FrancophonIA/ELRC3.0 huggingface dataset:
English: For CAPS and Still's disease, the dose depends on body weight and for CAPS, on the severity of the condition.
Danish: Til CAPS og Stills sygdom afhænger dosis af legemsvægten, og til CAPS af sygdommens sværhedsgrad.
English: Patients either received Kineret or another type of medicine, called a DMARD.
Danish: Patienterne fik enten Kineret eller medicin af DMARD-typen.
English: For the full list of side effects of Kineret, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger af Kineret fremgår af indlægssedlen.
English: A second study in 24 children showed similar results: 67 % had at least a 30% reduction in symptoms after one month compared with 8 % given placebo.
Danish: Tilsvarende resultater fandtes i en anden undersøgelse hos 24 børn: 67 % fik reduceret symptomerne med mindst 30 % efter en måned, sammenholdt med 8 % af dem, der fik placebo.
English: In the first study, 11 of 15 children with Still's disease (73 %) had at least a 30% reduction in symptoms after three months treatment with Kineret.
Danish: I den første undersøgelse havde 11 ud af 15 børn med Stills sygdom (73 %) fået reduceret symptomerne med mindst 30 % efter tre måneders behandling med Kineret.
English: In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
Danish: I den undersøgelse, hvor der blev anvendt en fast dosis af Kineret, oplevede 38 % af de patienter, der fik Kineret som tillægsbehandling, en reduktion af symptomerne på mindst 20 % efter seks måneder sammenlignet med 22 % af dem, der fik placebo som tillægsbehandling.
English: By attaching to the receptors that interleukin 1 would normally attach itself to, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
Danish: Anakinra blokerer aktiviteten af interleukin-1 ved at binde sig til de receptorer, som interleukin-1 normalt ville binde sig til, og medvirker dermed til at mindske disse sygdomssymptomer.
English: • Still's disease, a disease causing inflammation of joints as well as rash and fever.
Danish: • Stills sygdom, en sygdom, der forårsager ledbetændelse, udslæt og feber
English: Kineret must not be used in people who are hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Danish: Kineret må ikke anvendes hos patienter, der er overfølsomme over for anakinra eller andre af indholdsstofferne eller proteiner, der produceres af bakterien Escherichia coli.
English: What benefits of Kineret have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kineret?
English: Kineret must not be started in patients who have neutropenia (low levels neutrophils, a type of blood cell that fights infection).
Danish: Der må ikke påbegyndes behandling med Kineret hos patienter med lavt antal blodceller af typen neutrofile, som bekæmper infektioner (neutropeni).
English: The first study included 468 patients, some of whom had taken other medicines for their disease in the past, and who were given either Kineret on its own or placebo.
Danish: Den første undersøgelse omfattede 468 patienter, hvoraf nogle tidligere havde været behandlet med andre lægemidler for deres sygdom.
English: However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
Danish: Resultaterne blev imidlertid anset for utilstrækkelige til at underbygge anvendelsen af lægemidlet som eneste behandling, hvilket skyldes undersøgelsens udformning.
English: Kineret is available as a solution for injection under the skin.
Danish: Kineret fås som injektionsvæske, opløsning, til indsprøjtning under huden.
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Danish: • kryopyrinassocierede periodiske syndromer (CAPS) CAPS er en gruppe af sygdomme, hvor patienterne har en fejl i det gen, der danner proteinet kryopyrin.
English: This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage, and is also involved in the inflammation associated with CAPS and Still's disease.
Danish: Dette signalstof dannes i store mængder hos patienter med leddegigt og forårsager ledbetændelse og ledskader foruden at medvirke til den betændelse, der er knyttet til CAPS og Stills sygdom.
English: • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults.
Danish: • tegn og symptomer på leddegigt (rheumatoid arthritis) hos voksne.
English: How does Kineret work?
Danish: Hvordan virker Kineret?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kineret 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 Kineret.
English: For CAPS and Still's disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg. Kineret contains the active substance anakinra.
Danish: Til CAPS og Stills sygdom anvendes Kineret hos patienter fra 8 måneder med vægt mindst 10 kg.
English: adult patients who also received corticosteroids for their disease.
Danish: Den tredje undersøgelse blev foretaget hos 22 voksne patienter, som desuden fik binyrebarkhormoner mod sygdommen.
