What is Zoledronic acid medac?
Zoledronic acid medac is a medicine that contains the active substance zoledronic acid. It is available as a 4 mg / 100 ml solution for infusion (drip in a vein) and as 4 mg / 5 ml concentrate for solution for infusion.
Zoledronic acid medac is a "generic medicine". This means that Zoledronic acid medac is similar to a 'reference medicine' already authorized in the European Union (EU) called Zometa.
What is Zoledronic acid medac used for?
Zoledronic acid medac can be used in adults with advanced bone cancer to prevent bone complications including fractures (bone breakage), vertebral compressions (when the spinal cord is compressed by the bone), bone disorders requiring radiotherapy (treatment with radiation) or surgery and hypercalcaemia (high levels of calcium in the blood). Zoledronic acid medac can also be used to treat hypercalcaemia caused by tumors.
The medicine can only be obtained with a prescription.
How is zoledronic acid medac used?
Zoledronic acid medac should only be used by a doctor experienced in the use of this type of intravenously administered medicine. The normal dose of zoledronic acid medac is an infusion of 4 mg in at least 15 minutes. When the medicine is used to prevent bone complications, the infusion can be repeated every 3-4 weeks, and patients must also take calcium and vitamin D supplements. A lower dose is recommended for patients with bone metastases (when the tumor becomes it is spread to the bone) if they have mild to moderate kidney problems. It is not recommended in patients with severe kidney problems.
How does zoledronic acid medac work?
The active substance in zoledronic acid medac, zoledronic acid, is a bisphosphonate. It blocks the action of osteoclasts, the body's cells responsible for breaking down the bone tissue, thereby reducing bone loss. This reduction helps make the bones less prone to breakage, with an advantage in terms of preventing fractures in cancer patients with bone metastases.
Patients with tumors may have high levels of calcium in the blood, which is released from the bones. By inhibiting bone decomposition, zoledronic acid medac helps to reduce the levels of calcium released into the blood.
How has Zoledronic acid medac been studied?
The company presented data on zoledronic acid taken from the scientific literature. No further studies were needed, as zoledronic acid medac is a generic medicine, given by infusion and contains the same active substance as the reference medicine, Zometa.
What are the benefits and risks of Zoledronic acid medac
Because zoledronic acid medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Zoledronic acid medac been approved?
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa. Therefore, the CHMP considered that, as in the case of Zometa, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Zoledronic acid medac.
More information on Zoledronic acid medac
On 3 August 2012, the European Commission issued a marketing authorization for zoledronic acid medac, valid throughout the European Union.
For the full EPAR of Zoledronic acid medac, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on zoledronic acid medac therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website.
Last update of this summary: 06-2012.
