natgillin/translations-raw huggingface dataset:
0,6 ml to gange dagligt
0.6 ml twice daily
Initialdosis: 10 mg/kg to gange daglig
Starting dose: 10 mg/kg twice daily
250 til 500 mg 2 gange dagligt
250 to 500 mg twice daily
Levetiracetam udskilles i human mælk og bør ikke anvendes under amning.
Levetiracetam is excreted in human breast milk.
200 mg (2 ml) to gange daglig 600 mg (6 ml) to gange daglig
600 mg (6 ml) twice daily
1 Krayrechna Str.
Balkanpharma - Troyan AD 1 Krayrechna Str.
opmærksomhedsforstyrrelser (koncentrationsbesvær);
(impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
1,05 ml to gange dagligt
1.05 ml twice daily
0,8 ml to gange dagligt
0.8 ml twice daily
1,8 ml to gange dagligt
1.8 ml twice daily
• af voksne, unge, børn og spædbørn over 1 måned med partiel epilepsi med eller uden sekundær generalisering.
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
5 til 10 mg/kg (0,05 til 0,10 ml/kg) to gange dagligt
5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Effekten af levetiracetam, hos patienter over 12 år med idiopatisk generaliseret epilepsi med myoklone anfald i forskellige syndromer, blev påvist i et dobbeltblindt placebokontrolleret forsøg med en behandlingsvarighed på 16 uger.
Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
0,45 ml to gange dagligt
0.45 ml twice daily
0,35 ml to gange dagligt
0.35 ml twice daily
• muskelsvaghed, muskelsmerter;
• muscle weakness, myalgia (muscle pain);
Moderat
Mild
0,5 ml to gange dagligt
0.5 ml twice daily
84 mg (0,85 ml) to gange dagligt
28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Sådan skal du tage Levetiracetam Actavis Group
How to take Levetiracetam Actavis Group
28 mg (0,3 ml) to gange dagligt
60 mg (0.6 ml) twice daily
Koreoatetose, dyskinesi, hyperkinesi, gangforstyrrelse, encefalopati opmærksomhedsforstyrrelser
Rare disorders headache disorder, dizziness, lethargy, tremor impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention dyskinesia, hyperkinesia, gait disturbance, encephalopathy
6 ml to gange dagligt
6 ml twice daily
Følg lægens instruktioner.
please contact your doctor.
1 ml to gange dagligt
1 ml twice daily
• dobbeltsyn, sløret syn;
• diplopia (double vision), vision blurred;
Nervesystemet
Nervous system Somnolence,
60 mg (0,6 ml) to gange daglig 180 mg (1,8 ml) to gange daglig
180 mg (1.8 ml) twice daily
100 mg (1 ml) to gange daglig 300 mg (3 ml) to gange daglig
100 mg (1 ml) twice daily
Levetiracetam Actavis Group anvendes
How to store Levetiracetam Actavis Group
2,4 ml to gange dagligt
2.4 ml twice daily
0,3 ml to gange dagligt
0.3 ml twice daily
147 mg (1,5 ml) to gange dagligt
49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
2 ml to gange dagligt
2 ml twice daily
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 1 ml sprøjte
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 1 ml syringe
3 ml to gange dagligt
3 ml twice daily
Maksimal dosis: 0,3 ml/kg to gange dagligt
Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 3 ml sprøjte
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 3 ml syringe
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 1 ml sprøjte
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 1 ml syringe
Udtalt
Posology
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 10 ml sprøjte
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 10 ml syringe
105 mg (1,05 ml) to gange dagligt
35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
7 til 14 mg/kg en gang daglig (2) (4)
7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily (2)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 3 ml sprøjte
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 3 ml syringe
Skader ved uheld
Injury
2,5 ml to gange dagligt
2.5 ml twice daily
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 10 ml sprøjte
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 10 ml syringe
Brugsanvisning:
Choreoathetosis,
1,5 ml to gange dagligt
1.5 ml twice daily
Nyrer og urinveje
Renal and Urinary disorders
I alt 645 patienter i alderen 4-16 år er blevet behandlet med levetiracetam i placebokontrollerede og åbne, forlængede studier.
patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
En fælles undersøgelse anbefales.
