Referis Special Precautions

Strict aseptic administration shall be followed.
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 (haemoglobin, haematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose (Referis) injection; thus, serum iron values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported including life threatening and fatal anaphylactic/anaphylactoid reactions in patients receiving Iron sucrose.
Hypotension: Hypotension has been reported frequently in haemodialysis dependent chronic kidney disease patients receiving intravenous iron. Hypotension following administration of Iron sucrose (Referis) injection may be related to rate of 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 evaluate the carcinogenic potential of Iron sucrose. Iron sucrose (Referis) injection was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, or the mouse micronucleus test.
Iron Sucrose Injection (Referis) injection at IV doses up to 15 mg iron/kg/day (about 1.2 times the recommended maximum human dose on a body surface area basis) was found to have no effect on fertility and reproductive performance of male and female rats.
Use in Children: Safety and effectiveness of Iron sucrose (Referis) injection in paediatric patients have not been established.
Use in the Elderly: No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.