natgillin/translations-raw huggingface dataset:
• Til tonisk-kloniske anfald faldt antallet af anfald gennemsnitligt med 28 % hos de patienter, der fik placebo, sammenlignet med 57 % hos dem, der fik Keppra.
• for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra.
Til patienter med nyreproblemer (såsom ældre patienter) anvendes der lavere doser.
Lower doses are used in patients who have problems with their kidneys (such as older patients).
Hos spædbørn i alderen mellem en og seks måneder er startdosis 7 mg/kg to gange dagligt med den orale opløsning.
In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Hos patienter i alderen mellem seks måneder og 17 år, som vejer under 50 kg, er startdosis 10 mg pr. kg legemsvægt to gange dagligt, hvilket kan øges til op til 30 mg/kg to gange dagligt.
In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Keppra var hos børn også mere effektivt end placebo.
Keppra was also more effective than placebo in children;
• Til myoklone anfald blev Keppra undersøgt hos 122 patienter i alderen 12 år og opefter, som i op til 30 uger enten fik Keppra eller placebo i tillæg til deres normale antiepileptikum.
• in myoclonic seizures, Keppra was studied in 122 patients aged 12 years and over, who received either Keppra or placebo in addition to their normal anti-epileptic medicine for up to 30 weeks;
Keppra anvendt alene blev undersøgt hos 579 patienter på 16 år og derover med partielle anfald, som enten fik Keppra eller carbamazepin (et andet antiepileptikum) i op til to år.
Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
• Til myoklone anfald blev antallet af daglige anfald pr. uge halveret hos 58 % af de patienter, der fik Keppra, og hos 23 % af de patienter, der fik placebo.
• for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
Keppra kan uden supplerende behandling anvendes til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Hvad er Keppra?
What is Keppra?
Når Keppra anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Når Keppra anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
• myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter fra 12-års alderen med juvenil myoklon epilepsi
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Derefter kan dosis øges indtil 1 500 mg to gange dagligt.
The daily dose can be increased up to 1,500 mg twice a day.
Hvordan blev Keppra undersøgt?
How has Keppra been studied?
Afhængigt af patientens reaktion på behandlingen kan dosis med to ugers mellemrum yderligere øges til en maksimal dosis på 1 500 mg to gange dagligt.
The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Hvilken fordel viser undersøgelserne, at der er ved Keppra?
What benefit has Keppra shown during the studies?
Hvad anvendes Keppra til?
What is Keppra used for?
Hvordan anvendes Keppra?
How is Keppra used?
Hvordan virker Keppra?
How does Keppra work?
Dette sammendrag blev sidst ajourført i 02-2015.
This summary was last updated in 02-2015.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tasermity den 26. februar 2015.
The European Commission granted a marketing authorisation valid throughout the European Union for Tasermity on 26 February 2015.
Lægemidlet er identisk med Renagel, som allerede er godkendt i Den Europæiske Union (EU).
This medicine is the same as Renagel, which is already authorised in the European Union (EU).
Den fuldstændige EPAR for Tasermity findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Tasermity 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 Tasermity.
This is a summary of the European public assessment report (EPAR) for Tasermity.
Andre oplysninger om Tasermity
Other information about Tasermity
Der er udarbejdet en risikostyringsplan for at sikre, at Tasermity anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Tasermity is used as safely as possible.
Virksomheden, som fremstiller Renagel, har indvilget i, at dens videnskabelige oplysninger må anvendes for Tasermity (»informeret samtykke«).
The company that makes Renagel has agreed that its scientific data can be used for Tasermity (‘informed consent').
Tasermity leveres som tabletter (800 mg).
Tasermity is available as tablets (800 mg).
Dette bidrager til at nedsætte fosfatindholdet i blodet.
This helps to reduce the phosphate levels in the blood.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tasermity?
What measures are being taken to ensure the safe and effective use of Tasermity?
Tasermity skal tages sammen med måltider, og patienterne skal holde deres ordinerede diæt.
Tasermity must be taken with meals and patients should keep to their prescribed diets.
Den anbefalede startdosis for Tasermity er 1 eller 2 tabletter tre gange dagligt, afhængigt af det kliniske behov og fosfatindholdet i blodet.