A joint study is encouraged.
Ordlyden af betingelsen for markedsføringstilladelsen er blevet ændret i overensstemmelse hermed.
The wording of the condition to the marketing authorisation has been amended accordingly.
Andre offentliggjorte data fra store kohorter understøttede ikke disse resultater (Pol et al, 2016).
Other published data from larger cohorts did not support the findings (Pol et al, 2016).
Hepatocellulært carcinom
Hepatocellular carcinoma
Produktinformationen skal afspejle disse anbefalinger og informere sundhedspersonalet om risikoen.
The product information should reflect these recommendations and inform healthcare professionals about this risk.
Det anerkendes dog, at det vil være vanskeligt fuldt ud at kontrollere uafklarede sammenhænge i denne ikke-randomiserede sammenligning.
However, the difficulty of fully controlling confounding in this non-randomised comparison was recognised.
Derudover skal patienter rådgives om at kontakte sin læge, hvis vedkommende nogensinde har været inficeret med HBV, da tæt monitorering er påkrævet.
In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required.
Skulle brugen af eksisterende datakilder vise sig uhensigtsmæssig, skal der i forundersøgelsen indarbejdes et forslag til en prospektiv indsamling af data.
Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided.
Risikostyringsplanen (RMP) for de relevante lægemidler skal opdateres i overensstemmelse hermed.
The RMP of the relevant medicinal products will be updated accordingly.
BILAG IV VIDENSKABELIGE KONKLUSIONER
ANNEX IV SCIENTIFIC CONCLUSIONS
Nogle af de tilfælde, der blev identificeret med DAA'er, havde alvorlige konsekvenser med forværring af leverstatus og mindst ét tilfælde, hvor patienten måtte indstilles til levertransplantation.
Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient required liver transplantation.
CHMP's udtalelse og detaljerede redegørelse for den videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
CHMP opinion and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Produktinformationen vil inkludere en advarsel om, at informere om risikoen for hepatitis B-reaktivering og vil afspejle disse anbefalinger.
The product information will include a warning to inform about the risk of hepatitis B reactivation and reflect these recommendations.
Risikostyringsplanen skal opdateres i overensstemmelse hermed inden for 3 måneder af denne CHMPudtalelse.
The RMP should be updated accordingly within 3 months of this CHMP opinion.
Derudover skal "patienter med tidligere HCC" betragtes som manglende oplysninger, da denne patientgruppe blev udelukket fra tilgængelige kliniske forsøg.
In addition, ‘patients with previous HCC' should be considered as missing information, since this population was excluded from available clinical trials.
Direkte aktive antivirale lægemidler (DAA'er) er rettet mod specifikke non-strukturelle proteiner i hepatitis C-virus og resulterer i hæmning af viral replikation og infektion.
Direct-acting antiviral agents (DAAs) target specific non-structural proteins of the hepatitis C virus and result in disruption of viral replication and infection.
Da begge anmodninger for den påbegyndte procedure bunder i en gennemgang af data fra lægemiddelovervågningsaktiviteter, har Kommissionen udbedt sig, at udtalelsen vedtages af Udvalget for Lægemidler til Mennesker (CHMP) på grundlag af en anbefaling fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC).
Patienter med HBV/HCV coinfektion skal monitoreres under og efter behandlingen i henhold til gældende kliniske retningslinjer.
Patients with HBV/HCV co-infection should be monitored during and after treatment according to current clinical guidelines.
Derfor fremkom data om HBVreaktivering med DAA'er overvejende efter markedsføringen.
Therefore data on HBV reactivation with DAAs mostly arose post-marketing.
De virologiske og immunologiske aspekter af HBV/HCV co-infektion er ikke fuldt afklaret.
The virological and immunological aspects of HBV/HCV co-infection are not fully comprehended.
Det kan dog antages, at patienter, hvis leversygdom er mere fremskreden, kan have højere risiko for alvorlige kliniske komplikationer, hvis HBV-reaktivering skulle forekomme.
It may be assumed however that patients with more advanced liver disease may have a higher risk of severe clinical complications should HBV reactivation occur.
