FrancophonIA/ELRC3.0 huggingface dataset:
English: One of the studies also compared Toviaz with tolterodine (another medicine used in overactive bladder syndrome).
Danish: En af undersøgelserne sammenlignede også Toviaz med tolterodin (et andet lægemiddel mod overaktiv blæresyndrom).
English: This helps Toviaz to prevent unwanted urination.
Danish: Derved medvirker Toviaz til at forebygge ufrivillig vandladning.
English: Why has Toviaz been approved?
Danish: Hvorfor blev Toviaz godkendt?
English: Toviaz is a medicine containing the active substance fesoterodine.
Danish: Toviaz er et lægemiddel, der indeholder det aktive stof fesoterodin.
English: For the full list of all side effects reported with Toviaz, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Toviaz fremgår af indlægssedlen.
English: The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors', a group of medicines that may affect the way Toviaz is broken down in the body.
Danish: Dosen af Toviaz skal tilpasses inden, eller ikke gives til patienter, som har problemer med nyrer eller lever, alt efter, om de samtidig får ‘CYP3A4 inhibitorer', en gruppe af lægemidler, som kan påvirke den måde, Toviaz nedbrydes i kroppen på.
English: It is available as prolonged-release 4 mg tablets and 8 mg tablets.
Danish: Det fås som 4 mg- og 8 mgdepottabletter.
English: • myasthenia gravis (a disease of the nerves causing muscle weakness);
Danish: • myasthenia gravis (en nervesygdom, som medfører muskelsvækkelse)
English: Before treatment, patients needed to urinate about 12 times in 24 hours.
Danish: Før behandlingen var antal vandladninger i løbet af 24 timer 12.
English: The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på grundlag af antallet af vandladninger i løbet af en periode på 24-timer efter 12 ugers behandling.
English: What is Toviaz?
Danish: Hvad er Toviaz?
English: • severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding);
Danish: • svær colitis ulcerosa (alvorlig tyktarmsbetændelse, der medfører sårdannelse og blødning)
English: Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other ingredients, to peanut or to soya.
Danish: Toviaz må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for fesoterodin, jordnødder, soja eller andre af indholdsstofferne.
English: • urinary retention (difficulty in passing urine);
Danish: • urinretention (manglende evne til at lade vandet)
English: Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).
Danish: Toviaz gives til voksne med overaktiv blæresyndrom for at behandle sygdommens symptomer: øget vandladningshyppighed og -trang samt urgeinkontinens (pludselig vandladningstrang, der ikke kan tilbageholdes).
English: In the bladder, this causes the muscles that push urine out of the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way the bladder muscles contract as the bladder fills up.
Danish: Dette medfører en forøgelse af blærekapaciteten og ændringer af den måde, hvorpå blæremusklerne trækker sig sammen, når blæren fyldes.
English: What is Toviaz used for?
Danish: Hvad anvendes Toviaz til?
English: What benefit has Toviaz shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Toviaz?
English: How is Toviaz used?
Danish: Hvordan anvendes Toviaz?
English: How has Toviaz been studied?
Danish: Hvordan blev Toviaz undersøgt?
English: Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines.
Danish: • toksisk megacolon (en meget alvorlig komplikation af tyktarmsbetændelse) Toviaz må ikke anvendes til patienter med moderat eller moderat til svær nyre- eller leversygdom samtidig med andre lægemidler, som har en stærkt hæmmende effekt på CYP3A4.
English: How does Toviaz work?
Danish: Hvordan virker Toviaz?
English: • severe hepatic impairment (severe liver disease);
Danish: • svært nedsat leverfunktion (alvorlig leversygdom)
English: The key elements of these educational materials will be the following:
Danish: De vigtigste elementer af disse uddannelsesmaterialer vil være:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
English: • Information on how the KRAS testing should be appropriately conducted
Danish: • Information om, hvordan KRAS-testene udføres korrekt
English: The Marketing Authorisation Holder shall agree the format and content of the above materials with the National Competent Authority of each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal fastlægge ovenstående materialers format og indhold i enighed med den nationale tilsynsmyndighed.
