FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal and urinary disorders
Danish: Nyrer og urinveje Meget almindelig
English: 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Danish: Den anbefalede dosis cisplatin er 75 mg/m legemsoverflade infunderet over 2 timer cirka 30 minutter efter afsluttet infusion af pemetrexed på den første dag i hver 21-dages-serie.
English: Time to treatment failure (months) (95% CI)
Danish: Log Rank p-værdi* Tid til behandlingssvigt (måneder) (95 % CI)
English: Acute renal failure
Danish: Kvalme Opkastning
English: Cisplatin (N = 222)
Danish: (N=222)
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Permetrexed Fresenius Kabi 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Posology
Danish: Forstoppelse
English: Breast-feeding
Danish: pemetrexed
English: 19 January 2017 EMA/747766/2016
Danish: Den 19. januar 2017 EMA/747766/2016
English: It is used for people needing 10-40 units of insulin daily.
Danish: Den anvendes til personer, der behøver 10-40 enheder insulin dagligt.
English: Measures intended to reduce risk of confusion between two pens of different strengths
Danish: Tiltag, der skal mindske risikoen for at forveksle to penne med forskellig styrke
English: This could lead to fluctuations in blood glucose control.
Danish: Dette kan føre til udsving i reguleringen af blodsukkeret.
English: More information about Suliqua can be found on the Agency's website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243/human_ med_002064.jsp
Danish: Yderligere oplysninger om Suliqua findes på agenturets websted: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243/ human_med_002064.jsp
English: • When starting Suliqua and in the weeks thereafter you should measure your blood sugar levels more frequently than usual.
Danish: • Når du begynder på Suliqua og i de følgende uger, bør du måle dit blodsukker oftere end normalt.
English: Suliqua is a medicine that is used for the treatment of type-2 diabetes.
Danish: Suliqua er et lægemiddel, der anvendes til behandling af type 2-sukkersyge.
English: Before you use Suliqua be clear on how many dose steps you require.
Danish: Før du bruger Suliqua, skal du vide, hvor mange dosistrin du behøver.
English: Information for patients and carers
Danish: Anbefalinger til patienter og omsorgsgivere
English: • Ensure that patients and their caretakers are adequately informed on how to use their medicine.
Danish: • Sørg for, at dine patienter og deres omsorgsgivere er tilstrækkeligt informeret om, hvordan lægemidlet bruges.
English: • You must therefore not use the pens interchangeably as you could receive too much or too little lixisenatide and this could disrupt the control of your blood sugar levels.
Danish: • Du må derfor ikke bruge pennene i flæng, da du på denne måde kan få for meget eller for lidt lixisenatid, så reguleringen af dit blodsukker forstyrres.
English: To reduce the risk of medication errors, educational materials will be sent out to relevant healthcare professionals in the EU where the product is marketed, to raise awareness about the differences between the two pens, the way the dose is expressed and how to use the medicine correctly.
Danish: For at mindske risikoen for medicineringsfejl vil der blive udsendt oplysningsmateriale til relevante sundhedspersoner i EU, hvor produktet markedsføres, for at skærpe opmærksomheden omkring forskellene mellem de to penne, den måde, dosis er angivet på, og hvordan lægemidlet anvendes korrekt.
English: Patients will receive a ‘patient guide' from their healthcare professional which they should read carefully along with the package leaflet.
Danish: Patienterne vil af deres sundhedsperson få udleveret en "patientvejledning", som de bør læse omhyggeligt sammen med indlægssedlen.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the Suliqua pen device.
Danish: • Blinde eller svagtseende patienter skal instrueres om altid at få hjælp fra en anden person, som ser godt og er oplært i at bruge Suliqua-pennen.
English: • Read the instructions in your package leaflet carefully before using your medicine.
Danish: • Læs anvisningerne i indlægssedlen grundigt, før du bruger lægemidlet.
English: • Pharmacists should clarify with the prescriber any incomplete prescription.
Danish: • Apotekspersonalet bør over for den ordinerende læge påpege enhver ufuldstændig ordination.
English: Healthcare professionals should ensure that they train their patients on how to use Suliqua correctly.
