FONDAPARINUX SODIUM DR REDDYS

5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection. For patients with body weight < 50 kg, the recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg.

Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.

The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited. Special populations Elderly patients - No dosing adjustment is necessary. 4). 4). There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).

4). 3). Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. 2). 2). Method of administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.

Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection.

The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection. 6.

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings). 4). The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days.

4). The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to <1/1,000; very rare <1/10,000) and system organ class by decreasing order of seriousness.

System organ class MedDRA Adverse reactions in patients treated for VTE1 Blood and lymphatic system disorders Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero- vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise) Uncommon: anaemia, thrombocytopaenia Rare: other bleeding (hepatic, retroperitoneal, intracranial/intracerebral), thrombocythaemia Immune system disorders Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction) Metabolism and nutrition disorders Rare: non-protein-nitrogen (Npn)2 increased Nervous system disorders Uncommon: headache Rare: dizziness Gastrointestina l disorders Uncommon: nausea, vomiting Rare: abdominal pain Hepatobiliary disorders Uncommon: abnormal liver function, hepatic enzymes increased Skin and subcutaneous tissue disorders Rare: rash erythematous, pruritus General disorders and administration site conditions Uncommon: pain, oedema, Rare: reaction at injection site (1) Isolated AEs have not been considered except if they were medically relevant.

(2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. In post marketing experience, rare cases of gastritis, constipation, diarrhoea and bilirubinaemia have been reported. 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.

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.

g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below. As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established.

Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).

During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section

1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.