FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapid decreases in cortisol levels may be associated with decreases in white blood cell count.
Danish: Et hurtigt fald i kortisol-niveauet kan være forbundet med fald i antallet af hvide blodlegemer.
English: Hypokalaemia and/or hypomagnesaemia must be corrected prior to administration of Signifor and should be monitored periodically during therapy.
Danish: Hypokaliæmi og/eller hypomagnesiæmi skal korrigeres, før der gives Signifor, og skal monitoreres periodisk under behandlingen.
English: The human body naturally produces a substance called somatostatin, which blocks the production of certain hormones, including ACTH.
Danish: Kroppen producerer naturligt et stof, som kaldes somatostatin, der blokerer produktionen af visse hormoner, herunder ACTH.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue, dizziness or headache during treatment with Signifor.
Danish: Patienter bør rådes til at være forsigtige ved kørsel og ved betjening af maskiner, hvis de oplever træthed, svimmelhed eller hovedpine under behandling med Signifor.
English: How to inject Signifor
Danish: Hvordan du indsprøjter Signifor
English: For a range of 60-100 kg the reduction in AUCss with increasing weight is predicted to be approximately 27%, which is considered moderate and of minor clinical significance.
Danish: Inden for området 60-100 kg forudsiges reduktionen af AUC ss at være ca. 27% med stigende vægt, hvilket betragtes som moderat og af mindre klinisk betydning.
English: The eligibility criteria included a mean urinary free cortisol (mUFC) value of between 1.5 and 5 times upper limit of normal (ULN) at screening.
Danish: Udvælgelseskriterierne omfattede en gennemsnitsværdi af frit kortisol i urin (mUFC) på mellem 1,5 og 5 gange den øvre normale grænse (ULN) ved screening.
English: This may involve measuring the levels of cortisol in your blood or urine.
Danish: Det kan eventuelt indebære at måle niveauet af kortisol i dit blod eller din urin.
English: • After adding the solvent, shake the vial moderately for a minimum of 30 seconds until a uniform suspension is formed.
Danish: • Efter tilsætning af solvens rystes hætteglasset moderat i mindst 30 sekunder, indtil der er dannet en ensartet suspension.
English: The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female.
Danish: Patienternes gennemsnitsalder var ca. 40 år, og flertallet af patienterne (77,8%) var kvinder.
English: IGF-1 mean values at baseline were 2.6, 2.8 and 2.9 x ULN, respectively.
Danish: Middel-IGF-1 ved baseline var henholdsvis 2,6, 2,8 og 2,9 x ULN.
English: Most findings seen in repeated toxicity studies were reversible and attributable to the pharmacology of pasireotide.
Danish: De fleste af de resultater, der er set i gentagne toksicitetsundersøgelser, har været reversible og skyldtes pasireotids farmakologi.
English: Pasireotide was not genotoxic in in vitro and in vivo assays.
Danish: Pasireotid har ikke været genotoksisk i in vitro- og in vivo-assays.
English: - Store in a refrigerator (2°C-8°C).
Danish: - Opbevares i køleskab (2 °C-8 °C).
English: During your treatment with Signifor - Signifor controls over-production of cortisol.
Danish: Under din behandling med Signifor - Signifor kontrollerer overproduktion af kortisol.
English: Table 1 Adverse reactions by preferred term for pasireotide intramuscular use
Danish: Tabel 1 Bivirkninger efter foretrukken term for pasireotid til intramuskulær anvendelse
English: Multipack: 3 packs of 1 injection kit
Danish: Multipakning: 3 pakninger med 1 injektionskit
English: Note: If not used within 24 hours, the injection kit can be returned to the fridge.
Danish: Bemærk: Hvis det ikke anvendes inden for 24 timer, kan kittet sættes tilbage i køleskabet.
English: If you see blood in the syringe, first remove the needle from the skin, then replace the short needle with a new one and insert it into a different injection site.
Danish: Hvis du ser blod i sprøjten, skal du først fjerne kanylen fra huden og derefter udskifte den korte kanyle med en ny kanyle og finde et andet injektionssted.
English: Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
Danish: Gentag den moderate omrystning i endnu 30 sekunder, hvis pulveret ikke er fuldstændigt opslæmmet.
English: In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient's clinical status, until resolution of the symptoms.
Danish: I tilfælde af overdosering anbefales passende understøttende behandling baseret på patientens kliniske status, indtil symptomerne forsvinder.
English: Rapid, complete or near-complete suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially to transient hypocortisolism/hypoadrenalism.
