FrancophonIA/ELRC3.0 huggingface dataset:
English: • Requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2
Danish: • Krav om tæt monitorering af blodtryk, puls, iltmætning og sluttidal-CO2, når produktet sprøjtes, • Hvilke(n) regulator(er) der skal anvendes, i overensstemmelse med producentens anbefalinger
English: The RaplixaSpray device comes with the rigid nozzle attached, which can be easily removed and the flexible nozzle attached depending on the intended use and surgeon preference.
Danish: Denne kan nemt fjernes, og den bøjelige spids kan påsættes, alt efter anvendelse og kirurgens præference.
English: What do I need
Danish: Hvad har jeg brug for
English: Treatment should not be restarted.
Danish: Behandling bør ikke genoptages.
English: Long-term follow-up data are not available.
Danish: Langsigtede opfølgningsdata foreligger ikke.
English: (figure B).
Danish: (figur B).
English: This is a long-term treatment, possibly lasting for years.
Danish: Dette er en langtidsbehandling, som eventuelt vil vare i flere år.
English: Please follow their instructions.
Danish: Du skal følge deres instruktioner.
English: Date of first authorisation: 24 April 2012 Date of latest renewal: 18 November 2016
Danish: Dato for første markedsføringstilladelse: 24. april 2012 Dato for seneste fornyelse: 18. november 2016
English: 192 patients were treated.
Danish: 192 patienter blev behandlet.
English: Month 6 Month 12
Danish: Måned 6 Måned 12
English: The improvement observed up to week 24 between the treatment groups was also not statistically significant.
Danish: Den forbedring, der blev observeret indtil uge 24 mellem behandlingsgrupperne, var heller ikke statistisk signifikant.
English: Other side effects of Signifor may include:
Danish: Andre bivirkninger af Signifor kan omfatte:
English: If this happens, tell your doctor immediately.
Danish: Hvis dette sker, skal du straks fortælle det til lægen.
English: Sites showing signs of inflammation or irritation should be avoided.
Danish: Steder, der viser tegn på inflammation eller irritation, skal undgås.
English: Normalisation of IGF-1
Danish: Normalisering af IGF-1
English: The dose may be decreased either temporarily or permanently.
Danish: Dosis kan reduceres midlertidigt eller permanent.
English: This variation is moderate and considered of minor significance considering the wide age range in which the effect was observed.
Danish: Denne variation er moderat og betragtes som værende af mindre betydning i betragtning af det brede aldersområde, hvor virkningen er observeret.
English: Signifor reduces the production of these hormones and possibly also the size of the adenoma.
Danish: Signifor nedsætter produktionen af disse hormoner og muligvis også adenomets størrelse.
English: An audible “click” confirms proper activation.
Danish: Et hørbart ”klik” betyder korrekt aktivering.
English: Do not let the needle touch anything.
Danish: Lad ikke kanylen berøre noget.
English: The patient should be monitored for response and tolerability and further dose adjustments may be needed.
Danish: Patienten bør overvåges for respons og tolerabilitet, og yderligere dosisjusteringer kan være nødvendige.
English: To give yourself an injection you will need:
Danish: For at give dig selv en injektion, har du brug for følgende:
English: Do not give this medicine to children and adolescents below 18 years old because no data are available in this age group.
Danish: Denne medicin må ikke gives til børn og unge under 18 år, fordi der ikke foreligger data vedrørende denne aldersgruppe.
English: The study enrolled 150 patients.
Danish: Til studiet rekrutteredes 150 patienter.
English: There are two critical steps in the reconstitution of Signifor.
Danish: Der er to kritiske trin i rekonstitutionen af Signifor.
English: Cushing's disease study G2304
Danish: Cushings sygdom-studie G2304
English: When you are ready to give yourself the injection, carefully follow the steps below: - Wash your hands thoroughly with soap and water.
Danish: Når du er klar til at give dig selv injektionen, skal du nøje følge følge nedenstående trin: - Vask dine hænder omhyggeligt med vand og sæbe.
English: Tell your doctor straight away if you get any of the following:
Danish: Fortæl straks din læge, hvis du får en af følgende bivirkninger:
English: - Use new disposable needles and syringes every time you give yourself an injection.
Danish: - Brug nye engangskanyler og -sprøjter hver eneste gang du giver dig selv en injektion.
English: - You should not use Signifor during pregnancy unless clearly necessary.
Danish: - Signifor må ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: The dose may be titrated every 2 to 4 months based on response and tolerability.