Man fandt, at, udover reaktivering af hepatitis B-virus, burde risikoen for hepatocellulært carcinom ligeledes undersøges nærmere og at passende foranstaltninger til optimering af sikker og effektiv anvendelse af disse lægemidler burde overvejes.
It was considered that in addition to the hepatitis B virus reactivation, the risk of hepatocellular carcinoma should also be further investigated and that consideration should be given for adequate measures to optimise the safe and effective use of these medicinal products.
PRAC var af den opfattelse, at alle patienter skal screenes for hepatitis B-virus-infektion inden behandlingsstart med DAA'er.
The PRAC was of the view that all patients should be screened for hepatitis B virus infection before initiation of treatment with DAAs.
I anbefalingerne fra The European Association for the Study of the Liver (EASL) om behandling af hepatitis C bliver der gjort opmærksom på den potentielle risiko for HBV-reaktivering under eller efter HCV-clearance.
The European Association for the Study of the Liver (EASL) recommendations on treatment of hepatitis C makes reference to the potential risk of HBV reactivation during or after HCV clearance.
• PRAC fandt, at proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, der var foranlediget af lægemiddelovervågningsdata om direkte aktive antivirale lægemidler (DAA'er) indiceret til behandling af kronisk hepatitis C.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the treatment chronic hepatitis C.
Europa-Kommissionen udvidede derfor omfanget af proceduren i april 2016 af hensyntagen til andre data til vurdering risikoen for hepatocellulært carcinom og carcinomets indvirkning på benefit/risk-forholdet for alle DAA'er i behandlingen af kronisk hepatitis C.
The European Commission therefore extended the scope of the procedure in April 2016 to allow consideration of other data to assess the risk of hepatocellular carcinoma and its impact on the benefit-risk balance for all DAAs in the treatment of chronic hepatitis C.
Disse kohorter var dog ikke sammensat med henblik på vurdering af HCC-recidiv, som tilfældet er med ANRS CO22 HEPATHER-kohorten, eller inkluderede et begrænset antal patienter med et tidligere HCC, hvor patienten opnåede fuldstændigt radiologisk respons og derefter blev behandlet med DAA'er som i ANRS CO12 CirVir-kohorten.
However, these cohorts were either not designed for assessing HCC recurrence, as is the case of the ANRS CO22 HEPATHER cohort, or included a limited number of patients with a previous HCC reaching complete radiological response and subsequently treated with DAAs as in the ANRS CO12 CirVir cohort.
Selvom der er beskrevet alvorlige og endog fatale tilfælde af HBV-reaktivering i litteraturen, indikerer tilgængelige data, at reaktiveringen af HBV-replikation i de fleste tilfælde er mild og uden kliniske konsekvenser.
Although severe and even fatal cases of HBV reactivation have been described in the literature, the available data indicate that reactivation of HBV replication may mostly be mild and without clinical consequences.
I tilfælde taget fra litteraturen (Balagopal et al., 2015, Collins et al., 2015 og Ende et al., 2015) beskrives der en stigning i HBV-virusbyrden efter et hurtigt fald i HCV-virusbyrden hos patienter behandlet med direkte aktive antivirale lægemidler (DAA'er) i behandlinger uden interferon, og der er derudover identificeret tilfælde i EudraVigilance.
Literature cases (Balagopal et al., 2015; Collins et al., 2015; Ende et al., 2015) described HBV viral load increase after a rapid decline of HCV viral load in patients treated with direct acting antivirals (DAA) in interferon-free regimens, and further cases have been identified in EudraVigilance.
PRAC mener ligeledes at "opståen af hepatocellulært carcinom" og "recidiv af hepatocellulært carcinom" bør betragtes som vigtige potentielle risici.
The PRAC was also of the view that ‘emergence of hepatocellular carcinoma' and ‘recurrence of hepatocellular carcinoma' should be considered as important potential risks.
Forskningen skal prospektivt registrere kendte risikofaktorer for HCC og regelmæssige billedundersøgelser med henblik på HCC-diagnose i henhold til de aktuelle kliniske retningslinjer fra EASL.