Danish: Hurtig, fuldstændig eller næsten fuldstændig undertrykkelse af ACTH kan medføre, at det cirkulerende kortisolniveau falder, og at der forbigående kan forekomme hypokortisolisme/hypoadrenalisme.
English: Pasireotide 10 mg N=74
Danish: Pasireotid 10 mg N=74
English: The response in the 0.9 mg dose arm seemed to be higher for patients with lower mean UFC at baseline.
Danish: Responsen hos 0,9 mg-doseringsgruppen syntes at være højere hos patienter med et lavere gennemsnitligt UFC ved baseline.
English: Crossover phase
Danish: Crossover-fase
English: The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.
Danish: Den næste dosis skal derefter planlægges til 4 uger efter injektionen er administreret således, at der fortsættes i det normale regime med en dosis hver 4. uge.
English: These episodes were sporadic and of single occurrence with no clinical consequence observed.
Danish: Disse episoder var sporadiske, forekom kun én gang, og der observeredes ingen kliniske følger.
English: Pasireotide for intramuscular use is formulated as microspheres for long-acting release.
Danish: Pasireotid til intramuskulær anvendelse er formuleret som mikrosfærer med langtidvirkende udløsning.
English: The thighs and the abdomen are good areas for subcutaneous injection.
Danish: Lårene og maven er gode områder for subkutane injektioner.
English: At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery.
Danish: Ved måned 12 var reduktionen i tumorvolumen sammenlignelig mellem behandlingsgrupperne og hos patienter med og uden forudgående hypofyseoperation.
English: Pasireotide binds with high affinity to four of the five hssts.
Danish: Pasireotid binder sig med høj affinitet til fire af de fem hsst'er.
English: Based on in vitro data pasireotide appears to be a substrate of efflux transporter P-gp (P-glycoprotein).
Danish: Baseret på in-vitro data synes pasireotid at være et substrat for effluxtransportøren P-gp (Pglykoprotein).
English: Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine.
Danish: Graviditet, amning og frugtbarhed Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: Population pharmacokinetic analyses of Signifor suggest that race and gender do not influence pharmacokinetic parameters.
Danish: Farmakokinetiske populationsanalyser af Signifor tyder på, at race og køn ikke påvirker de farmakokinetiske parametre.
English: Before you proceed to step 4, clean the injection site with an alcohol wipe.
Danish: Før du fortsætter til trin 4, skal du rense injektionsstedet med en spritserviet.
English: You may experience sudden back pain or pain in the right side of your abdomen.
Danish: Du kan opleve pludselige rygsmerter eller smerter i højre side af maven.
English: The frequency and severity of adverse reactions tended to be higher with the higher starting dose of 30 mg, but this was not consistent for all adverse reactions.
Danish: Der sås en tendens til øget hyppighed og sværhedsgrad af bivirkninger ved den højere startdosis på 30 mg, men dette var ikke konsekvent for alle bivirkninger.
English: Pasireotide should be used with caution and the benefit risk carefully weighed in patients who are at significant risk of developing prolongation of QT, such as those: - with congenital long QT syndrome.
Danish: Pasireotid skal anvendes med forsigtighed og benefit-risk forholdet skal afvejes nøje hos patienter, der har signifikant risiko for at udvikle QT-forlængelse, for eksempel: - ved medfødt lang QT-syndrom.
English: Three-quarters of patients had previously been treated with octreotide intramuscular use and a quarter with lanreotide deep subcutaneous injection.
Danish: Tre fjerdedele af patienterne var tidligere blevet behandlet med octreotid til intramuskulær anvendelse og en fjerdedel med lanreotid som dyb subkutan injektion.
English: If response was not achieved at month 6 or if the response was not maintained during the open-label treatment period, dosage could be increased by 0.3 mg twice daily.
Danish: Hvis der ikke var opnået respons efter 6 måneder, eller hvis responsen ikke opretholdtes i den åbne behandlingsperiode, kunne doseringen øges med 0,3 mg to gange dagligt.
English: During the extension phase, tumour volume continued to decrease.
Danish: I løbet af forlængelsesfasen så man en fortsat reduktion i tumorvolumen.
English: Pasireotide 30 mg N=76
Danish: Pasireotid 30 mg N=76
English: Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg twice daily.
Danish: Patienter, som ikke opfyldte disse kriterier, blev afblindet, og dosis øgedes med 0,3 mg to gange dagligt.
