natgillin/translations-raw huggingface dataset:
Udvalget konkluderede derfor, at fordelene ved Eurartesim opvejer risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Eurartesim.
Therefore, the Committee concluded that the benefits of Eurartesim outweigh its risks and recommended that it be granted marketing authorisation.
Hos børn var de hyppigste bivirkninger ved Eurartesim (set hos flere end 1 ud af 10 patienter) influenza, hoste og feber.
In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and fever.
Eurartesim piperaquintetrafosfat/artenimol
Eurartesim piperaquine tetraphosphate / artenimol
Udvalget bemærkede, at Eurartesim overholder Verdenssundhedsorganisationens anbefalinger vedrørende behandling af P. falciparummalaria ved at tilbyde en ny, alternativ artemisinin-kombinationsterapi bestående af to aktive stoffer, som virker på forskellige måder.
The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways.
Piperaquintetrafosfat er et såkaldt bisquinolon.
Piperaquine tetraphosphate is a so-called bisquinolone.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Eurartesim?
What measures are being taken to ensure the safe use of Eurartesim?
De aktive stoffer i Eurartesim, piperaquintetrafosfat og artenimol, er malariamidler, der dræber parasitten P. falciparum.
The active substances in Eurartesim, piperaquine tetraphosphate and artenimol, are antimalarial substances which kill the P. falciparum parasite.
Eurartesim er et lægemiddel mod malaria, der indeholder de aktive stoffer piperaquintetrafosfat og artenimol.
Eurartesim is a malaria medicine that contains the active substances piperaquine tetraphosphate and artenimol.
Eurartesim anvendes til behandling af ukompliceret malaria forårsaget af parasitten Plasmodium falciparum.
Eurartesim is used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.
Den fuldstændige liste over bivirkninger ved Eurartesim fremgår af indlægssedlen.
For the full list of all side effects with Eurartesim, see the package leaflet.
Eurartesim blev undersøgt i to hovedundersøgelser omfattende patienter med ukompliceret P. falciparum-malaria.
Eurartesim was investigated in two main studies in patients with uncomplicated P. falciparum malaria.
Hvilken risiko er der forbundet med Eurartesim?
What is the risk associated with Eurartesim?
I den anden undersøgelse var 93 % af de patienter, der fik Eurartesim, helbredt 28 dage efter behandlingen sammenlignet med 95 % af de patienter, der blev behandlet med sammenligningslægemidlet.
In the second study, 28 days after treatment 93% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
Hovedeffektmålet var andelen af patienter, som var helbredt 63 dage efter behandlingen.
The main measure of effectiveness was the proportion of patients who were cured 63 days after treatment.
I den første undersøgelse var 97 % af de patienter, der fik Eurartesim, helbredt 63 dage efter behandlingen sammenlignet med 95 % af de patienter, der blev behandlet med sammenligningslægemidlet.
In the first study, 63 days after treatment 97% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
I den anden undersøgelse blev Eurartesim sammenlignet med et andet lægemiddel, der indeholder artemeter og lumefantrin, hos 1 553 børn.
In the second study, Eurartesim was compared with another medicine containing artemether and lumefantrine in 1,553 children.
I den første undersøgelse blev Eurartesim sammenlignet med et andet malariamiddel, der indeholder artesunat og mefloquin, hos 1 150 patienter.
In the first study, Eurartesim was compared with another malaria medicine containing artesunate and mefloquine in 1,150 patients.
Hovedeffektmålet var andelen af patienter, som var helbredt 28 dage efter behandlingen.
The main measure of effectiveness was the proportion of patients who were cured 28 days after treatment.
CHMP konkluderede, at det er påvist, at Eurartesim er effektivt til behandling af ukompliceret P. falciparum-malaria, mens bivirkningerne var de samme som ved sammenlignelige behandlinger.
The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated P. falciparum malaria while the side effects were similar to those seen with comparable treatments.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Eurartesim.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eurartesim have also been included in the summary of product characteristics and the package leaflet.
Hvorfor blev Eurartesim godkendt?
Why has Eurartesim been approved?
Eurartesim viste sig at være effektivt til behandling af ukompliceret P. falciparum-malaria.
