FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean HbA1c increases were less pronounced in patients with normal glycaemia at study entry in comparison to pre-diabetic patients or diabetic patients.
Danish: Stigninger i gennemsnitlig HbA1c var mindre udtalte hos patienter med normal glykæmi ved indtræden i studiet sammenlignet med prædiabetiske eller diabetiske patienter.
English: Use syringes and needles only once.
Danish: Brug kun sprøjter og kanyler en gang.
English: Anticipated pharmacokinetic interactions resulting in effects on other medicinal products
Danish: Forventede farmakokinetiske interaktioner, som kan påvirke andre lægemidler
English: Ask your doctor about the need for contraception before taking this medicine.
Danish: Tal med din læge om brug af prævention, før du tager dette lægemiddel.
English: As a result, it reduces the symptoms of acromegaly, which include headache, increased sweating, numbness of the hands and feet, tiredness and joint pain.
Danish: Som følge deraf mindsker det symptomerne på akromegali, som omfatter hovedpine, øget svedtendens, følelsesløshed i hænder og fødder, træthed og ledsmerter.
English: In patients with poor glycaemic control, diabetes management and monitoring should be intensified prior to initiation and during pasireotide therapy.
Danish: Hos patienter med dårlig glykæmisk kontrol bør diabetesbehandling og monitorering intensiveres før initiering og under behandling med pasireotid.
English: Concomitant administration of pasireotide and ciclosporin may require adjustment of the ciclosporin dose to maintain therapeutic levels.
Danish: Hvis pasireotid og ciclosporin gives samtidig, kan en dosisjustering af ciclosporin være nødvendig for at opretholde terapeutiske niveauer.
English: Patients had to be treated with maximum indicated doses of octreotide intramuscular use (30 mg) or lanreotide deep subcutaneous injection (120 mg) for at least 6 months prior to randomisation.
Danish: Patienterne skulle være behandlet med maksimalt indicerede doser octreotid til intramuskulær anvendelse (30 mg) eller lanreotid som dyb subkutan injektion (120 mg) i mindst 6 måneder før randomisering.
English: In acromegaly, the safety assessment was made based on 491 patients who received pasireotide (419 patients received pasireotide intramuscular use and 72 received pasireotide subcutaneous use) in phase I, II and III studies.
Danish: For akromegali blev der foretaget en sikkerhedsvurdering baseret på 491 patienter, som fik pasireotid (419 patienter fik pasireotid til intramuskulær anvendelse, og 72 fik pasireotid til subkutan anvendelse) i fase I-, II- og III-studier.
English: Bradycardia has been reported with the use of pasireotide (see section 4.8).
Danish: Bradykardi er rapporteret ved brug af pasireotid (se pkt 4.8).
English: Further decrease in tumour volume was observed at month 12 after crossover for both treatment groups, and was higher in patients who crossed over to pasireotide intramuscular use (-24.7%) than in patients who crossed over to octreotide intramuscular use (-17.9%).
Danish: En yderligere reduktion i tumorvolumen blev observeret ved måned 12 efter crossover for begge behandlingsgrupper og var højere hos patienter, der skiftede til pasireotid til intramuskulær anvendelse (-24,7 %), end hos patienter, der skiftede til octreotid til intramuskulær anvendelse (-17,9 %).
English: Biochemical control was achieved early in the study (i.e. month 3) by a higher proportion of patients in the pasireotide intramuscular use arm than in the octreotide intramuscular use arm (30.1% and 21.4%) and was maintained in all subsequent evaluations during the core phase.
Danish: Biokemisk kontrol blev opnået tidligt i studiet (dvs. måned 3) hos en højere andel af patienter i armen med pasireotid til intramuskulær anvendelse end i armen med octreotid til intramuskulær anvendelse (30,1 % og 21,4 %) og blev opretholdt ved alle efterfølgende evalueringer i løbet af hovedfasen.
English: Multipack containing 3 intermediate cartons
Danish: Multipakning, der indholder 3 delpakninger
English: Sinus bradycardia*, QT prolongation
Danish: Sinus-bradykardi*, QTforlængelse
English: Renal clearance has a minor contribution to the elimination of pasireotide in humans.
Danish: Clearance via nyrerne spiller en mindre rolle i udskillelsen af pasireotid hos mennesker.
English: Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit.
Danish: To måneder efter behandlingsstart med Signifor skal der foretages en klinisk evaluering af den gavnlige virkning på patienterne.
English: Signifor 40 mg and Signifor 60 mg are also available in multipacks containing 3 intermediate packs.
