FrancophonIA/ELRC3.0 huggingface dataset:
English: Baseline characteristics were balanced between the two randomised dose groups, except for marked differences in the mean value of baseline 24-hour UFC (1156 nmol/24 h for the 0.6 mg twice daily group and 782 nmol/24 h for the 0.9 mg twice daily group; normal range 30-145 nmol/24 h).
Danish: Ved baseline var der balance mellem de to randomiserede doseringsgruppers karakteristika, bortset fra markante forskelle i den gennemsnitlige døgn-UFC (1156 nmol/24 t i den gruppe, som fik 0,6 mg to gange dagligt, og 782 nmol/24 t i den gruppe, som fik 0,9 mg to gange dagligt; normalområdet er 30-145 nmol/24 t).
English: After a single injection, the plasma pasireotide concentration shows an initial burst release on the injection day, followed by a dip from day 2 to day 7, then a slow increase to maximum concentration around day 21, and a slow declining phase over the next weeks, concomitant with the terminal degradation phase of the polymer matrix of the dosage form.
Danish: Herefter en langsom stigning til den maksimale koncentration omkring dag 21 og over de næste uger en fase med langsom reduktion i forbindelse med den sidste nedbrydningsfase af doseringsformens polymermatrix.
English: Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Danish: Der findes pakninger indeholdende 6 ampuller og multipakninger indeholdende 18 (3 x 6), 30 (5 x 6) eller 60 (10 x 6) ampuller.
English: - Problems with bile flow (cholestasis).
Danish: - Problemer med galdestrømmen (kolestase).
English: Bradycardic medicinal products
Danish: Lægemidler med bradykardiel virkning
English: Glycosylated haemoglobin increased, alanine aminotransferase increased, aspartate aminotransferase increased, gammaglutamyltransferase increased, blood glucose increased, blood creatine phosphokinase increased, lipase increased
Danish: Forhøjet glykosyleret hæmoglobin, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gammaglutamyltransferase, forhøjet blodglucose, forhøjet blodkreatinkinase, forhøjet lipase
English: If you have liver disease before you start Signifor treatment, your doctor may want to start your treatment with a dose of one ampoule of Signifor 0.3 mg twice a day.
Danish: Hvis du har leversygdom før du starter i behandling med Signifor, vil din læge muligvis vurdere, at du skal starte behandlingen med en dosis på en ampul af Signifor 0,3 mg to gange daglig.
English: Elderly patients (≥65 years) Age is not a significant covariate in the population pharmacokinetic analysis of patients.
Danish: Ældre patienter (≥65 år) En farmakokinetisk populationsanalyse af patienter har vist, at alder ikke er en signifikant kovariat.
English: Acromegaly study C2402, inadequately controlled patients Study C2402 was a phase III, multicentre, randomised, parallel-group, three-arm study of double-blind pasireotide intramuscular use 40 mg and 60 mg versus open-label octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg in patients with inadequately controlled acromegaly.
Danish: Akromegalistudie C2402, utilstrækkeligt kontrollerede patienter C2402-studiet var et randomiseret fase III-multicenterstudie med parallelle grupper og tre behandlingsarme med dobbeltblindet pasireotid 40 mg og 60 mg til intramuskulær anvendelse versus open label octreotid 30 mg til intramuskulær anvendelse eller lanreotid 120 mg som dyb subkutan injektion hos patienter med utilstrækkeligt kontrolleret akromegali.
English: 30 ampoules (5x6)
Danish: 30 ampuller (5x6)
English: 6 ampoules
Danish: 6 ampuller
English: Holding the vial adapter packaging, position the vial adapter on top of the vial and push it fully down so that it snaps in place, confirmed by a “click”.
Danish: Hold om hætteglasadapternes pakning, placer hætteglasadapteren oven på hætteglasset og skub den helt ned, så den klikker på plads med et hørbart "klik".
English: Dose reduction by decrements of 0.3 mg twice a day is suggested.
Danish: Det foreslås at dosisreducere med 0,3 mg to gange dagligt.
English: Other medicines and Signifor
Danish: Brug af anden medicin sammen med Signifor
English: The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
Danish: Ved gentagne injektioner skal venstre og højre glutealmuskel anvendes skiftevis som injektionssted.
English: Renal impairment No dose adjustment is required in patients with impaired renal function (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt 5.2).
