WebJun 13, 2005 · Imiglucerase. Imiglucerase is a form of recombinant human beta-glucocerebrosidase enzyme used to replace the deficient endogenous enzyme in the treatment of Gaucher disease. Human Beta-glucocerebrosidase or Beta-D-glucosyl-N-acylsphingosine glucohydrolase E.C. 3.2.1.45. 497 residue protein with N-linked … WebDec 17, 2009 · Cerezyme is one of Genzyme's bestselling drugs, and the new expansion will enhance its production. Genzyme Corporation is one of most prominent biotechnology companies in the US. Based in Cambridge, Massachusetts, it was established in 1981 and has grown to become the third largest in the world, with 11,000 employees in 40 …
NDA 20-367/S-055 CEREZYME® (imiglucerase for injection)
WebWhat is Cerezyme? Cerezyme Cerezyme Cerezyme An enzyme unit (U) is defined as the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per minute at 37°C. The product is stored at 2-8°C (36-46°F). WebSep 20, 2024 · Cerezyme catalyzes the hydrolysis of glucocerebroside to glucose and ceramide. Pharmacodynamics. No formal pharmacodynamic studies have been conducted with Cerezyme. Pharmacokinetics. During one-hour intravenous infusions of four doses (7.5, 15, 30, 60 units/kg) of Cerezyme, steady-state enzymatic activity was achieved by … ireland tax on investments
Dosing and Administration Cerezyme® (imiglucerase)
WebApr 3, 2024 · The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), coughing, urticaria (hives) or angioedema (swelling beneath the skin), pruritus (itching), rash and hypersensitivity (allergic) reactions. For the full list of all side effects reported with Cerezyme, see the … WebMay 25, 2024 · Cerezyme (imiglucerase) for injection is intended for intravenous use. It is supplied as a sterile, nonpyrogenic, white to off-white lyophilized powder for … Web[Cerezyme (imiglucerase); Elelyso (taliglucerase alfa); Vpriv (velaglucerase alfa)] for the treatment of Gaucher disease (GD) for when appropriate criteria are met. The intent of the drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines, and clinical studies. ireland tax treaty irs