Danish: Signifor 40 mg og Signifor 60 mg fås også i multipakninger, der indeholder 3 delpakninger.
English: The study met the primary efficacy objective for the 0.9 mg twice-daily group as the lower limit of the 95% CI is greater than the pre-specified 15% boundary.
Danish: Studiet opfyldte det primære effektivitetsmål for den gruppe, der fik 0,9 mg to gange dagligt, eftersom den nedre grænse af 95% CI er mere end den forud fastsatte grænse på 15%.
English: Signifor is intended for intramuscular use.
Danish: Signifor er beregnet til intramuskulær anvendelse.
English: The solution should be free of visible particles, clear and colourless.
Danish: Opløsningen skal være fri for synlige partikler, klar og farveløs.
English: Median change in UFC (% from baseline)
Danish: Median ændring i UFC (% fra baseline)
English: Due to its broad binding profile to somatostatin receptors, pasireotide has the potential to stimulate both hsst2 and hsst5 subtype receptors relevant for inhibition of GH and IGF-1 secretion and therefore to be effective for the treatment of acromegaly.
Danish: På grund af stoffets brede bindingsprofil til somatostatinreceptorer kan pasireotid potentielt stimulere receptorer af både subtype hsst2 og hsst5, som er relevante for hæmning af GH- og IGF-1-sekretion, og dermed være effektivt til behandling af akromegali.
English: Sinus bradycardia includes bradycardia and sinus bradycardia.
Danish: Sinusbradykardi inkluderer bradykardi og sinusbradykardi.
English: If you interrupt your treatment with Signifor your symptoms may come back.
Danish: Hvis du afbryder behandlingen med Signifor, kan dine symptomer vende tilbage.
English: Hypocortisolism
Danish: Hypokortisolisme
English: Make sure there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.
Danish: Kontroller, at der ikke er nogen luftbobler i sprøjten ved at trykke stemplet ind, indtil den første dråbe kommer ud af spidsen af kanylen.
English: The overall incidence of hyperglycaemia-related adverse reactions was 75.3% (all grades) and 22.7% (CTC Grade 3).
Danish: Den samlede incidens af hyperglykæmi-relaterede bivirkninger var 75,3 % (alle grader) og 22,7 % (CTC-grad 3).
English: Signifor is thus able to block the production of ACTH, helping to control the over-production of cortisol and improve the symptoms of Cushing's disease.
Danish: Signifor er derfor i stand til at blokere produktionen af ACTH, der hjælper med at kontrollere overproduktionen af kortisol, og dæmpe symptomerne på Cushings sygdom.
English: This medicine will be given to you by a trained healthcare professional.
Danish: Du vil få denne medicin af relevant uddannet sundhedspersonale.
English: Recommended procedure: hold the ampoule in an upright position with the coloured dot facing away from you.
Danish: Anbefalet fremgangsmåde: Hold ampullen lodret med det farvede punkt vendt væk fra dig.
English: No change in the pharmacokinetics (rate or extent of exposure) of pasireotide was observed.
Danish: Der blev ikke observeret nogen ændring i pasireotids farmakokinetik (hastighed eller eksponeringsgrad).
English: Monitoring of liver function is recommended prior to treatment with pasireotide intramuscular use and after the first two to three weeks, then monthly for three months on treatment.
Danish: Monitorering af leverfunktion anbefales før påbegyndelse af behandling med pasireotid til intramuskulær anvendelse og efter de første to til tre uger og derefter månedligt i tre måneder af behandlingen.
English: During the pivotal study, HbA1c levels increased significantly and stabilised but did not return to baseline values (see section 4.8).
Danish: Under det pivotale studie steg HbA1c-niveauer signifikant og stabiliseredes, men de vendte ikke tilbage til baseline-niveau (se pkt.
English: In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were mostly grade 1 or 2 in severity.
Danish: I fase III-studierne var reaktioner relateret til injektionsstedet (fx smerte på injektionsstedet, ubehag på injektionsstedet) hovedsagelig af sværhedsgrad 1 eller 2.
English: If no clinical benefit is observed, the patient should be considered for discontinuation.
Danish: Hvis der ikke observeres nogen klinisk fordel, bør det overvejes at seponere patientens behandling.
English: - Slow heart beat.
Danish: - Langsomme hjerteslag.
English: If side effects occur your doctor may temporarily reduce your dose by 0.3 mg per injection.
Danish: Hvis der opstår bivirkninger, kan din læge midlertidigt vælge at nedsætte din dosis til 0,3 mg pr. injektion.
