natgillin/translations-raw huggingface dataset:
Den farmakokinetiske populationsanalyse af avatrombopag hos raske forsøgsdeltagere og forsøgsdeltagere med trombocytopeni som følge af kronisk leversygdom indikerede lignende eksponeringer mellem raske forsøgsdeltagere og forsøgsdeltagere med let og moderat nedsat nyrefunktion (CrCl ≥ 30 ml/min, Cockcroft-Gault).
The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault).
Der er rapporteret portvenetrombose med øget hyppighed hos patienter med kronisk leversygdom, som havde trombocyttal > 200 x 109/l, og som fik en trombopoietinreceptoragonist (se pkt.
Portal vein thrombosis has been reported at an increased frequency in patients with chronic liver disease who had platelet counts > 200 x 109/L receiving a thrombopoietin receptor agonist (see section 4.8).
Hvis du ammer, skal du spørge lægen eller apotekspersonalet til råds, inden du tager Doptelet.
If you are breast-feeding, ask your doctor or pharmacist for advice before taking Doptelet.
Portvenetrombose
Portal vein thrombosis
Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 120,8 mg lactosemonohydrat.
Each film-coated tablet contains 120.8 mg of lactose monohydrate.
P-gp-hæmmer
P-gp inhibitor
Filmovertræk: polyvinylalkohol [E1203]; talcum [E553b]; macrogol 3350 [E1521]; titandioxid [E171]; gul jernoxid [E172].
Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
• Din dosis afhænger af antallet af blodplader i dit blod (dit trombocyttal).
• Your dose will depend on your platelet counts.
Behandling med avatrombopag bør kun indledes hos patienter med svært nedsat leverfunktion, hvis den forventede fordel opvejer de forventede risici (se pkt.
Avatrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2).
Kohorte med lavt trombocyttal ved baseline (< 40 x 109/l)
Low baseline platelet count cohort (< 40 x 109/L)
Kohorte med højt trombocyttal ved baseline (≥ 40 til < 50 x 109/l)
High baseline platelet count (≥ 40 to < 50 x 109/L)
Samtidig brug af stærke CYP3A4/5- eller CYP2C9-induktorer reducerer eksponeringen for avatrombopag og kan medføre en nedsat virkning på trombocyttallet.
Concomitant use of strong CYP3A4/5 or CYP2C9 inducers reduces avatrombopag exposure, and may result in a decreased effect on platelet counts; however, no dose adjustment is recommended (see section 5.2).
Stærke CYP3A4/5- eller CYP2C9-induktorer
Strong CYP3A4/5 or CYP2C9 inducers
En farmakokinetisk populationsanalyse af plasmakoncentrationer af avatrombopag fra de kliniske studier med raske forsøgsdeltagere og patienter med trombocytopeni som følge af kronisk leversygdom indikerede, at eksponering for avatrombopag var ens på tværs af de forskellige undersøgte racer.
Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied.
Doptelet bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender sikker kontraception.
Doptelet is not recommended during pregnancy and in women of childbearing potential not using contraception.
Moderat CYP2C9- og stærk CYP3A-induktor
Moderate CYP2C9 and strong CYP3A inducer
Der er ingen anbefalinger om dosisjustering (se pkt.
No dose adjustment is recommended (see section 5.2).
Doptelet 20 mg tabletter avatrombopag
Doptelet 20 mg tablets avatrombopag
P-gp- og moderat CYP3A-hæmmer
P-gp and moderate CYP3A inhibitor
Dosis en gang dagligt
Once-daily dose
Sådan skal du tage Doptelet
How to take Doptelet
Doptelet 20 mg filmovertrukne tabletter avatrombopag
Doptelet 20 mg film-coated tablets avatrombopag
Doptelet 20 mg filmovertrukne tabletter
Doptelet 20 mg film-coated tablets
Overfølsomhed over for avatrombopag eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
CYP3A4/5- og CYP2C9-hæmmere
CYP3A4/5 and CYP2C9 inhibitors
Moderat CYP3A- og CYP2C9-hæmmer
Moderate CYP3A and CYP2C9 inhibitor
Tallene nåede deres højeste værdier på dag 10-13 og var vendt tilbage til værdier nær baseline på dag 35 (figur 1).