The recommended starting dose of Tasermity is 1 or 2 tablets three times a day, depending on clinical need and the level of phosphate in the blood.
Dette kan i det lange løb medføre komplikationer, der påvirker hjertet og knoglerne.
This leads to phosphate accumulating in the body, which, in the long term, can cause complications affecting the heart and the bones.
Patienter med svær nyresygdom kan ikke udskille fosfat.
Patients with severe kidney disease cannot eliminate phosphate from their bodies.
De hyppigste bivirkninger ved Tasermity (som optræder hos mere end 1 ud af 10 patienter) er kvalme og opkastning.
The most common side effects with Tasermity (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Tasermity, 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 Tasermity, including the appropriate precautions to be followed by healthcare professionals and patients.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tasermity til behandling af hypofosfatæmi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tasermity's benefits are greater than its risks for the treatment of hyperphosphataemia and recommended that it be approved for use in the EU.
Det er ikke en praktisk vejledning i, hvordan Tasermity bør anvendes.
It is not intended to provide practical advice on how to use Tasermity.
Dosis af Tasermity bør korrigeres hver anden til tredje uge, indtil fosfatindholdet i blodet er acceptabelt, hvorefter det bør overvåges regelmæssigt.
The dose of Tasermity should be adjusted every two to three weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Tasermity sevelamerhydrochlorid
Tasermity sevelamer hydrochloride
Hvad er Tasermity, og hvad anvendes det til?
What is Tasermity and what is it used for?
Den fuldstændige liste over bivirkninger og begrænsninger ved Tasermity fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Tasermity, see the package leaflet.
Hvis du ønsker yderligere oplysninger om behandling med Tasermity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Tasermity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvorfor blev Tasermity godkendt?
Why is Tasermity approved?
Hvilke risici er der forbundet med Tasermity?
What are the risks associated with Tasermity?
Det kan både anvendes hos patienter i hæmodialyse (hvor der bruges apparatur til at filtrere blodet) og i peritonealdialyse (hvor der pumpes væske ind i bughulen, og blodet filtreres af kroppens egen indvendige hinde).
It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Det aktive stof i Tasermity, sevelamerhydrochlorid, er en fosfatbinder.
The active substance in Tasermity, sevelamer hydrochloride, is a phosphate binder.
Tasermity indeholder det aktive stof sevelamerhydrochlorid.
Tasermity contains the active substance sevelamer hydrochloride.
Undersøgelser har vist, at Tasermity nedsætter fosfatindholdet i blodet væsentligt hos patienter, der har nyresygdom og er i dialyse.
Studies have shown that Tasermity significantly reduces blood phosphate levels in patients with kidney disease undergoing dialysis.
Hvis du ønsker praktisk vejledning om anvendelsen af Tasermity, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Tasermity, patients should read the package leaflet or contact their doctor or pharmacist.
Tasermity er et lægemiddel, der anvendes til at kontrollere for højt fosfatindhold i blodet (hyperfosfatæmi) hos voksne patienter, der får renset blodet ved dialyse.
Tasermity is a medicine used to control hyperphosphataemia (high blood phosphate levels) in adult patients on dialysis (a blood clearance technique).
I en undersøgelse med 84 patienter i hæmodialyse var det gennemsnitlige fald i fosfatindholdet 0,65 mmol/l hos de patienter, der fik Tasermity i 8 uger.
In a study of 84 patients undergoing haemodialysis, there was an average fall in phosphate levels of 0.65 mmol/l in patients taking Tasermity for 8 weeks, compared with a fall of 0.68 mmol/l in patients taking calcium acetate, another phosphate-lowering medicine.
For at forebygge knoglesygdom bør Tasermity anvendes sammen med andre behandlinger, såsom tilskud af calcium og D-vitamin.
Tasermity should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Når Tasermity tages sammen med et måltid, bliver madens indhold af fosfat bundet til sevelamermolekylerne i tarmen, så det ikke optages i kroppen.
When taken with meals, the sevelamer molecules in Tasermity attach in the gut to phosphate from food, preventing it from being absorbed into the body.
