FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on theoretical considerations DRV/COBI may alter norethindrone plasma concentrations.
Danish: Baseret på teoretiske overvejelser kan DRV/COBI ændre plasmakoncentrationen af norethisteron.
English: 30 tablets
Danish: Tabletkerne
English: Based on theoretical considerations DRV/COBI may increase ergot derivative exposure.
Danish: Baseret på teoretiske overvejelser kan DRV/COBI øge eksponeringen for sekalealkaloider.
English: Based on theoretical considerations DRV/COBI is expected to increase colchicine plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af colchicin.
English: Based on theoretical considerations DRV/COBI is expected to increase metformin plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af metformin.
English: - Fesoterodine, solifenacin (to treat urologic disorders).
Danish: - Fentanyl, oxycodon, tramadol (til smertebehandling) - Fesoterodin, solifenacin (til behandling af sygdomme i urinvejene).
English: - Clonazepam (to prevent seizures).
Danish: - Rifabutin (mod bakterieinfektioner).
English: Based on theoretical considerations DRV/COBI is expected to increase these anti-depressant plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af disse antidepressiva.
English: Based on theoretical considerations these anticonvulsants are expected to decrease darunavir and/or cobicistat and/or tenofovir alafenamide plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes disse antiepileptika at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat og/eller tenofoviralafenamid.
English: Based on theoretical considerations DRV/COBI is expected to increase these PDE-5 inhibitor plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af disse PDE-5-hæmmere.
English: No dose adjustment of Symtuza is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, Symtuza should be used with caution in these patients, as the darunavir and cobicistat components of Symtuza are metabolised by the hepatic system.
Danish: Dog skal Symtuza anvendes med forsigtighed hos sådanne patienter, eftersom indholdsstofferne darunavir og cobicistat i Symtuza metaboliseres i leveren.
English: Based on theoretical considerations DRV/COBI is expected to increase these antiarrhythmic plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af disse antiarytmika.
English: Co-administration of Symtuza and ergot derivatives is contraindicated (see section 4.3).
Danish: Co-administration af perikon og Symtuza er kontraindiceret (se pkt.
English: - lopinavir/ritonavir - St. John's wort (Hypericum perforatum)
Danish: 4.5): - carbamazepin, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - perikon (Hypericum perforatum)
English: - Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Perphenazine, risperidone, thioridazine (psychiatric medicines) - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Danish: - Amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst).
English: Tell your doctor if you take: - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures) - Carvedilol, metoprolol, timolol (for heart disease) - Warfarin (to reduce clotting of the blood) as its therapeutic effect or side effects may be altered;
Danish: Du skal fortælle det til din læge, hvis du tager: - Alfentanil (stærkt smertestillende middel til injektion med kort virkningstid, der anvendes ved operationer).
English: Based on theoretical considerations DRV/COBI is expected to increase lumefantrine plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af lumefantrin.
English: Amiodarone, dronedarone, ivabradine, quinidine, or ranolazine to treat certain heart disorders (e.g. abnormal heart rhythm)
Danish: 4.5): - alfuzosin - amiodaron, dronedaron, ivabradin, kinidin, ranolazin - colchicin ved anvendelse hos patienter med nedsat nyre- eller leverfunktion (se pkt.
English: Therapeutic drug monitoring of the immunosuppressive agent must be done when co-administration with Symtuza occurs.
Danish: Ved co-administration med Symtuza er terapeutisk lægemiddelovervågniong af det immunsupprimerende middel nødvendig.
English: Based on theoretical considerations DRV/COBI is expected to increase these beta-blocker plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af disse betablokkere.
English: Based on theoretical considerations DRV/COBI is expected to increase these calcium channel blocker plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes DRV/COBI at øge plasmakoncentrationen af disse calciumantagonister.
English: The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4.2, 4.3 and 4.4).
Danish: Effekten af svært nedsat leverfunktion på darunavirs farmakokinetik er ikke blevet undersøgt (se pkt.
English: A single dose of
Danish: En enkelt dosis på
English: NovoSeven received a marketing authorisation valid throughout the EU on 23 February 1996.
Danish: NovoSeven fik en markedsføringstilladelse med gyldighed i hele EU den 23. februar 1996.
English: A higher dose may be needed in children.
Danish: Børn kan have behov for en højere dosis.
English: It is used in patients with the following conditions:
Danish: Det anvendes til patienter med følgende lidelser:
English: Other information about NovoSeven
Danish: Andre oplysninger om NovoSeven
English: Further information on NovoSeven can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/novoseven.
Danish: Yderligere information om NovoSeven findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/novoseven.
