The efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A should be given alone mainly in case of intolerance or contraindication to ribavirin.

- Follicular non-Hodgkin's lymphoma.

- Advanced renal cell carcinoma.

- Patients with AJCC stage II malignant melanoma (Breslow tumour thickness > 1.5 mm, no lymph node involvement or cutaneous spread) who are free of disease after surgery.

4.2 Posology and method of administration

 Not all available Roferon-A strengths can be used for all indications mentioned in section 4.1 Therapeutic indications. The prescribed strength should correspond with the recommended dose for each individual indication.

- HAIRY CELL LEUKAEMIA

Initial dosage:

Three million IU daily, given by subcutaneous injection for 16 - 24 weeks. If intolerance develops, either the daily dose should be lowered to 1.5 million IU or the schedule changed to three times per week, or both.

Maintenance dosage:

Three million IU, given three times per week by subcutaneous injection. If intolerance develops, the dose should be lowered to 1.5 million IU three times per week.

Duration of treatment:

Patients should be treated for approximately six months before the physician decides whether to continue treatment in responding patients or to discontinue treatment in non-responding patients. Patients have been treated for up to 20 consecutive months. The optimal duration of Roferon-A treatment for hairy cell leukaemia has not been determined.

The minimum effective dose of Roferon-A in hairy cell leukaemia has not been established.

- AIDS-RELATED KAPOSI'S SARCOMA

Roferon-A is indicated for the treatment of AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count > 250/mm3. AIDS patients with CD4 counts < 250/mm3, or those with a history of opportunistic infections or constitutional symptoms, are unlikely to respond to Roferon-A therapy and therefore should not be treated. The optimal posology has not yet been well established.

Roferon-A should not be used in conjunction with protease inhibitors. With the exception of zidovudine, there is a lack of safety data for the combination of Roferon-A with reverse transcriptase inhibitors.

Initial dosage:

Roferon-A should be given by subcutaneous injection, and escalated to at least 18 million IU daily and if possible to 36 million IU daily for a total of ten to twelve weeks in patients of 18 years or older. The recommended escalation schedule is as follows:

 
days 1-3
 3 million IU daily
 
days 4-6
 9 million IU daily
 
days 7-9
 18 million IU daily - and, if tolerated, increase to:
 
days 10-84
 36 million IU daily
 

Maintenance dosage:

Roferon-A should be given by subcutaneous injection three times per week at the maximum dose which is acceptable to the patient, but not exceeding 36 million IU.

Patients with AIDS-related Kaposi's sarcoma treated with 3 million IU of Roferon-A given daily showed a lower response rate than those treated with the recommended dosage.

Duration of treatment:

The evolution of lesions shou