FrancophonIA/ELRC3.0 huggingface dataset:
English: ⇒ Despite wide inter- and intra-individual variations of steroid plasma concentrations, high contraceptive efficacy is consistently demonstrated in COC's with 0.030 mg ethinylestradiol and 0150 mg levonorgestrel, ⇒ There is a poor correlation between plasma steroid levels and contraceptive efficacy, ⇒ The pharmacokinetics of progestogens and EE do not adequately reflect safety parameters, such as endometrial bleeding or common adverse events nor rare effects such as risk of thromboembolic disease,
Danish: at der trods stor inter- og intraindividuel variation i plasmasteroidkoncentration vedholdende påvises høj kontraceptiv virkning af COC-produkter indeholdende 0,030 mg ethinylestradiol og 0,150 mg levonorgestrel, at der er ringe korrelation mellem plasmasteroidkoncentration og kontraceptiv virkning,
English: Marketing authorisation Holder
Danish: Indehaver af markedsføringstill adelse
English: However, a review of the literature suggests that effects on ovarian function and the endometrium occur at doses that are considerably lower than those in currently approved COCs and does not support the view that COCs in general have a narrow therapeutic margin in terms of efficacy/safety parameters.
Danish: En gennemgang af litteraturen synes imidlertid at vise, at virkningen på ovariefunktionen og endometriet optræder ved doser, der er betydeligt under dem, der findes i aktuelt godkendte COC
English: It has been reported that the following conditions may occur, or worsen both during pregnancy and during use of oral contraceptives, but the evidence of a relationship with use of oral contraceptives is inconclusive: Jaundice and/or pruritus in connection with cholestasis; development of gallstones; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; loss of hearing due to otosclerosis.
Danish: Gulsot og/eller pruritus i forbindelse med cholestasis; udvikling af galdesten; porfyri; systemisk erytematosus; hæmolytisk uræmisk syndrom; Sydenham's chorea; herpes gestationis; nedsat hørelse som følge af otosklerose.
English: Missed tablets
Danish: Overtrukne tabletter
English: Hence, the use of oral contraceptives cannot generally be recommended until the lactating mother has completely weaned off the child. Small amounts of contraceptive steroids and/or their metabolites may be excreted with the milk.
Danish: Anvendelse af orale præventionsmidler kan derfor generelt ikke anbefales, før den ammende moder har vænnet barnet helt fra.
English: ⇒ Adequate contraceptive efficacy has been demonstrated with COCs even containing lower doses than Rigevidon and with lower dosed progestogen-only products,
Danish: at der er godtgjort tilstrækkelig kontraceptiv virkning af COC-produkter med lavere doser end Rigevidon og af produkter, der udelukkende indeholder gestagen i lavere dosering, at Rigevidon i nogle medlemsstater har været på markedet, uden at der har været tegn på utilstrækkelig virkning eller sikkerhed,
English: Drug interactions resulting in an increased clearance of sexual hormones may lead to break through bleeding and contraceptive failure.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Lægemiddelinteraktioner, der medfører en øget udskillelse af kønshormoner, kan medføre gennembrudsblødning og svigt af præventionsmidlet.
English: Incompatibilities Not applicable.
Danish: Ikke relevant.
English: − Malignant tumours in the breast
Danish: Maligne brysttumorer
English: - Hypertension.
Danish: Hypertension.x
English: Ocular Lesions
Danish: Øjenlæsioner
English: − breast tenderness, spotting, oligomenorrhoea, amenorrhoea, changes in libido
Danish: kvalme, lettere hovedpine, vægtforøgelse, irritabilitet, tung fornemmelse i benene brystømhed, pletblødning, oligomenorré, amenorré, ændringer i libido øjenirritation ved anvendelse af kontaktlinser.
