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Cefepime (Cefepime)

Trade Name : CEFEPIME

SAMSON MEDICAL TECHNOLOGIES LLC

INJECTION, POWDER, FOR SOLUTION

Strength 100 g/1

CEFEPIME HYDROCHLORIDE Cephalosporin Antibacterial [EPC],Cephalosporins [CS]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cefepime (Cefepime) which is also known as CEFEPIME and Manufactured by SAMSON MEDICAL TECHNOLOGIES LLC. It is available in strength of 100 g/1 per ml. Read more

Cefepime (Cefepime) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cefepime for Injection, USP is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime and other antibacterial drugs, cefepime should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ()
  • Pneumonia. ()
  • Empiric therapy for febrile neutropenic patients. ()
  • Uncomplicated and complicated urinary tract infections (including pyelonephritis). ()
  • Uncomplicated skin and skin structure infections. ()
  • Complicated intra-abdominal infections (used in combination with metronidazole) in adults. ()
  • THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY.u00a0 BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 100 mg/mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION. u00a0
  • For intravenous use only over approximately 30 minutes ()
  • THIS IS A PHARMACY BULK PACKAGE - NOT FOR DIRECT INJECTION.u00a0n n
  • Pediatric Patients (2 months to 16 years)
  • Recommended dosage in pediatric patients with CrCL greater than 60 mL/min. ()
  • The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia). ()
  • Patients with Renal Impairment
  • Cefepime for Injection, USP is a sterile white to pale yellow powder in 100 gram SmartPak Pharmacy Bulk Packages.
  • THIS IS A PHARMACY BULK PACKAGE u2013 NOT FOR DIRECT INJECTION.
  • Cefepime for Injection, USP, is a sterile powder available as Pharmacy Bulk Package bags, 100 grams ()
  • THIS IS A PHARMACY BULK PACKAGE u2013 NOT FOR DIRECT INJECTION
  • Cefepime for Injection, USP is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.
  • Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. ()
  • No data
  • Hypersensitivity Reactions
  • Neurotoxicity
  • Arrayn- Associated Diarrhea (CDAD)
  • The following adverse reactions are discussed in the Warnings and Precautions section and below:
  • To report SUSPECTED ADVERSE REACTIONS, contact Samson Medical Technologies, L.L.C. at 1-877-418-3600 or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch
  • The most common adverse reactions (incidence u2265 1%) were local reactions, positive Coombs test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. ()
  • At the highest dose (2 g every 8 hours), incidence of adverse reactions was u2265 1% for rash, diarrhea, nausea, vomiting, pruritus, fever, and headache. ()
  • No data
  • Aminoglycosides: increased potential of nephrotoxicity and ototoxicity.u00a0 Monitor renal function. ()
  • Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.u00a0 Monitor renal function. ()
  • No data
  • Geriatric Use: Serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime. ()
  • Pediatric Use: Cefepime for Injection u2013 Pharmacy Bulk Package bag, SmartPaku00ae should not be used in pediatric patients requiring less than a 500 mg dose of cefepime.
  • Arrayn- Array
  • Patients who receive an overdose should be carefully observed and given supportive treatment.u00a0 In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body.u00a0 Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus [].
  • Cefepime for Injection, Pharmacy Bulk Package bag SmartPaku00ae should not be used in patients who require less than a 500 mg dose of cefepime.
  • Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration.u00a0 The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7-(-(-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:
  • BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES CONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY.
  • Cefepime hydrochloride is a white to pale yellow powder.u00a0 Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (CHNOS) per mg, calculated on an anhydrous basis.u00a0 It is highly soluble in water.
  • Cefepime for Injection, USP is supplied in a SmartPaku00a0pharmacy bulk package containing the equivalent of 100 grams of cefepime. Cefepime for Injection is a sterile, dry mixture of cefepime hydrochloride and L-arginine.u00a0 The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6.u00a0 Freshly constituted solutions of Cefepime for Injection will range in color from pale yellow to amber.
  • Each SmartPaku00a0Pharmacy Bulk Package contains sterile Cefepime Hydrochloride, USP, equivalent to 100 grams of cefepime and is intended for intravenous infusion only.u00a0 Its L-arginine content is approximately 70.7 grams.u00a0 A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses.u00a0 The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion.u00a0 FURTHER DILUTION IS REQUIRED BEFORE USE.u00a0 n
  • No data
  • No animal carcinogenicity studies have been conducted with cefepime.u00a0 In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells.u00a0 In other assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.u00a0 Moreover, assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity.u00a0 No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a body surface area basis).
  • No data
  • No data
  • How Supplied
  • Cefepime for Injection, USP in the dry state is a white to pale yellow powder.u00a0 Constituted solutions of Cefepime for Injection, USP can range in color from pale yellow to amber.u00a0u00a0 Cefepime for Injection, USP is u00a0available in the following SmartPakPharmacy Bulk Package:
  • 100 grams*
  • *Each 100 gram Pharmacy Bulk Package contains sterile cefepime hydrochloride equivalent to 100 grams of cefepime and 70.7 grams of L-arginine.
  • SmartPak system components are not made with natural rubber latex.
  • Storage and Handling
  • Cefepime for Injection, USP in the dry state should be stored at 20 to 25u00b0C (68 to 77u00b0F) [see USP controlled room temperature.] and protected from light. The inner bag should be retained in the outer bag until time of use.
  • No data
  • Rx only
  • SmartPak is a registered trademark of Samson Medical Technologies, L.L.C.
  • C8100a
  • Manufactured for Samson Medical Technologies, L.L.C.Cherry Hill, NJ 08003byACS Dobfar S.p.A.20067 Tribiano (Milano) Italy
  • Printed in USA *6628881001*
  • NDC 66288-8100-1u00a0u00a0u00a0SmartPak
  • Cefepime for Injection, USP
  • 100 grams [ONE HUNDRED GRAMS] per Pharmacy Bulk Package Bag
  • PHARMACY BULK PACKAGE -
  • NOT FOR DIRECT INFUSION
  • FOR INTRAVENOUS USE ONLY
  • NOT TO BE DISPENSED AS A UNIT
  • Rx Only
  • IMPORTANT: READ PACKAGE INSERT FOR PRECAUTIONS AND DIRECTIONS FOR USE. AFTER CONSTITUTION, MUST BE FURTHER DILUTED.
  • Sterile, Nonpyrogenic, Preservative-Free
  • Each 100 gram Pharmacy Bulk Package contains sterile cefepime hydrochloride equivalent to 100 grams of cefepime and L-arginine for pH adjustment.USUAL DOSAGE: See package insert.Prior to constitution, store dry powder at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).[see USP Controlled Room Temperature.]After constitution, dilute and use promptly. DISCARD BAG WITHIN 4 HOURS AFTER INITIAL ENTRY. See package insert for full information.
  • THIS PHARMACY BULK PACKAGE IS INTENDED FOR PREPARING MANY SINGLE DOSES IN A PHARMACY ADMIXTURE PROGRAM.
  • See package insert for detailed constitution, final dilution, and administration instructions. Protect from light: THE INNER BAG SHOULD BE RETAINED IN THE OUTER BAG UNTIL TIME OF USE.SmartPak system components are not made with natural rubber latex.
  • Manufactured in Italy for Samson Medical Technologies, L.L.C.Cherry Hill, NJ 08003
  • Product No. 8100A8100

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