수크로스수산화제이철착염

Iron Sucrose Injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron Sucrose Injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Known hypersensitivity to Iron Sucrose Injection • Known hypersensitivity to Iron Sucrose Injection ( 4 )

• Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload.( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Iron Sucrose Injection. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Iron Sucrose Injection immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with …

8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes ( see Data ). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risk to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ). Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses …