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DANAPAROID SODIUM is a brand name for Danaparoid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: · Prevention of deep vein thrombosis and its possible consequences in patients undergoing general or orthopaedic surgery. · Treatment of thrombo-embolic disorders in patients who require urgent parenteral anti-coagulation because of the development or history of heparin-induced thrombocytopenia (HIT).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology a) Non-HIT patients (DVT prophylaxis) In general, Danaparoid sodium should be administered by subcutaneous injection at a dose of 750 anti-factor Xa units, twice daily for 7 to 10 days or until the risk of thromboembolism has diminished.
In surgical patients it is recommended to start this dosing pre-operatively and to give the last pre-operative dose 1-4 hours before surgery. Plasma anti-Xa activity is linearly related to the dose of Danaparoid Sodium given. If it is necessary to monitor anticoagulant activity, and for individual dose setting, a functional anti-factor Xa test using a chromogenic peptide substrate should be used.
In this test Danaparoid Sodium should be used as standard for constructing the reference curve. b) HIT patients The diagnosis of HIT should as a minimum be based on: 1) thrombocytopenia (platelet count<100x109/L) occurring during heparin administration and 2) exclusion of all other causes of thrombocytopenia In general monitoring of plasma anti-Xa activity is not necessary.
However, in patients suffering from renal insufficiency and/or patients weighing over 90kg, monitoring (using an amidolytic assay) is recommended. Danaparoid Sodium should be administered intravenously as a bolus of 2500 anti-Xa units (for patients less than 55kg 1250 units, if over 90kg, 3750 units) followed by an intravenous infusion of 400units/h for 2 hours, then 300 units/h for 2 hours, then a maintenance infusion of 200 units/h for 5 days.
8 units/ml during the maintenance infusion.
Elderly:
Clearance of anti-factor Xa activity has not been shown to be markedly reduced in the elderly and the usual dosage is recommended.
Children (age up to 17 years):
There is insufficient experience with the use of Danaparoid Sodium in children to suggest a dosage regimen for this group of patients.
Hepatic or renal impairment:
Danaparoid Sodium should be used with caution in patients with moderately impaired renal and/or liver function with impaired haemostasis. Conversion to anticoagulants is possible, however it is advisable only to start such a therapy once there is adequate antithrombotic control with Danaparoid Sodium.
Enhanced bleeding or haematoma may occur at the operation site. Bruising and/or pain may occur at injection sites. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. ) site: - haemorrhage - discomfort - hypersensitivity - irritation - coldness - pruritus inj.
4). All above terms in this section and synonym terms (with same or less severity) coded with the MedDRA dictionary are considered as ‘listed’. All haemorrhages are listed adverse events for Danaparoid Sodium. g. anaemia, decreased Hb, rbc, hematocrit, faintness, tiredness, tamponade) are listed adverse events.
Liver abnormalities such as changes in transaminase and alkaline phosphatase have been observed, but no clinical significance has been demonstrated. Very rarely, cases of epidural and spinal haematomas were reported in association with prophylactic use of heparins in the context of peridural or spinal anaesthesia and of spinal puncture.
4 ‘Special warnings and precautions for use’). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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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.
As with heparins, in patients receiving Danaparoid Sodium for treatment rather than for prophylaxis, locoregional anaesthesia in elective surgical procedures is contra- indicated. g. haemophilia and idiopathic thrombocytopenic purpura, unless the patient also has HIT and no alternative anti-thrombotic treatment is available * haemorrhagic stroke in the acute phase * uncontrollable active bleeding state * severe renal- and/or hepatic insufficiency, unless the patient also has HIT and no alternative anti-thrombotic treatment is available * severe uncontrolled hypertension * active gastroduodenal ulcer, unless it is the reason for operation * diabetic retinopathy * acute bacterial endocarditis * a positive in vitro aggregation test for the heparin-induced antibody in the presence of Danaparoid Sodium in patients with a history of thrombocytopenia induced by heparin or heparin-like anticoagulants * hypersensitivity to sulfite.
* hypersensitivity to the active substance or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5. 6 ml subcutaneously twice a day, then 24 hours later start anticoagulants 48-72 hours before Danaparoid Sodium is withdrawn to give time for the prothrombin time, Thrombotest and international normalised ratio to reach therapeutic levels (measurement of these parameters is not reliable within 5 hours of Danaparoid Sodium injection (See “Interactions with other medicaments and other forms of interactions”)) or (b) stop the infusion, give no further Danaparoid Sodium then start the anticoagulants 12 hours later.
Method of administration For subcutaneous or intravenous use Solutions may be diluted before use. 6.
• 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.
The risk is increased by the prolonged use of a peridural or spinal catheter for analgesia, by the concomitant use of drugs affecting haemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), and by traumatic or repeated puncture.
• In decision-making on the interval between the last administration of Danaparoid Sodium at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account.
Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed. • Should a physician decide to administer Danaparoid Sodium in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits (numbness and weakness in lower limbs) and bowel or bladder dysfunction.
Nurses should be trained to detect such signs and symptoms. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these. • If signs or symptoms of epidural or spinal haematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.
This medicinal product contains sodium sulfite. May rarely cause severe hypersensitivity reactions and bronchospasm. This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium-free’.