English: Tartaric acid Sodium hydroxide Water for injections
Danish: Natriumhydroxid Vand til injektionsvæske
English: No studies have been conducted to evaluate the bioavailability of pasireotide in humans.
Danish: Der har ikke været gennemført studier for at vurdere pasireotids biotilgængelighed hos mennesker.
English: In healthy volunteers, pasireotide intramuscular use is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
Danish: Hos raske forsøgspersoner distribueres pasireotid til intramuskulær anvendelse bredt med et stort tilsyneladende fordelingsvolumen (Vz/F >100 liter).
English: Adverse reactions reported up to the cut-off date of the analysis are presented in Table 1.
Danish: Tabel 1 viser de bivirkninger, der rapporteredes indtil skæringsdatoen for analysen.
English: A sharps container or other rigid closed disposal container
Danish: En kanyleboks eller anden tæt og lukket beholder
English: Acromegaly: the recommended initial dose for acromegaly patients with moderate hepatic impairment (Child Pugh B) is 20 mg every 4 weeks, and the maximum recommended dose for these patients is 40 mg every 4 weeks (see section 5.2).
Danish: Akromegali: Den anbefalede startdosis til patienter med akromegali med moderat nedsat leverfunktion (Child Pugh B) er 20 mg hver 4. uge, og den maksimale anbefalede dosis til disse patienter er 40 mg hver 4. uge (se pkt.
English: Secondary end-points included, among others, changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease.
Danish: Sekundære endepunkter var bl.a. ændringer i forhold til baseline i: døgn-UFC, plasma-ACTH, serumkortisolniveauer og kliniske tegn og symptomer på Cushings sygdom.
English: Most (83.3%) patients had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
Danish: De fleste (83,3%) af patienterne havde persisterende eller tilbagevendende Cushings sygdom, og kun få (≤5%) i begge behandlingsgrupper havde gennemgået strålebehandling af hypofysen.
English: Pasireotide administered via the subcutaneous route 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, der blev administreret subkutant, 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: Ultrasonic examination of the gallbladder before and at 6 to 12 month intervals during Signifor therapy is therefore recommended.
Danish: Ultralydscanning af galdeblæren anbefales derfor før behandling med Signifor og med 6-12 måneders mellemrum under behandlingen.
English: Signifor intramuscular use 40 mg
Danish: Signifor intramuskulær anvendelse 40 mg
English: Do not use Signifor if you notice the solution is not clear or contains particles.
Danish: Tag ikke Signifor, hvis du opdager, at opløsningen ikke er klar eller indeholder partikler.
English: Rare cases of concurrent elevations in ALT (alanine aminotransferase) greater than 3 x ULN and bilirubin greater than 2 x ULN have also been observed (see section 4.8).
Danish: Der er også observeret sjældne tilfælde af samtidig stigning i ALAT (alaninaminotransferase) mere end 3 x ULN og bilirubin mere end 2 x ULN (se pkt.
English: In both dose groups, Signifor resulted in a decrease in mean UFC after 1 month of treatment which was maintained over time.
Danish: I begge doseringsgrupper resulterede behandlingen med Signifor i et fald i gennemsnitligt UFC efter 1 måneds behandling, hvilket opretholdtes over tid.
English: Gamma glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, blood glucose increased, blood amylase increased, prothrombin time prolonged
Danish: Forhøjet gammaglutamyltransferase, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet lipase, forhøjet blodglucose, forhøjet blodamylase, forlænget protrombintid
English: The development of hyperglycaemia appears to be related to decreases in secretion of insulin (particularly in the post-dose period) and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Danish: Udvikling af hyperglykæmi synes at være relateret til fald i sekretionen af insulin (især i perioden efter indgivelse af dosis) og inkretinhormoner (dvs. glukagonlignende peptid-1 [GLP-1] og glucoseafhængigt, insulinotropisk polypeptid [GIP]).
English: What Signifor contains - The active substance is pasireotide.
Danish: Signifor indeholder - Aktivt stof: pasireotid.
English: Asymptomatic elevations in lipase and amylase were observed in patients receiving pasireotide in clinical studies.
Danish: Asymptomatiske lipase- og amylaseforhøjelser er observeret i kliniske studier hos patienter, der fik pasireotid.
