FrancophonIA/ELRC3.0 huggingface dataset:
English: St John's wort is often used in herbal medicines that you can buy yourself.
Danish: Perikon er et naturlægemiddel, som kan fås i håndkøb.
English: Possible side effects
Danish: Hyppighed Bivirkning
English: Animal data have shown reproductive toxicity (see section 5.3).
Danish: Dyredata har vist reproduktionstoksicitet (se pkt.
English: Talk to your doctor before taking Ritonavir Mylan.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Ritonavir Mylan.
English: Specific recommendations for use of ritonavir as a pharmacokinetic enhancer in patients with hepatic impairment are dependent on the protease inhibitor with which it is co-administered.
Danish: Konkrete anbefalinger vedrørende brugen af ritonavir som en farmakokinetisk forstærker til patienter med nedsat leverfunktion afhænger af den proteasehæmmer, det gives sammen med. Produktresuméet for den proteasehæmmer, der gives sammen med ritonavir, bør gennemgås med hensyn til konkrete oplysninger om dosering til denne patientgruppe.
English: 100 q12 h
Danish: 100 mg hver 12. time
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of loratadine.
Danish: Ritonavir doseret som farmakokinetisk forstærker eller som antiretroviralt lægemiddel hæmmer CYP3A og forventes som følge heraf at øge plasmakoncentrationen af loratadin.
English: Monitor for ADRs related to ceritinib.
Danish: Der skal monitoreres for ceritinib-relaterede bivirkninger.
English: For further information, physicians should refer to the Summary of Product Characteristics for saquinavir.
Danish: For yderligere oplysninger henvises til produktresuméet for saquinavir.
English: Co-administration of fosamprenavir with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated.
Danish: Der er ikke foretaget en klinisk vurdering af samtidig administration af fosamprenavir og ritonavir ved højere doser end 100 mg to gange dagligt.
English: Haemophilia
Danish: Hyperglykæmi
English: Metabolism
Danish: Tabletdosis
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of buspirone.
Danish: Ritonavir doseret som farmakokinetisk forstærker eller som antiretroviralt lægemiddel hæmmer CYP3A og forventes som følge heraf at øge plasmakoncentrationerne af buspiron.
English: 500q12h,↓ 36% ↓ 38% Increased methadone dose may be necessary when concomitantly administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer due to induction of glucuronidation.
Danish: En øget methadondosis kan være nødvendig, når methadon indgives sammen med ritonavir doseret som antiretroviralt lægemiddel eller som farmakokinetisk forstærker på grund af induktion af glukuronidering.
English: • laboratory test results: changes in blood test results (such as blood chemistry and blood count)
Danish: ændringer i resultaterne af blodprøver
English: Ritonavir co-administration is likely to result in increased plasma concentrations of ergot derivatives and is therefore contraindicated (see section 4.3).
Danish: Samtidig administration af ritonavir vil sandsynligvis resultere i forhøjet plasmakoncentration af ergotaminderivater og er derfor kontraindiceret (se pkt.
English: Menorrhagia
Danish: Anafylaksi
English: 200 q12 h
Danish: 200 mg hver 12. time
English: 500 q12 h ↑ 4-fold
Danish: 500 mg hver 12. time ↑ 4 gange ↑ 38 gange gange gange
English: 100 q12 h 500 q12 h
Danish: 200 mg hver 12. time ↑ 2,4 gange
English: Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition.
Danish: Ritonavir øger serumniveauerne af indinavir som resultat af CYP3A4-hæmning.
English: 600, single
Danish: 300, enkeltdosis
English: 700 q12 h
Danish: Fosamprenavir 700 mg hver 12. time
English: Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition.
Danish: Ritonavir øger serumniveauerne af amprenavir som resultat af CYP3A4-hæmning.
English: morphine and morphine-like medicines used to treat severe pain (e.g. methadone, fentanyl); sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by injection; tranquillisers (e.g. haloperidol, risperidone, thioridazine); colchicine, a treatment for gout.
