1 PRODUCT MONOGRAPH - DVT ORGARAN Danaparoid Sodium ...

isks with the potential benefits to the patient in determining whether to administer a low
molecular weight heparin or heparinoid in this patient population.
PRECAUTIONS
ORGARAN ® (DANAPAROID SODIUM) CANNOT BE USED INTERCHANGEABLY (UNIT
FOR UNIT) WITH UNFRACTIONATED HEPARIN OR LOW MOLECULAR WEIGHT
HEPARINS (LMWHs) AS THEY DIFFER IN THEIR MANUFACTURING PROCESS,
MOLECULAR WEIGHT DISTRIBUTION, ANTI-XA AND ANTI-IIA ACTIVITIES, UNITS
DOSAGES AND MODE OF ACTION. SPECIAL ATTENTION AND COMPLIANCE WITH
INSTRUCTIONS FOR USE OF EACH SPECIFIC PRODUCT IS REQUIRED DURING ANY
CHANGE IN TREATMENT.
In stroke patients, intracranial/intracerebral haemorrhage (haemorrhagic stroke) should be
excluded by CT scan prior to the administration of ORGARAN ® .
Biochemical Monitoring
ORGARAN ® has only a moderate prolonging effect on clotting time assays such as APTT or
thrombin time. For lab monitoring of effect, plasma anti-Xa activity using amidolytic methods are
recommended. For all assay methods, ORGARAN ® should be used as the calibrator for the
reference standard. Dose increases aimed at prolonging APTT to the same extent as with
unfractionated heparin could cause overdose and bleeding.
ORGARAN ® is administered subcutaneously, and therefore, the individual patient’s antifactor Xa
activity level will not remain within the range that would be expected with unfractionated heparin
by continuous i.v. infusion throughout the entire dosing interval. The peak plasma antifactor Xa
level occurs 4 hours after subcutaneous administration. Administration of single doses of up to
3200 U ORGARAN ® produce levels of less than 0.5 U/mL anti-Xa activity. ORGARAN ®
administered as a bolus dose of 4000-4800 U produces mean anti-Xa levels of greater than 0.5
U/mL Steady state plasma anti-Xa levels are reached at day 4-5. ORGARAN ® should be
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