FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 50 40 IU/ml suspension for injection in a vial Insulin human
Danish: Insulin Human Winthrop Comb 50 40 IE/ml injektionsvæske, suspension, i hætteglas Human insulin
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 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 Insulin Human Winthrop Rapid ").
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, - får mere motion end normalt eller er udsat for 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 punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Rapid”).
English: - The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insulin Human Winthrop Comb 15”), hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: protaminsulphat, meta--kresol, phenol, zinkklorid, natriumdihydrogenphosphatdihydrat, glycerol, natriumhydroxid (se punkt 2 under ”Vigtig information om nogle af de øvrige indholdsstoffer i Insulin Human Winthrop Comb15), saltsyre (til pH justering)og vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Rapid SoloStar 100 IU/ml solution for injection in a pre-filled pen.
Danish: LÆGEMIDLETS NAVN Insulin Human Winthrop Rapid Solostar 100 IE/ml injektionsvæske, opløsning, i en fyldt pen
English: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, your insulin pen does not work properly, you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insulin Human Winthrop Comb 50").
Danish: Hvis du for eksempel: ikke har injiceret dit insulin eller ikke har injiceret nok, eller hvis insulinet har mistet noget af sin virkning for eksempel på grund af forkert opbevaring, - har en insulinpen, der ikke virker ordentligt, - dyrker mindre motion end normalt eller er stresset (sindsbevægelse, følelsesmæssigt ude af balance, ophidselse), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - tager eller har taget visse andre lægemidler (se punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 50”).
English: Winthrop, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: - du tager eller har taget visse andre lægemidler (se punkt 2, "Brug af anden medicin sammen med Insulin Human Winthrop Infusat").
English: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, your insulin pen does not work properly, you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insulin Human Winthrop Comb 15").
Danish: Hvis du for eksempel: ikke har injiceret dit insulin eller ikke har injiceret nok, eller hvis insulinet har mistet noget af sin virkning for eksempel på grund af forkert opbevaring, - har en insulinpen, der ikke virker ordentligt, - dyrker mindre motion end normalt eller er stresset (sindsbevægelse, følelsesmæssigt ude af balance, ophidselse), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - tager eller har taget visse andre lægemidler (se punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 15”).
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 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 Insulin Human Winthrop Infusat").
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, - får mere motion end normalt eller er udsat for 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 punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Infusat”).
English: Suspension for injection in a cartridge.
Danish: Injektionsvæske, suspension i cylinderampul
English: Insulin Human Winthrop Comb 15 SoloStar 100 IU/ml suspension for injection in a pre-filled pen.
Danish: Insulin Human Winthrop Comb 15 SoloStar 100 IE/ml injektionsvæske, suspension i en fyldt pen Human insulin
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 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 Insulin Human Winthrop Comb 30").
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, - får mere motion end normalt eller er udsat for 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 punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 30”).
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 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 Insulin Human Winthrop Comb 50").
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, - får mere motion end normalt eller er udsat for 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 punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 50”).
English: Immediately before withdrawal from the vial into the injection syringe, the insulin must be resuspended.
Danish: Insulinet skal resuspenderes umiddelbart før, det trækkes fra hætteglasset op i injektionssprøjten.
English: Before insertion into the pen, Insulin Human Winthrop Comb 30 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Danish: Insulin Human Winthrop Comb 30 skal før det sættes ind i pennen opbevares ved stuetemperatur i 1 - 2 timer og herefter resuspenderes for at kontrollere suspensionen.
English: Examples include: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, your insulin pen does not work properly, you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insulin Human Winthrop Comb 30").
Danish: Hvis du for eksempel: ikke har injiceret dit insulin eller ikke har injiceret nok, eller hvis insulinet har mistet noget af sin virkning for eksempel på grund af forkert opbevaring, - har en insulinpen, der ikke virker ordentligt, - dyrker mindre motion end normalt eller er stresset (sindsbevægelse, følelsesmæssigt ude af balance, ophidselse), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - tager eller har taget visse andre lægemidler (se punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 30”).
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 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 Insulin Human Winthrop Comb 15").
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, - får mere motion end normalt eller er udsat for 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 punkt 2, ”Brug af anden medicin sammen med Insulin Human Winthrop Comb 15”).
English: Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will determine how much Insulin Human Winthrop Comb 50 per day you will need, tell you when to check your blood sugar level, and whether you need to carry out urine tests, tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Comb 50.
Danish: Alt efter din levevis og resultatet af dine blodsukkermålinger (glucosemålinger) vil din læge - afgøre hvor meget Insulin Human Winthrop Comb 50 du skal have om dagen, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at udføre urintests, - fortælle digm, hvornår du eventuelt skal have en større eller mindre dosis Insulin Human
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a vial
Danish: LÆGEMIDLETS NAVN Insulin Human Winthrop Comb 25 100 IE/ml injektionsvæske, suspension, i hætteglas
English: Before insertion into the pen, Insulin Human Winthrop Comb 50 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Danish: Insulin Human Winthrop Comb 50 skal før det sættes ind i pennen opbevares ved stuetemperatur i 1 - 2 timer og herefter resuspenderes for at kontrollere suspensionen.
English: BATCH NUMBER BN
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Before insertion into the pen, Insulin Human Winthrop Comb 15 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Danish: Insulin Human Winthrop Comb 15 skal før det sættes ind i pennen opbevares ved stuetemperatur i 1 - 2 timer og herefter resuspenderes for at kontrollere suspensionen.
