FrancophonIA/ELRC3.0 huggingface dataset:
English: Episodes of torsade de pointes were not observed either in those studies or in clinical studies in other patient populations.
Danish: Der er ikke observeret torsade de pointes-episoder, hverken i disse studier eller i studier med andre patientpopulationer.
English: Important information about some of the ingredients of Signifor Signifor contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.
Danish: Vigtig information om nogle af indholdsstofferne i Signifor Signifor indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige ”natrium-fri”.
English: The therapeutic benefits of a reduction or normalisation of serum cortisol levels in female patients with Cushing's disease could potentially restore fertility.
Danish: De terapeutiske fordele ved reduktion eller normalisering af serum kortisol-nivauet hos kvindlige patienter med Cushings sygdom kan potentielt genoprette fertiliteten.
English: The safety profile of pasireotide intramuscular use was largely similar between the acromegaly and Cushing's disease indications.
Danish: Sikkerhedsprofilen for pasireotid til intramuskulær brug er stort set den samme for indikationerne akromegali og Cushings sygdom.
English: FOR DEEP INTRAMUSCULAR INJECTION ONLY.
Danish: KUN TIL DYB INTRAMUSKULÆR INJEKTION.
English: Patients with significantly increased prothrombin time (PT) and partial thromboplastin time (PTT) values or patients receiving coumarin-derivative or heparin-derivative anticoagulants were excluded from clinical studies with pasireotide as the safety of the combination with such anticoagulants has not been established.
Danish: Patienter med væsentligt forhøjede værdier for protrombintid (PT) og partiel tromboplastintid (PTT) og patienter, der fik coumarin- eller heparinlignende antikoagulantia, blev udelukket fra kliniske studier med pasireotid, da sikkerheden ved kombination med disse antikoagulantia ikke er klarlagt.
English: The study met its primary efficacy endpoint for both pasireotide intramuscular use doses.
Danish: Studiet opfyldte det primære virkningsendepunkt for begge de anvendte doser pasireotid til intramuskulær anvendelse.
English: If a dose of Signifor is missed, the next injection should be administered at the scheduled time.
Danish: Hvis en Signifor-dosis glemmes, skal den næste injektion administreres på det planlagte tidspunkt.
English: 51.6% p=0.536 * Primary endpoint (patients with IGF-1 <lower limit of normal (LLN) were not considered “responders”).
Danish: 51,6 % p=0,536 * Primært endepunkt (patienter med IGF-1<nedre normalgrænse (LLN) blev ikke betragtet som “respondenter”).
English: A supportive efficacy analysis was conducted in which patients were further classified into 3 response categories regardless of up-titration at month 3: Fully controlled (UFC ≤1.0 x ULN), partially controlled (UFC >1.0 x ULN but with a reduction in UFC ≥50% compared to baseline) or uncontrolled (reduction in UFC <50%).
Danish: Der blev gennemført en understøttende virkningsanalyse, hvor patienterne blev yderligere opdelt i 3 responskategorier uden hensyntagen til optitrering ved 3 måneder: fuldt kontrolleret (UFC ≤1,0 x ULN), delvis kontrolleret (UFC >1,0 x ULN, men med en UFC-reduktion ≥50% i forhold til baseline) eller ukontrolleret (UFC-reduktion <50%).
English: You may experience extreme weakness, tiredness, weight loss, nausea,
Danish: Du kan opleve ekstrem svaghed, træthed, vægttab, kvalme, opkastning,
English: 59.7% and 56% of patients in the pasireotide intramuscular use and octreotide intramuscular use treatment groups, respectively, were patients without previous pituitary surgery (de novo).
Danish: 59,7 % og 56 % af patienterne i de behandlingsgrupper, der fik henholdsvis pasireotid til intramuskulær anvendelse og octreotid til intramuskulær anvendelse, var patienter uden forudgående hypofyseoperation (de novo).
English: Dose increase for efficacy was allowed at the discretion of the investigators after three and six months of treatment if biochemical parameters showed a mean GH ≥2.5 µg/l and/or IGF-1 >ULN (age and sex related).
Danish: Dosisøgning for at opnå effekt var tilladt i henhold til investigators vurdering efter tre og seks måneders behandling, hvis de biokemiske parametre viste en middel-GH ≥2,5 µg/l og/eller IGF-1 >ULN (alders- og kønsrelateret).
English: Treatment with Signifor leads to rapid suppression of ACTH (adrenocorticotropic hormone) secretion in Cushing's disease patients.
Danish: Behandling med Signifor bevirker hurtig undertrykkelse af sekretionen af ACTH (adrenokortikotropisk hormon) hos patienter med Cushings sygdom.