Danish: Sundhedspersoner bør sørge for at instruere deres patienter i korrekt anvendelse af Suliqua.
English: It is used together with diabetes medicines taken by mouth in adults whose blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or metformin combined with either a glucose-lowering medicine or insulin.
Danish: Det anvendes sammen med orale diabetesmidler hos voksne, hvis blodsukker ikke kan reguleres tilfredsstillende med metformin alene eller metformin kombineret med enten et blodsukkernedsættende lægemiddel eller med insulin.
English: Healthcare professionals and patients expected to use the diabetes medicine Suliqua will be given educational materials to ensure that the medicine is used correctly and prevent medication errors such as confusion between the two different strengths of the product.
Danish: Sundhedspersoner og patienter, der forventes at anvende diabetesmidlet Suliqua, skal have udleveret oplysningsmateriale for at sikre, at lægemidlet anvendes korrekt, og for at forhindre medicineringsfejl såsom forveksling af de to forskellige styrker af produktet.
English: Suliqua is available in two different pens:
Danish: Suliqua fås i to forskellige penne:
English: The doses of insulin and lixisenatide contained in increasing dose steps are given in the figure below:
Danish: Doserne af insulin og lixisenatid indeholdt i et stigende antal dosistrin er givet i nedenstående figur:
English: The lixisenatide strength is lower to ensure an adequate but not excessive dose in people requiring higher doses of insulin.
Danish: Styrken af lixisenatid er mindre for at sikre en tilstrækkelig, men ikke for stor dosis til dem, der kræver højere doser insulin.
English: • Tell patients to closely monitor their blood sugar levels when starting Suliqua and in the weeks thereafter.
Danish: • Fortæl patienterne, at deres blodsukker skal overvåges ved påbegyndelse af behandlingen med Suliqua og i ugerne efter.
English: • Because the two pens contain different concentrations of lixisenatide, the dose step of one pen is not equivalent to the dose step of the other.
Danish: • Da de to penne indeholder forskellige koncentrationer af lixisenatid, svarer dosistrinnet på den ene pen ikke til dosistrinnet på den anden.
English: You must never use a syringe to remove the medicine from its pen as this may lead to dosing errors and serious harm.
Danish: Du må aldrig trække lægemidlet op af dets pen med en sprøjte, da det kan medføre doseringsfejl og alvorlig skade.
English: • Provide patients with the patient guide prior to prescribing or dispensing Suliqua.
Danish: • Udlevér patientvejledningen til patienten før ordination eller dispensering af Suliqua.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device.
Danish: • Suliqua leveres i en fyldt pen og må altid kun bruges med denne pen.
English: Pharmacists should also check that patients have been trained on how to use the pen.
Danish: Apotekspersonalet bør desuden kontrollere, at patienterne har fået instruktion i at bruge pennen.
English: Your healthcare professional will train you on how to use the pen.
Danish: Din sundhedsperson vil instruere dig i, hvordan pennen bruges.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of Suliqua, the dose range of the pre-filled pen and the dose counter of the pen device before dispensing Suliqua.
Danish: • Apotekspersonale opfordres til at kontrollere, at patienter og omsorgsgivere er i stand til at aflæse styrken af Suliqua, den fyldte pens dosisområde og pennens dosistæller, før lægemidlet udleveres.
English: The lixisenatide strength is higher to ensure an adequate dose in people requiring lower doses of insulin.
Danish: Styrken af lixisenatid er større for at sikre tilstrækkelig dosis til dem, der kræver mindre doser insulin.
English: One dose step always contains one unit of insulin, regardless of the Suliqua pen being used.
Danish: Ét dosistrin indeholder altid én enhed insulin, uanset hvilken Suliqua-pen der benyttes.
English: • Suliqua must only be used with its pre-filled pen.
Danish: • Suliqua må kun bruges med den tilhørende fyldte pen.
English: The amount of lixisenatide per dose step however varies (0.50 micrograms per dose step for the 10-40 pen and 0.33 micrograms per dose step for the 30-60 pen).
Danish: Mængden af lixisenatid pr. dosistrin varierer imidlertid (0,50 mikrogram/dosistrin for 10-40pennen, og 0,33 mikrogram/dosistrin for 30-60-pennen).
