FONDAPARINUXSODIUM

Indications & Dose:

Subcutaneous administration;The sites of subcutaneous injection 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. This product 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 package leaflet (see Instructions for Use/Handling). Intravenous administration (first dose in STEMI patients only);Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50m1) 0.9% saline minibag. 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 intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered, If administered via a mini-bag, the infusion should be given over 1 to 2 minutes Adults: PREVENTION OF VTE:Orthopaedic and abdominal surgery: the recommended dose of is 2.5 mg once daily, administered postoperatively by subcutaneous injection. The timing of the first dose should be no earlier than 6 hours following surgical closure, and only after hemostasis has been established (see Warnings and Precautions). Treatment should be continued until the risk of venous thromboembolism 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. In these patients the use of prolonged prophylaxis with should be considered for up to an additional 24 days (see Clinical Studies). Medical patients at risk of thromboembolic complications: the recommended dose of is 2.5 mg once daily administered by subcutaneous injection. A treatment duration of 6 to 14 days has been clinically studied in medical patients (see Clinical Studies).TREATMENT OF DVT AND PE:The recommendeddose of to be administered by subcutaneous injection once daily is:• 5 mg for body weight less than 50 kg; • 7.5 mg for body weight 50 to 100 kg; • 10 mg for body weight greater than 100 kg. Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalized Ratio 2 to 3). Concomitant treatment with vitamin K antagonists should be initiated as soon as possible, usually within 72 hours. The usual duration of treatment is 5 to 9 days (see Clinical Studies).TREATMENT OF UNSTABLE ANGINA NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (UAINSTEMI):The recommended dose of is 2.5 mg once daily, administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge. If a patient is to undergo percutaneous coronary intervention (PCI) while on , unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient’s potential risk of bleeding, including the time since the last dose of (see Warnings and Precautions). The timing of restarting subcutaneous after sheath removal should be based on clinical judgment. In the UA/NSTEMI clinical trial treatment with was restarted no earlier than 2 hours after sheath removal. In patients who are to undergo coronary artery bypass graft (CABG) surgery, where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.TREATMENT OF ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI): The recommended dose of is 2.5 mg once daily. The first dose of is administered intravenously and subsequent doses are administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge. If a patient is to undergo non-primary percutaneous coronary intervention (PCI) while on , unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient’s potential risk of bleeding, including the time since the last dose of (see Warnings and Precautions). The timing of restarting subcutaneous after sheath removal should be based on clinical judgment. In the STEMI clinical trial treatment with was restarted no earlier than 3 hours after sheath removal. In patients who are to undergo coronary artery bypass graft (CABG) surgery, where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.ChildrenThe safety and efficacy of in patients under the age of 17 has not been established. Elderly (from 75 years) should be used with caution in elderly patients as renal function decreases with age (see Renal impairment, Warnings and Precautions). In patients undergoing surgery, the timing of the first dose of requires strict adherence (see Warnings and Precautions).Patients with body weight less than 50 kg Patients with body weight below 50 kg are at increased risk of bleeding (see Warnings and Precautions). In patients undergoing surgery, the timing of the first dose of requires strict adherence (see Warnings and Precautions).Renal impairmentPrevention and treatment of VTE: should not be used in patients with a creatinine clearance of less than 30 mI/min (see Warnings and Precautions and Pharmacokinetics). No dosage reduction is required for patients with a creatinine clearance greater than or equal to 30 mI/mm. In patients undergoing surgery, the timing of the first dose of requires strict adherence.Treatment of UAINSTEMI and STEM!:is not recommended for use in patients with a creatinine clearance of less than 20 mI/mm (see Warnings and Precautions). No dosage reduction is required for patients with a creatinine clearance greater than or equal to 20 mI/mm. Hepatic impairmentNo dosing adjustment of is necessary (see Pharmacokinetics). In patients with severe hepatic impairment, should be used with caution (see Warnings and Precautions).

Contraindications:

Known hypersensitivity to or any of the excipients. Active clinically significant bleeding.Acute bacterial endocarditis.Pregnancy and Lactation Pregnancy: There are limited clinical data available on exposed pregnancies. should not be prescribed to pregnant women unless the benefit outweighs the risk.

Side Effects:

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Discontinuation and search for the primary cause. Initiation of appropriate therapy which may include surgical homeostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.

Lactations:

Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with Effects on Ability to Drive and Use Machines: No studies on the effect on the ability to drive and to use machines have been performed.

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Discontinuation and search for the primary cause. Initiation of appropriate therapy which may include surgical homeostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.

Patient And Carer Advice: