Elaprase 6 mg/3 mL Concentrate for solution for infusion (sterile concentrate)
PDF Leaflet Revision Date: 03 October 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of Hunter syndrome (MPS II).
Dosage (summary)
0.5 mg/kg weekly by IV infusion over 3 hours.
Special Populations
- Renal impairment
- Hepatic impairment
- Elderly patients
Pregnancy & Breastfeeding
Not recommended during pregnancy; unknown if excreted in breast milk.
Contraindications
- Hypersensitivity to idursulfase or excipients
Common side effects
- Infusion-related reactions
- Rash
- Fever
- Headache
- Nausea
Counselling Points
- Infusions should be supervised by a healthcare professional.
- Be aware of potential infusion reactions.
- Consider home infusions if tolerated well.
Serious warnings
- Risk of anaphylactic reactions
- Monitor patients with respiratory issues
Important Disclaimer
The Elaprase 6 mg/3 mL Concentrate for solution for infusion (sterile concentrate) professional information leaflet below is the property of Sanofi-Aventis South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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