Erythropoietin - Recombinant Human- (FDC- List ) (Jan 1993)
Drug Name:
Erythropoietin - Recombinant Human- (FDC- List ) (Jan 1993)
List Of Brands:
Indication Type Description:
Drug Interaction:
Haematinics enhance efficiency.Increased dose of heparin in patients undergoing dialysis.
Indication:
Treatment of anemia associated with CRF,anemia, of HIV infected patients, anemia due to malignancies.
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Eryhthropoietin Anaemia due to chronic January 1993
(rDNA) renal failure
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Erythropoietin Biopharmaceutical Amgen Inc 03-12-2013
Erthropoietin Biopharmaceutical Amgen Inc 20-08-2013
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Etythropoietin 2000 IU /4000 IU 15-06-1995
Mannitol 40mg/40mg +
Nacl 7mg/7mg +
Monobasic sod Phosphate 2.8mg/2.8mg +
Dibasic Sod Phosphate 8mg/8mg +
Human Albumin 5mg/5mg lyophillised 2ml injection
In the treatment of anemia due to chronic renal failure
and stage renal disease
Adverse Reaction:
Hypertensive crisis with encephlopathy like symptoms-headache, confusion, generalised
seizures.
Thrombosis Hypertension,myalgia,arthralgia,flu-like syndrome,rashes and urticaria.
Contra-Indications:
Uncontrolled hypertension,hypersens to mamalian cell products and hypersens to human
albumin.
Special precaution:
CRF,IHD,hypertension,pregnancy,seizures,liver dysfunction.
Dosages/ Overdosage Etc:
Date of Approval 1993
Indications:
Treatment of anemia associated with CRF,anemia, of HIV infected patients, anemia due to
malignancies.
Dosage:
Individualise dose.
Dialysis patients- median dose is 75u/kg 3 times weekly.
Nondialysis CRF patients - usual dose is 75 to 150u/kg per week.