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KEPPRA Concentrate for solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Keppra 100 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

Each ml contains 100 mg of levetiracetam. Each 5 ml vial contains 500 mg of levetiracetam. Excipient with known effect: Each vial contains 19 mg of sodium. For the full list of excipients, see section ...

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). Clear, colourless, liquid.

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 Keppra therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily ...

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 There is no specific antidote for ...

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

The pharmacokinetic profile has been characterized following oral administration. A single dose of 1500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes ...

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

Sodium acetate Glacial acetic acid Sodium chloride Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

3 years. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions of the diluted medicinal product, see section 6.3.

Nature and contents of container

5 ml glass vial (type I) closed by a polytetrafluoroethylene grey chlorobutyl rubber stopper or an uncoated grey bromobutyl rubber stopper and sealed with an aluminium/polypropylene flip cap. Each carton ...

Special precautions for disposal and other handling

See Table 1 for the recommended preparation and administration of Keppra concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses. ...

Marketing authorization holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Marketing authorization number(s)

EU/1/00/146/030 EU/1/00/146/033

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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