Elaprase monograph
WebMonographie MDd’ELAPRASE Page 1 de 34. MONOGRAPHIE DE PRODUIT . INCLUANT LES RENSEIGNEMENTS SUR LE MÉDICAMENT POUR LE PATIENT . Pr ELAPRASEMD. idursulfase pour injec tion . Formule concentrée de 2 mg/mL à diluer en solution pour perfusion intraveineuse . Enzymothérapie de remplacement . WebELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has …
Elaprase monograph
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WebPediatric drug monographs for elaprase provide an overview of the product, therapeutic uses, key development issues, regulatory information on ScriptSave WellRx. WebJul 24, 2006 · Drug Review Package. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA
WebAug 10, 2024 · Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. The prophylactic ITR will consist of a 5-week cycle of: Rituximab (intravenously [IV], weekly for 4 weeks); Methotrexate (oral, 3 times per week for 5 weeks) and intravenous immunoglobulin … WebELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line. In conjunction with the market approval of ELAPRASE, Shire Human Genetic Therapies (the Shire business unit focused on genetic diseases) has introduced a new product support center called …
WebDec 19, 2024 · ELAPRASE is an intravenous enzyme replacement therapy approved for the treatment of patients with Hunter syndrome in 70+ countries worldwide including countries in Africa, Asia Pacific, Europe, Latin America and North America. 1. In the E.U., ELAPRASE is indicated for the long-term treatment of patients with Hunter syndrome. 2 WebBlack Box Warnings. Anaphylactoid reactions, which may be life threatening, have been observed in some patients during idursulfase infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after infusions, regardless of duration of the ...
WebElaprase (idursulfase) dosing, indications, interactions, adverse effects, and more Drugs & Diseases idursulfase (Rx) Brand and Other Names: Elaprase Classes: Enzymes, …
WebOct 21, 2024 · Prepare and use ELAPRASE according to the following steps using aseptic technique: Determine the total volume of ELAPRASE to be administered and the number of vials needed based on the patient's weight and the recommended dose of 0.5 mg/kg. Patient's weight (kg) × 0.5 mg per kg of ELAPRASE ÷ 2 mg per mL =. Total mL of … basaltfaserbandWebPediatric drug monographs for elaprase provide an overview of the drug product, therapeutic uses, key development issues, regulatory information, and therapeutic classifications on ScriptSave WellRx. basaltex meridaWebIndications and Usage ELAPRASE ® (Idursulfase) is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long … svi cdc/atsdrWebOct 1, 2024 · Prepare and use Elaprase according to the following steps using aseptic technique: Determine the total volume of Elaprase to be administered and the number of … svi ccnaWebDec 5, 2024 · DESCRIPTION. ELAPRASE is a formulation of idursulfase, a purified form of human iduronate-2-sulfatase, a lysosomal enzyme.Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans dermatan … basaltfaserWebELAPRASE is a prescription medicine for patients with Hunter syndrome. ELAPRASE has been shown to improve walking ability in patients 5 yrs and older. In patients 16 months to 5 yrs old, ELAPRASE did not show improvement in disease-related symptoms or long-term clinical result; however, treatment with ELAPRASE has reduced spleen size similarly ... svi cdc atsdrWebProduct Monograph. CUVITRU® Normal Immunoglobulin (Human) Product Monograph. DEXILANT ® dexlansoprazole. Product Monograph: ELAPRASE ® idursulfase for … basaltfiber