English: Overall reductions in these parameters were observed in patients with full and partial mean UFC control but tended to be greater in patients with normalised UFC.
Danish: Der blev observeret generelle fald i disse parametre hos patienter med fuldt og delvist kontrolleret gennemsnitlig UFC, men der var en tendens til større fald i disse parametre hos patienter med normaliseret UFC.
English: Amylase increased, prothrombin time prolonged
Danish: Forhøjet amylase, forlænget protrombintid
English: • cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
Danish: • cholinesterasehæmmere (rivastigmin, physostigmin); - medicin, der bruges til at kontrollere elektrolytbalancen (kalium, magnesium) i kroppen.
English: Glycaemic status (fasting plasma glucose/haemoglobin A1c [FPG/HbA1c]) should be assessed prior to starting treatment with pasireotide.
Danish: Den glykæmiske status (fastende plasmaglucose/hæmoglobin A1c [FPG/HbA1c]) skal vurderes, før behandling med pasireotid påbegyndes.
English: Somatostatin analogues bind to hsst receptors with different potencies (see Table 2).
Danish: Somatostatinanaloger binder sig til hsst-receptorer med forskellig styrke (se Tabel 2).
English: If you have liver disease before you start Signifor treatment for acromegaly, your doctor may want to start your treatment with a dose of 20 mg.
Danish: Hvis du har leversygdom før du starter i behandling med Signifor for akromegali, vil din læge muligvis vurdere, at du skal starte behandlingen med en dosis på 20 mg.
English: This leads the body to over-produce a hormone called adrenocorticotropic hormone (ACTH), which in turn results in over-production of another hormone called cortisol.
Danish: Det får kroppen til at producere for meget af det såkaldte adenokortikotropiske hormon (ACTH), hvilket igen forårsager overproduktion af et andet hormon, som kaldes kortisol.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, d.v.s. den er i det væsentlige natriumfri.
English: Slowly depress the plunger until the syringe is empty.
Danish: Pres langsomt stemplet i bund, indtil sprøjten er tom.
English: If concomitant use of coumarin-derivative or heparin-derivative anticoagulants with Signifor intramuscular use cannot be avoided, patients should be monitored regularly for alterations in their coagulation parameters (PT and PTT) and the anticoagulant dose adjusted accordingly.
Danish: Hvis samtidig anvendelse af coumarin- eller heparinlignende antikoagulantia og Signifor til intramuskulær anvendelse ikke kan undgås, skal patienterne monitoreres regelmæssigt for ændringer i koagulationsparametre (PT og PTT), og antikoagulansdosis skal justeres derefter.
English: During the extension phase, 74 patients continued receiving pasireotide intramuscular use and 46 patients continued with octreotide intramuscular use treatment.
Danish: I forlængelsesfasen fortsatte 74 patienter med pasireotid til intramuskulær anvendelse, og 46 patienter fortsatte med octreotid til intramuskulær anvendelse.
English: Pasireotide intramuscular use n (%) N=176
Danish: Pasireotid intramuskulær anvendelse n (%) N=176
English: In Cushing's disease, the safety assessment of the intramuscular formulation was made based on 150 patients who received pasireotide in the phase III study G2304 (median duration of exposure: 57 weeks).
Danish: For Cushings sygdom blev en sikkerhedsvurdering af den intramuskulære formulering foretaget og var baseret på 150 patienter, som fik pasireotid i fase III-studiet G2304 (median eksponeringsvarighed: 57 uger).
English: In the event of documented hypocortisolism, temporary exogenous steroid (glucocorticoid) replacement therapy and/or dose reduction or interruption of Signifor therapy may be necessary.
Danish: I tilfælde af dokumenteret hypokortisolisme kan det være nødvendigt med temporær eksogen steroid (glukokortikoid) erstatningsterapi og/eller dosisreduktion eller afbrydelse af behandlingen med Signifor.
English: Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogues due to the association between cholelithiasis and acute pancreatitis.
Danish: Pancreatitis er en potentiel bivirkning i forbindelse med brug af somatostatinanaloger på grund af sammenhængen mellem kolelitiasis og akut pancreatitis.
English: If uncontrolled hyperglycaemia persists despite appropriate medical management, the dose of Signifor should be reduced or Signifor treatment discontinued (see also section 4.5).
Danish: Hvis hyperglykæmien ikke kan bringes under kontrol trods passende medicinering, skal dosis af Signifor reduceres eller behandling med Signifor ophøre (se også pkt 4.5).
