FrancophonIA/ELRC3.0 huggingface dataset:
English: Zynquista contains the active substance sotagliflozin.
Danish: Zynquista indeholder det aktive stof sotagliflozin.
English: Side effects reported with Zynquista are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Zynquista vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Zynquista?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zynquista?
English: The European Medicines Agency decided that Zynquista's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Zynquista opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In addition, precautions have been recommended to reduce the risk of diabetic ketoacidosis.
Danish: Desuden anbefales en række forsigtighedsforanstaltninger for at minimere risikoen for diabetisk ketoacidose.
English: The medicine should be used with precautions to reduce the risk of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Danish: Lægemidlet bør anvendes med forsigtighed for at mindske risikoen for diabetisk ketoacidose (en alvorlig komplikation ved diabetes med højt niveau af ketonstoffer i blodet).
English: For more information about using Zynquista, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Zynquista, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: In the third study involving 1,405 patients, only the higher dose of Zynquista (400 mg) was studied.
Danish: I det tredje studie med 1.405 patienter undersøgte man kun den høje dosis Zynquista (400 mg).
English: An overview of Zynquista and why it is authorised in the EU
Danish: En oversigt over Zynquista, og hvorfor det er godkendt i EU
English: Other common side effects (which may affect up to 1 in 10 people) include diabetic ketoacidosis, diarrhoea and genital infection in men.
Danish: Andre almindelige bivirkninger (der kan forekomme hos op til 1 ud af 10 patienter) omfatter diabetisk ketoacidose, diarré og infektion i kønsorganerne hos mænd.
English: The main measure of effectiveness was the proportion of patients who had HbA1c levels less than 7.0% and no episodes of severe hypoglycaemia (low blood glucose levels) or diabetic ketoacidosis.
Danish: Det primære mål for virkningen var andelen af patienter med et HbA1C-niveau under 7,0 % og ingen episoder med alvorlig hypoglykæmi (lavt blodsukker) eller diabetisk ketoacidose.
English: The company that markets Zynquista will provide information on measures to reduce the risk of diabetic ketoacidosis, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Danish: Den virksomhed, der markedsfører Zynquista, skal udarbejde informationsmateriale om forsigtighedsregler til minimering af risikoen for diabetisk ketoacidose, herunder et patientkort og en vejledning til patienterne og deres omsorgspersoner samt en vejledning til sundhedspersoner, inklusive en tjekliste til ordinerende læger.
English: Why is Zynquista authorised in the EU?
Danish: Hvorfor blev Zynquista godkendt i EU?
English: It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Danish: Det anvendes hos overvægtige patienter (BMI på mindst 27 kg/m2), når insulin alene ikke giver tilstrækkelig regulering af blodsukkeret.
English: The most common side effect with Zynquista (which may affect more than 1 in 10 people) is genital infection in women.
Danish: Den hyppigste bivirkning ved Zynquista (der kan forekomme hos mere end 1 ud af 10 patienter) er infektion i kønsorganerne hos kvinder.
English: However, since Zynquista increases the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes, it is recommended only in overweight and obese patients who are expected to benefit most from treatment.
Danish: Da Zynquista imidlertid øger risikoen for diabetisk ketoacidose betragteligt hos patienter med type 1-diabetes, anbefales det kun til overvægtige og svært overvægtige patienter, der forventes at have størst gavn af behandlingen.
English: Adding Zynquista 200 or 400 mg to insulin led to a reduction in HbA1c levels of about 0.4 percentage points after 24 weeks of treatment, compared with almost no reduction in HbA1c levels after adding placebo to insulin.
Danish: Tillæg af Zynquista 200 eller 400 mg til insulin medførte et fald i HbA1C-niveauet på ca. 0,4 procentpoint efter 24 ugers behandling, sammenholdt med næsten intet fald i HbA1C-niveauet efter tillæg af placebo til insulin.
English: What is Zynquista and what is it used for?
