What is Ivabradine JensonR and what is it used for?
Ivabradine JensonR is a heart medicine used for the symptomatic treatment of chronic stable angina pectoris (pain in the chest, jaw and back following physical exertion) in adult patients with coronary artery disease (heart disease caused by obstruction of the blood vessels blood supplying the heart muscle). The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute. It is used both in patients who cannot take beta-blockers (another type of medicine to treat " angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blocker alone.
Ivabradine JensonR is also used in patients with chronic heart failure (when the heart cannot pump enough blood to the rest of the body) and with a normal heart rhythm, which is at least 75 beats per minute. It is used in combination. with standard therapy, which may include a beta blocker.
Ivabradine JensonR contains the active substance ivabradine. It is a 'generic medicine'. This means that Ivabradine JensonR is similar to a 'reference medicine' already authorized in the European Union (EU) called Procoralan. For more information on generic medicines, please see the questions and answers by clicking here.
How is Ivabradine JensonR used?
Ivabradine JensonR is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription. The recommended starting dose is 5 mg twice a day with meals, which your doctor may increase to 7.5 mg twice a day or reduce to 2.5 mg (half a 5 mg tablet) twice a day depending on the patient's heart rate and symptoms. In patients over 75 years of age, a lower starting dose of 2.5 mg twice daily may be used. Treatment should be stopped if heart rate persistently decreases below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue. When used for angina, treatment should be stopped if symptoms do not improve after 3 months. In addition, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or frequency. cardiac.
How does Ivabradine JensonR work?
The symptoms of angina are caused by the heart not getting enough oxygenated blood. In stable angina, these symptoms occur during physical exertion. The active substance in Ivabradine JensonR, ivabradine, blocks the 'If current' in the sinus node, the natural 'pacemaker' that regulates heart rate. When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood. Therefore, Ivabradine JensonR reduces or prevents the symptoms of angina.
Symptoms of heart failure are caused by the heart not pumping enough blood around the body. By lowering the heart rate, Ivabradine JensonR reduces the strain on the heart, thereby slowing the progression of heart failure and improving symptoms.
What benefit has Ivabradine JensonR shown during the studies?
Since Ivabradine JensonR is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Procoralan. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Ivabradine JensonR 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.
What are the risks associated with Ivabradine JensonR?
Because Ivabradine JensonR 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 Ivabradine JensonR been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine JensonR has been shown to have comparable quality and to be bioequivalent to Procoralan. Therefore, the CHMP considered that, as in the case of Procoralan, the benefits outweigh the identified risks and recommended that Ivabradine JensonR be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Ivabradine JensonR?
The recommendations and precautions to be observed by healthcare professionals and patients for Ivabradine JensonR to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
Other information about Ivabradine JensonR
For the complete version of Ivabradina JensonR's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Ivabradine JensonR therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. The full version of the EPAR for the reference medicine can also be found on the Agency's website.
The information on Ivabradine JensonR 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.
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