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Bondenza (Ibandronic Acid Roche) (ibandronic acid) - M05BA06

Updated on site: 05-Oct-2017

Naziv lijekaBondenza (Ibandronic Acid Roche)
ATK šifraM05BA06
Tvaribandronic acid
ProizvođačRoche Registration Ltd.
Bondenza can be given either as a tablet or as an injection into a vein. If the tablet is used, the dose is one tablet every month, preferably on the same date each month. The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water. (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.) The patient must not lie down for one hour after taking the tablet. The dose by injection is 3 mg once every three months. Patients taking Bondenza should also take vitamin D and calcium supplements if they do not get enough from their diet.
1 Previously known as Ibandronic Acid Roche.

What is Bondenza?

ibandronic acid
This is a summary of the European public assessment report (EPAR)authorisedfor Bondenza. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in
favour of granting a marketing authorisation and its recommendationslonger on the conditions of use for Bondenza.
Bondenza is a medicine that contains the active substanceno ibandronic acid. It is available as tablets
(150 mg) and as a solution for injectionproductin a prefilled syringe (3 mg).
What is Bondenza used for?
Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been
through the menopauseMedicinaland are at risk of developing bone fractures (breaks). Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of
the femur (the top of the th ghbone) has not been established. The medicine can only be obtained with a prescription.

How is Bondenza used?

Bondenza1
EMA/162292/2013
EMEA/H/C/000502
EPAR summary for the public

How does Bondenza work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.

The active substance in Bondenza, ibandronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss.

How has Bondenza been studied?

Bondenza has been studied in three main studies involving women with osteoporosis. The first study

The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets. The studies looked at the change in the density of the bones in the spine and the hip over two years.

compared Bondenza 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures wereauthorisedseen in the pati nts over three years.

The 2.5-mg once-daily tablets used in the studies are no longer .

What benefit has Bondenza shown duringlongerthe studies?

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