Danaparoid Sodium should not be used if an in vitro test for the heparin- induced antibody in the presence of Danaparoid Sodium is positive in patients with thrombocytopenia induced by heparin or heparin-like anticoagulants, unless no suitable alternative antithrombotic treatment is available.
The incidence of serological cross-reactivity of Danaparoid Sodium with the heparin-induced antibody before the start of therapy is approximately 5%. The incidence of clinical cross-reactivity developing during Danaparoid Sodium therapy is approximately 3% and many of these patients had a negative pre- treatment serological cross-reactivity test.
e. clinical cross-reactivity) is very small, it is advisable to check the number of platelets daily during the first week of treatment, on alternate days during the second and third weeks, and weekly to monthly thereafter. If a pre- treatment cross-reactivity test with Danaparoid Sodium is positive but it is decided to use Danaparoid Sodium, then the number of platelets should be checked daily until Danaparoid Sodium treatment is stopped.
If antibody- induced thrombocytopenia occurs, one should stop the use of Danaparoid Sodium and consider alternative treatment. g. haemophilia and idiopathic thrombocytopenic purpura, unless the patient also has HIT and no suitable alternative antithrombotic treatment is available.
Danaparoid Sodium should not be used in patients with severe renal and hepatic insufficiency unless the patient also has HIT and no alternative antithrombotic treatment is available. Danaparoid Sodium should be used 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.
Danaparoid Sodium should not be administered to patients with active gastric or duodenal ulceration, unless it is the reason for operation. • Since severe bleeding may occur post-operatively in HIT patients undergoing a cardiopulmonary bypass procedure, Danaparoid Sodium is not recommended during the procedure, unless no other antithrombotic treatment is available.
• Danaparoid Sodium should not be given by the intramuscular route. • The safety and efficacy of Danaparoid Sodium in patients with non- haemorrhagic stroke remains to be confirmed. • No incidences of osteoporosis have been reported in patients treated with the recommended dose of Danaparoid Sodium.
However, as for heparin, treatment with glycosaminoglycuronan may result in osteoporosis if the dosage is inappropriate. • It should be noted that the anti-Xa units of Danaparoid Sodium have a different relationship to clinical efficacy than those of heparin and low molecular weight heparins.
• As with heparins, in patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of Danaparoid Sodium may theoretically be associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.