natgillin/translations-raw huggingface dataset:
andre ændringer i blodsalte (set i blodprøver) - Angstsymptomer, forvirring og desorientering, depression, humørsvingninger, mareridt, 
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,
influenzalignende sygdom, nervøsitet, abnorm følelsestilstand, multiorgansvigt, trykken for brystet, temperaturintolerance fald, sår, stramhed i brystet, tørst øget fedtvæv 
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
I tilfælde af forhøjede ciclosporinblodkoncentrationer bør doseringen udsættes. 
Dosing should be delayed in the presence of elevated ciclosporin blood levels.
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. 
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.
Hver depottablet indeholder 4 mg tacrolimus (som monohydrat). 
Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Hver depottablet indeholder 1,0 mg tacrolimus (som monohydrat). 
Each prolonged-release tablet contains 1.0 mg tacrolimus (as monohydrate).
Hver depottablet indeholder 1 mg tacrolimus (som monohydrat). 
Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 59320 Ennigerloh Tyskland eller 
Ostenfelder Straβe 51 - 61
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, 
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
Hver depottablet indeholder 4,0 mg tacrolimus (som monohydrat). 
Each prolonged-release tablet contains 4.0 mg tacrolimus (as monohydrate).
Envarsus 4 mg depottabletter 
Envarsus 4 mg prolonged-release tablets
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 
- 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
Immunsuppressionen skal opretholdes for at undertrykke transplantatafstødning. 
To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 41,7 mg lactosemonohydrat. 
Each tablet contains 41.7 mg lactose monohydrate.
Envarsus 1 mg depottabletter 
Envarsus 1 mg prolonged-release tablets
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 
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
perikardieekssudat 
Posology
Denne indlægsseddel blev senest ændret. 
This leaflet was last revised in. Other sources of information
Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 104 mg lactosemonohydrat. 
Each tablet contains 104 mg lactose monohydrate.
Disse bivirkninger var sædvanligvis lette eller moderate. 
These side effects were generally of mild or moderate severity.
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. 
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xydalba den 19. februar 2015. 
The European Commission granted a marketing authorisation valid throughout the European Union for Xydalba on 19 February 2015.
Xydalba gives én gang om ugen ved en infusion, der varer 30 minutter. 
Xydalba is given once a week by an infusion lasting 30 minutes.
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. 
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.
De patienter, der fik vancomycin og havde gavn af behandlingen, fik mulighed for at skifte til linezolid efter tre dage. 
Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xydalba. 
This is a summary of the European public assessment report (EPAR) for Xydalba.
I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på den andel af patienterne, hos hvem infektionen var helbredt efter behandlingen. 
In all the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
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. 
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.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Xydalba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Der er udarbejdet en risikostyringsplan for at sikre, at Xydalba anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Xydalba is used as safely as possible.
Andre oplysninger om Xydalba 
Other information about Xydalba
Xydalba var mindst lige så effektivt som vancomycin og linezolid til at helbrede infektionen. 
Xydalba was at least as effective as vancomycin or linezolid at curing the infection.
De hyppigste bivirkninger ved Xydalba (som kan forekomme hos mellem 1 og 3 ud af 100 personer), er kvalme, diarré og hovedpine. 
The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea (feeling sick), diarrhoea and headache.
Ved ordination af Xydalba bør lægen tage hensyn til de officielle retningslinjer for forsvarlig brug af antibiotika. 
Before using Xydalba, doctors should consider official guidance on the appropriate use of antibiotics.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xydalba? 
What measures are being taken to ensure the safe and effective use of Xydalba?
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. 
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.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xydalba, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvad er Xydalba, og hvad anvendes det til? 
What is Xydalba and what is it used for?
Hvorfor blev Xydalba godkendt? 
Why is Xydalba approved?
Det er ikke en praktisk vejledning i, hvordan Xydalba bør anvendes. 
It is not intended to provide practical advice on how to use Xydalba.
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. 
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.
