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Cafcit Injection
儿科标签批准日期
2020/3/2 0:00:00
特定指示/秒
Postmarketing study
标签更改摘要
- Expanded indication to include a broader gestational age (GA) range of premature infants. The lower and upper GA limits were removed from the Indications and Usage; previously indicated for the short-term use in infants between 28- <32 weeks gestational age.
- The term “short-term” was removed from the Indications and Usage section allowing for a longer treatment duration.
- In a published randomized, placebo-controlled, clinical trial that studied the use of caffeine citrate in apnea of prematurity in approximately 2000 patients, necrotizing enterocolitis was not more common in caffeine treated patients compared to placebo.
- Information on dosing, adverse reactions, and clinical trial.
- Off-patent Written Request.