FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma “trough” levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Danish: Plasma-dal-koncentrationen af insulin glargin og dets vigtigste M1- og M2-metabolitter blev målt hos børn behandlet med insulin glargin.
English: What Semglee looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Semglee").
Danish: Hvis du for eksempel: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning eller diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se afsnit 2, "Brug af anden medicin sammen med Semglee").
English: In-use pens
Danish: Uanbrudte penne
English: Pens in use must not be stored in the refrigerator.
Danish: Må ikke opbevares i køleskab.
English: The prolonged duration of action of Semglee is dependent on its injection into subcutaneous tissue.
Danish: Subkutan injektion af Semglee er en forudsætning for den lange virkningsvarighed.
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - sulfonamide antibiotics.
Danish: Medicin, der kan få dit blodsukker til at falde (hypoglykæmi), omfatter: - alle øvrige lægemidler til behandling af diabetes, - angiotensinkonverterende enzym (ACE)-hæmmere (anvendes til behandling af visse hjertesygdomme eller højt blodtryk), - disopyramid (anvendes til behandling af visse hjertesygdomme),
English: The cartridge is assembled in a disposable pen injector.
Danish: Cylinderampullen er anbragt i en injektionspen til engangsbrug.
English: Inject your dose A - If instructed by your healthcare provider you can pinch the cleaned skin between your fingers.
Danish: A - Klem den rensede hud sammen mellem dine fingre, hvis din læge eller sundhedspersonalet har bedt dig gøre det.
English: A - Always prime a new pen needle before each injection.
Danish: A - Du skal altid kontrollere insulin-flowet før hver injektion.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If you use more Semglee than you should
Danish: Hvis du har brugt for meget Semglee
English: D - Replace the pen cap over the cartridge.
Danish: D - Sæt hætten tilbage på cylinderampullen.
English: Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Danish: Der blev vist ens effekt på glycohæmoglobin og incidensen af symptomatisk hypoglykæmi i begge behandlingsgrupper.
English: Always use a new sterile needle for each injection as this helps stop blocked needles and prevents infections.
Danish: Det hjælper med at forebygge blokering af nålen og infektion.
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
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 apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Pen assembly:
Danish: Pennens bestanddele:
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Danish: Farmakoterapeutisk klassifikation: Antidiabetica.
English: Frequency of administration
Danish: Virkningsvarigheden af
English: Do not throw it away.
Danish: Du må ikke smide løse nåle i skraldespanden.
English: Posology
Danish: BRUGSANVISNING
English: The safety and efficacy of Semglee have not been established.
Danish: Semglees sikkerhed og virkning er ikke påvist hos børn under 2 år.
English: Medicinal product subject to medical prescription
Danish: LÆGEMIDLETS NAVN
English: This summary was last updated in 07-2014.
Danish: Dette sammendrag blev senest ajourført i 07-2014.
English: Black patients may require higher doses than white patients.
Danish: Sorte patienter kan behøve højere dosis end hvide.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Envarsus on 18 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Envarsus den 18. juli 2014.
English: This is a summary of the European public assessment report (EPAR) for Envarsus.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Envarsus.
English: Envarsus should be taken once daily with water, on an empty stomach.
Danish: Envarsus indtages én gang dagligt med vand på tom mave.
English: The full EPAR and risk management plan summary for Envarsus 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 Envarsus findes på agenturets websted underema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Envarsus is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Envarsus anvendes så sikkert som muligt.
English: Other information about Envarsus
Danish: Andre oplysninger om Envarsus
English: What measures are being taken to ensure the safe and effective use of Envarsus?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Envarsus?
English: Doses of Envarsus are calculated based on the patient's weight.
Danish: Dosis af Envarsus beregnes efter patientens vægt.
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within certain limits.
Danish: Lægen bør overvåge blodets indhold af tacrolimus for at sikre, at det er inden for visse grænser.
English: Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
Danish: Patienterne fik enten deres behandling lagt om til Envarsus én gang dagligt eller fortsatte med Prograf to gange dagligt.
English: In the prevention of rejection, doses should start at 0.17 mg per kg of body weight daily in patients who have had a kidney transplant, and 0.11 to 0.13 mg per kg daily in those who have had a liver transplant.
Danish: Til forebyggelse af afstødning er startdosis 0,17 mg/kg legemsvægt til patienter, der har fået en nyretransplantation, og 0,11-0,13 mg/kg dagligt til dem, der har fået en levertransplantation.
