FrancophonIA/ELRC3.0 huggingface dataset:
English: - Doribax will be prepared and given to you by a doctor or nurse over one or four hours as an intravenous infusion into one of your veins (this is sometimes known as a “drip”).
Danish: Det gives som en intravenøs infusion i en af dine blodårer (også kendt som et ”drop”) i løbet af 1 eller 4 timer.
English: (see sections 4.2 and 5.1).
Danish: 4.2 og 5.1).
English: Doribax should not be used during pregnancy unless clearly necessary.
Danish: Doribax bør kun anvendes på tvingende indikation til gravide.
English: Each vial contains 500 mg doripenem (as monohydrate).
Danish: Hvert hætteglas indeholder 500 mg doripenem (som monohydrat).
English: Infusion solution
Danish: Infusionstid
English: Due to limited clinical data and an expected increased exposure to doripenem and its metabolite (doripenem-M-1), Doribax should be used with caution in patients with severe renal impairment (see
Danish: På grund af de begrænsede data og en forventet stigning i eksponeringen for doripenem-M-1-metabolitten tilrådes omhyggelig monitorering af patienter, der er i kontinuerlig renal substitutionsterapi (se pkt.
English: Close safety monitoring is advised for patients on continuous renal replacement therapy, due to limited clinical data and an expected increased exposure to doripenem-M-1 metabolite (see section 4.4).
Danish: Doribax bør anvendes med forsigtighed til patienter med svært nedsat nyrefunktion på grund af begrænsede kliniske data og en forventet forhøjet eksponering for doripenem og dets metabolit (doripenem-M-1) (se pkt.
English: (see sections 4.2 and 5.2)
Danish: 4.2 og 5.2).
English: Talk to your doctor, pharmacist or nurse before being given Doribax, and if you have: - Kidney problems.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Doribax, og hvis du har: - Problemer med nyrerne.
English: Infuse all of the remaining solution to administer a 250 mg dose of doripenem.
Danish: Infunder den resterende del af opløsningen, således at der indgives en dosis på 250 mg doripenem.
English: provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time.
Danish: * Når infusionsvæsken er fjernet fra køleskabet, skal den indgives inden for holdbarhedstiden for opbevaring ved stuetemperatur, forudsat at den samlede opbevaringstid i køleskab, tiden til temperering til stuetemperatur og infusionstiden ikke overskrider holdbarhedstiden for opbevaring i køleskab.
English: No studies on the effects of Doribax on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella spp.
Danish: Klebsiella pneumoniae* Klebsiella oxytoca Morganella morganii Proteus mirabilis* Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella spp.
English: Frequency Infusion time 500 mg or 1 g* every 8 hours 1 or 4 hours**
Danish: hver 8. time 1 eller 4 timer**
English: Each vial contains 250 mg doripenem (as monohydrate).
Danish: Hvert hætteglas indeholder 250 mg doripenem (som monohydrat).
English: In patients with mild renal impairment (i.e. creatinine clearance (CrCl) is > 50 to  80 ml/min), no dose adjustment is necessary.
Danish: Dosisjustering er ikke nødvendig til patienter med let nedsat nyrefunktion (dvs. kreatininclearance (CrCl) > 50 til  80 ml/min).
English: - If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections) as you may also be allergic to Doribax.
Danish: - Hvis du er allergisk over for andre antibiotika, f.eks. penicillin, cefalosporin eller carbapenem
English: Justification for not using Braille accepted
Danish: Fritaget fra krav om brailleskrift
English: The concomitant use of doripenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Danish: Lægemiddelinteraktion med valproinsyre Det frarådes at tage doripenem og valproinsyre/natriumvalproat samtidig (se pkt.
English: CRRT: continuous renal replacement therapy; CVVH: continuous venovenous haemofiltration; CVVHDF: continuous venovenous haemodiafiltration; MIC: minimum inhibitory concentration
Danish: CVVHDF: kontinuerlig venovenøs hæmodiafiltration.
English: and Acinetobacter spp.
Danish: og Acinetobacter spp.
English: Species for which acquired resistance may be a problem:
Danish: Arter, for hvilke erhvervet resistens kan være et problem: Acinetobacter baumannii*
English: VIAL
Danish: Lot
English: Infuse all of this solution to administer a 500 mg dose of doripenem.
Danish: Infunder hele denne opløsning, således at der indgives en dosis på 500 mg doripenem.
