MedPath
HSA Product

RECORMON PRE-FILLED SYRINGE 10000 iu/0.6 ml

Product approved by Health Sciences Authority (SG)

Basic Information

RECORMON PRE-FILLED SYRINGE 10000 iu/0.6 ml

INJECTION

Regulatory Information

SIN11423P

November 1, 2000

Prescription Only

Therapeutic

INTRAVENOUS, SUBCUTANEOUS

August 10, 2023

June 4, 2025

XB03XA01

Company Information

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Active Ingredients

EPOETIN BETA

Strength: 10000 iu/0.6 ml

Detailed Information

Contraindications

**2.3 Contraindications** Recormon must not be used in the presence of poorly controllable hypertension and known hypersensitivity to the active substance or to any of the excipients. In the indication “increasing the yield of autologous blood”, Recormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

Indication Information

**2.1 Therapeutic Indications** Recormon is indicated for: - Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. - Treatment of symptomatic renal anemia in patients not yet undergoing dialysis. - Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy. - Increasing the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10 to 13 g/dl \[6.2 to 8.1 mmol/l\], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females; 5 or more units for males). \\* Deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

© Copyright 2025. All Rights Reserved by MedPath