English: • Brief introduction to the Vectibix indication and the purpose of this tool
Danish: • En kort introduktion til indikationen for Vectibix og formålet med dette værktøj
English: • Brief introduction to KRAS and its role in the panitumumab mechanism of action
Danish: • En kort introduktion til KRAS og dens rolle i panitumumabs virkningsmekanisme
English: • Recommendation that Vectibix: o should only be used in patients whose tumours are wild-type KRAS o should not be used as monotherapy or in combination with FOLFIRI in patients whose tumours are mutant KRAS or patients whose tumours have not been tested for KRAS status o is contraindicated in combination with FOLFOX in patients with mutant KRAS tumours or in patients with unknown KRAS tumour status
Danish: • Anbefaling om, at Vectibix: o kun bør bruges til patienter, hvis tumorer er vildtype-KRAS o ikke bør bruges som monoterapi eller i kombination med FOLFIRI til patienter med muterede KRAS-tumorer, eller patienter, hvor tumors KRAS-status ikke er fastlagt o er kontraindiceret i kombination med FOLFOX til patienter med muterede KRAStumorer og til patienter med ukendt KRAS-tumorstatus
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe Vectibix are provided with educational materials informing them of the importance of KRAS ascertainment before treatment with panitumumab.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere Vectibix, får udleveret uddannelsesmaterialer med information om betydningen af fastlæggelse af KRAS-status inden behandling med panitumumab.
English: • Information that in patients with mutant KRAS tumours panitumumab has shown a detrimental effect in combination with FOLFOX and no effect as monotherapy and in combination with FOLFIRI
Danish: • Information om, at panitumumab har udvist skadelig virkning i kombination med FOLFOX og ingen virkning som monoterapi og i kombination med FOLFIRI hos patienter med muterede KRAS-tumorer
English: (in EEA)
Danish: (i EEA)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over lægemidlernes særnavne, lægemiddelformer, styrker, administrationsvej og indehavere af markedsføringstilladelse i medlemsstaterne
English: 1640 Rhode-St-Genèse Belgium
Danish: 1640 Rhode-St-Genèse Belgien
English: Invented name Name
Danish: Særnavn Styrke
English: Solution for sealant Intralesional use
Danish: Intralæsional anvendelse
English: QUIXIL solution for sealant
Danish: QUIXILopløsning til vævsklæber
English: Fibronectin, human: 30 mg Human fibrinogen: 30 mg Arginine hydrochloride 19 mg Acidum tranexamicum 95 mg Glycine 7,9 mg Sodium chloride 7 mg
Danish: Fibronektin, humant: 30 mg Humant fibrinogen: 30 mg Argininhydrochlorid: 19 mg Acidumtranexamicum: 95 mg Glycin: 7,9 mg Natriumchlorid: 7 mg
English: France OMRIX Biopharmaceuticals S.A. Chaussée de Waterloo 200
Danish: Frankrig OMRIX Biopharmaceuticals S.A. Chaussée de Waterloo 200
English: Tranexamic acid 85 mg/ml -105mg /ml 2nd Component (Thrombin) Thrombin 800 IU /ml - 1200 IU /ml Calcium chloride: 5,6 mg/ml - 6,2 mg /ml
Danish: Fibrinogen-Fibronektin: 40 mg/ml-60 mg/ml Tranexam: 85 mg/ml-105 mg/ml 2. komponent (Trombin) Trombin: 800 IE/ml-1200 IE/ml Calciumchlorid: 5,6 mg/ml-6,2 mg/ml
English: OMRIX Biopharmaceuticals S.A. Chaussée de Waterloo 200 1640 Rhode-St-Genèse Belgium
Danish: OMRIX Biopharmaceuticals S.A. Chaussée de Waterloo 200 1640 Rhode-St-Genèse Belgien
English: Denmark Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgium
Danish: Danmark Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgien
English: Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgium
Danish: England Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgien
English: Tranexamic acid: 85 mg/ml -105 mg/ml
Danish: Calciumchlorid: 5,9 mg/ml Tranexamsyre: 95 mg/ml
English: Thrombin: 800 IU/ml -1,200 IU/ml Calcium Chloride: 5.6 mg/ml - 6.2 mg/ml
Danish: Fibrinogen og Fibronektin: 40 mg/ml-60 mg/ml Tranexamsyre: 85 mg/ml-105 mg/ml Trombin: 800 IE/ml-1200 IE/ml Calciumchlorid: 5,6 mg/ml-6,2 mg/ml
English: Clottable protein conc: 50mg/ml Thrombin: 1000 IU/ml Calcium chloride: 5.9 mg/ml Tranexamic acid: 95mg/ml
Danish: Koncentrat af koagulerbart protein: 50 mg/ml Trombin: 1000 IE/ml
English: Adults (including the elderly ≥ 65 years of age)
Danish: Voksne (inklusive ældre ≥ 65 år gamle)
English: In addition, you may also occasionally experience muscular problems.