Danish: Dosis kan titreres hver 2. til 4. måned på baggrund af respons og tolerabilitet.
English: The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established.
Danish: Signifors sikkerhed og virkning hos børn og unge i alderen 0-18 år er ikke klarlagt.
English: Also contains:
Danish: Indeholder også:
English: Table 3 Key results at week 24 (Study C2402)
Danish: Tabel 3 Vigtigste resultater ved uge 24 (studie C2402)
English: Using Signifor at the same time each day will help you remember when to use your medicine.
Danish: Hvis du tager Signifor på det samme tidspunkt hver dag, kan det hjælpe dig til at huske, hvornår du skal tage din medicin.
English: Plasma protein binding is moderate (88%) and independent of concentration.
Danish: Plasmaproteinbindingen er moderat (88%) og uafhængig af koncentrationen.
English: A total of 358 patients were randomised and treated.
Danish: I alt blev 358 patienter randomiseret og behandlet.
English: The reconstituted Signifor is now ready for immediate administration.
Danish: Det rekonstituerede Signifor er nu klar til omgående administration.
English: Linearity and time dependency
Danish: Linearitet og tidsafhængighed
English: - Prolonged QT interval (an abnormal electrical signal in your heart that can be seen in tests).
Danish: - Forlænget QT-interval (et unormalt elektrisk signal i dit hjerte, som kan ses ved undersøgelser).
English: ULN = upper limit of normal
Danish: ULN=øvre normalgrænse
English: It is used to treat acromegaly in adult patients.
Danish: Det bruges til at behandle akromegali hos voksne patienter.
English: Patients uncontrolled at both month 1 and month 2 are likely (90%) to remain uncontrolled at months 6 and 12.
Danish: Patienter, der er ukontrollerede ved både måned 1 og måned 2, vil sandsynligvis (90%) stadig være ukontrollerede ved måned 6 og 12.
English: These receptor subtypes are expressed in different tissues under normal physiological conditions.
Danish: Disse receptorundertyper eksprimeres i forskellige væv under normale fysiologiske forhold.
English: All QT-related events were transient and resolved without therapeutic intervention.
Danish: Alle QT-relaterede hændelser var forbigående og forsvandt uden terapeutisk intervention.
English: - Take the ampoule out of the box.
Danish: - Tag ampullen ud af æsken.
English: Thereafter liver function should be monitored as clinically indicated.
Danish: Derefter bør leverfunktionen monitoreres som klinisk indiceret.
English: Signifor may affect the way some other medicines work.
Danish: Signifor kan påvirke måden anden medicin virker på.
English: You should also read the instructions at the end of this leaflet.
Danish: Du bør også læse vejledningen til sidst i denne indlægsseddel.
English: Cushing's disease
Danish: Cushings sygdom
English: Distribution between blood cells and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%).
Danish: Fordelingen mellem blodceller og plasma er koncentrationsafhængig og viser, at pasireotid primært er lokaliseret i plasmaet (91%).
English: - If you are a sexually active woman, you should use an effective method of contraception during treatment.
Danish: - Hvis du er en seksuelt aktiv kvinde, skal du bruge et effektivt præventionsmiddel under behandlingen.
English: The incidence of such events was highest in the first 3 months of treatment.
Danish: Forekomsten af sådanne bivirkninger var højest i de første 3 måneder af behandlingen.
English: These reactions resolved spontaneously and required no intervention.
Danish: Disse reaktioner forsvandt spontant og krævede ingen indgriben.
English: The injection site is the place on your body where you are going to give yourself the injection.
Danish: Injektionsstedet er det sted på kroppen, hvor du vil tage injektionen.
English: Similar results were also seen at month 12.
Danish: Der blev også observeret lignende resultater ved måned 12.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Din læge vil holde øje med din tilstand regelmæssigt og kontrollere, at behandlingen har den ønskede virkning.
English: This medicine comes in an ampoule, i.e. a small glass container.
Danish: Dette lægemiddel leveres i en ampul, dvs. en lille glasbeholder.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: YDERKARTON AF MULTIPAKNING (INKLUSIVE BLUE BOX)
English: In both these cases, return the entire pack to the pharmacy.
Danish: I begge disse tilfælde skal du returnere hele pakningen til apoteket.
English: There is a limited amount of data from the use of pasireotide in pregnant women.
Danish: Der er begrænsede data fra anvendelse af pasireotid til gravide kvinder.
English: A total of 181 patients completed the core phase (24 weeks) of the study.