Hvilke fordele viser undersøgelserne, at der er ved Tasermity?
What benefits of Tasermity have been shown in studies?
Tasermity må ikke anvendes hos personer med for lavt fosfatindhold i blodet (hypofosfatæmi) eller tarmslyng (ileus).
Tasermity must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Hvordan anvendes Tasermity?
How is Tasermity used?
I en tredje, mere langvarig undersøgelse (over 44 uger) bevirkede Tasermity et gennemsnitligt fald på 0,71 mmol/l.
Similar results with Tasermity were seen in another 8-week study involving 172 haemodialysis patients, while in a third longer-term study (over 44 weeks) Tasermity led to an average fall of 0.71 mmol/l.
I denne undersøgelse opnåede de patienter, der fik Tasermity, i løbet af 12 uger samme fald i fosfatindholdet som dem, der fik calciumacetat (henholdsvis 0,52 og 0,58 mmol/l).
The benefit of Tasermity has also been shown in a study of 143 patients undergoing peritoneal dialysis: patients receiving Tasermity in this study had similar falls in phosphate levels over 12 weeks as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Hvordan virker Tasermity?
How does Tasermity work?
EU nummer Særnavn Styrke
EU Number Invented name Strength
1,3 GBq/ml på den referencedato
2 to 4 GBq per vial at calibration date
Indhold (koncentration) Pakningsstørrelse
Package size
Emballage
Intravenous use
Intravenøs anvendelse Pulver: hætteglas 1.5 - 1.3 ml
1.5 - 3.1 ml 1 vial
Lægemiddelform Indgivelsesvej
Pharmaceutical form Route of administration Packaging Content
... og i 2 timer efter
... and for 2 hours after
Men der vil stadig være noget tilbage i flasken, selvom du ikke nødvendigvis kan se det.
But there will still be some left in the bottle, even though you may not be able to see it.
Dato for første markedsføringstilladelse: 11. marts 2010 Dato for seneste fornyelse: 15. januar 2015
Date of first authorisation: 11 March 2010 Date of latest renewal: 15 January 2015
• progressive, eller
• progressive, or
Lægen vil diskutere dette med dig.
Your doctor will discuss this with you.
Det er normalt).
This is normal.)
Undgå direkte kontakt med lægemidlet.
Avoid direct contact with the medicine.
• varer ved i ≥ 4 uger, eller
• persistent for ≥4 weeks, or
Du har nu givet barnet næsten hele dets dosis medicin.
You have now given the child nearly all of their dose of medicine.
Før du begynder Læs denne information først
Before you start Read these messages first
Det er vigtigt, at du fortæller lægen, hvis du udvikler disse symptomer.
It is important to tell a doctor if you develop these symptoms.
Multilineært respons var rapporteret af 45 % af patienterne.
Multilineage responses were reported by 45% of patients.
• ledsages af øget direkte bilirubin, eller
• accompanied by increased direct bilirubin, or
% patienter, der opnåede virologisk respons
% patients achieving virologic response
• Prøv at undgå, at medicinen berører din hud.
• Try not to let the medicine touch your skin.
Dette blev målt ved forsinket fototoksisk indeks.
This was measured by delayed phototoxic index.
Du skal nu gennemføre trin 11 til 13 for at sikre, at barnet får al medicinen.
Now you need to complete steps 11 to 13 to make sure the child receives all of the medicine.
Patienterne fik forsøgsmedicinen i op til 8 år (i EXTEND).
Patients received study medication for up to 8 years (in EXTEND).
• Vask dine hænder med sæbe og vand.
• Wash your hands with soap and water.
Kør ikke bil og betjen ikke maskiner, medmindre du er sikker på, at du ikke er påvirket.
Don't drive or use machines unless you are sure you're not affected.
Sørg for at give barnet tid til at synke.
Make sure the child has time to swallow.
Virkningen var mindre alvorlig ved lavere doser og var kendetegnet ved en række regenerative ændringer.
Effects were less severe at lower doses and were characterised by a spectrum of regenerative changes.
