REVASC Powder and solvent for solution for injection Ref.[9397] Active ingredients: Desirudin

Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders. Instructions for the preparation of Revasc are provided in section 6.6.

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.

Patients with renal impairment

Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/min corresponding to a serum creatinine > 2.5mg/dl or 221μmol/l; see section 4.3). In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.

Patients with liver impairment

Desirudin is contraindicated in severe hepatic impairment (see section 4.3). In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.

There is no antidote for desirudin. Overdosage of desirudin could lead to bleeding complications. In such cases desirudin should be discontinued. If necessary, plasma expanders and/or blood transfusion may be used.

Shelf life: 3 years.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in controlled and validated aseptic conditions.

Do not store above 25°C.

Keep the vial and ampoule in the outer carton in order to protect from light.

For storage conditions of the reconstituted medicinal product, see section 6.3.

15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).

Pack size of 1, 2 or 10.

Not all pack sizes may be marketed.

To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection. The active substance is rapidly redispersed by shaking gently producing a clear solution.

The reconstituted solution should be used as soon as possible (see section 6.3 above).

Any unused product or waste material should be disposed in accordance with local requirements.

Do not use reconstituted vials containing visible particles.