Danish: Desuden kan De også af og til få muskelproblemer.
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The median exposure time was 43 days.
Danish: Den mediane eksponeringstid var 43 dage.
English: Some patients had more than one cause of pain.
Danish: Nogle patienters smerte havde mere end én årsag.
English: The technical data are given only for information and should not limit health-care providers' choice.
Danish: De tekniske data gives kun til information og bør ikke begrænse sundhedsudbyderens valg.
English: Only five had malignant pain.
Danish: Kun fem havde malign smerte.
English: However, in view of limited data, the development of tolerance cannot be excluded.
Danish: I betragtning af de begrænsede data kan udvikling af tolerans dog ikke udelukkes.
English: One vial per carton.
Danish: Ét hætteglas per karton.
English: Depression of Central Nervous System (CNS)
Danish: Depression af centralnervesystemet (CNS)
English: Specific instructions for using the pumps must be obtained from the manufacturer.
Danish: Specifikke anvisninger vedrørende brug af pumperne skal fremskaffes fra fremstilleren.
English: Subsequently the pump should be emptied and refilled every 60 days.
Danish: Efterfølgende bør pumpen tømmes og genfyldes hver 60. dage.
English: Therefore, pharmacological effects related to systemic exposure should be minimal.
Danish: Derfor bør de farmakologiske virkninger relateret til systemisk eksponering være minimal.
English: The efficacy of IT ziconotide was apparent in all groups.
Danish: Effektiviteten af intratekal ziconotid var tydelig i alle grupper.
English: An external catheter system should only be used when an internal system cannot be implanted.
Danish: Der bør kun anvendes et eksternt katetersystem i situationer, hvor et internt system ikke kan implanteres.
English: Combination studies with IT Morphine
Danish: Kombinationsstudier med IT morfin
English: In case of a need for long term treatment, monitoring may be necessary (as decided by your doctor).
Danish: Hvis langvarig behandling er nødvendig, kan kontrol være nødvendig (besluttes af Deres læge).
English: The biological activity of the various expected proteolytic degradation products has not been assessed.
Danish: Den biologiske aktivitet af de forskellige forventede proteolytiske nedbrydningsprodukter er ikke blevet vurderet.
English: The initial fill must therefore be replaced after 14 days.
Danish: Den første påfyldning skal derfor udskiftes efter 14 dage.
English: It is an N-type calcium channel blocker (NCCB).
Danish: Det er en N-type calciumkanal-blokker (NCCB).
English: Ask your doctor for advice before you drive or operate machinery.
Danish: Spørg Deres læge til råds, inden De fører motorkøretøj eller betjener maskiner.
English: Therefore, caution is needed during long-term treatment.
Danish: Der skal derfor udvises forsigtighed i forbindelse med langtidsbehandling.
English: These may be signs of a severe allergic reaction.
Danish: Disse kan være tegn på en alvorlig overfølsomhedsreaktion.
English: These results do not indicate a significant risk to humans due to the relatively high systemic exposures needed to elicit these effects in rats and rabbits.
Danish: Disse resultater indikerer ikke en signifikant risiko for mennesker på grund af de relativt høje systemiske eksponeringer, der var nødvendige til at frembringe disse virkninger hos rotter og kaniner.
English: The frequency and severity of adverse reactions were also lower.
Danish: Hyppigheden og sværheden af bivirkninger var ligeledes lavere.
English: In clinical trials, 88% of patients experienced adverse reactions.
Danish: I kliniske forsøg oplevede 88 % af patienterne bivirkninger.
English: At the start of your treatment your doctor may increase your dose every 1 to 2 days or more.
Danish: I starten af behandlingen kan Deres læge øge dosis hver dag, hver anden dag eller oftere.
English: CL = clearance; Vd = distribution volume; t½ = half life
Danish: CL = clearance; Vd = distributionsvolumen; t½ = halveringstid
English: However, maximal effects may be delayed for approximately 24 hours in some patients.