A measured increase in platelet counts was observed in both avatrombopag treatment groups over time beginning on Day 4 post-dose, which peaked on Day 10-13 and then returned to near baseline values by Day 35 (Figure 1); mean platelet count remained greater than or equal to 50 x 109/L on Day 17 (Visit 5).
Filmovertræk Polyvinylalkohol (E1203) Talcum (E553b) Macrogol 3350 (E1521) Titandioxid (E171) Gul jernoxid (E172)
Macrogol 3350 (E1521) Titanium dioxide (E171) Iron oxide yellow (E172)
Stærk CYP3A-hæmmer
Strong CYP3A inhibitor
Avatrombopag udskilles overvejende via fæces.
The predominant route of avatrombopag excretion is via faeces.
I kohorten med lavt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for den gruppe, der fik behandling med avatrombopag, 31,1 x 109/l, og for den gruppe, der fik placebo, var det 30,7 x 109/l.
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L.
Tal med lægen eller apotekspersonalet, inden du tager Doptelet, hvis du er i tvivl.
If you are not sure, talk to your doctor or pharmacist before taking Doptelet.
I kohorten med lavt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for den gruppe, der fik behandling med avatrombopag, 32,7 x 109/l, og for den gruppe, der fik placebo, var det 32,5 x 109/l.
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 32.7 x 109/L and for placebo-treated patients was 32.5 x 109/L.
Virkning og anvendelse 2.
What Doptelet is and what it is used for 2.
Knoglesmerter Myalgi
Bone pain Myalgia
5.2), men på grund af behandlingens korte varighed gives der ingen anbefalinger om dosisjustering.
Avatrombopag has not been studied in patients with severe renal impairment (see section 5.2); however, given the short duration of treatment, no dose adjustment is recommended.
I kohorten med højt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for de patienter, der fik behandling med avatrombopag, 44,3 x 109/l, og for den gruppe, der fik placebo, var det 44,9 x 109/l.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.9 x 109/L.
Hvis du har taget for meget Doptelet
If you take more Doptelet than you should
I kohorten med højt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for de patienter, der fik behandling med avatrombopag, 44,3 x 109/l, og for den gruppe, der fik placebo, var det 44,5 x 109/l.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.5 x 109/L.
Knogler, led, muskler og bindevæv
Musculoskeletal & connective tissue disorders
Udseende og pakningsstørrelser
What Doptelet looks like and contents of the pack
Tal med lægen eller apotekspersonalet, inden du tager Doptelet, hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl.
If any of the above applies to you, or you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Memantine Accord skal gives én gang dagligt på samme klokkeslæt hver dag.
Memantine Accord should be given once a day at the same time every day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine Accord den 04. december 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Accord on 04 December 2013.
Behandlingen bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom.
Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Den fuldstændige EPAR for Memantine Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Memantine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Memantine Accord leveres som tabletter (5 mg, 10 mg, 15 mg og 20 mg) og udleveres kun efter recept.
Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine Accord.
This is a summary of the European public assessment report (EPAR) for Memantine Accord.
Det anvendes til behandling af moderat til svær Alzheimers sygdom, som er en hjernesygdom (en form for demens), der gradvis angriber hukommelse, intellektuelle evner og adfærd.
It is used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør der regelmæssigt igen tages stilling til fordelene ved at fortsætte behandlingen med Memantine Accord.
The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine Accord should be re-assessed on a regular basis.
For at undgå bivirkninger øges dosis af Memantine Accord gradvist i løbet af de tre første uger af behandlingen: I den første uge er den daglige dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15
To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Memantin virker ved at blokere NMDA- (N-methyl-D-aspartat-) receptorerne, som signalstoffet glutamat normalt bindes til.
Memantine works by blocking types of receptors called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches.
Der er udarbejdet en risikostyringsplan for at sikre, at Memantine Accord anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible.
At lægemidlerne er bioækvivalente, vil sige, at de forventes at frembringe samme mængde aktivt stof i kroppen.
‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Det betyder, at Memantine Accord er identisk med et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU).
This means that Memantine Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Axura.
Behandlingen bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt overvåger patientens indtagelse af Memantine Accord.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Accord by the patient.