English: Inadequately controlled patients in study C2402 are defined as patients with a mean GH concentration of a 5-point profile over a 2-hour period >2.5 μg/l and sex- and age-adjusted IGF-1 >1.3 × ULN.
Danish: Utilstrækkeligt kontrollerede patienter i C2402-studiet defineres som patienter med en middel-GHkoncentration >2,5 μg/l ud fra en profil med 5 punkter over en periode på 2 timer og køns- og aldersjusteret IGF-1 >1,3 × ULN.
English: It is therefore necessary to monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyperkalaemia, hyponatraemia, hypoglycaemia).
Danish: Det er derfor nødvendigt at overvåge patienterne og oplyse dem om tegn og symptomer, der er forbundet med hypokortisolisme (fx svaghed, træthed, anoreksi, kvalme, opkastning, hypotension, hyperkalæmi, hyponatriæmi, hypoglykæmi).
English: Getting started
Danish: Hvordan kommer jeg igang
English: Gallbladder and related events
Danish: Galdeblære og relaterede hændelser
English: The degree and frequency of hyperglycaemia observed in the two pivotal studies in acromegaly patients were higher with Signifor intramuscular use than with active control (octreotide intramuscular use or lanreotide deep subcutaneous injection).
Danish: Graden og hyppigheden af hyperglykæmi, som blev observeret i de to pivotalstudier hos akromegalipatienter, var højere ved behandling med Signifor til intramuskulær anvendelse end med den aktive kontrol (octreotid i.m.
English: If you have been told to use two needles, you should use the long thick blunt one for this step.
Danish: Hvis du bruger to kanyler, skal du bruge den lange, tykke, stumpe kanyle i dette trin.
English: Withdraw the needle from the injection site and activate the safety guard.
Danish: Tag nålen ud fra injektionsstedet og aktiver sikkerhedsbeskyttelsen.
English: All cases of concurrent elevations were identified within ten days of initiation of treatment with Signifor.
Danish: Alle tilfælde med samtidige stigninger blev opdaget inden for 10 dage efter påbegyndelse af behandling med Signifor.
English: The efficacy of pasireotide intramuscular use has been demonstrated in two phase III, multicentre studies in acromegaly patients and in one phase III, multicentre study in Cushing's disease patients.
Danish: Virkningen af pasireotid til intramuskulær anvendelse er blevet påvist i to fase III-multicenterstudier hos akromegalipatienter og i et fase III-multicenterstudie hos patienter med Cushings sygdom.
English: Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Danish: Kolecystitis inkluderer akut kolecystitis og kronisk kolecystitis.
English: The primary efficacy endpoint was the proportion of patients with a reduction of mean GH level to <2.5 μg/l and the normalisation of IGF-1 to within normal limits (age and sex related) at month 12.
Danish: Det primære virkningsendepunkt var andelen af patienter med et reduktion i middel-GHkoncentrationen til <2,5 μg/l og normalisering af IGF-1 til inden for normalgrænserne (alders- og kønsrelateret) ved måned 12.
English: Once the ampoule is open, put it upright on a clean, flat surface.
Danish: Stil den åbne ampul opret på en ren, plan overflade.
English: The percentage of patients achieving biochemical control, including those patients with IGF-1 <LLN was 25.9% in the pasireotide intramuscular use group and 0% in the octreotide intramuscular use group.
Danish: Procentdelen af patienter, der opnåede biokemisk kontrol, inklusive patienter med IGF-1 <LLN, var 25,9 % i gruppen, der fik pasireotid til intramuskulær anvendelse, og 0 % i gruppen, der fik octreotid til intramuskulær anvendelse.
English: At month 25, 48.6% of patients (36/74) in the pasireotide intramuscular use group and 45.7% (21/46) in the octreotide intramuscular use group achieved biochemical control.
Danish: Ved måned 25 havde 48,6 % af patienterne (36/74) i gruppen, der fik pasireotid til intramuskulær anvendelse, og 45,7 % (21/46) i gruppen, der fik octreotid til intramuskulær anvendelse, opnået biokemisk kontrol.
English: Month 12 * Includes one patient with significant outlying results who had a percent change from baseline of
Danish: Måned 6 Måned 12 * Omfatter én patient med signifikant afvigende resultater, som havde en ændringsprocent i forhold til baseline på +542,2%.
English: Injection site reaction, fatigue
Danish: Reaktion på injektionsstedet, træthed
English: Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor.
Danish: Håndtering af formodede bivirkninger eller over-respons på behandlingen (IGF-1< lavere normalgrænse) kan kræve midlertidig reduktion af Signifor-dosis.
