FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with baseline HbA1c ≥7% or who were taking antidiabetic medicinal products prior to randomisation tended to have higher mean changes in fasting plasma glucose and HbA1c relative to other patients.
Danish: Der var en tendens til, at patienter med baseline-HbA1c ≥7%, eller som tog antidiabetika før randomiseringen, havde højere gennemsnitsforandringer i deres fastende plasmaglucose og HbA1c i forhold til andre patienter.
English: In Cushing's disease patients, pasireotide demonstrates linear and time-independent pharmacokinetics in the dose range of 0.3 mg to 1.2 mg twice a day.
Danish: Hos patienter med Cushings sygdom udviser pasireotid lineær og tidsafhængig farmakokinetik inden for doseringsområdet 0,3 mg til 1,2 mg to gange dagligt.
English: Type 2 diabetes mellitus, glucose tolerance impaired, decreased appetite
Danish: Type 2-diabetes mellitus, nedsat glucosetolerance, nedsat appetit
English: As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than GH and/or IGF-1 in patients with acromegaly and ACTH/cortisol in patients with Cushing's disease cannot be ruled out.
Danish: Da pasireotids farmakologiske aktivitet ligner somatostatins, kan hæmning af andre hypofysehormoner end GH og/eller IGF-1 hos patienter med akromegali og ACTH/kortisol hos patienter med Cushings sygdom ikke udelukkes.
English: Lanreotide
Danish: Lanreotid
English: Management of suspected adverse reactions or over-response to treatment (cortisol levels < lower limit of normal) may require dose reduction, interruption or discontinuation of Signifor.
Danish: Håndtering af formodede bivirkninger eller over-respons på behandlingen (kortisolniveauer < nedre normalgrænse) kan kræve reduktion af dosis, afbrydelse eller seponering af Signifor.
English: Dose reductions or discontinuation of treatment with pasireotide due to hyperglycaemia were infrequent in clinical studies with pasireotide.
Danish: Dosisreduktion eller seponering af pasireotid på grund af hyperglykæmi forekom sjældent i kliniske studier med pasireotid.
English: PK exposures had a slight correlation with body weight in the study with medical treatment naïve patients, but not in the study with inadequately controlled patients.
Danish: PK-eksponeringer viste en svag korrelation med kropsvægt i studiet med behandlingsnaive patienter, men ikke i studiet med patienter, der var utilstrækkeligt kontrollerede.
English: Common (may affect up to 1 in 10 people) - Low cortisol levels.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Lave kortisolniveauer.
English: In the studied age range 18-73 years, the area under the curve at steady state for one dosing interval of 12 hours (AUCss) is predicted to range from 86% to 111% of that of the typical patient of 41 years.
Danish: Der er set nedsat samlet kropsclearance og øgede farmakokinetiske eksponeringer med stigende alder. I den undersøgte aldersgruppe på 18-73 år forudsiges arealet under kurven ved steady state for ét doseringsinterval på 12 timer (AUCss) at variere fra 86% til 111% i forhold til den typiske værdi for en patient på 41 år.
English: The elevations were mostly asymptomatic, of low grade and reversible with continued treatment.
Danish: Forhøjelserne var som regel asymptomatiske, svage og reversible ved fortsat behandling.
English: The primary efficacy endpoint was met; the percentage of patients achieving biochemical control was 31.3% and 19.2% for pasireotide intramuscular use and octreotide intramuscular use, respectively, demonstrating a statistically significant superior result favouring pasireotide intramuscular use (p-value = 0.007) (Table 4).
Danish: Det primære virkningsendepunkt blev nået; procentdelen af patienter, der opnåede biokemisk kontrol, var henholdsvis 31,3 % og 19,2 % for pasireotid til intramuskulær anvendelse og octreotid til intramuskulær anvendelse, hvilket viste et statistisk signifikant overlegent resultat til fordel for pasireotid til intramuskulær anvendelse (p = 0,007) (tabel 4).
English: Decreases in systolic and diastolic blood pressure and in body weight were observed in both dose groups at month 7.
Danish: Fald i systolisk og diastolisk blodtryk og fald i legemsvægt blev observeret i begge doseringsgrupper ved måned 7.
English: Furthermore, a higher proportion of patients on pasireotide intramuscular use (18.5% and 10.8% for 40 mg and 60 mg, respectively) than active comparator (1.5%) achieved a reduction in tumour volume of at least 25%.
Danish: Endvidere opnåede en højere andel af patienterne på pasireotid til intramuskulær anvendelse (18,5 % og 10,8 % for henholdsvis 40 mg og 60 mg) end på aktiv komparator (1,5 %) et fald i tumorvolumen på mindst 25 %.
