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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
Ocps) Used in the NM Family Planning Program (FPP
The following slides are intended to familiarize nurses and clinicians with oral contraceptive pills (OCPs) used in the NM Family Planning Program (FPP). The FPP does not intend for this information to supersede the Family Planning Protocol particularly on the requirement for Public Health Nurses in the Public Health Offices to consult a clinician as stated in the Protocol when in doubt or if it is necessary to switch the client’s OCP type. 1 2 Combined oral contraceptives (COCs) contain two hormones; estrogen and progestin. In general, any combined OCP is good for most women who are eligible to take estrogen according to the CDC U.S. Medical Eligibility Criteria (MEC). Once again, refer to the US MEC chart to find out if OCP is a suitable choice for clients with specific health conditions. To learn a little bit about what each hormone does, the FPP is providing the following summary: Estrogen: provides endometrial stability = menstrual cycle control. A higher estrogen dose increases the venous thromboembolism (VTE) or clot risk but OCP clot risk is still less harmful than the clot risk related to pregnancy and giving birth. Progestin: provides most of the contraceptive effect by ‐Preventing luteinizing hormone (LH) surge /ovulation ‐Thickening the cervical mucus to prevent sperm entry. Two major OCP formations are available. Monophasic: There is only one dose of estrogen and progestin in each active pill in the packet; and Multiphasic: There are varying doses of hormones, particularly progestin in the active pills. 3 Section 3 of the FPP Protocol contains the OCP Substitute Table, which groups OCPs into 6 classes according to the estrogen dosage, the type of progestin and the formulations. -
Product List March 2019 - Page 1 of 53
Wessex has been sourcing and supplying active substances to medicine manufacturers since its incorporation in 1994. We supply from known, trusted partners working to full cGMP and with full regulatory support. Please contact us for details of the following products. Product CAS No. ( R)-2-Methyl-CBS-oxazaborolidine 112022-83-0 (-) (1R) Menthyl Chloroformate 14602-86-9 (+)-Sotalol Hydrochloride 959-24-0 (2R)-2-[(4-Ethyl-2, 3-dioxopiperazinyl) carbonylamino]-2-phenylacetic 63422-71-9 acid (2R)-2-[(4-Ethyl-2-3-dioxopiperazinyl) carbonylamino]-2-(4- 62893-24-7 hydroxyphenyl) acetic acid (r)-(+)-α-Lipoic Acid 1200-22-2 (S)-1-(2-Chloroacetyl) pyrrolidine-2-carbonitrile 207557-35-5 1,1'-Carbonyl diimidazole 530-62-1 1,3-Cyclohexanedione 504-02-9 1-[2-amino-1-(4-methoxyphenyl) ethyl] cyclohexanol acetate 839705-03-2 1-[2-Amino-1-(4-methoxyphenyl) ethyl] cyclohexanol Hydrochloride 130198-05-9 1-[Cyano-(4-methoxyphenyl) methyl] cyclohexanol 93413-76-4 1-Chloroethyl-4-nitrophenyl carbonate 101623-69-2 2-(2-Aminothiazol-4-yl) acetic acid Hydrochloride 66659-20-9 2-(4-Nitrophenyl)ethanamine Hydrochloride 29968-78-3 2,4 Dichlorobenzyl Alcohol (2,4 DCBA) 1777-82-8 2,6-Dichlorophenol 87-65-0 2.6 Diamino Pyridine 136-40-3 2-Aminoheptane Sulfate 6411-75-2 2-Ethylhexanoyl Chloride 760-67-8 2-Ethylhexyl Chloroformate 24468-13-1 2-Isopropyl-4-(N-methylaminomethyl) thiazole Hydrochloride 908591-25-3 4,4,4-Trifluoro-1-(4-methylphenyl)-1,3-butane dione 720-94-5 4,5,6,7-Tetrahydrothieno[3,2,c] pyridine Hydrochloride 28783-41-7 4-Chloro-N-methyl-piperidine 5570-77-4 -
Prescription Pattern of Primary Osteoarthritis in Tertiary Medical
Published online: 2020-04-21 Running title: Primary Osteoarthritis Nitte University Journal of Health Science Original Article Prescription Pattern of Primary Osteoarthritis in Tertiary Medical Centre Sowmya Sham Kanneppady1, Sham Kishor Kanneppady2, Vijaya Raghavan3, Aung Myo Oo4, Ohn Mar Lwin5 1Senior Lecturer and Head, Department of Pharmacology, Faculty of Medicine, Lincoln University College, Selangor Darul Ehsan, Malaysia, 2Senior Lecturer, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia, 3Head of the Department of Pharmacology, KVG Medical College and Hospital, Kurunjibag, Sullia, Karnataka, India. 