Quest for the right Drug
לבטיראצטם אלטן 100 מ"ג/מ"ל LEVETIRACETAM ALTAN 100 MG/ML (LEVETIRACETAM)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
תרכיז להכנת תמיסה לאינפוזיה : CONCENTRATE FOR SOLUTION FOR INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 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 the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications. Since there was limited exposure for Levetiracetam 100 mg/ml intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of Levetiracetam Altan 100 mg/ml intravenous will rely on Levetiracetam oral use. Tabulated list of adverse reactions Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency. Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). MedDRA Frequency category SOC Very Common Uncommon Rare Very rare common Infections and Nasopharyn Infection infestations gitis Blood and Thrombocytopeni Pancytopenia, lymphatic a, leukopenia neutropenia, system agranulocytosi disorders s Immune Drug reaction system with disorders eosinophilia and systemic symptoms (DRESS), Hypersensitivi ty (including angioedema and anaphylaxis) Metabolism Anorexia Weight decrease, Hyponatraemi and nutrition weight increase a disorders Psychiatric Depression, Suicide attempt, Completed Obsessive disorders hostility/ suicidal ideation, suicide, compulsive aggression, anxiety, psychotic personality disorder** insomnia, disorder, disorder, nervousness/irritabi abnormal thinking lity behaviour, abnormal, hallucination, delirium anger, confusional state, panic attack, affect lability/mood swings, agitation Nervous Somnolence Convulsion, Amnesia, memory Choreoathetosi system , headache balance disorder, impairment, s, dyskinesia, disorders dizziness, lethargy, coordination hyperkinesia, tremor abnormal/ataxia, gait paraesthesia, disturbance, disturbance in encephalopath attention y, seizures aggravated Eye disorders Diplopia, vision blurred Ear and Vertigo labyrinth disorders Cardiac Electrocardiog disorders ram QT prolonged Respiratory, Cough thoracic and mediastinal disorders Gastrointestin Abdominal pain, Pancreatitis al disorders diarrhoea, dyspepsia, vomiting, nausea Hepatobiliary Liver function test Hepatic disorders abnormal failure, hepatitis Renal and Acute kidney Urinary injury Disorders Skin and Rash Alopecia, eczema, Toxic subcutaneous pruritus, epidermal tissue necrolysis, disorders Stevens- Johnson syndrome, erythema multiforme Musculoskelet Muscular Rhabdomyolys al and weakness, is and blood connective myalgia creatine tissue phosphokinase disorders increased* General Asthenia/fatigue disorders and administration site conditions Injury, Injury poisoning and procedural complications *Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients. Evidence also suggests a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS). **Very rare cases of development of obsessive-compulsive disorders (OCD) in patients with underlying history of OCD or psychiatric disorders have been observed in post-marketing surveillance. Description of selected adverse reactions The risk of anorexia is higher when levetiracetam is coadministered with topiramate. In several cases of alopecia, recovery was observed when levetiracetam was discontinued. Bone marrow suppression was identified in some of the cases of pancytopenia. Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation. Paediatric population In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. Sixty of these patients were treated with levetiracetam in placebo-controlled studies. In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. 233 of these patients were treated with levetiracetam in placebo-controlled studies. In both these paediatric age ranges, these data are supplemented with the post- marketing experience of the use of levetiracetam. In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study. No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy. The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications. Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults. In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile. In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile. A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. It was concluded that Levetiracetam 100 mg/ml was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population. Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL – Achenbach Child Behavior Checklist). However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il
פרטי מסגרת הכללה בסל
א. התרופה האמורה תינתן לטיפול באפילפסיה. ב. מתן התרופה ייעשה לפי המלצת רופא מומחה בנוירולוגיה.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
א. התרופה האמורה תינתן לטיפול באפילפסיה. ב. מתן התרופה ייעשה לפי המלצת רופא מומחה בנוירולוגיה. | 01/03/2021 | נוירולוגיה | אפילפסיה | |
א. התרופה האמורה תינתן לטיפול באפילפסיה , ורק אם החולה אינו מאוזן על ידי טיפול בתרופה אנטי אפילפטית אחת אחרת כגון Carbamazepine, Valproic acid, Phenytoin, Primidone . ב. מתן התרופה ייעשה לפי המלצת רופא מומחה בנוירולוגיה. | 23/01/2011 | נוירולוגיה | אפילפסיה | |
א. לטיפול באפילפסיה, ורק אם החולה אינו מאוזן (לפחות ארבעה התקפים בחודש) בשלושה קווי טיפול קודמים. ב. מתן התרופה ייעשה לפי המלצת רופא מומחה בנוירולוגיה | 15/05/2006 | נוירולוגיה | אפילפסיה |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
15/05/2006
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
מידע נוסף