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Click on an International country below to locate a Treatment Center near you:
Australia Brazil Canada Czech/Slovak Republic Denmark Finland France Germany Italy Japan Russia Sweden United Kingdom The Children's Hospital at Westmead Department of Clinical Genetics Locked Bag 4001, Westmead 2145 Australia Phone: 061 2 9845 3273 http://www.chw.edu.au/ Hospital de Clínicas de Porto Alegre, Serviço de Genética Médica Porto Alegre, Brazil Phone: 55 51 3316 8309 Fax: 55 51 3316 8010 Email: genetica@hcpa.ufrgs.br http://www.hcpa.ufrgs.br/ Alberta Children's Hospital 1820 Richmond Road Calgary, AB T2T 5C7 Phone: 403-229-7373 B.C. Research Institute for Children's & Women's Health Center for Growth and Development 950 West 28 Ave, Vancouver, BC V5Z 4H4 Phone: 604-875-3194 Fax: 604-875-2496 www.bcricwh.bc.ca Children's Hospital Section of Clinical Genetics Health Sciences Centre Room FE229 820 Sherbrooke Street Winnipeg, MB R3A 1R9 Phone: 204-787-2494 IWK Children's Hospital Room L2103 Halifax, NS B3J 3G9 Phone: 902-428-8764 Janeway Child Health Centre Janeway Place St. John's, NF A1W 1R8 Phone: 709-778-4363 Montreal Children's Hospital Division of Medical Genetics Room A-608 2300 Tupper Street Montreal, QC H3H 1P3 Phone: 514-412-4427 The Hospital For Sick Children Bone Marrow Transplant Program 555 University Ave. Toronto, ON M5G 1X8 Phone: 416- 813-7512 University of British Columbia Department of Medical Genetics 416-2125 East Mall Vancouver, BC V6T 1Z4 Phone: 604-228-0926 Center for treatment of Inherited metabolic diseases Pediatric Department Ke Karlovu 2 Prague 2, 128 00 Czech Republic Phone: 00420224967793/or 00420224967792 Klinisk Genetisk Klinik Rigshospitalet Blegdamsvej 9 København Ø, 2100 Denmark Hôpital Édouard-Herriot 5 Place d'Arsonval 69437 Lyon cedex 03 France Phone: 04 72 11 7737 Fax: 04 72 11 0343 Children's Hospital University of Mainz Department of Pediatrics Center for Lysosomal Storage Disorders Langenbeckstrasse 1 Mainz, D55131 Germany Phone: 49 0 61 31 17 23 98 or - 2781 Fax: 49 0 61 31 17 66 93 http://www.kinder.klinik.uni-mainz.de/ Clinica Pediatrica Ospedale Salesi Via Corridoni 11 60123 Ancona Italy Phone: 39 071 5962360 Fax: 39 071 36281 Istituti Clinici di Perfezionamento Dip. Pediatria via Commenda 9 20122 MILANO Italy Phone:+39 (02) 5510510 Fax:+39 (02) 5510510 E-mail:rossella.parini@unimi.it Università degli Studi di Padova Clinica Pediatrica via Giustiniani 3 35138 PADOVA Italy Phone: +39 (049) 8213592 Fax: +39 (049) 8213502 E-mail: maurizio.scarpa@unipd.it Università degli Studi di Padova Neurochirurgia via Giustiniani 3 35138 PADOVA Italy Phone: +39 (049) 8830627 Fax: +39 (049) 8211781 E-mail: luca.rigobello@unipd.it The Jikei University School of Medicine, Department of Pediatrics, 3-25-8 Nishishinbashi, Minato-ku, Tokyo 105, Japan Phone: 81 33 433 1111 Fax: 81 33 435 8665 Helsinki University Hospital Dept of Genetics Haartmaninkatu 2 FIN-00029 HUS Finland Phone: 35894711 Medical Genetic Scientific Center Russia Medical Academy Laboratory of Hereditary Storage Disease Moskvorechie, #1 Moscow, 115478 Russia Phone: (095) 324 20 04 Children's Hospital Huddinge Hospital Dept of Neuropaediatrics Stockholm Sweden Phone: 46 8 585 80388 Fax: 46 8 774 1317 Children's Hospital Huddinge University Hospital Pediatric Stockholm, SE - 141 86 Sweden Phone: 46858580000 Royal Manchester Children's Hospital, Willink Biochemical Genetics Unit Pendlebury, Manchester, M27 4HA, U.K Phone/Fax: 0161 727 2137 http://www.cmmc.nhs.uk/hospitals/childrens
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ALDURAZYME® (laronidase) is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established.
ALDURAZYME has been shown to improve pulmonary function and walking capacity. ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder.
Important Safety Information
WARNING
Risk of anaphylaxis. Life-threatening anaphylactic reactions have been observed in some patients during ALDURAZYME infusions. Therefore, appropriate medical support should be readily available when ALDURAZYME is administered. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.
Life-threatening anaphylactic reactions have been observed in some patients during or up to 3 hours after ALDURAZYME infusions. Reactions have included: respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, airway obstruction, hypoxia, hypotension, bradycardia, and urticaria. Interventions have included: resuscitation, mechanical ventilatory support, emergency tracheotomy, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids.
In clinical trials and postmarketing safety experience with ALDURAZYME, approximately 1% of patients experienced severe or serious allergic reactions. In patients with MPS I, pre-existing upper airway obstruction may have contributed to the severity of some reactions. Due to the potential for severe allergic reactions, appropriate medical support should be readily available when ALDURAZYME is administered. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation. The risks and benefits of re-administering ALDURAZYME following an anaphylactic or severe allergic reaction should be considered.
Patients with an acute illness at the time of ALDURAZYME infusion may be at greater risk for infusion-related reactions. Careful consideration should be given to the patient’s clinical status prior to administration of ALDURAZYME.
Patients should receive antipyretics and/or antihistamines prior to infusion. If an infusion reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or administration of additional antipyretics and/or antihistamines may ameliorate the symptoms.
The most common adverse reactions associated with ALDURAZYME treatment in the clinical studies were upper respiratory tract infection, rash, and injection site reaction The most common adverse reactions requiring intervention were infusion-related reactions involving flushing, fever, headache, and rash.
In postmarketing experience with ALDURAZYME, severe and serious infusion-related reactions have been reported, some of which were life-threatening. The most frequently reported adverse reactions included: chills, vomiting, nausea, arthralgia, diarrhea, tachycardia, abdominal pain, blood pressure increased, and oxygen saturation decreased.
Approximately 91% of patients treated with ALDURAZYME in clinical studies were positive for antibodies to laronidase. The clinical significance of antibodies to ALDURAZYME is not known, including the potential for product neutralization. Adverse events should be reported promptly to Genzyme Medical Information at 800-745-4447, option 2. ALDURAZYME is available by prescription only. To learn more, please see the full prescribing information (PDF) including boxed warning, visit www.ALDURAZYME.com or contact Genzyme at 1-800-745-4447. |
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Terms and Conditions of Use Privacy Policy This site is intended for United States residents only. ©2003-2009 Genzyme Corporation. All rights reserved. | T/MPSI/US/P090/04/08 |
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