Method of administration: Subcutaneous administration: The sites of subcutaneous injection should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall. To 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.
Fondaparinux sodium is intended for use under a physician's guidance. Patients may self-inject only if their physician determines that it is appropriate, and with medical follow-up as necessary. Proper training in subcutaneous injection technique should be provided. Instruction for self-administration is included in the monograph (See Instruction for use under Cautions for Usage).
Step by step instructions: Fondaparinux sodium is administered by subcutaneous or intravenous injection. Fondaparinux sodium should not be administered by intramuscular injection. Subcutaneous injection is administered in the same way as with a standard syringe. Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50 mL) 0.9% saline mini bag.
Adults: Prevention of VTE: Orthopaedic and abdominal surgery: The recommended dose of Fondaparinux sodium is 2.5 mg once daily, administered post-operatively by subcutaneous injection. The timing of the first dose should be no earlier than 6 hours following surgical closure, and only after haemostasis has been established (see PRECAUTIONS).
Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patients 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. In these patients the use of prolonged prophylaxis with Fondaparinux sodium should be considered for up to additional 24 days.
Medical patients at risk of thromboembolic complications: The recommended dose of Fondaparinux sodium is 2.5 mg once daily administered by subcutaneous injection. A treatment duration of 6 to 14 days.
Special Population: Children: The safety and efficacy of Fondaparinux sodium in patients under the age of 17 has not been established.
Elderly (from 75 years): Fondaparinux sodium should be used with caution in elderly patients as renal function decreases with age (see Renal impairment under PRECAUTIONS). In patients undergoing surgery, the timing of the first dose of Fondaparinux sodium requires strict adherence (see PRECAUTIONS).
Patients with body weight less than 50 kg: Patients with body weight below 50 kg are at increased risk of bleeding (see PRECAUTIONS). In patients undergoing surgery the timing of the first dose of Fondaparinux sodium requires strict adherence (see PRECAUTIONS).
Renal impairment: Prevention of venous thromboembolic event (VTE).
No dosage reduction is required in patients with a creatinine clearance greater than or equal to 30 mL/min. In patients with a creatinine clearance of between 20 to 30 mL/min in whom the physician determines that the benefit of thromboprophylaxis exceeds the risk, a dose of 2.5 mg on alternate days (each dose approximately 48 hours apart) is recommended (see PRECAUTIONS).
Fondaparinux sodium is not recommended for use in patients with a creatinine clearance of less than 20 mL/min (see PRECAUTIONS). In patients undergoing surgery, the timing of the first dose of Fondaparinux requires strict adherence.
Treatment of venous thromboembolic event (VTE): No dosage reduction is required in patients with a creatinine clearance greater than or equal to 30 mL/min. Fondaparinux sodium should not be used in patients with a creatinine clearance of less than 30 mL/min (see PRECAUTIONS).
Hepatic impairment: No dosing adjustment of Fondaparinux sodium is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, Fondaparinux sodium should be used with caution (see PRECAUTIONS).
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