Heparin-BP

Heparinum

1 ml solution for injection contains heparin sodium 5000 IU (1 vial of 5 ml contains heparin sodium 25000 IU). Excipients with known effect: benzyl alcohol 9 mg/ml, sodium 4.7 mg/ml.

Indication: Indicated in adults, adolescents and children for the prophylaxis of deep vein thrombosis and pulmonary embolism; treatment of deep vein thrombosis, pulmonary embolism, unstable angina and acute peripheral arterial occlusive disease; prophylaxis of mural thrombosis after myocardial infarction; as an anticoagulant in haemodialysis and extracorporeal circulation.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to heparin or to any of the excipients listed in section 6.1
− Premature infants, newborns, pregnant or breast-feeding women (contains benzyl alcohol)
− Patients with active bleeding, haemophilia; history of or suspected immune-mediated heparin-induced thrombocytopenia or thrombocytopenia induced by heparin derivatives, including low-molecular-weight heparins; haemorrhagic diatheses; other bleeding disorders
− Severe liver disease (including oesophageal varices), purpura, active gastric or duodenal ulcer, other organic lesions with a risk of bleeding
− Severe hypertension; acute-phase ischaemic stroke, with or without impaired consciousness; the first 72 hours after a stroke of embolic origin;
− Cerebral haemorrhage
− Active tuberculosis
− Increased capillary permeability
− Acute bacterial endocarditis
− Loco-regional anaesthesia (spinal, epidural) for elective surgical procedures or lumbar puncture. Use of epidural anaesthesia during delivery in pregnant women treated with heparin is contraindicated
− Recent trauma or surgery involving the eyes, ears or central nervous system, and in women at risk of miscarriage
− Heparin-BP must not be given by intramuscular injection. This medicinal product must not be administered to young children (under 3 years of age) for more than one week, because of the increased risk from accumulation of benzyl alcohol in young children.
Special warnings and precautions for use
Clotting time is prolonged immediately after heparin dosing, up to 6 hours after intravenous administration. Outpatients should be warned of the risk of bleeding associated with possible trauma. It is recommended to avoid procedures that may injure blood vessels, except for strict intravenous injections. Intravenous injections should be avoided in patients with hepatic or renal impairment, hypertension and retinal vascular disease. Like other anticoagulant treatments, heparin must be used with caution in clinical conditions with an increased risk of bleeding, such as: history of peptic ulcer, history of ischaemic stroke, diabetic retinopathy, other chorioretinal vascular disorders. Platelet counts should be performed before starting treatment, on the first day of heparin treatment, and at short intervals during treatment. When it occurs, thrombocytopenia usually appears between the 5th and 21st day after starting treatment. If the platelet count decreases significantly (by 30 to 50% from the baseline value), treatment must be discontinued immediately. Such cases are an indication for investigation to confirm the presence of immune-mediated (type II) heparin-induced thrombocytopenia. If this is confirmed, the patient must be informed that,

Special warnings and precautions (SmPC sec. 4.4, excerpt): (not specified in the SmPC)