What is Zoledronic Acid Teva Generics used for and what is it used for?
Zoledronic acid Teva Generics is a medicine containing zoledronic acid (5 mg). It is indicated for the treatment of osteoporosis (a disease that makes bones fragile) in post-menopausal women and in men. It is used in patients at risk of fractures (bone breakage) and in patients whose osteoporosis is associated with long-term treatment with glucocorticoids (a type of steroid). Zoledronic acid Teva Generics is also used in adults in the treatment of Paget's bone disease, a disease in which the normal process of bone growth is altered. Zoledronic acid Teva Generics is a "generic" medicine. This means that Zoledronic acid Teva Generics is similar to a 'reference medicine' already authorized in the European Union (EU) called Aclasta. For more information on generic medicines, see the questions and answers by clicking here.
How is Zoledronic Acid Teva Generics used?
Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription. Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes. This can be repeated once a year in patients being treated for osteoporosis. For Paget's disease, only an infusion of Zoledronic acid Teva Generics is usually performed, but additional infusions can be considered in case of relapse. The effects of each infusion last for at least a year. Before and after treatment the quantity of fluids present in the patients must be adequate; in addition, an adequate amount of vitamin D and calcium supplements must be administered. In the treatment of Paget's disease, Zoledronic acid Teva Generics should only be used by a doctor who has experience in the treatment of the disease. For more information, see the package leaflet.
How does Zoledronic acid Teva Generics work?
Osteoporosis arises when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to fractures. In women, osteoporosis is more common after menopause, when levels of the female estrogen hormone decrease. Osteoporosis can also occur in both sexes as an undesirable effect of glucocorticoid treatment. In Paget's disease the bones are consumed faster and when they grow back they are weaker than normal. Zoledronic acid, the active ingredient in Zoledronic acid Teva Generics, is a bisphosphonate. It blocks the action of osteoclasts, the body's cells responsible for breaking down the bone tissue. This leads to less bone loss with regard to osteoporosis and to less activity of Paget's disease.
What studies have been performed on Zoledronic acid Teva Generics?
Since Zoledronic acid Teva Generics is a generic medicine given by infusion and contains the same active substance as the reference medicine, Aclasta, further studies were not necessary.
What are the benefits and risks of Zoledronic acid Teva Generics?
Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are considered to be the same as the reference medicine's.
Why has Zoledronic Acid Teva Generics been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics was shown to be comparable to Aclasta. Therefore, the CHMP considered that, as in the case of Aclasta, the benefits outweigh the identified risks and recommended to approve the use of Zoledronic Acid Teva Generics in the EU.
What measures are being taken to ensure the safe and effective use of Zoledronic Acid Teva Generics?
A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic Acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Zoledronic acid Teva Generics
On 27 March 2014, the European Commission issued a marketing authorization for Zoledronic Acid Teva Generics, valid throughout the European Union. For the full EPAR and the summary of the Zoledronic acid risk management plan Teva Generics, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Zoledronic Acid Teva Generics, 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: 03-2014.