English: As for all medicines, data on the use of NovoSeven are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af NovoSeven løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of NovoSeven?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NovoSeven?
English: It activates another factor called factor X, which starts the clotting process.
Danish: Det aktiverer en anden faktor kaldet faktor X, som iværksætter størkningsprocessen.
English: An overview of NovoSeven and why it is authorised in the EU
Danish: En oversigt over NovoSeven, og hvorfor det er godkendt i EU
English: Patients or carers may be able to give NovoSeven themselves after suitable training.
Danish: Patienterne eller deres plejere kan selv indgive NovoSeven, når de er blevet behørigt instrueret heri.
English: Why is NovoSeven authorised in the EU?
Danish: Hvorfor blev NovoSeven godkendt i EU?
English: For more information about using NovoSeven, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af NovoSeven, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that NovoSeven's benefits are greater than its risks and it can be authorised in the EU..
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved NovoSeven opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with NovoSeven are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for NovoSeven vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The main measure of effectiveness was the number of bleeding episodes that were controlled effectively.
Danish: Virkningen blev hovedsagelig bedømt på antallet af blødningsepisoder, som effektivt blev kontrolleret.
English: 270 micrograms/kg may be used in adults with a mild or moderate bleeding episode.
Danish: 270 mikrogram/kg kan anvendes til voksne med en mild til moderat blødningsepisode.
English: What is NovoSeven and what is it used for?
Danish: Hvad er NovoSeven, og hvad anvendes det til?
English: • Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).
Danish: • Glanzmanns trombasteni (en sjælden blødningsforstyrrelse), som ikke kan behandles med transfusion af blodplader (komponenter, der hjælper blodet til at størkne).
English: However the following side effects may affect between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), fever and reduced effectiveness of treatment.
Danish: Dog kan følgende bivirkninger optræde hos mellem 1 og 10 ud af 1.000 patienter: venøse tromboemboliske komplikationer (problemer forårsaget af blodpropper i venerne), udslæt, kløe, urticaria (nældefeber), feber og nedsat virkning af behandling.
English: NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.
Danish: NovoSeven kan også anvendes til at erstatte den manglende faktor VII hos patienter med faktor VII-mangel.
English: Eptacog alfa works in the same way as factor VII.
Danish: Eptacog alfa virker på samme måde som faktor VII.
English: By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.
Danish: Ved at aktivere faktor X giver NovoSeven en midlertidig kontrol over blødningsforstyrrelsen.
English: What are the risks associated with NovoSeven?
Danish: Hvilke risici er der forbundet med NovoSeven?
English: NovoSeven is a medicine used to treat and to prevent bleeding after surgical procedures.
Danish: NovoSeven er et lægemiddel, der anvendes til behandling og forebyggelse af blødning efter kirurgiske indgreb.
English: Data on the use of NovoSeven in patients with Glanzmann's thrombasthenia were obtained from a registry of patients treated with the medicine, which showed that treatment with NovoSeven was successful in 79% of the bleeding episodes (262 out of 333) and 88% of the surgeries (140 out of
Danish: Der blev indsamlet data vedrørende brugen af NovoSeven hos patienter med Glanzmanns trombasteni fra et register over patienter behandlet med lægemidlet, som viste, at behandlingen med NovoSeven var vellykket ved 79 % af blødningsepisoderne (262 ud af 333) og 88 % af de kirurgiske indgreb (140 ud af 159).
English: NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.
Danish: NovoSeven må ikke anvendes til personer, som er overfølsomme (allergiske) over for eptacog alfa, muse-, hamster- eller okseproteiner eller andre af indholdsstofferne.
English: The active substance in NovoSeven, eptacog alfa, is almost identical to a human protein called factor VII.
Danish: Det aktive stof i NovoSeven, eptacog alfa, er næsten identisk med et humant protein kaldet faktor VII.
English: In a study involving 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven.
Danish: I et studie, som omfattede 61 hæmofilipatienter med inhibitorer, blev 84 % af de 57 svære blødninger og 59 % af de 38 kirurgiske blødninger effektivt kontrolleret med NovoSeven.
English: In another study in 60 patients with mild to moderate bleeding episodes, which investigated whether NovoSeven could be used in the home setting, 90% of the bleeding episodes were controlled effectively.
Danish: I et andet studie, som omfattede 60 patienter med milde til moderate blødningsepisoder, hvor det blev undersøgt, om NovoSeven kunne anvendes i hjemmet, blev 90 % af blødningsepisoderne effektivt kontrolleret.
English: It is available as a powder and solvent that are made up into a solution to be injected into a vein.
