Pharmaceutical combination preparations containing erythropoietin and iron preparations

Abstract

The present invention is directed to a pharmaceutical combination preparation comprising 2,000-7,000 U of recombinant human erythropoietin (EPO) and 5-20 mg of an Fe(III) complex, wherein the rhEPO and the Fe(III) complex may be present in separate administration forms or in an integrated administration form. The pharmaceutical preparation is used in the treatment of anemias or hemodialysis patients.

1 . A pharmaceutical combination preparation, comprising 2,000-7,000 U of EPO and 1-20 mg of an equivalent amount of iron ions of a physiologically tolerable iron preparation.  
     
     
         2 . The combination preparation according to  claim 1 , characterized in that it contains 3,000-7,000 U of EPO and 5-20 mg of iron ions.  
     
     
         3 . The combination preparation according to  claim 1  or  2 , characterized in that it contains 5,000 U of EPO and 10 mg of iron ions.  
     
     
         4 . The combination preparation according to  claim 1 , characterized in that it contains 2,000-4,000 U of EPO and 3-10 mg of iron ions.  
     
     
         5 . The combination preparation according to  claim 4 , characterized in that it contains 3,000 U of EPO and 5 mg of iron ions.  
     
     
         6 . The combination preparation according to one of claims  1 - 5 , characterized in that the iron preparation is a complex having a molecular weight of between 30,000-100,000 D, preferably Fe(III) saccharate.  
     
     
         7 . The combination preparation according to one of claims  1 - 5 , characterized in that the iron preparation is Fe(III) gluconate.  
     
     
         8 . The combination preparation according to one of claims  1 - 3 ,  6  or  7  for the treatment of hemodialysis patients.  
     
     
         9 . The combination preparation according to one of claims  1  or  4 - 7  for the treatment of anemias.  
     
     
         10 . A method for the production of pharmaceutical combination preparations according to claims  1 - 9 , characterized in that 2,000-7,000 U of rhEPO and 1-20 mg of an equivalent amount of iron ions of a physiologically tolerable iron preparation are formulated together with pharmaceutically common carriers or adjuvants, and the respective preparations are provided in the form of combination preparations.  
     
     
         11 . Use of EPO in the production of combination preparations containing 2,000-7,000 U of EPO for combined administration together with 1-20 mg of an equivalent amount of iron ions of a physiologically tolerable iron preparation for the treatment of hemodialysis patients.  
     
     
         12 . Use of EPO in the production of combination preparations containing 2,000-4,000 U of EPO for combined administration together with 3-10 mg of an equivalent amount of iron ions of a physiologically tolerable iron preparation for the treatment of anemias.  
     
     
         13 . A pharmaceutical packing unit, comprising 2,000-7,000 U of EPO and 1-20 mg of an equivalent amount of iron ions of a physiologically tolerable iron preparation as an integrated administration form in a single container or as separate administration forms in separate containers.  
     
     
         14 . The packing unit according to  claim 13 , characterized in that each of EPO and iron preparation are present in separate administration forms as injection and/or infusion solutions or as lyophilizates.  
     
     
         15 . The packing unit according to  claim 13 , characterized in that the EPO and the iron preparation are present in an integrated administration form as an injection and/or infusion solution or as a lyophilizate.  
     
     
         16 . A method for determining the iron status in a sample of body fluids, wherein in a first step, the concentrations of iron, transferrin and ferritin as well as the transferrin saturation, and in a second step, the transferrin/ferritin saturation are determined.  
     
     
         17 . The method according to  claim 16  for determining the iron status in hemodialysis patients.  
     
     
         18 . A method f or determining the iron status in a sample of body fluids, wherein in a first step, the concentrations of ferritin and the transferrin receptor (TfR), and in a second step, the transferrin receptor/ferritin saturation are determined.  
     
     
         19 . The method according to  claim 18  for determining the iron status in anemia patients.