FrancophonIA/ELRC3.0 huggingface dataset:
English: In study C2305, grade 3 elevated fasting glucose levels were reported in 9.7% and 0.6% and grade 4 in 0.6% and 0% of acromegaly patients treated with pasireotide intramuscular use and octreotide intramuscular use, respectively.
Danish: I C2305-studiet blev der indberettet forhøjede fasteglucosekoncentrationer af grad 3 hos 9,7 % og 0,6 % og grad 4 hos 0,6 % og 0 % af akromegalipatienter, der blev behandlet med henholdsvis pasireotid til intramuskulær anvendelse og octreotid til intramuskulær anvendelse.
English: Signifor may have a minor effect on the ability to drive and use machines, because some of the side effects you may experience while using Signifor, such as headache, dizziness and tiredness, may reduce your ability to drive and use machines safely.
Danish: Signifor kan have en mindre indvirkning på evnen til at føre motorkøretøj og betjene maskiner, fordi nogle af de bivirkninger, du oplever, mens du bruger Signifor, som fx svimmelhed, hovedpine og træthed, måske kan påvirke din evne til at køre eller betjene maskiner på sikker vis.
English: Remove the Signifor injection kit from refrigerated storage.
Danish: Tag Signifor-injektionskittet ud af køleskabet.
English: Mean FPG levels commonly increased within the first month of treatment with decreases and stabilisation observed in subsequent months.
Danish: De gennemsnitlige FPG-niveauer steg normalt inden for den første måned af behandlingen, mens fald og stabilisering blev observeret i de efterfølgende måneder.
English: At month 6, normalisation of mean UFC levels was observed in 14.6% (95% CI 7.0-22.3) and 26.3% (95% CI 16.6-35.9) of patients randomised to pasireotide 0.6 mg and 0.9 mg twice daily, respectively.
Danish: Ved 6 måneder observeredes en normalisering af de gennemsnitlige UFC-niveauer hos henholdsvis 14,6% (95% CI 7,0-22,3) og 26,3% (95% CI 16,6-35,9) af de patienter, der var randomiseret til pasireotid 0,6 mg og 0,9 mg to gange dagligt.
English: <2.5 µg/l and normalisation of IGF-1 at the same time point was also comparable between the two treatment arms.
Danish: Procentdelen af patienter med middel-GH <2,5 µg/l og normaliseret IGF-1 på samme tidspunkt var også sammenlignelige i de to behandlingsarme.
English: The primary efficacy end-point was the proportion of patients in each arm who achieved normalisation of mean 24-hour UFC levels (UFC ≤ULN) after 6 months of treatment and who did not have a dose increase (relative to randomised dose) during this period.
Danish: Det primære endepunkt for virkningen var den del af patienterne i hver gruppe, der opnåede normalisering af døgngennemsnittet for UFC-niveauer (UFC≤ULN) efter 6 måneders behandling, og som ikke fik øget dosis (i forhold til den randomiserede dosis) i denne periode.
English: To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
Danish: Signifor klargøres til dyb intramuskulær injektion ved at følge nedenstående vejledning:
English: The starting dose was 40 mg for pasireotide intramuscular use and 20 mg for octreotide intramuscular use.
Danish: Startdosis var 40 mg for pasireotid til intramuskulær anvendelse og 20 mg for octreotid til intramuskulær anvendelse.
English: FPG and HbA1c increases were dose-dependent, and values generally decreased following pasireotide intramuscular use discontinuation but remained above baseline values.
Danish: Stigninger i FPG og HbA1c var dosisafhængige, og værdierne faldt generelt efter seponering af pasireotid til intramuskulær anvendelse, men forblev over baseline-værdier.
English: It is not known whether Signifor passes into breast milk.
Danish: Det vides ikke, om Signifor udskilles i modermælk.
English: Anticipated pharmacokinetic interactions resulting in effects on pasireotide
Danish: Forventede farmakokinetiske interaktioner, som kan påvirke pasireotid
English: Glycosylated haemoglobin increased
Danish: Forhøjet glykosyleret hæmoglobin
English: As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than ACTH cannot be ruled out.
Danish: Da pasireotids farmakologiske aktivitet ligner somatostatins, kan hæmning af andre hypofysehormoner end ACTH ikke udelukkes.
English: Acromegaly study C2305 patients who had no prior medical treatment A phase III multicentre, randomised, blinded study was conducted to assess the safety and efficacy of pasireotide intramuscular use versus octreotide intramuscular use in medically naïve patients with active acromegaly.