English: The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insulin Human Winthrop Comb 50”), hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: protaminsulphat, metakresol, phenol, zinkklorid, natriumdihydrogenphosphatdihydrat, glycerol, natriumhydroxid (se punkt 2 under ”Vigtig information om nogle af de øvrige indholdsstoffer i Insulin Human Winthrop Comb 50), saltsyre (til pH justering)og vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 30 100 IU/ml suspension for injection in a cartridge Insulin human
Danish: Insulin Human Winthrop Comb 30 100 IE/ml injektionsvæske, suspension, i hætteglas Human insulin
English: Before insertion into the pen, Insulin Human Winthrop Comb 25 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Danish: Insulin Human Winthrop Comb 25 skal før det sættes ind i pennen opbevares ved stuetemperatur i 1 - 2 timer og herefter resuspenderes for at kontrollere suspensionen.
English: How to use Insulin Human Winthrop Infusat
Danish: Sådan skal du tage Insulin Human Winthrop Infusat
English: • major depression;
Danish: • svær depression
English: The response to treatment should be assessed regularly.
Danish: Behandlingens virkning bør vurderes regelmæssigt.
English: A response is usually seen in two to four weeks.
Danish: Der ses sædvanligvis virkning efter to til fire uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Lilly on 8 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duloxetin Lilly den 8. december 2014.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angst (langvarig angst eller nervøsitet over hverdagsanliggender)
English: This prevents the active substance being destroyed by the acid in the stomach.
Danish: Derved undgås, at det aktive stof ødelægges af mavesyren.
English: Most of these are mild or moderate, starting early in treatment and getting milder as treatment continues.
Danish: De fleste af bivirkningerne er lette eller moderate og sætter ind tidligt under behandlingen, men bliver mildere i løbet af behandlingen.
English: The full EPAR and risk management plan summary for Duloxetine Lilly 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 Duloxetin Lilly findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Danish: Behandlingen må ikke påbegyndes hos patienter med ukontrolleret forhøjet blodtryk (hypertension), da dette kan medføre risiko for pludselig farlig blodtryksstigning (hypertensiv krise).
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.
Danish: I begge undersøgelser sås smertereduktion fra den første uge af behandlingen og i op til 12 uger.
English: The main measure of effectiveness was the change in the severity of pain each week.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i smerternes sværhed hver uge.
English: This medicine contains the active substance duloxetine and is the same as Cymbalta, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel indeholder det aktive stof duloxetin og er identisk med Cymbalta, som allerede er godkendt i Den Europæiske Union (EU).
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Lilly.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duloxetin Lilly.
English: The most common side effects with Duloxetine Lilly (which may affect more than 1 in 10 people) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Danish: De hyppigste bivirkninger ved Duloxetin Lilly (som kan optræde hos mere end 1 ud af 10 patienter) er kvalme, hovedpine, mundtørhed, søvnighed (somnolens) og svimmelhed.
English: Most patients will need to take 60 mg per day.
Danish: De fleste patienter behøver 60 mg dagligt.
English: The company that makes Cymbalta has agreed that its scientific data can be used for Duloxetine Lilly (‘informed consent').
Danish: Virksomheden, som fremstiller Cymbalta, har indvilget i, at dens videnskabelige oplysninger må anvendes for Duloxetin Lilly ("informeret samtykke").
English: Patients who also have major depression should start with 60 mg once a day.
Danish: Patienter, der også har svær depression, skal begynde med 60 mg én gang dagligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Lilly'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 Duloxetin Lilly opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
Danish: Fire af undersøgelserne vedrørte behandling af sygdommen med registrering af reduktionen i symptomer efter 9 til 10 uger.
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Duloxetine Lilly.
Danish: Den femte undersøgelse vedrørte, hvor lang tid det tog for symptomerne at vende tilbage hos 429 patienter, som oprindelig havde haft virkning af Duloxetin Lilly.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Danish: Neurotransmittere er kemiske signalstoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: Duloxetine Lilly is a medicine that is used to treat adults with the following diseases:
Danish: Duloxetin Lilly er et lægemiddel til behandling af voksne med følgende sygdomme:
English: A risk management plan has been developed to ensure that Duloxetine Lilly is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Duloxetin Lilly anvendes så sikkert som muligt.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Danish: Enterokapsler er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når tarmen.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne serotonin (5-hydroxytryptamin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months.
Danish: Seks af undersøgelserne vedrørte behandling af depression, og her blev ændringen i symptomer registreret i op til seks måneder.
English: Duloxetine Lilly must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotics).
Danish: Duloxetin Lilly bør ikke anvendes samme med MAO-hæmmere (monoaminoxidasehæmmere, en anden type medicin mod depression), fluvoxamin (et andet middel mod depression) eller ciprofloxacin eller enoxacin (to typer antibiotika).
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Danish: Ved generaliseret angst er den anbefalede startdosis 30 mg i gang dagligt, men dosis kan sættes op til 60, 90 eller 120 mg, afhængigt af virkningen hos patienten.
English: For major depression, the recommended dose of Duloxetine Lilly is 60 mg once a day.
Danish: Til svær depression er den anbefalede dosis af Duloxetin Lilly 60 mg én gang dagligt.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af disse neurotransmittere i mellemrummene mellem nervecellerne og forbedrer derved kommunikationen mellem cellerne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Lilly, 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 Duloxetin Lilly, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Danish: Ved diabetiske neuropatiske smerter er den anbefalede dosis 60 mg dagligt, men nogle patienter kan have behov for en højere dosis på 120 mg dagligt.
English: It also took longer for symptoms to return in patients taking Duloxetine Lilly than in those taking placebo.
Danish: Det tog også længere tid for symptomerne at vende tilbage hos patienter, der fik Duloxetin Lilly, end hos dem, der fik placebo.