English: • if you have other heart problems;
Danish: • hvis du har andre hjerteproblemer;
English: Date of first authorisation: 08 April 2016
Danish: Dato for første markedsføringstilladelse: 8. april 2016
English: Volume of distribution c, d,
Danish: Fordelingsvolumen c, d,
English: 0.075 mg) versus intravenous ondansetron.
Danish: 0,075 mg) versus intravenøst ondansetron.
English: Clearance c, L/h/kg
Danish: Clearance c, l/t/kg
English: Intent-to-treat cohort.
Danish: Intent-to-treat-kohorte.
English: Ten percent of patients have a mean terminal elimination halflife greater than 100 hours.
Danish: Ti procent af patienterne har en middel terminal eliminationshalveringstid, der er længere end 100 timer.
English: N=3 N=5 N=7 N=10 N=6 N=5
Danish: N=5 N=7 N=10 N=6 N=5
English: Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/kg.
Danish: Palonosetron i den anbefalede dosering fordeles i vid udstrækning i kroppen med et fordelingsvolumen på ca. 6,9 til 7,9 l/kg.
English: • if you have an imbalance of certain minerals in your blood such as potassium and magnesium which has not been treated.
Danish: • hvis visse mineraler i dit blod, såsom kalium eller magnesium, er i ubalance, og det ikke er behandlet.
English: Paediatric population No case of overdose has been reported in paediatric clinical studies.
Danish: Pædiatrisk population Der er ikke indberettet tilfælde af overdosering i pædiatriske kliniske studier.
English: When the dose was increased from 10 μg/kg to 20 μg/kg a dose-proportional increase in mean AUC was observed.
Danish: Når dosis blev øget fra 10 μg/kg til 20 μg/kg, blev der observeret en dosisproportional forhøjelse i gennemsnitlig AUC.
English: Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3 -antagonist administration.
Danish: Hypokaliæmi og hypomagnesiæmi skal korrigeres før administration af en 5HT3-antagonist.
English: • At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Manufacturer Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Danish: Fremstiller Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Storbritannien
English: • high or low blood pressure
Danish: • for højt eller for lavt blodtryk
English: • high levels of sugar in the blood or sugar in the urine
Danish: • høje niveauer af sukker i blodet eller urinen
English: • change in the colour of the vein and/or veins becoming larger
Danish: • ændring i blodårens farve, og/eller blodårerne bliver større
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Danish: Den antiemetiske virkning blev iagttaget over 0-24 timer, 24-120 timer og 0120 timer.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since Palonosetron Hospira is intended for single application in humans, these findings are not considered relevant for clinical use.
Danish: De tilgrundliggende mekanismer er ikke helt forstået, men på grund af de høje anvendte doser og da Palonosetron Hospira er beregnet til enkelt dosering hos mennesker, betragtes disse fund ikke som værende relevante i forhold til klinisk anvendelse.
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Danish: Fertilitet Der foreligger ingen data vedrørende effekten af palonosetron på fertiliteten.
English: Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 μg/kg.
Danish: Den mediane halveringstid var 29,5 timer i de samlede aldersgrupper, og i intervallet fra ca. 20 til 30 timer over alle aldersgrupper efter administration af 20 μg/kg.
English: Palonosetron Hospira should be injected over 30 seconds.
Danish: Palonosetron Hospira skal injiceres over 30 sekunder.
English: Complete Response (No Emesis and No Rescue Medication)
Danish: Fuld respons (ingen kvalme eller opkastning og ingen behovsmedicin)
English: • pain at the site of infusion
Danish: • smerter på infusionsstedet
English: • high levels of the pigment bilirubin in the blood
Danish: • høje niveauer af pigmentet bilirubin i blodet
English: As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Danish: Da der ikke findes data vedrørende udskillelse af palonosetron i mælk, bør amning ophøre under behandlingen.
English: In the unlikely event of overdose with Palonosetron Hospira, this should be managed with supportive care.
Danish: I det usandsynlige tilfælde, at der skulle ske en overdosering med Palonosetron Hospira, skal dette håndteres med understøttende behandling.
English: These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Danish: De blev klassificeret som almindelige (≥1/100 til <1/10) eller ikke almindelige (≥1/1.000 til <1/100).
English: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italy
Danish: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italien
English: The safety and efficacy of palonosetron in children aged less than 1 month have not been established.
Danish: Palonosetrons sikkerhed og virkning hos børn i alderen under 1 måned er ikke klarlagt.