Danish: Hvad er Zynquista, og hvad anvendes det til?
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which indicates how well blood glucose is controlled.
Danish: Det primære mål for virkningen var niveauet af glykeret hæmoglobin (HbA1c), der viser, hvor godt blodsukkeret er reguleret.
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with the medicine.
Danish: Virksomheden skal også gennemføre et studie til vurdering af, hvor hyppigt diabetisk ketoacidose forekommer hos patienter med type 1-diabetes, som behandles med lægemidlet.
English: The active substance in Zynquista, sotagliflozin, blocks the action of two proteins known as glucose transporters (SGLT1 and SGLT2) which are found in the intestine and the kidneys.
Danish: Det aktive stof i Zynquista, sotagliflozin, blokerer to proteiner, de såkaldte glukosetransportere (SGLT1 og SGLT2), der findes i tarmene og nyrerne.
English: Zynquista's common side effects, which are related to the way the medicine works, such as increased genital infections, are considered manageable and similar to those of other medicines of a similar class.
Danish: De hyppigste bivirkninger ved Zynquista, der er relateret til lægemidlets virkemåde, f.eks. infektion i kønsorganerne, anses for at være håndterbare og at svare til dem, der er ved andre lægemidler af samme klasse.
English: What are the risks associated with Zynquista?
Danish: Hvilke risici er der forbundet med Zynquista?
English: Zynquista can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in managing type 1 diabetes.
Danish: Zynquista udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af type 1-diabetes.
English: For the full list of side effects and restrictions with Zynquista, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Zynquista fremgår af indlægssedlen.
English: In two of these studies, involving a total of 1,575 patients, two doses of Zynquista (200 and 400 mg) were compared with placebo when given in addition to insulin.
Danish: I to af studierne, hvor i alt 1.575 patienter deltog, blev to doser af Zynquista (200 og 400 mg) sammenlignet med placebo (ikke-aktivt stof), begge i tillæg til insulin.
English: Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes.
Danish: Zynquista er et lægemiddel mod diabetes, der anvendes sammen med insulin til at behandle voksne med type 1-diabetes.
English: In type 1 diabetes, the body does not make enough insulin to control the amount of glucose (sugar) in the blood, resulting in high levels of glucose in the blood.
Danish: Ved type 1-diabetes danner kroppen ikke nok insulin til at regulere indholdet af glukose (sukker) i blodet, og det medfører forhøjet blodsukker.
English: On this basis, Zynquista 400 mg added to insulin was effective in around 29% of patients, compared with 15% of patients receiving placebo plus insulin.
Danish: I den forbindelse sås en effekt hos ca. 29 % af de patienter, der fik Zynquista 400 mg i tillæg til insulin, sammenholdt med 15 % af de patienter, der fik placebo plus insulin.
English: Zynquista, taken together with insulin, is effective in lowering blood glucose levels in patients with type 1 diabetes whose blood sugar is not controlled well enough with insulin alone.
Danish: Når Zynquista tages i tillæg til insulin, er det effektivt til at sænke blodsukkeret hos patienter med type 1-diabetes, hvis blodsukker ikke er tilstrækkeligt reguleret med insulin alene.
English: By blocking SGLT1 in the intestine, sotagliflozin delays the absorption of glucose into the blood after a meal.
Danish: Ved at blokere SGLT1 i tarmene forsinker sotagliflozin optagelsen af glukose i blodet efter et måltid.
English: How is Zynquista used?
Danish: Hvordan anvendes Zynquista?
English: What benefits of Zynquista have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zynquista?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynquista have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zynquista.
English: In the kidneys, sotagliflozin blocks SGLT2 involved in stopping glucose in the bloodstream from being passed out into the urine.
Danish: I nyrerne blokerer sotagliflozin SGLT2, der er med til at forhindre glukosen i blodbanen i at blive udskilt i urinen.
English: As result, sotagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Danish: Derved får sotagliflozin nyrerne til at udskille mere glukose gennem urinen, så glukoseindholdet i blodet falder.
