Use of Ceftaroline in Hospitalized Patients with and Without COVID-19: a Descriptive Cross-Sectional Study
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Ceftazidime for Injection) PHARMACY BULK PACKAGE – NOT for DIRECT INFUSION
PRESCRIBING INFORMATION FORTAZ® (ceftazidime for injection) PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4 thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1 azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6. FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. The Pharmacy Bulk Package vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3mEq) per gram of ceftazidime. FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 6g of anhydrous ceftazidime. The Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE. -
Dabigatran Amoxicillin Clavulanate IV Treatment in the Community
BEST PRACTICE 38 SEPTEMBER 2011 Dabigatran Amoxicillin clavulanate bpac nz IV treatment in the community better medicin e Editor-in-chief We would like to acknowledge the following people for Professor Murray Tilyard their guidance and expertise in developing this edition: Professor Carl Burgess, Wellington Editor Dr Gerry Devlin, Hamilton Rebecca Harris Dr John Fink, Christchurch Dr Lisa Houghton, Dunedin Programme Development Dr Rosemary Ikram, Christchurch Mark Caswell Dr Sisira Jayathissa, Wellington Rachael Clarke Kate Laidlow, Rotorua Peter Ellison Dr Hywel Lloyd, GP Reviewer, Dunedin Julie Knight Associate Professor Stewart Mann, Wellington Noni Richards Dr Richard Medlicott, Wellington Dr AnneMarie Tangney Dr Alan Panting, Nelson Dr Sharyn Willis Dr Helen Patterson, Dunedin Dave Woods David Rankin, Wellington Report Development Dr Ralph Stewart, Auckland Justine Broadley Dr Neil Whittaker, GP Reviewer, Nelson Tim Powell Dr Howard Wilson, Akaroa Design Michael Crawford Best Practice Journal (BPJ) ISSN 1177-5645 Web BPJ, Issue 38, September 2011 Gordon Smith BPJ is published and owned by bpacnz Ltd Management and Administration Level 8, 10 George Street, Dunedin, New Zealand. Jaala Baldwin Bpacnz Ltd is an independent organisation that promotes health Kaye Baldwin care interventions which meet patients’ needs and are evidence Tony Fraser based, cost effective and suitable for the New Zealand context. Kyla Letman We develop and distribute evidence based resources which describe, facilitate and help overcome the barriers to best Clinical Advisory Group practice. Clive Cannons nz Michele Cray Bpac Ltd is currently funded through contracts with PHARMAC and DHBNZ. Margaret Gibbs nz Dr Rosemary Ikram Bpac Ltd has five shareholders: Procare Health, South Link Health, General Practice NZ, the University of Otago and Pegasus Dr Cam Kyle Health. -
Flucloxacillin Capsules in This Leaflet: 1 What Flucloxacillin Capsules Are
Flucloxacillin capsules This information is a summary only. It does not contain all information about this medicine. If you would like more information about the medicine you are taking, check with your doctor or other health care provider. No rights can be derived from the information provided in this medicine leaflet. In this leaflet: If you take more than you should 1 What Flucloxacillin capsules are and what they are used for If you (or someone else) swallow a lot of capsules at the same time, or you think a 2 Before you take child may have swallowed any contact your nearest hospital casualty department 3 How to take or tell your doctor immediately. Symptoms of an overdose include feeling or 4 Possible side effects being sick and diarrhoea. 5 How to store If you forget to take the capsules 1 What Flucloxacillin capsules are and what they are used for Do not take a double dose to make up for a forgotten dose. If you forget to take a Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that dose take it as soon as you remember it and carry on as before, try to wait about can cause them. It belongs to a group of antibiotics called “penicillins”. four hours before taking the next dose. Flucloxacillin capsules are used to treat: • chest infections If you stop taking the capsules • throat or nose infections Do not stop treatment early because some bacteria may survive and cause the • ear infections infection to come back. • skin and soft tissue infections • heart infections 4 Possible side effects • bones and joints infections Like all medicines, Flucloxacillin capsules can cause side effects, although not • meningitis everybody gets them. -
Clinical Review (Cubicin)
Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) CLINICAL REVIEW Application Type NDA supplement Application Number(s) 21572 Priority or Standard Priority Submit Date(s) June 30, 2016 Received Date(s) June 30, 2016 PDUFA Goal Date March 30, 2017 (Major amendment) Division / Office DAIP/OAP Reviewer Name(s) Amol Purandare, MD Review Completion Date March 23, 2017 Established Name Daptomycin (Proposed) Trade Name Cubicin Therapeutic Class Cyclic Lipopeptide Applicant Cubist Pharmaceuticals Formulation(s) Injection Dosing Regimen 5 mg/kg (12-<18 years), 7 mg/kg (7-11 years), 9 mg/kg (2-6 years), and 10 mg/kg (1-< 2 years) Indication(s) Complicated Skin and Skin Structure Infections 1 Reference ID: 4075320 Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) Intended Population(s) Ages 1 year to <18 years Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT..........................................6 1.1 Recommendation on Regulatory Action ..............................................................6 1.2 Risk Benefit Assessment .....................................................................................6 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ....6 1.4 Recommendations for Postmarket Requirements and Commitments.................7 2 INTRODUCTION AND REGULATORY BACKGROUND .........................................7 2.1 Product Information .............................................................................................7 -
Severe Sepsis and Septic Shock Antibiotic Guide
Stanford Health Issue Date: 05/2017 Stanford Antimicrobial Safety and Sustainability Program Severe Sepsis and Septic Shock Antibiotic Guide Table 1: Antibiotic selection options for healthcare associated and/or immunocompromised patients • Healthcare associated: intravenous therapy, wound care, or intravenous chemotherapy within the prior 30 days, residence in a nursing home or other long-term care facility, hospitalization in an acute care hospital for two or more days within the prior 90 days, attendance at a hospital or hemodialysis clinic within the prior 30 days • Immunocompromised: Receiving chemotherapy, known systemic cancer not in remission, ANC <500, severe cell-mediated immune deficiency Table 2: Antibiotic selection options for community acquired, immunocompetent patients Table 3: Antibiotic selection options for patients with simple sepsis, community acquired, immunocompetent patients requiring hospitalization. Risk Factors for Select Organisms P. aeruginosa MRSA Invasive Candidiasis VRE (and other resistant GNR) Community acquired: • Known colonization with MDROs • Central venous catheter • Liver transplant • Prior IV antibiotics within 90 day • Recent MRSA infection • Broad-spectrum antibiotics • Known colonization • Known colonization with MDROs • Known MRSA colonization • + 1 of the following risk factors: • Prolonged broad antibacterial • Skin & Skin Structure and/or IV access site: ♦ Parenteral nutrition therapy Hospital acquired: ♦ Purulence ♦ Dialysis • Prolonged profound • Prior IV antibiotics within 90 days ♦ Abscess -
Clinical Management of Staphylococcus Aureus Bacteremia in Neonates, Children, and Adolescents
Clinical Management of Staphylococcus aureus Bacteremia in Neonates, Children, and Adolescents Brendan J. McMullan, BMed (Hons), FRACP, FRCPA,a,b,c,* Anita J. Campbell, MBBS, DCH, DipPID, FRACP,d,e,f,* Christopher C. Blyth, MBBS (Hons), PhD, DCH, FRACP, FRCPA,d,e,f,g J. Chase McNeil, BS, MD,h Christopher P. Montgomery, BA, MD,i,j Steven Y.C. Tong, MBBS (Hons), PhD, FRACP,k,l Asha C. Bowen, BA, MBBS, PhD, FRACPd,e,f,k,m Staphylococcus aureus is a common cause of community and health abstract – care associated bacteremia, with authors of recent studies estimating the aDepartment of Immunology and Infectious Diseases, incidence of S aureus bacteremia (SAB) in high-income countries between 8 Sydney Children’s Hospital, Randwick, New South Wales, , Australia; bSchool of Women’s and Children’s Health, and 26 per 100 000 children per year. Despite this, 300 children worldwide University of New South Wales, Sydney, New South Wales, have ever been randomly assigned into clinical trials to assess the efficacy Australia; cNational Centre for Infections in Cancer, of treatment of SAB. A panel of infectious diseases physicians with clinical University of Melbourne, Melbourne, Victoria, Australia; dDepartment of Infectious Diseases, Perth Children’s and research interests in pediatric SAB identified 7 key clinical questions. Hospital, Nedlands, Western Australia, Australia; The available literature is systematically appraised, summarizing SAB eWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, -
