Elaprase monograph

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August undefined, 2024

WebELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in these patients. … 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 ...

Reference ID: 3330570 - Food and Drug Administration

WebEach vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution. Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use. It is recommended to deliver the total volume of infusion using a 0.2 µm in line filter. WebTotal mL of ELAPRASE . Total mL of ELAPRASE ÷ 3 mL per vial = Total number of vials . Round up to the next whole vial to determine the total number of vials needed. Remove the required number of vials from the refrigerator to allow them to reach room temperature. b. Before withdrawing the ELAPRASE solution from the vial, ly visualinspect each ... loopmancer trailer

Press Release - sec.gov

WebPediatric drug monographs for elaprase provide an overview of the drug product, therapeutic uses, key development issues, regulatory information, and therapeutic classifications on ScriptSave WellRx. WebDec 5, 2024 · Elaprase is a prescription medicine used to treat symptoms of Hunter Syndrome. Elaprase may be used alone or with other medications. Elaprase belongs to … WebElaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials. 4.2 Posology and method of administration This treatment should be supervised by a physician or other healthcare professional experienced in the loopmancer wiki

Elaprase: Package Insert - Drugs.com

WebElaprase improved lung function and the walking ability of the patients. At the start of the study, the patients could walk an average of around 395 metres in six minutes. After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could WebELAPRASE® Product Monograph Page 7 of 31 Immune Hypersensitivity Allergic reactions have included respiratory distress, hypoxia, decreased blood pressure, angioedema, or … loop marchinha carnavalWebIdursulfase (brand name Elaprase), manufactured by Takeda, is a drug used to treat Hunter syndrome (also called MPS-II). It is a purified form of the lysosomal enzyme iduronate-2 … loopmaster electro swing download

"WebIndications 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 term ... " - Elaprase monograph

Elaprase monograph

ELAPRASE® Information for Healthcare Professionals

WebDrug Names # A B C D E F G H WebPediatric drug monographs for elaprase provide an overview of the product, therapeutic uses, key development issues, regulatory information on ScriptSave WellRx.

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WebELAPRASE ® (Idursulfase) is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking … 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 …

WebProduct Monograph. CUVITRU® Normal Immunoglobulin (Human) Product Monograph. DEXILANT ® dexlansoprazole. Product Monograph: ELAPRASE ® idursulfase for … WebELAPRASE ® (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 term clinical …

WebElaprase (idursulfase) dosing, indications, interactions, adverse effects, and more Drugs & Diseases idursulfase (Rx) Brand and Other Names: Elaprase Classes: Enzymes, … WebELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has …

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 .

WebFeb 16, 2024 · The information in a product information document has been written by the pharmaceutical company responsible for the medicine and has been approved by the TGA. It provides objective information about the quality, safety and effectiveness of the medicine, as demonstrated in the data provided to the TGA by the pharmaceutical company. loop marketing edmontonWebELAPRASE. IDURSULFASE (EYE dur SUL fase) is used to replace an enzyme that is missing in patients with Hunter syndrome. It is not a cure. ELAPRASE Monographs. … loop martin garrix bpmWebJan 11, 2024 · What is Elaprase? Elaprase is an IV infusion used to treat some of the symptoms of a genetic condition called Hunter's syndrome, also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis). Idursulfase contains a natural enzyme that some people lack because of a genetic disorder. Elaprase helps … horchow comforter setsWebDec 15, 2024 · Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in … loopmancer keyWebELAPRASE 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 ... loop martial artsWebELAPRASE 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 … loopmash cubase 12 horchow comforters queen