Danish: Akromegalistudie C2305, patienter som ikke tidligere havde fået medicinsk behandling Et randomiseret, blindet fase III-multicenterstudie blev udført for at vurdere sikkerhed og virkning af pasireotid til intramuskulær anvendelse versus octreotid til intramuskulær anvendelse hos behandlingsnaive patienter med aktiv akromegali.
English: The total proportion of patients with either full or partial mean UFC control at month 6 was 34% and 41% of the randomised patients to the 0.6 mg and 0.9 mg dose, respectively.
Danish: Den totale andel af patienter med enten fuldt kontrolleret eller partielt kontrolleret gennemsnits-UFC ved måned 6 udgjorde henholdsvis 34% og 41% for doser på henholdsvis 0,6 mg og 0,9 mg.
English: A baseline ECG is recommended prior to initiating therapy with Signifor.
Danish: Det anbefales at tage EKG før opstart af behandling med Signifor.
English: What you need to know before you use Signifor
Danish: Det skal du vide, før du begynder at bruge Signifor
English: The recommended initial dose for patients with moderate hepatic impairment (Child Pugh B) is 0.3 mg twice a day (see section 5.2).
Danish: Den anbefalede startdosis til patienter med moderat nedsat leverfunktion (Child Pugh B) er 0,3 mg to gange dagligt (se pkt.
English: Your doctor or nurse will inject Signifor.
Danish: Din læge eller sygeplejerske vil give dig indsprøjtningen med Signifor.
English: A phase III, multicentre, randomised study was conducted to evaluate the safety and efficacy of different dose levels of Signifor over a twelve-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Danish: Et randomiseret fase III-multicenterstudie er gennemført for at vurdere sikkerheden og virkningen af Signifor ved forskellige doseringsniveauer over en 12-måneders behandlingsperiode hos patienter med persisterende eller tilbagevendende Cushings sygdom eller de novo patienter, for hvem operation ikke var indiceret, eller som afslog operation.
English: The proportion of patients with a reduction or no change in pituitary tumour volume at week 24 was 81.0% and 70.3% on pasireotide intramuscular use 40 and 60 mg, and 50.0% on active control.
Danish: Andelen af patienter med et fald eller ingen ændring i hypofysetumorvolumen ved uge 24 var 81,0 % og 70,3 % på pasireotid 40 og 60 mg til intramuskulær anvendelse og 50,0 % på aktiv kontrol.
English: The elevations of fasting plasma glucose and HbA1c observed with pasireotide intramuscular use treatment are reversible after discontinuation.
Danish: De stigninger, der ses i fasteplasmaglucose og HbA1c ved pasireotid til intramuskulær anvendelse, er reversible efter seponering.
English: Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8).
Danish: Hyperglykæmi og, mindre hyppigt, hypoglykæmi, er observeret hos patienter, som har deltaget i kliniske studier med pasireotid (se pkt 4.8).
English: How much Signifor to use
Danish: Hvor meget Signifor skal du tage
English: The proportion of patients achieving biochemical control was 15.4% (p-value = 0.0006) and 20.0% (p-value <0.0001) for pasireotide intramuscular use 40 mg and 60 mg, respectively at 24 weeks compared with zero in the active control arm (Table 3).
Danish: Andelen af patienter, der opnåede biokemisk kontrol, var henholdsvis 15,4 % (p-værdi=0,0006) og 20,0 % (p-værdi <0,0001) for pasireotid 40 mg og 60 mg til intramuskulær anvendelse ved 24 uger sammenlignet med 0 % i armen med aktiv kontrol (tabel 3).
English: Patients were randomised in a 1:1 ratio to a starting dose of either 10 mg or 30 mg pasireotide intramuscular use every 4 weeks.
Danish: Patienterne blev randomiseret i forholdet 1:1 til en startdosis på enten 10 mg eller 30 mg pasireotid til intramuskulær anvendelse hver 4. uge.
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 5 (3.1%) and 4 (2.5%) patients, respectively.
Danish: Hyperglykæmi og diabetes mellitus medførte udtrædelse af studiet for henholdsvis 5 (3,1%) og 4 (2,5%) patienters vedkommende.
English: Self monitoring of blood glucose and/or FPG assessments should be done weekly for the first three months and periodically thereafter, as clinically appropriate, as well as over the first four to six weeks after any dose increase.