En liste over de bakterier, som Xydalba virker mod, findes i produktresuméet (også en del af denne EPAR). 
A list of bacteria against which Xydalba is active can be found in the summary of product characteristics (also part of the EPAR).
Det er påvist, at dalbavancin virker mod bakterier, som sædvanlige antibiotika ikke virker mod (såsom meticillinresistente Staphylococcus aureus (MRSA)). 
Dalbavancin has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA))
Hvilke risici er der forbundet med Xydalba? 
What are the risks associated with Xydalba?
Det aktive stof i Xydalba, dalbavancin, er et antibiotikum af glykopeptidtypen. 
The active substance in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide.
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. 
For more information about treatment with Xydalba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Xydalba indeholder det aktive stof dalbavancin. 
It contains the active substance dalbavancin.
Den fuldstændige liste over bivirkninger og begrænsninger ved Xydalba fremgår af indlægssedlen. 
For the full list of all side effects and restrictions with Xydalba, see the package leaflet.
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. 
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.
Hvis du ønsker praktisk vejledning om anvendelsen af Xydalba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Xydalba, patients should read the package leaflet or contact their doctor or pharmacist.
Hvilke fordele viser undersøgelserne, at der er ved Xydalba? 
What benefits of Xydalba have been shown in studies?
Hvordan anvendes Xydalba? 
How is Xydalba used?
Xydalba fås som et pulver, der blandes til en infusionsvæske, opløsning (drop), til infusion i en vene. 
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.
De typiske bivirkninger af glykopeptider over for hørelsen og nyrefunktionen er ikke set i de kliniske undersøgelser med Xydalba i den ansøgte dosering. 
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.
Hvordan virker Xydalba? 
How does Xydalba work?
Ved stærkt nedsat nyrefunktion er det nødvendigt at nedsætte dosen af Xydalba. 
The dose of Xydalba needs to be reduced in patients with severely impaired kidney function.
Andre oplysninger om Rekovelle 
Other information about Rekovelle
Det primære mål for virkning var implantations- og graviditetsraten. 
The main measure of effectiveness was the rate of implantation and pregnancy.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rekovelle. 
This is a summary of the European public assessment report (EPAR) for Rekovelle.
Den fuldstændige EPAR for Rekovelle findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Rekovelle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hvad er Rekovelle, og hvad anvendes det til? 
What is Rekovelle and what is it used for?
Hvorfor blev Rekovelle godkendt? 
Why is Rekovelle approved?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rekovelle? 
What measures are being taken to ensure the safe and effective use of Rekovelle?
Forekomsten af bivirkninger kan blive mindre ved gentagne behandlingscyklusser. 
The frequency of side effects may decrease with repeated treatment cycles.
Det er ikke en praktisk vejledning i, hvordan Rekovelle bør anvendes. 
It is not intended to provide practical advice on how to use Rekovelle.
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. 
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.
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. 
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.
Hvilke risici er der forbundet med Rekovelle? 
What are the risks associated with Rekovelle?
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Rekovelle opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af fertilitetsproblemer. 
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.
Det vurderes, at Rekovelle har den samme, acceptable sikkerhedsprofil som GONAL-f. 
The safety profile of Rekovelle was considered acceptable and similar to that of GONAL-f.
I svære tilfælde kan OHSS give åndedrætsbesvær og problemer med blodets størkningsevne. 
In severe cases OHSS may lead to difficulty breathing and problems with blood clotting.
Rekovelle indeholder det aktive stof follitropin delta. 
Rekovelle contains the active substance follitropin delta.
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). 
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).
Startdosen af Rekovelle afhænger af kvindens legemsvægt og niveauet af antimüllersk hormon i blodet (et hormon, der angiver, hvor godt æggestokkene reagerer på stimulationen). 
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).
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. 
For more information about treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Derefter kan dosen ændres i de følgende cyklusser, alt efter hvor godt kvinden reagerer på behandlingen. 
The dose can then be modified in subsequent cycles according to the woman's response.