Danish: bupropion, der er et lægemiddel, som anvendes til at hjælpe dig med at holde op med at ryge; lægemidler mod epilepsi (f.eks. carbamazepin, divalproex, lamotrigin, phenytoin); hjertemedicin (f.eks. disopyramid, mexiletin og calciumantagonister som f.eks. amlodipin, diltiazem og nifedipin); lægemidler med indvirkning på immunsystemet (f.eks. ciclosporin, tacrolimus, everolimus); levothyroxin (mod problemer med skjoldbruskkirtlen); morphin og morphin-lignende lægemidler til behandling af stærke smerter (f.eks. methadon, fentanyl); sovepiller (f.eks. alprazolam, zolpidem) og endvidere midazolam indgivet som injektion; beroligende lægemidler (f.eks. haloperidol, risperidon, thioridazin); colchicin, til behandling af urinsyregigt;
English: 117 Allée des Parcs, Saint-Priest, 69800, France
Danish: Saint-Priest, 69800
English: Phosphodiesterase (PDE5) inhibitors
Danish: Phosphodiesterase-5hæmmere
English: Calcium channel antagonists
Danish: Mave-tarm-kanalen
English: • stomach bleeding
Danish: • blødning fra mavesækken
English: Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition.
Danish: Ritonavir øger serumniveauerne af nelfinavir som resultat af f CYP3A4-hæmning.
English: 100, single oral dose
Danish: 100 mg, enkeltdosis, oral
English: For more detailed dose recommendations, including those for children, see the Package Leaflet of the anti-HIV medicines Ritonavir Mylan is given in combination with.
Danish: Se indlægssedlen for de anti hiv-lægemidler, Ritonavir Mylan gives sammen med, for mere detaljerede anbefalinger omdosis.
English: 600 q24 h
Danish: 100 mg hver 24. time
English: Co-administered Medicinal Product
Danish: Antimykobakterielle lægemidler
English: ↑ 3-7 fold
Danish: Atazanavir1 ↑ 2 gange ↑ 3-7
English: • seizures (fits)
Danish: • krampe (anfald)
English: Anticonvulsants Carbamazepine
Danish: Carbamazepin
English: 50, single dose 200q12h ↑ 2.4-fold ↑ 34% An increase in the incidence in trazodone-related adverse reactions was noted when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Danish: En øget forekomst af trazodon-relaterede bivirkninger er registreret ved indgift sammen med ritonavir doseret som antiretroviralt lægemiddel eller som farmakokinetisk forstærker.
English: Nevirapine
Danish: Buprenorphin
English: Other medicines and Ritonavir Mylan
Danish: INFORMATION I BRAILLE-SKRIFT Ritonavir Mylan
English: Co-administered Medicinal Products
Danish: Samtidigt indgivet lægemiddel
English: 1,250 q12 h 750, single
Danish: 1.250 mg hver 12. time
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dutrebis den 26. marts 2015.
English: This is a summary of the European public assessment report (EPAR) for Dutrebis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dutrebis.
English: What is Dutrebis and what is it used for?
Danish: Hvad er Dutrebis, og hvad anvendes det til?
English: The effectiveness and safety are taken to be the same as that for the two individual active substances, which are well characterised and do not raise any particular concern.
Danish: Effektiviteten og sikkerheden antages at være den samme som for hvert af to aktive stoffer, som er velkarakteriserede og ikke giver grund til særlige betænkeligheder.
English: The full EPAR and risk management plan summary for Dutrebis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Dutrebis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Dutrebis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Dutrebis anvendes så sikkert som muligt.
English: The Committee noted that the two active substances in Dutrebis are frequently taken together in clinical practice.
Danish: Udvalget bemærkede, at de to aktive stoffer i Dutrebis ofte tages sammen i klinisk praksis.
English: What are the risks associated with Dutrebis?
Danish: Hvilke risici er der forbundet med Dutrebis?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Dutrebis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is used together with other HIV medicines and can be used in patients from 6 years of age and weighing at least 30 kg.
Danish: Det anvendes sammen med andre hiv-lægemidler hos patienter fra 6 års-alderen, som vejer mindst 30 kg.
English: It blocks an enzyme called integrase that is needed for the subsequent stage of virus replication.
Danish: Det blokerer et enzym kaldet integrase, som er nødvendigt til det efterfølgende trin i virussets formering.
