ZOLEDRONIC ACID ENNOGEN

Zoledronic acid Ennogen must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Zoledronic acid Ennogen should be given the package leaflet and the patient reminder card.

Posology Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and older people The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid monohydrate every 3 to 4 weeks.

Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily. The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.

0 mmol/l) is a single dose of 4 mg zoledronic acid monohydrate.

Renal impairment TIH:

Zoledronic acid Ennogen treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. 5 mg/dl were excluded. 4). Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Ennogen in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.

CLcr is calculated from serum creatinine using the Cockcroft- Gault formula. Zoledronic acid Ennogen is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.

0 mg/dl were excluded. 66 (mg•hr/l) (CLcr = 75 ml/min). The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min. Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Ennogen and treatment should be withheld if renal function has deteriorated.

0 mg/dl or 88 μ mol/l. 4). Zoledronic acid Ennogen treatment should be resumed at the same dose as that given prior to treatment interruption. Paediatric population The safety and efficacy of zoledronic acid monohydrate in children aged 1 year to 17 years have not been established.

1 but no recommendation on a posology can be made. Method of administration Intravenous use. 6), should be given as a single intravenous infusion in no less than 15 minutes. 4). 6. 9% w/v sodium chloride solution or 5% w/v glucose solution.

The dose must be given as a single intravenous infusion over no less than 15 minutes. Zoledronic acid Ennogen concentrate must not be mixed with calcium or other divalent cation- containing infusion solutions such as lactated Ringer’s solution, and should be administered as a single intravenous solution in a separate infusion line.

Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Ennogen. 4 Special warnings and precautions for use General Patients must be assessed prior to administration of Zoledronic acid Ennogen to ensure that they are adequately hydrated.

Overhydration should be avoided in patients at risk of cardiac failure. Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Ennogen therapy.

If hypocalcaemia, hypophosphatemia, or hypomagnesaemia occurs, short- term supplemental therapy may be necessary. Untreated hypercalcaemia patients generally have some degree of renal function […]