Danish: Det leveres som pulver og solvens, der blandes til en opløsning til indsprøjtning i en vene.
English: In the body, factor VII is involved in blood clotting.
Danish: Faktor VII er i kroppen medvirkende til, at blodet størkner.
English: • congenital factor VII deficiency;
Danish: • medfødt faktor VII-mangel
English: • In factor VII deficiency, the dose is 15 to 30 micrograms/kg every 4 to 6 hours until the bleeding is controlled.
Danish: • Ved faktor VII-mangel gives der en dosis på 15-30 mikrogram/kg hver fjerde til sjette time, indtil blødningen er under kontrol.
English: NovoSeven contains the active substance eptacog alfa.
Danish: NovoSeven indeholder det aktive stof eptacog alfa.
English: • In Glanzmann's thrombasthenia, the dose is 90 micrograms/kg every 2 hours, for at least three doses.
Danish: • Ved Glanzmanns trombasteni gives der en dosis på 90 mikrogram/kg hver anden time, og der gives mindst tre doser.
English: NovoSeven can only be obtained with a prescription and treatment and should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders.
Danish: NovoSeven udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili eller blødningsforstyrrelser.
English: NovoSeven has been studied in patients with haemophilia and in patients with factor VII deficiency.
Danish: NovoSeven er blevet undersøgt hos patienter med hæmofili og patienter med faktor VII-mangel.
English: • congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors' (antibodies) against factor VIII or IX;
Danish: • medfødt hæmofili (en blødningsforstyrrelse, som er til stede allerede fra fødslen), hvor patienten har udviklet eller forventes at udvikle "inhibitorer" (antistoffer) mod faktor VIII eller IX
English: • acquired haemophilia (a bleeding disease caused by the development of inhibitors to factor VIII);
Danish: • erhvervet hæmofili (en blødningssygdom, der skyldes udvikling af inhibitorer mod faktor VIII)
English: Side effects with NovoSeven are not common.
Danish: Almindeligvis forekommer der ikke bivirkninger ved NovoSeven.
English: What benefits of NovoSeven have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved NovoSeven?
English: For the full list of side effects of NovoSeven, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved NovoSeven fremgår af indlægssedlen.
English: • In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every 2 to 3 hours until the bleeding is controlled.
Danish: • Ved hæmofili er dosis 90 mikrogram pr. kilo kropsvægt gentaget hver anden til tredje time, indtil blødningen er under kontrol.
English: How is NovoSeven used?
Danish: Hvordan anvendes NovoSeven?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoSeven 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 NovoSeven.
English: Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX.
Danish: NovoSeven kan anvendes til hæmofilipatienter, som har udviklet inhibitorer mod faktor VIII og IX, fordi faktor VII indvirker direkte på faktor X, uafhængigt af faktor VIII og IX.
English: How does NovoSeven work?
Danish: Hvordan virker NovoSeven?
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen henviser til den sidste dag i den måned.
English: The updated guidelines were established during the Maastricht 22000 Consensus meeting.
Danish: De ajourførte retningslinjer blev fastlagt på konsensusmødet Maastricht 22000.
English: The usual dose is
Danish: Den sædvanlige dosis er
English: Please follow your doctor's recommendations
Danish: Følg din læges anbefalinger.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan skade dem, selvom de fremviser symptomer, der ligner dine.
English: The influence of this combined administration has not yet been investigated systemically.
Danish: Indflydelsen fra denne kombinerede administration er endnu ikke systematisk undersøgt.
English: Effect*
Danish: Virkning*
English: Dosage and duration of combined administration
Danish: Dosering og varighed af kombineret administration
English: This was not seen in monkeys, dogs or mice.
Danish: Dette blev ikke set hos aber, hunde eller mus.
English: This medicine has the best effect when taken into empty stomach.
Danish: Dette lægemiddel virker bedst, når det tages på tom mave.
English: - The other ingredients are:
Danish: - De andre indholdsstoffer er:
English: Absorption and distribution:
Danish: Absorption og fordeling:
English: There is no change in half-life during treatment.
Danish: Der er ingen ændring i halveringstiden under behandling.
English: “Possible side effects”).
Danish: “Mulige bivirkninger”).
English: Benefit/Risk considerations
Danish: Benefit/risk-forholdet
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: SÆRLIGE FORHOLDSREGLER FOR BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALDSMATERIALER AFLEDT FRA SÅDANNE LÆGEMIDLER, HVIS PASSENDE
English: 7, 10, 10x1, 14, 14x1, 20, 28, 28x1, 30, 30x1, 56, 56x1, 60, 98, 98x1, 100 and 100x1 capsules Not all pack sizes may be marketed.
