Spirulin-BP

Spirulina platensis

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 − Preterm infants, newborns, pregnant or breast-feeding women (contains benzyl alcohol) − Patients with active bleeding, haemophilia; history or suspicion of heparin-induced immune thrombocytopenia or that induced by its 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 arterial hypertension; acute 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. Epidural anaesthesia during delivery is contraindicated in pregnant women treated with heparin − Recent trauma or surgery involving the eyes, ears or central nervous system, and in women at risk of miscarriage − Heparin-BP must not be administered by intramuscular injection. This medicinal product must not be given to young children (under 3 years of age) for longer than one week, because of the increased risk caused by accumulation of benzyl alcohol in young children. Special warnings and precautions for use Clotting time is prolonged immediately after dosing with heparin and remains so for up to 6 hours after intravenous administration. Outpatients should be warned of the risk of bleeding related to possible trauma. Manoeuvres liable to injure blood vessels should be avoided, 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 develops between the 5th and 21st day after starting treatment. If the platelet count falls significantly (by 30 to 50% from baseline), treatment must be discontinued immediately. Such cases are an indication for investigation to confirm the presence of heparin-induced immune (type II) 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)