国: オランダ
言語: オランダ語
ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LEVETIRACETAM 100 mg/ml
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N03AX14
LEVETIRACETAM 100 mg/ml
Concentraat voor oplossing voor infusie
AZIJNZUUR (E 260), GECONCENTREERD ; NATRIUMACETAAT 3-WATER (E 262) ; NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,
Intraveneus gebruik
Levetiracetam
Hulpstoffen: AZIJNZUUR (E 260), GECONCENTREERD; NATRIUMACETAAT 3-WATER (E 262); NATRIUMCHLORIDE; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;
2011-12-29
Hexal A.G. Page 1/8 Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor infusie RVG 108505 1313-v12 1.3.1.3 Bijsluiter September 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ LEVETIRACETAM SANDOZ INFUUS 100 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE levetiracetam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you use[Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). [Nationally completed name] is used: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits. • as an add-on to other antiepileptic medicines to treat:_ _ ▪ partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age ▪ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 y 完全なドキュメントを読む
1 Hexal AG. Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor infusie Page 1/17 RVG 108505 1311-v11 1.3.1.1 Samenvatting van de Productkenmerken September 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml concentrate for solution for infusion contains 100 mg of levetiracetam. Each vial of 5 ml contains 500 mg of levetiracetam. Excipient with known effect Each vial contains 19.1 mg of sodium. One ml of concentrate contains 3.82 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless concentrate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] 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. [Nationally completed name] is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. [Nationally completed name] is an alternative for patients when oral administration is temporarily not feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology [Nationally completed name] 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 dose and frequency of administration should be maintained. _Partial onset seizures _ The recommended dosing for monotherapy (from 16 years 完全なドキュメントを読む