Elaprase Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage 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

Idursulfase

Indications/Uses

Improve walking capacity in patients w/ Hunter syndrome (mucopolysaccharidosis II).

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Dosage/Direction for Use

0.5 mg/kg IV infusion once wkly.

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Overdosage

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Warnings

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Special Precautions

Hypersensitivity reactions including anaphylaxis. Discontinue use if anaphylactic or other acute reactions occur. Patients w/ compromised resp & cardiac function or acute febrile or resp illness; susceptible to fluid overload. Serious adverse reactions & Ab development in patients w/ severe genetic mutations. Pregnancy & lactation. Ped <16 mth. Elderly >31 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity reactions eg, rash, urticaria, pruritus, flushing, pyrexia, headache; hypoxic episodes.

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Storage

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Description

View Elaprase description for details of the chemical structure and excipients (inactive components).

Action

View Elaprase mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB09 - idursulfase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Elaprase soln for infusion 2 mg/mL

Packing/Price

3 mL x 1's

Elaprase

idursulfase

Manufacturer:

Sanofi

Distributor:

DKSH