FrancophonIA/ELRC3.0 huggingface dataset:
English: and combination tablets, used to treat HIV infection - HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir), used to treat hepatitis C - nilotinib and imatinib (used to treat certain cancers) - mycophenolic acid, used to suppress the immune system to prevent transplant rejection - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - antiemetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine,
Danish: Du skal især fortælle det til lægen, hvis du tager medicin eller har gjort det fornylig som: - svampemidler og antibiotika, især såkaldte makrolide antibiotika, der anvendes til behandling af infektioner (f.eks. ketoconazol, fluconazol, itraconazol, voriconazol, clotrimazol og isavuconazol, erythromycin, clarithromycin, josamycin, isoniazid og rifampicin) - hiv-protease-hæmmere (f.eks. ritonavir, nelfinavir, saquinavir), boostermedicinen cobicistat og kombinationstabletter, der anvendes til behandling af hiv-infektion - HCV-protease-hæmmere (f.eks. telaprevir, boceprevir og kombinationen ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir), der anvendes til behandling af hepatitis C - nilotinib og imatinib (bruges til behandling af visse typer cancer) - mycophenolsyre, der bruges til at undertrykke immunsystemet for at forhindre afstødning af et transplantat - lægemidler mod mavesår og halsbrand (f.eks. omeprazol, lansoprazol eller cimetidin) - antiemetika, der anvendes til behandling af kvalme og opkastning (f.eks. metoclopramid) - cisaprid eller magnesium-aluminium-hydroxid, et syreneutraliserende middel, der anvendes til behandling af halsbrand
English: Envarsus 0.75 mg prolonged-release tablets
Danish: Envarsus 0,75 mg depottabletter
English: Each prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate).
Danish: Hver depottablet indeholder 0,75 mg tacrolimus (som monohydrat).
English: Oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side.
Danish: Oval, hvid til grålighvid uovertrukket tablet præget med "4" på den ene side og "TCS" på den anden side
English: Oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side.
Danish: Oval, hvid til grålighvid uovertrukket tablet præget med "1" på den ene side og "TCS" på den anden side
English: Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Danish: Puh/Tel: + 39 0521 2791
English: • Envarsus 0.75 mg tablets: 41.7 mg
Danish: • Envarsus 0,75 mg tabletter:
English: increased uric acid or lipids in the blood, decreased appetite, loss of appetite, increased acidity of the blood, other changes in the blood salts (seen in blood tests) - anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
Danish: andre ændringer i blodsalte (set i blodprøver) - Angstsymptomer, forvirring og desorientering, depression, humørsvingninger, mareridt,
English: General disorders and administration site conditions febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance fall, ulcer, chest tightness, thirst fat tissue increased
Danish: influenzalignende sygdom, nervøsitet, abnorm følelsestilstand, multiorgansvigt, trykken for brystet, temperaturintolerance fald, sår, stramhed i brystet, tørst øget fedtvæv
English: Dosing should be delayed in the presence of elevated ciclosporin blood levels.
Danish: I tilfælde af forhøjede ciclosporinblodkoncentrationer bør doseringen udsættes.
English: CYP3A4 inducers potentially leading to decreased tacrolimus blood levels Clinically, the following substances have been shown to decrease tacrolimus blood levels: Interactions have been observed with rifampicin, phenytoin, and St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Danish: Der er observeret interaktioner med rifampicin, phenytoin og prikbladet perikum (Hypericum perforatum), som kan gøre det nødvendigt at øge dosis af tacrolimus hos næsten alle patienter.
English: Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Danish: Hver depottablet indeholder 4 mg tacrolimus (som monohydrat).
English: Each prolonged-release tablet contains 1.0 mg tacrolimus (as monohydrate).
Danish: Hver depottablet indeholder 1,0 mg tacrolimus (som monohydrat).
English: Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Danish: Hver depottablet indeholder 1 mg tacrolimus (som monohydrat).