English: How does Zynquista work?
Danish: Hvordan virker Zynquista?
English: Zynquista was found effective at controlling blood glucose levels in 3 main studies in patients with type 1 diabetes.
Danish: Det er i 3 hovedstudier påvist, at Zynquista er effektivt til at regulere glukoseniveauet hos patienter med type 1-diabetes.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1021/001 Pregabalin Zentiva 25 mg Capsule, hard
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: He or she will take the appropriate measures.
Danish: Han eller hun vil træffe de nødvendige foranstaltninger.
English: Volume of distribution at steady state
Danish: Distributionsvolumen ved steady state
English: *Produced from the plasma of human donors.
Danish: *Produceret ud fra plasma fra humane donorer.
English: Submission of final clinical study report by 31 March 2025
Danish: Fremsendelse af den endelige kliniske studierapport senest den 31. marts 2025
English: Date of first authorisation: 20 August 2015
Danish: Dato for første markedsføringstilladelse: 20. august 2015
English: Because of this damage, the lungs do not work properly.
Danish: På grund af denne beskadigelse fungerer lungerne ikke korrekt.
English: * n=18 subjects.
Danish: * n=18 forsøgspersoner.
English: The population estimate of mean half-life was 6.8 days.
Danish: Populationsestimatet for den gennemsnitlige halveringstid var 6,8 dage.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også ukendte eller nyopdagede vira og andre patogener.
English: RAPID studies
Danish: RAPID-studier
English: No alternative dose regimen can be recommended in those patients.
Danish: Der kan ikke anbefales noget alternativt dosisregime for disse patienter.
English: The subjects ranged in age from 29 to 68 years (median age 49 years).
Danish: Forsøgspersonerne var i alderen 29 til 68 år (median alder 49 år).
English: • how to keep a treatment diary
Danish: • hvordan du fører en behandlingsdagbog
English: This medicine is not for use in children or adolescents below 18years of age.
Danish: Dette lægemiddel må ikke anvendes til børn og unge under 18 år.
English: However, Respreeza should be given with caution to pregnant women.
Danish: Respreeza skal imidlertid gives med forsigtighed til gravide kvinder.
English: The amount of Respreeza you are given is based on your body weight.
Danish: Mængden af Respreeza, du skal have, er baseret på din kropsvægt.
English: Terminal half-life (t1/2ß)
Danish: Terminal halveringstid (t1/2ß)
English: If your doctor decides that you are suitable for such home-treatment / selfadministration, he or she will instruct you in:
Danish: Hvis din læge beslutter, at du er egnet til en sådan hjemmebehandling/selvadministration, vil han eller hun vise dig:
English: • The product must be reconstituted, administered and handled with caution using aseptic technique to maintain product sterility.
Danish: • Produktet skal rekonstitueres, administreres og håndteres med forsigtighed under anvendelse af aseptisk teknik for at opretholde produktets sterilitet.
English: Maximum concentration (Cmax)
Danish: Maksimum-koncentration (Cmaks)
English: The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”.
Danish: Hyppigheden efter markedsføring anses udelukkende for at være "ikke kendt” (kan ikke estimeres ud fra forhåndenværende data).
English: For intravenous use.
Danish: Kun til intravenøs brug.
English: During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period.
Danish: Ved de første infusioner skal patientens kliniske tilstand, herunder vitale tegn, overvåges nøje under hele infusionen.
English: No special investigations have been performed.
Danish: Der er ikke blevet udført specielle studier.
English: 603 (±129) mL/day
Danish: 603 (±129) ml/dage
English: Consequences of overdose are unknown.
Danish: Konsekvenserne ved overdosering er ikke kendt.
English: Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Danish: Respreeza kan derfor i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Hyperhidrosis, pruritus
Danish: Hyperhidrose, pruritus
English: Hypersensitivity or allergic reactions have been observed during the treatment.