English: dextrose 50 mg/ml (5%) solution for injection
Danish: 50 mg/ml (5 %) glucoseinjektionsvæske 4 timer
English: It has been shown that co-administration of doripenem and valproic acid significantly reduces serum valproic acid levels below the therapeutic range.
Danish: Det er vist, at serumkoncentrationen af valproinsyre sænkes signifikant under det terapeutiske niveau ved samtidig indgift af doripenem og valproinsyre.
English: Infuse all of this solution to administer a 250 mg dose of doripenem.
Danish: Infunder hele denne opløsning, således at der indgives en dosis på 250 mg doripenem.
English: The volume of distribution at steady state is approximately 16.8 l, similar to extracellular fluid volume in man. Doripenem penetrates well into several body fluids and tissues, such as uterine tissue, retroperitoneal fluid, prostatic tissue, gallbladder tissue and urine.
Danish: Doripenem fordeles godt til flere kropsvæsker og væv, f.eks. livmodervæv, retroperitonealvæske, prostatavæv, galdeblærevæv og urin.
English: If you are concerned that you may have been given too much Doribax, talk to your doctor, pharmacist or nurse straight away.
Danish: Sådan indgives Doribax - Doribax klargøres og indgives af en læge eller sygeplejerske.
English: Uncommon: hypersensitivity reactions (see section 4.4) Not known: anaphylaxis (see section 4.4)
Danish: 4.4) Ikke kendt: anafylaksi (se pkt.
English: 24 hours* * Once removed from the refrigerator, infusions should be completed within the room temperature stability time,
Danish: 24 timer* * Når infusionsvæsken er fjernet fra køleskabet, skal den indgives inden for holdbarhedstiden for opbevaring ved stuetemperatur, forudsat at den samlede opbevaringstid i køleskab, tiden til temperering til stuetemperatur og infusionstiden ikke overskrider holdbarhedstiden for opbevaring i køleskab.
English: What Doribax is and what it is used for What you need to know before you use Doribax
Danish: Oversigt over indlægssedlen 1 Virkning og anvendelse Det skal du vide, før du begynder at bruge Doribax Sådan bruges Doribax
English: The overall 28-day all cause mortality rate was numerically higher for doripenem treated subjects in the MITT analysis set (21.5% versus 14.8%; 95% CI: -5.0%; 18.5%).The difference in clinical cure rate between doripenem versus imipenem/cilastatin was greater in patients with APACHE score > 15 (16/45 [36%] versus 23/46 [50%]) and in patients infected with Pseudomonas aeruginosa
Danish: Forskellen i klinisk helbredelsesrate mellem doripenem og imipenem/cilastin var større hos patienter med APACHE-score > 15 (16/45 [36 %] versus 23/46 [50 %]) og hos patienter, der var inficeret med Pseudomonas aeruginosa 7/17 [41 %] versus 6/10
English: In a study where 12 subjects with end stage renal disease received a single 500 mg dose of doripenem as a 1-hour i.v.
Danish: I et studie, hvor 12 forsøgspersoner med nyresygdom i terminalstadiet fik en enkelt dosis doripenem på 500 mg som i.v.-infusion over 1 time, øgedes den systemiske eksponering for doripenem og doripenem-M-1 sammenlignet med raske forsøgspersoner.
English: Prolonged use of Doribax should be
Danish: Længerevarende behandling med Doribax bør undgås.
English: Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to
Danish: På baggrund af indberettede bivirkninger forventes det ikke, at Doribax vil påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Adverse drug reactions identified during clinical trials and post-marketing experience with Doribax Common: oral candidiasis, vulvomycotic infection Uncommon: thrombocytopenia, neutropenia
Danish: Bivirkninger klarlagt under kliniske studier og post-marketing erfaring med Doribax Infektioner og parasitære sygdomme
English: Each vial contains doripenem monohydrate equivalent to 500 mg doripenem.
Danish: Hvert hætteglas indeholder doripenemmonohydrat svarende til 500 mg doripenem.
English: Each vial contains doripenem monohydrate equivalent to 250 mg doripenem.
Danish: Hvert hætteglas indeholder doripenemmonohydrat svarende til 250 mg doripenem.
English: (methicillin susceptible strains only)
Danish: (kun methicillinfølsomme stammer)^ Streptococcus pneumoniae*
English: If you are not sure, talk to your doctor, pharmacist or nurse before being given Doribax.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, før du får Doribax, hvis du er i tvivl.
English: - Complicated infections of the area around your stomach (abdominal infections).
Danish: - Komplicerede infektioner i mave eller tarm.
