natgillin/translations-raw huggingface dataset:
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.
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.
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”).
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").
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”).
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").
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
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.
LÆGEMIDLETS NAVN Insulin Human Winthrop Comb 25 100 IE/ml injektionsvæske, suspension, i hætteglas
NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a vial
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.
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.
FREMSTILLERENS BATCHNUMMER Lot
BATCH NUMBER BN
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.
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.
- 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.
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.
Insulin Human Winthrop Comb 30 100 IE/ml injektionsvæske, suspension, i hætteglas Human insulin
NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 30 100 IU/ml suspension for injection in a cartridge Insulin human
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.
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.
Sådan skal du tage Insulin Human Winthrop Infusat
How to use Insulin Human Winthrop Infusat
• svær depression
• major depression;
Behandlingens virkning bør vurderes regelmæssigt.
The response to treatment should be assessed regularly.
Der ses sædvanligvis virkning efter to til fire uger.
A response is usually seen in two to four weeks.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duloxetin Lilly den 8. december 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Lilly on 8 December 2014.
• generaliseret angst (langvarig angst eller nervøsitet over hverdagsanliggender)
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Derved undgås, at det aktive stof ødelægges af mavesyren.
This prevents the active substance being destroyed by the acid in the stomach.
De fleste af bivirkningerne er lette eller moderate og sætter ind tidligt under behandlingen, men bliver mildere i løbet af behandlingen.
Most of these are mild or moderate, starting early in treatment and getting milder as treatment continues.
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.
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.
Behandlingen må ikke påbegyndes hos patienter med ukontrolleret forhøjet blodtryk (hypertension), da dette kan medføre risiko for pludselig farlig blodtryksstigning (hypertensiv krise).
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).
I begge undersøgelser sås smertereduktion fra den første uge af behandlingen og i op til 12 uger.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.
Virkningen blev hovedsagelig bedømt på ændringen i smerternes sværhed hver uge.
The main measure of effectiveness was the change in the severity of pain each week.
Dette lægemiddel indeholder det aktive stof duloxetin og er identisk med Cymbalta, som allerede er godkendt i Den Europæiske Union (EU).
This medicine contains the active substance duloxetine and is the same as Cymbalta, which is already authorised in the European Union (EU).
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duloxetin Lilly.
This is a summary of the European public assessment report (EPAR) for Duloxetine Lilly.
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.
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.
De fleste patienter behøver 60 mg dagligt.
Most patients will need to take 60 mg per day.
Virksomheden, som fremstiller Cymbalta, har indvilget i, at dens videnskabelige oplysninger må anvendes for Duloxetin Lilly ("informeret samtykke").
The company that makes Cymbalta has agreed that its scientific data can be used for Duloxetine Lilly (‘informed consent').
Patienter, der også har svær depression, skal begynde med 60 mg én gang dagligt.
Patients who also have major depression should start with 60 mg once a day.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Duloxetin Lilly opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Fire af undersøgelserne vedrørte behandling af sygdommen med registrering af reduktionen i symptomer efter 9 til 10 uger.
Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
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.
The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Duloxetine Lilly.
Neurotransmittere er kemiske signalstoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Duloxetin Lilly er et lægemiddel til behandling af voksne med følgende sygdomme:
Duloxetine Lilly is a medicine that is used to treat adults with the following diseases:
Der er udarbejdet en risikostyringsplan for at sikre, at Duloxetin Lilly anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Duloxetine Lilly is used as safely as possible.
Enterokapsler er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når tarmen.
‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Det virker ved at forhindre, at neurotransmitterne serotonin (5-hydroxytryptamin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
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.
Seks af undersøgelserne vedrørte behandling af depression, og her blev ændringen i symptomer registreret i op til seks måneder.
Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months.
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).
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).
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.
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.
Til svær depression er den anbefalede dosis af Duloxetin Lilly 60 mg én gang dagligt.
For major depression, the recommended dose of Duloxetine Lilly is 60 mg once a day.
Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af disse neurotransmittere i mellemrummene mellem nervecellerne og forbedrer derved kommunikationen mellem cellerne.