4Assistant Professor, Department of Biochemistry, Faculty of Medicine, Lincoln University College, Selangor Darul Ehsan, Malaysia, 5Post graduate student, Department of Physiology, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia. *Corresponding Author : Sowmya Sham Kanneppady, Senior Lecturer and Head,Department of Pharmacology, Faculty of Medicine, Lincoln University College, No. 2, Jalan Stadium, SS 7/15, Kelana Jaya, 47301, Petaling Jaya, Selangor Darul Ehsan, Malaysia. E-mail : [email protected]. Received : 12.10.2017 Abstract Review Completed : 05.12.2017 Objectives: Osteoarthritis (OA) is one of the commonest joint/musculoskeletal disorders, Accepted : 06.12.2017 affecting the middle aged and elderly, although younger people may be affected as a result of injury or overuse. The study aimed to analyze the data, evaluate the prescription pattern and Keywords: Osteoarthritis, anti- rationality of the use of drugs in the treatment of primary OA with due emphasis on the inflammatory agents, prevalence available treatment regimens. Materials and methods: Medical case records of patients suffering from primary OA attending Access this article online the department of Orthopedics of a tertiary medical centre were the source of data. -
Use of Chemical Chelators As Reversal Agents for Drug
(19) TZZ_ _ZZZ_T (11) EP 1 210 090 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/724 (2006.01) A61K 31/194 (2006.01) 18.06.2014 Bulletin 2014/25 A61P 39/04 (2006.01) (21) Application number: 00964006.1 (86) International application number: PCT/EP2000/007694 (22) Date of filing: 07.08.2000 (87) International publication number: WO 2001/012202 (22.02.2001 Gazette 2001/08) (54) USE OF CHEMICAL CHELATORS AS REVERSAL AGENTS FOR DRUG- INDUCED NEUROMUSCULAR BLOCK VERWENDUNG VON CHEMISCHEN CHELATOREN ZUR UMKEHRUNG VON PHARMAKOLOGISCH-INDUZIERTER NEUROMUSKULÄRER BLOCKIERUNG UTILISATION D’AGENTS CHIMIQUES CHELATANTS COMME AGENTS DE NEUTRALISATION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES MEDICAMENTS (84) Designated Contracting States: (56) References cited: AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU AU-A- 3 662 895 MC NL PT SE • B DESIRE: "Inactivaton of sarin and soman by (30) Priority: 13.08.1999 EP 99306411 cyclodextrins in vitro" EXPERIENTIA, vol. 43, no. 4, 1987, pages 395-397, XP000907287 (43) Date of publication of application: • B. DESIRE: "Interaction of soman with beta- 05.06.2002 Bulletin 2002/23 cyclodextrin" FUNDAMENTAL AND APPLIED TOXICOLOGY, vol. 7, no. 4, 1986, pages 647-657, (73) Proprietor: Merck Sharp & Dohme B.V. XP000911170 2031 BN Haarlem (NL) • C. MAY: "Development of a toxin-binding agent as a treatment for tunicamycinuracil toxicity: (72) Inventors: protection against tunicamycin poisoning of • BOM, Antonius, Helena, Adolf sheep" AUSTRALIAN VETERINARY JOURNAL, Ratho, Midlothian EH28 8NY (GB) vol. 76, no. -
WHO Pharmaceuticals Newsletters
2021 WHO Pharmaceuticals No.1 NEWSLETTER The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines WHO Vision for Medicines Safety and legal actions taken by regulatory authorities around No country left behind: the world. It also provides signals based on information worldwide pharmacovigilance for safer medicines, safer patients derived from the WHO global database of individual case safety reports, VigiBase. In addition, this edition of the Newsletter includes a The aim of the Newsletter is to disseminate regulatory summary of discussions and key recommendations of information on the safety of Advisory Committee on Safety of Medicinal Products pharmaceutical products, (ACSoMP) Seventeenth meeting. based on communications received from our network of national pharmacovigilance centres and other sources such as specialized bulletins and journals, as well as partners in WHO. The information is produced in the form of résumés in English, full texts of which may be obtained on request from: Safety and Vigilance: Medicines, EMP-HIS, World Health Organization, 1211 Geneva 27, Switzerland, Contents E -mail address: [email protected] This Newsletter is also available at: Regulatory matters http://www.who.int/medicines Safety of medicines Signal Feature WHO Pharmaceuticals Newsletter No. 1, 2021 ISBN 978-92-4-002136-5 (electronic version) ISBN 978-92-4-002137-2 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. -