English: The proportion of patients with a reduction of tumour volume greater than 20% at month 12 was 80.8% for pasireotide intramuscular use and 77.4% for octreotide intramuscular use.
Danish: Andelen af patienter med en reduktion i tumorvolumen på mere end 20 % ved måned 12 var 80,8 % for pasireotid til intramuskulær anvendelse og 77,4 % for octreotid til intramuskulær anvendelse.
English: The phase III clinical studies in acromegaly patients did not identify any clinically meaningful differences in the QT prolongation events between pasireotide intramuscular use and the somatostatin analogues which were tested as active comparator.
Danish: de kliniske fase III-studier hos akromegalipatienter blev der ikke identificeret klinisk signifikante forskelle med hensyn til forlænget QT-interval mellem pasireotid til intramuskulær anvendelse og de somatostatinanaloger, der blev anvendt som aktiv komparator.
English: ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature.
Danish: OBS: Det er yderst vigtigt først at starte rekonstitutionsproceduren, når injektionskittet har opnået stuetemperatur.
English: Keeping your thumbs together above and below the neck, break off the top of the ampoule at the breaking point.
Danish: Hold tommelfingrene sammen over og under knækpunktet og knæk toppen af ampullen.
English: GH<2.5 μg/l * Primary endpoint (patients with IGF-1< lower limit of normal (LLN) were not considered “responders”).
Danish: GH<2,5 μg/l * Primært endepunkt (patienter med IGF-1< nedre normalgrænse (LLN) blev ikke betragtet som “respondenter”).
English: The study enrolled 162 patients with a baseline UFC >1.5 x ULN who were randomised in a 1:1 ratio to receive a subcutaneous dose of either 0.6 mg or 0.9 mg Signifor twice daily.
Danish: Til studiet rekrutteredes 162 patienter med UFC >1,5 x ULN ved baseline, som blev randomiseret i forholdet 1:1 til en subkutan dosis på enten 0,6 mg eller 0,9 mg Signifor to gange dagligt.
English: Prepare the injection site with an alcohol wipe.
Danish: Klargør injektionsstedet med en spritserviet.
English: The reactions were most frequently reported as local pain, erythema, haematoma, haemorrhage and pruritus.
Danish: Reaktionerne har hyppigst været lokale smerter, erytem, hæmatom, blødning og pruritus.
English: Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Danish: Bivirkninger af grad 3 og 4 var i de fleste tilfælde relateret til hyperglykæmi.
English: Patients were randomised in a 1:1 ratio to one of two treatment groups in each of the following two strata: 1) patients who had undergone one or more pituitary surgeries but had not been treated medically or 2) de novo patients presenting a visible pituitary adenoma on MRI who had refused pituitary surgery or for whom pituitary surgery was contraindicated.
Danish: Patienterne blev randomiseret i forholdet 1:1 til en af to behandlingsgrupper i hvert af følgende to strata: 1) patienter, der havde gennemgået en eller flere hypofyseoperationer, men som ikke var blevet behandlet medicinsk 2) de novo-patienter med synligt hypofyseadenom ved MR-scanning, og som havde afvist hypofyseoperation, eller hvor hypofyseoperation var kontraindiceret.
English: In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. Cmax and AUC are approximately dose-proportional following administration of single and multiple doses.
Danish: Pasireotid blev absorberet hurtigt hos raske forsøgspersoner, og den højeste plasmakoncentration nås inden for 0,25-0,5 t. Cmax og AUC er omtrent dosisproportionale efter indgivelse af enkelte og multiple doser.
English: ATTENTION: Keep the plunger pressed and shake the vial moderately for a minimum of 30 seconds so that the powder is completely suspended.
Danish: BEMÆRK: Hold stemplet i bund og ryst hætteglasset moderat i mindst 30 sekunder, til alt pulveret er fuldstændigt opslæmmet.
English: Based on the accumulation ratios of AUC, the calculated effective half-life (t1/2,eff) in healthy volunteers was approximately 12 hours.
Danish: Baseret på akkumulationsratioer af AUC, er den beregnede effektive halveringstid (t½,eff) for raske forsøgspersoner ca. 12 timer.
English: Non-clinical safety data from studies performed with pasireotide administered via the subcutaneous route reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske sikkerhedsdata fra studier udført med subkutant administreret pasireotid viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: To reduce local discomfort, it is recommended that the solution is at room temperature before administration.