English: If such a switch should be required, it is recommended to maintain an interval of at least 28 days between the last intramuscular injection and the first subcutaneous injection, and to initiate the subcutaneous injections at a dose of 0.6 mg pasireotide twice a day.
Danish: Hvis et sådan skift er påkrævet, anbefales det at opretholde et interval på mindst 28 dage mellem den sidste intramuskulære injektion og den første subkutane injektion, og at de subkutane injektioner initieres i en dosis på 0,6 mg pasireotid to gange dagligt.
English: At month 7, most patients demonstrated either improvement in or stable signs of Cushing's disease such as hirsuitism, striae, bruising and muscle strength.
Danish: Ved måned 7 udviste de fleste patienter enten forbedring eller stabilisering af tegn på Cushings sygdom som for eksempel hirsutisme, striae, blå mærker og muskelstyrke.
English: The apparent clearance (CL/F) of pasireotide intramuscular use in healthy volunteers is on average 4.5-8.5 litres/h.
Danish: Den tilsyneladende clearance (CL/F) af pasireotid til intramuskulær anvendelse hos raske frivillige er i gennemsnit 4,5-8,5 l/t.
English: In vitro studies have shown that corticotroph tumour cells from Cushing's disease patients display a high expression of hsst5, whereas the other receptor subtypes either are not expressed or are expressed at lower levels.
Danish: In vitro-studier har vist, at kortikotrope tumorceller fra patienter med Cushings sygdom har et højt hsst5-ekspressionsniveau, mens de andre receptorundertyper enten ikke eksprimeres eller eksprimeres i mindre omfang.
English: The dose should not exceed 40 mg.
Danish: Dosis bør ikke overstige 40 mg.
English: GH <2.5 μg/l
Danish: GH <2,5 µg/l
English: The mean age was 35.8 years, and the majority of patients were female (78.8%).
Danish: Gennemsnitsalderen var 35,8 år, og størstedelen af patienterne var kvinder (78,8 %).
English: • The injection kit must reach room temperature.
Danish: • Injektionskittet skal opnå stuetemperatur.
English: Therefore, do not stop using Signifor unless your doctor tells you to.
Danish: Hold derfor ikke op med at bruge Signifor, medmindre din læge giver dig besked om det.
English: Monitoring of liver function is recommended prior to treatment with pasireotide and after one, two, four, eight and twelve weeks during treatment.
Danish: Monitorering af leverfunktion anbefales før påbegyndelse af behandling med pasireotid og efter en, to, fire, otte og tolv uger under behandlingen.
English: Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Danish: Følg nedenstående vejledning nøje for at sikre korrekt rekonstitution af Signifor pulver og solvens til injektionsvæske, suspension før dyb intramuskulær injektion.
English: The dose should not exceed 60 mg.
Danish: Dosis bør ikke overstige 60 mg.
English: Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
Danish: Der rapporteredes bivirkninger af grad 1 og 2 hos 57,4% af patienterne.
English: Hold the base of the ampoule in one hand.
Danish: Hold den nederste del af ampullen i den ene hånd.
English: You should also avoid injections at sites that are sore or where the skin is irritated.
Danish: Du bør også undgå at tage injektionen, hvor du er øm, eller huden er irriteret.
English: Facial rubor improved in 43.5% (47/108) of patients, and more than a third of patients demonstrated improvement in supraclavicular fat pad (34.3%) and dorsal fat pad (34.6%).
Danish: Ansigtsrødmen var forbedret hos 43,5 % (47/108) af patienterne, og over en tredjedel af patienterne udviste forbedring i supraclavikulær fedtpude (34,3 %) og dorsal fedtpude (34,6 %).
English: Very common
Danish: Meget almindeligt
English: During your treatment with Signifor: - Signifor may cause your blood sugar to increase.
Danish: Under din behandling med Signifor - Signifor kan få dit blodsukker til at stige.
English: Changes for the octreotide intramuscular use or lanreotide deep subcutaneous injection group were not statistically significant.
Danish: Ændringerne i grupperne, der fik octreotid til intramuskulær anvendelse eller lanreotid som dyb subkutan injektion, var ikke statistisk signifikante.
English: Baseline demographics were well balanced between the two randomised dose groups and consistent with the epidemiology of the disease.
Danish: Ved baseline var der en god demografisk balance mellem de to randomiserede grupper, som også var i overensstemmelse med sygdommens epidemiologi.
English: Paediatric population No studies have been performed in paediatric patients.
Danish: Pædiatrisk population Der er ikke gennemført studier med pædiatriske patienter.
