Aclasta solution for infution 5mg/100ml vial #1

Aclasta Infusion Solution 5 mg/100 ml vial

Composition:

• Active ingredient: zoledronic acid

• 100 ml solution contains 5 mg zoledronic acid (anhydrous), equivalent to 5.33 mg zoledronic acid monohydrate

• Excipients: mannitol (E421), sodium citrate, injection water

Indications:

• Treatment of osteoporosis in postmenopausal women and men to reduce the risk of hip, vertebral, and other fractures by increasing bone mineral density

• Prevention of recurrent fractures after hip fracture in men and women

• Treatment and prevention of glucocorticoid-induced osteoporosis

• Paget’s disease of bone (osteitis deformans)

Contraindications:

• Hypersensitivity to the active substance or any other ingredient, or hypersensitivity to bisphosphonates

• Severe renal impairment (creatinine clearance < 35 ml/min)

• Hypocalcemia

• Pregnancy and breastfeeding

Dosage and Administration:

For osteoporosis (postmenopausal women and men), glucocorticoid-induced osteoporosis, and prevention of recurrent fractures after hip fracture:

• Recommended dose: Aclasta 5 mg as a single intravenous infusion once a year.

For Paget’s disease:

• Recommended dose: Aclasta 5 mg as a single intravenous infusion.

• Prescribing is reserved for physicians experienced in Paget’s disease treatment.

• No data available on repeated treatment.

• After a single infusion, a long remission period may be observed.

• Repeat treatment may be considered in patients with disease relapse indicated by elevated serum alkaline phosphatase levels, failure to normalize these levels, or persistent symptoms within 12 months after treatment.

Administration instructions:

• Aclasta (5 mg/100 ml ready-to-use infusion solution) is administered via intravenous infusion using an infusion set with a stable infusion rate.

• Infusion duration should be at least 15 minutes.

• Adequate hydration before and after infusion is important, especially for elderly patients and those receiving diuretics.

• In osteoporosis, supplementation with calcium and vitamin D is necessary if dietary intake is insufficient.

• For Paget’s disease patients, adequate daily vitamin D and calcium supplementation should be ensured for 10 days after infusion.

Special populations:

• Patients with renal impairment:

• Not recommended for patients with creatinine clearance < 35 ml/min due to insufficient clinical experience.

• No dose adjustment needed for patients with creatinine clearance ≥ 35 ml/min.

• Patients with hepatic impairment:

• No dose adjustment necessary.

• Elderly patients (≥ 65 years):

• No dose adjustment necessary; pharmacokinetics similar to younger adults.

Instructions:

• Aclasta should not be mixed or administered intravenously with any other medicinal product.

• Administer as a single infusion with a separate intravenous infusion set at a constant rate.

• If the solution has been refrigerated, allow it to reach room temperature before use.

• Follow aseptic techniques when preparing the infusion.

• The preparation is for single use only.

• Discard any unused solution after infusion.

• From a microbiological standpoint, use the prepared solution immediately.

• If not used immediately, storage time and conditions prior to use are the user’s responsibility.

• Unused solution can be stored for up to 24 hours at 2–8°C.

Storage conditions:

• The unopened vial does not require special storage conditions.

• Store opened vials for up to 24 hours at 2–8°C.

• Keep out of reach of children.