Danish: For at mindske ubehag på injektionsstedet, bør opløsningen opnå stuetemperatur inden administration.
English: The primary efficacy end point was the proportion of patients in each arm who achieved mean 24-hour UFC levels ≤ULN after 7 months of treatment, regardless of prior dose increase.
Danish: Det primære virkningsendepunkt var andelen af patienter i hver arm, som opnåede gennemsnitlig UFC niveau ≤ULN ved 24 timer efter 7 måneders behandling, uanset om dosis var blevet forhøjet.
English: Solvent: clear, colourless to slightly yellow or slightly brown solution.
Danish: Solvens: klar, farveløs til gullig eller brunlig opløsning.
English: Breast-feeding should be discontinued during treatment with Signifor.
Danish: Amning skal ophøre under behandling med Signifor.
English: The most common adverse reactions (incidence ≥1/10) from the pooled safety data from the phase III studies C2305 and C2402 were (in decreasing order): diarrhoea (most common in study C2305), cholelithiasis, hyperglycaemia (most common in study C2402) and diabetes mellitus.
Danish: De hyppigste bivirkninger (hyppighed ≥1/10) fra puljede sikkerhedsdata fra fase III-studierne C2305 og C2402 var (i rækkefølge med faldende hyppighed): diarré (hyppigst i C2305-studiet), kolelithiasis, hyperglykæmi (hyppigst i C2402-studiet) og diabetes mellitus.
English: QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups.
Danish: QTcF >480 ms blev indberettet for henholdvis 3 og 2 patienter i gruppen, der fik pasireotid til intramuskulær anvendelse, og gruppen, der fik octreotid til intramuskulær anvendelse, og QTcFforlængelse >60 ms fra baseline blev indberettet for 2 patienter versus 1 patient i de respektive grupper.
English: The data described below reflect exposure of 162 Cushing's disease patients to Signifor in the phase III study.
Danish: Nedenstående data viser resultatet af 162 patienter med Cushings sygdom eksponeret for Signifor i fase III-studiet.
English: After three months of treatment, patients with a mean 24-hour UFC ≤2 x ULN and below or equal to their baseline value continued blinded treatment at the randomised dose until month 6.
Danish: Efter tre måneders behandling fortsatte patienter med et døgngennemsnit på UFC ≤2 x ULN og derunder eller lig med deres baselineværdi med blindet behandling med den randomiserede dosis indtil måned 6.
English: To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension.
Danish: For at undgå bundfældning kan sprøjten rystes forsigtigt, så suspensionen forbliver ensartet.
English: Signifor should only be administered by a trained healthcare professional.
Danish: Signifor må kun administreres af relevant uddannet sundhedspersonale.
English: After you have started treatment, your doctor may also decide to increase your dose to one ampoule of Signifor 0.9 mg twice a day.
Danish: Efter du er startet i behandling, kan din læge vælge at øge din dosis til én ampul med Signifor 0,9 mg to gange daglig.
English: How long to use Signifor You should continue using Signifor for as long as your doctor tells you to.
Danish: Så længe skal du tage Signifor Du skal fortsætte med at tage Signifor, så længe din læge siger, at du skal gøre det.
English: Signifor must be given only by deep intramuscular injection.
Danish: Signifor må kun gives som dyb intramuskulær injektion.
English: Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Danish: Solvens: farveløs fyldt injektionssprøjte (glas) med front- og stempelprop (chlorbutylgummi), der indeholder 2 ml solvens.
English: Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing's disease patients.
Danish: Forhøjet glucose var den hyppigst rapporterede laboratorieabnormalitet af grad 3 (23,2% af patienterne) i fase III-studiet hos patienter med Cushings sygdom.
English: Pasireotide is not recommended for use during pregnancy and in women of childbearing potential who are not using contraception (see section 4.4).
Danish: Pasireotid bør ikke anvendes under graviditet og til kvinder i den fertile alder, som ikke anvender sikker kontraception (se pkt.
English: Signifor solution for injection should be free of visible particles, clear and colourless.
Danish: Signifor injektionsvæske, opløsning skal være fri for synlige partikler, klar og farveløs.
English: Fasting plasma glucose and HbA1c values generally decreased over the 28 days following pasireotide discontinuation but remained above baseline values.
Danish: De fastende plasmaglucose- og HbA1c-værdier faldt generelt i løbet af de 28 dage, der fulgte efter behandlingsophør, men lå stadig over baseline-værdierne.
English: Remove the injection kit from the fridge and let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Danish: Tag injektionskittet ud af køleskabet, og lad kittet stå ved stuetemperatur i mindst 30 minutter før rekonstitution, men overskrid ikke 24 timer.