English: Ostenfelder Straβe 51 - 61
Danish: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 59320 Ennigerloh Tyskland eller
English: Uncommon side effects (may affect up to 1 in 100 people): - changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests) - dehydration, inability to urinate - psychotic behaviour, such as delusions, hallucinations, and confusion - abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase - coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems - clouding of the eye lens, partial or total inability to hear - irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal - blood clot in a vein of a limb, shock - difficulties in breathing, respiratory tract disorders, asthma - acute or chronic inflammation of the pancreas, inflammation of the lining of the inner wall of the abdomen, obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach contents in your throat, delayed emptying of the stomach - inflammation of the skin, burning sensation in the sunlight - joint disorders - painful menstruation and abnormal menstrual bleeding - multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 behandlede): - Ændringer i blodstørkning, nedsat antal af alle typer blodceller (set i blodprøver) - Dehydrering, manglende evne til at lade vandet - Psykotisk adfærd, såsom vrangforestillinger, hallucinationer og forvirring - Unormale resultater fra blodprøver: nedsat protein eller sukker, øget fosfat, stigning i enzymet laktatdehydrogenase - Koma, blødning i hjernen, slagtilfælde, lammelse, hjerneforstyrrelse, tale- og sprogforstyrrelser,
English: Each prolonged-release tablet contains 4.0 mg tacrolimus (as monohydrate).
Danish: Hver depottablet indeholder 4,0 mg tacrolimus (som monohydrat).
English: Envarsus 4 mg prolonged-release tablets
Danish: Envarsus 4 mg depottabletter
English: - Collection of fluid around the heart - Acute breathlessness - Cyst formation in your pancreas, pre-stage of a blockage in your bowel - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; - Increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 behandlede): - Små blødninger i huden på grund af blodpropper - Øget muskelstivhed - Blindhed, døvhed - Væskeansamling omkring hjertet - Akut åndenød - Cystedannelse i bugspytkirtlen, begyndende stadie af tarmblokering - Problemer med blodomløbet i leveren - Alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne - Øget behåring - Tørst, øget tendens til at falde, stramhed i brystet, nedsat bevægelighed, sår
English: To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Danish: Immunsuppressionen skal opretholdes for at undertrykke transplantatafstødning.
English: Each tablet contains 41.7 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 41,7 mg lactosemonohydrat.
English: Envarsus 1 mg prolonged-release tablets
Danish: Envarsus 1 mg depottabletter
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Posology
Danish: perikardieekssudat
English: This leaflet was last revised in. Other sources of information
Danish: Denne indlægsseddel blev senest ændret.
English: Each tablet contains 104 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 104 mg lactosemonohydrat.
English: These side effects were generally of mild or moderate severity.
Danish: Disse bivirkninger var sædvanligvis lette eller moderate.
English: The recommended dose is 1,500 mg, given either as a single infusion or as 1,000 mg in the first week followed by 500 mg one week later.
Danish: Den anbefalede dosis er 1 500 mg, der enten gives som en enkelt infusion eller som 1 000 mg i den første uge efterfulgt af 500 mg en uge senere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xydalba on 19 February 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xydalba den 19. februar 2015.
English: Xydalba is given once a week by an infusion lasting 30 minutes.
Danish: Xydalba gives én gang om ugen ved en infusion, der varer 30 minutter.
English: In the 3 studies, between 87% and 94% of patients treated with Xydalba were cured, compared with between 91% and 93% of patients treated with any of the two comparators.
Danish: I de tre undersøgelser blev mellem 87 % og 94 % af de patienter, der fik Xydalba, helbredt, sammenholdt med mellem 91 % og 93 % af dem, der fik et af de to sammenligningslægemidler.
English: Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days.
Danish: De patienter, der fik vancomycin og havde gavn af behandlingen, fik mulighed for at skifte til linezolid efter tre dage.
English: This is a summary of the European public assessment report (EPAR) for Xydalba.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xydalba.
English: In all the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Danish: I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på den andel af patienterne, hos hvem infektionen var helbredt efter behandlingen.
English: The full EPAR and risk management plan summary for Xydalba 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 Xydalba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xydalba's 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 Xydalba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom for which standard antibiotics do not work.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: A risk management plan has been developed to ensure that Xydalba is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Xydalba anvendes så sikkert som muligt.