English: • low levels of calcium in the blood
Danish: • lave niveauer af calcium i blodet
English: If you are pregnant or think you might be, your doctor will not administer Palonosetron Hospira to you unless it is clearly necessary.
Danish: Hvis du er gravid, eller har mistanke om, at du er gravid, vil din læge ikke behandle dig med Palonosetron Hospira, medmindre det er strengt nødvendigt.
English: There are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age.
Danish: Der foreligger begrænsede data om anvendelse af palonosetron til forebyggelse af kvalme og opkastning hos børn under 2 år.
English: Adults Cancer Patients
Danish: Voksne cancerpatienter
English: It is not known whether Palonosetron Hospira will cause any harmful effects when used during pregnancy.
Danish: Det er ukendt, om Palonosetron Hospira kan medføre skadelige virkninger, hvis det anvendes under graviditet.
English: • abnormal heart rate or lack of blood flow to the heart
Danish: • unormal hjerterytme eller mangel på blodtilførsel til hjertet
English: • jerky body movements
Danish: • rykvise kropsbevægelser
English: • if you have acute bowel obstruction or a history of repeated constipation;
Danish: • hvis du har akut forstoppelse eller en sygehistorie med gentagne tilfælde med forstoppelse;
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 μg/kg or 3 μg/kg (88% vs 84%).
Danish: Andelen af patienter uden emesis 0-72 timer efter operation var den samme efter palonosetron 1 μg/kg og 3 μg/kg (88 % versus 84 %)..
English: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium
Danish: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgien
English: A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy.
Danish: En læge eller en sygeplejerske vil normalt indsprøjte Palonosetron Hospira ca. 30 minutter før starten af kemoterapi.
English: Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists.
Danish: Palonosetron Hospira hører til en gruppe lægemidler, der kaldes serotonin (5HT3)-antagonister.
English: In clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Danish: I kliniske studier blev følgende bivirkninger observeret som mulige eller sandsynlige i forbindelse med palonosetron.
English: Given the pre-specified noninferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Danish: Med den præspecificerede noninferioritetsmargin på -10 % var det stratumjusterede Mantel-Haenszel statistiske noninferioritetskonfidensinterval for forskellen i det primære endepunkt, fuldstændigt respons (CR), [-10,5; 1,7 %], og derfor blev noninferioritet ikke påvist.
English: Following single dose intravenous infusion of Palonosetron 20 μg/kg, peak plasma concentrations (CT) reported at the end of the 15 minute infusion were highly variable in all age groups and tended to be lower in patients < 6 years than in older paediatric patients.
Danish: Efter en enkelt intravenøs infusion med palonosetron 20 μg/kg var de rapporterede, maksimale plasmakoncentrationer (CT) ved slutningen af den 15-minutters infusion meget variable for alle aldersgrupper, og de havde en tendens til at være lavere hos patienter < 6 år end hos ældre pædiatriske patienter.
English: Palonosetron Hospira will be given as a slow infusion into a vein.
Danish: Palonosetron Hospira vil blive givet som en langsom infusion i en vene.
English: • if you are using Palonosetron Hospira in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin,
Danish: • hvis du bruger Palonosetron Hospira sammen med andre lægemidler, som kan medføre en abnorm hjerterytme såsom amiodaron, nicardipin, quinidin, moxifloxacin, erythromycin,
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA05
Danish: Farmakoterapeutisk klassifikation: Antiemetika og midler mod kvalme, serotonin-(5HT3)-antagonister, ATC-kode: A04AA05
English: These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting.
Danish: Disse lægemidler kan blokere virkningen af det kemiske stof serotonin, der fremkalder kvalme og opkastning.
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Danish: En nedre grænse større end - 15 % viser ikke dårligere kvalitet mellem palonosetron og kontrollen.
English: CYP2D6 inducers and inhibitors.
Danish: CYP2D6-induktorer og -hæmmere
English: The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation.
Danish: Studiet viste ingen virkning på varigheden af QT/QTc-intervallet eller noget andet ekg-interval ved doser på op til 2,25 mg. Der blev ikke fundet nogen kliniske signifkant ændring af hjerterytmen, den atrioventrikulære overledning og repolariseringen af hjertet.
English: In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
Danish: I et klinisk studie blev der ikke påvist nogen farmakokinetisk interaktion mellem en enkelt intravenøs dosis palonosetron og steady state koncentration af oral metoclopramid, som er en CYP2D6-hæmmer.
