Desirudin product information pdf

Desirudin is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Iprivask desirudin for injection is a specific inhibitor of human thrombin. The risk of bleeding increases as the severity of your kidney problems increases. Desirudin is contraindicated in patients with severe renal impairment creatinine. Desirudin subcutaneous route precautions mayo clinic. Qualitative and quantitative composition each vial contains 15 mg desirudin. Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms. Study finds desirudin superior to enoxaparin in patients. Desirudin dosing and monitoring in moderate renal impairment.

Anticoagulants argatroban, dabigatran, bivalirudin, desirudin. Desirudin dosing and monitoring in moderate renal impairment article in the journal of clinical pharmacology 506. Interactions for information on use of iprivask in conjunction with other drugs affecting coagulation. Refer to full prescribing information for important instructions on use of the adasuve inhaler 2. Iprivask fda prescribing information, side effects and uses. Desirudin drug information indications, dosage, side. Desirudin is for use after hip replacement surgery. This risk is higher if you have a catheter in your back for pain medicine or anesthesia sometimes called an epidural, or if you have kidney problems. Desirudin is a synthetic recombinant form of the naturally occurring hirudin, the anticoagulant substance found in leech. Prevention of deepvein thrombosis after total hip replacement. Desirudin is a parenterally administered, selective thrombin inhibitor that is used to decrease the risk of deep vein thrombosis and pulmonary embolus in patients undergoing hip replacement surgery.

Bacillus calmetteguerin substrain tice live antigen the therapeutic efficacy of bacillus calmetteguerin substrain tice live antigen can be decreased when used in combination with everolimus. Desirudin is a selective and almost irreversible inhibitor of thrombin, both free and clotbound, by blocking its active site. Create, edit, convert, annotate, protect, merge, watermark, compress, and sign pdf files in a better way. Desirudin has not been linked to serum enzyme elevations during therapy or to clinically apparent liver injury with jaundice. Drug name active ingredients strength dosage formroute marketing status te code rld. Iprivask desirudin dose, indications, adverse effects. Inquire about dmf, cgmp, price, availability, samples, sourcing, purity and more.

Important information about some of the ingredients of revasc. Nov 09, 2018 desirudin is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Reconstitution should be carried out under sterile conditions. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to aspirin alone are discussed below. Desirudin side effects, dosage, interactions drugs. Iprivask desirudin dosing, indications, interactions. Therefore, mobic tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Hirudin is a single polypeptide chain of 65 amino acids residues and contains three disulfide. See full prescribing information for complete boxed warning. Jul 20, 2017 out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Hirudin derivative an overview sciencedirect topics. Desirudin cannot be used interchangeably with other hirudins e. Desirudin is used to prevent a type of blood clot called deep vein thrombosis dvt, which can. Drug name active ingredients strength dosage formroute marketing status te code rld rs.

May 22, 2019 product assembly iprivask instructions for use desirudin for injection patients are encouraged to refer to complete patient instruction sheet for additional information on iprivask assembly and administration. Desirudin may increase your chance of bleeding or bruising. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. Although not all of these side effects may occur, if they do occur they may need medical attention.

After careful consideration, bayer healthcare would like to inform you that we will discontinue marketing refludan lepirudin rdna for injection on may 31, 2012 and no further product is. It has a protein structure that is similar to that of hirudin, the naturally occurring anticoagulant present in the peripharyngeal glands in the medicinal leech, hirudo medicinalis. Study finds desirudin superior to enoxaparin in patients with poor kidney function undergoing orthopedic surgery new study findings presented at arteriosclerosis, thrombosis and vascular biology. Learn how to pronounce the drugs name, its indications, dosage, how to take, when to take. Iprivask 15 mg desirudin for injection, for subcutaneous injection. Desirudin is a hirudin used for thromboprophylaxis in patients undergoing. Desirudin fda orange book approved drug product list. Iprivask desirudin for injection is a direct inhibitor of human thrombin. Intravenous administration of desirudin was studied in over 10,000 patients in phase 1 to 3 clinical trials using a formulation similar to the available commercial product approved for subcutaneous administration.

