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ERTAPENEM- ertapenem sodium injection, powder, lyophilized, for solution


  1. Patient Information
  2. Manufactured For:
  3. Revised: 8/2019document Id:

Patient Information 

17.1 Instructions for Patients

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions may require immediate treatment. Advise patients to report any previous hypersensitivity reactions to ertapenem for injection, other beta-lactams or other allergens.

Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with ertapenem for injection. If treatment with ertapenem for injection is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.

Patients should be counseled that antibacterial drugs including ertapenem for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ertapenem for injection 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 taken 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 ertapenem for injection or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, USA

PREMIERProRxis a registered trademark of Premier Healthcare Alliance, L.P., used under license.

uspi-mk0826-i-1906r002-plprem

R06/2019

OS221P-01-95-03

Manufactured For: 

Figure

Lake Zurich, IL 60047
www.fresenius-kabi.com/us

Made in Italy

451641
Issued: July 2019

Principal Display Panel Carton

NDC 63323-823-20

Ertapenem
for Injection

1 g per vial

For Intravenous or Intramuscular Use
10 Single dose vials

Rx only

Principal Display Panel     Carton

Principal Display Panel Vial Label

NDC 63323-823-01

Ertapenem
for Injection

1 g per vial

For Intravenous or
Intramuscular Use

Single dose vial

Rx only

Principal Display Panel     Vial Label
ERTAPENEM
ertapenem sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-823
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERTAPENEM SODIUM(UNII: 2T90KE67L0) (ERTAPENEM - UNII:G32F6EID2H)ERTAPENEM1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Coloryellow ((colorless to pale yellow))Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-823-2010 in 1 CARTON10/10/2019
1NDC:63323-823-011 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20879010/10/2019
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
ACS Dobfar S.p.A.439962157manufacture(63323-823)

Revised: 8/2019document Id: 

90a506cd-aa77-a622-e053-2a95a90ad352Set id: 666c9f33-ea9e-4667-b8bd-f8b1b6b6be51Version: 1Effective Time: 20190821Fresenius Kabi USA, LLC



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