Tabel 4 Sekundære effektresultater fra RAISE
Table 4 Secondary efficacy results from RAISE
Begynd altid med et helt nyt sæt for hver 30 breve.
Always start with a complete new kit for each 30 sachets.
Hvis du har MDS og tager Revolade, kan din MDS blive værre.
If you have MDS and take Revolade, your MDS may get worse.
Absorption og biotilgængelighed
Absorption and bioavailability
Læs og følg disse anvisninger for at fremstille en dosis Revolade, og for at give den til barnet.
Read and follow these instructions to prepare a dose of Revolade and give it to the child.
Juvenile dyrestudier
Juvenile animal studies
• mangel på energi
• lack of energy
Ældre personer (65 år og derover)
Older people (65 years and above)
Dobbeltblindede, placebokontrollerede studier
Double-blind placebo-controlled studies
Størstedelen af TEEs var ikke alvorlige og var ikke længere til stede ved studiets afslutning.
The majority of TEEs were non-serious and resolved by the end of the study.
• og i 2 timer, efter at du har taget Revolade ikke indtager et eller flere af følgende produkter:
• and the 2 hours after you take Revolade you don't consume any of the following:
Hvis behandling er klinisk indiceret, kræves tæt monitorering af disse patienter.
If treatment is considered clinically indicated, close monitoring of these patients is required.
Kontakt lægen eller apotekspersonalet med det samme.
Contact a doctor or pharmacist immediately.
Bivirkninger, hvor frekvensen ikke er kendt Frekvensen kan ikke estimeres ud fra forhåndenværende data
Side effects with frequency not known Frequency cannot be estimated from the available data
Det kan tage 1-2 uger, før Revolade virker.
Revolade may take 1 to 2 weeks to work.
Stop ikke med at tage Revolade uden at have talt med lægen.
Don't stop taking Revolade without talking to your doctor.
Tabel 5 Effektresultater fra TRA100773B
Table 5 Efficacy results from TRA100773B
Sørg for, at du
Make sure that
Sørg for, at flasken, hætten og låget er tørre, før du bruger dem.
Make sure that the bottle, cap and lid are dry before you use them.
QT/QTc-forlængelse
QT/QTc prolongation
Indlægsseddel: Information til patienten
Package Leaflet: Information for the patient
Den kliniske betydning af disse QTc-forlængelser er ukendt.
The clinical significance of these QTc prolongation events is unknown.
Hos ikke-splenektomerede patienter bør dette inkludere evaluering i forhold til splenektomi.
In non-splenectomised patients this should include evaluation relative to splenectomy.
Tag ikke mere end 1 dosis Revolade om dagen.
Do not take more than one dose of Revolade in one day.
Hvis du ikke overholder ovenstående, vil medicinen ikke blive ordentligt optaget i din krop.
If you do, the medicine will not be properly absorbed into your body.
• Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
• Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Hvis laboratorieresultater og kliniske observationer er modstridende, kan gentagen undersøgelse ved hjælp af en anden metode muligvis hjælpe med at bestemme resultaternes validitet.
If the laboratory results and clinical observations are inconsistent, re-testing using another method may help in determining the validity of the result.
Fyld sprøjten igen, denne gang med 10 ml drikkevand.
Again fill the syringe, this time with 10 ml of drinking water.
De ovenstående advarsler og forsigtighedsregler for ITP, gælder også for den pædiatriske population.
The above warnings and precautions for ITP also apply to the paediatric population.
• VIGTIGT: Da nogle rester af medicinen vil blive tilbage i flasken, skal følgende trin udføres:
• IMPORTANT: Because some medicine will remain in the mixing bottle, complete the following steps.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Revolade:
Warnings and precautions Talk to your doctor before taking Revolade:
Til at fremstille og give en dosis Revolade skal du bruge:
To prepare and give a dose of Revolade, you need:
Albuminniveauer f
Albumin levels f
VIGTIGT:
IMPORTANT:
• hvis du har leverproblemer.
• if you have liver problems.
• Klargør suspensionen udelukkende med vand.
• Prepare the suspension with water only.
Eltrombopag er i høj grad bundet til humane plasmaproteiner (> 99,9 %), hovedsagelig albumin.