English: − Venous thromboembolism or medical history of venous thromboembolism (deep venous thrombosis, pulmonary embolism) with or without risk factors (see section 4.4)
Danish: Venøs tromboemboli eller venøs tromboemboli i anamnesen (dyb venetrombose, lungeemboli) med eller uden risikofaktorer (se afsnit 4.4) Arteriel tromboemboli eller arteriel tromboemboli i anamnesen, specielt myokardieinfarkt, cerebrovaskulære lidelser (se afsnit 4.4) Betydelige eller adskillige risikofaktorer for venøs eller arteriel trombose (se afsnit 4.4) Tidligere prodromale symptomer på trombose (f.eks. forbigående cerebral iskæmi, angina pectoris)
English: This is due to induction of drug metabolising enzymes by St John's wort.
Danish: Dette skyldes, at perikum påfører lægemiddelnedbrydende enzymer.
English: − serious, abnormal headache, migraine, dizziness, visual disturbances
Danish: alvorlig, abnorm hovedpine, migræne, svimmelhed, synsforstyrrelser forværring af epilepsi leveradenom, kolestatisk gulsot chloasma
English: Rigevidon
Danish: Talkum
English: − Severe hypertension
Danish: Majsstivelse Laktosemonohydrat
English: − vomiting;
Danish: implantat)
English: − depressions;
Danish: Nedbrydning:
English: Dzuveo should not be used for more than 48 hours.
Danish: Dzuveo bør ikke anvendes i mere end 48 timer.
English: It is a ‘hybrid medicine'.
Danish: Det er et "hybridt lægemiddel".
English: Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet.
Danish: Patienterne bør ikke spise eller drikke og bør tale så lidt som muligt i 10 minutter efter administration af resoribletten.
English: Further information on Dzuveo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Dzuveo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Dzuveo
Danish: Andre oplysninger om Dzuveo
English: The tablet must not be chewed or swallowed.
Danish: Resoribletten må ikke tygges eller sluges.
English: The most common side effects (which may affect more than 1 in 10 people) are nausea, vomiting and fever.
Danish: De hyppigste bivirkninger (som optræder hos mere end 1 ud af 10 patienter) er kvalme, opkastning og feber.
English: As for all medicines, data on the use of Dzuveo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Dzuveo løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Dzuveo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dzuveo?
English: This means that it is similar to a ‘reference medicine' (called Sufenta Forte) containing the same active substance.
Danish: Det betyder, at det er identisk med et "referencelægemiddel" (der hedder Sufenta Forte), som indeholder det samme aktive stof.
English: It should be given by a healthcare professional experienced in treating pain and in a place (such as a hospital) where the patient can be monitored.
Danish: Det bør gives af en sundhedsperson med erfaring i behandling af smerter og på et sted, hvor patienten kan overvåges (f.eks. på hospitalet).
English: Dzuveo must not be used in patients with serious lung or breathing problems.
Danish: Dzuveo må ikke anvendes hos patienter med alvorlige lunge- eller vejrtrækningsproblemer.
English: For more information about using Dzuveo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Dzuveo se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Dzuveo contains the active substance sufentanil.
Danish: Dzuveo indeholder det aktive stof sufentanil.
English: The European Medicines Agency therefore decided that Dzuveo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dzuveo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Dzuveo authorised in the EU?
Danish: Hvorfor blev Dzuveo godkendt i EU?
English: An overview of Dzuveo and why it is authorised in the EU
Danish: Oversigt over Dzuveo, og hvorfor det er godkendt i EU
English: The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000.
Danish: De alvorligste bivirkninger ved sufentanil er svære vejrtrækningsproblemer, som forekommer hos ca. 6 ud af 1.000 patienter.
English: What is Dzuveo and what is it used for?
Danish: Hvad er Dzuveo, og hvad anvendes det til?
English: Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.
Danish: I begge studier anvendtes en smerteskala (SPID12), der måler smertereduktionen over 12 timer.
English: Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Dzuveo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Dzuveo can only be obtained with a prescription.
Danish: Dzuveo udleveres kun efter recept.
English: Attaching to these receptors in the brain helps relieve the patient's pain.
Danish: Ved at binde sig til disse receptorer medvirker lægemidlet til at lindre patientens smerter.
