Pulmonary Embolism in Non-Brain Tumor Patients After Surgery—A Retrospective Study in China
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WHO Drug Information Vol. 12, No. 3, 1998
WHO DRUG INFORMATION VOLUME 12 NUMBER 3 • 1998 RECOMMENDED INN LIST 40 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA Volume 12, Number 3, 1998 World Health Organization, Geneva WHO Drug Information Contents Seratrodast and hepatic dysfunction 146 Meloxicam safety similar to other NSAIDs 147 Proxibarbal withdrawn from the market 147 General Policy Issues Cholestin an unapproved drug 147 Vigabatrin and visual defects 147 Starting materials for pharmaceutical products: safety concerns 129 Glycerol contaminated with diethylene glycol 129 ATC/DDD Classification (final) 148 Pharmaceutical excipients: certificates of analysis and vendor qualification 130 ATC/DDD Classification Quality assurance and supply of starting (temporary) 150 materials 132 Implementation of vendor certification 134 Control and safe trade in starting materials Essential Drugs for pharmaceuticals: recommendations 134 WHO Model Formulary: Immunosuppressives, antineoplastics and drugs used in palliative care Reports on Individual Drugs Immunosuppresive drugs 153 Tamoxifen in the prevention and treatment Azathioprine 153 of breast cancer 136 Ciclosporin 154 Selective serotonin re-uptake inhibitors and Cytotoxic drugs 154 withdrawal reactions 136 Asparaginase 157 Triclabendazole and fascioliasis 138 Bleomycin 157 Calcium folinate 157 Chlormethine 158 Current Topics Cisplatin 158 Reverse transcriptase activity in vaccines 140 Cyclophosphamide 158 Consumer protection and herbal remedies 141 Cytarabine 159 Indiscriminate antibiotic -
Doacs) and the Antidote Idarucizumab
Update overview 2019 of reports on direct oral anticoagulants (DOACs) and the antidote idarucizumab Introduction Lareb previously published yearly overviews of reports (most recently in 2018) in consultation with the Medicines Evaluation Board CBG-MEB, concerning the direct oral anticoagulants (DOACs) dabigatran Pradaxa®, registered in the Netherlands in 2008 [1], rivaroxaban Xarelto®, registered in 2008 [2], apixaban Eliquis®, registered in 2011 [3] and edoxaban (Lixiana®), registered in 2015 [4-9]. The current overview provides a new yearly update of the reports received by Lareb for these DOACs. Furthermore, reports received by Lareb for the antidote idarucizumab are described in this overview. Idarucizumab is a specific antidote for dabigatran and was registered in the Netherlands in 2015 [10]. For this overview, data from the national ADR database were used. These data include reports with serious outcome from the Lareb Intensive Monitoring System (LIM). The DOACs have been monitored with the LIM methodology since September 2012. Prescription data The number of patients using DOACs in the Netherlands according to the GIP database is shown in table 1 [11]. These data are based on extramurally provided medication included in the Dutch health insurance package. Because the antidote idarucizumab is administered in the hospital and not reimbursed directly via the healthcare insurance, these data are not available for this drug. The number of reports received by the Netherlands Pharmacovigilance Centre Lareb per year since 2013 for each DOAC, is also shown in table 1. Furthermore, table 1 shows the calculated number of these reports per 1.000 users according to the GIP database. As noted before, the data from the GIP database represent reimbursed medicines and these may differ from actually prescribed medicines. -
Low Molecular Weight Heparins and Heparinoids
