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
Aclasta 5 mg solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of osteoporosis
• in post-menopausal women
• in men
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
• in post-menopausal women
• in men
at increased risk of fracture.
Treatment of Paget's disease of the bone in adults.
4.2 Posology and method of administration
Posology
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-eva luated periodically based on the benefits and potential risks of Aclasta on an individual patient basis, particularly after 5 or more years of use.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1).
For the treatment of Paget's disease, Aclasta should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Aclasta.
Re-treatment of Paget's disease: specific re-treatment data are not available. After a single treatment with Aclasta in Paget's disease an extended remission period is observed in responding patients. However, re-treatment with Aclasta may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalisation of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice (see section 5.1).
Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important for the elderly and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
Patients with renal impairment
Aclasta should not be used in patients with creatinine clearance < 35 ml/min (see section 4.4).
No dose adjustment is necessary in patients with creatinine clearance 35 ml/min.
35 ml/min.
