are supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder. . General Clinical Recommendations Patients and caregivers should be informed that anaphylactic reactions, severe allergic reactions, and immune mediated reactions have been observed in some patients having received Myozyme infusions. Warnings and Precautions (5.1 risk of Cardiorespiratory Failure, patients with compromised cardiac or respiratory function may be at risk for serious acute exacerbation of their cardiac or respiratory compromise due to infusion reactions, and require additional monitoring. Package Carton Principle Dispay Panel 50 mg Carton Package contains one vial of Myozyme (alglucosidase alfa) 50 mg Store Refrigerated At 2-8C (36-46F) Do Not Freeze or Shake Protect From Light Contains No Preservatives For Single Use Only.S. Infusion reactions occurred in some patients after receiving antipyretics, antihistamines, or steroids. . Label( pack( ) Establishment Name Address ID/FEI Operations ILS Limited analysis( ) Genzyme Corporation Medical Disclaimer Next Pregnancy Warnings Add to My Med List More about Myozyme (alglucosidase alfa) Consumer resources Professional resources Other brands: Lumizyme Related treatment guides. Twenty of 39 patients (51) treated with Myozyme in clinical studies developed infusion reactions. Survival without invasive ventilatory support was greater in the Myozyme-treated patients (83) as compared with overall survival in the historical control group (2). . Acute cardiorespiratory failure has been observed in a few infantile-onset Pompe disease patients with underlying cardiac hypertrophy, possibly associated with fluid overload with intravenous administration of alglucosidase alfa see Boxed Warning and Warnings and Precautions (5.3) and Instructions for Use (2.2). Systemic exposure was approximately dose proportional between the 20 and 40 mg/kg doses. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with Myozyme.
It is therefore recommended to perform periodic urinalysis. Within the first 12 months of treatment, 3 of 18 Myozyme-treated patients required invasive ventilatory support (17, with 95 confidence interval 4 to 41 there were no deaths. . The Pompe Registry will also monitor the effects of alglucosidase alfa on pregnant women and their offspring see Use in Specific Populations (8). It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with.3 mL Sterile Water for Injection, USP. . 50 of 2 recommend Get Deal Deal Bird Baths At Hayneedle Enjoy big savings at m today! The most common treatment-emergent adverse reactions occurring in 20 of patients were fever, diarrhea, rash, vomiting, cough, pneumonia, otitis media, upper respiratory tract infection, gastroenteritis and decreased oxygen saturation. Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons for the polypeptide chain, and a total mass of approximately 110 kilo Daltons, including carbohydrates. . aims-assessed gains in motor function occurred in 13 patients. . The most common treatment-emergent adverse reactions observed with Myozyme treatment in this study were headache (4.1 pharyngitis (9.1 upper abdominal pain (15.2 malaise (6.1) and rhinitis (6.1). Le Rve chez Vous - Ajout le - Expire le : Date de validit non communique 20 de rduction.