NEW DRUGS, OLD DRUGS NEW DRUGS, OLD DRUGS Low molecular weight heparins and heparinoids John W Eikelboom and Graeme J Hankey UNFRACTIONATED HEPARIN has been used in clinical ABSTRACT practice for more than 50 years and is established as an effective parenteral anticoagulant for the prevention and ■ Several low molecular weight (LMW) heparin treatment of various thrombotic disorders. However, low preparations, including dalteparin, enoxaparin and molecularThe Medical weight Journal (LMW) of heparinsAustralia haveISSN: recently 0025-729X emerged 7 October as nadroparin, as well as the heparinoid danaparoid sodium, more2002 convenient, 177 6 379-383 safe and effective alternatives to unfrac- are approved for use in Australia. 1 tionated©The heparin Medical (BoxJournal 1). of AustraliaIn Australia, 2002 wwwLMW.mja.com.au heparins are ■ LMW heparins are replacing unfractionated heparin for replacingNew Drugs,unfractionated Old Drugs heparin for preventing and treating the prevention and treatment of venous thromboembolism venous thromboembolism and for the initial treatment of and the treatment of non-ST-segment-elevation acute unstable acute coronary syndromes. The LMW heparinoid coronary syndromes. danaparoid sodium is widely used to treat immune heparin- ■ induced thrombocytopenia. The advantages of LMW heparins over unfractionated heparin include a longer half-life (allowing once-daily or twice-daily subcutaneous dosing), high bioavailability and Limitations of unfractionated heparin predictable anticoagulant response (avoiding the need -
Edoxaban Switch Programme - Frequently Asked Questions
Edoxaban Switch Programme - Frequently Asked Questions What should I tell patients? NHS Tayside is reviewing all patients currently receiving a Direct Oral Anticoagulant (DOAC) for stroke prevention in NV-AF(non-valvular atrial fibrillation) Edoxaban has been identified as the first choice DOAC. It is similarly effective to the other DOAC options but costs considerably less Clinical experts in Tayside are supporting the use of edoxaban All newly diagnosed NV-AF patients will be started on edoxaban as 1st choice for those unsuitable for warfarin Existing patients already on a DOAC for NV-AF are to be reviewed and considered for switch to edoxaban This will help to ensure that the money available to spend on medicines is being used appropriately Is edoxaban as good as the other DOACs? Yes, the evidence is that it is as effective as warfarin and the other DOACs. It is licensed for this indication and has been recommended by the Scottish Medicines Consortium Other Scottish Health Boards are also considering the use of edoxaban A recent Health Improvement Scotland (HIS) summary (http://www.healthcareimprovementscotland.org/our_work/cardiovascular_dis ease/programme_resources/doac_review_report.aspx) is consistent with this Tayside switch recommendation Lead clinicians from cardiology, stroke, vascular medicine, relevant MCN’s and haematology are all supportive of this Tayside guidance on the basis of current evidence Will we need to do a further switch if the price of other DOACs falls? The rebate on edoxaban is in place for five -
Anatomisch-Therapeutisch-Chemische Klassifikation Mit Tagesdosen Für Den Deutschen Arzneimittelmarkt Gemäß § 73 Abs
Wissenschaftliches Institut der AOK GKV-Arzneimittelindex Anatomisch-therapeutisch-chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß § 73 Abs. 8 Satz 5 SGB V. 14. Sitzung der Arbeitsgruppe ATC/DDD des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen am 27. November 2015, BMG in Berlin © WIdO 2015 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 2 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 3 GKV-Arzneimittelindex Das Anatomisch-therapeutisch-chemische Klassifikationssystem A Alimentäres System und Stoffwechsel B Blut und blutbildende Organe C Kardiovaskuläres System D Dermatika G Urogenitalsystem und Sexualhormone H Systemische Hormonpräparate, exkl. Sexualhormone u. Insuline J Antiinfektiva zur systemischen Anwendung L Antineoplastische und immunmodulierende Mittel M Muskel- und Skelettsystem N Nervensystem P Antiparasitäre Mittel, Insektizide und Repellenzien R Respirationstrakt S Sinnesorgane V Varia © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 4 GKV-Arzneimittelindex Das Anatomisch-therapeutisch-chemische -