Eurartesim was shown to be effective in treating uncomplicated P. falciparum malaria.
Hvad er Eurartesim?
What is Eurartesim?
Hvilken fordel viser undersøgelserne, at der er ved Eurartesim?
What benefit has Eurartesim shown during the studies?
Hvordan blev Eurartesim undersøgt?
How has Eurartesim been studied?
Hvad anvendes Eurartesim til?
What is Eurartesim used for?
Hvordan anvendes Eurartesim?
How is Eurartesim used?
Hvordan virker Eurartesim?
How does Eurartesim work?
Dets nøjagtige virkningsmekanisme kendes ikke, men man ved, at det bindes til flere forskellige receptorer på nerveceller i hjernen.
Its exact mechanism of action is unknown, but it attaches to several different receptors on nerve cells in the brain.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Aripiprazole Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Sandoz.
This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz.
Aripiprazol ændrer derved aktiviteten af de nerveceller, der menes at give anledning til de psykotiske og maniske symptomer, og forhindrer symptomerne i at komme igen.
In this way, aripiprazole helps to change the activity of the nerve cells which are thought to give rise to psychotic or manic symptoms and preventing them from returning.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Sandoz anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible.
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Sandoz i kroppen.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Sandoz is broken down in the body.
Udvalget anbefalede, at Aripiprazole Sandoz godkendes til anvendelse i EU.
The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.
Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en "partiel agonist") på receptorerne for neurotransmitterne dopamin og 5hydroxytryptamin (også kaldet serotonin).
Aripiprazole is thought to act mainly by being a ‘partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Aripiprazole Sandoz er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Aripiprazole Sandoz anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, hos hvem lægemidlet tidligere har givet bedring i sygdommen.
Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.
Aripiprazole Sandoz aripiprazol
Aripiprazole Sandoz aripiprazole
Det betyder, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Aripiprazole Sandoz anvendes hos patienter med følgende psykiske sygdomme:
Aripiprazole Sandoz is used in patients with the following mental illnesses:
Det aktive stof i Aripiprazole Sandoz, aripiprazol, er et antipsykotisk lægemiddel.
The active substance in Aripiprazole Sandoz, aripiprazole, is an antipsychotic medicine.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Sandoz, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Da Aripiprazole Sandoz er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Aripiprazole Sandoz is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Andre oplysninger om Aripiprazole Sandoz
Other information about Aripiprazole Sandoz
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Sandoz?
What measures are being taken to ensure the safe and effective use of Aripiprazole Sandoz?
Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Aripiprazole Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvilke fordele og risici er der forbundet med Aripiprazole Sandoz?
What are the benefits and risks of Aripiprazole Sandoz?
Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af kemiske signalstoffer (neurotransmittere).
This disrupts signals transmitted between brain nerve cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Virksomheden udførte bioækvivalensundersøgelser for at fastslå, at Aripiprazole Sandoz er bioækvivalent med referencelægemidlet, Abilify.
The company carried out ‘bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Aripiprazole Sandoz fås som tabletter og udleveres kun efter recept.
Aripiprazole Sandoz is available as tablets and can only be obtained with a prescription.
Virksomheden fremlagde data fra faglitteraturen om aripiprazol.
The company provided data from the published literature on aripiprazole.
Det er ikke en praktisk vejledning i, hvordan Aripiprazole Sandoz bør anvendes.
It is not intended to provide practical advice on how to use Aripiprazole Sandoz.
Med henblik på anvendelse hos patienter over 13 år med moderate til svære maniske episoder ved bipolar lidelse I skal den virksomhed, der markedsfører Aripiprazole Sandoz, desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne.
In addition, when used for patients aged 13 years or older with moderate to severe manic episodes in bipolar I disorder, the company that markets Aripiprazole Sandoz will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in these patients.
Aripiprazole Sandoz anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger.
Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Hvad er Aripiprazole Sandoz, og hvad anvendes det til?
What is Aripiprazole Sandoz and what is it used for?
Aripiprazole Sandoz anvendes til patienter over 15 år,
Aripiprazole Sandoz is used in patients aged 15 years or over;
Hvis du ønsker praktisk vejledning om anvendelsen af Aripiprazole Sandoz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Aripiprazole Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Aripiprazole Sandoz er et "generisk" og "hybridt" lægemiddel.