English: The elevations were mostly low grade and reversible while continuing treatment.
Danish: Forhøjelserne har overvejende været lave og reversible ved fortsat behandling.
English: Activate the safety guard over the needle, in one of the two methods shown: - either press the hinged section of the safety guard down onto a hard surface (figure A), - or push the hinge forward with your finger
Danish: Aktiver kanylens sikkerhedsbeskyttelse ved hjælp af en af de to viste metoder: - tryk enten det hængslede stykke af sikkerhedsbeskyttelsen ned mod en hård overflade (figur A), - eller skub hængslet fremover med fingeren
English: The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete.
Danish: Den relative biotilgængelighed af pasireotid til intramuskulær anvendelse i forhold til pasireotid til subkutan anvendelse er fuldstændig.
English: The patients recovered without clinical sequelae and liver function test results returned to baseline values after discontinuation of treatment.
Danish: Patienterne kom sig uden kliniske komplikationer og resultater fra leverfunktionstests vendte tilbage til baseline-niveau efter afbrydelse af behandling.
English: Data on the use of Signifor in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).
Danish: Data for brug af Signifor til patienter over 65 år er begrænsede, men der findes ingen dokumentation for, at dosisjustering er nødvendig hos disse patienter (se pkt.
English: Pasireotide 0.9 mg twice daily % change (n)
Danish: Pasireotid 0,9 mg to gange dagligt % ændring (n)
English: Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation.
Danish: Det bør overvejes at ophøre med behandling hos patienter, der ikke har responderet på Signifor efter to måneders behandling.
English: The injection can be prepared using either two different needles to draw up and inject the solution or one short fine injection needle for both steps.
Danish: I forbindelse med injektionen kan du anvende enten to forskellige kanyler til henholdsvis at trække injektionsvæsken op og indsprøjte den eller en kort, tynd injektionskanyle til begge trin.
English: Doses should not be doubled to make up for a missed dose.
Danish: Der må ikke gives dobbeltdosis som erstatning for en glemt dosis.
English: Abdominal pain includes abdominal pain and abdominal pain upper.
Danish: Abdominalsmerte inkluderer abdominalsmerte og smerte i øvre abdomen.
English: Pasireotide 0.6 mg twice daily % change (n)
Danish: Pasireotid 0,6 mg to gange dagligt % ændring (n)
English: lumefantrine); - medicines to control blood pressure such as:
Danish: lumefantrin); - medicin, der bruges til at kontrollere blodtrykket, som fx:
English: Pasireotide binds and activates four of the five hssts, especially hsst5, in corticotrophs of ACTH-producing adenomas, resulting in inhibition of ACTH secretion.
Danish: Pasireotid binder sig til og aktiverer fire af de fem hsst'er, især hsst5, i kortikotroper af ACTH-producerende adenomer, hvorved ACTH-sekretionen hæmmes.
English: Monitoring for an effect on the QTc interval is advisable 21 days after the beginning of the treatment and as clinically indicated thereafter.
Danish: Monitorering for påvirkning af QTc-intervallet anbefales 21 dage efter behandlingsstart og derefter som klinisk indiceret.
English: In both studies, mean FPG and HbA1c levels peaked within the first three months of treatment with pasireotide intramuscular use.
Danish: begge studier blev det maksimale middelniveau af FPG og HbA1c nået inden for de første tre måneders behandling med pasireotid til intramuskulær anvendelse.
English: Severe hepatic impairment (Child Pugh C).
Danish: Svær nedsat leverfunktion (Child Pugh C).
English: One short fine sterile needle
Danish: En kort, tynd steril kanyle
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: In subjects with moderate and severe hepatic impairment, AUCinf was increased 60% and 79%, Cmax was increased 67% and 69%, and CL/F was decreased 37% and 44%, respectively.
Danish: Hos forsøgspersoner med moderat og svær nedsat leverfunktion steg AUCinf med 60 % og 79 %, Cmax steg med 67 % og 69 %, og CL/F faldt med henholdsvis 37 % og 44 %.
English: Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Danish: Lad kittet stå ved stuetemperatur i mindst 30 minutter før rekonstitution, men overskrid ikke 24 timer.
English: Non-clinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske sikkerhedsdata viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingtoksicitet.
English: • metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines).
Danish: • metformin, liraglutid, vildagliptin, nateglinid (medicin mod diabetes).
English: Octreotide
Danish: Octreotid
English: The unbound plasma pasireotide exposure (AUCinf,u) was increased in subjects with renal impairment (mild: 33%; moderate: 25%, severe: 99%, ESRD: 143%) compared to control subjects.
