Posology : מינונים

4.2   Posology and method of administration

Posology
•     Adults
The recommended dose of fludarabine is 25 mg/m2 body surface given daily for 5 consecutive days (= one cycle) every 28 days by the intravenous route.
The required dose (calculated on the basis of the patient's body surface) is drawn up into a syringe.
For intravenous bolus injection this dose is further diluted in10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Alternatively, for infusion, the required dose may be diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or in 100 to 125 ml of glucose 5% solution and infused intravenously over a period of approximately 30 minutes (see also section 6.6).
The optimal duration of treatment has not been clearly established. The duration of treatment depends on the treatment success and the tolerability of the medicinal product.
It is recommended to administer fludarabine until response is achieved (usually after 6 cycles) and then the medicinal product should be discontinued.

•     Patients with hepatic impairment
No data are available concerning the use of fludarabine in patients with hepatic impairment. In this group of patients, fludarabine should be used with caution.
•     Patients with renal impairment
Doses should be adjusted for patients with reduced kidney function. If creatinine clearance is between 30 and 70 ml/min, the dose must be reduced by up to 50% and close haematological monitoring should be used to assess toxicity (see section 4.4). Fludarabine treatment is contraindicated, if creatinine clearance is below 30 ml/min (see section 4.3).

•         Paediatric population
Fludarabine is not recommended for use in children below the age of 18 years due to a lack of data on safety and/or efficacy.

•         Older people
Since there are only limited data available concerning the use of fludarabine phosphate in older people (> 75 years), caution should be exercised when fludarabine phosphate is used for these patients.
In patients over the age of 65 years, creatinine clearance should be measured before start of treatment (see ‘Patients with renal impairment’ and section 4.4).

Method of administration
Fludarabine should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.

It is strongly recommended that fludarabine should be only administered intravenously. No cases have been reported in which paravenously administered fludarabine led to severe local adverse reactions. However, unintentional paravenous administration of fludarabine must be avoided.