|Heparin Sodium BP
|Sodium Chloride EP
|Disodium Phosphate Dodecahydrate EP
|Citric Acid Monohydrate EP
DosageDosage of heparin should be titrated against patient response.
Heparinisation for dialysis proceduresDosage is dependent upon the age, weight and clinical condition of the patient.It is suggested that a proper heparinisation schedule is used before, and maintained throughout the procedure to prevent clotting and subsequent blood path obstruction.
Maintenance of Catheter PatencyThe dosage should be adapted to catheter characteristics and the clinical condition of the patient.
AdministrationAdministration is by intravenous infusion.
Elderly patientsA higher incidence of bleeding has been reported in patients over 60 years of age, especially women. Clinical studies indicate that lower doses of heparin may be indicated in these patients.
Pregnancy:The safety of heparin sodium in 0.9% w/v Sodium Chloride intravenous infusion has not been demonstrated in pregnant women.There are no or limited amount of data from the use of Heparin Sodium in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.Heparin Sodium is not recommended during pregnancy.
Breast-feeding:Heparin does not pass the placental barrier; it is not excreted in human milk Heparin Sodium can be used during breast-feeding.
Adverse Drug Reactions
|System Organ Class (SOC)
|MedDRA Preferred Term
|Blood and lymphatic system disorders
|Renal and urinary disorders
|Skin and subcutaneous tissue disorders
|Musculoskeletal, connective tissue and bone disorders
|Immune system disorders
|Metabolism and nutrition disorders
|Reproductive system and breast disorders
|General disorders and administration site conditions
|Injection site reaction,
|Alanine aminotransferase increased; Aspartate aminotransferase increased
Haemorrhage:Haemorrhage is the chief complication that may result from heparin therapy. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug. It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific haemorrhage complications may be difficult to detect.Adrenal haemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal haemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient's death.Ovarian (corpus luteum) haemorrhage developed in a number of women of reproductive age receiving short or long-term anticoagulant therapy. This complication if unrecognized may be fatal.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.Website: www.mhra.gov.uk/yellowcard