ZOLEDRONIC ACID HOSPIRA 4mg/100ml Solution for infusion (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zoledronic Acid Hospira 4 mg/100 ml solution for infusion.

Qualitative and quantitative composition

One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate). One ml of the solution contains 0.04 mg zoledronic acid (as monohydrate). Excipient with known effect: Zoledronic Acid Hospira ...

Pharmaceutical form

Solution for infusion. Clear and colourless solution.

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 ...

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. Patients treated with zoledronic acid ...

Contraindications

Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).

Special warnings and precautions for use

General Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated. Overhydration should be avoided in patients at risk of cardiac failure. Standard ...

Interaction with other medicinal products and other forms of interaction

In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring. ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data on the use of zoledronic acid in pregnant women. Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3). The potential ...

Effects on ability to drive and use machines

Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving ...

Undesirable effects

Summary of the safety profile Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, ...

Overdose

Clinical experience with acute overdose of zoledronic acid is limited. The administration of doses up to 48 mg of zoledronic acid in error has been reported. Patients who have received doses higher than ...

Pharmacodynamic properties

Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates ATC code: M05BA08 Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone. It is ...

Pharmacokinetic properties

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

Preclinical safety data

Acute toxicity The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats. Subchronic and chronic toxicity Zoledronic acid was well tolerated when administered ...

List of excipients

Mannitol Sodium citrate Sodium chloride Water for injections

Incompatibilities

This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion ...

Shelf life

Unopened bag: 2 years. After first opening: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior ...

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 1 bag. ...

Special precautions for disposal and other handling

Aseptic techniques must be followed during the preparation of the infusion. For single use only. Only clear solution free from particles and discolouration should be used. Healthcare professionals are ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/12/800/003

Date of first authorization / renewal of the authorization

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

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