Danish: 7, 10, 10x1, 14, 14x1, 20, 28, 28x1, 30, 30x1, 56, 56x1, 60, 98, 98x1, 100 og 100x1 kapsler Ikke alle pakningsstørrelser bliver muligvis markedsført.
English: After eight days of repeated administration the reduction is about 85%.
Danish: Efter otte dage med gentagen administration er reduktionen omkring 85%.
English: Metabolism and elimination:
Danish: Metabolisme og elimination:
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Du bør kontrollere det med din læge eller apoteket, hvis du ikke er sikker.
English: Individual patients may receive a clinically relevant decrease.
Danish: Individuelle patienter kan få en klinisk relevant nedgang.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ADMINISTRATIONSMÅDE OG RUTE(R) Oral anvendelse.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: ANDRE SÆRLIGE ADVARLER OM NØDVENDIGT
English: The Lansoprazole dose should therefore be taken at least an hour prior or after.
Danish: Dosis af lansoprazol bør derfor tages mindst en time før eller efter.
English: Hepatitis and icterus
Danish: Hepatitis og icterus
English: Driving and using machines
Danish: Kørsel og betjening af maskiner
English: Increased interactions with other medicines are likely.
Danish: Øgede interaktioner med andre lægemidler er sandsynligt.
English: Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients.
Danish: På grund af begrænsede sikkerhedsdata for patienter på vedligeholdelsesbehandling i længere end 1 år, bør regelmæssig gennemgang af behandlingen og en grundig vurdering af risiko og fordel regelmæssigt gennemføres for disse patienter.
English: Interstitial nephritis.
Danish: Interstitiel nephritis.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det til din læge eller på apoteket, hvis du tager eller for nylig har taget nogen andre lægemidler, inklusive lægemidler uden recept.
English: These affect the absorption, availability to the body, the breakdown and the elimination of these medicines.
Danish: Disse påvirker absorptionen, tilgængelighed til kroppen, nedbrydningen og udskillelsen af disse lægemidler.
English: Bioavailability after a single dose of 30 mg and after repeated daily administration is 80-90%.
Danish: Biotilgængelighed efter en enkeltdosis på 30 mg og efter gentagen daglig administration er 80-90%.
English: Consideration should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
Danish: Officielle lokale retningslinjer bør tages i betragtning (f.eks. nationale anbefalinger) med hensyn til bakterieresistens og den passende anvendelse og ordinering af antibakterielle midler.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apoteket om råd, inden du tager nogen medicin.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: For alle oplysninger om dette lægemiddel bedes man kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: About 15-50% of the metabolites are secreted in the urine and the remainder in the faeces.
Danish: Omkring 15-50% af metabolitterne udskilles i urinen og resten i fæces.
English: Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain
Danish: Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spanien
English: Absorption from the duodenum is rapid and plasma peak concentration is achieved within 1.5-2.0 hours.
Danish: Absorption fra duodenum er hurtig, og plasma peak koncentration opnås inden for 1,5-2,0 timer.
English: Visual disturbances.
Danish: Visuelle forstyrrelser.
English: Metronidazole was originally considered as an alternative to amoxicillin but there is now tendency to reserve it for rescue therapy in the case of a first eradication failure.
Danish: Metronidazol blev oprindeligt betragtet som et alternativ til amoxicillin, men der er nu en tendens til, at det forbeholdes redningsbehandling, i tilfælde af at den første eradikationsbehandling slår fejl.
English: These gastro-resistant capsules are available in blister packs containing 14, 28, 56 or 98 capsules.
Danish: Disse gastro-resistente kapsler forefindes i blisterpakninger indeholdende 7, 14, 28, 56 eller 98 kapsler.
English: Gynecomastia and galactorrhoea.
Danish: Gynecomasti og galactorrhoea.
English: Always take Lansoprazol-CT exactly as your doctor has told you.
Danish: Tag altid Lansoprazol-CT nøjagtigt som din læge har givet dig besked på.
English: Since then new data became available that necessitated an update of the original guidelines in order to provide practical management guidelines that would be acceptable across clinical practice, both in primary care and the specialist level.
Danish: Nye oplysninger har siden nødvendiggjort en ajourføring af de oprindelige retningslinjer for at opnå praktiske behandlingsretningslinjer, som kan accepteres i klinisk praksis, både inden for primær pleje og på specialistniveau.
English: Elimination of lansoprazole in the elderly is slightly delayed.
Danish: Elimination af lansoprazol hos ældre er en anelse forsinket.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Danish: Dyreundersøgelser indikerer ikke direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryonal/føtal udviklin, parturition eller postnatal udvikling.