País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ZOLEDRONIC ACID
Fresenius Kabi Limited
M05BA08
ZOLEDRONIC ACID
4/5 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Biphosphonates
Authorised
2012-10-12
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion Zoledronic acid Package leaflet: Information for the user V006 M087454/04 UK/IE The following information is intended for healthcare professionals only How to prepare and administer Zoledronic acid − To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic acid concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution. If a lower dose of Zoledronic acid is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution. Do not mix Zoledronic acid concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer’s solution. Instructions for preparing reduced doses of Zoledronic acid: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose - For single use only. Any unused solution should be discarded. Only clear solution free from particles and discolouration should be used. Aseptic techniques must be followed during the preparation of the infusion. - Shelf life after dilution: chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8ºC. From a microbiological point of view, the diluted solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C. The refrigerated solution should then be equilibrated to room temperature prior to administration. V006 Read all of this leaflet carefully before you are given this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further quest Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoledronic acid 4 mg/5 ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg of zoledronic acid (as monohydrate). One ml concentrate contains 0.8 mg of zoledronic acid (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. - Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Posology _Prevention of skeletal related events in patients with advanced malignancies involving bone_ _Adults and elderly_ The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid 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. _Treatment of TIH_ _Adults and elderly_ The recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid. _Renal impairment_ _TIH:_ Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded. N Leia o documento completo