Danish: Dog kan de maksimale virkninger hos nogle patienter være forsinket i cirka 24 timer.
English: The safety and efficacy of ziconotide in children aged 0 to 18 years have not been established.
Danish: Ziconotids sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: The primary endpoint was the percent change in VASPI score.
Danish: Det primære endepunkt var den procentmæssige ændring i VAS-score.
English: - You may have an increased level of an enzyme called creatine kinase in your blood and although this does not usually cause any symptoms or problems, your doctor is likely to monitor its level.
Danish: - De kan have et forhøjet niveau af et enzym kaldet kreatinkinase i blodet, og selvom dette normalt ikke forårsager nogen symptomer eller problemer, er det sandsynligt, at Deres læge vil overvåge niveauet af dette.
English: This is because almost all of the filtered active substance is rapidly endocytosed and ultimately transported back to the systemic circulation.
Danish: Dette skyldes, at næsten alt det filtrerede aktive stof hurtigt gennemgår endocytose og ultimativt transporteres tilbage til det systemiske kredsløb.
English: It is unknown whether ziconotide/metabolites are excreted in human milk.
Danish: Det er ukendt, om ziconotid/metabolitter udskilles i human mælk.
English: The duration of treatment has ranged from one-hour bolus infusion to continuous use for more than 6 years.
Danish: Varigheden af behandlingen har ligget i området fra én times bolusinfusion til kontinuerlig brug i mere end 6 år.
English: Prialt may also cause or worsen depression in people that are already susceptible.
Danish: Prialt kan også forårsage eller forværre depression hos allerede disponerede personer.
English: t½ (hr)
Danish: t½ (t)
English: However, the potential for severe allergic reactions cannot be excluded and spontaneous reports of anaphylactic reactions have been received.
Danish: Dog kan muligheden for alvorlige allergiske reaktioner ikke udelukkes, og der er modtaget spontane rapporter om anafylaktiske reaktioner.
English: These studies suggest that these alternative methods of administration of ziconotide may be possible however, due to the limited numbers of patients, these results are inconclusive and there is currently insufficient evidence available to make definitive recommendations for such alternative dosing regimens.
Danish: Disse studier tyder på, at disse alternative administrationsmetoder af ziconotid kan være en mulighed, men grundet det begrænsede antal patienter er disse resultater imidlertid inkonklusive, og der er aktuelt ikke tilstrækkelige beviser tilgængelige til at give afgørende anbefalinger for sådanne alternative doseringsregimer.
English: All patients in the 301 study had failed IT therapy with combinations of analgesics and their physicians considered that 97% of the patients were refractory to currently available treatments.
Danish: Hos alle patienter i studie 301 havde IT behandling med kombinationsanalgetika slået fejl, og deres læger vurderede, at 97 % af patienterne var refraktære over for aktuelt tilgængelige behandlinger.
English: Ziconotide was not teratogenic in rats and rabbits at exposures < 100 times human plasma levels.
Danish: Ziconotid var ikke teratogen hos rotter og kaniner ved eksponeringer < 100 gange de humane plasma niveauer.
English: Children and adolescents Prialt is not recommended for use in children and adolescents.
Danish: Børn og unge Prialt bør ikke anvendes til børn og unge.
English: b164 patients provided VASPI scores for ziconotide at the end of titration.
Danish: b164 patienter afgav VAS-score for ziconotid ved slutningen af titreringen.
English: No accumulation of ziconotide in plasma following long-term IT administration (up to 9 months) has been observed.
Danish: Der er ikke observeret akkumulation af ziconotid i plasma efter længevarende IT administration (op til 9 måneder).
English: The efficacy of IT ziconotide in study 301 was lower than in the previous two, short-term studies.
Danish: Effekten af intratekal ziconotid var i studie 301 mindre end i de forrige to kortvarige studier.
English: Initial treatment assignment
Danish: Initial tilskrivning af behandling
English: There are no or limited amount of data from the use of ziconotide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ziconotid til gravide kvinder.
English: Changes in neurological signalling have not been studied in experimental animals.
Danish: Ændringer i neurologisk signalering er ikke blevet undersøgt hos forsøgsdyr.
English: Although only limited data are available, there is no obvious effect of race, height, weight, gender or age on CSF ziconotide exposure after IT administration.
