FrancophonIA/ELRC3.0 huggingface dataset:
English: Effentora 800 micrograms buccal tablets
Danish: Effentora 800 mikrogram bukkaltabletter
English: Effentora 200 micrograms buccal tablets
Danish: Effentora 200 mikrogram bukkaltabletter
English: Effentora 600 micrograms buccal tablets
Danish: Effentora 600 mikrogram bukkaltabletter
English: Cold sweat Facial swelling Generalised pruritus Alopecia
Danish: Generel pruritus Alopeci
English: Effentora 100 micrograms buccal tablets Fentanyl
Danish: Effentora 100 mikrogram bukkaltabletter Fentanyl
English: Effentora 200 micrograms buccal tablets Fentanyl
Danish: Effentora 200 mikrogram bukkaltabletter Fentanyl
English: Effentora 400 micrograms buccal tablets Fentanyl
Danish: Effentora 400 mikrogram bukkaltabletter Fentanyl
English: What Effentora is and what it is used for What you need to knowbefore you use Effentora How to use Effentora
Danish: Det skal De vide, før De begynder at tage Effentora Sådan skal De tage Effentora Bivirkninger
English: Effentora 600 micrograms buccal tablets Fentanyl
Danish: Effentora 600 mikrogram bukkaltabletter Fentanyl
English: Convulsion
Danish: Dosistitrering
English: stomach pain, uncomfortable stomach, indigestion, toothache, oral thrush
Danish: maveubehag, fordøjelsesbesvær, tandpine, trøske
English: • 200 micrograms fentanyl (as citrate)
Danish: • 200 mikrogram fentanyl (som citrat)
English: • 800 micrograms fentanyl (as citrate)
Danish: • 800 mikrogram fentanyl (som citrat)
English: • 400 micrograms fentanyl (as citrate)
Danish: • 400 mikrogram fentanyl (som citrat)
English: • itching, excessive sweating, rash
Danish: • kløe, voldsom svedtendens, udslæt
English: Effentora 400 micrograms buccal tablets
Danish: Effentora 400 mikrogram bukkaltabletter
English: The backing foil should be peeled back to expose the tablet.
Danish: Træk folien på bagsiden af blister-enheden af for at blotlægge tabletten.
English: If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
Danish: Så længe De ikke oplever gennembrudssmerter, skal De ikke tage Effentora.
English: Buccal tablet.
Danish: Se pkt.
English: • 600 micrograms fentanyl (as citrate)
Danish: • 600 mikrogram fentanyl (som citrat)
English: Effentora 100 micrograms buccal tablets
Danish: Effentora 100 mikrogram bukkaltabletter
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “8”.
Danish: Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “8”
English: • 100 micrograms fentanyl (as citrate)
Danish: • 100 mikrogram fentanyl (som citrat)
English: Dose readjustment
Danish: Efterjustering af dosis
English: Pyrexia Neonatal withdrawal syndrome (see section 4.6)
Danish: Neonatalt abstinenssyndrom (se pkt.
English: Each buccal tablet contains 800 micrograms fentanyl (as citrate)
Danish: Hver bukkaltablet indeholder 800 mikrogram fentanyl (som citrat)
English: The active substance is fentanyl.
Danish: Aktivt stof: fentanyl.
English: Each buccal tablet contains 200 micrograms fentanyl (as citrate)
Danish: Hver bukkaltablet indeholder 200 mikrogram fentanyl (som citrat).
English: Nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency.
Danish: Kvalme, opkastning, anoreksi, træthed, svaghed, svimmelhed og lavt blodtryk.
English: Each buccal tablet contains 600 micrograms fentanyl (as citrate)
Danish: Hver bukkaltablet indeholder 600 mikrogram fentanyl (som citrat).
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”.
Danish: Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “6”
English: Each buccal tablet contains 100 micrograms fentanyl (as citrate)
Danish: Hver bukkaltablet indeholder 100 mikrogram fentanyl (som citrat).
English: Each buccal tablet contains 400 micrograms fentanyl (as citrate)
Danish: Hver bukkaltablet indeholder 400 mikrogram fentanyl (som citrat).
English: Oral mucosal blistering Dry lip
Danish: Forstoppelse Stomatitis Mundtørhed Diare
English: Muscle twitching Muscular weakness
Danish: • muskelsmerter, rygsmerter
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”.
Danish: Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “2”
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”.
Danish: Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “1”
English: feeling unwell, chest discomfort, thirst, feeling cold, feeling hot, difficulty passing urine
Danish: • koldsved, hævet ansigt, generel kløe, hårtab, muskeltrækninger, muskelsvaghed, en følelse af ikke at have det godt, ubehag i brystet, tørst, man fryser eller har det varmt, besvær med at lade vandet
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”.
