Appendix 10: Administering Drugs Via Feeding Tubes
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Routine Use of Feeding Jejunostomy in Pancreaticoduodenectomuy: A
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 95 JuneSeptember 2020 2020 doi:10.20944/preprints202006.0114.v1 doi:10.20944/preprints202006.0114.v2 Routine use of Feeding Jejunostomy in Pancreaticoduodenectomuy: A Metaanalysis. DR.Bhavin Vasavada Consultant HepatoPancreaticobiliary and Liver Transplant Surgeon, Shalby Hospitals, Ahmedabad. Email: [email protected] Dr.Hardik Patel Consultant HepatoPancreaticobiliary and Liver Transplant Surgeon, Shalby Hospitals, Ahmedabad. Conflict of Interests: none. Funding disclosure: none. Abbreviations: Post operative pancreatic fistula (POPF), total parentral nutrition (TPN), Surgical site infections. (SSI) Keywords: Pancreaticoduodenectomy; feeding jejunostomy; morbidity; mortality Abstract: Aims and objectives: The primary aim of our study was to evaluate morbidity and mortality following feeding jejunostomy in pancreaticoduodenectomy compared to the control group. We © 2020 by the author(s). Distributed under a Creative Commons CC BY license. Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 95 JuneSeptember 2020 2020 doi:10.20944/preprints202006.0114.v1 doi:10.20944/preprints202006.0114.v2 also evaluated individual complications like delayed gastric emptying, post operative pancreatic fistula, superficial and deep surgical site infection. We also looked for time to start oral nutrition and requirement of total parentral nutrition. Material and Methods: The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and MOOSE guidelines. [9,10]. We searched pubmed, cochrane library, embase, google scholar with keywords like “feeding jejunostomy in pancreaticodudenectomy”, “entral nutrition in pancreaticoduodenectomy, “total parentral nutrition in pancreaticoduodenectomy’, “morbidity and mortality following pancreaticoduodenectomy”. Two independent authors extracted the data (B.V and H.P). The meta-analysis was conducted using Open meta-analysis software. -
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 ........................................................................................................................ -
AP Suspension and Powder
AP Suspension and Powder • Easily application and distribution • Ultrafine surface • Excellent stability Struers AP Suspensions and Powders are based on ultra pure aluminium oxides (alumina). They are available in two forms, Struers ApS deagglomerated and agglomerated. Pederstrupvej 84 DK-2750 Ballerup, Denmark Phone +45 44 600 800 Fax +45 44 600 801 [email protected] www.struers.com AUSTRALIAN & NEW ZEALAND NETHERLANDS Struers Australia Struers GmbH Nederland 27 Mayneview Street Zomerdijk 34 A Milton QLD 4064 3143 CT Maassluis Australia Telefoon +31 (10) 599 7209 Phone +61 7 3512 9600 Fax +31 (10) 5997201 Fax +61 7 3369 8200 [email protected] [email protected] NORWAY BELGIUM (Wallonie) Struers ApS, Norge Deagglomerated Agglomerated Struers S.A.S. Sjøskogenveien 44C 370, rue du Marché Rollay 1407 Vinterbro F- 94507 Champigny Telefon +47 970 94 285 Deagglomerated sur Marne Cedex [email protected] Téléphone +33 1 5509 1430 AP-D, deagglomerated aluminas are premium polishing abrasive and are agglomerate-free. The uniform Télécopie +33 1 5509 1449 AUSTRIA [email protected] Struers GmbH crystals ensure an ultrafine surface. Zweigniederlassung BELGIUM (Flanders) Österreich Struers GmbH Nederland Betriebsgebiet Puch Nord 8 Agglomerated Zomerdijk 34 A 5412 Puch 3143 CT Maassluis Telefon +43 6245 70567 AP-A, agglomerated aluminas are easily broken down during the polishing process while still providing Telefoon +31 (10) 599 7209 Fax +43 6245 70567-78 Fax +31 (10) 5997201 [email protected] faster initial stock removal. [email protected] POLAND CANADA Struers Sp. z o.o. Alumina powders Struers Ltd. Oddział w Polsce 7275 West Credit Avenue ul. Jasnogórska 44 Alumina powders consist of uniform particles with a narrow particle size distribution. -