Danish: Selv om der kun er begrænsede data tilgængelige, er der ingen udtalt virkning af race, højde, vægt, køn eller alder på CSF ziconotid eksponering efter IT administration.
English: Other special populations
Danish: Andre specielle populationer:
English: The minimal interval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more.
Danish: Det minimale interval mellem dosisforøgelserne er 24 timer; det anbefalede interval er af sikkerhedsgrunde 48 timer eller mere.
English: You must tell your doctor immediately if you experience any of the above symptoms.
Danish: De skal omgående kontakte Deres læge, hvis De oplever et eller flere af ovenstående symptomer.
English: The patient usually remains conscious and breathing is not depressed.
Danish: Patienten forbliver sædvanligvis ved bevidsthed, og åndedrættet bliver ikke nedsat.
English: From a microbiological point of view, if the product is diluted it should be transferred to the infusion pump immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet, hvis det er fortyndet, omgående overføres til infusionspumpen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2005
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21. februar 2005 Dato for seneste fornyelse: 18. september 2014
English: Your doctor will discuss with you the kind of pump that will be most suitable for you and when you need to have your pump refilled.
Danish: Deres læge vil tale med Dem om, hvilken slags pumpe der vil være bedst egnet til Dem, og hvornår pumpen skal fyldes op.
English: In turn, this inhibits their release of neurotransmitters (including Substance P) and therefore, the spinal signalling of pain.
Danish: Dette resulterer i hæmning af deres frigørelse af neurotransmitterne (inklusive substans P) og herigennem det spinale smertesignal.
English: Dose at end of titration (μg/hr)
Danish: Dosis ved slutningen af titreringen (μg/t)
English: The re-introduction of ziconotide is not recommended in these patients.
Danish: Genoptagelse af ziconotidbehandling anbefales ikke til disse patienter.
English: The generated free amino acids are expected to be taken up by cellular carrier systems and either subjected to normal intermediary metabolism or used as substrates for constitutive biosynthetic processes.
Danish: De genererede frie aminosyrer forventes at blive optaget af cellulære transportsystemer og enten udsat for normal intermediær metabolisme eller anvendt som substrater til konstitutive biosyntetiske processer.
English: Only a small number of patients have received systemic chemotherapy and IT ziconotide.
Danish: Kun et lille antal patienter har fået systemisk kemoterapi og IT ziconotid.
English: The patient and health-care providers must be familiar with the handling of the external or internal infusion system and be aware of the need to guard against infection.
Danish: Patienten og sundhedspersonalet skal være fortrolige med håndtering af det eksterne eller interne infusionssystem og skal være opmærksomme på nødvendigheden af at undgå infektion.
English: SD - Standard Deviation.
Danish: SD -Standard Deviation (Standardafvigelse).
English: There was no indication of respiratory depression.
Danish: Der var ingen indikation på nedsat åndedrætsfunktion.
English: Because of this, after the first use of Prialt, the reservoir should be emptied and refilled after 14 days.
Danish: På grund af dette bør reservoiret, efter den første brug af Prialt, tømmes og genfyldes efter 14 dage.
English: Efficacy results from study 96-002
Danish: Effektresultater fra studie 96-002
English: • Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).
Danish: • Selvmordstanker eller selvmordsforsøg (kan forekomme hos op til 1 ud af 100 personer).
English: Ziconotide does not interact with opiate receptors.
Danish: Ziconotid interagerer ikke med opiat-receptorer.
English: Many responsive patients obtain near-maximal analgesia within a few hours of delivery of an appropriate dose.
Danish: Mange responderende patienter opnår tæt ved maksimal analgesi inden for nogle få timer efter indgift af en passende dosis.
English: If this happens, consult your doctor or hospital immediately.
Danish: Hvis dette sker, skal De omgående kontakte Deres læge eller hospital.
English: Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000)
English: Your doctor will adjust the dose of Prialt according to the severity of your pain by adding no more than 2.4 micrograms/day.
Danish: Deres læge vil, alt efter sværheden af Deres smerte, justere dosen af Prialt ved at tilføje ikke over 2,4 mikrogram/dag.
English: The use of lower doses through continuous administration was demonstrated to achieve efficacy with fewer adverse reactions.
Danish: Anvendelsen af lavere doser via kontinuerlig administration viste, at der blev opnået en virkning med færre bivirkninger.