Posology : מינונים

4.2       Posology and method of administration

Adults:

Posology of intravenous administration:
The recommended dose of Carmustine as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks. This may be given as asingle dose or divided into two daily injections such as 75 to 100 mg/m2 on two successive days.

When Carmustine is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should beadjusted accordingly.

A repeat course of Carmustine should not be given until circulating blood elementshave returned to acceptable levels (platelets above 100,000/ mm3, leukocytes above4,000/ mm3), and this is usually in six weeks. Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed hematologic toxicity.

Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products. The following schedule is suggested as a guide to dosage adjustment:

Nadir after Prior Dose                             Percentage of prior dose Leucocytes/ mm3      Platelets/ mm3                to be given
>4000                >100,000                      100
3000 - 3999          75,000 - 99,999               100
2000 - 2999          25,000 - 74,999               70
<2000                <25,000                       50

Children:
Carmustine should be used with extreme caution in children due to the high risk of pulmonary toxicity (see Warnings).

Elderly:
In general, dose selection for an elderly patient should be cautious, usually starting atthe low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Because elderly patients are more likely to have decreased renal function, care shouldbe taken in dose selection, and renal function should be monitored.


Method of administration:
Following reconstitution (please, see Section 6.6) with sterile diluent (3 ml vial provided) and dilution with water for injection, Carmustine should be administered byintravenous drip over one to two hour period. The time of infusion should not be less than one hour otherwise it leads to burning and pain at the injected area. The injectedarea should be monitored during the administration.
There are no limits for the period of application of carmustine therapy. In case thetumor remains uncurable or some serious or untolerable side effects appear, the carmustine therapy must be terminated.