English: As for similar combination medicines used for the treatment of diabetes, the dose of Suliqua is expressed in ‘dose steps', with each dose step corresponding to one unit of insulin plus a fixed amount of lixisenatide.
Danish: Ligesom for tilsvarende kombinationspræparater til behandling af diabetes angives dosen af Suliqua i "dosistrin", hvor hvert dosistrin svarer til én enhed insulin, plus en fast mængde lixisenatid.
English: deliver between 10 and 40 dose steps per day (and is also referred to as Suliqua 10-40).
Danish: Denne pen kan afgive mellem 10 og 40 dosistrin pr. dag (den kaldes også Suliqua 10-40).
English: • If you have any questions about your treatment, speak to your healthcare professional.
Danish: • Spørg din sundhedsperson, hvis der er mere, du vil vide om behandlingen.
English: • Suliqua is given in dose steps which correspond to a set number of units of insulin plus a fixed amount of lixisenatide.
Danish: • Suliqua gives i dosistrin, der svarer til et bestemt antal enheder insulin plus en fast mængde lixisenatid.
English: • Explain the design and features of the pen to the patient and if the patient has been transferred from another pen device, highlight the differences in design between the two devices to avoid confusion (focus on colour differentiation, warning statements on carton/label).
Danish: Hvis patienten har skiftet fra en anden pen, så understreg forskellene i udformning af de to anordninger for at undgå forveksling (påpeg farveforskelle og advarsler på kartonen/etiketten.
English: A syringe must never be used to withdraw insulin glargine and lixisenatide from the pre-filled pen as this may lead to dosing errors and serious harm.
Danish: Træk aldrig ved hjælp af en sprøjte insulin glargin og lixisenatid op af den fyldte pen, da det kan føre til doseringsfejl og alvorlig skade.
English: • Explain to your patient that the dose counter of the pen device shows the number of dose steps to be injected.
Danish: • Forklar patienten, at pennens dosistæller viser det antal dosistrin, der skal injiceres.
English: It is available as a solution for injection in pre-filled pens.
Danish: Det fås som injektionsvæske, opløsning, i fyldte penne.
English: • The dose counter of the pen device shows the number of dose steps to be injected.
Danish: • Pennens dosistæller viser det antal dosistrin, der skal indsprøjtes.
English: Your healthcare professional will give you this information.
Danish: Det får du at vide af din sundhedsperson.
English: The prescription must state the type of pen to be used (either Suliqua 10-40 or Suliqua 30-60), the strength (i.e. insulin glargine 100 units/ml + lixisenatide 50 micrograms/ml or insulin glargine 100 units/ml + lixisenatide 33 micrograms/ml) and the number of dose steps to be administered.
Danish: Af ordinationen skal det fremgå, hvilken type pen, der skal anvendes (enten Suliqua 10-40 eller Suliqua 30-60), styrken (dvs. insulin glargin, 100 enheder/ml, + lixisenatid, 50 mikrogram/ml, eller insulin glargin, 100 enheder/ml + lixisenatid, 33 mikrogram/ml), og det antal dosistrin, der skal administreres.
English: • Suliqua is a fixed combination of insulin glargine/lixisenatide available in two strengths:
Danish: • Suliqua er en fast kombination af insulin glargin og lixisenatid og fås i to styrker:
English: One dose step always contains one unit of insulin plus a fixed amount of lixisenatide.
Danish: Ét dosistrin indeholder altid én enhed insulin plus en fast mængde lixisenatid.
English: Suliqua contains a combination of insulin glargine and a non-insulin medicine, lixisenatide.
Danish: Suliqua indeholder en kombination af insulin glargin og et ikke-insulin, lixisenatid.
English: • Suliqua contains insulin glargine and a non-insulin medicine, lixisenatide.
Danish: • Suliqua indeholder insulin glargin og et ikke-insulin, lixisenatid.