English: The study met the primary efficacy objective for both dose groups (lower bound of the 95% CI for the response rate of each treatment arm >15%).
Danish: Studiet nåede det primære effektivitetsmål for begge doseringsgrupper (nedre grænse for 95 % CI for responsrate i hver behandlingsarm >15 %).
English: Switch from intramuscular to subcutaneous formulation
Danish: Skift fra intramuskulær til subkutan formulering
English: Do not inject a double dose of Signifor to make up for a forgotten dose.
Danish: Du må ikke indsprøjte en dobbeltdosis af Signifor som erstatning for den glemte dosis.
English: The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter.
Danish: Patienten skal have foretaget en klinisk evaluaering af den gavnlige virkning efter den første behandlingsmåned og periodisk herefter.
English: The median exposure to the treatment up to the cut-off date of the primary efficacy and safety analysis was 10.37 months (0.03-37.8), with 66.0% of patients having at least six months' exposure.
Danish: Medianeksponeringen indtil afskæringsdatoen for den primære virknings- og sikkerhedsanalyse var 10,37 måneder (0,03-37,8), og 66,0% af patienterne havde været eksponeret i mindst seks måneder.
English: If you interrupt your treatment with Signifor your cortisol level may increase again and your symptoms may come back.
Danish: Hvis du afbryder behandlingen med Signifor, kan dit kortisolniveau stige igen, og dine symptomer kan vende tilbage.
English: Like the natural peptide hormones somatostatin-14 and somatostatin-28 (also known as somatotropin release inhibiting factor [SRIF]) and other somatostatin analogues, pasireotide exerts its pharmacological activity via binding to somatostatin receptors.
Danish: Ligesom de naturlige hormoner somatostatin-14 og somatostatin-28 (også kaldet somatotropin release inhibiting factor [SRIF]) og andre somtatostatinanaloger udøver pasireotid sin farmakologiske virkning ved binding til somatostatinreceptorer.
English: The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor at 40 mg.
Danish: Dosis kan øges til højst 60 mg hos patienter, hvis serumkoncentration af væksthormon (GH) og/eller insulin-lignende vækstfaktor-1 (IGF-1) ikke er fuldt ud kontrolleret efter 3 måneders behandling med Signifor 40 mg.
English: After you have started treatment, your doctor may reassess your dose.
Danish: Efter du er startet i behandling, kan din læge eventuelt revurdere din dosis.
English: • calcium channel blockers (bepridil, verapamil, diltiazem)
Danish: • calciumantagonister (bepridil, verapamil, diltiazem)
English: If not used within 24 hours, the injection kit can be returned to the fridge.
Danish: Hvis det ikke anvendes inden for 24 timer, kan kittet sættes tilbage i køleskabet.
English: It is unknown whether pasireotide is excreted in human milk.
Danish: Det er ukendt om pasireotid udskilles i human mælk.
English: Health-related quality of life was assessed by a disease-specific patient-reported outcome measure (CushingQoL) and a generic quality of life measure (SF-12v2 General Health Survey).
Danish: Helbredsrelateret livskvalitet blev vurderet ud fra en sygdomsspecifik patientrapporteret målemetode (CushingQoL) og en generisk livskvalitetsmåling (SF-12v2 General Health Survey).
English: If you have been told to use two needles, you should now replace the long needle with the short one.
Danish: Hvis du bruger to kanyler, skal du nu udskifte den lange kanyle med den korte.
English: Octreotide intramuscular use n (%) N=182
Danish: Octreotid intramuskulær anvendelse n (%) N=182
English: A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Danish: I alt 201 patienter med Cushings sygdom har fået Signifor i fase II- og III-studier.
English: Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Danish: Tabel 5 Vigtigste resultater - fase III-studie af patienter med Cushings sygdom (intramuskulær formulering)
English: The adenoma leads the body to over-produce hormones that control growth of tissues, organs and bones, resulting in an increase in the size of bones and tissues, especially in the hands and feet.
Danish: Adenomet får kroppen til at producere for meget af de hormoner, der styrer væksten af væv, organer og knogler, således at knoglernes og vævets størrelse øges, især i hænderne og fødderne.
English: In patients treated with pasireotide intramuscular use in whom reductions in GH and IGF-1 levels were observed, these changes occurred during the first 3 months of treatment and were maintained up to week 24.