English: Very common (may affect more than 1 in 10 people) - Changed level of sugar in the blood.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter) - Ændret blodsukker.
English: Turn syringe and vial upside down, slowly pull the plunger back and draw the entire content from the vial into the syringe.
Danish: Vend sprøjte og hætteglas med bunden i vejret og træk langsomt stemplet tilbage, så hele hætteglassets indhold overføres til sprøjten.
English: Cushing's disease is caused by an enlargement in the pituitary gland (a gland at the base of the brain) called a pituitary adenoma.
Danish: Cushings sygdom skyldes en forstørrelse af hypofysen (en kirtel på hjernens underside), som kaldes et hypofyseadenom.
English: DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
Danish: BRUG IKKE AMPULLEN, hvis den er gået i stykker, eller hvis væsken er uklar eller indeholder partikler.
English: Cushings disease: the recommended initial dose for Cushing's disease patients with moderate hepatic impairment (Child Pugh B) is 10 mg every 4 weeks, and the maximum recommended dose for these patients is 20 mg every 4 weeks (see section 5.2).
Danish: Cushings sygdom: Den anbefalede startdosis til patienter med Cushings sygdom med moderat nedsat leverfunktion (Child Pugh B) er 10 mg hver 4. uge, og den maksimale anbefalede dosis til disse patienter er 20 mg hver 4. uge (se pkt.
English: Common (may affect up to 1 in 10 people) - Prolonged QT interval (an abnormal electrical signal in your heart that can be seen in tests) - Loss of appetite - Vomiting - Headache - Dizziness - Hair loss - Itching (pruritus) - Muscle pain (myalgia) - Joint pain (arthralgia) - Abnormal results of liver function tests - Abnormal results of pancreatic function tests - Abnormal blood coagulation properties
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Forlænget QT-interval (et unormalt elektrisk signal i dit hjerte, der kan ses ved målinger) - Appetitløshed - Opkastning - Hovedpine - Svimmelhed - Hårtab - Kløe (pruritus) - Muskelsmerter (myalgi) - Ledsmerter (artralgi) - Unormale resultater af leverfunktionsprøver - Unormale resultater af bugspytkirtelfunktionsprøver - Unormale blodstørkningsegenskaber
English: Very common (may affect more than 1 in 10 people) - High level of sugar in the blood.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter) - Højt blodsukker.
English: The solvent is a clear, colourless to slightly yellow or slightly brown solution in a pre-filled syringe.
Danish: Solvensen er en klar, farveløs til gullig eller brunlig opløsning i en fyldt injektionssprøjte.
English: Mild transient elevations in aminotransferases are commonly observed in patients treated with pasireotide.
Danish: Milde, forbigående stigninger i aminotransferaseniveau er hyppigt observeret hos patienter i behandling med pasireotid.
English: If you are using other medicines at the same time as Signifor (including medicines obtained without a prescription), your doctor may need to monitor your heart more carefully or change the dose of Signifor or the other medicines.
Danish: medicin uden recept), kan lægen muligvis blive nødt til at kontrollere dit hjerte mere omhyggeligt eller justere din dosis af Signifor eller den anden medicin.
English: The maximum dose of Signifor in Cushing's disease is 40 mg every 4 weeks.
Danish: Den maksimale dosis af Signifor ved Cushings sygdom er 40 mg hver 4. uge.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Danish: Træk forsigtigt stemplet lidt ud for at sikre, at du ikke har ramt en blodåre.
English: In a human ADME study 55.9±6.63% of the radioactive pasireotide subcutaneous dose was recovered over the first 10 days after administration, including 48.3±8.16% of the radioactivity in faeces and 7.63±2.03% in urine.
Danish: I en human ADME-studie genfandtes 55,9 ± 6,63% af den radioaktive subkutane pasireotiddosis i løbet af de første 10 dage efter indgivelse, 48,3 ± 8,16% i faeces og 7,63 ± 2,03% i urinen.
English: Signifor intramuscular use 60 mg
Danish: Signifor intramuskulær anvendelse 60 mg
English: If you forgot to inject a dose of Signifor, simply inject the next dose at the scheduled time.
Danish: Hvis du har glemt en dosis, skal du blot tage næste dosis til sædvanlig tid.
English: Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also section 4.4).
