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HEPARIN SODIUM ROVI is a brand name for Heparin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prophylaxis of deep vein thrombosis and pulmonary embolism, - Treatment of deep vein thrombosis and pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion, - Prophylaxis of mural thrombosis following myocardial infarction, - Use in extracorporeal circulation and haemodialysis.
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration By continuous intravenous infusion or by intermittent intravenous injection or by subcutaneous injection. The intravenous injection volume of heparin injection should not exceed 15 mL. As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.
Posology Prophylaxis of deep vein thrombosis and pulmonary embolism Adults: 2 hours pre-operatively: 5,000 units subcutaneously followed by: 5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant No laboratory monitoring should be necessary during low dose heparin prophylaxis.
If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged.
Elderly:
Dosage reduction and monitoring of APTT may be advisable.
Paediatric population:
No dosage recommendations.
Treatment of deep vein thrombosis and pulmonary embolism Adults:
Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism) Maintenance: 1,000-2,000 units/hour by intravenous infusion, or 10,000-20,000 units 12- hourly subcutaneously, or 5,000-10,000 units 4-hourly by intravenous injection Elderly: Dosage reduction may be advisable.
Children and small adults:
Loading dose: 50 units/kg intravenously Maintenance: 15-25 units/kg/hour by intravenous infusion, or 250 units/kg 12-hourly subcutaneously, or 100 units/kg 4-hourly by intravenous injection Treatment of unstable angina pectoris and acute peripheral arterial occlusion Adults: Loading dose: 5,000 units intravenously Maintenance: 1,000-2,000 units/hour by intravenous infusion, or 5,000-10,000 units 4-hourly by intravenous injection Elderly: Dosage reduction may be advisable.
5 x midpoint of normal range or control value. Prophylaxis of mural thrombosis following myocardial infarction Adults: 12,500 units 12-hourly subcutaneously for at least 10 days.
The following adverse reactions have been observed and reported during treatment with Heparin sodium with the following frequencies: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (<1/10 000), not known (cannot be estimated from available data).
System Organ Class MedDRA Preferred Term Frequency Vascular disorders Haemorrhage Epistaxis Contusion Not known Not known Not known Blood and lymphatic system disorders Thrombocytopenia Not known Renal and urinary disorders Haematuria Not known Endocrine disorders Adrenal insufficiency Hypoaldosteronism Not known Not known Skin and subcutaneous tissue disorders Alopecia Skin necrosis Bullous haemorrhagic dermatosis Not known Not known Not known Musculoskeletal and connective tissue disorders Osteoporosis Not known Immune system disorders Hypersensitivity Not known Metabolism and nutrition disorders Rebound hyperlipidaemia Hyperkalaemia Hypokalaemia Not known Not known Not known Reproductive system and breast disorders Priapism Not known General disorders and administration site conditions Injection site reaction Not known Investigations Alanine aminotransferase increased; Asparate aminotransferase increased Not known Not known Erythematous nodules, or infiltrated and sometimes eczema-like plaques, at the site of subcutaneous injections are common, occurring 3-21 days after starting heparin treatment.
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.
Heparin should be used with caution in patients with hypersensitivity to low molecular weight heparin. Care should be taken when heparin is administered to patients with increased risk of bleeding complications, hypertension, renal or hepatic insufficiency.
Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre- existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs.
The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.
5). In patients undergoing peri-dural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peri-dural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs, platelet inhibitors or anticoagulants and by traumatic or repeated puncture.
In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peri-dural 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 anti-coagulation in the context of peri-dural 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 and bowel or bladder dysfunction.
1. This heparin formulation contains the preservative benzyl alcohol and so must not be given to children under 3 years old, premature babies or neonates. As benzyl alcohol may cross the placenta the use of this formulation must be avoided in pregnancy.
Current (or history of) immune-mediated heparin-induced thrombocytopenia. An epidural anaesthesia during birth in pregnant women treated with heparin is contraindicated. Regional anaesthesia in elective surgical procedures is contra-indicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.
Generalised or local haemorrhagic tendency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Elderly:
Dosage reduction may be advisable.
In extracorporeal circulation and haemodialysis:
Adults: Cardiopulmonary bypass: Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.
Haemodialysis and haemofiltration:
Initially: 1,000-5,000 units Maintenance: 1,000-2,000 units/hour, adjusted to maintain clotting time >40 minutes Heparin resistance Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect.
4, Special warnings and precautions for use.
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. Cases of haemorrhagic bullous dermatosis associated with heparin use have been described in the medical literature; therefore, the frequency cannot be established.
The reaction is characterized by the appearance of tense, haemorrhagic blisters distant from the heparin injection site, with a favourable clinical course after dose reduction, discontinuation, or even maintenance. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these. Heparin should not be administered by intramuscular injection due to the risk of haematoma. Due to increased bleeding risk, care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.
As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.
Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. Heparin sodium ROVI contains benzyl alcohol (10mg/ml) as preservative. Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”).
The minimum amount of benzyl alcohol at which toxicity may occur is not known. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).