Danish: I alt gennemførte 181 patienter studiets hovedfase (24 uger).
English: Pasireotide did not affect insulin sensitivity.
Danish: Pasireotid påvirkede ikke insulinfølsomheden.
English: N=65 n (%), p value
Danish: N=65 n (%), p-værdi
English: Store Signifor ampoules according to the storage conditions listed on the box.
Danish: Opbevar Signifor-ampullerne i henhold til opbevaringsbetingelserne beskrevet på æsken.
English: Additional dose adjustments (up to a maximum of 40 mg) were allowed at months 7 and 9 of the core phase.
Danish: Yderligere dosisjusteringer (maksimalt op til 40 mg) blev tilladt i kernefasen ved måned 7 og 9.
English: Solvent for Signifor
Danish: Solvens til Signifor
English: You may experience yellowing of the skin, dark urine,
Danish: Du kan opleve gulfarvning af huden, mørk urin,
English: Insert the needle fully into the left or right gluteus at a 90° angle to the skin.
Danish: Stik kanylen helt ind i den venstre eller højre glutealmuskel i en vinkel på 90° i forhold til huden.
English: - with hypokalaemia and/or hypomagnesaemia.
Danish: - ved hypokaliæmi og/eller hypomagnesiæmi.
English: In all these cases, return the entire pack to the pharmacy.
Danish: I alle disse tilfælde skal du returnere hele pakningen til apoteket.
English: You are now ready to inject.
Danish: Du er nu klar til selve injektionen.
English: Not following them could result in failure to deliver the injection appropriately.
Danish: Hvis de ikke følges, kan det medføre, at injektionen ikke gives korrekt.
English: Check the expiry date which is stated on the ampoule label (after “EXP”) and check that the ampoule contains the dose that your doctor has prescribed.
Danish: Kontroller udløbsdatoen, som er angivet på ampullens etiket (efter ”EXP”) og kontroller, at ampullen indeholder den dosis, som din læge har ordineret til dig.
English: Carcinogenicity studies conducted in rats and transgenic mice did not identify any carcinogenic potential.
Danish: Karcinogenicitetsstudier med rotter og transgene mus har ikke identificeret noget karcinogent potentiale.
English: Pharmacokinetic steady state for pasireotide intramuscular use is achieved after three months.
Danish: Farmakokinetisk steady state for pasireotid til intramuskulær anvendelse opnås efter tre måneder.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Danish: Hyppighederne var defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til
English: - Inspect the ampoule.
Danish: - Kontroller ampullen.
English: Your doctor may wish to monitor your heart rate using a machine that measures electrical activity of the heart (an “ECG”, or electrocardiogram).
Danish: Din læge vil måske overvåge din hjertefrekvens ved hjælp af en maskine, der måler hjertets elektriske aktivitet (tage et ”EKG” eller elektrokardiogram).
English: The clinical significance of this prolongation is unknown.
Danish: Den kliniske betydning af denne forlængelse er ukendt.
English: Medicinal products that prolong the QT interval
Danish: Lægemidler, som forlænger QT-intervallet
English: Pasireotide
Danish: Pasireotid
English: This may involve measuring the levels of growth hormone or other hormones in your blood.
Danish: Det kan eventuelt indebære at måle mængden af væksthormon eller andre hormoner i dit blod.
English: Effect on female fertility
Danish: Virkning på fertiliteten hos kvinder
English: ATTENTION:
Danish: BEMÆRK:
English: If you have any questions about how Signifor works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Signifor virker, eller hvorfor det er ordineret til dig, skal du spørge din læge.
English: Results are the meanSEM of IC50 values expressed as nmol/l.
Danish: Resultaterne er gennemsnittet ± SEM af IC50-værdierne udtrykt i nmol/l.
English: One case of ketosis and one case of ketoacidosis have been reported during compassionate use of Signifor.
Danish: Et tilfælde af ketose og et tilfælde af ketoacidose er rapporteret i forbindelse med ”compassionate use” af Signifor.
English: The clinical relevance of these effects in humans is unknown.
Danish: Den kliniske relevans af disse påvirkninger hos mennesker kendes ikke.
English: Adverse reactions are listed according to MedDRA primary system organ class.
Danish: Bivirkningerne er ordnet efter MedDRA's primære systemorganklasser.
English: Check the expiry date and the dose
Danish: Kontroller udløbsdatoen og dosering
English: Tap the syringe with your fingers to get rid of air bubbles.
