There is evidence from clinical studies that the risk of bleeding increases with decreasing creatinine clearance and hence also reduced plasma clearance of tirofiban. Patients with decreased renal function (creatinine clearance <60ml/min) should therefore be carefully monitored for bleeding during treatment with Aggrastat and the heparin effect should be carefully monitored. In severe kidney failure the Aggrastat dosage should be reduced (see section 4.2).
Femoral artery line

During treatment with Aggrastat there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced. Care should be taken to ensure that only the anterior wall of the femoral artery is punctured. Arterial sheaths may be removed when coagulation has returned to normal, e.g. when activated clotting time (ACT) is less than 180 seconds, (usually 2–6 hours after discontinuation of heparin).

After removal of the introducer sheath, careful haemostasis should be ensured under close observation.
General nursing care

The number of vascular punctures, and intramuscular injections should be minimised during the treatment with Aggrastat. I.V. access should only be obtained at compressible sites of the body. All vascular puncture sites should be documented and closely monitored. The use of urinary catheters, nasotracheal intubation and nasogastric tubes should be critically considered.
Monitoring of laboratory values

Platelet count, haemoglobin and haematocrit levels should be determined before treatment with Aggrastat as well as within 2-6 hours after start of therapy with Aggrastat and at least once daily thereafter while on therapy (or more often if there is evidence of a marked decrease). In patients who have previously received GPIIb/IIIa receptor antagonists (cross reactivity can occur), the platelet count should be monitored immediately e.g. within the first hour of administration after re-exposure (see section 4.8). If the platelet count falls below 90,000/mm3, further platelet counts should be carried out in order to rule out pseudothrombocytopenia. If thrombocytopenia is confirmed, Aggrastat and heparin should be discontinued. Patients should be monitored for bleeding and treated if necessary (see section 4.9).

In addition, activated thromboplastin time (APTT) should be determined before treatment and the anticoagulant effects of heparin should be carefully monitored by repeated determinations of APTT and the dose should be adjusted accordingly (see section 4.2). Potentially life-threatening bleeding may occur especially when heparin is administered with other products affecting haemostasis, such as GPIIb/IIIa receptor antagonists.
Sodium content

Aggrastat Solution

Aggrastat solution for infusion contains approximately 917 mg of sodium per 250 ml bag which should be taken into consideration by patients on a controlled sodium diet.

Aggrastat Concentrate

Aggrastat concentrate for solution for infusion contains approximately 189 mg of sodium per 50 ml vial which should be taken into consideration by patients on a controlled sodium diet.

**TIMI major bleeds are defined as a haemoglobin drop of > 50 g/l with or without an identified site, intracranial haemorrhage, or cardiac tampo