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DAPTOMYCIN injection, powder, lyophilized, for solution


  1. Patient Information
  2. Manufactured For:
  3. Revised: 6/2019document Id:

Patient Information 

Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin.[SeeWarnings and Precautions (5.1).]

Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness.[SeeWarnings and Precautions (5.2,5.4).]

Advise patients to report any symptoms of cough, breathlessness, or fever.[SeeWarnings and Precautions (5.3).]

Advise patients that diarrhea is a common problem caused by antibacterials that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.[SeeWarnings and Precautions (5.6).]

Counsel patients that antibacterial drugs, including daptomycin, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When daptomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by daptomycin or other antibacterial drugs in the future.

Manufactured by:
Jiangsu Hengrui Medicine Co., Ltd.
Lianyungang, Jiangsu 222047, China

Distributed by:
eVenus Pharmaceutical Laboratories, Inc.
506 Carnegie Center, Suite 100
Princeton, NJ 08540 USA

Revised: June 2019

Rev. 04

Manufactured For: 

Figure

Made in India

www.fresenius-kabi.com/us

451623A
LEA-020198-00
Code No. AP/DRUGS/103/97

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Daptomycin 350 mg Vial Label
NDC 63323-585-15
Daptomycin for Injection
350 mg per vial
MUST BE REFRIGERATED
For Intravenous Infusion.
Single-Dose Vial
Discard Unused Portion Rx only

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Daptomycin 350 mg Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Daptomycin 350 mg Carton Panel
NDC 63323-585-15
Daptomycin for Injection
350 mg per vial
MUST BE REFRIGERATED
For Intravenous Infusion.

Use 0.9% Sodium Chloride Injection for reconstitution only.

One Single-Dose Vial
Discard Unused Portion

Rx only

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Daptomycin 350 mg Carton Panel
DAPTOMYCIN
daptomycin injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-585
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DAPTOMYCIN(UNII: NWQ5N31VKK) (DAPTOMYCIN - UNII:NWQ5N31VKK)DAPTOMYCIN350 mg in 7 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-585-151 in 1 CARTON06/01/2019
17 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20994906/01/2019
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238manufacture(63323-585)

Revised: 6/2019document Id: 

8b136aa7-1ef2-3556-e053-2a95a90a617fSet id: 74c99d03-3f9e-4fba-9f94-407add944382Version: 2Effective Time: 20190611Fresenius Kabi USA, LLC



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