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ELFERRI S 100 INJ. :

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  Elferri S 100 (5ml Ampoule)
  Each ml contains:
Ferric Hydroxide in Complex with Sucrose
equivalent to elemental Iron 20mg
   
   
  Therapeutic Indications & Usage
   
  Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD) patients
receving an Erythropoietin.
   
  Peritoneal Dialysis Dependent Chronic Kidney Disease ( PDD-CKD)
patient receiving an Erythro.
   
  Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) patients
receiving or not receiving an Erythropoietin.
   
  Contraindications
   
  The use of Iron sucrose is contraindicated in patients with evidence of iron overload ,in patients with known hypersensitivity to it or any of its inactive components, and in patients with anemia not caused by iron deficiency.
   
   
  Precautions
   
  General : Because body iron excretion is limited and excess tissue iron can be hazardous,caution should be exercised to withhold iron administration in the presence of evidence of tissue iron overload.Patients receiving Iron sucrose require periodic monitoring of hematologic and hematinic parameters. Iron theraphy should be withheld in patients with evidence of Iron overload.Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus, serum iron values may be reliably obtained 48 hours after IV dosing .
   
   
  Hypersensitivity Reactions : serious hypersensitivity reactions have been rarely reported in patients receiving Iron sucrose.
   
  Hypotension : Hypotension has been reported in chronic kidney disease patients receiving intravenous iron. Hypotension following administration and total dose administered.
   
  Caution -should be taken to administer Iron Sucrose according to recommended guidelines.
   
  Carcinogenesis,Mutagenesis,and Impairment of Fertility : No long-term studies in animals have been performed to evalute the carcinogenic potential of Iron sucrose.
   
  Pregnancy Category B : No adequate and well controlled studies in pregnant women have been reported.because animal reproduction studies are not always predictive of human response,this drug should be exercised when Iron sucrose is administered to a nursing woman.
   
  Pediatric Use : Safety and effectiveness of Iron sucrose in pediatric patients have not been established.
   
  Geriatric Use : There are no identified difference in responses between elderly and younger pateints, but greater sensitivity of some of the other individuals.cannot be ruled out.
   
  Warnings
   
  Hypersensitivity reaction have been reported with injectable iron products.
   
   
  Special Precautions :
   
  Adverse reaction include hypotension, chest pain, hypertension, hypervolemia, CHF, cramps, musculoskeletal pain, diarrhea, nausea, vomitting, abdominal pain, elevated liver enzymes, skin irritation, pruitis, application site reaction, dizziness, dyspnea, pneumonia, cough, headache, fever, asthenia, malaise.
   
   
  Drug Interactions
   
  Iron sucrose should not be adminstered,concomitantly with oral iron preparations since the absorption of oral iron is reduced.
   
  Recommended Dosage & Administration
   
  The dosage of Iron sucrose is expressed in terms of mg of elemental iron.
Each ml contains 20 mg of elemental iron.
   
  Adminstration : Iron sucrose must only be administered intravenously either by slow injection or by infusion.
   
  Presentations :
   
  Elferri S 100 is available in a 5 ml Ampoule containing 100 mg of Iron Sucrose
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
         
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