English: • Suliqua is supplied in two pre-filled pens:
Danish: • Suliqua fås i to fyldte penne:
English: deliver between 30 and 60 dose steps per day (and is also referred to as Suliqua 30-60) Since the two pens contain different amounts of lixisenatide for each dose step, it is important that they are not used interchangeably as this would result in patients receiving too much or too little lixisenatide.
Danish: Da de to penne indeholder forskellig mængde lixisenatid for hvert dosistrin, er det vigtigt, at de ikke bruges i flæng, da patienterne derved vil få for meget eller for lidt lixisenatid.
English: − Suliqua 30-60 (containing insulin glargine 100 units/ml with lixisenatide 33 micrograms/ml)this pen can deliver between 30 and 60 dose steps per day.
Danish: − Suliqua 30-60 (som indeholder insulin glargin, 100 enheder/ml, med lixisenatid, 33 mikrogram/ml) - denne pen kan afgive mellem 30 og 60 dosistrin pr. dag.
English: Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml) - this pen can deliver between 10 and 40 dose steps per day.
Danish: Suliqua 10-40 (som indeholder insulin glargin, 100 enheder/ml, med lixisenatid, 50 mikrogram/ml) - denne pen kan afgive mellem 10 og 40 dosistrin pr. dag.
English: − Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml)this pen can deliver between 10 and 40 dose steps per day.
Danish: − Suliqua 10-40 (som indeholder insulin glargin, 100 enheder/ml, med lixisenatid, 50 mikrogram/ml) - denne pen kan afgive mellem 10 og 40 dosistrin pr. dag.
English: • As for similar medicines containing insulin with a non-insulin medicine, the dose is expressed in dose steps.
Danish: • Dosis er angivet i dosistrin ligesom for lignende lægemidler, der indeholder insulin med et ikkeinsulin.
English: It has been available in the EU since the 1950s.
Danish: Det har været på markedet i EU siden 1950'erne.
English: such as dehydration, severe infection or shock;
Danish: såsom dehydrering, svær infektion eller chok
English: The majority of these data had already been used in the authorisation of Forxiga.
Danish: Størstedelen af dataene var allerede blevet benyttet ved godkendelsen af Forxiga.
English: Xigduo received a marketing authorisation valid throughout the EU on 16 January 2014.
Danish: Xigduo fik en markedsføringstilladelse med gyldighed i hele EU den 16. januar 2014.
English: Further information on Xigduo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xigduo.
Danish: Yderligere information om Xigduo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/xigduo.
English: Xigduo contains two different active substances, which work in different ways:
Danish: Xigduo indeholder to forskellige aktive stoffer, der virker på hver sin måde:
English: Other information about Xigduo
Danish: Andre oplysninger om Xigduo
English: As for all medicines, data on the use of Xigduo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Xigduo løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Xigduo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xigduo?
English: Regarding its safety profile, this was considered similar to the safety profile of dapagliflozin.
Danish: Hvad angår sikkerhedsprofilen, blev den anset for at svare til sikkerhedsprofilen for dapagliflozin.
English: What is Xigduo and what is it used for?
Danish: Hvad er Xigduo, og hvad anvendes det til?
English: The European Medicines Agency decided that Xigduo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Xigduo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: • patients with reduced liver function;
Danish: • patienter med nedsat leverfunktion
English: Why is Xigduo authorised in the EU?
Danish: Hvorfor er Xigduo godkendt i EU?
English: An overview of Xigduo and why it is authorised in the EU
Danish: En oversigt over Xigduo og hvorfor det er godkendt i EU
English: • in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Danish: • i kombination med andre lægemidler mod diabetes, når disse lægemidler sammen med metformin ikke kan regulere diabetes tilstrækkeligt.
English: • patients who are intoxicated with alcohol (drunkenness) or who regularly drink excessive amounts of alcohol.
Danish: • patienter, som er påvirket af alkohol, eller som regelmæssigt indtager meget alkohol.
English: Side effects reported with Xigduo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Xigduo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It contains the active substances dapagliflozin and metformin.
Danish: Det indeholder de aktive stoffer dapagliflozin og metformin.
English: Xigduo can also be used to replace dapagliflozin and metformin taken as separate tablets.
Danish: Xigduo kan derudover anvendes til at erstatte dapagliflozin og metformin som separate tabletter.