Laparoscopic Truncal Vagotomy and Gatrojejunostomy for Pyloric Stenosis
ORIGINAL ARTICLE pISSN 2234-778X •eISSN 2234-5248 J Minim Invasive Surg 2015;18(2):48-52 Journal of Minimally Invasive Surgery Laparoscopic Truncal Vagotomy and Gatrojejunostomy for Pyloric Stenosis Jung-Wook Suh, M.D.1, Ye Seob Jee, M.D., Ph.D.1,2 Department of Surgery, 1Dankook University Hospital, 2Dankook University School of Medicine, Cheonan, Korea Purpose: Peptic ulcer disease (PUD) remains one of the most prevalent gastrointestinal diseases and Received January 27, 2015 an important target for surgical treatment. Laparoscopy applies to most surgical procedures; however Revised 1st March 9, 2015 its use in elective peptic ulcer surgery, particularly in cases of pyloric stenosis, has not been popular. 2nd March 28, 2015 The aim of this study was to describe the role of laparoscopic surgery and an easily performed Accepted April 20, 2015 procedure for pyloric stenosis. We accordingly performed laparoscopic truncal vagotomy with gastrojejunostomy in 10 consecutive patients with pyloric stenosis. Corresponding author Ye Seob Jee Methods: Data were collected prospectively from all patients who underwent laparoscopic truncal Department of Surgery, Dankook vagotomy with gastrojejunostomy from August 2009 to May 2014 and reviewed retrospectively. University Hospital, Dankook Results: A total of 10 patients underwent laparoscopic trucal vagotomy with gastrojejunostomy for University School of Medicine, 119, peptic ulcer obstruction from August 2009 to May 2014 in ○○ university hospital. The mean age was Dandae-ro, Dongnam-gu, Cheonan 62.6 (±16.4) years old and mean BMI was 19.3 (±2.5) kg/m2. There were no conversions to open 330-714, Korea surgery and no occurrence of intra-operative complications. -
Eluxadoline: a Treatment for IBS with Diarrhoea in Adults
■ NEW PRODUCT Eluxadoline: a treatment for IBS with diarrhoea in adults STEVE CHAPLIN Eluxadoline (Truberzi) KEY POINTS is an oral mixed opioid- receptor agonist/ ■ Eluxadoline is an opioid-receptor agonist/antagonist with low systemic absorption antagonist licensed for ■ It is licensed for the treatment of irritable bowel syndrome with diarrhoea in the treatment of irritable adults and is recommended by NICE as a second-line agent bowel syndrome with ■ The recommended dosage is 75–100mg orally twice daily diarrhoea in adults. ■ In clinical trials, response rates were 27%–31% with eluxadoline and 19.5% with placebo after 26 weeks’ treatment This article examines its ■ Common adverse effects include constipation, nausea and abdominal pain properties, efficacy in ■ Pancreatitis and sphincter of Oddi spasm were uncommon adverse events clinical trials and side- ■ Treatment with eluxadoline costs £88.20 per month. effects. he initial management of irritable locally within the gastrointestinal tract, Tbowel syndrome (IBS) entails dietary slowing gastrointestinal transit, reducing and lifestyle change and treatment with urgency and improving stool consistency; antispasmodic agents.1 For people with its abuse potential is low. IBS and diarrhoea, loperamide is the anti- Eluxadoline is licensed for the treat- motility agent of first choice, adjusting the ment of IBS with diarrhoea in adults. The dose to achieve optimum stool consist- recommended dosage is 100mg twice ency. If this is unsatisfactory, treatment daily (reduced to 75mg twice daily if with a low-dose tricyclic antidepressant poorly tolerated). Treatment should be should be considered, with an SSRI a initiated at the lower dose in older people further option if this is unsuccessful. -
