FrancophonIA/ELRC3.0 huggingface dataset:
English: You may experience excessive thirst, high urine output,
Danish: Du kan opleve stærk tørst, rigelig vandladning, øget appetit med vægttab,
English: Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products, such as beta blockers (e.g. metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (e.g. rivastigmine, physostigmine), certain calcium channel blockers (e.g. verapamil, diltiazem, bepridil), certain antiarrhythmics (see also section 4.4).
Danish: Klinisk monitorering af hjertefrekvens, især i begyndelsen af behandlingen, anbefales hos patienter, der får pasireotid samtidig med bradykardika som for eksempel betablokkere (fx metoprolol, carteolol, propranolol, sotalol), acetylcholinesterasehæmmere (fx rivastigmin, physostigmin), visse calciumantagonister (fx verapamil, diltiazem, bepridil), visse antiarytmika (se også pkt.
English: Powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
Danish: Pulver: poly(D,L-lactid-co-glycolid) (50-60:40-50), poly(D,L-lactid-co-glycolid) (50:50).
English: However, before using the ampoule, please read the following information carefully.
Danish: Læs alligevel nedenstående information omhyggeligt, før du bruger ampullen.
English: Pasireotide is a cyclohexapeptide, injectable somatostatin analogue.
Danish: Pasireotid er et cyklohexapeptid, en injicerbar somatostatinanalog.
English: Included in the injection kit: a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″)
Danish: Injektionskittet indeholder: a Et hætteglas med pulver b En fyldt injektionssprøjte med solvens c En hætteglasadapter til brug ved rekonstitution af lægemidlet d En sikkerhedskanyle (20G x 1,5″)
English: a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″)
Danish: a Et hætteglas med pulver b En fyldt injektionssprøjte med solvens c En hætteglasadapter til brug ved rekonstitution af lægemidlet d En sikkerhedskanyle (20G x 1,5″)
English: Female patients of childbearing potential should be advised to use adequate contraception during treatment with Signifor (see section 4.6).
Danish: Kvindlige patienter i den fødedygtige alder bør rådes til at anvende sikker kontraception under behandling med Signifor (se pkt.
English: Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection
Danish: Signifor 10 mg pulver og solvens til injektionsvæske, suspension Signifor 20 mg pulver og solvens til injektionsvæske, suspension Signifor 30 mg pulver og solvens til injektionsvæske, suspension Signifor 40 mg pulver og solvens til injektionsvæske, suspension Signifor 60 mg pulver og solvens til injektionsvæske, suspension
English: Powder: slightly yellowish to yellowish powder.
Danish: Pulver: let gulligt til gulligt pulver.
English: Studies in rats have shown effects on female reproductive parameters (see section 5.3).
Danish: Studier med rotter har vist påvirkning af de reproduktive parametre hos hunrotter (se pkt.
English: - In the solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Danish: I solvensen: carmellosenatrium, mannitol, poloxamer 188, vand til injektionsvæsker
English: Common (may affect up to 1 in 10 people) - Tiredness, fatigue, pale skin (signs of low level of red blood cells) - Loss of appetite - Headache - Bloating - Vomiting - Dizziness - Pain, discomfort, pruritis and swelling at the injection site - Change in liver function test results
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Træthed, energiløshed, bleg hud (tegn på lavt antal røde blodceller) - Appetitløshed - Hovedpine - Oppustethed - Opkastning - Svimmelhed - Smerte, ubehag, kløe og hævelse på indsprøjtningsstedet - Ændringer i resultaterne af leverfunktionsundersøgelse - Unormale blodprøveresultater (tegn på forhøjet kreatinkinase, glykosyleret hæmoglobin, lipase i blodet) - Hårtab
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 acromegaly and pituitary gigantism, and 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 akromegali og hypofysær gigantisme og med hypofyseafhængig Cushings sygdom, overproduktion af hypofyse-ACTH og hypofyseafhængig hyperadrenokorticisme (se pkt.
English: GH<2.5 μg/l and normalised IGF-1*
Danish: GH<2,5 μg/l og normaliseret IGF-1*
English: 1 vial of powder + 1 pre-filled syringe with 2 ml solvent+ 1 safety-engineered needle + 1 vial adapter.
Danish: 1 hætteglas med pulver + 1 fyldt injektionssprøjte med 2 ml solvens + 1 sikkerhedskanyle + 1 hætteglasadapter.