For the Use Only of Registered Medical Practitioner Or a Hospital Or a Laboratory
For the use only of Registered Medical Practitioner or a Hospital or a Laboratory FRAXIPARINE® Nadroparin Calcium Injection QUALITATIVE AND QUANTITATIVE COMPOSITION FRAXIPARINE® [Nadroparin calcium solution for injection (9,500 IU AXa /ml)] Pre-filled syringes: - Each pre-filled (0.2 ml) syringe contains: Nadroparin Calcium BP 1,900 IU AXa. - Each pre-filled (0.3 ml) syringe contains: Nadroparin Calcium BP 2,850 IU AXa. - Each pre-filled (0.4 ml) syringe contains: Nadroparin Calcium BP 3,800 IU AXa. Graduated pre-filled syringes: - Each pre-filled (0.6 ml) syringe contains: Nadroparin Calcium BP to 5,700 IU AXa. - Each pre-filled (0.8 ml) syringe contains: Nadroparin Calcium BP to 7,600 IU AXa. - Each pre-filled (1 ml) syringe contains: Nadroparin Calcium BP to 9,500 IU AXa. PHARMACEUTICAL FORM Solution for injection. CLINICAL PARTICULARS Therapeutic Indications The prophylaxis of thromboembolic disorders, such as: - those associated with general or orthopedic surgery - those in high risk medical patients (respiratory failure and/or respiratory infection and/or cardiac failure), hospitalised in intensive care unit. The treatment of thromboembolic disorders. The prevention of clotting during haemodialysis. The treatment of unstable angina and non-Q wave myocardial infarction. Posology and Method of Administration Particular attention should be paid to the specific dosing instructions for each proprietary Low Molecular Weight Heparin, as different units of measurement (units or mg) are used to 1 express doses. Nadroparin should therefore not be used interchangeably with other low molecular weight heparins during ongoing treatment. In addition, care should be taken to use the correct formulation of nadroparin, either single or double strength, as this will affect the dosing regimen. -
Lixiana, INN-Edoxaban
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets Lixiana 30 mg film-coated tablets Lixiana 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lixiana 15 mg film-coated tablets Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). Lixiana 30 mg film-coated tablets Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate). Lixiana 60 mg film-coated tablets Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Lixiana 15 mg film-coated tablets Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. Lixiana 30 mg film-coated tablets Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”. Lixiana 60 mg film-coated tablets Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lixiana is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Lixiana is indicated in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). 2 4.2 Posology and method of administration Posology Prevention of stroke and systemic embolism The recommended dose is 60 mg edoxaban once daily. -
Laboratory Monitoring of Direct Oral Anticoagulants (Doacs)
biomedicines Review Laboratory Monitoring of Direct Oral Anticoagulants (DOACs) Claire Dunois HYPHEN BioMed, Sysmex Group, 95000 Neuville sur Oise, France; [email protected] Abstract: The introduction of direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, edoxaban, and betrixaban, provides safe and effective alternative to previous anticoagulant therapies. DOACs directly, selectively, and reversibly inhibit factors IIa or Xa. The coagulation effect follows the plasma concentration–time profile of the respective anticoagulant. The short half-life of a DOAC constrains the daily oral intake. Because DOACs have predictable pharmacokinetic and pharmacodynamic responses at a fixed dose, they do not require monitoring. However in specific clinical situations and for particular patient populations, testing may be helpful for patient management. The effect of DOACs on the screening coagulation assays such as prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) is directly linked to reagent composition, and clotting time can be different