Danish: Plasmaeksponering af ubundet pasireotid (AUCinf,u) var forhøjet hos forsøgspersoner med nedsat nyrefunktion (let: 33 %, moderat: 25 %, svær: 99 %, ESRD: 143 %) sammenlignet med forsøgspersoner i kontrolgruppen.
English: A few cases of concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN have been observed with the subcutaneous formulation, however not in patients treated with pasireotide intramuscular use.
Danish: Nogle få tilfælde af samtidige stigninger i ALAT på mere end 3 x ULN og bilirubin på mere end 2 x ULN er observeret med den subkutane formulering, men ikke hos patienter, der blev behandlet med pasireotid til intramuskulær anvendelse.
English: Common Toxicity Criteria (CTC) Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Danish: Bivirkninger af Common Toxicity Criteria (CTC) grad 3 og 4 var hovedsageligt relateret til hyperglykæmi.
English: Patients who develop increased transaminase levels should be monitored frequently until values return to pre-treatment levels.
Danish: Patienter, der udvikler forøgede transaminaseniveauer, bør monitoreres hyppigt, indtil værdierne vender tilbage til samme niveau som før påbegyndelse af behandlingen.
English: Based on in vitro data pasireotide is not a substrate of the efflux transporter BCRP (breast cancer resistance protein) nor of the influx transporters OCT1 (organic cation transporter 1), OATP (organic anion-transporting polypeptide) 1B1, 1B3 or 2B1.
Danish: Baseret på in-vitro data er pasireotid ikke substrat for effluxtransportøren BCRP (breast cancer resistance protein) eller for influxtransportørerne OCT1 (organic cation transporter 1), OATP (organic anion-transporting polypeptide) 1B1, 1B3 eller 2B1.
English: Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
Danish: Bank forsigtigt på sprøjten for at fjerne eventuelle synlige bobler og pres dem ud af sprøjten.
English: vomiting and low blood pressure.
Danish: og lavt blodtryk.
English: In a clinical study with single subcutaneous dose administration of 900 µg pasireotide in subjects with impaired renal function, renal impairment of mild, moderate or severe degree, or end stage renal disease (ESRD) did not have a significant impact on total pasireotide plasma exposure.
Danish: I et klinisk studie med administration af en enkelt subkutan dosis på 900 µg pasireotid hos forsøgspersoner med nedsat nyrefunktion, havde let, moderat eller svær nedsat nyrefunktion eller terminal nyresygdom (ESRD) ikke signifikant indflydelse på total plasmaeksponering af pasireotid.
English: The presence of gallstones in Signifor-treated patients is largely asymptomatic; symptomatic stones should be managed according to clinical practice.
Danish: Galdesten hos patienter, der behandles med Signifor, er stort set asymptomatiske, hvis de giver symptomer, skal de behandles i overensstemmelse med klinisk praksis.
English: Alopecia, pruritus
Danish: Alopeci, kløe
English: Activate the safety guard over the needle, in one of the two methods shown: - either press the hinged section of the safety guard down onto a hard surface - or push the hinge forward with your finger An audible “click” confirms proper activation.
Danish: Aktiver kanylens sikkerhedsbeskyttelse ved hjælp af en af de to viste metoder: - tryk enten det hængslede stykke af sikkerhedsbeskyttelsen ned mod en hård overflade - eller skub hængslet fremover med fingeren Et hørbart ”klik” betyder korrekt aktivering.
English: Decreases were also demonstrated by the overall percentage change from baseline in mean and median mUFC levels at month 7 and 12.
Danish: Faldet kunne også ses i den samlede procentdel af ændringer fra baseline i mUFC-middel- og medianværdier ved måned 7 og 12 .
English: In a pooled analysis of the two pivotal studies, the overall incidence of hyperglycaemia-related adverse reactions was 58.6% (all grades) and 9.9% (CTC Grade 3 and 4) for Signifor intramuscular use versus 18.0% (all grades) and 1.1% (CTC Grade 3 and 4) for the active control.
Danish: I en puljet analyse af de to pivotalstudier var den samlede incidens af hyperglykæmi-relaterede bivirkninger 58,6 % (alle grader) og 9,9 % (CTC-grad 3 og 4) for Signifor til intramuskulær anvendelse versus 18,0 % (alle grader) og 1,1 % (CTC-grad 3 og 4) for den aktive kontrol.
English: Baseline mean GH was 17.6 µg/l, 12.1 µg/l and 9.5 µg/l, in the 40 mg, 60 mg and active control groups, respectively.