English: Other information about Xydalba
Danish: Andre oplysninger om Xydalba
English: Xydalba was at least as effective as vancomycin or linezolid at curing the infection.
Danish: Xydalba var mindst lige så effektivt som vancomycin og linezolid til at helbrede infektionen.
English: The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea (feeling sick), diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Xydalba (som kan forekomme hos mellem 1 og 3 ud af 100 personer), er kvalme, diarré og hovedpine.
English: Before using Xydalba, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Ved ordination af Xydalba bør lægen tage hensyn til de officielle retningslinjer for forsvarlig brug af antibiotika.
English: What measures are being taken to ensure the safe and effective use of Xydalba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xydalba?
English: In light of the need for new antibiotics targeting multi-resistant bacteria, the CHMP concluded that Xydalba, which showed activity against certain bacteria resistant to other antibiotics, could be a valuable alternative treatment option.
Danish: Da der er behov for nye antibiotika, der virker mod multiresistente bakterier, konkluderede CHMP, at Xydalba kunne være en værdifuld behandlingsmulighed, da det virkede mod visse bakterier, der er resistente over for andre antibiotika.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xydalba, 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 Xydalba, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What is Xydalba and what is it used for?
Danish: Hvad er Xydalba, og hvad anvendes det til?
English: Why is Xydalba approved?
Danish: Hvorfor blev Xydalba godkendt?
English: It is not intended to provide practical advice on how to use Xydalba.
Danish: Det er ikke en praktisk vejledning i, hvordan Xydalba bør anvendes.
English: Xydalba was compared with vancomycin (another glycopeptide) or with linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of around 2,000 patients with serious infections of the skin and soft tissue under the skin, such as cellulitis, skin abscesses and wound infections.
Danish: Xydalba blev sammenlignet med et andet glykopeptid (vancomycin) eller med linezolid (et antibiotikum, der kan tages gennem munden) i tre hovedundersøgelser med i alt ca. 2 000 patienter med alvorlige infektioner i huden og det underliggende blødvæv, såsom cellulitis, hudabscesser og sårinfektioner.
English: A list of bacteria against which Xydalba is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de bakterier, som Xydalba virker mod, findes i produktresuméet (også en del af denne EPAR).
English: Dalbavancin has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA))
Danish: Det er påvist, at dalbavancin virker mod bakterier, som sædvanlige antibiotika ikke virker mod (såsom meticillinresistente Staphylococcus aureus (MRSA)).
English: What are the risks associated with Xydalba?
Danish: Hvilke risici er der forbundet med Xydalba?
English: The active substance in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide.
Danish: Det aktive stof i Xydalba, dalbavancin, er et antibiotikum af glykopeptidtypen.
English: For more information about treatment with Xydalba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xydalba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It contains the active substance dalbavancin.
Danish: Xydalba indeholder det aktive stof dalbavancin.
English: For the full list of all side effects and restrictions with Xydalba, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xydalba fremgår af indlægssedlen.
English: Xydalba is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Danish: Xydalba er et antibiotikum til behandling af voksne for kortvarige (akutte) bakterielle infektioner i huden og de underliggende hudstrukturer, såsom betændelse i de dybe lag af huden (cellulitis), bylder (hudabscesser) og sårinfektioner.
English: For practical information about using Xydalba, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Xydalba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Xydalba have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Xydalba?
English: How is Xydalba used?
Danish: Hvordan anvendes Xydalba?
English: Xydalba is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Danish: Xydalba fås som et pulver, der blandes til en infusionsvæske, opløsning (drop), til infusion i en vene.
English: Xydalba's safety profile is comparable to that of other antibiotics of the glycopeptide class; side effects affecting hearing and kidney function, which are typical for glycopeptides, have not been shown with the proposed regimens of Xydalba in the clinical trials.
Danish: De typiske bivirkninger af glykopeptider over for hørelsen og nyrefunktionen er ikke set i de kliniske undersøgelser med Xydalba i den ansøgte dosering.
