidity. Gynecology, Oregon Health feature: & Science University, Portland Do we have a Source: Wright JD, et al. Quality of perioperative venous thromboembolism John C. Hobbins, MD problem? prophylaxis in gynecologic surgery. Obstet Gynecol 2011;118:978-986. Professor, Department of Obstetrics and Gynecology, Obesity and University of Colorado Health contraception he objective of this study was to estimate the use of vte pro- Sciences Center, Denver page 61 Tphylaxis in women undergoing major gynecologic surgery and to Frank W. -
Solpadeine Max Soluble Tabs 03
FRONT LEADING EDGE File title: 9034_SOLPM00890812v1_Solpadeine Max Soluble tabs PIL v5F Item No.: 40L564D(OPI) Last edit: 22nd November 2013 8.2mm This medicine is for the short term Brand: Solpadeine treatment of acute moderate pain Do not take Solpadeine Max Soluble Tablets: when other painkillers have not If you have ever had an allergic reaction Variant: MAX soluble tablets worked. You should only take this product for taking other medicines containing paracetamol. Component: Leaflet a maximum of 3 days at a time. If under 12 years: you need to take it for longer than 3 For pain relief in children and adolescents (0-18 years of age) after removal Market/s: UK of their tonsils or adenoids due to obstructive sleep apnoea syndrome days you should see your doctor Dimensions: 150 x 105mm (Drw No. OTC.LT.008) or pharmacist for advice. If you know that you metabolise very rapidly codeine into morphine If you are breastfeeding. This medicine contains codeine, which can cause addition if you take it 64.2mm Copy position: 1 OUTSIDE, 5 INSIDE print continuously for more than 3 days. This can give you withdrawal Ask your doctor before you take this medicine: symptoms from the medicine when you stop taking it. Printer: Chesapeake St Pierre If you take this medicine for headaches for more than 3 days, it can make liver kidney disease alcoholic liver disease them worse. bowel problems Substrate: Paper Please read right through this leaflet before you start using this medicine. operation to remove your gall bladder intolerance to EAN Code: N/A some sugars controlled sodium diet. -
Oesophageal Stricture Associated with Emepronium Bromide Therapy 1
Postgrad Med J: first published as 10.1136/pgmj.58.675.43 on 1 January 1982. Downloaded from Postgraduate Aledical Journal (January 1982) 58, 43-44 Oesophageal stricture associated with emepronium bromide therapy 1. W. FELLOWS A. L. OGILVIE M.B., M.R.C.P. M.B., M.R.C.P. M. ATKINSON M.D., F.R.C.P. University Hospital, Queen's Medical Centre, Nottingham Summary Barium swallow showed a small fixed hiatus Emepronium bromide, a drug used to control urinary hernia with a stricture above it and an ulcer crater frequency, has been reported as causing oesophageal therein. ulceration but not stricture formation. This paper Endoscopy showed a 5-mm diameter benign presents 3 cases in which the use of emepronium stricture at 33 cm from the alveolar margin; the bromide preceded development of an oesophageal stricture was 1 cm long and was ulcerated. Below it stricture and suggests that the drug played a causative was a hiatus hernia. The stricture was dilated, the role. emepronium stopped and she was given cimetidine and Asilone gel. One further dilatation was needed Case reports 4 months later but she has swallowed well for the Case I last 6 months. copyright. A 50-year-old woman, with a 6-year history of multiple sclerosis causing spastic paraparesis of the Case 3 lower limbs, presented with a 2-month history of A 74-year-old woman presented with progressive dysphagia for solids, retrosternal pain and 12-7 kg dysphagia for solids for a few weeks and mild weight loss. She was taking baclofen, carbamazepine, heartburn.