The National Drugs List
^ ^ ^ ^ ^[ ^ The National Drugs List Of Syrian Arab Republic Sexth Edition 2006 ! " # "$ % &'() " # * +$, -. / & 0 /+12 3 4" 5 "$ . "$ 67"5,) 0 " /! !2 4? @ % 88 9 3: " # "$ ;+<=2 – G# H H2 I) – 6( – 65 : A B C "5 : , D )* . J!* HK"3 H"$ T ) 4 B K<) +$ LMA N O 3 4P<B &Q / RS ) H< C4VH /430 / 1988 V W* < C A GQ ") 4V / 1000 / C4VH /820 / 2001 V XX K<# C ,V /500 / 1992 V "!X V /946 / 2004 V Z < C V /914 / 2003 V ) < ] +$, [2 / ,) @# @ S%Q2 J"= [ &<\ @ +$ LMA 1 O \ . S X '( ^ & M_ `AB @ &' 3 4" + @ V= 4 )\ " : N " # "$ 6 ) G" 3Q + a C G /<"B d3: C K7 e , fM 4 Q b"$ " < $\ c"7: 5) G . HHH3Q J # Hg ' V"h 6< G* H5 !" # $%" & $' ,* ( )* + 2 ا اوا ادو +% 5 j 2 i1 6 B J' 6<X " 6"[ i2 "$ "< * i3 10 6 i4 11 6! ^ i5 13 6<X "!# * i6 15 7 G!, 6 - k 24"$d dl ?K V *4V h 63[46 ' i8 19 Adl 20 "( 2 i9 20 G Q) 6 i10 20 a 6 m[, 6 i11 21 ?K V $n i12 21 "% * i13 23 b+ 6 i14 23 oe C * i15 24 !, 2 6\ i16 25 C V pq * i17 26 ( S 6) 1, ++ &"r i19 3 +% 27 G 6 ""% i19 28 ^ Ks 2 i20 31 % Ks 2 i21 32 s * i22 35 " " * i23 37 "$ * i24 38 6" i25 39 V t h Gu* v!* 2 i26 39 ( 2 i27 40 B w< Ks 2 i28 40 d C &"r i29 42 "' 6 i30 42 " * i31 42 ":< * i32 5 ./ 0" -33 4 : ANAESTHETICS $ 1 2 -1 :GENERAL ANAESTHETICS AND OXYGEN 4 $1 2 2- ATRACURIUM BESYLATE DROPERIDOL ETHER FENTANYL HALOTHANE ISOFLURANE KETAMINE HCL NITROUS OXIDE OXYGEN PROPOFOL REMIFENTANIL SEVOFLURANE SUFENTANIL THIOPENTAL :LOCAL ANAESTHETICS !67$1 2 -5 AMYLEINE HCL=AMYLOCAINE ARTICAINE BENZOCAINE BUPIVACAINE CINCHOCAINE LIDOCAINE MEPIVACAINE OXETHAZAINE PRAMOXINE PRILOCAINE PREOPERATIVE MEDICATION & SEDATION FOR 9*: ;< " 2 -8 : : SHORT -TERM PROCEDURES ATROPINE DIAZEPAM INJ. -
An Approach to the Patient with a Dry Mouth
MedicineToday 2014; 15(4): 30-37 PEER REVIEWED FEATURE 2 CPD POINTS An approach to the patient with a dry mouth Key points • The subjective complaint of ELHAM AFLAKI MD; TAHEREH ERFANI MD; NICHOLAS MANOLIOS MB BS(Hons), PhD, MD, FRACP, FRCPA; xerostomia needs to be MARK SCHIFTER FFD, RCSI(Oral Med), FRACDS(Oral Med) differentiated from true salivary hypofunction. Dry mouth is a common and disabling problem. After exclusion of treatable • Salivary hypofunction can significantly reduce quality causes, treatment is symptomatic to prevent the consequences of salivary of life through its adverse hypofunction, such as tooth decay and infection of the oral mucosa. effects on taste, mastication, swallowing, cleansing of the erostomia, or the subjective feeling of neuropathic-induced orofacial dysaesthesia) mouth, killing of microbes a dry mouth, is a common complaint. and psychological and psychiatric disorders, and speech. It is often a consequence of salivary such as anxiety and depression. • Salivary hypofunction is a hypofunction (hyposalivation), in substantive risk factor for X which there is objective evidence of reduced NORMAL SALIVA PRODUCTION dental caries, oral mucosal salivary output or qualitative changes in saliva. Under normal physiological conditions, the disease and infection, Typically, patients complain of oral dryness salivary glands produce 1000 to 1500 mL of particularly oral candidiasis. only when salivary secretion is reduced by more saliva daily as an ultrafiltrate from the circu- • Patients should be than half.1 As saliva has a crucial role in taste lating plasma. Therefore, simple dehydration investigated for contributory perception, mastication, swallowing, cleansing reduces saliva production. The parotid glands and underlying causes, of the mouth, killing of microbes and speech, are the major source of serous saliva (60 to 65% which include drugs and abnormalities in saliva production can signif- of total saliva volume), producing the stimu- rheumatological diseases. -