English: No dose adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency
Danish: Der kræves ingen dosisjustering hos ældre, bortset fra hos patienter med moderat eller svært nedsat nyrefunktion (se pkt.
English: Gastrointestinal disorders
Danish: Glomerulær filtrationshastighed
English: Common: hepatic enzyme increased
Danish: Almindelig: forhøjede leverenzymer
English: filiāle Latvijā
Danish: Latvija
English: What Doribax is and what it is used for
Danish: Hvor meget Doribax bliver der indgivet?
English: infusion, the amount of doripenem and doripenem-M-1 removed during a 4-hour haemodialysis session was approximately 46% and 6% of the dose, respectively.
Danish: I et studie, hvor seks forsøgspersoner med nyresygdom i terminalstadiet fik en enkelt dosis doripenem på 500 mg som intravenøs infusion, blev doripenem og doripenem-M-1 fjernet under 4 timers hæmodialyse i mængder svarende til henholdsvis ca. 46 % og 6 % af dosis.
English: Doribax 500 mg powder for infusion doripenem
Danish: Doribax 500 mg pulver til infusionsvæske doripenem
English: Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of 1 or 4 hours.
Danish: 6.6) før indgift ved intravenøs infusion over en periode på 1 eller 4 timer.
English: Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 50 ml or 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Danish: Træk suspensionen op i en injektionssprøjte med kanyle og tilsæt den i en infusionspose indeholdende enten 50 ml eller 100 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske eller 50 ml eller 100 ml 50 mg/ml (5 %) glucoseinjektionsvæske.
English: Doribax 250 mg powder for infusion doripenem
Danish: Doribax 250 mg pulver til infusionsvæske doripenem
English: Dose adjustment is necessary in patients with moderate and severe
Danish: Dosisjustering er nødvendig hos patienter med moderat eller svært nedsat nyrefunktion (se pkt.
English: Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Danish: Træk suspensionen op i en injektionssprøjte med kanyle, og tilsæt den i en infusionspose indeholdende enten 100 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske eller 100 ml 50 mg/ml (5 %) glucoseinjektionsvæske, og bland indholdet, til det er helt opløst.
English: Preparation of 250 mg dose of solution for infusion using the 250 mg vial Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 250 mg vial and shake it to form a suspension.
Danish: Klargøring af infusionsvæske, opløsning med dosis på 250 mg ud fra 250 mg hætteglas Tilsæt 10 ml sterilt vand til injektionsvæsker eller 9 mg/ml (0,9 %) natriumchloridinjektionsvæske i 250 mg hætteglasset og ryst det, til der dannes en suspension.
English: JANSSEN-CILAG B.V. Tel: +31 13 583 73 73
Danish: JANSSEN-CILAG, S.A. Tel: +34 91 722 81 00
English: Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): ● Nosocomial pneumonia (including ventilator-associated pneumonia)
Danish: Doribax er indiceret til behandling af følgende infektioner (se pkt.
English: Preparation of 500 mg dose of solution for infusion using the 500 mg vial Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 500 mg vial and shake it to form a suspension.
Danish: Klargøring af infusionsvæske, opløsning med dosis på 500 mg ud fra 500 mg hætteglas Tilsæt 10 ml sterilt vand til injektionsvæsker eller 9 mg/ml (0,9 %) natriumchloridinjektionsvæske i 500 mg hætteglasset og ryst det, til der dannes en suspension.
English: AM MANGION LTD Tel: +356 2397 6000
Danish: Eesti filiaal Tel: + 372 617 7410
English: Preparation of 250 mg dose of solution for infusion using the 500 mg vial Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 500 mg vial and shake it to form a suspension.
Danish: Klargøring af infusionsvæske, opløsning med dosis på 250 mg ud fra 500 mg hætteglas Tilsæt 10 ml sterilt vand til injektionsvæsker eller 9 mg/ml (0,9 %) natriumchloridinjektionsvæske i 500 mg hætteglasset og ryst det, til der dannes en suspension.
English: Janssen-Cilag International NV
Danish: United Kingdom JANSSEN-CILAG Ltd.
English: Hepatobiliary disorders
Danish: Grampositive aerobe
English: Breast-feeding
Danish: CVVHDF
English: United Kingdom JANSSEN-CILAG Ltd. Tel: +44 1494 567 444
Danish: Deutschland JANSSEN-CILAG GmbH Tel: +49 2137 955 955
English: No dose adjustment is
Danish: Nedsat leverfunktion Der kræves ingen dosisjustering.
