Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
ELIGARD 22.5 mg, powder and solvent for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One prefilled syringe with powder for solution for injection contains 22.5 mg leuprorelin acetate, equivalent to 20.87 mg leuprorelin.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection,
Powder (Syringe B):
Pre-filled syringe with a white to off-white powder.
Solvent (Syringe A):
Pre-filled syringe with a clear, colourless to pale yellow solution
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
ELIGARD 22.5 mg is indicated for the treatment of hormone dependent advanced prostate cancer
4.2 Posology and method of administration
Dosage for 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.
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.
Administration
The contents of the two pre-filled sterile syringes must be mixed immediately prior to administration of ELIGARD 22.5 mg by subcutaneous injection.
Regarding the mixing procedure, see section 6.6.
Based on data from animal experience, intra-a
