Presentation and Status in Health Basket
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Concentrate for solution for infusion 1 X 2 ml |
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Concentrate for solution for infusion 1 X 10 ml |
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Related information
Dosage
The recommended dose is 30 milligrams per kilogram administered once weekly.
Administration: Administered as a 35 to 60-minute intravenous infusion via an in-line 0.2 micron filter. Flush the line with 0.9% Sodium Chloride before and after infusion. Do not mix with other medicinal products or infuse through the same IV line.
If a dose is missed, it may be administered as soon as possible after the scheduled time.
Premedication: Application of a topical anesthetic cream to the infusion site prior to administration of may be considered.
Preparation: Allow vials to warm to room temperature. Gently invert vials 2-3 times (do not shake). Dilute the withdrawn product in 0.9% Sodium Chloride Injection, USP, to make a total volume of 100-150 ml.
Indications
Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
Contra-Indications
Hypersensitivity to the active substance or to any of the excipients
Special Precautions
Hypersensitivity Reactions: Hypersensitivity reactions, including bronchospasm, chest pain, cough, tachycardia, and urticaria, have occurred. If a reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting therapy.
Side Effects
Most common: Balance disorder, Vomiting, Contact dermatitis
See prescribing information for full details.
Drug interactions
No clinical drug interaction studies have been conducted. The active substance is not expected to interact with CYP450 enzymes based on in vitro data.
Pregnancy and Lactation
Pregnancy: There are no human data on the use of the medicinal product in pregnant women.
Lactation: There is no information regarding the presence of the drug in human milk, effects on the breastfed infant, or effects on milk production.
Important notes
Complete infusion of diluted solution within 8 hours of dilution. If immediate use is not possible, the diluted solution may be stored for up to 24 hours at 2ºC to 8ºC. Do not freeze.
