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ProHance Injection; ProHance Multipack Injection
儿科标签批准日期
2020/12/19 0:00:00
特定指示/秒
Use in magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with abnormal blood-brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.
标签更改摘要
- Safety and effectiveness have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age.
- Pediatric use is based on evidence of effectiveness in adults and in 103 pediatric patients 2 years of age and older, in addition to experience in 125 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data.
- Adverse reactions in pediatric patients were similar to those reported in adults.
- Safety and efficacy of > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied in pediatric patients
- No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.
- Pharmacokinetic studies suggest that weight normalized clearance of ProHance is similar in pediatric patients and adults, including pediatric patients age younger than 2 years.
- Normal estimated GFR (eGFR) is around 30 mL/min/1.73m2 at birth and increases to mature levels around 1 year of age, reflecting growth in both glomerular function and relative body surface area.
- Clinical studies in pediatric patients younger than 1 year have been conducted in patients with the following minimum eGFR; 59.37 mL/min/1.73m2 (age just after birth to < 30 days), 118.84 mL/min/1.73m2 (age 30 days to < 6 months), 140.44 mL/min/1.73m2 (age 6 to 12 months).
治疗类别
Radioactive Diagnostic Agent