English: Dutrebis is a medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: Dutrebis er et lægemiddel til behandling af patienter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er årsag til erhvervet immundefektsyndrom (aids).
English: The active substances in Dutrebis are already available in the European Union (EU) as singlecomponent medicines: lamivudine as Epivir since 1996, and raltegravir as Isentress since 2007.
Danish: De aktive stoffer i Dutrebis fås i forvejen i Den Europæiske Union (EU) som lægemidler med kun et enkelt aktivt stof: lamivudin som Epivir siden 1996, og raltegravir som Isentress siden 2007.
English: The two active substances in Dutrebis act by blocking different stages of the process by which the HIV virus replicates itself in the body.
Danish: De to aktive stoffer i Dutrebis virker ved at blokere forskellige trin i den proces, hvorved hiv-virus formerer sig i kroppen.
English: For more information about treatment with Dutrebis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dutrebis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The other active substance, raltegravir, is an ‘integrase inhibitor'.
Danish: Det andet aktive stof, raltegravir, er en "integrasehæmmer".
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Dutrebis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Dutrebis, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Dutrebis can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Danish: Dutrebis udleveres kun efter recept, og behandlingen bør ordineres af en læge med erfaring i behandling af hiv-infektion.
English: The most common side effects with lamivudine or raltegravir (which may affect up to 1 in 10 people) are headache and nausea (feeling sick).
Danish: De hyppigste bivirkninger med lamivudin og raltegravir (som optræder hos mere end 1 ud af 10 personer) er hovedpine og kvalme.
English: It is not intended to provide practical advice on how to use Dutrebis.
Danish: Det er ikke en praktisk vejledning i, hvordan Dutrebis bør anvendes.
English: The company also looked at the way Dutrebis was absorbed in the body in comparison with two separate tablets containing lamivudine and raltegravir.
Danish: Virksomheden undersøgte desuden, hvordan Dutrebis blev optaget i kroppen sammenlignet med to separate tabletter med lamivudin og raltegravir.
English: What measures are being taken to ensure the safe and effective use of
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dutrebis?
English: For the full list of all side effects and restrictions with Dutrebis, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Dutrebis fremgår af indlægssedlen.
English: One active substance, lamivudine, is a ‘nucleoside reverse transcriptase inhibitor' (NRTI).
Danish: Det ene aktive stof, lamivudin, er en nukleosid revers transkriptasehæmmer (NRTI).
English: Other common side effects with lamivudine are malaise (feeling generally unwell), tiredness, nasal signs and symptoms, diarrhoea and cough.
Danish: Andre almindelige bivirkninger med lamivudin er utilpashed, træthed, symptomer fra næsen, diarré og hoste.
English: The main measure of effectiveness was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml, which was 68.8%.
Danish: Behandlingens virkning blev hovedsagelig bedømt på andelen af patienter, der fik nedsat virusindholdet i blodet til færre end 50 kopier af hiv-RNA pr. ml.
English: Dutrebis allows them to be taken as a single tablet, although this will have to be taken twice daily and with other medicines for HIV.
Danish: Med Dutrebis kan de tages i én enkelt tablet, som dog skal tages to gange dagligt sammen med andre hiv-lægemidler.
English: Dutrebis reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym mindsker Dutrebis hiv-indholdet i blodet og holder det på et lavt niveau.
English: What benefits of Dutrebis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Dutrebis?
English: Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir, and the recommended dose is one tablet twice a day.
Danish: Dutrebis leveres som tabletter med 150 mg lamivudin og 300 mg raltegravir.
English: Because lamivudine and raltegravir are already approved individually to treat HIV infection, the company presented data from the studies used to approve these medicines, including a study involving 160 patients given raltegravir with lamivudine (plus another HIV medicine, tenofovir) for a total of 240 weeks.
Danish: Virksomheden fremlagde derfor data fra de undersøgelser, der blev anvendt ved godkendelsen af disse lægemidler, herunder en undersøgelse omfattende 160 patienter, der fik raltegravir med lamivudin (plus endnu et hiv-lægemiddel, tenofovir) i sammenlagt 240 uger.
English: Dutrebis must be used in combination with other HIV medicines.
