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Aldurazyme

Aldurazyme

Manufacturer:

Sanofi

Distributor:

DKSH
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Laronidase
Indications/Uses
Hurler & Hurler-Scheie forms of mucopolysaccharidosis I & Scheie form w/ moderate to severe symptoms.
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Dosage/Direction for Use
0.58 mg/kg IV infusion once wkly. Infusion rate: Initially 10 mcg/kg/hr, may be increased every 15 min during 1st hr as tolerated up to max: 200 mcg/kg/hr.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Aldurazyme detailed prescribing information
Special Precautions
Discontinue use immediately if severe hypersensitivity, anaphylaxis or infusion-associated reactions occur. Acute febrile or resp illness; sleep apnea; pre-existing upper airway obstruction; susceptibility to fluid overload, w/ acute underlying resp illness or compromised cardiac &/or resp function. Immunogenicity. Pretreatment w/ antihistamine, antipyretics or both 60 min prior to infusion. Evaluate airway patency prior to treatment initiation. Concomitant use w/ epinephrine. Pregnancy & lactation. Mildly affected ped w/ Scheie form. Elderly ≥65 yr.
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Adverse Reactions
Infusion reactions. Pyrexia, rash, tachycardia, pruritus. Patients ≥6 yr: Flushing, headache. Angioedema (eg, face oedema), hypotension, paresthesia, feeling hot, hyperhidrosis, vomiting, back pain, cough, bronchospasm, dyspnea, urticaria. Patients ≤6 yr: Chills, increased BP, decreased O2 saturation. Pallor, tremor, resp distress, wheezing, pulmonary crepitations.
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Storage
View Aldurazyme storage conditions for details to ensure optimal shelf-life.
Description
View Aldurazyme description for details of the chemical structure and excipients (inactive components).
Action
View Aldurazyme mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AB05 - laronidase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Patient Counseling Information
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Presentation/Packing
Form
Aldurazyme soln for infusion 2.9 mg/5 mL
Packing/Price
1's
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