English: Multipack: 18 (3 packs of 6) ampoules.
Danish: Multipakning: 18 (3 pakninger med 6) ampuller.
English: Your doctor or nurse will have instructed you on how to use Signifor ampoules.
Danish: Din læge eller sygeplejerske har instrueret dig i, hvordan du skal tage Signifor.
English: Hepatic impairment Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child Pugh A).
English: Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.
Danish: Fjern plasthætten fra hætteglasset og rens gummiproppen på hætteglasset med en spritserviet.
English: Treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.
Danish: Behandling af voksne patienter med Cushings sygdom, hvor operation ikke er en mulighed, eller hvor operationen mislykkedes.
English: Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection pasireotide
Danish: Signifor 10 mg pulver og solvens til injektionsvæske, suspension Signifor 20 mg pulver og solvens til injektionsvæske, suspension Signifor 30 mg pulver og solvens til injektionsvæske, suspension Signifor 40 mg pulver og solvens til injektionsvæske, suspension Signifor 60 mg pulver og solvens til injektionsvæske, suspension pasireotid
English: The usual starting dose of Signifor in Cushing's disease is 10 mg every 4 weeks.
Danish: Den sædvanlige startdosis af Signifor for Cushings sygdom er 10 mg hver 4. uge.
English: The recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Danish: Den anbefalede startdosis, til behandling af Cushings sygdom, er 10 mg pasireotid ved dyb intramuskulær injektion hver 4. uge.
English: Female acromegaly patients had a higher exposure of 32% and 51% compared to male patients in studies with medical treatment naïve patients and inadequately controlled patients, respectively; these differences in exposure were not clinically relevant based on efficacy and safety data.
Danish: Kvindelige akromegalipatienter havde en højere eksponering på 32 % og 51 % sammenlignet med mandlige patienter i studierne med henholdsvis behandlingsnaive patienter og patienter, der var utilstrækkeligt kontrollerede.
English: Dispose of the used syringe and needle immediately in a sharps container or other rigid closed disposal container.
Danish: Smid den brugte sprøjte og kanyle i en kanyleboks eller en anden tæt og lukket boks straks efter brug.
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter) - Diarré - Kvalme - Mavesmerter - Træthed
English: Cholelithiasis is a recognised adverse reaction associated with long-term use of somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Danish: Kolelitiasis er en kendt bivirkning ved langvarig brug af somatostatinanaloger og er hyppigt rapporteret i kliniske studier med pasireotid (se pkt 4.8).
English: Slowly push the plunger all the way down to transfer all the solvent in the vial.
Danish: Skub langsomt stemplet helt i bund så al solvensen overføres til hætteglasset.
English: Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
Danish: Signifor må ikke anvendes hos patienter med svær nedsat leverfunktion (Child Pugh C) (se pkt.
English: Multipack: 30 (5 packs of 6) ampoules.
Danish: Multipakning: 30 (5 pakninger med 6) ampuller.
English: The efficacy and safety of pasireotide intramuscular use was evaluated in a phase III, multicentre study over a 12-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Danish: Et fase III-multicenterstudie vurderede over en behandlingsperiode på 12 måneder virkning og sikkerhed af pasireotid til intramuskulær anvendelse, hos patienter med Cushings sygdom med persisterende eller tilbagevende sygdom eller de novo-patienter, for hvem operation ikke var indiceret eller som afslog operation.
English: One sterile syringe
Danish: En steril sprøjte
English: congestive heart failure, unstable angina or clinically significant bradycardia.
Danish: - ved ukontrolleret eller signifikant hjertesygdom, herunder nylig myokardieinfarkt, kongestiv hjerteinsufficiens, ustabil angina pectoris eller klinisk signifikant bradykardi.
English: Percentage of patients with: mUFC ≤ULN at Month 7 (95% CI) * mUFC ≤ULN and no prior dose increase at Month 7 (95% CI) mUFC ≤ULN or ≥50% decrease from baseline at month 7 (95% CI) Median (min, max) % mUFC change from baseline at month 7 Median (min, max) % mUFC change from baseline at month 12 * Primary endpoint using LOCF (last observation carried forward) mUFC: mean urinary free cortisol; ULN: upper limit of normal; CI: confidence interval
Danish: Procentdel af patienter med: mUFC ≤ULN ved måned 7 (95 % CI) * mUFC ≤ULN og ingen tidligere dosisøgning ved måned 7 (95 % CI) mUFC ≤ULN eller ≥50 % fald i forhold til baseline ved måned 7 (95 % CI) Median (min., maks.)