Antimicrobial Stewardship Guidance
Antimicrobial Stewardship Guidance Federal Bureau of Prisons Clinical Practice Guidelines March 2013 Clinical guidelines are made available to the public for informational purposes only. The Federal Bureau of Prisons (BOP) does not warrant these guidelines for any other purpose, and assumes no responsibility for any injury or damage resulting from the reliance thereof. Proper medical practice necessitates that all cases are evaluated on an individual basis and that treatment decisions are patient-specific. Consult the BOP Clinical Practice Guidelines Web page to determine the date of the most recent update to this document: http://www.bop.gov/news/medresources.jsp Federal Bureau of Prisons Antimicrobial Stewardship Guidance Clinical Practice Guidelines March 2013 Table of Contents 1. Purpose ............................................................................................................................................. 3 2. Introduction ...................................................................................................................................... 3 3. Antimicrobial Stewardship in the BOP............................................................................................ 4 4. General Guidance for Diagnosis and Identifying Infection ............................................................. 5 Diagnosis of Specific Infections ........................................................................................................ 6 Upper Respiratory Infections (not otherwise specified) .............................................................................. -
Australian Public Assessment Refport for Ceftaroline Fosamil (Zinforo)
Australian Public Assessment Report for ceftaroline fosamil Proprietary Product Name: Zinforo Sponsor: AstraZeneca Pty Ltd May 2013 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>. About AusPARs • An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. • An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. -
Synermox 500 Mg/125 Mg Tablets
New Zealand Data Sheet 1. PRODUCT NAME Synermox 500 mg/125 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Synermox 500 mg/125 mg Tablets: Each film‐coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin, with potassium clavulanate equivalent to 125 mg clavulanic acid. Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Synermox 500 mg/125 mg Tablets: White to off‐white, oval shaped film‐coated tablets, debossed with “RX713” on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Synermox is indicated in adults and children (see sections 4.2, 4.4 and 5.1) for short term treatment of common bacterial infections such as: Upper Respiratory Tract Infections (including ENT) e.g. Tonsillitis, sinusitis, otitis media. Lower Respiratory Tract Infection e.g. acute exacerbations of chronic bronchitis, lobar and broncho‐pneumonia. Genito‐urinary Tract Infections e.g. Cystitis, urethritis, pyelonephritis, female genital infections. Skin and Soft Tissue Infections. Bone and Joint Infections e.g. Osteomyelitis. Other Infections e.g. septic abortion, puerperal sepsis, intra‐abdominal sepsis, septicaemia, peritonitis, post‐surgical infections. Synermox is indicated for prophylaxis against infection which may be associated with major surgical procedures such as those involving: Gastro‐intestinal tract Pelvic cavity 1 | Page Head and neck Cardiac Renal Joint replacement Biliary tract surgery Infections caused by amoxicillin susceptible organisms are amenable to Synermox treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organisms in conjunction with Synermox‐susceptible beta‐lactamase‐producing organisms may therefore be treated by Synermox. -
IV Vancomycin Dosing and Monitoring Antibiotic Guidelines Reference Number: 144TD(C)25(H3) Version Number: 6.1 Issue Date: 21/07/2020 Page 1 of 12
Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) IV Vancomycin dosing and monitoring Antibiotic Guidelines Lead Author: Antibiotic Steering Group Additional author(s) Elizabeth Trautt, Consultant Microbiologist; Sue Wei Chong, Antimicrobial Pharmacist Division/ Department:: NCA Diagnostics and Pharmacy Group Applies to: Salford Royal Care Organisation Approving Committee Medicines Management Group Date approved: 02/07/2020 Expiry date: July 2023 Contents Contents 1. Overview (What is this guideline about?) ....................................................................... 2 2. Scope (Where will this document be used?) .................................................................. 2 3. Background (Why is this document important?) ............................................................. 2 4. What is new in this version? ............................................................................................ 3 5. Guideline ......................................................................................................................... 3 5.1 Method of administration ................................................................................................. 3 5.2. Dose calculation .............................................................................................................. 3 5.3. Patients with Renal failure/Kidney disease (CrCl<30ml/min or dialysis) .......................... 4 5.4 Therapeutic drug level monitoring .................................................................................. -
Eml-2017-Antibacterials-Eng.Pdf
Consideration of antibacterial medicines as part of the revisions to 2017 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) Section 6.2 Antibacterials including Access, Watch and Reserve Lists of antibiotics This summary has been prepared by the Health Technologies and Pharmaceuticals (HTP) programme at the WHO Regional Office for Europe. It is intended to communicate changes to the 2017 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) to national counterparts involved in the evidence-based selection of medicines for inclusion in national essential medicines lists (NEMLs), lists of medicines for inclusion in reimbursement programs, and medicine formularies for use in primary, secondary and tertiary care. This document does not replace the full report of the WHO Expert Committee, 2017 and this summary should be read in conjunction with the full report (WHO Technical Report Series, No. 1006; http://apps.who.int/iris/bitstream/10665/259481/1/9789241210157-eng.pdf?ua=1). The revised lists of essential medicines (in English) are available as follows: 2017 WHO Model List of Essential Medicines for adults (EML) http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017_FINAL_amend edAug2017.pdf?ua=1 2017 Model List of Essential Medicines for children (EMLc) http://www.who.int/medicines/publications/essentialmedicines/6th_EMLc2017_FINAL_amend edAug2017.pdf?ua=1 Summary of changes to Section 6.2 Antibacterials: Section 6 of the EML covers anti-infective medicines. Disease-specific subsections within Section 6, such as those covering medicines for tuberculosis, HIV, hepatitis and malaria, have been regularly reviewed and updated, taking into consideration relevant WHO treatment guidelines. -
Flucloxacillin 500Mg Capsules BP (Flucloxacillin Sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER Flucloxacillin 250mg Capsules BP Flucloxacillin 500mg Capsules BP (flucloxacillin sodium) Read all of this leaflet carefully before you start taking Warnings and precautions this medicine because it contains important information Talk to your doctor or pharmacist before taking this medicine if for you. you: - Keep this leaflet. You may need to read it again. • are 50 years of age or older - If you have any further questions, ask your doctor, • have other serious illness (apart from the infection this pharmacist or nurse. medicine is treating). - This medicine has been prescribed for you only. Do not • suffer from kidney problems, as you may require a lower pass it on to others. It may harm them, even if their signs dose than normal (convulsions may occur very rarely in of illness are the same as yours. patients with kidney problems who take high doses). - If you get any side effects, talk to your doctor or • suffer from liver problems, as this medicine could cause pharmacist. This includes any possible side effects not them to worsen. listed in this leaflet. See section 4. • are taking this medicine for a long time as regular tests of liver and kidney function are advised What is in this leaflet • are taking or will be taking paracetamol 1. What Flucloxacillin Capsules are and what they are used • are on a sodium-restricted diet. for • are giving this medicine to a newborn child 2. What you need to know before you take Flucolxacillin Capsules The use of flucloxacillin, especially in high doses, may reduce 3.