English: It is unknown whether this constitutes a class effect.
Danish: Det er ukendt, om dette udgør en klasseeffekt.
English: Efficacy over a 52-week period
Danish: Virkning over en periode på 52 uger
English: Patient name:-------------------------Date ZYNQUISTA first prescribed:--------------------------Center name:--------------------------Treating HCP name:-----------------Treating HCP contact number:---------------------
Danish: Patientens navn:-------------------------Dato for første ordination af ZYNQUISTA:--------------------------Navn på lægepraksis/afdeling:--------------------------Navn på ordinerende læge:-----------------Tlf.nr.
English: No clinically relevant differences were noted between the two populations.
Danish: Der blev ikke konstateret nogen klinisk relevante forskelle mellem de to populationer.
English: You can help by reporting any side effects you may get: [To be adjusted per Country (include phone number…)]
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, du får: [To be adjusted per Country (include phone number…)]
English: N: all randomised and treated patients
Danish: N: alle randomiserede og behandlede patienter
English: o Is adequately informed about managing sick days.
Danish: o Er velinformeret om håndtering af sygedage.
English: Patients with hypovolemia may be more susceptible to these changes.
Danish: Patienter med hypovolæmi kan være mere følsomme over for disse ændringer.
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Danish: Tal med lægen om, hvordan du bedst kontrollerer dit blodsukker, mens du er gravid.
English: - Patients with excessive alcohol consumption or who use illicit drugs.
Danish: - Patienter med overdreven alkoholforbrug eller som anvender ulovlige stoffer.
English: Frequency of occurrence Very common Common
Danish: Hyppighed Meget almindelig Almindelig
English: • if you are using a low dose of insulin
Danish: • hvis du bruger en lav dosis insulin
English: • Zynquista should be taken once daily by mouth.
Danish: • Zynquista indtages gennem munden en gang dagligt.
English: These changes were not considered relevant for humans as TSH is not carcinogenic in humans.
Danish: Disse forandringer blev ikke anset som relevante for mennesker, da TSH ikke er carcinogent hos mennesker.
English: Ketone levels should be measured again after two hours.
Danish: Ketonniveauet bør måles igen efter to timer.
English: Patients should be monitored and treated as appropriate.
Danish: Patienterne skal monitoreres og behandles efter behov.
English: It should be evaluated if additional safety monitoring is needed when using these substrates.
Danish: Der bør foretages en vurdering af om yderligere sikkerhedsmonitorering er nødvendig ved anvendelse af disse substrater.
English: Fournier´s gangrene has to be treated immediately.
Danish: Fourniers gangræn kræver øjeblikkelig behandling.
English: * See section 4.4 † See subsections below for additional information.
Danish: 4.4 † Se nedenstående underafsnit for yderligere oplysninger.
English: Each study was of 52 weeks duration, with primary and key secondary endpoints at 24 weeks.
Danish: Begge studier var af 52 ugers varighed med de primære og vigtigste sekundære endepunkter ved uge 24.
English: This atypical presentation of DKA can delay diagnosis and treatment.
Danish: Denne atypiske præsentation af DKA kan forsinke diagnosen og behandlingen.
English: Volume depletion*, c, †
Danish: Volumendepletering*, c, †
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonæsken efter EXP.
English: Substrates of these enzymes should be monitored for decreases in efficacy.
Danish: Substrater for disse enzymer bør monitoreres for reduceret virkning.
English: Your doctor will decide whether to increase your dose to 400 mg once a day.
Danish: Lægen vil afgøre, om din dosis skal øges til 400 mg en gang dagligt.
English: Elimination/excretion
Danish: Elimination/udskillelse
English: However, the differences in exposure were not considered clinically meaningful and therefore no dose adjustment is required based on weight.
Danish: Forskellene i eksponering blev dog ikke betragtet som klinisk relevante, og dosisjustering baseret på vægt er derfor ikke nødvendig.
English: * 5.35% more time in range, correspond to 1.3 hours † 11.71% more time in range, correspond to 2.8 hours
Danish: * 5,35 % mere tid i interval, svarende til 1,3 timer † 11,71 % mere tid i interval, svarende til 2,8 timer
English: • ZYNQUISTA increases the risk of DKA.
Danish: • ZYNQUISTA øger risikoen for DKA.
English: These are the signs and symptoms of diabetic ketoacidosis (see also section 2 under ‘Warnings and precautions'):
Danish: Følgende er tegn og symptomer på diabetisk ketoacidose (se også afsnit 2 “Advarsler og forsigtighedsregler”):
English: Your doctor will prescribe the dose that is right for you.