Desirudin definition of desirudin by medical dictionary. Pradaxa dabigatran etexilate minimum product information. Desirudin revase generic is a parenteral anticoagulant, prescribed for prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism. Total urinary excretion of unchanged desirudin amounts to 40% to 50% of the administered dose. Mar 21, 2007 desirudin is metabolized by the liver and excreted by the kidney. A doubleblind trial has compared subcutaneous heparin and desirudin in 1119patients having hip surgery. There is limited information regarding desirudin pharmacology in the drug label. Adobe provides everything you need to design and deliver exceptional digital experiences. Highlights of prescribing information heart failure and edema. Nov 06, 2019 everolimus related product information. Desirudin is used to prevent a type of blood clot called deep vein thrombosis dvt, which can lead to blood clots in the lungs pulmonary embolism.

Intramuscular injections of concomitant medications should be confined to the upper extremities which permit easy access for manual. Iprivask desirudin for injection prescribing information. Multicenter trial of desirudin for the prophylaxis of. Opdp form fda 2253 and request for advisory comment. For storage information, see specific product information within the how supplied section. Sep 17, 2012 desirudin is significantly more effective as prophylaxis for dvt after total hip replacement than either unfractionated heparin or enoxaparin. Our iprivask desirudin for injection side effects drug center provides a comprehensive. Approved drug products containing desirudin listed in the fda orange book. Antithrombin alfa the risk or severity of bleeding can be increased when antithrombin alfa is combined with. Desirudin subcutaneous route side effects mayo clinic. Action selectively inhibits free and clotbound thrombin. Ketorolac tromethamine tablets ketorolac tromethamine dose.

Ibm micromedex along with its needed effects, a medicine may cause some unwanted effects. Toxnet has moved as part of a broader nlm reorganization, most of nlms toxicology information services have been integrated into other nlm products and services. Desirudin is used to prevent a type of blood clot called deep vein thrombosis, which can lead to blood clots in the lungs pulmonary embolism. An increased incidence of myocardial infarction and stroke was found through analysis of data regarding the use of a cox2 selective nsaid for the treatment of pain in the first 10 to 14 days after cabg surgery. Not all possible interactions are listed in this medication guide. Highlights of prescribing information heart failure and. Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more.

Drug names that are ambiguous or not compatible with the rxnorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Final gross price and currency may vary according to local vat and billing address. Discontinuation of refludan lepirudin rdna for injection dear health care professional. Side effects of iprivask desirudin for injection, warnings, uses. Desirudin could be used for the treatment of hit as an offlabel substitute for discontinued lepirudin. Options for anticoagulation have been expanding steadily over the past few decades, providing a greater number of agents for prevention and management of thromboembolic disease. If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral. Lgm pharma offers this active ingredient but not the finished dosage forms.

The mean terminal elimination halflife is approximately two to three hours. The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human plasma. Request pdf desirudin dosing and monitoring in moderate renal impairment desirudin is a renally eliminated direct thrombin inhibitor approved to prevent. Ketorolac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery cabg. Desirudin is a selective inhibitor of free circulating and clotbound thrombin. Desirudin for injection is a specific inhibitor of human thrombin. C indications prevention of deepvein thrombosis dvt after hipreplacement surgery.

Desirudin can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia epidural, especially if you are also using other drugs that can affect blood clotting, including blood thinners or nsaids. Discontinuation of refludan lepirudin rdna for injection. Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with nonvalvular atrial fibrillation with. Desirudin, a subcutaneously sc administered direct thrombin inhibitor, is indicated for. Desirudin drug information, uses, side effects, chemistry. Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of ms. The medwatch form fda 3500a is used for the submission of adverse experience reports and reports of product problems required under the food, drug, and cosmetic act fdca or by fda regulations by. Desirudin by injection desirudin desiroodin treats or prevents blood clots after hip surgery. After reconstitution one vial contains 15 mg desirudin per 0.

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