English: Population pharmacokinetic analysis suggests that based on Cmax and AUC, 90% of steady state in Cushing's disease patients is reached after approximately 1.5 and 15 days, respectively.
Danish: Den farmakokinetiske populationsanalyse tyder på, at 90% af steady state nås hos patienter med Cushings sygdom efter henholdsvis ca. 1,5 og 15 dage baseret på Cmax og AUC.
English: * Grouped terms: Adrenal insufficiency includes adrenal insufficiency and blood cortisol decreased.
Danish: * Grupperede termer: Binyrebarkinsufficiens inkluderer binyrebarkinsufficiens og nedsat kortisol i blodet.
English: The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day.
Danish: Den anbefalede startdosis er 0,6 mg pasireotid ved subkutan injektion to gange dagligt.
English: Mean HbA1c increases were less pronounced in patients with normal glycaemia (n=62 overall) at study entry (i.e. 5.29% and 5.22% at baseline and 6.50% and 6.75% at month 6 for the 0.6 and 0.9 mg twice daily dose groups, respectively) relative to pre-diabetic patients (i.e. n=38 overall; 5.77% and 5.71% at baseline and 7.45% and 7.13% at month 6) or diabetic patients (i.e. n=54 overall; 6.50% and 6.42% at baseline and 7.95% and 8.30% at month 6).
Danish: De gennemsnitlige HbA1cforhøjelser var mindre udtalte hos patienter med normal glykæmi (n=62 i alt) ved indtrædelse i studiet (dvs. 5,29% og 5,22% ved baseline og 6,50% og 6,75% ved 6 måneder for henholdsvis den gruppe, der fik 0,6 mg to gange dagligt, og den gruppe, der fik 0,9 mg to gange dagligt) i forhold til prædiabetiske patienter (dvs. n=38 i alt; 5,77% og 5,71% ved baseline og 7,45% og 7,13% ved 6 måneder) eller diabetiske patienter (dvs. n=54 i alt; 6,50% og 6,42% ved baseline og 7,95% og 8,30% ved 6 måneder).
English: Alterations in blood glucose levels have been frequently reported in healthy volunteers and patients treated with pasireotide.
Danish: Ændringer i blodglucoseniveauet er rapporteret hyppigt hos raske forsøgspersoner og patienter, der behandles med pasireotid.
English: The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus.
Danish: De hyppigste bivirkninger (hyppighed ≥1/10) i fase III-studiet G2304 var hyperglykæmi, diarré, kolelitiasis og diabetes mellitus.
English: Additionally, tolerability and repeated dose toxicity studies were conducted with pasireotide via the intramuscular route.
Danish: Der er desuden udført studier af tolerabilitet og toksicitet efter gentagne doser med intramuskulært administreret pasireotid.
English: Following discontinuation of treatment with pasireotide, patients should be monitored until resolution.
Danish: Efter afbrydelse af behandling med pasireotid, bør patienter monitoreres indtil symptomerne ophører.
English: - Do not use this medicine after the expiry date which is stated on the carton, vial and pre-filled syringe after “EXP”.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på yderkarton, hætteglasset og den fyldte injektionssprøjte efter ”Udløbsdato”/”EXP”.
English: All observed cases of concurrent elevations were identified within ten days of initiation of treatment.
Danish: Alle observerede tilfælde med samtidige stigninger blev opdaget inden for 10 dage efter behandlingsstart.
English: The safety profile of pasireotide intramuscular use is consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Danish: Sikkerhedsprofilen for pasireotid til intramuskulær brug svarer til andre somatostatinanalogers med undtagelse af den højere grad og hyppighed af hyperglykæmi, som sås ved pasireotid til intramuskulær anvendelse.
English: In healthy volunteers, pasireotide is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
Danish: Hos raske forsøgspersoner distribueres pasireotid bredt med et stort tilsyneladende fordelingsvolumen (Vz/F >100 liter).
English: Careful monitoring is recommended in patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia or acute myocardial infarction, high-grade heart block, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation.
Danish: Omhyggelig monitorering anbefales hos patienter med hjertesygdom og/eller risiko for bradykardi som for eksempel ved tidligere klinisk signifikant bradykardi eller akut myokardieinfarkt, atrioventrikulær blok kongestiv hjerteinsufficiens (NYHA klasse III eller IV), ustabil angina pectoris, vedvarende ventrikeltakykardi, ventrikelfibrillation.
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Danish: Det betyder, at det indsprøjtes i fedtvævet lige under huden med en kort kanyle.
