Addition of following text under section 4.2:

Paediatric patients: As no dose adjustment is necessary, the recommended dose is 0.20 mg/kg/day.

Addition of following text under section 5.1:

Paediatric patients

In pivotal clinical studies, 246 patients (<18 years) were treated with rasburicase at doses of 0.15 mg/kg/day or 0.20 mg/kg/day for 1 to 8 days (mainly 5 to 7 days). Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma uric acid levels) of 96.1%. Safety results on 246 patients were consistent with the adverse events profile in the overall population.

In long term safety studies, an analysis of data from 867 patients (< 18 years) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.

4.2       Posology and method of administration

The duration of treatment with Fasturtec may vary between 5 and 7 days.

Replace the above with: The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.

4.6       Pregnancy and lactation

Animal studies with respect to effects on pregnancy, embryonic/fœtal development, parturition and postnatal development have not been performed (see section 5.3. ).

Replace the above with: Animal studies with respect to effects on parturition and postnatal development have not been performed (see section 5.3.).

10.       DATE OF REVISION OF THE TEXT

09/2006

1. Name of the Medicinal Product

Removal of the black triangle.

3. Pharmaceutical Form

Replacement of: -

The reconstituted solution is clear and colourless.

With

The powder is an entire or broken white to off white pellet

The solvent is a colourless and clear liquid

4.3. Contraindications

Hypersensitivity to uricases or any of the excipients.

Changed to

Hypersensitivity to the active substance or any of the excipients.

4.8. Undersirable Events

Update to the following table

Addition of hypotension, rhinitis and haemolytic anaemia as possible allergic reactions; update frequencies of hypersensitivity reactions in line with most recent (including downgrading of nausea and vomiting).

Addition of the statement

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness