Revasc

Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders. 6. Adult and elderly patients The recommended dose is 15 mg twice daily. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.

Treatment with desirudin is then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first. Currently, there is no clinical experience to support the use of desirudin beyond 12 days.

Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. Children There is no experience in children. 3). 4) activated partial thromboplastin time (aPTT) should be monitored.

3). 4) aPTT monitoring is recommended.

In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.

As with other anticoagulants, bleeding is the most common adverse reaction. The following related adverse reactions were listed below by system organ class and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000).

6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.

Rare:

Anti-hirudin antibodies have been detected upon re-exposure to desirudin in clinical trials. Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.

Medicinal product no longer authorised 6

8). Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course. Although fatal reactions have not been reported with desirudin, alternative treatment options must be considered before the decision to re-expose a patient to Revasc.

As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk. Treatment initiation with Revasc should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.

Patients should be informed that they have received Revasc. Desirudin should not be administered by intramuscular injection owing to the risk of local haematoma. g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary bleeding within the past 3 months.

Precautions When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.

If necessary, therapy with desirudin should be interrupted until aPTT returns to less than twice the control value at which time treatment with desirudin can be resumed at a reduced dose. Desirudin should be used with care in patients receiving anticoagulants, and/or platelet inhibitors, and/or non-steroidal anti-inflammatory medicinal products.

5). The concomitant use of desirudin with thrombolytics and ticlopidine has not been investigated in this patient population. The anticoagulant effect of desirudin is poorly reversible.

Medicinal product no longer authorised 4 Laboratory Tests:

Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/or renal or hepatic impairment. Peak aPTT should not exceed twice the control value. 5).

6) - with severe uncontrolled hypertension and subacute bacterial endocarditis.