FrancophonIA/ELRC3.0 huggingface dataset:
English: Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Danish: Anvendes straks efter rekonstituering (kemisk og fysisk stabilt ved 2 °C - 8 °C i 24 timer eller ved almindelig stuetemperatur i 4 timer).
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Danish: Farveløst type I hætteglas, grå fluor-resina-dækket butyl gummiprop, holdt på plads med et ombøjet aluminiumsbånd, blå polypropylen aftagelig låg, indeholdende 20 mg basiliximab som pulver til injektions- og infusionsvæske, opløsning.
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion.
Danish: Farveløst type I hætteglas, grå fluor-resina-dækket butyl gummiprop, holdt på plads med et ombøjet aluminiumsbånd, blå polypropylen aftagelig låg, indeholdende 10 mg basiliximab som pulver til injektions- og infusionsvæske, opløsning.
English: The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
Danish: Den første dosis skal gives indenfor de sidste to timer før transplantationen, og den anden dosis 4 dage efter transplantationen.
English: The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Danish: De mest almindelige rapporterede bivirkninger efter to-stofs- eller tre-stofs-terapi, hos begge behandlingsgrupper (basiliximab vs. placebo) var forstoppelse, urinvejsinfektion, smerte, kvalme, perifert ødem, hypertension, anæmi, hovedpine, hyperkalæmi, hyperkolesterolæmi, postoperative sårkomplikationer, vægtøgning, stigning i blod kreatinin, hypophosphatæmi, diarré og øvre luftvejsinfektion.
English: The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
Danish: Den anden dosis skal udelades, hvis der enten opstår en alvorlig overfølsomhedsreaktion over for Simulect eller post-operative komplikationer såsom graft tab (se pkt.
English: It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Danish: Det kan administreres i en tre-stofs immunsuppressiv behandling baseret på ciclosporin som microemulsion og kortikosteroid samt azathioprin eller mycofenolmofetil.
English: These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.
Danish: Disse inkluderede anafylaksilignende reaktioner såsom udslæt, urticaria, pruritus, nysen, hiven efter vejret, hypotension, takykardi, dyspnø, bronkospasme, lungeødem, hjertesvigt, respirationsinsuffiens og vaskulært lækagesyndrom.
English: The first 20 mg dose should be given within 2 hours prior to transplantation surgery.
Danish: De første 20 mg skal gives inden for 2 timer inden transplantationen.
English: One ml of the reconstituted solution contains 4 mg basiliximab.
Danish: 1 ml af den opblandede opløsning indeholder 4 mg basiliximab.
English: The first dose should be given within 2 hours prior to transplantation surgery.
Danish: Den første dosis bør gives inden for 2 timer før transplantationen.
English: Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome (see section 4.4).
Danish: Overfølsomheds-/anafylaksilignende reaktioner såsom udslæt, urticaria, pruritus, nysen, hiven efter vejret, bronkospasme, dyspnø, lungeødem, hjerteinsufficiens, hypotension, takykardi, respirationsinsufficiens, vaskulært lækagesyndrom (se pkt.
English: Powder and solvent for solution for injection or infusion
Danish: Pulver og solvens til injektions- og infusionsvæske, opløsning
English: What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab.
Danish: Simulect leveres som hvidt pulver i et farveløst hætteglas indeholdende 10 mg basiliximab.
English: What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab.
Danish: Simulect leveres som hvidt pulver i et farveløst hætteglas indeholdende 20 mg basiliximab.
English: Simulect is also available in vials with 20 mg basiliximab.
Danish: Simulect fås også i hætteglas med 20 mg basiliximab.
English: Simulect is also available in vials with 10 mg basiliximab.
Danish: Simulect fås også i hætteglas med 10 mg basiliximab.
English: Sudden severe allergic reactions have been reported in patients treated with Simulect.
Danish: Nogle patienter, der er blevet behandlet med Simulect, har oplevet pludselige, alvorlige allergiske reaktioner.
English: Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).
Danish: Kemisk og fysisk stabilitet af den rekonstituerede opløsning er påvist i 24 timer ved 2 °C - 8 °C eller i 4 timer ved almindelig stuetemperatur (se pkt.
English: To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder.
Danish: For at tilberede injektions- eller infusionsopløsningen, træk 2,5 ml vand til injektionsvæsker aseptisk fra den medfølgende 5 ml ampul og tilføj aseptisk disse 2,5 ml vand til injektionsvæsker til hætteglasset, der indeholder Simulect pulver.
English: If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.
Danish: Du bør ikke få anden dosis Simulect, hvis du har oplevet alvorlige allergiske reaktioner over for Simulect, eller hvis du har haft komplikationer efter din operation såsom graft-tab.
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Danish: Den færdigfremstillede opløsning er isotonisk og kan gives som en bolusinjektion eller fortyndet til et volumen på 50 ml eller mere med normal saltvandsopløsning eller glucose 50 mg/ml (5 %) til infusion.
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Danish: Den færdigfremstillede opløsning er isotonisk og kan gives som en bolusinjektion eller fortyndet til et volumen på 25 ml eller mere med normal saltvandopløsning eller glucose 50 mg/ml (5 %) til infusion.
English: Each vial contains 20 mg basiliximab*.
Danish: Hvert hætteglas indeholder 20 mg basiliximab*.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
Danish: Kemisk og fysisk stabilitet under brug er påvist efter rekonstituering i 24 timer ved 2°C - 8°C eller 4 timer ved normal stuetemperatur.
English: Simulect 10 mg powder and solvent for solution for injection or infusion
Danish: Simulect 10 mg pulver og solvens til injektions- og infusionsvæske, opløsning
English: Simulect 20 mg powder and solvent for solution for injection or infusion
Danish: Simulect 20 mg pulver og solvens til injektions- og infusionsvæske, opløsning
English: One vial contains 10 mg of basiliximab.
Danish: 1 hætteglas indeholder 10 mg basiliximab.
English: For infusion, the reconstituted solution should be diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%).
Danish: Til infusionbrug skal den opblandede opløsning fortyndes til et volumen på 25 ml eller mere med isotonisk saltvand eller glucose 50 mg/ml (5 %).
English: For infusion, the reconstituted solution should be diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%).
Danish: Til infusionbrug skal den opblandede opløsning fortyndes til et volumen på 50 ml eller mere med isotonisk saltvand eller glucose 50 mg/ml (5 %).
English: Simulect 20 mg powder and solvent for solution for injection or infusion basiliximab
Danish: Simulect 20 mg pulver og solvens til injektions- og infusionsvæske, opløsning basiliximab
English: One vial contains 20 mg of basiliximab.
Danish: 1 hætteglas indeholder 20 mg basiliximab.
English: Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab
Danish: Simulect 10 mg pulver og solvens til injektions- og infusionsvæske, opløsning basiliximab
English: Simulect 20 mg powder for solution for injection/infusion basiliximab
Danish: Simulect 20 mg pulver til injektions-/infusionsvæske, opløsning basiliximab
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8C or for 4 hours at room temperature.
Danish: Kemisk og fysisk stabilitet er påvist efter opblanding i 24 timer ved 2°C - 8C eller ved almindelig stuetemperatur i 4 timer.
English: AMPOULE LABEL
Danish: AMPULETIKET
English: Simulect 10 mg powder for solution for injection/infusion basiliximab
Danish: Simulect 10 mg pulver til injektions-/infusionsvæske, opløsning basiliximab
English: Each vial contains 10 mg of basiliximab.
Danish: Hvert hætteglas indeholder 10 mg basiliximab.
English: To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder.
Danish: For at fremstille opløsningen til infusion eller injektion, tilsættes aseptisk 5 ml vand til injektionsvæsker fra den medfølgende ampul til hætteglasset med Simulect pulver.
English: Each vial contains 20 mg of basiliximab.
Danish: Hvert hætteglas indeholder 20 mg basiliximab.
English: VIAL LABEL
Danish: HÆTTEGLASETIKET
English: See package leaflet
Danish: Oversigt over indlægssedlen
English: Posology
Danish: PRODUKTRESUME
English: These measures will help protect the environment.
Danish: Disse forholdsregler vil hjælpe til at beskytte miljøet.
English: It is important to tell your doctor:
Danish: Det er vigtigt at fortælle lægen:
English: However, try to take it at the same time each day.
Danish: Prøv imidlertid at tage den på samme tid hver dag.
English: A double dose should not be taken on the same day.
Danish: En dobbeltdosis må ikke tages på samme dag.
English: This will help you to remember to take it.
Danish: Det vil gøre det nemmere for dig at huske at tage den.
English: These conditions can cause dehydration.
Danish: Disse forhold kan forårsage dehydrering.
English: • Your doctor will prescribe the strength that is right for you.
Danish: • Din læge vil ordinere den styrke, der passer til dig.
English: The signs of low blood sugar may include:
Danish: Tegnene på for lavt blodsukker kan omfatte:
English: • You can take the tablet at any time of the day.
Danish: • Du kan tage tabletten på et hvilket som helst tidspunkt på dagen.
English: Then take your next dose at the usual time.
Danish: Derefter skal du tage din næste dosis på det sædvanlige tidspunkt.
English: eGFR ≥45 to
Danish: eGFR ≥45 til
English: Pruritus (generalised)
Danish: Pruritus (generaliseret)
English: • excessive hunger, headache
Danish: • overdreven sult, hovedpine
English: Other side effects while taking Jardiance:
Danish: Andre bivirkninger ved at tage Jardiance:
English: Measure your blood sugar if possible and rest.