Danish: Der er blevet observeret overfølsomhed og allergiske reaktioner under behandlingen.
English: Table 1 shows the mean results for the Respreeza pharmacokinetic parameters.
Danish: Tabel 1 viser gennemsnitsresultaterne for Respreezas farmakokinetiske parametre.
English: There are limited data regarding the use of this medicinal product in home-treatment / selfadministration.
Danish: Der er begrænsede data vedrørende anvendelse af dette lægemiddel i forbindelse med hjemmebehandling/selvadministration.
English: If you are breast-feeding, your doctor will discuss with you the risks and benefits of taking this medicine.
Danish: Hvis du ammer, vil din læge tale med dig om fordele og risici ved at tage dette lægemiddel.
English: This infusion rate may be adjusted, based upon patient tolerability.
Danish: Denne infusionshastighed kan justeres, baseret på patientens tolerabilitet.
English: After the first infusions, you or your caregiver might also administer Respreeza, but only after receiving adequate training.
Danish: Efter de første infusioner kan du selv eller en omsorgsperson indgive Respreeza, men kun efter at have fået tilstrækkelig oplæring.
English: The other side effects may include:
Danish: Andre bivirkninger kan omfatte:
English: Such studies are not considered meaningful due to the production of antibodies against the heterologous human protein in animals.
Danish: Sådanne studier synes ikke at give mening pga. dannelse af antistoffer mod det heterologe humane protein hos dyr.
English: • how to keep the product sterile (aseptic infusion techniques)
Danish: • hvordan du opretholder et sterilt præparat (aseptiske infusionsteknikker)
English: The safety of Respreeza has been assessed in several preclinical studies.
Danish: Respreezas sikkerhed er blevet vurderet i adskillige prækliniske studier.
English: If treatment with Respreeza is stopped, your condition may worsen.
Danish: Hvis du stopper behandlingen med Respreeza, kan din tilstand forværres.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and short term toxicity studies.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi og kortvarige toksicitetsstudier.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Do NOT take Respreeza
Danish: Tag ikke Respreeza
English: • Inspect the reconstituted solution for particulate matter and discoloration prior to administration.
Danish: • Kontroller den rekonstituerede opløsning for partikler og misfarvning før administration.
English: Conditions that increase neutrophil accumulation and activation in the lung, such as respiratory infection and smoking, will in turn increase levels of NE.
Danish: Tilstande, der øger akkumulering og aktivering af neutrofiler i lungerne, såsom lungeinfektion og rygning, vil til gengæld øge NE-niveauet.
English: In case of shock, emergency medical treatment should be administered.
Danish: I tilfælde af shock skal akut behandling iværksættes.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Danish: Fra en mikrobiologisk synsvinkel skal præparatet anvendes umiddelbart efter rekonstitution.
English: Proceed with your next dose immediately and continue at regular intervals as advised by your doctor or healthcare professional.
Danish: Fortsæt med din næste dosis straks og fortsæt med regelmæssige intervaller som tilrådet af din læge eller sundhedspersonalet.
English: Tobacco smoke is an important risk factor for the development and progression of emphysema.
Danish: Tobakrygning er en væsentlig risikofaktor for udvikling og progression af emfysem.
English: If you experience dizziness, you should not drive or use machines until the dizziness has passed (see section 4).
Danish: Hvis du oplever svimmelhed, må du ikke føre motorkøretøj eller betjene maskiner, før svimmelheden er overstået (se punkt 4).
English: • if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them.
Danish: • hvis du har mangel på visse blodproteiner kaldet immunglobulin type A (IgA) og har udviklet antistoffer mod dem.
English: That should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning til patienter, der er på en kontrolleret, natriumfattig diæt.
English: Solvent for Respreeza
Danish: Solvens til Respreeza
English: If more than 1 vial of Respreeza is needed to achieve the required dose, repeat instructions 1 to 11 above using an additional package containing an unused Mix2Vial set.