FDA Warns About an Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (Eluxadoline) in Patients Without a Gallbladder
FDA warns about an increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder Safety Announcement [03-15-2017] The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns. Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. The gallbladder is an organ that stores bile, one of the body’s digestive juices that helps in the digestion of fat. Stop taking Viberzi right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas, an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut. Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. -
Management of Chronic Problems
MANAGEMENT OF CHRONIC PROBLEMS INTERACTIONS BETWEEN ALCOHOL AND DRUGS A. Leary,* T. MacDonald† SUMMARY concerned. Alcohol may alter the effects of the drug; drug In western society alcohol consumption is common as is may change the effects of alcohol; or both may occur. the use of therapeutic drugs. It is not surprising therefore The interaction between alcohol and drug may be that concomitant use of these should occur frequently. The pharmacokinetic, with altered absorption, metabolism or consequences of this combination vary with the dose of elimination of the drug, alcohol or both.2 Alcohol may drug, the amount of alcohol taken, the mode of affect drug pharmacokinetics by altering gastric emptying administration and the pharmacological effects of the drug or liver metabolism. Drugs may affect alcohol kinetics by concerned. Interactions may be pharmacokinetic or altering gastric emptying or inhibiting gastric alcohol pharmacodynamic, and while coincidental use of alcohol dehydrogenase (ADH).3 This may lead to altered tissue may affect the metabolism or action of a drug, a drug may concentrations of one or both agents, with resultant toxicity. equally affect the metabolism or action of alcohol. Alcohol- The results of concomitant use may also be principally drug interactions may differ with acute and chronic alcohol pharmacodynamic, with combined alcohol and drug effects ingestion, particularly where toxicity is due to a metabolite occurring at the receptor level without important changes rather than the parent drug. There is both inter- and intra- in plasma concentration of either. Some interactions have individual variation in the response to concomitant drug both kinetic and dynamic components and, where this is and alcohol use. -
PROVERA Medroxyprogesterone Acetate Tablets 2.5Mg, 5Mg, 10Mg, 100 Mg, 200 Mg Tablets
PROVERA Medroxyprogesterone acetate tablets 2.5mg, 5mg, 10mg, 100 mg, 200 mg tablets What is in this leaflet establish a regular menstrual breast cancer or breast lumps cycle not diagnosed by your doctor This leaflet answers some common bleeding or discharge from questions about PROVERA. It does certain types of cancer including your nipples not contain all the available cancer of the breast, kidney and information. It does not take the endometrium (the lining of the miscarriage place of talking to your doctor or womb). pharmacist. cancer of the womb or ovary PROVERA, in combination with an uncontrolled high blood estrogen containing medicine, is All medicines have risks and pressure. benefits. Your doctor has weighed used to relieve symptoms of the risks of you taking PROVERA menopause in women with an intact Do not take PROVERA if you are against the benefits it is expected to uterus. This is called hormone pregnant