Danish: Mål dit blodsukker, hvis det er muligt, og hvil dig.
English: Do not change your dose unless your doctor has told you to.
Danish: Du må ikke ændre din dosis, medmindre din læge har sagt, at du skal.
English: There is no experience with doses above 800 mg in humans.
Danish: Der er ingen erfaring med doser på over 800 mg hos mennesker.
English: Systemic exposure of each metabolite was less than 10% of total drug-related material.
Danish: Den systemiske eksponering for de enkelte metabolitter var mindre end 10 % af det samlede lægemiddelrelaterede materiale.
English: Type 2 diabetes is a disease that comes from both your genes and your lifestyle.
Danish: Type 2-diabetes er en sygdom, der skyldes både dine gener og din livsstil.
English: Contact your doctor as soon as possible if you notice the following side effects:
Danish: Kontakt lægen så hurtigt som muligt, hvis du bemærker følgende bivirkninger:
English: This type usually starts when you are young and your body does not produce any insulin.
Danish: Denne type opstår som regel, når du er ung, hvis din krop slet ikke danner insulin.
English: These findings were absent after a 13 weeks drug-free recovery period.
Danish: Disse fund var ikke til stede efter en behandlingsfri restitutionsperiode på 13 uger.
English: Diet and exercise can help your body use its blood sugar better.
Danish: Diæt og motion kan hjælpe din krop med at forbruge sit blodsukker bedre.
English: • if you are 85 years old or older as you should not start taking Jardiance.
Danish: • hvis du er 85 år gammel eller derover, bør du ikke begynde at tage Jardiance.
English: • if you have serious kidney problems - your doctor may ask you to take a different medicine.
Danish: • hvis du har alvorlige nyreproblemer - din læge vil måske sige, at du skal tage en anden medicin.
English: Jardiance is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.
Danish: Børn og unge Jardiance anbefales ikke til børn og unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: Do not stop taking Jardiance without first consulting your doctor.
Danish: Du må ikke holde op med at tage Jardiance uden først at have rådført dig med din læge.
English: • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
Danish: • hvis du kaster op, har diarré eller har feber, eller hvis du ikke kan spise eller drikke.
English: • urine that appears cloudy
Danish: • urin, der ser uklar ud
English: • unusual thirst
Danish: • usædvanlig tørst
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Danish: Dato for første markedsføringstilladelse: 22. maj 2014
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Danish: Din læge vil fortælle dig, hvordan du skal behandle for lavt blodsukker, og hvad du skal gøre, hvis du mærker et eller flere af ovenstående tegn.
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Danish: Begge tumorer er almindelige hos rotter, og det er ikke sandsynligt, at de har relevans for mennesker.
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Danish: Der blev bemærket en forbedring i surrogatmarkører for beta-cellefunktion, herunder Homeostasis Model Assessment- β (HOMA-β).
English: The tablets can be taken with or without food, swallowed whole with water.
Danish: Tabletterne kan tages med eller uden mad og synkes hele med vand.
English: • fainting or loss of consciousness
Danish: • besvimelse eller bevidsthedstab
English: • if you have “type 1 diabetes”.
Danish: • hvis du har type 1-diabetes.
English: 24 weeks and maintained for 76 weeks.
Danish: Denne virkning blev observeret efter 24 uger og opretholdt i 76 uger.
English: Therapeutic experience in patients aged 85 years and older is limited.
Danish: Den terapeutiske erfaring hos patienter på 85 år og derover er begrænset.
English: Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase.
Danish: Derefter faldt plasmakoncentrationerne på en bifasisk måde med en hurtig fordelingsfase og en relativ langsom terminalfase.
English: Your doctor will decide whether to increase your dose to 25 mg once a day.
Danish: Din læge vil afgøre, om din dosis skal øges til 25 mg én gang dagligt.
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Danish: Systemisk eksponering af empagliflozin steg på en dosisproportional måde.
English: These changes were not considered to be clinically meaningful.
Danish: Disse ændringer blev ikke betragtet som klinisk relevante.
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Danish: De mulige tegn på, at du mister for meget væske fra kroppen, er anført i afsnit 4, ‘Bivirkninger'.
English: • Do not take a double dose of Jardiance to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • pain in the pelvis, or mid-back pain (when kidneys are infected)
Danish: • smerter i bækkenet eller midt på ryggen (når nyrerne er påvirket)
English: Do not drive or use any tools or machines, if you feel dizzy while taking Jardiance.
Danish: Du må ikke føre motorkøretøj eller bruge værktøj eller maskiner, hvis du føler dig svimmel, mens du tager Jardiance.
English: In both cases, treatment with empagliflozin may be restarted once the patient's condition has stabilised.
Danish: I begge tilfælde kan behandlingen med empagliflozin genoptages, når patientens tilstand er blevet stabil.
