FrancophonIA/ELRC3.0 huggingface dataset:
English: Meropenem belongs to the carbapenem class of antibiotics, which belongs to the wider group of antibiotics known as beta-lactams.
Danish: Meropenem hører til carbapenem-klassen af antibiotika under den bredere gruppe af antibiotika, der kaldes betalaktamer.
English: This action weakens the bacterial cell walls which can then collapse, ultimately causing the bacteria to die.
Danish: Derved svækkes bakteriernes cellevægge, så de falder sammen, og bakterierne dør.
English: What benefits of Vabomere have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vabomere?
English: For the full list of side effects of Vabomere, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Vabomere fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vabomere have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vabomere.
English: • complicated (difficult-to-treat) infections of the urinary tract, including kidneys;
Danish: • komplicerede infektioner (dvs. infektioner, der er vanskelige at behandle) i urinvejene, herunder nyrerne
English: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe).
Danish: herunder respirator-relateret lungebetændelse (lungebetændelse pådraget fra en respirator, der hjælper patienten med at trække vejret).
English: How does Vabomere work?
Danish: Hvordan virker Vabomere?
English: A risk to newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan derfor ikke udelukkes.
English: • Your doctor will prescribe the strength that is right for you.
Danish: • Din læge vil ordinere den styrke, der passer bedst til dig
English: It is important that you follow your doctor's instructions carefully.
Danish: Det er vigtigt, at du følger lægens anvisninger nøje.
English: Component of a multipack, can not be sold separately.
Danish: Del af en multipakning, må ikke sælges separat.
English: Tablets are to be swallowed whole.
Danish: Tabletterne skal synkes hele.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Danish: Indtagelse af alkohol og lægemidler, der indeholder alkohol, bør undgås.
English: These reductions were sustained over the treatment period and near maximal after the first day of treatment.
Danish: Disse reduktioner blev opretholdt i behandlingsperioden og var nær den maksimale værdi efter den første behandlingsdag.
English: • medicines that contain alcohol.
Danish: • medicin, der indeholder alkohol.
English: ATC code: A10BD16.
Danish: ATC-kode: A10BD16.
English: • It is best to take your tablet with a meal.
Danish: • Det er bedst at tage tabletten i forbindelse med et måltid.
English: • Try to take it at the same times each day.
Danish: • Forsøg at tage tabletten til samme tid hver dag.
English: • The dose of Vokanamet is one tablet twice a day.
Danish: • Dosis af Vokanamet er 1 tablet 2 gange dagligt
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 April 2014
Danish: Dato for første markedsføringstilladelse: 23. april 2014
English: Metformin may act via three mechanisms:
Danish: Metformin virker ved hjælp af tre mekanismer:
English: The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
Danish: Virkningen af at være homozygot (UGT1A9*3/*3, hyppighed < 0,1 %) er sandsynligvis mere markant, men den er ikke undersøgt.
English: Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Danish: Husk at tage alle lægemidler efter lægens anvisninger, så du opnår de bedste resultater for dit helbred.
English: For further detail, it may be advisable to contact the specific manufacturer of the 1,5-AG assay.
Danish: For nærmere oplysninger kan det være tilrådeligt at kontakte fremstilleren af den pågældende 1,5-AG-test.
English: • if you have a severe infection
Danish: • hvis du har en alvorlig infektion
English: Active controlled studies
Danish: Aktivt kontrollerede studier
English: • Swallow the tablet whole with at least a half glass of water.
Danish: • Synk tabletten hel med et halvt glas vand
English: Your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Din læge vil kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis
English: There are no data from the use of canagliflozin alone or Vokanamet in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af canagliflozin alene eller Vokanamet til gravide kvinder.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration er absorptionen af metformin mættelig og ufuldstændig.
English: Erythema, Pruritis, Urticaria
Danish: Erytem, pruritis, urticaria
English: Multiple dose study: Data are restricted to one study.
Danish: Studie med gentagne doser: Der foreligger kun data fra et enkelt studie.