English: • patients with diabetic precoma (a dangerous condition that can occur in diabetes);
Danish: • patienter med diabetisk prækoma (en farlig tilstand, der kan forekomme ved diabetes)
English: Xigduo must not be used in:
Danish: Xigduo må ikke anvendes til:
English: HbA1c (glycosylated haemoglobin) is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Danish: HbA1c (glykosyleret hæmoglobin) er et stof i blodet, der indikerer, hvor godt blodsukkeret er reguleret.
English: For further information about using Xigduo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Xigduo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Xigduo is used:
Danish: Xigduo anvendes:
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Danish: Dapagliflozin har været godkendt i EU under navnet Forxiga siden
English: What are the risks associated with Xigduo?
Danish: Hvilke risici er der forbundet med Xigduo?
English: Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes.
Danish: Dapagliflozin kombineret med metformin blev vurderet i seks hovedstudier med deltagelse af 3.200 voksne med type 2-diabetes.
English: • metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Danish: • Metformin virker hovedsagelig ved at mindske produktionen af blodsukker og mindske dets optagelse i tarmen.
English: • on its own in patients whose disease is not controlled well enough with metformin alone;
Danish: • som enkeltstofbehandling hos patienter, hvis sygdom ikke reguleres tilstrækkeligt med metformin alene
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Danish: Et langsigtet studie, der omfattede over 17.000 type 2-diabetespatienter så på virkningerne af dapagliflozin på hjerte-kar-sygdomme.
English: When Xigduo is added to treatment with insulin or a medicine that helps the body to produce insulin, such as a sulphonylurea, the doctor may need to lower the dose of insulin or sulphonylurea to prevent hypoglycaemia (low blood sugar levels).
Danish: Når Xigduo tilføjes til en behandling med insulin eller et lægemiddel, der hjælper kroppen med at producere insulin, f.eks. et sulfonylurinstof, kan lægen være nødt til at nedsætte dosen af insulin eller sulfonylurinstoffer for at forhindre hypoglykæmi (lavt blodsukker).
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Danish: Studiet viste, at dapagliflozins virkning svarede til virkningen af andre diabeteslægemidler, som også virker ved at blokere SGLT2.
English: • patients with severe reduction in kidney function or with conditions that could alter kidney function,
Danish: • patienter med svært nedsat nyrefunktion eller med tilstande, der kan ændre nyrefunktionen,
English: The Agency also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Danish: Agenturet bemærkede også, at kombinationen af dapagliflozin og metformin i én enkelt tablet kunne være en ekstra behandlingsmulighed for patienter med type 2-diabetes, og at dette kan hjælpe patienterne med at overholde behandlingen bedre.
English: Xigduo is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Danish: Xigduo fås som tabletter indeholdende 5 mg dapagliflozin med 850 mg metformin og som 5 mg dapagliflozin med 1.000 mg metformin.
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ‘ketones') or lactic acidosis (build-up of lactic acid in the body);
Danish: • patienter med en hvilken som helst form for akut metabolisk acidose (ophobning af syre i blodet), f.eks. diabetisk ketoacidose (høj koncentration af syrer i blodet kaldet ketoner) eller mælkesyreacidose (ophobning af mælkesyre i kroppen)
English: Xigduo is a diabetes medicine used, together with diet and exercise in adults with type 2 diabetes.
Danish: Xigduo er et lægemiddel mod diabetes, der anvendes sammen med diæt og motion til at behandle voksne med type 2-diabetes.
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: • Dapagliflozin blokerer virkningen af proteinet natrium-glukose-kotransporter 2 (SGLT2) i nyrerne.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og forbedrer dermed reguleringen af type 2diabetes.
English: This leads to high levels of glucose in the blood.
Danish: Det medfører for højt blodsukker.
English: The most common side effects with Xigduo (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Danish: De hyppigste bivirkninger ved Xigduo (som kan forekomme hos mere end 1 ud af 10 personer), er for lavt blodsukker (hypoglykæmi) (ved brug sammen med insulin eller et sulfonylurinstof) og symptomer fra mave-tarmkanalen (gastrointestinale symptomer).