English: Body weight has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Danish: Den farmakokinetiske populationsanalyse har vist, at kropsvægt er en kovariat hos patienter med Cushings sygdom.
English: - The other ingredients are mannitol, tartaric acid, sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, vinsyre, natriumhydroxid og vand til injektionsvæsker.
English: Episodes of torsade de pointes were not observed in any clinical study with pasireotide.
Danish: Der er ikke observeret episoder med torsades de pointes i kliniske studier med pasireotid.
English: Put the cover back on the needle.
Danish: Sæt beskyttelseshætten på kanylen igen.
English: Pasireotide is a novel cyclohexapeptide, injectable somatostatin analogue.
Danish: Pasireotid er et nyt cyklohexapeptid, en injicerbar somatostatinanalog.
English: Two cases of hyperglycaemia-related emergencies (diabetic ketoacidosis and diabetic hyperglycaemic coma) were reported following a dose increase of pasireotide to 60 mg in medical treatment naïve patients; one in a patient with untreated hyperglycaemia and HbA1c >8% prior to initiation of pasireotide and the other in a patient with untreated hyperglycaemia and a fasting plasma glucose of 359 mg/dl, respectively.
Danish: Det ene tilfælde var hos en patient med ubehandlet hyperglykæmi og HbA1c >8 %, før behandling med pasireotid blev initieret, og det andet tilfælde var hos en patient med ubehandlet hyperglykæmi og fasteplasmaglucose på 359 mg/dl. I
English: - your doctor may also wish to check your gallbladder, liver enzymes and pituitary hormones periodically, since these might all be affected by this medicine.
Danish: Hvis du bruger medicin for et hjerteproblem, er din læge måske også nødt til at justere doseringen af den. - Din læge vil muligvis også med jævne mellemrum kontrollere din galdeblære, dine leverenzymer og dine hypofysehormoner, da alle disse kan påvirkes af denne medicin.
English: Remove the packaging from the vial adapter by lifting it straight up.
Danish: Fjern pakningen fra hætteglasadapteren ved at løfte den lodret opad.
English: Also contains: Mannitol, tartaric acid, sodium hydroxide, water for injections.
Danish: Indeholder også: Mannitol, vinsyre, natriumhydroxid, vand til injektionsvæsker.
English: Screw the safety injection needle onto the syringe.
Danish: Skru sikkerhedskanylen på sprøjten.
English: Solution for injection (injection).
Danish: Injektionsvæske, opløsning (injektionsvæske)
English: IM
Danish: I
English: erythromycin, pentamidine); - medicines to treat fungal infections (ketoconazole, except in shampoo); - medicines to treat certain psychiatric disorders (chlorpromazine, thioridazine, fluphenazine,
Danish: clarithromycin, moxifloxacin; via injektion: erythromycin, pentamidin); - medicin, der bruges til at behandle svampeinfektioner (ketoconazol, undtagen i shampoo); - medicin, der bruges til at behandle visse psykiatriske sygdomme (chlorpromazin, thioridazin,
English: pale stools and itching.
Danish: bleg afføring og kløe.
English: Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in patients receiving pasireotide in clinical studies.
Danish: Forbigående forhøjelse af leverenzymtallet er rapporteret ved brug af somatostatinanaloger og er også observeret hos patienter, der har fået pasireotid i kliniske studier.
English: Vascular disorders
Danish: Koagulationsforstyrrelser
English: Available data in rats have shown excretion of pasireotide in milk (see section 5.3).
Danish: Tilgængelige data fra studier med rotter har vist, at pasireotid udskilles i mælk (se pkt.
English: In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
Danish: I Cushings sygdomsstudiet G2304, blev der for 2 patienter indberettet en QTcF-værdi >480 ms. Der blev ikke observeret QTcF-værdier >500 ms i nogen af pivotalstudierne.
English: You may experience dizziness, light headedness and dizziness or fainting on standing up.
Danish: Du kan opleve svimmelhed eller føle dig svimmel eller besvime, når du rejser dig op. - Problemer med galdestrømmen (kolestase).