English: Do not use Vokanamet if the packaging is damaged or shows signs of tampering.
Danish: Brug ikke Vokanamet, hvis pakningen er beskadiget eller viser tegn på, at den har været åbnet.
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations.
Danish: Et begrænset antal data fra anvendelse af metformin til gravide kvinder indikerer ikke en øget risiko for medfødte misdannelser.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Danish: Da den underliggende mekanisme ikke er blevet fastlagt, kendes risikofaktorerne for amputation ikke, bortset fra de generelle risikofaktorer.
English: • common: a metallic taste (taste disturbance)
Danish: • almindelig: en metallisk smag (smagsforstyrrelse)
English: This will help you remember to take it.
Danish: Så kan du lettere huske at tage den
English: Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin.
Danish: Canagliflozin bindes i udstrakt grad til plasmaproteiner (99 %), primært til albumin.
English: In both cases, treatment with Vokanamet may be restarted once the patient's condition has stabilised.
Danish: I begge tilfælde kan behandlingen med Vokanamet genoptages, når patientens tilstand er stabil.
English: This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
Danish: Dette blev ledsaget af en vedvarende reduktion i serum-urinsyre på ca. 20 %.
English: • The strength of Vokanamet that you will take varies depending on your condition and the amount of canagliflozin and metformin needed to control your blood sugar.
Danish: • Hvilken styrke af Vokanamet, du skal tage, afhænger af din tilstand og af, hvilken mængde canagliflozin og metformin du har behov for til at kontrollere blodsukkeret
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Danish: Det stimulerer ikke insulinsekretion og giver derfor ikke hypoglykæmi.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Danish: Type 2-diabetes er en tilstand, hvor kroppen ikke producerer nok insulin, og hvor den insulin, som kroppen producerer, ikke virker tilstrækkeligt.
English: • if you have liver problems
Danish: • hvis du har leverproblemer
English: Tell your doctor as soon as possible if you get any signs of low blood sugar.
Danish: Kontakt lægen snarest muligt, hvis du bemærker tegn på lavt blodsukker.
English: • if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension).
Danish: • hvis du får medicin til at sænke blodtrykket (antihypertensiva), eller hvis du nogensinde har haft lavt blodtryk (hypotension).
English: Metformin is excreted into human breast milk in small amounts.
Danish: Metformin udskilles i human mælk i små mængder.
English: If no adequate strength of Vokanamet is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Vokanamet, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: (i.e., urinary frequency).
Danish: (dvs. hyppig vandladning).
English: Your doctor may prescribe Vokanamet together with another glucose-lowering medicine.
Danish: Din læge kan ordinere Vokanamet sammen med et andet glucosesænkende lægemiddel.
English: The mean Vd ranged between 63- 276 litres.
Danish: Det gennemsnitlige Vd lå mellem 63 og 276 l.
English: No metabolites have been identified in humans.
Danish: Der er ikke fundet metabolitter hos mennesket.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Danish: En analyse af resultaterne for overvægtige patienter behandlet med metformin efter svigt af diæt alene viste:
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row
Danish: • hvis du har mistet meget vand fra kroppen (er dehydreret), f.eks. på grund af langvarig eller alvorlig diaré, eller hvis du har kastet op flere gange i træk
English: You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet.
Danish: Du skal straks fortælle det til din læge, hvis du opdager sår eller misfarvninger, eller hvis du oplever ømhed eller smerter i fødderne.
English: If necessary, the dose of glucose-lowering medicinal products should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal dosis af glucosesænkende lægemidler justeres under behandlingen med det andet lægemiddel og ved seponering af dette.
English: * Related to volume depletion; see section 4.4.
Danish: * Relateret til volumedepletering; se pkt.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres herom, og glucose skal monitoreres hyppigere, især i begyndelsen af behandlingen med disse lægemidler.