Danish: Bank på sprøjten med dine fingre for at slippe af med luftbobler.
English: Overall reductions in these parameters tended to be greater in patients that were mUFC responders.
Danish: De samlede reduktioner i disse parametre havde tendens til at være større hos patienter, som var mUFC-respondenter.
English: Similar trends were observed at month 12.
Danish: Lignende tendenser observeredes ved måned 12.
English: Improvements were observed in both dose groups for CushingQoL and the Mental Component Summary (MCS) of SF-12v2, but not for the Physical Component Summary (PCS) of SF-12v2.
Danish: Forbedringer blev observeret i begge doseringsgrupper for CushingQoL og Mental Component Summary (MCS) af SF-12v2, men ikke for Physical Component Summary (PCS) af SF-12v2.
English: Especially, tell your doctor if you are using: - medicines used in organ transplantation to reduce the activity of the immune system
Danish: Du skal specielt fortælle din læge, hvis du bruger: - medicin, som bruges ved organtransplantationer til at nedsætte aktiviteten af immunforsvaret
English: Use of the same injection site for two consecutive injections is not recommended.
Danish: Det frarådes at benytte samme injektionssted til to på hinanden følgende injektioner.
English: Your doctor will check regularly how you respond to the treatment with Signifor and determine which dose is best for you.
Danish: Din læge vil jævnligt kontrollere, hvordan du reagerer på behandlingen med Signifor for at kunne afgøre, hvilken dosis der er bedst for dig.
English: Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived.
Danish: Patienter, der oplever en signifikant reduktion af niveauet af frit kortisol i urinen (UFC), bør fortsat behandles med Signifor, så længe der opnås en gavnlig virkning.
English: Important safety information Caution: Keep the ampoules out of the reach of children.
Danish: Vigtig sikkerhedsinformation Advarsel: Opbevar ampullerne utilgængeligt for børn.
English: At the end of the core phase, patients not adequately responding to their initial therapy were allowed to switch treatment.
Danish: Ved afslutning af hovedfasen kunne patienter, der ikke havde responderet på deres initiale behandling, skifte behandling.
English: Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
Danish: Hold sprøjten i en hånd mellem to fingre med din tommelfinger for enden af stemplet.
English: Extension phase
Danish: Forlængelsesfase
English: After the initial 6 months in the study, patients entered an additional 6-month open-label treatment period.
Danish: Efter de første 6 måneder af studiet indledtes endnu en 6-måneders åben behandlingsperiode.
English: Signifor is a medicine that contains the active substance pasireotide.
Danish: Signifor er et lægemiddel, der indeholder det aktive stof pasireotid.
English: Your treatment with Signifor should continue for as long as your doctor tells you that it is necessary.
Danish: Din behandling med Signifor skal fortsætte, så længe lægen siger, at den er nødvendig.
English: FPG/HbA1c monitoring during treatment should follow established guidelines.
Danish: FPG/HbA1c-monitorering under behandlingen skal følge etablerede retningslinjer.
English: - You should not breast-feed while using Signifor.
Danish: - Du må ikke amme, mens du tager Signifor.
English: Fatigue includes fatigue and asthenia.
Danish: Træthed inkluderer træthed og asteni.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Virkninger er i prækliniske undersøgelser kun observeret ved eksponeringer, der anses for i tilstrækkelig grad at overstige den maksimale humane eksponering til, at de er af mindre relevans for klinisk anvendelse.
English: Five human somatostatin receptor subtypes are known: hsst1, 2, 3, 4, and 5.
Danish: Humane somatostatinreceptorer har fem kendte undertyper: hsst1, 2, 3, 4 og 5.
English: - Signifor may lower your heart rate.
Danish: - Signifor kan sænke din hjertefrekvens.
English: All analyses were conducted based on the randomised dose groups.
Danish: Alle analyser blev udført på baggrund af de randomiserede dosisgrupper.
English: One long thick blunt sterile needle for drawing up the solution (your doctor or nurse will tell you if this is needed)
Danish: En lang, tyk, stump steril kanyle til at trække injektionsvæsken op (din læge eller sygeplejerske vil fortælle dig, om det er nødvendigt)
English: Pasireotide may decrease the relative bioavailability of ciclosporin.
Danish: Pasireotid kan sænke ciclosporins relative biotilgængelighed.
English: Embryo toxicity was seen in rats and rabbits at doses that caused maternal toxicity but no teratogenic potential was detected.