Danish: Pasireotid skal anvendes med forsigtighed til patienter, som samtidig får QT-intervalforlængende lægemidler som for eksempel antiarytmika, klasse Ia (fx quinidin, procainamid, disopyramid) og klasse III (fx amiodaron, dronedaron, sotalol, dofetilid, ibutilid), visse antibakterielle midler (intravenøst erythromycin, pentamidin-injektioner, clarithromycin, moxifloxacin), visse antipsykotika (fx chlorpromazin, thioridazin, fluphenazin, pimozid, haloperidol, tiaprid, amisulprid, sertindol, metadon), visse antihistaminer (fx terfenadin, astemizol, mizolastin), antimalariamidler (fx chloroquin, halofantrin, lumefantrin), visse antimykotika (ketoconazol, gælder ikke shampoo) (se også pkt 4.4).
English: In the acromegaly studies, the events were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients, and were less frequent in inadequately controlled patients compared to medically naïve patients.
Danish: I akromegalistudierne var hændelserne sammenlignelige for patienter behandlet med pasireotid til intramuskulær anvendelse og octreotid til intramuskulær anvendelse, og de var mindre hyppige i studiet med patienter, der var utilstrækkeligt kontrollerede, end i studiet med behandlingsnaive patienter.
English: In a human ADME study 55.9±6.63% of the radioactive dose was recovered over the first 10 days after administration, including 48.3±8.16% of the radioactivity in faeces and 7.63±2.03% in urine.
Danish: I en human ADME-studie genfandtes 55,9 ± 6,63% af den radioaktive dosis i løbet af de første 10 dage efter indgivelse, 48,3 ± 8,16% i faeces og 7,63 ± 2,03% i urinen.
English: Signifor should be administered using sterile disposable syringes and injection needles.
Danish: Signifor skal indsprøjtes ved brug af sterile engangssprøjter og kanyler.
English: Monitoring of pituitary function (e.g. TSH/free T4) before and periodically during Signifor therapy should therefore be considered, as clinically appropriate.
Danish: Monitorering af hypofysefunktionen (fx TSH/frit T4) før og periodisk under behandling med Signifor skal derfor overvejes, hvis det er klinisk hensigtsmæssigt.
English: The development of hyperglycaemia appears to be related to decreases in secretion of insulin and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Danish: Udvikling af hyperglykæmi synes at være relateret til fald i sekretionen af insulin og inkretinhormoner (dvs. glukagonlignende peptid-1 [GLP-1] og glucoseafhængigt, insulinotropisk polypeptid [GIP]).
English: One-point-cut colourless, type I glass ampoule containing 1 ml of solution.
Danish: Farveløs, type I glasampul med knækkepunkt (one-point-cut) indeholdende 1 ml opløsning.
English: Put the needle into the ampoule and pull the plunger to draw up the entire contents of the ampoule into the syringe.
Danish: Stik kanylen ned i ampullen og træk stemplet ud, så hele ampullens indhold trækkes op i sprøjten.
English: The responder rate at month 12 was comparable to month 6, with 13.4% and 25.0% in the 0.6 mg and 0.9 mg twice-daily groups, respectively.
Danish: Responsraten ved 12 måneder var sammenlignelig med raten ved 6 måneder med henholdsvis 13,4% og 25,0% i den gruppe, der fik 0,6 mg to gange dagligt, og den gruppe, der fik 0,9 mg to gange dagligt.
English: Cushing's disease patients with poor glycaemic control (as defined by HbA1c values >8% while receiving antidiabetic therapy) may be at higher risk of developing severe hyperglycaemia and associated complications (e.g. ketoacidosis).
Danish: Hos patienter med Cushings sygdom med dårlig glykæmisk kontrol (defineret som HbA1c-værdier >8% under antidiabetisk behandling) kan der være en større risiko for, at der udvikles svær hyperglykæmi med tilstødende komplikationer (fx ketoacidose).
English: Do not use Signifor if the solution is not clear or contains particles.
Danish: Signifor må ikke bruges, hvis opløsningen er uklar eller indeholder partikler.
English: Cholecystitis*, cholestasis
Danish: Kolecystitis*, kolestase
English: Two-thirds of all patients had undergone prior surgery.
Danish: To tredjedele af patienterne var tidligere blevet opereret.
English: Remove the packaging from the vial adapter by lifting it straight up as shown.
