There is insufficient experience with the use of tirofiban hydrochloride in the following diseases and conditions, however, an increased risk of bleeding is suspected. Therefore, tirofiban hydrochloride is not recommended in:

• Traumatic or protracted cardiopulmonary resuscitation, organ biopsy or lithotripsy within the past two weeks

• Severe trauma or major surgery >6 weeks but <3 months previously

• Active peptic ulcer within the past three months

• Uncontrolled hypertension (>180/110 mm Hg)

• Acute pericarditis

• Active or a known history of vasculitis

• Suspected aortic dissection

• Haemorrhagic retinopathy

• Occult blood in the stool or haematuria

• Thrombolytic therapy (see section 4.5).

• Concurrent use of drugs that increase the risk of bleeding to a relevant degree (see section 4.5).

There is no therapeutic experience with tirofiban hydrochloride in patients for whom thrombolytic therapy is indicated. Consequently, the use of tirofiban hydrochloride is not recommended in combination with thrombolytic therapy.

Aggrastat infusion should be stopped immediately if circumstances arise that necessitate thrombolytic therapy (including acute occlusion during PCI) or if the patient must undergo an emergency coronary artery bypass graft (CABG) operation or requires an intra-aortic balloon pump.
Paediatric population

There is no therapeutic experience with Aggrastat in children, thus, the use of Aggrastat is not recommended in these patients.
Other precautionary notes and measures

There are insufficient data regarding the re-administration of Aggrastat.

Patients should be carefully monitored for bleeding during treatment with Aggrastat. If treatment of haemorrhage is necessary, discontinuation of Aggrastat should be considered (see section 4.9). In cases of major or uncontrollable bleeding, tirofiban hydrochloride should be discontinued immediately.

Aggrastat should be used with special caution in the following conditions and patient groups:

• Recent clinically relevant bleeding (less than one year)

• Puncture of a non-compressible vessel within 24 hours before administration of Aggrastat

• Recent epidural procedure (including lumbar puncture and spinal anaesthesia)

• Severe acute or chronic heart failure

• Cardiogenic shock

• Mild to moderate liver insufficiency

• Platelet count <150,000/mm3, known history of coagulopathy or platelet function disturbance or thrombocytopenia

• Haemoglobin concentration less than 11 g/dl or haematocrit <34%.

Special caution should be used during concurrent administration of ticlopidine, clopidogrel, adenosine, dipyridamole, sulfinpyrazone, and prostacyclin.
Efficacy with regard to dose

The administration of a 10 microgram/kg bolus regimen of tirofiban failed to show noninferiority in clinically relevant endpoints at 30 days compared to abciximab (see section 5.1).
Elderly patients, female patients, and patients with low body weight

Elderly and/or female patients had a higher incidence of bleeding complications than younger or male patients, respectively. Patients with a low body weight had a higher incidence of bleeding than patients with a higher body weight. For