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.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Duloxetin Lilly, 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 Duloxetine Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.
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.
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.
Det tog også længere tid for symptomerne at vende tilbage hos patienter, der fik Duloxetin Lilly, end hos dem, der fik placebo.
It also took longer for symptoms to return in patients taking Duloxetine Lilly than in those taking placebo.
Duloxetin Lilly må heller ikke anvendes hos patienter med nedsat leverfunktion eller svært nedsat nyrefunktion.
Duloxetine Lilly must also not be used in patients with reduced liver function or patients with severely reduced kidney function.
Duloxetin Lilly fås som enterokapsler (30 og 60 mg).
Duloxetine Lilly is available as gastroresistant capsules (30 mg and 60 mg).
Det aktive stof i dette lægemiddel, duloxetin, hæmmer genoptagelsen af serotonin og noradrenalin.
The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Hvis du ønsker yderligere oplysninger om behandling med Duloxetin Lilly, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Duloxetine Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hos patienter, der responderer på Duloxetin Lilly, bør behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage, eller længere hos patienter, der tidligere gentagne gange har haft perioder med depression.
In patients who respond to Duloxetine Lilly, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
I de to andre undersøgelser blev det registreret, hvor lang tid det tog for symptomerne at vende tilbage hos patienter, der i begyndelsen havde haft virkning af Duloxetin Lilly, herunder 288 patienter med tidligere gentagne episoder med depression i op til fem år.
The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Duloxetine Lilly, including 288 patients with a history of repeated episodes of depression for up to five years.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duloxetin Lilly?
What measures are being taken to ensure the safe and effective use of Duloxetine Lilly?
Duloxetin Lilly var mere effektivt end placebo til at behandle sygdommen og forebygge tilbagevenden af symptomerne.
Duloxetine Lilly was shown to be more effective than placebo at treating the disorder and preventing symptoms returning.
Mod neuropatiske smerter er Duloxetin Lilly blevet sammenlignet med placebo i to 12-ugers undersøgelser hos 809 voksne diabetespatienter.
For neuropathic pain, Duloxetine Lilly has been compared with placebo in two 12-week studies in 809 diabetic adults.
Hvad er Duloxetin Lilly, og hvad anvendes det til?
What is Duloxetine Lilly and what is it used for?
Andre oplysninger om Duloxetin Lilly
Other information about Duloxetine Lilly
I de to undersøgelser, hvor den godkendte dosis af Duloxetin Lilly blev sammenlignet med placebo, var Duloxetin Lilly mere effektivt.
In the two studies where the approved dose of Duloxetine Lilly was compared with placebo, Duloxetine Lilly was more effective.
Duloxetin Lilly duloxetin
Duloxetine Lilly duloxetine
• smerter ved diabetesbetingede nervelidelser som følge beskadigelse af nerverne i arme og ben (perifer neuropati)
• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Hvorfor blev Duloxetin Lilly godkendt?
Why is Duloxetine Lilly approved?
Hvis du ønsker praktisk vejledning om anvendelsen af Duloxetin Lilly, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Duloxetine Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Hos patienter, hos hvem Duloxetin Lilly virker, skal behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage.
In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.
Hvilke risici er der forbundet med Duloxetin Lilly?
What are the risks associated with Duloxetine Lilly?
Disse undersøgelser viste, at Duloxetin Lilly var mere effektivt til at nedsætte smerterne end placebo.
These studies showed that Duloxetine Lilly was more effective at reducing pain than placebo.
Det er ikke en praktisk vejledning i, hvordan Duloxetin Lilly bør anvendes.
It is not intended to provide practical advice on how to use Duloxetine Lilly.
Mod generaliseret angst er Duloxetin Lilly blevet sammenlignet med placebo i fem undersøgelser med i alt 2 337 patienter.
For generalised anxiety disorder, Duloxetine Lilly has been compared with placebo in five studies involving a total of 2,337 patients.