Eltrombopag is highly bound to human plasma proteins (>99.9%), predominantly to albumin.
(Blandeflasken kan blive misfarvet af medicinen.
(The mixing bottle may become stained from the medicine.
Rutinemæssig oftalmologisk monitorering af patienterne anbefales.
Routine ophthalmologic monitoring of patients is recommended.
Studierne bestod af to faser - en fase før antiviral behandling og en fase med antiviral behandling.
The studies consisted of two phases - a pre-antiviral treatment phase and an antiviral treatment phase.
Lægen vil gennemgå den medicin, du tager, og vil foreslå alternativer, hvis det er nødvendigt.
Your doctor will review the medicines you are taking, and suggest suitable replacements if necessary.
Asiatiske patienter
Asian patients
Ikke desto mindre kan en potentiel risiko for fotoallergi ikke udelukkes, idet intet specifikt præklinisk studie kunne udføres.
Nevertheless, a potential risk of photoallergy cannot be ruled out since no specific preclinical study could be performed.
• hvis du har andre blodsygdomme såsom myelodysplastisk syndrom (MDS).
• if you have another blood condition, such as myelodysplastic syndrome (MDS).
Pulveret til oral suspension er i breve, hvis indhold skal blandes, før du kan tage medicinen.
The powder for oral suspension is in sachets, the contents of which will need to mixed before you can take the medicine.
Gentag trin 7 til 10 - ryst flasken forsigtigt for at blande resten af medicinen, og giv derefter hele resten af væsken til barnet.
Repeat steps 7 to 10 - gently shake the bottle to mix the rest of the medicine, then give all the rest of the liquid to the child.
ITP-studie population
ITP study population
Rødlig-brunt til gult pulver.
Reddish-brown to yellow powder.
Hvis det sker, skal du straks vaske området med sæbe og vand.
If this happens, wash the area immediately with soap and water.
• Medicinen er en mørkebrun væske.
• The medicine is a dark brown liquid.
Seponer eltrombopag i mindst én uge.
Stop eltrombopag; for at least one week.
Data er begrænset til 21 ud af de planlagte 60 patienter med hæmatologisk respons rapporteret af 52 % af patienterne ved 6 måneder.
Data are limited to 21 out of the planned 60 patients with haematological responses reported by 52% of patients at 6 months.
Der er ikke identificeret nogen tilfælde af TEE fra et klinisk studie med refraktær SAA, men risikoen for disse hændelser kan ikke udelukkes i denne patientpopulation pga. begrænset antal eksponerede patienter.
No case of TEE was identified from a clinical study in refractory SAA, however the risk of these events cannot be excluded in this patient population due to the limited number of exposed patients.
Den absolutte, orale biotilgængelighed af eltrombopag efter administration til mennesker er ikke fastlagt.
The absolute oral bioavailability of eltrombopag after administration to humans has not been established.
• Den orale suspension administreres straks efter klargøring.
• Administer the oral suspension immediately after preparation.
Læs informationen under 'Leverproblemer' i punkt 4 i denne indlægsseddel.
Read the information ‘Liver problems' in section 4 of this leaflet.
• Sørg omhyggeligt for, at barnet ikke leger med flasken, hætten, låget eller sprøjterne - der er risiko for kvælning, hvis barnet putter dem i munden.
• Take care that the child does not play with the bottle, cap, lid or syringes - there is a risk of choking if the child puts them in their mouth.
Revolade kan gøre dig svimmel og du kan få bivirkninger, som gør dig mindre agtpågivende.
Revolade can make you dizzy and have other side effects that make you less alert.
Ryst forsigtigt og langsomt blandeflasken frem og tilbage i mindst 20 sekunder, så vandet blandes med pulveret.
Gently and slowly shake the mixing bottle backwards and forwards for at least 20 seconds to mix the water with the powder.
• ciclosporin anvendt i forbindelse med transplantationer eller sygdomme i immunsystemet
• ciclosporin used in the context of transplantations or immune diseases
Det er ukendt, om eltrombopag/metabolitter udskilles i human mælk.
It is not known whether eltrombopag/metabolites are excreted in human milk.