English: It is used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Danish: Det bruges til at behandle Cushings sygdom hos voksne patienter, hvor operation ikke er mulig, eller hvor operationen mislykkedes.
English: Diarrhoea, nausea, abdominal pain*
Danish: Mave-tarm-kanalen Diarré, kvalme, abdominalsmerte*
English: Available data in rats in which pasireotide was administered via the subcutaneous route have shown excretion of pasireotide in milk (see section 5.3).
Danish: Tilgængelige data fra studier med rotter, hvor pasireotid blev administreret subkutant, har vist, at pasireotid udskilles i mælk (se pkt.
English: Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Danish: En farmakokinetisk populationsanalyse har vist, at alder er en kovariat hos patienter med Cushings sygdom.
English: How to use Signifor
Danish: Sådan skal du bruge Signifor
English: Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in healthy subjects and patients receiving pasireotide in clinical studies.
Danish: Forbigående forhøjelse af leverenzymtallet er rapporteret ved brug af somatostatinanaloger og er også observeret hos raske forsøgspersoner og patienter, der har fået pasireotid i kliniske studier.
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Danish: Studier med rotter, hvor pasireotid blev administreret subkutant, har vist påvirkning af de reproduktive parametre hos hunrotter (se pkt.
English: The recommended starting dose of Signifor in acromegaly is 40 mg every 4 weeks.
Danish: Den sædvanlige startdosis Signifor for akromegali er 40 mg hver 4. uge.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: 4.6), hvis det er nødvendigt.
English: Sinus bradycardia, QT prolongation
Danish: Sinusbradykardi, QTforlængelse
English: Cholelithiasis is a recognised adverse reaction associated with somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Danish: Kolelitiasis er en kendt bivirkning ved brug af somatostatinanaloger og er hyppigt rapporteret i kliniske studier med pasireotid (se pkt 4.8).
English: No clinical studies in subjects with liver impairment have been performed with pasireotide intramuscular use.
Danish: Der er ikke udført kliniske studier med pasireotid til intramuskulær anvendelse hos forsøgspersoner med nedsat leverfunktion.
English: Slowly release the skin fold and gently pull the needle out.
Danish: Slip langsomt grebet om huden omkring injektionsstedet og træk kanylen forsigtigt ud.
English: Your doctor may want to monitor your blood sugar and start treatment with or adjust your antidiabetic medicine.
Danish: Din læge vil måske overvåge dit blodsukker og begynde at behandle dig med medicin mod diabetes eller justere dosis, hvis du allerede får det. - Signifor kan sænke din hjertefrekvens.
English: Diarrhoea, abdominal pain, nausea
Danish: Mave-tarm-kanalen Diaré, abdominalsmerter, kvalme
English: Dispose of syringe immediately in a sharps container.
Danish: Smid straks sprøjten i en kanyleboks beregnet til skarpe genstande.
English: Glucose metabolism
Danish: Glucosemetabolisme
English: Acromegaly
Danish: Akromegali
English: (hypoglycaemia); - heart problems such as a recent heart attack, congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or sudden and oppressive chest pain (usually felt as pressure, heaviness, tightening, squeezing or aching across the chest); - a heart rhythm disorder, such as an irregular heartbeat or an abnormal electrical signal called
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger Signifor, hvis du har eller har haft: - problemer med blodsukkerniveauet, enten for højt (som ved diabetes) eller for lavt (hypoglykæmi); - hjerteproblemer, som fx nyligt hjerteanfald, kongestiv hjertefejl (en hjertesygdom hvor hjertet ikke kan pumpe nok blod rundt i kroppen) eller pludselige eller trykkende brystsmerter (føles som regel som en trykkende, tyngende, strammende, knugende eller smertende fornemmelse omkring brystet); - problemer med hjerterytmen, fx uregelmæssigt hjerteslag eller et unormalt elektrisk signal kaldet ”forlængelse af QT-intervallet” eller ”QT-forlængelse”; - lave niveauer af kalium eller magnesium i blodet; - galdesten.
English: - If you are breast-feeding, ask your doctor for advice before taking this medicine, as it is not known whether Signifor passes into breast milk.
Danish: - Hvis du ammer, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: What Signifor looks like and contents of the pack Signifor powder is a slightly yellowish to yellowish powder in a vial.