Danish: Middel-GH ved baseline var henholdsvis 17,6 µg/l, 12,1 µg/l og 9,5 µg/l i grupperne, der fik 40 mg, 60 mg og aktiv kontrol.
English: Grade 3 adverse reactions were observed in 35.8% of patients and Grade 4 adverse reactions in 2.5% of patients.
Danish: Der blev observeret bivirkninger af grad 3 hos 35,8% af patienterne og bivirkninger af grad 4 hos 2,5% af patienterne.
English: For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”.
Danish: Se venligst afsnittet i slutningen af indlægssedlen ”Hvordan du injicerer Signifor” for vejledning om anvendelsen.
English: Table 3 Percentage change in mean and median UFC levels per randomised dose group at month 6 and month 12 compared to baseline values
Danish: Tabel 3 Procentvise ændringer i UFC-middel- og medianværdier pr. randomiseret doseringsgruppe ved måned 6 og måned 12 i forhold til baseline-værdierne
English: Monitoring for an effect on the QTc interval is advisable and ECG should be performed prior to the start of Signifor therapy, one week after the beginning of the treatment and as clinically indicated thereafter.
Danish: Monitorering for en virkning på QTc-intervallet er tilrådelig, og EKG bør foretages, før behandling med Signifor påbegyndes, en uge efter behandling er påbegyndt og derefter som klinisk indiceret.
English: This means that it is injected through a needle into the muscles of your buttocks.
Danish: Det vil sige, at det sprøjtes gennem en kanyle ind i en af dine baldemuskler.
English: The maximum recommended dose for these patients is 0.6 mg twice a day.
Danish: Den anbefalede maksimale dosis hos disse patienter er 0,6 mg to gange dagligt.
English: There are no clinical data available on switching from the intramuscular to the subcutaneous pasireotide formulation.
Danish: Der findes ingen tilgængelige kliniske data på skift fra den intramuskulære til den subkutane pasireotidformulering.
English: Fatigue*
Danish: Træthed*
English: 81 patients were crossed over from octreotide intramuscular use to pasireotide intramuscular use, and 38 patients were crossed over from pasireotide intramuscular use to octreotide intramuscular use.
Danish: 81 patienter skiftede fra octreotid til intramuskulær anvendelse til pasireotid til intramuskulær anvendelse, og 38 patienter skiftede fra pasireotid til intramuskulær anvendelse til octreotid til intramuskulær anvendelse.
English: Decreases in sitting systolic and diastolic blood pressure, body mass index (BMI) and total cholesterol were observed in both dose groups at month 6.
Danish: Fald i siddende systolisk og diastolisk blodtryk, body mass index (BMI) og samlet kolesterol observeredes hos begge doseringsgrupper ved måned 6.
English: If you forget to use Signifor
Danish: Hvis du har glemt at tage Signifor
English: The coloured dot on the top part marks the position of the breaking point on the neck of the ampoule.
Danish: Det farvede punkt på ampullens øverste del markerer det sted, hvor toppen skal knækkes af.
English: Decreases were also demonstrated by the overall percentage of change in mean and median UFC levels at month 6 and 12 as compared to baseline values (see Table 3).
Danish: Fald viste sig også i den samlede procentdel af ændringer i UFC-middel- og medianværdier ved 6 og 12 måneder i forhold til baseline-værdierne (se Tabel 3).
English: Most patients (82.0%) had undergone prior pituitary surgery, and the mean baseline mUFC was 470 nmol/24h (ULN: 166.5 nmol/24h).
Danish: De fleste patienter (82,0 %) havde tidligere fået foretaget en hypofyseoperation, og den gennemsnitlige baseline for mUFC var 470 nmol/24t (ULN: 166,5 nmol/24t).
English: If you accidentally use more Signifor than your doctor prescribed, immediately contact your doctor, nurse or pharmacist.
Danish: Hvis du er kommet til at tage mere Signifor, end din læge har ordineret, skal du straks kontakte enten din læge, sundhedspersonalet eller apoteket.
English: Injection site reactions were reported in 13.6% of patients enrolled in the phase III study in Cushing's disease.
Danish: Reaktioner på injektionsstedet rapporteredes hos 13,6% af de patienter, der rekrutteredes til fase IIIstudiet med Cushings sygdom.
English: Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Danish: Pulver: brunligt hætteglas (glas) med gummiprop (chlorbutylgummi), der indeholder det aktive stof (pasireotid).
English: In patients who developed hyperglycaemia, the condition generally appeared to respond to antidiabetic therapy.
Danish: Hos patienter, der udviklede hyperglykæmi, virkede antidiabetisk behandling generelt godt på tilstanden.