Danish: Selvmonitorering af blodglucose og/eller FPG-vurderinger skal foretages ugentligt de første tre måneder og derefter periodisk, som det findes klinisk hensigtsmæssigt, samt i løbet af de første fire til seks uger efter en dosisændring.
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP1B1 or 1B3, OAT1 or OAT3, OCT1 or OCT2, P-gp, BCRP, MRP2 and BSEP.
Danish: Ved terapeutiske dosisniveauer er pasireotid heller ikke en hæmmer af UGT1A1, OATP1B1 eller 1B3, OAT1 eller OAT3, OCT1 eller OCT2, P-gp, BCRP, MRP2 og BSEP.
English: (ciclosporin); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low
Danish: (ciclosporin); - medicin, der bruges til at behandle for højt blodsukker (som ved diabetes) eller for lavt blodsukker (hypoglykæmi), som fx:
English: Injection site reaction includes injection site pain, injection site nodule, injection site discomfort, injection site bruising, injection site pruritus, injection site reaction, injection site hypersensitivity and injection site swelling.
Danish: Reaktioner på injektionsstedet inkluderer smerte på injektionsstedet, knude på injektionsstedet, ubehag på injektionsstedet, blodudtrædning på injektionsstedet, kløe på injektionsstedet, reaktion på injektionsstedet, overfølsomhed på injektionsstedet og hævelse på injektionsstedet.
English: 18 ampoules (3x6)
Danish: 18 ampuller (3x6)
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing's disease.
Danish: Somatostatinreceptorer eksprimeres i mange vævstyper, især i neuroendokrine tumorer, hvor hormonerne udskilles i stærkt øget mængde, herunder ACTH ved Cushings sygdom.
English: - Inflammation of the gallbladder (cholecystitis).
Danish: - Betændelse i galdeblæren (kolecystitis).
English: In both dose groups, Signifor resulted in a decrease in mean UFC after 1 month of treatment, and this was maintained over time.
Danish: I begge doseringsgrupper resulterede Signifor i et fald i gennemsnitlig UFC efter 1 måneds behandling, og det blev opretholdt over tid.
English: Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products (e.g. metformin, liraglutide, vildagliptin, nateglinide) may be required when administered concomitantly with pasireotide (see also section 4.4).
Danish: Dosisjusteringer (ned eller op) af insulin og antidiabetika (fx metformin, liraglutid, vildagliptin, nateglinid) kan være nødvendige, når disse midler samtidig gives med pasireotid (se også pkt.
English: Pasireotide did not affect fertility in male rats but, as expected from the pharmacology of pasireotide, females presented abnormal cycles or acyclicity, and decreased numbers of corpora lutea and implantation sites.
Danish: Pasireotid påvirkede ikke hanrotters fertilitet, men som forventet ud fra pasireotids farmakologi udviste hunrotter abnorme cyklusser eller acyklicitet og nedsat antal corpora lutea og implantationssteder.
English: Self monitoring of blood glucose and/or FPG assessments should be done weekly for the first two to three months and periodically thereafter, as clinically appropriate, as well as over the first two to four weeks after any dose increase.
Danish: Selvmonitorering af blodglucose og/eller FPG-vurderinger skal foretages ugentligt de første to til tre måneder og derefter periodisk, som det findes klinisk hensigtsmæssigt, samt i løbet af de første to til fire uger efter en dosisændring.
English: Uncommon (may affect up to 1 in 100 people) - Change in pancreatic function blood test results (amylase) - Abnormal blood coagulation properties
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) - Ændringer i blodprøveresultater for bugspytkirtelfunktion (amylase) - Unormale blodstørkningsegenskaber
English: In Cushing's disease patients, elevated FPG levels was the most frequently reported CTC Grade 3 laboratory abnormality (14.7% of patients) in the phase III study G2304; with no cases of Grade 4 reported.
Danish: Hos patienter med Cushings sygdom var forhøjede FPG-niveauer den hyppigst indberettede CTCgrad 3 laboratorieabnormalitet (14,7 % af patienterne) i fase III-studiet G2304 og med ingen indberetninger af grad 4 tilfælde.
English: In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Danish: I et klinisk studie med forsøgspersoner med nedsat leverfunktion (Child-Pugh A, B og C), konstateredes statistisk signifikante forskelle mellem forsøgspersoner med moderat og forsøgspersoner med svær nedsat leverfunktion (Child-Pugh B og C).