English: The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.
Danish: Forskellen mellem produkterne er, at Dzuveo fås som sublinguale resoribletter (tabletter, der opløses under tungen), mens referencelægemidlet er en injektionsvæske (opløsning).
English: What are the risks associated with Dzuveo?
Danish: Hvilke risici er der forbundet med Dzuveo?
English: In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.
Danish: I det andet studie med 101 patienter efter fodkirurgi blev smerterne reduceret med ca. 6 point med Dzuveo, mens de tiltog med ca. 7 point med placebo.
English: In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment).
Danish: I det første studie med 163 patienter, som var blevet opereret i maven, blev smerterne reduceret med 26 point med Dzuveo sammenholdt med 13 point med placebo (en uvirksom behandling).
English: The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors.
Danish: Det aktive stof i Dzuveo, sufentanil, er en opioid, der virker ved at binde sig til receptorer (mål) i hjernen, der hedder μ-opioidreceptorer.
English: Dzuveo is available as 30 µg sublingual tablets.
Danish: Dzuveo fås som sublinguale 30 µg-resoribletter.
English: They can be given the tablets as needed but should wait at least one hour after one tablet before having another.
Danish: Resoribletterne kan gives efter behov, men der bør gå mindst én time mellem hver resoriblet.
English: The side effects seen with Dzuveo are those expected with opioids, and are considered manageable.
Danish: Bivirkningerne ved Dzuveo, er dem, som forventes ved brug af opioider, og de anses for at være håndterbare.
English: Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.
Danish: Dzuveo er et stærkt smertestillende lægemiddel (opioid), der anvendes til at behandle moderate til svære smerter hos voksne.
English: For the full list of side effects and restrictions with Dzuveo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Dzuveo fremgår af indlægssedlen.
English: Using a disposable applicator, the healthcare professional should place one tablet under the patient's tongue and leave it to dissolve.
Danish: Ved hjælp af en engangsapplikator placerer sundhedspersonen én resoriblet under patientens tunge, hvor den opløses.
English: Two main studies have shown that Dzuveo left to dissolve under the tongue is effective at reducing severe pain following surgeries.
Danish: To hovedstudier har påvist, at Dzuveo, der opløses under tungen, er effektivt til at mindske svære smerter efter operation.
English: Studies show that Dzuveo is effective at reducing severe pain following surgeries.
Danish: Studier har vist, at Dzuveo er effektivt til at mindske svære smerter efter operation.
English: What benefits of Dzuveo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dzuveo?
English: How is Dzuveo used?
Danish: Hvordan anvendes Dzuveo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dzuveo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Dzuveo.
English: How does Dzuveo work?
Danish: Hvordan virker Dzuveo?
English: The recommended dose is 60 mg once a day.
Danish: Den anbefalede dosis er 60 mg én gang dagligt.
English: Cabometyx received a marketing authorisation valid throughout the EU on 9 September 2016.
Danish: Cabometyx fik en markedsføringstilladelse med gyldighed i hele EU den 9. september 2016.
English: Further information on Cabometyx can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
Danish: Yderligere information om Cabometyx findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
English: Cabometyx is available as tablets (20, 40 and 60 mg).
Danish: Cabometyx fås som tabletter (20, 40 og 60 mg).
English: Patients should not eat for at least two hours before and one hour after taking Cabometyx.
Danish: Patienten må ikke spise i mindst to timer før og en time efter at have fået Cabometyx.
English: As for all medicines, data on the use of Cabometyx are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Cabometyx løbende overvåget.
English: The improvement in survival observed is considered significant considering that these patients have poor outcomes and few treatment options available.
Danish: Den konstaterede forbedring af overlevelsen anses for at være betydelig i betragtning af, at der kun er ringe behandlingseffekt hos disse patienter og kun få behandlingsmuligheder.
English: For more information about using Cabometyx, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Cabometyx, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Cabometyx?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cabometyx?
English: These patients have poor outcomes and a high unmet medical need.