Danish: Flad, hvid, rund tablet med skrå kanter, præget på den ene side med et “C” og på den anden side med “4”
English: redness, swelling or spots
Danish: Nyrer og urinveje
English: It is very important that you use Effentora exactly as the doctor tells you The initial dose is 100 micrograms.
Danish: Det er meget vigtigt, at De tager Effentora nøjagtigt efter lægens anvisning.
English: This medicine must be kept out of the sight and reach of children.
Danish: Opbevares utilgængeligt for børn.
English: • drug dependence (addiction)
Danish: • stofafhængighed
English: Route of Administration
Danish: Pakningsstør relse
English: London, 24 May 2007 Doc.
Danish: London, den 24. maj 2007 Ref.dok.
English: What is Vitragan?
Danish: Hvad er Vitragan?
English: The effects of Vitragan were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Vitragan blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VITRAGAN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VITRAGAN
English: The Committee was also concerned over the safety of the medicine and the consistency of the medicine between batches.
Danish: I udvalget var der desuden betænkelighed vedrørende lægemidlets sikkerhed og ensartetheden af de forskellige batches af lægemidlet.
English: International non-proprietary name (INN): hyaluronidase (ovine)
Danish: Internationalt fællesnavn (INN): hyaluronidase (ovin)
English: The company also presented the results of two main studies involving 1,306 patients with vitreous haemorrhage, where the effects of a single injection of Vitragan were compared with those of placebo (a dummy treatment).
Danish: Firmaet forelagde desuden resultaterne af to hovedundersøgelser med 1 306 patienter med glaslegemeblødning, hvor virkningen af en enkelt indsprøjtning af Vitragan blev sammenlignet med virkningen af placebo (virkningsløs behandling).
English: How far into the evaluation was the application when it was withdrawn?
Danish: Hvor langt var man nået med vurderingen af ansøgningen, da den blev trukket tilbage?
English: On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage.
Danish: Den 25. april 2007 meddelte ISTA Pharma Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse for Vitragan til behandling af glaslegemeblødning tilbage.
English: What was Vitragan expected to be used for?
Danish: Hvad forventedes Vitragan anvendt til?
English: Ref. EMEA/195786/2007
Danish: EMEA/253854/2007
English: It was to be made up into a solution for injection into the eye.
Danish: Det skulle benyttes til at fremstille en opløsning til indsprøjtning i øjet.
English: This was intended to improve vision and to help doctors in their diagnosis of underlying problems in the retina (the light-sensitive surface at the back of the eye).
Danish: Hensigten var at forbedre synet og gøre det lettere for lægerne at diagnosticere den tilgrundliggende sygdom i nethinden (den lysfølsomme overflade bagest i øjet).
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vitragan?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Vitragan eller i programmer for anvendelse med særlig udleveringstilladelse?
English: How is Vitragan expected to work?
Danish: Hvordan forventes Vitragan at virke?
English: The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep.
Danish: Det aktive stof i Vitragan, ovin hyaluronidase, er et enzym, der udvindes af får.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der sendes til firmaet.
English: Vitragan is a powder containing the active substance hyaluronidase (ovine).
Danish: Vitragan er er et pulver, der indeholder det aktive stof hyaluronidase (fra får).
English: The main measure of effectiveness was the improvement in vision three months after the injection, assessed using a standard letter chart.
Danish: Virkningen blev hovedsagelig bedømt på bedringen i synet tre måneder efter injektionen, målt med en almindelig synstavle.
English: The company informed the CHMP that there are currently no clinical trials or compassionate use programmes with Vitragan.
Danish: Firmaet har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Vitragan.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vitragan had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Vitragan ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af spørgsmålene fra CHMP var der i CHMP betænkelighed på tilbagetrækningstidspunktet, og udvalgets foreløbige standpunkt var, at Vitragan ikke kunne godkendes til behandling af glaslegemeblødning.
English: This was expected to allow phagocytes (specialised ‘scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour.
Danish: På denne måde forventedes det, at fagocytterne (immunsystemets specialiserede "ædeceller") ville kunne fjerne blodklumper i glaslegemet.
English: Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults.
Danish: Vitragan forventedes anvendt til behandling af blødning i glaslegemet (den geléagtige væske i øjets centrale del) hos voksne.
English: The CHMP had concerns over the benefits of Vitragan, since the main studies had not shown convincingly that it was more effective than available options for managing vitreous haemorrhage.
Danish: I CHMP var der betænkelighed over, at hovedundersøgelserne ikke på overbevisende måde havde vist, at Vitragan var mere effektivt end andre alternativer til behandling af glaslegemeblødning.
English: When the acid is broken down, the vitreous humour turns from a jelly into a liquid, allowing cells to move more freely through the vitreous humour.
Danish: Når hyaluronsyren nedbrydes, omdannes glaslegemets konsistens fra gelé til væske.
English: It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid.