English: Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Danish: Behandling af voksne patienter med akromegali, hvor operation ikke er en mulighed eller ikke har været helbredende, og som ikke er tilstrækkeligt kontrolleret ved behandling med en anden somatostatinanalog.
English: Nearly half of the patients had additional prior medical treatment for acromegaly other than somatostatin analogues.
Danish: Næsten halvdelen af patienterne havde desuden tidligere fået anden behandling for akromegali end somatostatinanaloger.
English: The adverse reactions in Table 1 include events reported in the pivotal studies with the intramuscular formulation in patients with acromegaly and with Cushing's disease.
Danish: Bivirkningerne i tabel 1 omfatter hændelser, der blev rapporteret i pivotalstudierne med den intramuskulære formulering hos patienter med akromegali og med Cushings sygdom.
English: The degree of hyperglycaemia appeared to be higher in patients with pre-diabetic conditions or established diabetes mellitus.
Danish: Graden af hyperglykæmi viste sig at være højere hos patienter med prædiabetes eller konstateret diabetes mellitus.
English: It is particularly important that you mention any of the following medicines: - ciclosporin (used in organ transplantation to reduce the activity of the immune system); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low (hypoglycaemia), such as:
Danish: Det er særligt vigtigt at du fortæller det, hvis du bruger noget af følgende medicin: - ciclosporin (bruges ved organtransplantationer til at nedsætte aktiviteten af immunforsvaret); - medicin, der bruges til at behandle for højt blodsukker (som ved diabetes) eller for lavt (hypoglykæmi), som fx:
English: One Signifor ampoule
Danish: En Signifor-ampul
English: If you stop using Signifor
Danish: Hvis du holder op med at bruge Signifor
English: - Extreme tiredness.
Danish: - Ekstrem træthed.
English: In the pivotal study with patients who did not receive prior medical treatment, the proportion of patients who required commencement of anti-diabetic therapy during the study was 36% in the Signifor arm compared to 4.4% in the active control arm.
Danish: I pivotalstudiet med patienter, der ikke tidligere havde fået medicinsk behandling, var andelen af patienter med behov for at starte i antidiabetisk behandling under studiet 36 % i Signifor-armen sammenlignet med 4,4 % i armen med aktiv kontrol.
English: No studies have been conducted to evaluate the absolute bioavailability of pasireotide in humans.
Danish: Der er ikke udført studier til evaluering af den absolutte biotilgængelighed af pasireotid hos mennesker.
English: Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor.
Danish: Håndtering af formodede bivirkninger, på et hvilket som helst tidspunkt i løbet af behandlingen, kan kræve midlertidig reduktion af Signifor-dosis.
English: If hyperglycaemia develops in a patient being treated with Signifor, the initiation or adjustment of antidiabetic treatment is recommended, following the established treatment guidelines for the management of hyperglycaemia.
Danish: Hvis der udvikles hyperglykæmi hos en patient, der behandles med Signifor, anbefales det at påbegynde eller justere diabetesbehandling jævnfør etablerede behandlingsvejledninger for hyperglykæmi.
English: Do not use Signifor - if you are allergic to pasireotide or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Signifor - hvis du er allergisk over for pasireotid eller et af de øvrige indholdsstoffer i Signifor (angivet i punkt 6).
English: Signifor may have a minor influence on the ability to drive and use machines.
Danish: Signifor påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • beta blockers (metoprolol, carteolol, propranolol, sotalol)
Danish: • betablokkere (metoprolol, carteolol, propranolol, sotalol)
English: A total of 198 patients were randomised to receive pasireotide intramuscular use 40 mg (n=65), pasireotide intramuscular use 60 mg (n=65) or active control (n=68).
Danish: I alt 198 patienter blev randomiseret til at få pasireotid 40 mg til intramuskulær anvendelse (n=65), pasireotid 60 mg til intramuskulær anvendelse (n=65) eller aktiv kontrol (n=68).
English: Remove the lid film of the vial adapter packaging, but do NOT remove the vial adapter from its packaging.
Danish: Fjern filmlåget fra hætteglasadapterens pakning, men fjern IKKE hætteglasadapteren fra pakningen.
English: The control may be too strong and you may experience signs or symptoms associated with a lack of cortisol, such as extreme weakness, tiredness, weight loss, nausea, vomiting or low blood pressure.
Danish: Kontrollen kan blive for stærk, og du vil måske opleve tegn eller symptomer på kortisolmangel, fx ekstrem svaghed, træthed, vægttab, opkastning eller lavt blodtryk.
English: In medically naïve patients (study C2305), the mean absolute increase in FPG and HbA1c was similar at most of the time points for all patients treated with pasireotide intramuscular use irrespective of baseline values.