Det aktive stof i Rekovelle, follitropin delta, er en kopi af det såkaldte follikelstimulerende hormon (FSH), et naturligt hormon, der spiller en afgørende rolle for kvinders frugtbarhed, idet det stimulerer produktionen af æg i æggestokkene. 
The active substance in Rekovelle, follitropin delta, is a copy of the natural hormone called folliclestimulating hormone (FSH) which plays a key role in fertility in women by stimulating the production of eggs in the ovaries.
Hvordan anvendes Rekovelle? 
How is Rekovelle used?
Rekovelle er blevet sammenlignet med en anden fertilitetsmedicin, GONAL-f (follitropin alfa), i en undersøgelse med 1 326 kvinder, der fik kontrolleret æggestokstimulerende behandling med henblik på reagensglasbefrugtning (IVF) eller mikroinsemination (ICSI). 
Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in one study involving 1,326 women who were undergoing controlled ovarian stimulation for IVF or ICSI.
Hvilke fordele viser undersøgelserne, at der er ved Rekovelle? 
What benefits of Rekovelle have been shown in studies?
Det gives for at stimulere æggestokkene til at producere flere æg ad gangen, der så kan opsamles og befrugtes i laboratoriet. 
It is used to stimulate the ovaries to produce several eggs at the time, which can then be collected and fertilised in the laboratory.
Rekovelle fås som injektionsvæske i en cylinderampul, der skal anvendes sammen med Rekovelleinjektionspennen. 
Rekovelle is available as a solution for injection, contained in a cartridge to be used with Rekovelle injection pen.
Rekovelle må ikke gives til kvinder, der har en tumor i hypofysen eller hypothalamus, eller som har brystkræft, livmoderkræft eller æggestokkræft. 
Rekovelle must not be used in women with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Rekovelle må ikke anvendes, hvis kvinden har en forstørret æggestok eller en cyste, der ikke skyldes såkaldt polycystisk ovariesyndrom (cyster på æggestokkene), eller hvis hun har uforklaret blødning fra skeden. 
Rekovelle must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian syndrome, or when there is unexplained bleeding from the vagina.
Hvis du ønsker praktisk vejledning om anvendelsen af Rekovelle, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Rekovelle, patients should read the package leaflet or contact their doctor or pharmacist.
Den fuldstændige liste over indberettede bivirkninger ved Rekovelle fremgår af indlægssedlen. 
For the full list of all side effects reported with Rekovelle, see the package leaflet.
Ved at give ekstra stimulation med Rekovelle øges antallet af æg, der produceres i æggestokkene, så der kan opsamles flere æg, som kan befrugtes i laboratoriet. 
Giving extra stimulation with Rekovelle helps increase the number of eggs produced in the ovaries, which means that more eggs can then be collected and fertilised in the laboratory.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rekovelle. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekovelle have been included in the summary of product characteristics and the package leaflet.
CHMP vurderer, at Rekovelle er effektivt til at stimulere æggestokkene til at producere flere æg ad gangen hos kvinder, der er i fertilitetsbehandling. 
The CHMP considered that Rekovelle was effective in obtaining several eggs at the same time following stimulation in women undergoing fertility treatment.
Rekovelle er et lægemiddel, som gives til kvinder, der er i fertilitetsbehandling som f.eks. reagensglasbefrugtning (IVF) eller mikroinsemination (ICSI). 
Rekovelle is a medicine given to women who are having fertility treatments such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Rekovelle gives som en injektion under huden én gang dagligt flere dage i træk i løbet af kvindens menstruationscyklus. 
Rekovelle is given by injection under the skin once a day for several consecutive days during the woman's menstrual cycle starting on day 2 or 3 of the cycle and is continued until sufficient eggs have developed.
Det kan give symptomer som f.eks. opkastning, diarré og smerter. 
OHSS is when a woman's ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain.
Hvordan virker Rekovelle? 
How does Rekovelle work?