INOVELON Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Inovelon 100 mg film-coated tablets. Inovelon 200 mg film-coated tablets. Inovelon 400 mg film-coated tablets.
Qualitative and quantitative composition
Oral Tablet: Each film-coated tablet contains 100 mg rufinamide. Each film-coated tablet contains 200 mg rufinamide. Each film-coated tablet contains 400 mg rufinamide. Excipients with known effect: Each ...
Pharmaceutical form
Film-coated tablet. 100 mg: Pink, ovaloid, slightly convex, approximately 10.2 mm in length, scored on both sides, embossed Є261 on one side and blank on the other side. The tablet can be divided into ...
Therapeutic indications
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
Posology and method of administration
Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy. Inovelon oral suspension and Inovelon film-coated tablets ...
Contraindications
Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Status epilepticus Status epilepticus cases have been observed during treatment with rufinamide in clinical development studies, whereas no such cases were observed with placebo. These events led to rufinamide ...
Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to affect rufinamide Other antiepileptic medicinal products Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known ...
Fertility, pregnancy and lactation
Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general: It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times ...
Effects on ability to drive and use machines
Inovelon may cause dizziness, somnolence and blurred vision. Depending on the individual sensitivity, rufinamide may have a minor to major influence on the ability to drive and use machines. Patients must ...
Undesirable effects
Summary of the safety profile The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide. The most commonly reported adverse reactions overall ...
Overdose
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for rufinamide. Treatment should be supportive and may include haemodialysis ...
Pharmacodynamic properties
Pharmacotherapeutic group: antiepileptics, carboxamide derivatives ATC code: N03AF03 Mechanism of action Rufinamide modulates the activity of sodium channels, prolonging their inactive state. Rufinamide ...
Pharmacokinetic properties
Absorption Maximum plasma levels are reached approximately 6 hours after administration. Peak concentration (C<sub>max</sub>) and plasma AUC of rufinamide increase less than proportionally with doses in ...
Preclinical safety data
Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses. Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver ...
List of excipients
Core: Lactose monohydrate Cellulose, microcrystalline Maize starch Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous Film coating: Hypromellose Macrogols ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal. This medicinal product could have potential risk for the environment. Any unused medicinal product or waste material should be disposed of in accordance with local ...
Marketing authorization holder
Eisai GmbH, Lyoner Straße 36, 60528, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Marketing authorization number(s)
EU/1/06/378/001-005 EU/1/06/378/006-010 EU/1/06/378/011-016
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 January 2007 Date of latest renewal: 09 January 2012
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