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FAM001159-0001 intervals of 4-7 days to usual dose of 75-100 mg Dolmatil® (Sanofi-Synthelabo) ~ 100 rag/5 mL, thioridazine 100 rag/ per course and max. 4 injections; max. duration of daily according to response; CHILD not recom- Tablets, both scored, sulpiride 200 rag, net price ’ net price 300 mL = £7.14. Label: 2 treatment 2 weeks---if maintenance treatment mended 100-tabpack=£13.85;400mg(f/c), 100-tab ! fNote. These suspensions should not be diluted but the necessary change to an oral antipsychotic 2-3 Short-term adjunctive management of severe pack = £36¯29. Label: 2 .: :~t~a preparations may be mixed with each other to days after last injection, or to a longer acting anti- anxiety, 15-20rag daily in divided doses; max. Sulpltil® (Pharmacia) I~ ~0iovid¢ intermediate strengths psychotic depot injection given concomitantly 40 mg daily; CHILD not recommended Tablets, scored, sulpiride 200 rag. Net price 28-tab "ff~-~p, brown, thioridazine (as hydrochloride) with last injection of zuclopenthixol acetate; By deep intramuscular injection, psychoses, mania, pack = £4.29; 112-tab pack = £12.85. Label: 2 ~ff.~5"~mg/5 mL, net price 300 mL = £1.98. Label: 2 CHILD not recommended prochlorperazine mesilate 12.5-25 mg 2-3 times Sulpor® (Rosemont) IPoMI Clopi~ol Acuphase® (Lundbeck) daily; CHILD not recommended Oral solution, sugar-free, lemon- and aniseed-fla. LUOPERAZINE Injection (oily), zuclopenthixol acetate 50 mg/mL. By rectum in suppositories, psychoses, mania, the voured, sulpiride 200 mg/5 mL, net price 150 mL (’~’n~ications: see under Dose; anti-emetic (section Net price I-mL amp = £5.20; 2-mL amp = £10.03 equivalent of prochlorperazine maleate 25 mg 2- = £27.00. -
Research Journal of Pharmaceutical, Biological and Chemical Sciences
ISSN: 0975-8585 Research Journal of Pharmaceutical, Biological and Chemical Sciences Formulation and Evaluation of Floating Drotaverine Hydrochloride Tablets Using Factorial Design Om Prakash*, S Saraf, M Rahman, Neeraj Agnihotri, and Vinay Pathak Department of Industrial chemistry, Integral University, Lucknow. Uttar Pradesh, India. ABSTRACT The main aim of this study was to optimize and evaluate the floating tablets of Drotaverine HCl that prolong the gastric residence time, increasing drug bioavailability and control pain for longer duration by oral administration. A floating drug delivery system(FDDS) was developed using gas forming agent like sodium bicarbonate, citric acid polymers like hydroxypropyl methyl cellulose(HPMC), Sod CMC, Carbopol-934P, PVP K-30. In 32 factorial design amount of HPMC(X1) and gas generating agents(X2) were selected as independent variable and % drug release for 30min,1h, 2h,4h,6h, 8h,12h, 16h , 24h and floating lag time (FLT) were taken as dependent variable. The floating tablet formulations were evaluated for Bulk density (gm/cm3), Tapped density(gm/cm3), Hausner ratio(HR), Carr index, Angle of repose, flow property, assay, in-vitro drug release, hardness, friability,weight variation. The results of in vitro release studies showed that the optimized formulation (F9) could sustain drug release (98.74%) for 24h and remain buoyant for more than 24h. The combination of hydrophilic (HPMC) and hydrophobic (carbopol-934P) polymer provides a better option for 24h release action, bioavailability, stability of tablets at 400C/75%RH, of optimized formulation was carried for one month and no significant change was observed. Keywords: floating drug delivery system(FDDS), Drotaverine HCl, gas generating agents, floating lag time (FLT), hydrophilic (HPMC) and hydrophobic (carbopol-934P) polymer. -
12-6202 Document: 01018895054 Date Filed: 08/10/2012 Page: 1 FILED United States Court of Appeals UNITED STATES COURT of APPEALS Tenth Circuit
