What is Rasagiline ratiopharm and what is it used for?
Rasagiline ratiopharm is a medicine indicated for the treatment of adult patients with Parkinson's disease, a progressive mental disorder that causes tremor, slow movement and muscle stiffness. Rasagiline ratiopharm can be used as monotherapy (alone) or as a combination therapy with levodopa (another drug used in the treatment of Parkinson's disease) in patients with end-of-dose 'fluctuations' in the time interval between doses of levodopa. Fluctuations occur when the effects of treatment wear off and symptoms recur. They are linked to a reduction in the effects of levodopa and the patient suddenly switches from the "on" state, in which he is able to move, to the "off" state. This medicine is similar to Azilect, which is already authorized in the European Union (EU). The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (“informed consent”). Rasagiline ratiopharm contains the active substance rasagiline.
How is Rasagiline ratiopharm used?
Rasagiline ratiopharm is available as tablets (1 mg). The standard dose is one tablet once a day. The medicine can only be obtained with a prescription.
How does Rasagiline ratiopharm - rasagiline work?
The active substance in Rasagiline ratiopharm, rasagiline, is a 'monoamine oxidase-B inhibitor'. It blocks the enzyme monoamine oxidase type B, which is responsible for the breakdown of the neurotransmitter dopamine in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. In patients with Parkinson's disease, the cells that produce dopamine begin to die. resulting in a decrease in the amount of this neurotransmitter in the brain. Patients therefore lose the ability to reliably control their movements. By increasing dopamine concentrations in the areas of the brain responsible for movement and coordination, Rasagiline ratiopharm improves the signs and symptoms of Parkinson's disease such as stiffness and slowness of movement.
What benefit has Rasagiline ratiopharm - rasagiline shown during the studies?
In three studies involving 1 563 patients Rasagiline ratiopharm has been shown to be effective both in relieving the symptoms of Parkinson's disease and in reducing the time patients spend in the 'off' state. In one of the studies, which involved a 26-week treatment with Rasagiline ratiopharm, there was an average decrease of 0.13 points in the UPDRS score (a standard scale for assessing symptoms of Parkinson's disease) from a baseline of 24.69 points, while in subjects treated with placebo there was an increase of 4.07 points starting from a starting value of 24.54 points. A decrease in the UPDRS score indicates improvement in symptoms, while an increase indicates worsening. In the other two studies, Rasagiline ratiopharm was given as add-on therapy to subjects with more advanced disease who were already on levodopa therapy, and was compared with placebo and another medicine, entacapone ( also used in combination with levodopa). 1 159 patients participated in the studies; the duration was 26 and 18 weeks, respectively. In both studies, patients taking Rasagiline ratiopharm reported, on average, about a "now less in the" off "state compared to subjects treated with placebo. Similar reductions in time spent in the “off” state were observed in subjects treated with entacapone.
What is the risk associated with Rasagiline ratiopharm - rasagiline?
The most common side effect with Rasagiline ratiopharm (which may affect more than 1 in 10 people) is headache. For the full list of side effects reported with Rasagiline ratiopharm, see the package leaflet. Rasagiline ratiopharm should not be used with other monoamine oxidase inhibitors and herbal preparations that do not require a prescription, such as St. John's wort (used to treat depression). It should also not be used with pethidine (a analgesic). There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting therapy with another monoamine oxidase inhibitor or with pethidine. Rasagiline ratiopharm is contraindicated in patients with severe hepatic impairment. The use of rasagiline should be avoided. in subjects with moderate hepatic insufficiency. People with mild liver disease should take Rasagiline ratiopharm with caution and should stop treatment if their liver disease worsens. For the full list of side effects reported with Rasagiline ratiopharm, see the package leaflet
Why has Rasagiline ratiopharm - rasagiline been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasagiline ratiopharm's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Rasagiline ratiopharm - rasagiline?
A risk management plan has been developed to ensure that Rasagiline ratiopharm is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Rasagiline ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan
More information about Rasagiline ratiopharm - rasagiline
On 12 January 2015, the European Commission granted a "Marketing Authorization" for Rasagiline ratiopharm, valid throughout the European Union. For more information on Rasagiline ratiopharm therapy, please read the package leaflet (enclosed with the EPAR) or consult your doctor or pharmacist. Last update of this summary: 01-2015.
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