English: The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Danish: De almindeligste bivirkninger med Envarsus (der ses hos flere end 1 af hver 10 patienter) er rysten, hovedpine, kvalme, diarré, nyreproblemer, for højt blodsukker (hyperglykæmi), sukkersyge (diabetes), for højt kaliumindhold i blodet (hyperkaliæmi), for højt blodtryk (hypertension) og søvnløshed.
English: This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men har en anden sammensætning og fås i andre doser.
English: Envarsus is a ‘hybrid medicine'.
Danish: Envarsus er et “hybridt lægemiddel”.
English: Patients may also have abnormal results in liver function tests.
Danish: Patienterne kan desuden få unormale resultater af leverfunktionsprøver.
English: Why is Envarsus approved?
Danish: Hvorfor er Envarsus blevet godkendt?
English: Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
Danish: Der var behandlingssvigt hos 18,3 % af dem, der fik Envarsus (49 ud af 268), og 19,6 % af dem, der fik Prograf (54 ud af 275).
English: Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
Danish: I begge grupper var der behandlingssvigt hos 2,5 % (4 af 162 patienter behandlet med Envarsus, og 4 af 162 behandlet med Prograf).
English: In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Danish: På grund af forskelle i sammensætning/dosering mellem Envarsus og Advagraf blev der desuden forelagt kliniske undersøgelser hos patienter.
English: Envarsus has been shown to be at least as effective as Prograf in two main studies in patients with kidney transplants.
Danish: Envarsus er påvist at være mindst ligeså effektivt som Prograf i to hovedundersøgelser hos patienter med nyretransplantat.
English: The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Danish: Den første undersøgelse omfattede 326 patienter, der i forvejen havde et nyretransplantat og var i behandling med Prograf og andre immundæmpende lægemidler for at forebygge afstødning.
English: Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Danish: Envarsus må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne, eller hos patienter, der er allergiske over for stoffer af typen makrolider (herunder antibiotika såsom erythromycin).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Envarsus i de godkendte doser er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Advagraf og Prograf.
English: Treatment is adjusted according to the medicine's blood levels and the patient's response.
Danish: Behandlingen tilpasses efter lægemidlets koncentration i blodet og dets virkning på patienten.
English: Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
Danish: Da Envarsus svarer til referencelægemidlet Advagraf, forelagde ansøgeren sammenlignede oplysninger om Advagraf.
English: The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Danish: I den anden undersøgelse blev Envarsus sammenlignet med Prograf som led i standardbehandling hos 543 patienter med en nytransplanteret nyre.
English: Envarsus is often given with other immunosuppressive medicines following the transplant.
Danish: Envarsus gives ofte sammen med andre immundæmpende lægemidler efter transplantation.
English: The main measure of effectiveness in both studies was the number of patients who had treatment failure (death, failure or rejection of the transplanted organ, or loss of the patient from follow-up) after 12 months.
Danish: I begge undersøgelser blev virkningen hovedsagelig bedømt på det antal patienter, hos hvem behandlingen efter 12 måneder havde slået fejl (dødsfald, svigt eller afstødning af det transplanterede organ, eller patienten tabt for opfølgning).
English: Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Danish: Tacrolimus, det aktive stof i Envarsus, er et immundæmpende lægemiddel.
English: What is Envarsus and what is it used for?
Danish: Hvad er Envarsus, og hvad anvendes det til?
English: Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Danish: Envarsus fås kun på recept og må kun ordineres af en læge med erfaring inden for immundæmpende lægemidler og behandling af transplantationspatienter.
English: Envarsus is a medicine that contains the active substance tacrolimus.
Danish: Envarsus er et lægemiddel, der indeholder det aktive stof tacrolimus.
English: The reference medicine for Envarsus is Advagraf.
Danish: Referencelægemidlet for Envarsus er Advagraf.
English: For more information about treatment with Envarsus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Envarsus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Envarsus?
Danish: Hvilke risici er der forbundet med Envarsus?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Envarsus, 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 Envarsus, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Switching or changes in immunosuppressive medicines should be started and monitored by experienced transplant doctors.
Danish: Hvis der skal skiftes til et andet immundæmpende lægemiddel eller behandlingen ændres, bør dette iværksættes og overvåges af læger med erfaring i transplantation.
English: Lower doses may be needed in patients with reduced liver function.
Danish: Ved nedsat leverfunktion kan det være nødvendigt med lavere dosis.