Danish: Signifor pulver er et let gulligt til gulligt pulver i et hætteglas.
English: Powder and solvent for suspension for injection
Danish: Pulver og solvens til injektionsvæske, suspension
English: The proportion of patients who either attained mUFC ≤ULN or a mUFC reduction from baseline of at least 50% was 50.0% in the 10 mg dose group and 56.6% in the 30 mg dose groups (Table 5).
Danish: Ved måned 7 blev der opnået et mUFC-respons hos 41,9 % og 40,8 % af patienterne randomiseret til henholdsvis 10 mg og 30 mg. Andelen af patienter, som enten opnåede mUFC ≤ULN eller en reduktion i mUFC i forhold til baseline på mindst 50 %, var 50,0 % i 10 mg doseringsgruppen og 56,6 % i 30 mg doseringsgruppen (tabel 5).
English: - medicines to treat certain psychiatric disorders (chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone); - medicines to treat hay fever and other allergies (terfenadine, astemizole, mizolastine); - medicines used in the prevention or treatment of malaria (chloroquine, halofantrine, lumefantrine); - medicines to control blood pressure such as:
Danish: - medicin, der bruges til at behandle uregelmæssig hjerterytme, som fx medicin der indeholder disopyramid, procainamid, quinidin, sotalol, dofetilid, ibutilid, amiodaron eller dronedaron; - medicin, der bruges til at behandle bakterieinfektioner (indtagelse igennem munden: clarithromycin, moxifloxacin; via injektion: erythromycin, pentamidin); - medicin, der bruges til at behandle svampeinfektioner (ketoconazol, undtagen i shampoo); - medicin, der bruges til at behandle visse psykiatriske sygdomme (chlorpromazin, thioridazin, fluphenazin, pimozid, haloperidol, tiaprid, amisulprid, sertindol, metadon); - medicin, der bruges til at behandle høfeber og andre allergier (terfenadin, astemizol, mizolastin); - medicin, der bruges som beskyttelse mod eller behandling af malaria (chloroquin, halofantrin, lumefantrin); - medicin, der bruges til at kontrollere blodtrykket, som fx:
English: Therapy with pasireotide should be discontinued if the patient develops jaundice or other signs suggestive of clinically significant liver dysfunction, in the event of a sustained increase in AST (aspartate aminotransferase) or ALT of 5 x ULN or greater, or if ALT or AST elevations greater than 3 x ULN occur concurrently with bilirubin elevations greater than 2 x ULN.
Danish: Hvis der forekommer en opretholdt stigning i ASAT (aspartat-aminotransferase) eller ALAT på 5 x ULN eller højere, eller hvis ALAT eller ASAT-stigninger på mere end 3 x ULN forekommer samtidig med stigning i bilirubin på mere end 2 x ULN, skal behandling med pasireotid seponeres, hvis patienten udvikler gulsot eller der opstår andre symptomer, der tyder på klinisk signifikant leverdysfunktion.
English: Breast-feeding
Danish: Binyrebarkinsuffiens
English: Due to the increase in unbound drug exposure, Signifor should be used with caution in patients with severe renal impairment or end stage renal disease (see section 5.2).
Danish: Signifor bør anvendes med forsigtighed til patienter med svær nedsat nyrefunktion eller terminal nyresygdom pga. forhøjet eksponering af ubundet lægemiddel (se pkt.
English: - The other ingredients are: - In the powder: poly(D,L-lactide-co-glycolide) (50-60:40-50),
Danish: - Øvrige indholdsstoffer: I pulveret: poly(D,L-lactid-co-glycolid) (50-60:40-50), poly(D,L-lactid-co-glycolid)
English: INSTRUCTIONS FOR USE OF SIGNIFOR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Danish: BRUGSANVISNING TIL SIGNIFOR PULVER OG SOLVENS TIL INJEKTIONSVÆSKE, OPLØSNING
English: The two treatment groups were well balanced in terms of baseline demographics and disease characteristics.
Danish: Demografiske karakteristika og sygdomskarakteristika ved baseline var sammenlignelige i de to behandlingsgrupper.
English: How long to use Signifor
Danish: Så længe skal du have Signifor
English: Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier med subkutan administration af pasireotid har påvist reproduktionstoksicitet (se pkt.