Danish: Hos behandlingsnaive patienter (studie C2305) var den absolutte middelstigning i FPG og HbA1c på de fleste tidspunkter sammenlignelig hos alle patienter, der blev behandlet med pasireotid til intramuskulær anvendelse, uanset baselineniveau.
English: In addition, monitoring of FPG 4 weeks and HbA1c 3 months after the end of the treatment should be performed.
Danish: Derudover bør monitorering af FPG og HbA1c fortsætte i henholdsvis 4 uger og 3 måneder efter afsluttet behandling.
English: After four months of treatment, patients with mUFC ≤1.5xULN continued on the blinded dose to which they were randomised, and patients with mUFC >1.5xULN had their doses increased in a blinded manner from 10 mg to 30 mg, or from 30 mg to 40 mg, provided there were no tolerability concerns.
Danish: Efter fire måneders behandling fortsatte patienter med mUFC ≤1,5xULN med den blindede dosis, de var randomiseret til, og patienter med mUFC >1,5xULN fik øget deres blindede dosis fra 10 mg til 30 mg eller fra 30 mg til 40 mg, forudsat at der ikke var tolerabilitetsproblemer.
English: Health-related quality of life measured by AcroQol indicated statistically significant improvements from baseline to week 24 in the Physical, Psychological-Appearance and Global scores for the 60 mg group and the Physical sub-score for the 40mg group.
Danish: Helbredsrelateret livskvalitet målt med AcroQol indikerede statistisk signifikante forbedringer fra baseline til uge 24 i fysisk, psykologisk fremtoning og global score for 60 mg-gruppen og den fysiske delscore for 40 mg-gruppen.
English: If a dose of Signifor is missed the missed injection should be administered as soon as possible.
Danish: Hvis en Signifor-dosis glemmes, skal den glemte injektion administreres hurtigst muligt.
English: If the finding is confirmed, the patient should be followed with frequent liver function monitoring until values return to pre-treatment levels.
Danish: Hvis den fundne værdi bekræftes, bør patienten følges med hyppig leverfunktionsmonitorering indtil værdierne vender tilbage til samme niveau som før påbegyndelse af behandlingen.
English: Reductions in serum cortisol and plasma ACTH levels were also observed at month 7 and 12 for each dose group.
Danish: Der blev også observeret reduktioner i serumkortisol og plasma-ACTH-niveauerne ved måned 7 og 12 for hver doseringsgruppe.
English: In clinical studies in Cushing's disease patients, QTcF of >500 msec was observed in two out of 201 patients.
Danish: I kliniske studier med patienter med Cushings sygdom er der observeret QTcF >500 msek hos to ud af 201 patienter.
English: Switch from subcutaneous to intramuscular formulation in Cushing's disease There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation.
Danish: Skift fra subkutan til intramuskulær formulering i Cushings sygdom Der er ingen tilgængelige kliniske data på skift fra subkutan til intramuskulær pasireotidformulering.
English: Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 10 mg to 60 mg every 4 weeks.
Danish: Efter gentagne månedlige doser udviser pasireotid til intramuskulær anvendelse tilnærmelsesvist dosisproportionale farmakokinetiske eksponeringer i dosisintervallet 10 mg til 60 mg hver 4. uge.
English: The therapeutic benefits of a reduction in growth hormone (GH) levels and normalisation of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients and 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 af væksthormon (GH)-koncentrationen og ved normalisering af koncentrationen af insulin-lignende vækstfaktor 1 (IGF-1) hos kvindelige patienter med akromegali og ved reduktion eller normalisering af serumkortisol-niveauer hos kvindelige patienter med Cushings sygdom kan potentielt genoprette fertiliteten.
English: Ampoules of Signifor of different strengths (0.3 mg, 0.6 mg and 0.9 mg) are available to match the specific dose prescribed by your doctor.
Danish: Signifor-ampuller er tilgængelige i forskellige styrker (0,3 mg, 0,6 mg og 0,9 mg), så de svarer til den specifikke dosis, som din læge har ordineret.
English: Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
Danish: PK-populationsanalyser af pasireotid til intramuskulær anvendelse tyder på, at race ikke påvirker PKparametrene.
English: Mean improvements from baseline were greater for pasireotide intramuscular use than for octreotide intramuscular use with no statistical significance.
Danish: Gennemsnitsforbedringerne fra baseline var større for pasireotid til intramuskulær anvendelse end for octreotid til intramuskulær anvendelse uden statistisk signifikans.