English: In the acromegaly study C2305, the proportion of patients with newly occurring notable QT/QTc intervals was comparable between pasireotide intramuscular use and octreotide intramuscular use groups up to crossover, with few notable outlying values.
Danish: I C2305-akromegalistudiet var andelen af patienter med nyopståede betydningsfulde QT/QTcintervaller sammenlignelig mellem gruppen, der fik pasireotid til intramuskulær anvendelse, og gruppen, der fik octreotid til intramuskulær anvendelse indtil crossover med få væsentlige afvigende værdier.
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Stomach pain - Pain at the injection site
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter) - Diaré - Kvalme - Mavesmerter - Smerter ved injektionsstedet
English: Pasireotide is eliminated mainly via hepatic clearance (biliary excretion), with a small contribution of the renal route.
Danish: Pasireotid udskilles hovedsagelig ved hepatisk clearance (udskillelse via galden) og i lille omfang via nyrerne.
English: The primary efficacy endpoint was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 μg/l and normalisation of sex- and age-adjusted IGF-1) at week 24 with pasireotide intramuscular use 40 mg or 60 mg versus continued treatment with active control (octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg), separately.
Danish: Det primære virkningsendepunkt var sammenligning af andelen af patienter, der opnåede biokemisk kontrol (defineret som GH-middelkoncentration <2,5 μg/l og normalisering af køns- og aldersjusteret IGF-1) ved uge 24 med pasireotid 40 mg eller 60 mg til intramuskulær anvendelse versus fortsat behandling med aktiv kontrol (octreotid 30 mg til intramuskulær anvendelse eller lanreotid 120 mg som dyb subkutan injektion), hver for sig.
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including GH in acromegaly and ACTH in Cushing's disease.
Danish: Somatostatinreceptorer eksprimeres i mange vævstyper, især i neuroendokrine tumorer, hvor hormonerne udskilles i stærkt øget mængde, herunder GH ved akromegali og ACTH ved Cushings sygdom.
English: Pituitary hormones
Danish: Hypofysehormoner
English: In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
Danish: I C2402-studiet var den eneste afvigende værdi, der var værd at bemærke, en QTcF-værdi >480 ms hos 1 patient i gruppen, der fik pasireotid 40 mg til intramuskulær anvendelse.
English: Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Danish: Pasireotid udviser lav clearance (CL/F ~7,6 liter/t hos raske forsøgspersoner og ~3,8 liter/t hos patienter med Cushings sygdom).
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 3 (2.0%) and 4 patients (2.7%), respectively.
Danish: Bivirkningerne hyperglykæmi og diabetes mellitus medførte udtræden af studiet for henholdsvis 3 (2,0 %) og 4 patienter (2,7 %).
English: Monitoring of pituitary function (e.g. TSH/free T4, GH/IGF-1) before and periodically during Signifor therapy should therefore be considered, as clinically appropriate.
Danish: Monitorering af hypofysefunktionen (fx TSH/fri T4, GH/IGF-1) før og periodisk under behandling med Signifor skal derfor overvejes, hvis det er klinisk hensigtsmæssigt.
English: In the pivotal study with patients inadequately controlled on another somatostatin analogue, the proportion of patients not previously treated with anti-diabetic agents who required commencement of anti-diabetic therapy during the study was 17.5% and 16.1% in the Signifor 40 mg and 60 mg arms compared to 1.5% in the active control arm.
Danish: I pivotalstudiet med patienter, der var utilstrækkeligt kontrolleret på anden somatostatinanalog, var andelen af patienter, som ikke tidligere var blevet behandlet med antidiabetika, og som havde behov for at starte i antidiabetisk behandling under studiet, 17,5 % og 16,1 % i Signifor 40 mg- og 60 mg-armen sammenlignet med 1,5 % i armen med aktiv kontrol.
English: Rare cases of concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN have been observed.
Danish: Sjældne tilfælde af samtidige stigninger i ALAT på mere end 3 x ULN og bilirubin på mere end 2 x ULN er observeret.
English: Each ampoule contains 1 ml of solution for injection.
Danish: Hver ampul indeholder 1 ml injektionsvæske, opløsning.
English: Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4).
Danish: Det anbefales at monitorere blodglucoseniveauerne hos patienter, der behandles med Signifor (se pkt.
English: At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor.
Danish: Ved indtrædelse i studiet randomiseredes patienterne til doser på enten 0,6 mg eller 0,9 mg Signifor to gange dagligt.