English: How does Xydalba work?
Danish: Hvordan virker Xydalba?
English: The dose of Xydalba needs to be reduced in patients with severely impaired kidney function.
Danish: Ved stærkt nedsat nyrefunktion er det nødvendigt at nedsætte dosen af Xydalba.
English: Other information about Rekovelle
Danish: Andre oplysninger om Rekovelle
English: The main measure of effectiveness was the rate of implantation and pregnancy.
Danish: Det primære mål for virkning var implantations- og graviditetsraten.
English: This is a summary of the European public assessment report (EPAR) for Rekovelle.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rekovelle.
English: The full EPAR for Rekovelle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rekovelle findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Rekovelle and what is it used for?
Danish: Hvad er Rekovelle, og hvad anvendes det til?
English: Why is Rekovelle approved?
Danish: Hvorfor blev Rekovelle godkendt?
English: What measures are being taken to ensure the safe and effective use of Rekovelle?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rekovelle?
English: The frequency of side effects may decrease with repeated treatment cycles.
Danish: Forekomsten af bivirkninger kan blive mindre ved gentagne behandlingscyklusser.
English: It is not intended to provide practical advice on how to use Rekovelle.
Danish: Det er ikke en praktisk vejledning i, hvordan Rekovelle bør anvendes.
English: The study showed that Rekovelle was as effective as GONAL-f at stimulating the ovaries: around 31% of women (204 out of 665) treated with Rekovelle became pregnant compared with around 32% of women (209 out of 661) treated with GONAL-f. Implantation rates were also similar: around 35% with Rekovelle versus around 36% with GONAL-f.
Danish: Undersøgelsen viste, at Rekovelle er lige så effektivt som GONAL-f til at stimulere æggestokkene: ca. 31 % af de kvinder (204 ud af 665), der blev behandlet med Rekovelle, blev gravide, sammenholdt med ca. 32 % af de kvinder (209 ud af 661), der blev behandlet med GONAL-f. Implantationsraten var også den samme: ca. 35 % ved brug af Rekovelle versus ca. 36 % ved brug af GONAL-f.
English: After the first injection, the woman or their partner may be able to give the injections themselves, if they have been trained and have access to expert advice.
Danish: Efter den første injektion kan kvinden selv eller hendes partner indgive injektionen, hvis de er blevet instrueret i, hvordan de skal gøre, og har adgang til kvalificeret rådgivning.
English: What are the risks associated with Rekovelle?
Danish: Hvilke risici er der forbundet med Rekovelle?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rekovelle's 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 Rekovelle opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af fertilitetsproblemer.
English: The safety profile of Rekovelle was considered acceptable and similar to that of GONAL-f.
Danish: Det vurderes, at Rekovelle har den samme, acceptable sikkerhedsprofil som GONAL-f.
English: In severe cases OHSS may lead to difficulty breathing and problems with blood clotting.
Danish: I svære tilfælde kan OHSS give åndedrætsbesvær og problemer med blodets størkningsevne.
English: Rekovelle contains the active substance follitropin delta.
Danish: Rekovelle indeholder det aktive stof follitropin delta.
English: The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS).
Danish: De hyppigste bivirkninger ved Rekovelle (som kan forekomme hos mellem 1 og 10 ud af 100 personer) er hovedpine, ubehag og smerter i bækkenområdet, der kommer fra æggestokkene, kvalme og træthed og såkaldt ovarielt hyperstimulationssyndrom (OHSS).
English: The starting dose of Rekovelle depends on the woman's bodyweight and on the blood level of the anti-Müllerian hormone (a hormone which indicates how well the ovaries will respond to stimulation).
Danish: Startdosen af Rekovelle afhænger af kvindens legemsvægt og niveauet af antimüllersk hormon i blodet (et hormon, der angiver, hvor godt æggestokkene reagerer på stimulationen).
English: For more information about treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rekovelle, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The dose can then be modified in subsequent cycles according to the woman's response.
Danish: Derefter kan dosen ændres i de følgende cyklusser, alt efter hvor godt kvinden reagerer på behandlingen.