The research should capture prospectively the known risk factors for HCC and the periodic image testing for HCC diagnosis, according to current European clinical guidelines (EASL).
Den aktuelle procedure for indbringelse af sager blev iværksat af Europa-Kommissionen for at muliggøre en nærmere undersøgelse af risikoen for hepatitis B-virus-replikation efter behandlingsstart med DAA'er og anbefale eventuelle relevante risikominimerende tiltag.
The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to minimise the risk.
Co-infektion med hepatitis В-virus (HBV) og hepatitis C-virus (HCV) er ikke ualmindeligt grundet de overlappende smitteveje.
Hepatitis В virus (HBV) and hepatitis C virus (HCV) co-infection is not uncommon due to overlapping transmission modes.
Der skal til dette formål indsendes en forundersøgelse om brugen af eksisterende datakilder til PRAC's evaluering senest 15. juni 2017.
A feasibility assessment of the use of existing data sources for this purpose should be submitted for PRAC assessment by 15 June 2017.
Grundet deres øgede styrke over for HCV og manglende anti-HBV-aktivitet kan risikoen for HBV-reaktivering være større ved nyere HCV-behandlinger end ved de tidligere godkendte interferon-baserede HCV-behandlinger.
Given their increased potency against HCV and lack of anti-HBV activity, the risk of HBV reactivation may be greater with newer HCV treatment regimens than with the previously approved interferon-based HCV treatments.
Selvom aktiviteten og progressionen i leversygdom generelt er mere alvorlig ved dobbeltinfektion, hæmmes HBV-replikationen ofte ved HCV co-infektion.
Although liver disease activity and progression are generally more severe in the presence of double infection, HBV replication is often suppressed in the presence of HCV coinfection.
Reaktiveringen forekom generelt kort tid efter behandlingsstart i et mønster, der antyder en forbindelse med det hurtige fald i HCV-virusbyrden, som karakteriserer virusbyrdens dynamik med DAA'er.
Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Efter yderligere overvejelser hvad angår de foreslåede tidsfrister for indsendelsen af den endelige undersøgelsesrapport og under hensyntagen til, at protokollen skal indsendes senest 15. juni 2017, fandt CHMP, at datoen for indsendelsen af den endelige undersøgelsesrapport skal udsættes til andet kvartal af 2021.
After further consideration of the timelines proposed for the submission of the final study report and taking into account that the protocol is due to be submitted by 15 June 2017, the CHMP was of the opinion that the date for the submission of the final study report should be postponed to Q2 2021 in order to allow sufficient time for agreement on a joint protocol and for collection of sufficient data to adequately respond to the scientific question.
Protokollen for denne undersøgelse skal indsendes til PRAC senest 15. juni 2017 og undersøgelsens endelige resultater skal indsendes senest i fjerde kvartal af 2019.
The protocol of this study shall be submitted to the PRAC by 15 June 2017 and the final study results by Q4 2019.
Med hensyn til gennemgangen af HCC med DAA'er, blev indehaverne af markedsføringstilladelserne bedt om at gennemføre en grundig gennemgang af alle tilgængelige data fra kliniske forøg, observationsundersøgelser, spontane rapporter og offentliggjort litteratur om HCC hos patienter med kronisk hepatitis C efter behandling med DAA'er.
With regards to the review of HCC with DAAs, MAHs were requested to perform a comprehensive review of all available data from clinical trials, observational studies, spontaneous reports and published literature on HCC in patients with chronic hepatitis C after treatment with DAAs.
Samlet set vurderede PRAC, at der var brug for flere undersøgelser for yderligere at kunne karakterisere risikoen for HCC-recidiv i forbindelse med DAA'er for derved at kunne afklare øvrige usikkerhedsmomenter omkring den potentielle risiko og for at kunne drage en konklusion om behovet for eventuel supplerende vejledning omkring klinisk behandling.
Overall, the PRAC considered that further studies were warranted to further characterise the risk of HCC recurrence associated with DAAs, in order to address remaining uncertainties about this potential risk and conclude on the need for any additional advice on clinical management.
