What is Zoledronic Acid Mylan?
Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid. It is available as a 4mg / 5ml concentrate for solution for infusion.
Zoledronic acid Mylan is a 'generic medicine'. This means that Zoledronic acid Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called. Zometa.
What is Zoledronic acid Mylan used for?
Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancers affecting the bones. These complications include fractures (broken bones), vertebral crushing (when the spinal cord is compressed by "bone), bone disorders that require radiation therapy (radiation treatment) or surgery, and hypercalcemia (high level of calcium in the blood ) Zoledronic acid Mylan can also be used in the treatment of hypercalcemia caused by tumors.
The medicine can only be obtained with a prescription.
How is Zoledronic acid Mylan used?
Zoledronic acid Mylan should only be used by a doctor who has experience in the use of this type of medicine given into a vein.
The usual dose of Zoledronic acid Mylan is a 4 mg infusion given over at least 15 minutes. If used to prevent bone complications, the infusion can be repeated every three to four weeks and patients should also take calcium and vitamin D supplements. It is recommended that the dose be reduced in patients with bone metastases (when the cancer has spread bone) if they have mild to moderate kidney problems It is not recommended in patients with severe kidney problems.
How does Zoledronic acid Mylan work?
Zoledronic acid, the active ingredient in Zoledronic acid Mylan, is a bisphosphonate that inhibits the action of osteoclasts, the body's cells involved in the resorption of bone tissue, reducing bone loss. The decrease in bone loss. makes bone break less likely, with consequent benefits in terms of fracture prevention in patients with bone metastases.
Cancer patients may have high blood levels of calcium which is released from the bones. By preventing bone resorption, Zoledronic acid Mylan also helps reduce the amount of calcium released into the blood.
How has Zoledronic acid Mylan been studied?
The company presented data from the scientific literature on zoledronic acid. No further studies were needed because Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
What are the benefits and risks of Zoledronic acid Mylan
Because Zoledronic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Zoledronic Acid Mylan been approved?
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan 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 a Marketing Authorization for Zoledronic Acid Mylan.
More information about Zoledronic acid Mylan
On 23 August 2012, the European Commission issued a "Marketing Authorization" for Zoledronic Acid Mylan, valid throughout the European Union.
For the complete version of the EPAR of Zoledronic Acid Mylan, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Zoledronic acid Mylan therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
The information on Zoledronic Acid Mylan published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