Appellate Case: 12-6202 Document: 01018895054 Date Filed: 08/10/2012 Page: 1 FILED United States Court of Appeals UNITED STATES COURT OF APPEALS Tenth Circuit FOR THE TENTH CIRCUIT August 10, 2012 Elisabeth A. Shumaker Clerk of Court MICHAEL EDWARD HOOPER, Plaintiff-Appellant, v. No. 12-6202 (D.C. No. 5:12-cv-00758-M) JUSTIN JONES, Director DOC; (W.D. Okla.) RANDALL G. WORKMAN, Warden; DOES, Unknown Executioners, Defendants-Appellees. ORDER AND JUDGMENT* Before MURPHY, O’BRIEN, and HOLMES, Circuit Judges. Michael Edward Hooper, an Oklahoma state prisoner scheduled for execution by lethal injection on August 14, 2012, appeals from the district court’s order * After examining the briefs and appellate record, this panel has determined unanimously that oral argument would not materially assist the determination of this appeal. See Fed. R. App. P. 34(a)(2); 10th Cir. R. 34.1(G). The case is therefore ordered submitted without oral argument. This order and judgment is not binding precedent, except under the doctrines of law of the case, res judicata, and collateral estoppel. It may be cited, however, for its persuasive value consistent with Fed. R. App. P. 32.1 and 10th Cir. R. 32.1. Appellate Case: 12-6202 Document: 01018895054 Date Filed: 08/10/2012 Page: 2 denying his motion for a preliminary injunction seeking to stay his execution. Exercising jurisdiction under 28 U.S.C. § 1292(a)(1), we AFFIRM.1 I Mr. Hooper was tried and convicted on three counts of first-degree murder and sentenced to death. See Hooper v. State, 947 P.2d 1090 (Okla. -
Comparing the Effects of Combined Oral Contraceptives Containing Progestins with Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis In
JMIR RESEARCH PROTOCOLS Amiri et al Review Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis in Patients With Polycystic Ovary Syndrome: Systematic Review and Meta-Analysis Mina Amiri1,2, PhD, Postdoc; Fahimeh Ramezani Tehrani2, MD; Fatemeh Nahidi3, PhD; Ali Kabir4, MD, MPH, PhD; Fereidoun Azizi5, MD 1Students Research Committee, School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 2Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 3School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 4Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic Of Iran 5Endocrine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran Corresponding Author: Fahimeh Ramezani Tehrani, MD Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti University of Medical Sciences 24 Parvaneh Yaman Street, Velenjak, PO Box 19395-4763 Tehran, 1985717413 Islamic Republic Of Iran Phone: 98 21 22432500 Email: [email protected] Abstract Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS. -
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). -
Quantitative Analysis of the Aminosteroidal Muscle Relaxant
J. Ecophysiol. Occup. Hlth. 3 & 4 (2013) 29-37 ® 2013 The Academy of Environmental Biology, India Quantitative Analysis of the Aminosteroidal Muscle Relaxant Vecuronium in Rat Liver and Kidneys using Ion-pairing and Liquid Chromatography-Tandem Mass Spectrometry Risha Jasmine Nathan*, P. Sharma, Lily Saroj Nathan1 Forensic Chemistry and Toxicology, Lok Nayak Jayaprakash Narayan National Institute of Criminology, New Delhi 1Ewing Christian College, University of Allahabad Abstract : Muscle relaxants are occasionally encountered in forensic toxicological cases for identification and quantitation. Due to unavailability of human samples, the analysis of the muscle relaxant vecuronium was done using post-mortem rat visceral samples. Rats were injected with bolus overdose of the drug and the post mortem samples were subject to ion-pair extraction with metanil yellow dye. Method for identification of the drug by LC-MS-MS was established first with secondary standard aqueous vecuronium solutions and then applied on the questioned samples. Quantitation was done to find the quantity of the drug in liver and kidney samples. Keywords : Aminosteroid, Muscle relaxant Vecuronium, Liquid Chromatography-Tandem Mass Spectrometry. Introduction ventilation is made available to the patient so as Muscle relaxants, better known as neuro- to maintain respiration as these drugs may also muscular-blocking drugs, are a class of drugs paralyze the diaphragm at the therapeutic dose that block neuromuscular transmission at required (Dripps, 1959). Despite taking neuromuscular junction which causes paralysis precautions, neuromuscular blocking drugs of the affected skeletal muscles. Of the two have been reported to have inadvertently classes, non-depolarizing neuromuscular caused deaths of patients by accident agents work without depolarizing the motor end (Newsletters, Nurse Advise, 2006).