English: Uncommon (may affect up to 1 in 100 people) - Low level of red blood cells (anaemia)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) - Lavt niveau af røde blodlegemer (anæmi)
English: Take the sterile syringe and attach the needle to it.
Danish: Tag den sterile sprøjte og sæt kanylen på.
English: Included in the injection kit:
Danish: Injektionskittet indeholder:
English: Multipacks (40 mg and 60 mg strengths only): each multipack contains 3 intermediate cartons, each containing a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety engineered needle for injection).
Danish: Multipakninger (kun styrkerne 40 mg og 60 mg): Hver multipakning indeholder 3 delpakninger, som hver indeholder en blisterbakke med et injektionskit (et hætteglas og i et separat forseglet rum: en fyldt injektionssprøjte, en hætteglasadapter og en sikkerhedskanyle til injektion).
English: Decreased appetite, type 2 diabetes mellitus, glucose tolerance impaired
Danish: Nedsat appetit, type 2 diabetes mellitus, nedsat glucosetolerance
English: - taking antiarrhythmic medicinal products or other substances that are known to lead to QT
Danish: - ved brug af antiarytmika eller andre stoffer, som man ved medfører QT-forlængelse (se pkt.
English: Patients were randomised in a 1:1 ratio to receive starting doses of either 10 mg or 30 mg pasireotide, with a possibility to up-titrate to a maximum dose of 40 mg every 28 days.
Danish: Patienterne blev randomiseret i forholdet 1:1 til at få en startdosis på enten 10 mg eller 30 mg pasireotid, med mulighed for optitrering til en maksimal dosis på 40 mg hver 28. dag.
English: Signifor is available in packs containing 6 ampoules or in multipacks containing 18 (3 packs of 6), 30 (5 packs of 6) or 60 (10 packs of 6) ampoules.
Danish: Signifor er tilgængelig i pakninger, der indeholder 6 ampuller eller i multipakninger indeholdende 18 (3 pakninger med 6), 30 (5 pakninger med 6) eller 60 (10 pakninger med 6) ampuller.
English: The most common adverse reactions (incidence ≥10%) were diarrhoea, nausea, abdominal pain, cholelithiasis, injection site reactions, hyperglycaemia, diabetes mellitus, fatigue and glycosylated haemoglobin increased.
Danish: De almindeligste bivirkninger (hyppighed ≥10%) var diaré, kvalme, mavesmerter, kolelitiasis, reaktioner ved injektionsstedet, hyperglykæmi, diabetes mellitus, træthed og forhøjet glykosyleret hæmoglobin.
English: Signifor is to be administered by deep intramuscular injection by a trained healthcare professional.
Danish: Signifor skal administreres ved dyb intramuskulær injektion af relevant uddannet sundhedspersonale.
English: Twelve months after crossover, the percentage of patients achieving biochemical control was 17.3% (14/81) for pasireotide intramuscular use and 0% (0/38) for octreotide intramuscular use.
Danish: Tolv måneder efter skiftet var procentdelen af patienter, der havde opnået biokemisk kontrol, 17,3 % (14/81) for pasireotid til intramuskulær anvendelse and 0 % (0/38) for octreotid til intramuskulær anvendelse.
English: Maximum allowed dose was 60 mg for pasireotide intramuscular use and 30 mg for octreotide intramuscular use.
Danish: Den højeste tilladte dosis var 60 mg for pasireotid til intramuskulær anvendelse og 30 mg for octreotid til intramuskulær anvendelse.
English: Table 1 Adverse reactions in the phase III study in Cushing's disease patients
Danish: Tabel 1 Bivirkninger i fase III-studiet hos patienter med Cushings sygdom
English: The safety profile of Signifor was consistent with the somatostatin analogue class, except for the occurrence of hypocortisolism and degree of hyperglycaemia.
Danish: Signifors sikkerhedsprofil svarede til andre somatostatinanalogers bortset fra forekomsten af hypokortisolisme og graden af hyperglykæmi.
English: Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or medicinal products to control electrolyte balance, may be necessary (see also section 4.5).
Danish: Det kan være nødvendigt at justere dosis af lægemidler som for eksempel betablokkere, calciumantagonister eller midler til kontrol af elektrolytbalance (se også pkt.
English: Cardiovascular related events
Danish: Kardiovaskulært betingede hændelser
English: Available toxicological data in animals have shown excretion of pasireotide in milk.
Danish: Tilgængelige farmakokinetiske data fra dyrestudier har påvist udskillelse af pasireotid i modermælk.