Danish: Hos patienter, der blev behandlet med pasireotid til intramuskulær anvendelse, og hvor der blev observeret et fald i GH- og IGF-1-koncentrationerne, skete ændringerne i løbet af de første 3 behandlingsmåneder og blev opretholdt indtil uge 24.
English: Based on the local clinical practice, your doctor or nurse will tell you which method to use.
Danish: Afhængigt af lokal praksis vil din læge eller sygeplejerske fortælle dig, hvor mange kanyler du skal bruge.
English: DO NOT USE if the medicine has expired or if the dose is incorrect.
Danish: BRUG IKKE medicinen, hvis udløbsdatoen er overskredet eller hvis doseringen er forkert.
English: In the pre- and postnatal study in rats, pasireotide had no effects on labour and delivery, but caused slight retardation in the development of pinna detachment and reduced body weight of the offspring.
Danish: I den præ- og postnatale undersøgelse med rotter havde pasireotid ingen indvirkning på fødselsveer og nedkomst, men medførte en let forsinkelse i udviklingen af frigørelse af det ydre øre og reduktion af afkommets kropsvægt.
English: The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug interaction study in healthy volunteers.
Danish: P-gp-hæmmeren verapamils indflydelse på farmakokinetikken af subkutan pasireotid blev undersøgt i et lægemiddelinteraktionsstudie med raske frivillige.
English: * Cholecystitis includes cholecystitis acute
Danish: *Kolecystitis inkluderer akut kolecystitis
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Danish: Farmakoterapeutisk klassifikation: hypofyse- og hypothalamushormoner og analoger, somatostatin og analoger, ATC-kode: H01CB05
English: Health-related quality of life measured by AcroQol indicated statistically significant improvements in the Physical, Psychological-Appearance and Global scores in both treatment groups at month 12.
Danish: Helbredsrelateret livskvalitet målt med AcroQol viste statistisk signifikante forbedringer i fysisk, psykologisk fremtoning og global score i begge behandlingsgrupper ved måned 12.
English: Based on population pharmacokinetic (PK) analyses, the estimated CL/F was approximately 4.8 to 6.5 litres/h for typical Cushing's disease patients, and approximately 5.6 to 8.2 litres/h for typical acromegaly patients.
Danish: Baseret på farmakokinetiske (PK) populationsanalyser var den estimerede CL/F ca. 4,8 til 6,5 liter/t for typiske patienter med Cushings sygdom og ca. 5,6 til 8,2 liter/t for typiske akromegalipatienter.
English: Not all strengths or pack sizes may be marketed in your country.
Danish: Ikke alle styrker eller pakningsstørrelser er nødvendigvis markedsført i dit land.
English: In healthy volunteers, pasireotide is predominantly found in unchanged form in plasma, urine and faeces.
Danish: Hos raske forsøgspersoner findes pasireotid hovedsagelig i uændret form i plasma, urin og fæces.
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding.
Danish: Patienter, der udvikler forøgede transaminaseniveauer, bør monitoreres med en yderligere leverfunktionstest for at bekræfte den fundne værdi.
English: More cases of discontinuation and a higher reporting rate of severe adverse events due to hyperglycaemia were reported in patients treated with the dose of 0.9 mg twice daily.
Danish: Flere tilfælde af seponering samt en højere rapporteringsratio af alvorlige bivirkninger pga. hyperglykæmi blev rapporteret hos patienter, som blev behandlet med en dosis på 0,9 mg to gange dagligt.
English: Signifor suspension must only be prepared immediately before administration.
Danish: Signifor suspension skal først tilberedes umiddelbart inden administration.
English: 6 ampoules.
Danish: 6 ampuller.
English: Depending on the results and how you are feeling, the dose of Signifor given in each injection may need to be reduced or increased.
Danish: Afhængigt af resultaterne og af, hvordan du har det, vil din Signifor-dosis i hver injektion måske skulle sættes ned eller op.
English: Reductions in plasma ACTH levels were also observed at each time point for each dose group.
Danish: Fald i plasma-ACTH-niveauerne observeredes også på hvert kontroltidspunkt for hver doseringsgruppe.
English: Table 4 Key results at month 12 - phase III study in acromegaly patients
Danish: Tabel 4 Vigtigste resultater ved måned 12 - fase III-studier hos akromegalipatienter
English: The suppression of ACTH (adrenocorticotropic hormone) secretion can result in hypocortisolism in patients treated with Signifor.
Danish: Undertrykkelse af ACTH- (adrenokortikotropisk hormon) sekretion kan medføre hypokortisolisme hos patienter i behandling med Signifor.