Danish: Dutrebis skal anvendes i kombination
English: Dutrebis contains the active substances lamivudine and raltegravir and is only for use in patients whose infection is not resistant to these medicines or certain related antiviral medicines.
Danish: Det anvendes kun hos patienter, hos hvem infektionen ikke er resistent mod disse lægemidler eller visse beslægtede antivirale lægemidler.
English: For practical information about using Dutrebis, patients should read the package leaflet or contact their
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Dutrebis, kan du læse indlægssedlen eller
English: The results of the studies showed that Dutrebis produced similar levels lamivudine in the body to lamivudine taken separately; although the levels of raltegravir were slightly different, Dutrebis was shown to produce levels of raltegravir that were similarly effective in controlling the virus.
Danish: For raltegravir var der en lille forskel i den optagne mængde, men Dutrebis frembragte en mængde raltegravir, der var lige så
English: Diliban retard is not yet placed in the EU market.
Danish: Diliban retard er endnu ikke markedsført i EU.
English: Of these 319 cases, almost all (98%) are from Sweden (67%) and Australia (31%).
Danish: Blandt disse 319 tilfælde er næsten alle (98 %) fra henholdsvis Sverige (67 %) og Australien (31 %).
English: Seven cases were reported to be unintentional but none of them were fatal.
Danish: 7 tilfælde blev indberettet som utilsigtede, men ingen af disse var dødelige.
English: There were 5 fatal cases reported out of the 319 cases.
Danish: Der var 5 dødsfald blandt de 319 tilfælde.
English: CMDh position
Danish: CMDh's indstilling
English: However, this has to be put in perspective of the limited exposure.
Danish: Det skal dog ses i lyset af den begrænsede eksponering.
English: Under normal conditions of use, it has an established favourable benefit/risk profile.
Danish: Under normale anvendelsesbetingelser har det et velkendt positivt benefit/riskforhold.
English: The PRAC adopted a recommendation on 30 November 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC vedtog den 30. november 2017 en anbefaling, der efterfølgende er blevet vurderet af CMDh, jf. artikel 107k i direktiv 2001/83/EF.
English: Conclusions on the benefit-risk balance following the re-examination procedure
Danish: Konklusioner vedrørende benefit/risk-forholdet efter revurderingsproceduren
English: The majority of patients recovered or improved while 2 patients needed liver transplants.
Danish: Flertallet af patienterne kom sig helt eller fik det bedre, og 2 patienter havde behov for levertransplantation.
English: Late crossing of the standard treatment nomogram were seen in 19% of the cases.
Danish: Der blev observeret en sen krydsning i nomogrammet for standardbehandling i 19 % af tilfældene.
English: PRAC was in agreement with the experts views.
Danish: PRAC var enig i ekspertgruppens synspunkter.
English: It has to also be taken into account that there could be a subgroup of tramadol abusers in which risk of suicidality is different.
Danish: Der skal også tages højde for, at der kan være en undergruppe af tramadol-misbrugere, hos hvem risikoen for selvmordsadfærd kan være anderledes.
English: A second expert group meeting was convened.
Danish: Der blev indkaldt til et nyt møde i ekspertgruppen.
English: Indeed, the product is already under prescription in the EU concerned Member States except in Portugal - this measure would have an effect limited to PT and would not further minimise the risk in other EU Member States.
Danish: Da produktet allerede er receptpligtigt i de berørte EUmedlemsstater, bortset fra Portugal, vil denne foranstaltning kun have effekt i Portugal og vil ikke minimere risikoen yderligere i andre EU-medlemsstater.
English: Both the absorption duration and the terminal halflive were prolonged in the poisoned patients, sometimes resulting in double peaks.
Danish: Både absorptionsvarigheden og den terminale halveringstid var forlænget hos de forgiftede patienter og resulterede nogle gange i dobbeltpeaks.
English: It is agreed in the scientific community that massive overdoses are particularly challenging to handle.
Danish: Det er anerkendt i videnskabelige kredse, at det er særligt udfordrende at håndtere store overdoser.
English: Most episodes of hepatotoxicity occur as a result of late presentation to hospital.
Danish: De fleste tilfælde af levertoksicitet sker som følge af for sent fremmøde på hospital.