Danish: Hvis det er nødvendigt med mere end 1 hætteglas med Respreeza for at opnå den nødvendige dosis, gentages anvisningerne 1 til 11 ovenfor med en ny pakning, der indeholder et ubrugt Mix2Vialsæt.
English: Make sure that the roller clamp on the administration set is closed.
Danish: Sørg for, at rulleklemmen på administrationssættet er lukket.
English: Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Danish: Hyppigheden pr. patient (baseret på seks måneders eksponering i kliniske studier) er blevet evalueret i henhold til følgende konvention: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: • Total reconstitution of the powder should be obtained within 5 minutes (1 g presentation) or 10
Danish: • Total rekonstitution af pulveret bør opnås inden for 5 minutter (1 g pakning) eller 10 minutter (4
English: Your doctor will determine the appropriate infusion rate for you by taking into account your weight and your tolerability to infusion.
Danish: Din læge vil bestemme den korrekte infusionshastighed for dig ved at tage højde for din vægt og for, hvor godt du tåler infusionen.
English: Urticaria, rash (including exfoliative and generalized)
Danish: Urticaria, udslæt (herunder eksfoliativt og generaliseret)
English: • The powder must be reconstituted with solvent (water for injections).
Danish: • Pulveret skal rekonstitueres med solvens (vand til injektionsvæsker).
English: Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of this medicine.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du bemærker sådanne reaktioner under infusionen af dette lægemiddel.
English: A population pharmacokinetic analysis was conducted using data from 90 Respreeza-treated subjects from the RAPID trial.
Danish: En farmakokinetisk populationsanalyse blev udført med data fra 90 Respreeza-behandlede forsøgspersoner fra RAPID-studiet.
English: Figure 1: Changes in Lung Density (TLC) from baseline in the RAPID and RAPID Extension studies
Danish: Figur 1: Ændringer i lungedensitet (TLC) fra baseline i RAPID-studiet og RAPIDforlængelsesstudiet
English: Slowly open the roller clamp on the administration set and let Respreeza flow until it reaches the end of the tubing with no air bubbles.
Danish: Åbn rulleklemmen på administrationssættet langsomt og lad Respreeza strømme ud, indtil det når enden af slangen uden luftbobler.
English: • The reconstitution should be performed according to the instructions provided below.
Danish: • Rekonstitution skal foretages i henhold til nedenstående anvisninger.
English: 144 (±27) µM x day
Danish: 144 (±27) µM x dag
English: The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebocontrolled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Danish: Respreezas sikkerhed og virkning blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (RAPID), efterfulgt af en toårig forlængelse af studiet med åben behandling (RAPID-forlængelsesstudiet).
English: Therefore cessation of smoking and the avoidance of environmental tobacco smoke are strongly recommended.
Danish: Derfor anbefales rygestop og undgåelse af passive rygning på det kraftigste.
English: Close the roller clamp.
Danish: Luk rulleklemmen.
English: However, as there is no information available regarding the safety of Respreeza use during pregnancy, if you are pregnant, this medicine should only be given to you with caution.
Danish: Da der imidlertid ikke er nogen oplysninger tilgængelige vedrørende sikkerheden ved Respreeza under graviditet, skal der udvises forsigtighed, hvis du er gravid og får dette lægemiddel.
English: It is unknown whether Respreeza passes into human milk.
Danish: Det er ukendt, om Respreeza passerer over i mælken hos mennesker.
English: Patients should be informed of signs of hypersensitivity reactions.
Danish: Patienten skal informeres om symptomer på overfølsomhedsreaktioner.
English: NOTE: Ensure all water has transferred into the Respreeza vial.
Danish: BEMÆRK: Sørg for, at alt vandet er blevet overført til hætteglasset med Respreeza.
English: It is unknown whether Respreeza / metabolites are excreted in human milk.
Danish: Det er ukendt, om Respreeza/metabolitter udskilles i human mælk.