KEPPRA Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Keppra 500 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 500 mg levetiracetam. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Yellow, 16 mm oblong, scored and debossed with the code ucb and 500 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ...
Therapeutic indications
Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Keppra ...
Posology and method of administration
Posology Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after ...
Contraindications
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Renal impairment The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is ...
Interaction with other medicinal products and other forms of interaction
Antiepileptic medicinal products Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal ...
Fertility, pregnancy and lactation
Women of child bearing potential Specialist advice should be given to women who are of childbearing potential. Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant. ...
Effects on ability to drive and use machines
Levetiracetam has minor or moderate influence on the ability to drive and use machines. Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The adverse reaction profile presented below is based on ...
Overdose
Symptoms Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses. Management of overdose After an acute overdose, the stomach ...
Pharmacodynamic properties
Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX14. The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), ...
Pharmacokinetic properties
Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential. Adverse effects not observed in clinical studies but ...
List of excipients
<u>Tablet core:</u> Croscarmellose sodium Macrogol 6000 Silica colloidal anhydrous Magnesium stearate <u>Film-coating:</u> Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 film- coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets. Aluminium/PVC perforated ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium
Marketing authorization number(s)
EU/1/00/146/006 EU/1/00/146/007 EU/1/00/146/008 EU/1/00/146/009 EU/1/00/146/010 EU/1/00/146/011 EU/1/00/146/012 EU/1/00/146/013 EU/1/00/146/035
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 September 2000 Date of latest renewal: 20 August 2015
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