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Safety of Orgaran

• Hypersensitivity to danaparoid sodium or any ingredients of Orgaran.



• In patients receiving Orgaran for treatment rather than for prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated. Severe haemorrhagic diathesis, unless the patient also has HIT. Haemorrhagic stroke in the acute phase.



• Uncontrollable active bleeding state. Severe renal and/or hepatic insufficiency, unless the patient also has HIT. Severe hypertension.



• Acute bacterial endocarditis.



• A positive in vitro aggregation test for the heparin-induced antibody in the presence of Orgaran in patients with a history of thrombocytopenia induced by heparin or heparin-like anticoagulants.


Precautions and warnings:


• Use with caution in patients with moderately impaired renal, and/or liver function with impaired haemostasis, ulcerative lesions of the gastro-intestinal tract or other diseases which may lead to an increased danger of haemorrhage into a vital organ or site.



• Contains sodium sulphite, asthma patients hypersensitive to sulphite may be at risk of bronchospasm and/or anaphylactic shock.



• Check the number of platelets regularly.



• If antibody-induced thrombocytopenia occurs, stop the use of Orgaran.



• Orgaran should not be given by the intramuscular route.



• Safety and efficacy in patients with non-haemorrhagic stroke not confirmed.


Interactions:


• No clinically significant interactions with other medications have been found.


Pregnancy & Lactation:


• Not recommended during pregnancy and lactation.


Adverse reactions:


• Enhanced bleeding or haematoma at the operation site.



• Bruising and/or pain at injection sites.



• Skin rashes.



• Other local or generalised hypersensitivity reactions.



• Antibody induced thrombocytopenia.



• Liver abnormalities without clinical significance.



• Very rarely, cases of epidural and spinal haematomas.


Overdosage:


• In the event of serious bleeding other than caused by a surgical error, Orgaran should be stopped and a blood transfusion should be considered.

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