English: In a randomised double-blinded mechanism study conducted in healthy volunteers, the development of hyperglycaemia with pasireotide administered as pasireotide subcutaneous use at doses of 0.6 and 0.9 mg twice a day was related to significant decreases in insulin secretion as well as incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Danish: I et randomiseret dobbeltblindet mekanismestudie med raske frivillige var udviklingen af hyperglykæmi med pasireotid administreret som pasireotid til subkutan anvendelse i doser på 0,6 og 0,9 mg to gange dagligt relateret til signifikante fald i insulinsekretion og inkretinhormoner (dvs. glucagonlignende peptid-1 [GLP-1] og glucoseafhængigt insulinotropt polypeptid [GIP]).
English: Most patients (83.3%) had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
Danish: De fleste af patienterne (83,3%) havde persisterende eller tilbagevendende Cushings sygdom og kun få (≤5%) i begge behandlingsgrupper havde tidligere gennemgået strålebehandling af hypofysen.
English: In acromegaly patients elevated fasting glucose level was the most frequently reported grade 3/4 laboratory abnormality in the two phase III studies.
Danish: Hos akromegalipatienter var forhøjede fasteglucose- (FPG) koncentrationer den hyppigst indberettede laboratorieabnormitet af grad 3/4 i de to fase III-studier.
English: These reactions were usually of low grade, required no intervention and improved with continued treatment.
Danish: Disse bivirkninger har dog normalt været lette, ikke krævet indgriben og blev mindre udtalte ved fortsat behandling.
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Danish: Ved terapeutiske dosisniveauer er pasireotid heller ikke en hæmmer af UGT1A1, OATP, 1B1 eller 1B3, P-gp, BCRP, MRP2 og BSEP.
English: Your doctor or nurse will instruct you on how to inject yourself with Signifor.
Danish: Din læge eller sygeplejerske vil vise dig, hvordan du skal give dig selv injektioner med Signifor.
English: Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of any major enzymes of CYP450.
Danish: Pasireotid er metabolisk særdeles stabilt og in vitro data viser, at pasioretid hverken er substrat for eller hæmmer af/ induktor af vigtige CYP450-enzymer.
English: In study C2402, grade 3 elevated fasting glucose levels were reported in 14.3% and 17.7% of acromegaly patients treated with pasireotide intramuscular use 40 mg and 60 mg respectively, and in no patients in the active control group.
Danish: I C2402-studiet blev der indberettet forhøjede fasteglucosekoncentrationer af grad 3 hos 14,3 % og 17,7 % af de akromegalipatienter, der blev behandlet med henholdsvis pasireotid 40 mg og 60 mg til intramuskulær anvendelse og hos ingen af patienterne i gruppen med aktiv kontrol.
English: Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of CYP450.
Danish: Pasireotid er metabolisk særdeles stabilt og in vitro data viser, at pasioretid hverken er substrat for eller hæmmer af/ induktor af CYP450.
English: Abdominal distension, vomiting
Danish: Abdominal distension, opkastning
English: Signifor is intended for subcutaneous use.
Danish: Signifor skal anvendes subkutant.
English: Mean fasting plasma glucose levels commonly increased within the first month of treatment, with decreases and stabilisation observed in subsequent months.
Danish: De gennemsnitlige fastende plasmaglucoseniveauer forhøjedes normalt i løbet af den første måned af behandlingen, men i de følgende måneder observeredes fald og stabilisering.
English: your doctor will monitor your coagulation parameters and may adjust your anticoagulant dose.
Danish: Din læge vil holde øje med dine blodstørkningstal og måske justere din dosis af det blodfortyndende lægemiddel.
English: GH <2.5 μg/l and IGF-1 ≤ULN Normalised IGF-1
Danish: GH <2,5 µg/l og IGF-1 ≤ULN Normaliseret IGF-1
English: Secondary end points included changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease.
Danish: Sekundære endepunkter omfattede ændringer i forhold til baseline for UFC ved 24 timer, plasma-ACTH, serumkortisolniveauer samt kliniske tegn og symptomer på Cushings sygdom.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
English: 60 ampoules (10x6)
Danish: 60 ampuller (10x6)
English: If such a switch should be required, the recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Danish: Hvis et sådan skift er påkrævet, er den anbefalede initialdosis til behandling af Cushings sygdom 10 mg pasireotid ved dyb intramuskulær injektion hver 4. uge.