Danish: Hos disse patienter er der ringe behandlingseffekt og et stort udækket medicinsk behov.
English: The European Medicines Agency therefore decided that Cabometyx's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Cabometyx opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The dose may need to be reduced or treatment stopped temporarily if serious or unacceptable side effects occur.
Danish: Dosen kan nedsættes, eller behandlingen stoppes midlertidigt, hvis patienten udvikler alvorlige eller uacceptable bivirkninger.
English: Other information about Cabometyx
Danish: Andre oplysninger om Cabometyx
English: Results also indicated that Cabometyx helped patients to live longer.
Danish: Resultaterne har også vist, at Cabometyx bidrager til, at patienterne lever længere.
English: Side effects reported with Cabometyx are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Cabometyx vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Cabometyx and why it is authorised in the EU
Danish: En oversigt over Cabometyx, og hvorfor det er godkendt i EU
English: It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor'.
Danish: Det anvendes hos patienter, der tidligere er behandlet med en type kræftlægemiddel, som hedder "vaskulær endotelial vækstfaktor (VEGF)hæmmer".
English: Cabometyx can only be obtained with a prescription and treatment should be started by a doctor who has experience of using cancer medicines.
Danish: Cabometyx udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i brug af kræftlægemidler.
English: Why is Cabometyx authorised in the EU?
Danish: Hvorfor er Cabometyx godkendt i EU?
English: It is also used in patients who have not had previous treatment and whose cancer is at moderate or high risk of rapidly getting worse.
Danish: Det anvendes også hos patienter, der ikke tidligere er blevet behandlet, og som har en moderat til høj risiko for, at kræften hurtigt forværres.
English: Treatment is continued for as long as the patient benefits from it or until side effects become unacceptable.
Danish: Behandlingen bør fortsættes, så længe patienten har fordel af den, eller indtil patienten får bivirkninger, som ikke kan tolereres.
English: Cabometyx is a cancer medicine used to treat adults with:
Danish: Cabometyx er et kræftlægemiddel, der anvendes til at behandle voksne patienter med:
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with renal cell carcinoma are high blood pressure, diarrhoea, nausea (feeling sick), loss of appetite, tiredness, dehydration, hyponatraemia and hypomagnesaemia (low blood levels of sodium and magnesium), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles) and embolism (clot in a blood vessel).
Danish: De hyppigste alvorlige bivirkninger (som optræder hos mere end 1 person ud af 100) ved Cabometyx hos patienter med nyrecellekarcinom er højt blodtryk, diarré, kvalme, nedsat appetit, træthed, dehydrering, hyponatriæmi og hypomagnesæmi (lavt indhold af natrium og magnesium i blodet), palmar-plantar erythrodysæstesisyndrom (hånd-fod syndrom med udslæt og følelsesløshed i håndflader og fodsåler) og emboli (blodprop i et blodkar).
English: The side effects of Cabometyx are similar to other tyrosine kinase inhibitors, and they are considered manageable.
Danish: Bivirkningerne ved Cabometyx er de samme som ved andre tyrosinkinasehæmmere, og de vurderes at være håndterbare.
English: The study involved 157 patients, and compared Cabometyx with another cancer medicine, sunitinib.
Danish: Studiet omfattede 157 patienter, og Cabometyx blev sammenlignet med et andet kræftlægemiddel (sunitinib).
English: What is Cabometyx and what is it used for?
Danish: Hvad er Cabometyx, og hvad anvendes det til?
English: A second main study showed that Cabometyx was effective in adults with previously untreated renal cell carcinoma that was locally advanced or had spread elsewhere in the body.
Danish: Et andet hovedstudie viste, at Cabometyx var effektivt hos voksne med tidligere ubehandlet nyrecellekarcinom, som var lokalt fremskredent, eller som havde spredt sig til andre dele af kroppen.
English: In the study, Cabometyx was compared with placebo (a dummy treatment).
Danish: Undersøgelsen sammenlignede Cabometyx med placebo (en uvirksom behandling).
English: By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of the cancer.
