HUNTERASE - Drug for the Long-Term Treatment of Patients with Hunter Syndrome

HUNTERASE® (INN: idursulfase beta) is drug for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis type II, MPS II).

Idursulfatase beta is a purified form of iduronate-2-sulfatase lysosomalenzyme: recombinant human iduronate-2-sulfatase (rhI2S)

The efficacy and safety of Hunterase were demonstrated in two clinical studies with a duration of 24–52 weeks including male patients with Hunter syndrome aged 38 months to 35 years (see the Instruction for Medical Use)

DOSAGE FORM

Concentrate for solution for injection 2 mg/ml

SHELF LIFE

2 years at 2–8 °C in a dark place

INDICATIONS

HUNTERASE® is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis type II, MPS II)*

MARKETING AUTHORIZATION OWNER

NANOLEK LLC, MA No. LP-004673 (??-004673), 2018

Consult a physician before use and read the Instruction for Medical Use. The information provided on this website is not a substitution for consultations with a physician and shall not be considered as such.

Dosage form
Concentrate for solution for injection 2 mg/ml

INN
idursulfase beta