ORGARAN 750 ANIT-XA UNITS/0.6 ML SOLUTION FOR INJE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
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Active ingredient:
DANAPAROID SODIUM
Available from:
Organon (Ireland) Limited
Dosage:
750IU International Unit
Pharmaceutical form:
Solution for Injection
Authorization date:
2005-01-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Orgaran
750 anti-Xa units/0.6 ml
Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Orgaran contains danaparoid sodium, which is a non-heparin mixture of low molecular weight sulfated
glycosaminoglycuronans derived from animal musoca, comprising heparan sulfate, dermatan sulfate and minor amount
of chondroitin sulfates. One ampoule (0.6 mL) contains 750 anti-factor Xa units danaparoid sodium corresponding to
1250 anti-factor Xa units per mL. The anti-Xa unit is derived from the international heparin standard in an antithrombin
containing buffer system.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear/colorless to pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
a. Prevention and treatment of thrombo-embolic disorders in patients who require urgent parenteral anticoagulation
because of the development or a history of heparin-induced thrombocytopenia (HIT).
b. Prevention of deep vein thrombosis (DVT) and its possible consequences, in particular in patients undergoing
orthopaedic, major abdominal or thoracic surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
a. HIT-patients
With respect to this therapeutic indication a number of dosing schedules is available, depending on the underlying
disease and the accompanying hemostatic defects.
Plasma anti-Xa activity is linearly related to the dose of Orgaran given. In general, monitoring of plasma anti-Xa
activity is not necessary. However, in patients suffering from renal insufficiency and/or patients >90 kg body weight
monitoring, once or twice a week during routine subcutaneous or intravenous therapy, is recommended to check for
drug accumulation or under dosing, respectively. If monitoring of anticoagulant
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