Andre oplysninger om Memantine Accord
Other information about Memantine Accord
Memantine Accord er et “generisk lægemiddel”.
Memantine Accord is a ‘generic medicine'.
Da Memantine Accord er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
Because Memantine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Hvilke fordele og risici er der forbundet med Memantine Accord?
What are the benefits and risks of Memantine Accord?
Det aktive stof i Memantine Accord, memantin, er et lægemiddel mod demens.
The active substance in Memantine Accord, memantine, is an antidementia medicine.
Memantine Accord er et lægemiddel, der indeholder det aktive stof memantin.
Memantine Accord is a medicine that contains the active substance memantine.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Memantine Accord er af sammenlignelig kvalitet og anses for at være bioækvivalent med Axura.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Accord has been shown to have comparable quality and is considered bioequivalent to Axura.
Memantine Accord memantin
Memantine Accord memantine
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Memantine Accord?
What measures are being taken to ensure the safe and effective use of Memantine Accord?
Hvis du ønsker yderligere oplysninger om behandling med Memantine Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Memantine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvad er Memantine Accord, og hvad anvendes det til?
What is Memantine Accord and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Memantine Accord bør anvendes.
It is not intended to provide practical advice on how to use Memantine Accord.
Udvalget anbefalede, at det godkendes til anvendelse i EU.
The Committee recommended that Memantine Accord be approved for use in the EU.
I produktresuméet og indlægssedlen for Memantine Accord er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Der krævedes ikke yderligere undersøgelser hos patienter, fordi Memantine Accord blev påvist at være af tilsvarende kvalitet som referencelægemidlet Axura og at være bioækvivalent med dette.
No additional studies in patients were required as Memantine Accord was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Axura.
Hvis du ønsker praktisk vejledning om anvendelsen af Memantine Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Memantine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor er Memantine Accord blevet godkendt?
Why is Memantine Accord approved?
Ved moderat eller svær nyresygdom kan lavere dosis være nødvendig.
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Derved forbedres signaloverførslen i hjernen, så symptomerne på Alzheimers sygdom mindskes.
By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Hvordan anvendes Memantine Accord?
How is Memantine Accord used?
Hvordan blev Memantine Accord undersøgt?
How has Memantine Accord been studied?
Hukommelsessvækkelsen ved Alzheimers sygdom er blevet sat i forbindelse med ændringer i signaloverførslen via glutamat i hjernen.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Hvordan virker Memantine Accord?
How does Memantine Accord work?
Skønt denne forskel ikke er stor, kan den være til fordel for visse patienter.
Although this difference is not large, it may benefit some patients.
Det gives kun én gang, højst 48 timer efter at symptomerne er sat ind.
It is given once only, within 48 hours after symptoms start.
Yderligere information om Alpivab findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Alpivab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der er risiko for svære allergiske reaktioner, som synes at være sjældne, skønt det ikke vides nøjagtigt, hvor ofte de forekommer.
There is a risk of severe allergic reactions, and although it is not known exactly how often these reactions occur, they appear to be rare.
Alpivab gives som en infusion, der varer 15-30 minutter.
Alpivab is given as an infusion lasting 15 to 30 minutes.
Som for alle lægemidler, er data vedrørende brug af Alpivab løbende overvåget.
As for all medicines, data on the use of Alpivab are continuously monitored.
Dosis afhænger af alder og legemsvægt og bør reduceres hos voksne og unge over 13 år med nedsat nyrefunktion.
The dose depends on age and body weight and should be reduced in adults and adolescents over 13 years of age with reduced kidney function.
Andre oplysninger om Alpivab
Other information about Alpivab
Det anvendes til behandling af ukompliceret influenza hos voksne og børn over 2 år.
It is used to treat uncomplicated influenza (flu) in adults and children over 2 years.
For mere information om brug af Alpivab, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Alpivab, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alpivab opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Alpivab's benefits are greater than its risks and it can be authorised for use in the EU.
Hvad er Alpivab, og hvad anvendes det til?
What is Alpivab and what is it used for?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alpivab?
What measures are being taken to ensure the safe and effective use of Alpivab?
Bivirkninger rapporteret for Alpivab vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Alpivab are carefully evaluated and any necessary action taken to protect patients.
