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
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DALVANCE ™ safely and effectively.
See full prescribing information for DALVANCE.
DALVANCE (dalbavancin) for injection, for intravenous use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
DALVANCE is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. (1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial drugs, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
Two-dose regimen: 1000 mg followed one week later by 500 mg (2.1)
Dosage adjustment for patients with creatinine clearance less than 30 mL/min and not receiving regularly scheduled hemodialysis: 750 mg followed one week later by 375 mg (2.2)
Administer by intravenous infusion over 30 minutes (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: 500 mg of lyophilized powder in a single-use vial for reconstitution (3)
CONTRAINDICATIONS
Hypersensitivity to dalbavancin (4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides. (5.1)
Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions. (5.2)
ALT elevations with DALVANCE treatment were reported in clinical trials. (5.3)
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. eva luate if diarrhea occurs. (5.4)
ADVERSE REACTIONS
The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). (6)  
To report SUSPECTED ADVERSE REACTIONS, contact Durata Therapeutics, Inc. at 1-855-387-2825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
USE IN SPECIFIC POPULATIONS
Dosage adjustment is required in patients whose creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis. (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Acute Bacterial Skin and Skin Structure Infections 1.2 Usage 2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose Regimen 2.2 Patients with Renal Impairment 2.3 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions 5.2 Infusion-Related Reactions 5.3 Hepatic Effects 5.4 Clostridium difficile-Associated Diarrhea 5.5 Development of Drug-Resistant Bacteria 6 A