English: SGLT2 inhibitors should be used with caution in these patients.
Danish: SGLT2-hæmmere skal anvendes med forsigtighed hos disse patienter.
English: However, animal studies have shown adverse effects on postnatal development (see section 5.3).
Danish: Dyrestudier har imidlertid påvist negative virkninger på den postnatale udvikling (se pkt.
English: Your doctor has prescribed this medicine to help lower your blood sugar.
Danish: Din læge har ordineret denne medicin for at hjælpe med at sænke dit blodsukker.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Danish: Erfaringen hos New York Heart Association (NYHA) klasse I-II er begrænset, og der er ingen kliniske erfaringer med empagliflozin hos NYHA klasse III-IV.
English: 2-hour post-prandial glucose
Danish: 2-timers postprandial glucose
English: If you forget to take Jardiance What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvad du skal gøre, hvis du har glemt at tage en tablet, afhænger af, hvor lang tid der er til din næste dosis.
English: The apparent steady-state volume of distribution was estimated to be 73.8 l based on the population pharmacokinetic analysis.
Danish: Det tilsyneladende fordelingsvolumen i steady state blev anslået til at være 73,8 l baseret på den farmakokinetiske populationsanalyse.
English: Do not use Jardiance if you are pregnant.
Danish: Du må ikke tage Jardiance, hvis du er gravid.
English: In the event of an overdose, treatment should be initiated as appropriate to the patient‘s clinical status.
Danish: I tilfælde af overdosering skal behandling initieres, som det er hensigtsmæssigt ifølge patientens kliniske status.
English: Empagliflozin is not genotoxic.
Danish: Empagliflozin er ikke genotoksisk.
English: Glimepirideb
Danish: Glimepiridb
English: • You can take the tablet with or without food
Danish: • Du kan tage tabletten med eller uden mad.
English: • Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
Danish: • Din læge vil måske begrænse din dosis til 10 mg én gang dagligt, hvis du har et nyreproblem.
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: Empagliflozin er et substrat for P-glycoprotein (P-gp) og breast cancer resistance protein (BCRP).
English: Treatment with empagliflozin provided reductions in seated SBP and DBP.
Danish: Behandling med empagliflozin gav reduktioner i siddende SBP og DBP.
English: • If it is 12 hours or more until your next dose, take Jardiance as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis, skal du tage Jardiance, så snart du kommer i tanker om det.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Danish: Patienterne skal straks tjekkes for ketoacidose, hvis de får disse symptomer, uanset blodglucoseniveau.
English: Your blood sugar levels may increase when you stop taking Jardiance.
Danish: Blodsukkerniveauet kan stige, hvis du holder op med at tage Jardiance.
English: It is important to stay on the diet and exercise program recommended by your doctor while taking Jardiance.
Danish: Det er vigtigt, at du overholder det diæt- og motionsprogram, som din læge har anbefalet, mens du tager Jardiance.
English: Your doctor may prescribe Jardiance together with another diabetes medicine.
Danish: Din læge kan ordinere Jardiance sammen med anden diabetesbehandling.
English: The observed increase in urine volume was not dose-dependent and is not clinically meaningful.
Danish: Den observerede forøgelse af urinvolumenet var ikke dosisafhængig og har ingen klinisk betydning.
English: There are no data from the use of empagliflozin in pregnant women.
Danish: Der er ingen data fra anvendelse af empagliflozin til gravide kvinder.
English: Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.
Danish: På grund af den måde dette lægemiddel virker på, vil prøver for sukker i urinen være positive, mens du tager lægemidlet.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med de sjældne arvelige tilstande som galactoseintolerans, Lapp-lactase-mangel eller glucose-galactose-malabsorption bør ikke tage dette lægemiddel.
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Danish: Kontakt straks læge eller nærmeste hospital, hvis du får en eller flere af følgende bivirkninger:
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Danish: Behandlingen skal afbrydes hos patienter, der indlægges med henblik på større kirurgiske indgreb eller på grund af akutte alvorlige medicinske sygdomme.
English: • The starting dose of Jardiance is one 10 mg tablet once a day.
Danish: • Startdosis af Jardiance er én 10 mg tablet én gang dagligt.
English: Empagliflozin does not inhibit P-gp at therapeutic doses.
Danish: Empagliflozin hæmmer ikke P-gp i terapeutiske doser.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Jardiance is used in combination with a sulphonylurea and/or insulin.
Danish: Patienter skal rådes til at tage forholdsregler for at undgå hypoglykæmi, når de fører motorkøretøj og betjener maskiner, særligt når Jardiance anvendes i kombination med et sulfonylurinstof og/eller insulin.
English: Your doctor may decide to temporarily or permanently stop your treatment with Jardiance.
Danish: Lægen kan beslutte at standse din behandling med Jardiance midlertidigt eller permanent.