or intend to become have for you. replacement therapy (HRT). pregnant. PROVERA is used to protect the If you have any concerns about lining of the uterus while the PROVERA may affect your taking this medicine, ask your estrogens relieve the symptoms of developing baby if you take it doctor or pharmacist. Keep this menopause. PROVERA is not during pregnancy. leaflet with your medicine. suitable as a HRT treatment in women who have undergone a Do not take PROVERA if the You may need to read it again. hysterectomy. packaging is torn or shows signs of tampering. Do not take Your doctor may have prescribed PROVERA after the expiry date What PROVERA is PROVERA for another purpose. -
Liquid Spray Formulations for Buccal Delivery of Cannabinoids
(19) TZZ_¥__T (11) EP 1 361 864 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/08 (2006.01) A61K 9/107 (2006.01) 04.12.2013 Bulletin 2013/49 A61K 36/185 (2006.01) (21) Application number: 02712063.3 (86) International application number: PCT/GB2002/000620 (22) Date of filing: 14.02.2002 (87) International publication number: WO 2002/064109 (22.08.2002 Gazette 2002/34) (54) LIQUID SPRAY FORMULATIONS FOR BUCCAL DELIVERY OF CANNABINOIDS FLÜSSIGE SPRAY FORMULIERUNGEN ZUR BUCCALEN VERABREICHUNG VON CANNABINOIDEN PREPARATIONS DE SPRAY LIQUIDE POUR L’ADMINISTRATION BUCCALE DE CANNABINOIDES (84) Designated Contracting States: (74) Representative: Schiller, Dominic Christopher et AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU al MC NL PT SE TR Harrison Goddard Foote LLP Designated Extension States: 4th Floor, Merchant Exchange RO SI 17-19 Whitworth Street West Manchester M1 5WG (GB) (30) Priority: 14.02.2001 GB 0103638 30.03.2001 US 280044 P (56) References cited: 05.04.2001 US 827158 WO-A-00/25127 WO-A-01/66089 11.05.2001 GB 0111597 WO-A-95/25504 WO-A1-02/32420 07.09.2001 GB 0121715 WO-A1-02/069993 US-A- 3 560 625 12.09.2001 US 951022 • EITAN ALHANATY; ET AL.: "Osmotic fragility of (43) Date of publication of application: liposomes as affected by antihemolytic 19.11.2003 Bulletin 2003/47 compounds" BIOCHIMICA ET BIOPHYSICA ACTA, vol. 339, no. 1, 1974, pages 146-155, (60) Divisional application: XP008008726 10180611.5 / 2 286 793 • PATRICIA S. -
Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
CONFIDENTIAL 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods Copyright 2012 ViiV Healthcare and the GlaxoSmithKline group of companies. All rights reserved. Unauthorized copying or use of this information is prohibited. 1 CONFIDENTIAL 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods TABLE OF CONTENTS PAGE ABBREVIATIONS ...........................................................................................................3 1. BACKGROUND AND OVERVIEW ...........................................................................4 1.1. Conclusions ..................................................................................................4 1.2. Formulation Development.............................................................................5 1.3. In Vitro Dissolution Data .............................................................................10 1.3.1. Comparative of 2 x 25 mg Clinical Tablets and 1 x 50 mg Clinical Tablets, Phase III Formulation.........................................10 1.3.2. Comparison of Phase III Clinical Image and Commercial Image Tablets..............................................................................13 1.4. Analytical Methods......................................................................................17 1.4.1. Validation.....................................................................................17 1.4.2. Summary of Within Study Quality