FONDAPARINUX SODIUM DR REDDYS

5 mg once daily administered post-operatively by subcutaneous injection. The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established. Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.

Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. 1). 5 mg once daily administered by subcutaneous injection. 1). 5 mg once daily, administered by subcutaneous injection.

5 mg treatment should have acute, symptomatic, isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long and documented by ultrasonographic investigation or other objective methods. Treatment should be initiated as soon as possible following diagnosis and after exclusion of concomitant DVT or superficial-vein thrombosis within 3 cm from the sapheno-femoral junction.

1). Patients could be recommended to self-inject the product when they are judged willing and able to do so. Physicians should provide clear instructions for self-injection. • Patients who are to undergo surgery or other invasive procedures In superficial vein thrombosis patients who are to undergo surgery or other invasive procedures, fondaparinux, where possible, should not be given during the 24 hours before surgery.

Fondaparinux may be restarted at least 6 hours post-operatively provided haemostasis has been achieved. Special populations Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine clearance ranging between 20 to 50 ml/min.

The first fondaparinux administration should be given not earlier than 6 hours following surgical closure. 4). 3). 2). No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min). 3). 2). No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).

) Hepatic impairment • Prevention of VTE - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. 2). 4). Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.

Low body weight • Prevention of VTE - Patients with body weight <50 kg are at increased risk of bleeding. Elimination of fondaparinux decreases with weight. 4). 4). Method of administration • Subcutaneous 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). 8 ml). These adverse reactions should be interpreted within the surgical or medical context of the indications.

The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000).

System organ class MedDRA common (≥ 1/100, <1/10) uncommon (≥ 1/1,000, <1/100) rare (≥ 1/10,000, <1/1,000) Infections and infestations post-operative wound infections Blood and lymphatic system disorders anaemia, post- operative haemorrhag e, uterovagina l haemorrhag e*, haemoptysi s, haematuria, haematoma , gingival bleeding, purpura, epistaxis, gastrointest inal thrombocytopenia, thrombocythaemia , platelet abnormal, coagulation disorder retroperitoneal bleeding*, hepatic, intracranial/ intracerebral bleeding* bleeding, hemarthrosi s*, ocular bleeding*, bruise* Immune system disorders allergic reaction (including very rare reports of angioedema, anaphylactoid/ anaphylactic reaction) Metabolism and nutrition disorders hypokalaemia, nonprotein- nitrogen (Npn) increased1* Nervous system disorders headache anxiety, confusion, dizziness, somnolence, vertigo Vascular disorders hypotension Respiratory, thoracic and mediastinal disorders dyspnoea coughing Gastrointestinal disorders nausea, vomiting abdominal pain, dyspepsia, gastritis, constipation, diarrhoea Hepatobiliary disorders abnormal liver function tests, hepatic enzymes increased bilirubinaemia Skin and subcutaneous tissue disorders rash erythematous, pruritus General disorders and administration site conditions oedema, oedema peripheral, pain, fever, chest pain, wound secretion reaction at injection site, leg pain, fatigue, flushing, syncope, hot flushes, oedema genital (1)Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.

8 ml. 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.

Fondaparinux must not be administered intramuscularly. 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.

For prevention of VTE- 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).

When required, 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 < 20 ml/min.