En oversigt over Alpivab og hvorfor det er godkendt i EU
An overview of Alpivab and why it is authorised in the EU
Alpivab er påvist at reducere den tid, symptomerne varede, hos patienter med influenza.
Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.
Hvorfor blev Alpivab godkendt i EU?
Why is Alpivab authorised in the EU?
Peramivir virker på neuraminidaser hos både influenza A- (det mest almindelige) og influenza B-virus.
Peramivir works on neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Ukompliceret vil sige, at influenzaen har typiske kendetegn (såsom feber, ømhed, hoste, ondt i halsen og løbende næse) og ikke er forværret af andre sygdomme.
Uncomplicated means that the flu has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse by other conditions.
Det aktive stof i Alpivab, peramivir, forhindrer influenzavirus i at spredes yderligere ved at blokere aktiviteten af enzymer, der er proteiner af typen neuraminidaser, på virussets overflade.
The active substance in Alpivab, peramivir, prevents the flu virus from spreading further by blocking the activity of enzymes (proteins) on the surface of the virus called neuraminidases.
Det varede ca. 2,5 døgn (59 timer), før symptomerne blev bedre, hos patienter, der fik Alpivab, sammenholdt med lidt under 3,5 døgn (82 timer) hos patienter, der fik placebo.
Symptoms took around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just under 3 and a half days (82 hours) in patients taking placebo.
Hvilke risici er der forbundet med Alpivab?
What are the risks associated with Alpivab?
Alvorlige bivirkninger med Alpivab er anafylaksi (en svær allergisk reaktion) og hudreaktioner, herunder erythema multiforme (en allergisk hudreaktion) og Stevens-Johnsons syndrom (en livstruende allergisk reaktion med influenzalignende symptomer og smertefuldt udslæt på hud, mund, øjne og kønsdele).
Serious side effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Alpivab er blevet sammenlignet med placebo (en uvirksom behandling) i et hovedstudie, der omfattede 296 voksne med influenza (hovedsagelig influenza A), der blev behandlet senest 48 timer efter, at symptomerne satte ind.
Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with influenza (mostly influenza A) treated within 48 hours of symptoms appearing.
Alpivab er et lægemiddel mod virus (et antiviralt lægemiddel), der indeholder det aktive stof peramivir.
Alpivab is an antiviral medicine that contains the active substance peramivir.
De hyppigste bivirkninger ved Alpivab (som kan forekomme hos op til 3 ud af 100 personer) er et nedsat antal hvide blodlegemer af typen neutrofiler samt kvalme.
The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick).
Den fuldstændige liste over bivirkninger og begrænsninger med Alpivab fremgår af indlægssedlen.
For the full list of side effects and restrictions with Alpivab, see the package leaflet.
Alpivab nedsætter varigheden af influenzasymptomer med gennemsnitligt en dag.
Alpivab reduces the length of time flu symptoms last by one day on average.
Virkningen blev hovedsagelig bedømt på den tid, der gik, før der var bedring i symptomerne (hoste, ondt i halsen, hovedpine, tilstoppet næse, feber eller kulderystelser, ømhed eller smerter i muskler eller led, og træthed).
The main measure of effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose, feverishness or chills, aches or pains of the muscle or joints and tiredness) got better.
Hvordan anvendes Alpivab?
How is Alpivab used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Alpivab.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alpivab have been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser studierne, at der er ved Alpivab?
What benefits of Alpivab have been shown in studies?
Hvordan virker Alpivab?
How does Alpivab work?
Alpivab fås som en opløsning, der efter fortynding indgives med drop (ved infusion) i en blodåre.
Alpivab is available as a solution to be diluted for infusion (drip) into a vein.
Den gensidige anerkendelsesprocedure (UK/V/0356/001/MR) indledtes den 26. November 2009.
The mutual recognition procedure (UK/V/0356/001/MR) started on 26 November 2009.
Den 2. juli 2010 indbragte Det Forenede Kongerige som referencemedlemsstat sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, eftersom en berørt medlemsstat, Frankrig, havde udtrykt bekymring for, at der ikke var fremlagt tilstrækkelig dokumentation for produktets sikkerhed og virkning.
On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by a Concerned Member States, France, that the safety and efficacy of the product had not been sufficiently demonstrated.