ZOLEDRONIC ACID HOSPIRA 5mg/100ml Solution for infusion (2021)

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Περιεχόμενα

Name of the medicinal product

Zoledronic Acid Hospira 5 mg/100 ml solution for infusion.

Qualitative and quantitative composition

Each bag with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate). Each ml of the solution contains 0.05 mg zoledronic acid anhydrous (as monohydrate). For the full list of excipients, see ...

Pharmaceutical form

Solution for infusion. Clear and colourless solution.

Therapeutic indications

Treatment of Pagets disease of the bone in adults.

Posology and method of administration

Posology Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira. This is especially important for the elderly (≥65 years) and for patients receiving diuretic therapy. ...

Contraindications

Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1. Patients with hypocalcaemia (see section 4.4). Severe renal impairment with creatinine ...

Special warnings and precautions for use

Renal function The use of Zoledronic Acid Hospira in patients with severe renal impairment (creatinine clearance <35 ml/min) is contraindicated due to an increased risk of renal failure in this population. ...

Interaction with other medicinal products and other forms of interaction

No interaction studies with other medicinal products have been performed. Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section ...

Fertility, pregnancy and lactation

Pregnancy Zoledronic Acid Hospira is contraindicated during pregnancy (see section 4.3). There are no adequate data on the use of zoledronic acid in pregnant women. Studies in animals with zoledronic acid ...

Effects on ability to drive and use machines

Adverse reactions, such as dizziness, may affect the ability to drive or use machines.

Undesirable effects

Summary of the safety profile The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively. Incidence of individual ...

Overdose

Clinical experience with acute overdose is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant ...

Pharmacodynamic properties

Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates ATC code: M05BA08 Mechanism of action Zoledronic acid belongs to the class of nitrogen-containing ...

Pharmacokinetic properties

Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent. Distribution After ...

Preclinical safety data

Acute toxicity The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats. In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic ...

List of excipients

Mannitol Sodium citrate Water for injections

Incompatibilities

This medicinal product must not be allowed to come into contact with any calcium-containing solutions. Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products. ...

Shelf life

Unopened bag:</u. 2 years. After opening: 24 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after first opening of the medicinal product, see section 6.3.

Nature and contents of container

100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap. Pack size: Zoledronic Acid Hospira is supplied as packs containing one bag.

Special precautions for disposal and other handling

For single use only. Only clear solution free from particles and discoloration should be used. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic ...

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization number(s)

EU/1/12/800/004

Date of first authorization / renewal of the authorization

Date of first authorization: 19 November 2012 Date of latest renewal: 24 August 2017

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