通用名称

dalteparin sodium

儿科标签批准日期

2019/5/16 0:00:00

特定指示/秒

Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month and older

标签更改摘要

- Safety and effectiveness for the treatment of symptomatic VTE have been established in pediatric patients aged 1 month and older. - Use is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate studies in pediatric patients aged 1 month and older with symptomatic VTE. - The frequency, type and severity of adverse reactions observed were generally consistent with those observed in adults. - Use preservative-free FRAGMIN in neonates and infants. - Serious adverse reactions including fatal reactions and the “gasping syndrome’ occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications. - Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. - When prescribing Fragmin multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including FRAGMIN multiple-dose vials and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. - Information on dosing, adverse reaction, PK parameters, and clinical trials.

治疗类别

Anti-Coagulant

立法类型

PREA Only

产品说明书链接