Virkningen af Duloxetin Lilly ved svær depression er blevet sammenlignet med virkningsløs behandling (placebo) i otte hovedundersøgelser med tilsammen 2 544 patienter.
For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Resultaterne af undersøgelserne vedrørende depression varierede, men i fire af undersøgelserne var Duloxetin Lilly mere effektivt end placebo.
Although the results of the depression studies varied, Duloxetine Lilly was more effective than placebo in four of the studies.
Den fuldstændige liste over indberettede bivirkninger ved Duloxetin Lilly fremgår af indlægssedlen.
For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.
Når deres genoptagelse i nervecellerne blokeres, opnår man derfor en bedring i depressionssymptomer og angst og i neuropatiske smerter.
Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Hvordan anvendes Duloxetin Lilly?
How is Duloxetine Lilly used?
Hvordan virker Duloxetin Lilly?
How does Duloxetine Lilly work?
Når behandlingen ophører, bør det ske ved gradvis nedsættelse af dosis af Duloxetin Lilly.
The dose of Duloxetine Lilly should be reduced gradually when stopping treatment.
Hvilke fordele viser undersøgelserne, at der er ved Duloxetin Lilly?
What benefits of Duloxetine Lilly have been shown in studies?
Patienterne var i behandling i otte uger.
The patients were treated for eight weeks.
Den bør ikke tages sammen med grapefrugtsaft.
It should not be taken together with grapefruit juice.
"Essentiel" betyder, at hypertensionen ikke har nogen klar årsag.
'Essential' means that the hypertension has no obvious cause.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rasitrio den 22. november 2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Rasitrio on 22 November 2011.
Det fås som tabletter i følgende styrker: 150/5/12,5 mg; 300/5/12,5 mg; 300/5/25 mg; 300/10/12,5 mg og 300/10/25 mg.
It is available as tablets in the following strengths: 150 /5/12.5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasitrio.
This is a summary of the European public assessment report (EPAR) for Rasitrio.
Patienten skal tage en tablet en gang om dagen sammen med et let måltid, helst på samme tid hver dag.
The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Den fuldstændige EPAR for Rasitrio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Rasitrio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Tabletten sluges hel med vand.
The tablet should be swallowed whole with water.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Rasitrio.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rasitrio.
CHMP bemærkede, at indtagelse af de tre aktive stoffer i én tablet i stedet for i separate tabletter kan føre til en bedre overholdelse af behandlingen.
The CHMP noted that taking the three active substances in one tablet, as opposed to taking separate tablets, may lead to better compliance with treatment.
Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, som calciumpartiklerne normalt kommer ind igennem.
It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Amlodipin er en calciumkanalblokker.
Amlodipine is a calcium channel blocker.
Hvis du ønsker yderligere oplysninger om behandling med Rasitrio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Rasitrio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hydrochlorthiazid er et diuretikum.
Hydrochlorothiazide is a diuretic.
Det primære effektmål var sænkningen af det gennemsnitlige systoliske blodtryk (blodtrykket, når hjertet trækker sig sammen), målt hos patienter i siddende stilling.
The main measure of effectiveness was the reduction in the average systolic blood pressure (blood pressure when the heart is contracting) measured when the patients were seated.
Efter otte uger var det systoliske blodtryk i siddende stilling hos patienter, der blev behandlet med Rasitrio, gennemsnitligt faldet 37,4 mmHg.
After eight weeks, patients treated with Rasitrio had an average reduction in sitting systolic blood pressure of 37.4 mmHg.
Patienterne skal gå over til den faste kombinationstablet af Rasitrio, der indeholder de samme doser, som tidligere blev anvendt individuelt.
Patients should be switched to the fixed combination tablet of Rasitrio that contains the same component doses as previously used individually.
CHMP besluttede derfor, at fordelene ved Rasitrio opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rasitrio.
The Committee therefore decided that Rasitrio's benefits are greater than its risks and recommended that it be given marketing authorisation.
Virksomheden fremlagde også resultaterne af undersøgelser, som viste, at tabletten, der indeholder alle tre stoffer, absorberes på samme måde i kroppen som de separate tabletter.
The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.