Danish: Embryotoksicitet er set hos rotter og kaniner ved doser, som medførte maternel toksicitet, men der er ikke detekteret teratogent potentiale.
English: Insulin and antidiabetic medicinal products
Danish: Insulin og antidiabetika
English: Each ampoule is packed in a cardboard tray which is placed in an outer box.
Danish: Hver ampul er pakket i en kartonbakke, der er placeret i en yderpakning.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX)
English: Within each system organ class, adverse reactions are ranked by frequency.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter frekvens.
English: Ampoules should be opened just prior to administration, and any unused portion discarded.
Danish: Ampullerne må først åbnes lige inden administration og ubrugt opløsning skal kasseres.
English: Treatment should not be restarted if the liver function abnormalities are suspected to be related to pasireotide.
Danish: Behandling bør ikke genoptages, hvis det mistænkes, at de abnorme leverfunktionsværdier er relateret til pasireotid.
English: Hyperglycaemia, diabetes mellitus
Danish: Hyperglykæmi, diabetes mellitus
English: Injection site reactions were also reported in clinical studies in other populations.
Danish: Reaktioner på injektionsstedet er også rapporteret fra kliniske studier hos andre populationer.
English: Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated).
Danish: Træk langsomt stemplet tilbage for at kontrollere, at et blodkar ikke er blevet perforeret (skift position, hvis et blodkar er blevet perforeret).
English: Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).
Danish: De foretrukne steder til subkutane injektioner er øverst på lårene og abdomen (ikke navle eller talje).
English: Active control N=68 n (%)
Danish: Aktiv kontrol N=68 n (%)
English: If you are pregnant or think that you may be, it is important to tell your doctor who will discuss with you whether you can use Signifor during your pregnancy.
Danish: Hvis du er eller tror, at du kan være gravid, skal du fortælle det til din læge, som så vil drøfte med dig, om du kan bruge Signifor under graviditeten.
English: - Signifor may cause your blood sugar to increase.
Danish: - Signifor kan få dit blodsukker til at stige.
English: A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient.
Danish: En dosisøgning til 0,9 mg kan overvejes baseret på patientens respons på behandlingen, så længe dosis på 0,6 mg er veltolereret af patienten.
English: Data on Cushing's disease patients older than 65 years are limited but do not suggest any clinically significant differences in safety and efficacy in relation to younger patients.
Danish: Data for patienter med Cushings sygdom, som er ældre end 65 år, er begrænsede, men tyder ikke på nogen klinisk signifikante forskelle i sikkerhed og virkning sammenlignet med yngre patienter.
English: Avoid soreness and skin irritation by choosing a different site from the previous one for each injection.
Danish: Undgå ømhed og hudirritation ved at vælge et andet sted end sidst til hver injektion.
English: Tap the ampoule with your finger in order to make sure there is no liquid in the top part when you open the ampoule.
Danish: Bank let på ampullen med din finger for at sikre, at der ikke er noget væske i toppen, når du åbner ampullen.
English: At the end of the core phase, patients achieving biochemical control or benefiting from the treatment as assessed by the investigator could continue to be treated in the extension phase with the study treatment to which they were initially randomised.
Danish: Ved afslutning af hovedfasen kunne patienter, der havde opnået biokemisk kontrol, eller som ifølge investigators skøn havde gavn af behandlingen, fortsætte behandling i forlængelsesfasen med den studiebehandling, de initialt var blevet randomiseret til.
English: Table 2 Binding affinities of somatostatin (SRIF-14), pasireotide, octreotide and lanreotide to the five human somatostatin receptor subtypes (hsst1-5)
Danish: Tabel 2 Bindingsaffinitet for somatostatin (SRIF-14), pasireotid, octreotid og lanreotid til de fem humane somatostatin-receptorundertyper (hsst1-5)
English: The 60 mg strength is only to be used in the treatment of acromegaly.
Danish: En 60 mg dosis må kun anvendes til behandling af akromegali.
English: Gently pinch the skin at the injection site and, holding the needle at an angle of approximately 45 degrees (as shown in the picture) insert it into the injection site.
Danish: Knib forsigtigt huden sammen ved injektionsstedet, og mens du holder kanylen i en vinkel på ca. 45 grader (som vist på billedet), stikkes den ind i injektionsstedet.
English: Withdraw the needle from the injection site and activate the safety guard (as shown in Step 8).
Danish: Tag nålen ud fra injektionsstedet og aktivér sikkerhedsbeskyttelsen (som vist i trin 8).