English: Noninferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Danish: Noninferioritetskriterierne var opfyldt, hvis den nedre grænse af 97,5 % konfidensintervallet for forskel i hyppigheden af fuldstændigt respons for intravenøst palonosetron minus intravenøst ondansetron var over -15 %.
English: In the palonosetron 10 μg/kg, 20 μg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Danish: I grupperne med palonosetron 10 μg/kg, 20 μg/kg og ondansetron var andelen af patienter med CR0-24t henholdsvis 54,2 %, 59,4 % og 58,6 %.
English: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy
Danish: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italien
English: It is not known if Palonosetron Hospira is found in breast milk.
Danish: Det er ukendt, om Palonosetron Hospira udskilles i mælk.
English: • if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for palonosetron eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives), burning or pain at the site of injection.
Danish: Tegn herpå kan være hævelse af læberne, ansigtet, tungen eller halsen, vejrtrækningsbesvær eller kollaps; du kan måske også få et kløende, ujævnt udslæt (nældefeber), en brændende fornemmelse eller smerte på injektionsstedet.
English: If affected, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel eller træt, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Danish: Ca. 40 % elimineres gennem nyrerne, og ca. 50 % metaboliseres, således at der dannes to primære metabolitter, som har mindre end 1% af palonosetrons 5HT3-receptor antagonistvirkning.
English: 0 - 24 hours 24 - 120 hours 0 - 120 hours Complete Control (Complete Response and No More Than Mild Nausea)
Danish: 0 - 24 timer 24 - 120 timer 0 - 120 timer Fuld kontrol (fuld respons og ikke mere end let kvalme)
English: Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively.
Danish: Virkningen af palonosetron 10 μg/kg sammenlignet med palonosetron 3 μg/kg var henholdsvis 54,1 % og 37,1 %.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. at det i det væsentlige er natriumfrit.
English: Pyrexia, infusion site pain, infusion site reaction, pain
Danish: Pyreksi, smerter på infusionsstedet, reaktion på infusionsstedet, smerter
English: Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Danish: Virkning var baseret på påvisning af noninferioritet af intravenøst palonosetron sammenlignet med intravenøst ondansetron.
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 μg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 μg/kg palonosetron doses via intravenous bolus.
Danish: Tabel 4: Farmakokinetiske parametre hos pædiatriske cancerpatienter efter intravenøs infusion af palonosetron 20 μg /kg i løbet af 15 min og hos voksne cancerpatienter, der fik 3 eller 10 μg/kg palonosetron-doser via intravenøs bolus.
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %).
Danish: I kliniske studier hos voksne med en dosering på 250 mikrogram (totalt 633 patienter) var de hyppigst observerede bivirkninger, der i det mindste muligvis var relaterede til Palonosetron Hospira, hovedpine (9 %) og obstipation (5 %).
English: Palonosetron Hospira is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
Danish: Palonosetron Hospira anvendes til forebyggelse af kvalme og opkastning i forbindelse med kemoterapi mod kræft hos voksne, unge og børn, som er over en måned gamle.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Danish: Kliniske farmakokinetiske parametre er imidlertid ikke signifikant forskellige ved sammenligning mellem stoffer, der er dårlige og gode til at metabolisere CYP2D6-substrater.
English: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, The Netherlands
Danish: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, Holland
English: • SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Danish: • SNRI'er (serotonin-noradrenalingenoptagshæmmere), der anvendes til at behandle depression og/eller angst, herunder venlafaxin, duloxetin.
English: Talk to your doctor or pharmacist before you are given Palonosetron Hospira:
Danish: Kontakt lægen eller apotekspersonalet, før du får Palonosetron Hospira:
English: Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3-90 μg/kg in healthy subjects and in cancer patients.
Danish: Middel maksimal plasmakoncentration (Cmax) og arealet under koncentrations-tids kurven (AUC0-∞) er overvejende dosis-proportional i dosisområdet fra 0,3-90 μg/kg hos raske studiepersoner og hos cancerpatienter.
English: Important information about some of the ingredients of Palonosetron Hospira This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Palonosetron Hospira Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. at det i det væsentlige er natriumfrit.
English: ° From post-marketing experience * Includes the following: burning, induration, discomfort and pain
Danish: * Omfatter følgende: brænden, induration, ubehag og smerter.