Danish: Det forventes at virke ved at nedbryde hyaluronsyre, som er et stof, der fines i glaslegemet.
English: MA (EU) number (Invented) name Strength Pharmaceutical
Danish: MF EU-nummer
English: Day 5, Day 14 and Day 28
Danish: Dag 5, dag 14 og dag 28
English: Date of latest renewal: 18 February 2016
Danish: Dato for seneste fornyelse: 18. februar 2016
English: No pattern was identified in the causes of death.
Danish: Der er ikke fundet noget mønster i årsagerne til dødsfaldene.
English: Study 2: extended criteria donors
Danish: Studie 2: extended criteria donorer
English: Long-term extension in Study 1 and Study 2
Danish: Langtidsopfølgning af Studie 1 og Studie 2
English: Day of transplantation, prior to implantation (Day 1)
Danish: Transplantationsdag, før implantation (Dag 1)
English: It is important that you read the entire PL for more information.
Danish: Det er vigtigt, at du læser hele PIL'en for yderligere oplysninger.
English: Patients with high PRA often require increased immunosuppression.
Danish: Patienter med høj PRA har ofte brug for øget immunsuppression.
English: From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks.
Danish: Fra 4. uge efter transplantationen vil du få behandling med NULOJIX hver 4. uge.
English: PML often leads to severe disability or death.
Danish: PML medfører ofte svær invaliditet og død.
English: NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Danish: NULOJIX er ikke undersøgt hos børn og unge under 18 år, og derfor anbefales det ikke til denne aldersgruppe.
English: You might get symptoms that you might not be aware of yourself.
Danish: Du får måske symptomer, som du ikke selv er klar over.
English: In general, these events occurred early and the majority resulted in graft loss.
Danish: Generelt forekom disse hændelser tidligt og størstedelen medførte transplantattab.
English: Belatacept should not be used in pregnant women unless clearly necessary.
Danish: Belatacept bør ikke anvendes til gravide kvinder, medmindre dette anses for klart nødvendigt.
English: Tell your family or caregiver about your treatment.
Danish: Fortæl din familie eller plejere om din behandling.
English: Dublin 15 - Ireland
Danish: Dublin 15 - Irland
English: Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6.
Danish: Ca. 80% af AR opstod ved måned 3 og var sjældne efter måned 6.
English: Common depression
Danish: Almindelig depression
English: * See section “Description of selected adverse reactions”.
Danish: * Se afsnittet ”Beskrivelse af udvalgte bivirkninger”.
English: The clinical relevance of such antibodies is unclear.
Danish: Den kliniske relevans af disse antistoffer er ikke kendt.
English: Single doses up to 20 mg/kg have been administered without apparent toxic effect.
Danish: Der er administreret enkeltdoser på op til 20 mg/kg uden synlig toksisk effekt.
English: Tell your doctor if you need to have vaccinations.
Danish: Fortæl det til lægen, hvis du skal vaccineres.
English: Early diagnosis and treatment may mitigate the impact of PML.
Danish: Tidlig diagnose og behandling kan nedsætte følgerne af PML.
English: The accumulation index for belatacept at steady state is 1.1.
Danish: Akkumuleringsindekset for belatacept ved steady state var 1,1.
English: ** Includes all events reported over a median of 3.3 years in the Phase 3 studies, and a median of approximately 7 years in the Phase 2 study.
Danish: ** Omfatter alle hændelser rapporteret over gennemsnitligt 3,3 år i fase 3-studierne og over gennemsnitligt 7 år i fase 2-studiet.
English: Up to Year 3*,**
Danish: Op til år 3*,**
English: This medicine will be stored in the healthcare facility where it is administered.
Danish: Denne medicin vil blive opbevaret på det hospital, hvor det anvendes.
English: The card will have your doctor's name and phone number and the date when you started treatment, your last treatment visit, and your next visit for treatment.
Danish: Kortet indeholder din læges navn og telefonnummer og datoen for, hvornår du startede behandlingen, datoen for din sidste behandling og datoen for din næste behandling.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machines.
Danish: Patienter bør informeres om, at hvis de oplever disse symptomer, skal de undgå potentielt farlige aktiviteter såsom bilkørsel og betjening af maskiner.
English: This should be taken into consideration when treating patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning ved behandling af patienter på natriumkontrolleret diæt.
English: Up to Year 1
Danish: Op til år 1
English: Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4.
Danish: To aminosyresubstitutioner (L104 til E; A29 til Y) er udført i den ligandbindende region af CTLA-4.
English: Each pack of the medicine contains an alert card that should be given to the patient.
Danish: I hver pakke med denne medicin er der et informationskort, som skal gives til patienten.
English: Belatacept was shown to cross the placenta in rats and rabbits.
Danish: Belatacept har vist sig at passere placenta hos rotter og kaniner.