Danish: Ved at blokere virkningen af disse enzymer i kræftcellerne medvirker Cabometyx til at begrænse kræftens vækst og spredning.
English: In addition, results indicated that patients treated with Cabometyx lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months).
Danish: Derudover pegede resultaterne på, at patienter, der blev behandlet med Cabometyx, generelt levede længere end patienter, der blev behandlet med everolimus (gennemsnitligt i 21,4 måneder sammenlignet med 16,5 måneder).
English: It is used on its own in patients who have already been treated with the cancer medicine sorafenib.
Danish: Det anvendes alene hos patienter, der tidligere har været behandlet med kræftlægemidlet sorafenib.
English: In the study, Cabometyx was compared with the cancer medicine everolimus.
Danish: Cabometyx blev i studiet sammenlignet med kræftlægemidlet everolimus.
English: What are the risks associated with Cabometyx?
Danish: Hvilke risici er der forbundet med Cabometyx?
English: Cabometyx contains the active substance cabozantinib.
Danish: Cabometyx indeholder det aktive stof cabozantinib.
English: For the full list of side effects and restrictions with Cabometyx, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cabometyx fremgår af indlægssedlen.
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with hepatocellular carcinoma are hepatic encephalopathy (harmful effects on the brain caused by liver damage), palmar-plantar erythrodysaesthesia syndrome, weakness and diarrhoea.
Danish: De hyppigste alvorlige bivirkninger (som optræder hos mere end 1 person ud af 100) ved Cabometyx hos patienter med levercellekarcinom er leverencefalopati (skadelige virkninger på hjernen forårsaget af leverskade), palmar-plantar erythrodysæstesisyndrom, svaghed og diarré.
English: One main study involving 707 adults with hepatocellular carcinoma who had already been treated with sorafenib showed that Cabometyx was effective at prolonging how long patients lived (overall survival).
Danish: Et hovedstudie, der omfattede 707 voksne med levercellekarcinom, som allerede var blevet behandlet med sorafenb, viste, at Cabometyx var effektivt til at forlænge patienternes levetid (samlet overlevelse).
English: One main study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor showed that Cabometyx is effective at prolonging the time patients lived without their disease getting worse (progression-free survival).
Danish: Et hovedstudie, der omfattede 658 voksne med fremskredent nyrecellekarcinom, som var blevet værre trods behandling med en VEGF-hæmmer, viste, at Cabometyx er effektivt til at forlænge den tid, patienterne levede, uden at deres sygdom forværredes (progressionsfri overlevelse).
English: In previously untreated patients with moderate or high risk disease, Cabometyx also provided clinically relevant benefit, delaying the progression of the cancer and the need for other treatments.
Danish: Cabometyx giver også tidligere ubehandlede patienter med moderat eller høj kræftrisiko en klinisk relevant fordel, idet stoffet forsinker kræftsygdommens forløb og behovet for andre behandlinger.
English: The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor'.
Danish: Det aktive stof i Cabometyx, cabozantinib, er en såkaldt tyrosinkinasehæmmer.
English: • hepatocellular carcinoma (a liver cancer).
Danish: • levercellekarcinom (en leverkræft).
English: In hepatocellular carcinoma, Cabometyx was shown to prolong survival in patients who had been treated with sorafenib.
Danish: Ved levercellekarcinom blev Cabometyx påvist at forlænge overlevelsen hos patienter, der var blevet behandlet med sorafenib.
English: Patients treated with Cabometyx lived on average for 10.2 months, compared with 8.0 months in patients who received placebo.
Danish: De patienter, der blev behandlet med Cabometyx, levede i gennemsnit i 10,2 måneder sammenlignet med 8,0 måneder hos de patienter, der fik placebo.
English: These enzymes can be found in certain receptors in cancer cells, where they are involved in activating processes that include cell division and the growth of new blood vessels to supply the cancer.
Danish: Her aktiverer de en række processer, herunder celledeling og vækst af nye blodkar, der forsyner kræftsvulsten.