2014年5月27日,抗生素产品Dalvance（dalbavancin）注射液获FDA批准，用于治疗由革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSI）。
Dalvance是首个也是唯一一个获批用于ABSSSI治疗的双剂量方案的静脉注射（IV）抗生素，首次给药1000mg，随后500mg给药一周，每次给时间大于30分钟。
批准日期：2014年5月27日；公司：Durata Therapeutics，Inc.
注射用达巴万星DALVANCE(dalbavancin)冻干粉为静脉使用
剂量和给药方法
⑴ 2剂方案：1000mg接着一周后500mg.
⑵对有肌酐清除率小于30mL/min和不接受常规时间表血液透析患者调整剂量: 750mg 接着一周后375mg.
⑶通过静脉输注历时30分钟给药.
剂型和规格
注射用：为重建在一个单次-使用小瓶500mg冻干粉

DALVANCE Rx
Generic Name and Formulations:
Dalbavancin 500mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Company:
Durata Therapeutics, Inc.
Indications for DALVANCE:
Acute bacterial skin and skin structure infections caused by susceptible Gram (+) organisms.

Adult:
Give by IV infusion over 30 mins. Initially 1000mg, followed by 500mg one week later. Renal impairment (CrCl <30mL/min) and who are not receiving hemodialysis: initially 750mg followed by 375mg one week later.

Children:
Not established.

Pharmacological Class:
Lipoglycopeptide.

Warnings/Precautions:
History of glycopeptide allergy. Discontinue if serious hypersensitivity or skin reactions occur. Risk of Clostridium difficile-associated diarrhea; discontinue if suspected or confirmed. Moderate or severe hepatic impairment (Child-Pugh Class B or C). Renal impairment (CrCl <30mL/min). Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions:
Nausea, headache, diarrhea, vomiting, rash, pruritus; ALT elevations, infusion-related reactions (eg, Red-Man Syndrome), C. difficile-associated diarrhea.

How Supplied:
Single-use vial—1