Prescription Drugs Prescription Drugs
Hunterase
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Effects
Treatment for Hunter syndrom (Mucopolysaccharidosis II, MPS II)
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Description & Ingredients
Idursulfase beta
- Characteristics
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· Hunterase is an injection in a colorless and transparent vial containing a clear to slightly whitish, colorless solution. It is developed for the second time in the world as a treatment for Hunter syndrome.
- Ingredients
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1 vial (3mL) contains,
· Idursulfase- β(Host : CHO DG44, Vector :
pJK-dhfr-Or2-IDS) ----------------------- 6.0 mg
· Monobasic Sodium Phosphate
Monohydrate -------------------------- 6.75 mg
· Dibasic Sodium Phosphate
Heptahydrate -------------------------- 2.97 mg
· Sodium Chloride ------------------------- 24 mg
· Polysorbate 20 ------------------------- 0.66 mg
· Water for Injection ------------------------- q.s.
- Effects
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As an enzyme replacement therapy, Hunterase is indicated for patients with Hunter syndrome.
- Usage/Dosage
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1. RECOMMENDED DOSAGE
The recommended dosage regimen of Hunterase is 0.5 mg/kg of body weight administered every week as an intravenous infusion. Hunterase is a concentrated solution for intravenous infusion and must be diluted in 100 mL of 0.9% Sodium Chloride Injection. Each vial of Hunterase contains a 2.0 mg/mL solution of idursulfase- β protein (6.0 mg) in an extractable volume of 3.0 mL and is for single use only. Use of an infusion set equipped with a 0.2 micrometer (μm) filter is recommended.
The total volume of infusion may be administered over a period of 1 to 3 hours. Patients may require longer infusion times due to infusion reactions; however, infusion times should not exceed 8 hours. The initial infusion rate should be 8 mL/hr for the first 15 minutes. If the infusion is well tolerated, the rate may be increased by 8 mL/hr increments at 15 minute intervals in order to administer the full volume within the desired period of time. However, at no time should the infusion rate exceed 100 mL/hr. The infusion rate may be slowed and/or temporarily stopped, or administration may be stopped, based on clinical judgment, if infusion reactions were to occur. Hunterase should not be infused with other products in the infusion tubing.
2. PREPARATION AND ADMINISTRATION INSTRUCTIONS : USE ASEPTIC TECHNIQUES
Hunterase should be prepared and administered by a health care professional.
Determine the total volume of Hunterase to be administered and the number of vials needed based on the patient’s weight and the recommended dose of 0.5 mg/kg.
Patient’s weight (kg) x 0.5 mg/kg of Hunterase 2 mg/mL = Total # (mL) of Hunterase
Total # (mL) of Hunterase 3 mL/vial = Total # of (vial)
(Round up to determine the number of whole vials needed from which to withdraw the calculated volume of Hunterase to be administered.)
Perform a visual inspection of each vial. Hunterase is a clear to slightly whitish, colorless solution. Do not use if the solution in the vials is discolored or particulate matter is present. Hunterase should not be shaken.
Dilute the total calculated volume of Hunterase in 100 mL of 0.9% Sodium Chloride Injection. After dilution, the solution in the infusion bag should be mixed gently, but not shaken. Diluted solution should be discarded if not administered or refrigerated within 8 hours of preparation. Diluted solution may be stored refrigerated for up to 48 hours.
Hunterase is for single-use only. Remaining Hunterase after use should be discarded immediately.
- Precaution for use
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· If you want to read a precaution for the administration, please click the manual button to download.
- Quantity per pack
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· 3mL/vial x In-house package unit
- Other
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· Store at 2℃ to 8℃ in hermetic container.
· The shelf-life of this product is 24 months from the date of manufacture.
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