Aripiprazole Sandoz contains the active substance aripiprazole and is a ‘generic' and a ‘hybrid' medicine.
Mens referencelægemidlet, Abilify, fås som tabletter på 5 mg, 10 mg, 15 mg og 30 mg, fås Aripiprazole Sandoz desuden som 20-mg-tabletter.
This means that it is similar to a ‘reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets.
Hvorfor blev Aripiprazole Sandoz godkendt?
Why is Aripiprazole Sandoz approved?
Hvordan blev Aripiprazole Sandoz undersøgt?
How has Aripiprazole Sandoz been studied?
Hvordan anvendes Aripiprazole Sandoz?
How is Aripiprazole Sandoz used?
Hvordan virker Aripiprazole Sandoz?
How does Aripiprazole Sandoz work?
Der er ikke blevet rapporteret nogen risikofaktorer eller alternativ ætiologi i nogen af disse tilfælde.
No risk factors or alternative aetiology have been reported in any of these cases.
Del ikke pennen med andre, for at undgå at overføre en infektion til dem eller selv få en
Do not share the pen with anyone else to avoid giving an infection to them or getting an
• Hvis nogle steder er for vanskelige for dig at nå, kan du bede en trænet hjælper om
• If some areas are too difficult for you to reach, ask a carer who has been trained to
Der er modtaget 4 nye alvorlige tilfælde af colitis, der er bekræftet af sundhedspersonale, i løbet af denne periode.
Four new serious cases of colitis confirmed by health-care professionals have been received during this period.
Vælg et injektionssted og aftør huden med
Choose an injection site and wipe the skin
Daclizumab beta havde ingen virkning på den peri- og post-natale udvikling hos afkommet fra fødslen og op til 6 måneder efter fødslen.
Daclizumab beta had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
In vitro studier antyder, at mikrogliale aggregater ikke skyldes en direkte virkning af daclizumab beta på mikrogliale celler, men sandsynligvis kan tilskrives en stigning i lokal IL-2-biotilgængelighed.
In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab beta on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
• Patienter med 2 eller flere attakker på 1 år og med 1 eller flere Gd-forstærkede læsioner på MR
• Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain
Kumulativt er der indhentet 24 tilfælde af colitis fra kliniske studier.
Cumulatively, 24 cases of colitis have been retrieved from clinical trials.
Dette lille fordelingsvolumen angiver, at daclizumab beta primært fordeles til vaskulære og interstitielle rum.
This small volume of distribution indicates that daclizumab beta is primarily confined to the vascular and interstitial spaces.
Daclizumab betas farmakokinetik er velbeskrevet ved en 2-kompartmentsmodel med førsteordens absorption og elimination.
Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Der var en begrænset erfaring med eksponering hos patienter over 55 år fra kliniske studier med daclizumab beta.
There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
12 tilfælde af sarkoidose, bekræftet af sundhedspersonale, er rapporteret kumulativt fra kliniske studier.
Twelve cases of sarcoidosis confirmed by health-care professionals were reported from clinical trials cumulatively.
Daclizumab beta produceres i en pattedyrscellelinje (NS0) vha. rekombinant dna-teknologi.
Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Efter subkutan administration af daclizumab beta var gennemsnitstiden til opnåelse af maksimale serumkoncentrationer (Tmax) mellem 5 og 7 dage.
Following subcutaneous administration of daclizumab beta, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Du b. c.
You b. c.
Lad injektionsstedet tørre af sig selv, inden
Let the injection site dry on its own before
• Behovet for at screene for hepatitis B og C før behandlingen iværksættes, og at anbefale, at patienter, der tester positivt for HBV- eller HCV-infektion kontakter en læge med speciale i
• The need to screen for hepatitis B and C prior to treatment initiation and to recommend patients who test positive for HBV or HCV infection to consult with a physician with expertise in the
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for daclizumab beta er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for daclizumab beta, the scientific conclusions of CHMP are as follows:
• hududslæt, herunder betændt, irriteret, kløende, tør eller skællende hud (dermatitis, eksem,
• skin rashes, including inflamed, irritated, itchy, dry or peeling skin (dermatitis, eczema,
Potentielle bivirkninger over dette niveau forventes at være i overensstemmelse med sikkerhedsprofilen for daclizumab beta hos MS-patienter.
Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab beta in MS patients.
Der var ingen klar sammenhæng mellem udviklingen af antistoffer mod lægemidlet eller neutraliserende antistoffer og den kliniske respons, bivirkninger eller den farmakodynamiske profil for daclizumab beta.
There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab beta.
På baggrund af de videnskabelige konklusioner for daclizumab beta er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder daclizumab beta, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen
On the basis of the scientific conclusions for daclizumab beta the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing daclizumab beta is unchanged subject to the proposed changes to the product information
Natriumsuccinat, ravsyre, natriumchlorid, polysorbat 80, vand til injektionsvæsker
Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Kronisk administration af daclizumab beta i alle doser øgede incidensen af hudreaktioner (sammenlignet med kontroldyrene).
Chronic administration of daclizumab beta at all doses increased the incidence of skin findings (compared to those observed in control animals).
• Anbefalingen om ikke at iværksætte behandlingen hos patienter med autoimmunsygdomme
• The recommendation not to initiate treatment in patients with autoimmune disorders (other than
Daclizumab beta er et humaniseret IgG1 monoklonalt antistof, der binder til CD25 (IL-2Rα) og forhindrer IL-2-binding til CD25.
Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Daclizumab beta kunne detekteres i mælken hos 11 ud af 14 diegivende aber med niveauer, der var <0,122% af moderens serumniveau, uden observation af bivirkninger hos afkommet.
Daclizumab beta was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Tilsammen menes disse immunmodulerende virkninger af daclizumab beta at reducere de CNS-patologiske træk ved MS og derved reducere forekomsten af attakker og sygdomsprogression.
Together, these immunomodulatory effects of daclizumab beta are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Baseret på den tværgående farmakokinetiske analyse af studiepopulationen kunne kropsvægt redegøre for mindre end 40% af den inter-individuelle variabilitet i daclizumab betas clearance.
Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab beta clearance.
Anvend ikke pennen, hvis den har været
Do not use the pen if it has been dropped or
Baseret på den tværgående farmakokinetiske analyse af studiepopulationen blev daclizumab betas farmakokinetik ikke påvirket af alder (interval 18 til 66 år; n = 1.670) eller køn (n = 567 mænd og 1.103 kvinder).
Based on the cross-study population pharmacokinetic analysis, daclizumab beta pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Kontroller medicinvinduet og se efter, at Zinbryta-injektionsvæsken er farveløs til let
Check the medicine window and make sure the Zinbryta medicine is colourless to
Ved steady state var den gennemsnitlige maksimale serumkoncentration af daclizumab beta (Cmax), den minimale serumkoncentration (Cmin) og arealet under serumkoncentration-tid-kurven over doseringsintervallet (AUCtau) henholdsvis cirka 30 mikrogram/ml, 15 mikrogram/ml og 640 dag∙mikrogram/ml med en inter-individuel variation (% CV) på cirka 40%.
At steady state, daclizumab beta mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentration-time curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Daclizumab beta modulerer IL-2-signalering ved at blokere CD25afhængig, høj-affinitets IL-2-receptorsignalering, hvilket resulterer i højere niveauer af IL-2, som er tilgængelig for signalering via IL-2-receptoren med intermediær affinitet.
Daclizumab beta modulates IL-2 signalling by blocking CD25dependent, high-affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Daclizumab beta påvirkede ikke reproduktionsevnen hos cynomolgus-hunner eller -hanner (AUC hos hunner og hanner op til henholdsvis 85 og 100 gange højere end eksponeringen ved den kliniske dosis).
Daclizumab beta did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Det aktive stof i Zinbryta er daclizumab beta.
The active substance in Zinbryta is daclizumab beta.
I overensstemmelse med resultater fra individuelle studier indikerede en tværgående farmakokinetisk analyse af studiepopulationen, at eksponeringen for daclizumab beta er mere end proportional med dosis i dosisintervallet 50 mg til 100 mg subkutant, og proportional med dosis i dosisintervallet 100 mg til 300 mg subkutant.
Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.