• PRAC var også af den opfattelse, at virkningen af DAA-behandling på incidensen og typen af de novo hepatocellulært carcinom skal undersøges yderligere gennem en prospektiv kohorte undersøgelse hos HCV-inficerede patienter med cirrose.
• The PRAC was also of the opinion that the impact of DAAs treatment on the incidence and type of de novo hepatocellular carcinoma should be further investigated though a prospective cohort study in HCV infected patients with cirrhosis.
HBV-replikation efter behandlingsstart med DAA'er for HCV-infektion er i øjeblikket ikke beskrevet i produktinformationen for eksisterende godkendte lægemidler og på grund af de alvorlige hændelser, der er beskrevet, behovet for intervention for HBV-replikation og den biologiske sandsynlighed for replikationen, blev det konkluderet, at en nærmere undersøgelse var berettiget.
HBV replication after starting treatment with DAAs for HCV infection is not currently described in the product information of currently authorised products and in view of the seriousness of the events described, the need for intervention on HBV replication and the biological plausibility of the replication it was considered that further investigation was warranted.
Der skal derudover indsendes foreløbige resultater til PRAC's vurdering senest i fjerde kvartal af 2019.
In addition, interim results should be submitted for PRAC assessment by Q4 2019.
HCV-infektion vides at forårsage hæmning af HBV-replikation hos coinficerede patienter.
HCV infection is known to cause suppression of HBV replication in co-infected patients.
Der blev på baggrund af resultaterne fra Reig et al også rejst betænkelighed ved udviklingen af de novo HCC hos cirrotiske HCV-patienter behandlet med DAA, da disse patienter kan have HCC, der ikke er diagnosticeret endnu.
Based on the findings of Reig et al, concerns on the development of de novo HCC in cirrhotic HCV patients treated with DAA were also raised, as these patients may harbour not yet diagnosed HCC.
• Hvad angår risikoen for HCC-recidiv hos patienter, der bruger DAA'er, fandt PRAC, at der er behov for flere oplysninger om virkningen af behandling med DAA'er på incidensen af HCCrecidiv.
• Concerning the risk of recurrence of HCC in patients using DAAs, the PRAC considered that further data are required on the impact of DAAs treatment on the incidence of HCC recurrence.
2016), der blev gennemført i perioden oktober 2014 til december 2015 på hepatologiafdelinger på fire spanske universitetshospitaler hos patienter med kronisk hepatitis C, og hvis anamnese inkluderede hepatocellulært carcinom (HCC), og som var behandlet med DAA'er, et uventet, tidligt recidiv af HCC.
Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested unexpected early HCC recurrence.
For a minimere risikoen for HBV-reaktivering anbefalede PRAC, at alle patienter screenes for HBVinfektion inden behandlingsstart med DAA'er, og at patienter med HBV/HVC co-infektion monitoreres og behandles i henhold til de aktuelle kliniske retningslinjer.
In order to minimise the risk of HBV reactivation, the PRAC recommended that all patients should be screened for HBV infection before initiation of treatment with DAAs and that patients presenting a coinfection HBV/HCV should be monitored and managed according to current clinical guidelines.
Betydningen af karakteristikaene ved kronisk HCV-infektion, som f.eks. HCV-genotype, virusbyrde og histopatologisk stadieinddeling, for risikoen for forekomsten af HBV-reaktivering kunne ikke afklares ud fra de tilgængelige data.
The impact of chronic HCV infection characteristics, such as HCV genotype, viral load and histopathologic staging, on the risk of occurrence of HBV reactivation could not be clarified from the available data.
• PRAC gennemgik alle indsendte skriftlige data og mundtlige forklaringer fra indehaverne af markedsføringstilladelserne med hensyn til risikoen for hepatitis B-reaktivering og de betænkeligheder dette gav anledning til efter rapporter om hepatocellulært carcinom hos patienter, der bruger DAA'er, samt resultaterne fra mødet, der blev afholdt af den videnskabelige rådgivende gruppe, om hiv-/virussygdomme.
• The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral diseases.
CHMP finder følgeligt, at benefit/risk-forholdet for Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax fortsat er positivt under forudsætning af, at de nævnte ændringer indføres i produktinformationen og i henhold til ovennævnte betingelser.
The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above.