肝小静脉闭塞病药物去纤苷说明书

Hepatic veno-occlusive disease drug instructions

[Drug Name] Defibroside, Defibrotide Sodium, Defibrotide, Defitelio, defiteli

[Indications for defibrotide] It is suitable for the treatment of adults and children with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), and renal or pulmonary dysfunction after hematopoietic stem cell transplantation (HSCT).

[Defibrotide Dosage] The recommended dose of defibrotide for adult and pediatric patients is 6.25 mg/kg given every 6 hours as a 2-hour intravenous infusion. The dose should be based on the patient's baseline weight, which is defined as the patient's weight before the HSCT preparation protocol.

Defibrotide was administered for a minimum of 21 days. If signs and symptoms of hepatic VOD have not resolved after 21 days, continue defibrotide until resolution of VOD or up to a maximum of 60 days.

Defibrotide must be diluted prior to infusion.

Prior to administration of defibrotide, confirm that the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor.

Defibrotide was administered by constant intravenous infusion over a 2-hour period.

Administer the diluted defibrotide solution using an infusion set equipped with a 0.2 μm in-line filter. Flush the intravenous administration line (peripheral or central) with 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, before and immediately after administration.

Do not coadminister defibrotide with other intravenous medications at the same time and in the same intravenous line.

[Defibrinoside adverse reactions] The most common (incidence ≥10% and independent causal relationship) are hypotension, diarrhea, vomiting, nausea and epistaxis.

[Notes on defibrination]

1. Defibrotide needs to be administered by injection, and defibrotide must be diluted before infusion.

2. Before administration of defibrotide, confirm that the patient has not experienced clinically significant bleeding and is hemodynamically stable on no more than one vasopressor.

3. Do not co-administer defibrotide and other intravenous drugs in the same intravenous line at the same time.

4. Bleeding: Monitor the patient for bleeding. If significant bleeding occurs, withhold or discontinue defibrotide.

5. Hypersensitivity reaction: If severe or life-threatening allergic reaction occurs, discontinue, follow standard medical care, and monitor until signs and symptoms resolve.

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