Danish: Fjern pakningen fra hætteglasadapteren ved at løfte den lodret opad som vist.
English: Step 8
Danish: Trin 8
English: Each unit pack contains the vial and pre-filled syringe in a sealed blister tray with one vial adapter and one safety-engineered needle for injection.
Danish: Hver enkeltpakning indeholder hætteglasset og den fyldte injektionssprøjte i en forseglet blisterbakke med en hætteglasadapter og en sikkerhedskanyle til indsprøjtning.
English: Poly(D,L-lactide-co-glycolide) (50-60:40-50) Poly(D,L-lactide-co-glycolide) (50:50)
Danish: Poly(D,L-lactid-co-glycolid) (50-60:40-50) Poly(D,L-lactid-co-glycolid) (50:50)
English: Solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Danish: Solvens: carmellosenatrium, mannitol, poloxamer 188, vand til injektionsvæsker.
English: The injection site
Danish: Injektionsstedet
English: Acromegaly The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
Danish: Akromegali Den anbefalede startdosis til behandling af akromegali er 40 mg pasireotid hver 4. uge.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in pituitary-dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Signifor i alle undergrupper af den pædiatriske population med den hypofyseafhængige Cushings sygdom, overproduktion af hypofyse-ACTH og hypofyseafhængig hyperadrenokorticisme (se pkt.
English: Injection site reaction*
Danish: Reaktioner på injektionsstedet*
English: Patients with poor glycaemic control (as defined by HbA1c values >8% while receiving antidiabetic therapy) may be at higher risk of developing severe hyperglycaemia and associated complications (e.g. ketoacidosis).
Danish: Hos patienter med dårlig glykæmisk kontrol (defineret som HbA1c-værdier >8% under antidiabetisk behandling) kan der være en større risiko for, at der udvikles svær hyperglykæmi med tilstødende komplikationer (fx ketoacidose).
English: Powder and solvent for suspension for injection (powder for injection).
Danish: Pulver og solvens til injektionsvæske, suspension (injektionsvæske).
English: Gastrointestinal disorders were frequently reported with Signifor.
Danish: Der er hyppigt rapporteret mave-tarm-sygdomme ved behandling med Signifor.
English: The recommended dose is one ampoule of Signifor 0.6 mg twice a day.
Danish: Den sædvanlige dosis er en ampul med Signifor 0,6 mg to gange daglig.
English: - Do not use this medicine after the expiry date which is stated on the ampoule label and carton after “EXP”.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på ampuletiketten og æsken efter
English: Acromegaly is caused by a type of tumour called a pituitary adenoma which develops in the pituitary gland at the base of the brain.
Danish: Akromegali skyldes en tumor, der kaldes hypofyseadenom, som udvikles i hypofysen (en kirtel på hjernens underside).
English: In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients.
Danish: Hos akromegalipatienter var mave-tarm-sygdomme mindre hyppige i studiet med patienter, der var utilstrækkeligt kontrollerede, sammenlignet med studiet med behandlingsnaive patienter.
English: Unit packs (all strengths): each unit pack contains a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety-engineered needle for injection).
Danish: Enkeltpakninger (alle styrker): Hver enkeltpakning indeholder en blisterbakke med et injektionskit (et hætteglas og i et separat forseglet rum: en fyldt injektionssprøjte, en hætteglasadapter og en sikkerhedskanyle til injektion).
English: Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child Pugh A).
English: In a clinical study of a single subcutaneous dose of pasireotide in subjects with impaired hepatic function, statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Danish: I et klinisk studie med en enkelt subkutan dosis pasireotid hos forsøgspersoner med nedsat leverfunktion, konstateredes statistisk signifikante forskelle mellem forsøgspersoner med moderat og forsøgspersoner med svær nedsat leverfunktion (Child-Pugh B og C).
English: Signifor solution for injection is filled in a break-off ampoule.
Danish: Signifor injektionsvæsken leveres i en ampul, der kan knækkes.
English: Remove the cap from the syringe pre-filled with solvent and screw the syringe onto the vial adapter.
Danish: Fjern hætten fra den fyldte sprøjte med solvens og skru sprøjten på hætteglasadapteren.
English: Multipack: 60 (10 packs of 6) ampoules.
Danish: Multipakning: 60 (10 pakninger med 6) ampuller.