from reagent to reagent, depending on the DOAC’s reagent sensitivity. Liquid chromatography–mass spectrometry (LC-MS/MS) is considered the gold standard method for DOAC measurement, but it is time consuming and requires expensive equipment. The general consensus for the assessment of a DOAC is clotting or chromogenic assays using specific standard calibrators and controls. This review provides a short summary of DOAC properties and an update on laboratory methods for measuring DOACs. Keywords: DOAC; monitoring; screening assays; quantitative assays Citation: Dunois, C. Laboratory Monitoring of Direct Oral Anticoagulants (DOACs). 1. Introduction Biomedicines 2021, 9, 445. https:// Direct oral anticoagulants (DOACs) constitute first-line therapy used for many throm- doi.org/10.3390/biomedicines9050445 boembolic indications, such as prevention and treatment of venous thromboembolism (VTE) and stroke prevention in atrial fibrillation (AF) [1,2]. -
Perioperative Management of Patients Treated with Antithrombotics in Oral Surgery
SFCO/Perioperative management of patients treated with antithrombotic agents in oral surgery/Rationale/July 2015 SOCIÉTÉ FRANÇAISE DE CHIRURGIE ORALE [FRENCH SOCIETY OF ORAL SURGERY] IN COLLABORATION WITH THE SOCIÉTÉ FRANÇAISE DE CARDIOLOGIE [FRENCH SOCIETY OF CARDIOLOGY] AND THE PERIOPERATIVE HEMOSTASIS INTEREST GROUP Space Perioperative management of patients treated with antithrombotics in oral surgery. RATIONALE July 2015 P a g e 1 | 107 SFCO/Perioperative management of patients treated with antithrombotic agents in oral surgery/Rationale/July 2015 Abbreviations ACS Acute coronary syndrome(s) ADP Adenosine diphosphate Afib Atrial Fibrillation AHT Arterial hypertension Anaes Agence nationale d’accréditation et d’évaluation en santé [National Agency for Accreditation and Health Care Evaluation] APA Antiplatelet agent(s) aPTT Activated partial thromboplastin time ASA Aspirin BDMP Blood derived medicinal products BMI Body mass index BT Bleeding Time cAMP Cyclic adenosine monophosphate COX-1 Cyclooxygenase 1 CVA Cerebral vascular accident DIC Disseminated intravascular coagulation DOA Direct oral anticoagulant(s) DVT Deep vein thrombosis GEHT Study Group on Hemostasis and Thrombosis (groupe d’étude sur l’hémostase et la thrombose) GIHP Hemostasis and Thrombosis Interest Group (groupe d’intérêt sur l’hémostase et la thrombose) HAS Haute autorité de santé [French Authority for Health] HIT Heparin-induced thrombocytopenia IANB Inferior alveolar nerve block INR International normalized ratio IV Intravenous LMWH Low-molecular-weight heparin(s) -
Anticoagulant Pradaxa (Dabigatran Etexilate Mesylate) Savaysa (Edoxaban) Xarelto 2.5Mg (Rivaroxaban) Effective 01/01/2021
Anticoagulant Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban) Xarelto 2.5mg (rivaroxaban) Effective 01/01/2021 ☒ MassHealth Plan ☒ ☐Commercial/Exchange Prior Authorization Program Type ☒ Quantity Limit ☒ Pharmacy Benefit Benefit ☐ Step Therapy ☐ Medical Benefit (NLX) Specialty N/A Limitations Specialty Medications All Plans Phone: 866-814-5506 Fax: 866-249-6155 Non-Specialty Medications Contact MassHealth Phone: 877-433-7643 Fax: 866-255-7569 Information Commercial Phone: 800-294-5979 Fax: 888-836-0730 Exchange Phone: 855-582-2022 Fax: 855-245-2134 Medical Specialty Medications (NLX) All Plans Phone: 844-345-2803 Fax: 844-851-0882 Exceptions N/A Overview Xarelto and Savaysa are factor Xa inhibitors which inhibit platelet activation and fibrin clot formation. Pradaxa is a thrombin inhibitor which blocks free and fibrin bound thrombin. These medications are indicated for: . Treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) – Pradaxa and Savaysa . Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. – Pradaxa, Xarelto, and Savaysa . Prophylaxis of DVT and/or PE in patients who have undergone total hip arthroplasty. - Xarelto and Pradaxa . Prophylaxis of venous thromboembolism (VTE) – Xarelto . Reduction in the risk of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) – Xarelto . Reduction of risk of major cardiovascular (CV) events (CV death, myocardial infarction, and stroke) in patients with coronary artery disease (chronic) or peripheral artery disease. - Xarelto No PA PA required Pradaxa® (dabigatran etexilate mesylate 110 mg) ≤ 70 Pradaxa® (dabigatran etexilate mesylate 75 mg, 150 capsules/365 days mg) Pradaxa® (dabigatran etexilate mesylate 110 mg) > 70 Eliquis® (apixaban) PD capsules/365 days ® ® Xarelto (rivaroxaban 10 mg, 15 mg, 20 mg, starter pack) Savaysa (edoxaban) ® Xarelto (rivaroxaban 2.5 mg tablet) PD Preferred Drug. -
BIOPHEN™ Heparin LRT Assay Can Be Calibrated for the Assay of Various Anti-Xa Anti-Xa Drugs Are Absent from Normal Plasma
BIOPHEN™ Heparin LRT REF 221011 R1 R2 4 x 7.5 mL REF 221013 R1 R2 3 x 3 mL Sales and Support: CoaChrom Diagnostica GmbH REF 221015 R1 R2 4 x 5 mL www.coachrom.com | [email protected] Tel: +43-1-236 222 1 | Fax: +43-1-236 222 111 Toll-free contact for Germany: Tel: 0800-24 66 33-0 | Fax: 0800-24 66 33-3 Anti-Xa chromogenic method for the assay of Heparin and their analogs, and direct FXa inhibitors, with ready to use liquid reagents English, last revision: 04-2019 INTENDED USE: For manual method, allow to stabilize for 30 minutes at room temperature (18-25°C), The BIOPHEN™ Heparin LRT kit is an anti-Xa chromogenic method for the in vitro homogenize before use. quantitative determination of heparin and theirs analogs, in human citrated plasma, using a manual or automated method. This method is appropriate for the Apixaban, STORAGE AND STABILITY: Rivaroxaban and Edoxaban assay, direct Factor Xa (FXa) inhibitors. This method is Unopened reagents should be stored at 2-8°C in their original packaging. Under these also appropriate for the determination of anti-Xa activity assay of Arixtra® conditions, they can be used until the expiry date printed on the kit. (Fondaparinux) and Orgaran® (Sodium Danaparoïd), indirect inhibitors whose activity is mediated by plasma antithrombin (AT). Reagents are in the liquid presentation, ready R1 R2 Reagent stability after opening, free from any contamination or evaporation, to use (LRT, Liquid reagent Technology). and stored closed, is of: ▪ 6 months at 2-8°C. -
The Treatment and Prevention Ofacute Ischemic Stroke
EDITORIAL Alvaro Nagib Atallah* The treatment and prevention of acute ischemic stroke rotecting the brain from the consequences .of alternated with placebo (lower dose) and placebo injections vascular obstruction is obviously very important. every 12 hours, for 10 days. The evaluation at 6 months PHowever, how to manage this is a very complex showed that the treated group had a lower incidence rate task. Three recent studies have provided evidence that of poor outcomes, death or dependency in daily activities, I 3 should not be ignored or misinterpreted by physicians. - 45 vs. 65%. In other words, it was necessary to treat 5 The National Institute of Neurological Disorders and patients to benefit one. Evaluations at 10 days did not show Stroke rt-PA Stroke Study Groupl shows the results of a differences in death rates or haemorrhage transformation randomized, collaborative placebo-controlled trial. Six of the cerebral infarction. hundred and twenty-four patients were studied. The The Multicentre Acute Stroke Trial-Italy (MAST-I) treatment was started before 90' of the start of the stroke Group compared the effectiveness of streptokinase, aspirin or before 180'. Patients received recombinant rt-PA and a combination of both for the treatment of ischemic (alteplase) 0.9 mg/kg or placebo. A careful neurological stroke. Six hundred and twenty-two patients were evaluation was done at 24 hours and 3 months after the randomized to receive I hour infusions of 1.5 mD of stroke. streptokinase alone, the same dose of streptokinase plus There were no significant differences between the 300 mg of buffered aspirin, or 300 mg of aspirin alone for groups at 24 hours after the stroke.