Posology : מינונים

4.2    Posology and method of administration

Posology
Adult Males
ELIGARD should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment.

ELIGARD 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a three-month period.

As a rule, therapy of advanced prostate cancer with ELIGARD 22.5 mg entails long-term treatment and therapy should not be discontinued when remission or improvement occurs.

ELIGARD 22.5 mg may be used as neoadjuvant or adjuvant therapy in combination with radiotherapy and an anti-androgen, in high-risk localised and locally advanced prostate cancer.

Response to ELIGARD 22.5 mg should be monitored by clinical parameters and by measuring prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical castration levels within 3 - 4 weeks. Once attained, castrate levels were maintained as long as medicinal product therapy continued (< 1% testosterone breakthroughs). In case the patient’s response appears to be sub-optimal, it should be confirmed that serum testosterone levels have reached or are remaining at castrate levels. As lack of efficacy may result from incorrect preparation, reconstitution, or administration, testosterone levels should be evaluated in cases of suspected or known handling errors (see section 4.4).

Paediatric population
Safety and efficacy in children aged 0 to 18 years have not been established (see also section 4.3).

Specific Patient Populations
No clinical studies were performed in patients with either liver or kidney impairment.
Method of administration

ELIGARD 22.5 mg should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures. Instructions for reconstitution and administration must be strictly followed (see section 4.4 and 6.6). If the product is not prepared appropriately, it should not be administered.

The contents of the two pre-filled sterile syringes must be mixed immediately prior to administration of ELIGARD 22.5 mg by subcutaneous injection.

Based on data from animal experience, intra-arterial or intravenous injection, respectively, has to be strictly avoided.

As with other medicinal products administered by subcutaneous injection, the injection site should be varied periodically.