Danish: Lægen vil ordinere den dosis, der passer bedst til dig.
English: Blood Ketone (betahydroxybutyrate)
Danish: Blodketon (betahydroxybutyrat)
English: - Patients unable or unwilling to monitor ketones.
Danish: - Patienter der ikke er i stand til eller vil monitorere ketonniveauet.
English: Your blood sugar levels may increase when you stop taking Zynquista.
Danish: Dit blodsukkerniveau kan stige, hvis du holder op med at tage Zynquista.
English: This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Danish: Dette er en sjælden, men potentielt livstruende tilstand, som kræver akut kirurgisk intervention og antibiotikabehandling.
English: Therefore, sotagliflozin is not recommended during the second and third trimesters of pregnancy.
Danish: Derfor anbefales det ikke at anvende sotagliflozin i det andet og tredje trimester af graviditeten.
English: Patients should be monitored for signs and symptoms of hypotension after initiating therapy.
Danish: Patienten skal monitoreres for tegn og symptomer på hypotension efter initiering af behandling.
English: Diarrhoea, flatulence
Danish: Diarre, flatulens
English: HbA1c (%)
Danish: N HbA1c (%)
English: Insulin optimisation was continued throughout the study.
Danish: Insulinoptimering blev opretholdt i hele studiets varighed.
English: • if you might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] or lower blood pressure or if you are over 65 years old).
Danish: • hvis du har risiko for at få væskemangel (f.eks. hvis du tager medicin, der øger urinproduktionen [vanddrivende medicin] eller sænker blodtrykket, eller hvis du er over 65 år.
English: HbA1c < 7.0% at week 24, n (%)
Danish: HbA1c < 7,0 % ved uge 24, n (%)
English: Zynquista is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Danish: Zynquista bør ikke anvendes til børn og unge under 18 år, da det ikke er blevet undersøgt hos disse patienter.
English: Like for all diabetic patients it is important to counsel patients on routine preventative footcare.
Danish: Som det gælder for alle diabetespatienter, er det vigtigt at informere patienterne om rutinemæssig forebyggende fodpleje.
English: Consequently, low-weight patients may have somewhat increased exposure and patients with high weight somewhat decreased exposure.
Danish: Som følge heraf kan patienter med lav vægt have en noget højere eksponering og patienter med høj vægt en noget lavere eksponering.
English: The safety and efficacy of sotagliflozin in children and adolescents has not yet been established.
Danish: Sotagliflozins sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: Check your ketones regularly during the first two weeks after starting Zynquista.
Danish: Du skal måle dit ketonniveau regelmæssigt i de første 2 uger efter du er begyndt at tage Zynquista.
English: *Systolic blood pressure was assessed at week 16 † p <0.001 ‡ p=0.002
Danish: *Systolisk blodtryk blev målt ved uge 16 † p < 0,001 ‡ p= 0,002
English: Hypotension/ volume depletion
Danish: Hypotension/volumendepletering
English: 1 episode in the past 6 months).
Danish: måneder eller flere end 1 episode i de sidste 6 måneder).
English: Multiple doses of 800 mg once daily were administrated in healthy volunteers and these doses were well tolerated.
Danish: Flere doser på 800 mg en gang dagligt er blevet administreret til raske forsøgspersoner, og disse doser var veltolereret.
English: Animal studies have shown that sotagliflozin crosses the placenta.
Danish: Dyrestudier har vist, at sotagliflozin passerer placenta.
English: It is important that you also continue with your diet and exercise plan and insulin treatment as agreed with your doctor, pharmacist or nurse.
Danish: Det er vigtigt, at du også fortsætter med den diæt eller motionsplan og insulinbehandling, som du har aftalt med lægen, apotekspersonalet eller sundhedspersonalet.
English: Insulin may increase the risk of hypoglycaemia.
Danish: Insulin kan øge risikoen for hypoglykæmi.
English: Zynquista should not be used during the last six months of pregnancy.
Danish: Du bør ikke tage Zynquista de sidste 6 måneder af din graviditet.
English: - who are able to monitor ketone levels and are educated in when it is most appropriate to do so.
Danish: - som er i stand til at monitorere ketonniveauet og er blevet trænet i at vide, hvornår det skal gøres.
English: • Sotagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity).
Danish: • Sotagliflozin kan ikke erstatte insulin (og ændrer ikke insulinfølsomheden).