English: This includes unexpectedly prolonged paracetamol exposure and double peaks.
Danish: Det omfatter uventet forlænget eksponering for paracetamol og dobbeltpeaks.
English: PRAC discussion on the detailed grounds for re-examination
Danish: PRAC's drøftelse af de detaljerede begrundelser for revurdering
English: Following the adoption of the PRAC recommendation in September 2017, two MAHs (GSKCH and KRKA d.d., Novo mesto) have requested the re-examination of the recommendation and submitted detailed grounds for the re-examination.
Danish: Efter vedtagelsen af PRAC's anbefaling i september 2017 har to indehavere af markedsføringstilladelse (GSKCH og KRKA d.d., Novo Mesto) anmodet om en revurdering af anbefalingen og indsendt detaljerede begrundelser for revurderingen.
English: Dose is an important factor when interpreting poisoning data with paracetamol.
Danish: Dosis er en vigtig faktor, når man skal fortolke data vedrørende paracetamol-forgiftning.
English: An ad-hoc expert group meeting was held within this procedure with scientific and clinical experts in the management of poisoning.
Danish: I forbindelse med denne procedure er der afholdt et møde i en ad hoc-ekspertgruppe med deltagelse af videnskabelige og kliniske eksperter i behandling af forgiftning.
English: In the literature only few studies investigate whether treatment guidelines are followed and these are mostly done with IR formulation and mainly in Australia.
Danish: I litteraturen har kun få undersøgelser set nærmere på, om behandlingsvejledningerne følges, og disse undersøgelser er primært foretaget med lægemidler med øjeblikkelig udløsning og primært i Australien.
English: Eleven patients (21%) had a serum alanine aminotransferase (ALT), above the reference range (ALT >50 IU/L) at 24 h or later.
Danish: 11 patienter (21 %) havde et serum-ALAT-niveau (alaninaminotransferase) over referenceintervallet (ALAT > 50 IE/l) efter 24 timer eller senere.
English: Having reviewed the PRAC recommendation, the CMDh agree with the PRAC overall conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CMDh sig anbefalingens overordnede konklusioner og begrundelser.
English: In cases where ingested dose is unknown or time of ingestion is unknown or different substances were taken, treatment with NAC is usually promptly started.
Danish: I de tilfælde, hvor hverken den indtagne dosis eller tidspunktet for indtagelse er kendt, eller hvor der er taget forskellige stoffer, påbegyndes behandling med NAC som regel øjeblikkeligt.
English: The CMDh considered the documentation submitted by one MAH (KRKA d.d., Novo mesto) in support of their product and concluded that it did not affect the conclusions of the PRAC.
Danish: CMDh vurderede den dokumentation, som den ene indehaver af markedsføringstilladelse (KRKA d.d., Novo Mesto) havde indsendt til støtte for sit produkt, og konkluderede, at den ikke havde nogen betydning for PRAC's konklusioner.
English: Notwithstanding the feasibility of a revised overdose protocol, it is not acceptable for the PRAC to expose the patients to such revised protocol without sufficient evidence on its effectiveness.
Danish: Uanset gennemførligheden af en revideret overdoseringsprotokol finder PRAC det ikke acceptabelt at eksponere patienterne for en sådan revideret protokol uden tilstrækkelig evidens for dens virkning.
English: Separate model for the combination, based on appropriate data would be necessary to address uncertainties in the management of a combination overdose.
Danish: Det er nødvendigt at anvende en separat model for kombinationen, baseret på relevante data, for at tage højde for usikkerheden ved behandling af en kombinationsoverdosis.
English: Available data indicates that patients considered at high risk of hepatotoxicity are those with high initial paracetamol concentrations.
Danish: De tilgængelige data indikerer, at de patienter, der skønnes at have høj risiko for levertoksicitet, er patienter, der har høje initiale koncentrationer af paracetamol.
English: Products with modified or prolonged release properties containing paracetamol, which are intended to have a longer action, are available in several EU Member States.
Danish: Lægemidler med modificeret eller forsinket udløsning af paracetamol, der er beregnet på længere virkning, fås i adskillige EU-medlemsstater.