English: The safety and efficacy of belatacept in children and adolescents 0 to 18 years of age have not yet been established.
Danish: Belatacepts sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
English: The dose and treatment frequency is given below.
Danish: Dosis og behandlingshyppighed er anført nedenfor.
English: The recommended dose is based on patient body weight (kg).
Danish: Den anbefalede dosis er baseret på patientens kropsvægt (kg).
English: Tell your family or caregiver about your treatment as you might get symptoms that you might not be aware of yourself.
Danish: Fortæl din familie eller plejere om din behandling, da du måske får symptomer, som du ikke selv er klar over.
English: Tests may show:
Danish: Test kan vise:
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til engangsbrug.
English: It will be given to you by infusion (as a "drip") into one of your veins over a period of about 30 minutes.
Danish: Det gives som infusion (som drop) i en af dine vener over en periode på ca. 30 minutter.
English: Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Danish: Belatacept er ikke blevet undersøgt hos patienter med Panel Reactive Antibody (PRA) > 30% (som ofte har behov for øget immunsuppression).
English: These are medicines that reduce the activity of the immune system, the body's natural defences.
Danish: Disse typer medicin mindsker aktiviteten af immunsystemet, som er kroppens naturlige forsvarssystem.
English: Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the transplant vascular anastomoses.
Danish: Infusion af den første dosis bør gives umiddelbart i den præoperative periode eller under operationen, men inden afslutning af transplantatets vaskulære anastomose.
English: The use of live vaccines should be avoided with the use of NULOJIX.
Danish: Brugen af levende vacciner bør undgås sammen med NULOJIX.
English: There are no adequate data from use of belatacept in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data for brug af belatacept hos gravide kvinder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents.
Danish: På grund af abatacepts lighed med belatacept hvad angår struktur og virkningsmekanisme og dets højere aktivitet i gnavere blev abatacept anvendt som en mere aktiv homolog for belatacept i gnavere.
English: Poor appetite, loss of taste, decreased hearing
Danish: Dårlig appetit, mistet smagssans, nedsat hørelse
English: At the recommended dosing regimen, serum concentration generally reached steady-state by Week 8 in the initial phase following transplantation and by Month 6 during the maintenance phase.
Danish: Ved det anbefalede dosisregime nåede serumkoncentrationer generelt steady state ved uge 8 i initialfasen efter transplantation og ved måned 6 i vedligeholdelsesfasen.
English: Therefore, during treatment with belatacept, vaccinations may be less effective although this has not been studied in clinical trials.
Danish: Derfor kan vaccinationer under behandling med belatacept være mindre effektive, skønt dette ikke er blevet undersøgt i kliniske studier.
English: NULOJIX weakens the body's ability to fight infections.
Danish: NULOJIX svækker kroppens evne til at bekæmpe infektioner.
English: However, NULOJIX can cause serious side effects that may need treatment.
Danish: NULOJIX kan imidlertid forårsage alvorlige bivirkninger, som det kan være nødvendigt at behandle.
English: It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Danish: Det er sandsynligt, at den øgede følsomhed over for opportunistiske infektioner, der er observeret hos unge rotter, er associeret med eksponering for abatacept inden udvikling af hukommelsesrespons.
English: The most common CNS infection was cryptococcal meningitis.
Danish: Den hyppigste CNS-infektion var kryptokokmeningitis.
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Danish: Forsøg med voksne mus og aber har ikke vist lignende fund.
English: The distribution of the card will also prompt dialogue on any new or changes in symptoms since the prior visit.
Danish: Udlevering af kortet lægger også op til en dialog om nye eller ændrede symptomer siden sidste konsultation.
English: The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppigheden er defineret som følger: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelige (≥ 1/1.000 til  1/100).
English: A total of 250 subjects were randomised to 1 of 5 treatment groups (3 belatacept and 2 tacrolimus groups).
Danish: I alt 250 personer blev randomiseret til 1 af 5 behandlingsgrupper (3 belatacept- og 2 tacrolimus-grupper).
English: Autoimmune process
Danish: Autoimmun proces
English: Please take the exact steroid dose as determined by your doctor.
Danish: Tag præcis den steroiddosis, som din læge har angivet.
English: It is also recommended to administer an interleukin(IL)-2 receptor antagonist during the first week after transplantation.
Danish: Det anbefales også at behandle med en interleukin(IL)-2-receptorantagonist i den første uge efter transplantationen.
English: Dead tissue because of stopped blood supply
Danish: Vævsdød pga. stoppet blodtilførsel
English: PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus.
Danish: PML er en sjælden, ofte hurtigt progredierende og fatal, opportunistisk infektion i CNS forårsaget af John Cunningham (JC)-virus.
English: Plasmapheresis may accelerate removal of belatacept.
Danish: Plasmaferese kan fremskynde fjernelsen af belatacept.