English: The Committee recommended that Envarsus be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Envarsus.
English: It is not intended to provide practical advice on how to use Envarsus.
Danish: Det er ikke en praktisk vejledning i, hvordan Envarsus bør anvendes.
English: Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Danish: Tacrolimus virker på immunsystemets T-celler, som er hovedansvarlige for, at det transplanterede organ angribes (afstødes).
English: Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Danish: Envarsus leveres som depottabletter med 0,75, 1 eller 4 mg tacrolimus.
English: These ‘prolonged-release' tablets allow tacrolimus to be released slowly from the tablet over several hours and in a form that the body can absorb easily, so that it need be given only once a day.
Danish: Tacrolimus frigives langsomt i løbet af flere timer fra depottabletten i en form, så det let optages af kroppen.
English: It is used for the long-term treatment of adult patients who have had a kidney or a liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Danish: Der bruges som langtidsbehandling for at forebygge afstødning hos voksne efter en nyre- eller levertransplantation (ved afstødning angriber immunsystemet det transplanterede organ).
English: These starting doses may also be tried for the treatment of rejection.
Danish: Til behandling af afstødning kan man prøve at give de samme startdoser.
English: Therefore, the CHMP's view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for de andre former af tacrolimus.
English: Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Danish: Envarsus kan desuden bruges til at behandle organafstødning hos voksne patienter, når andre immundæmpende lægemidler ikke virker.
English: How is Envarsus used?
Danish: Hvordan anvendes Envarsus?
English: For practical information about using Envarsus, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Envarsus, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Envarsus see the package leaflet
Danish: Den fuldstændige liste over indberettede bivirkninger med Envarsus fremgår af indlægssedlen.
English: These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Danish: Prograf er et udbredt og anerkendt lægemiddel, som indeholder tacrolimus, men frigiver det hurtigere.
English: What benefits of Envarsus have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Envarsus?
English: Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Danish: Ved skift til Envarsus skal patienter, der i forvejen er i behandling med en anden sammensætning (formulering) af tacrolimus, derfor have en 30 % lavere dosis af Envarsus end deres hidtidige dosis.
English: In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
Danish: Materialet skal nævne de godkendte anvendelser og den godkendte dosering og påpege, at der skal udvises forsigtighed, hvis der skiftes mellem de forskellige former af tacrolimus.
English: The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Danish: Virksomheden forelagde desuden undersøgelser, der viste, at indtagelse af Envarsus fremkaldte koncentrationer af tacrolimus i kroppen, der tidligere var påvist at være effektive til behandling og forebyggelse af afstødning.
English: How does Envarsus work?
Danish: Hvordan virker Envarsus?
English: This is a summary of the European public assessment report (EPAR) for Adynovi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adynovi.
English: It can be used in adults and children from 12 years of age.
Danish: Det kan anvendes hos voksne og børn i alderen 12 år og derover.
English: The full EPAR for Adynovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Adynovia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Adynovi
Danish: Andre oplysninger om Adynovia
English: Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver kan selv injicere Adynovi i hjemmet efter at have fået passende oplæring.
English: Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.
Danish: Da dette kan tænkes at medføre problemer, især hos børn under 12 år, er Adynovi kun godkendt til voksne og børn i alderen 12 år og derover.
English: The European Medicines Agency decided that Adynovi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Adynovi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Adynovi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adynovi?
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og hyppighed af behandlingen afhænger af, om den skal anvendes til behandling eller til forebyggelse af blødning, sygdommens sværhedsgrad, blødningens omfang og beliggenhed samt patientens tilstand og legemsvægt.
English: It is not intended to provide practical advice on how to use Adynovi.
Danish: Det er ikke en praktisk vejledning i, hvordan Adynovi bør anvendes.
English: Why is Adynovi approved?
Danish: Hvorfor blev Adynovi godkendt?
English: What is Adynovi and what is it used for?
Danish: Hvad er Adynovi, og hvad anvendes det til?
English: Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Danish: Allergiske reaktioner er ikke almindelige med Adynovi (kan forekomme hos op til 1 ud af 100 patienter) og kan omfatte hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, rødme, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hvæsende vejrtrækning.
English: During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working.
Danish: I denne periode oplevede ca. 38 % af patienterne (25 ud af 66) ingen blødningsepisoder, og ingen af patienterne udviklede antistoffer mod Adynovi, som ville kunne stoppe lægemidlets virkning.
English: For the full list of all side effects see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger fremgår af indlægssedlen.