English: Surgical and medical procedures uncommon
Danish: Kirurgiske og medicinske procedurer Ikke almindelig
English: However, as precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Danish: Som en forebyggende foranstaltning bør der dog træffes foranstaltninger med henblik på en tæt overvågning af patienter med øget risiko for amputation og at rådgive patienterne om vigtigheden af rutinemæssig forebyggende fodpleje og opretholdelse af passende hydrering.
English: As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Danish: Da dosis titreres individuelt ud fra glykæmisk kontrol, har dette begrænset klinisk relevans.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take 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 apotekspersonalet til råds, før du tager dette lægemiddel.
English: • if you drink alcohol to excess (either every day or from time to time)
Danish: • hvis dit alkoholforbrug er for højt (enten i det daglige eller i perioder)
English: If interrupted, consideration should be given to more frequent glucose monitoring.
Danish: Ved afbrydelse af behandlingen bør hyppigere glykæmisk kontrol overvejes.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis blev der genfundet en ikke-absorberet fraktion i fæces på 20-30 %.
English: The doctor may decide to temporarily or permanently stop the treatment with Vokanamet.
Danish: Lægen kan beslutte at stoppe behandlingen med Vokanamet midlertidigt eller permanent.
English: Both UGT1A9 and UGT2B4 are subject to genetic polymorphism.
Danish: Både UGT1A9 og UGT2B4 udviser genetisk polymorfisme.
English: Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%).
Danish: Ca. 33 % af den administrerede radioaktive dosis blev udskilt i urinen, hovedsageligt som O-glukuronidmetabolitter (30,5 %).
English: • in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation
Danish: • i muskler ved at øge insulinfølsomheden og forbedre perifer optagelse og udnyttelse af glucose
English: If you need to have major surgery you must stop taking Vokanamet during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Vokanamet under indgrebet og i nogen tid herefter.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dl).
Danish: I en række af disse tilfælde fremstod tilstanden atypisk med kun moderat forhøjet blodglucose, under 14 mml/l (250 mg/dl).
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n = 2,313) described above.
Danish: Bivirkningerne i tabel 1 er baseret på den puljede analyse af de fire 26-ugers placebokontrollerede studier (N = 2.313) beskrevet ovenfor.
English: • in patients already being treated with the combination of canagliflozin and metformin as separate tablets.
Danish: • hos patienter, der allerede er i behandling med en kombination af canagliflozin og metformin som separate tabletter.
English: • in patients not adequately controlled on their maximally tolerated doses of metformin alone
Danish: • hos patienter, der ikke er velkontrollerede med den maksimale tolererede dosis metformin alene
English: If you are already taking both canagliflozin and metformin as single tablets, Vokanamet can replace them in one tablet.
Danish: Hvis du allerede tager både canagliflozin og metformin som adskilte tabletter, kan Vokanamet erstatte disse med en enkelt tablet.
English: Maximum total daily dose is 300 mg.
Danish: Maksimal total daglig dosis er 300 mg.
English: Patients taking digoxin or other cardiac glycosides (e.g., digitoxin) should be monitored appropriately.
Danish: Patienter, der tager digoxin eller andre hjerteglykosider (f.eks. digitoxin), skal monitoreres på passende vis.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Danish: I et 12ugers klinisk studie steg ustimuleret LH ikke hos mandlige patienter, der blev behandlet med canagliflozin.
English: Therefore, 1,5-AG assays should not be used for assessment of glycemic control in patients on Vokanamet.
Danish: Derfor bør 1,5-AG-tests ikke anvendes til at vurdere glykæmisk kontrol hos patienter, der får Vokanamet.
English: d p = 0.013 compared to placebo.
Danish: d p = 0,013 sammenlignet med placebo.
English: Most infections were mild to moderate with no increase in the occurrence of serious adverse reactions.
Danish: De fleste infektioner var lette til moderate, og der sås ingen stigning i forekomsten af alvorlige bivirkninger.
English: • digoxin or digitoxin (medicines used for certain heart problems).
Danish: • digoxin eller digitoxin (midler mod visse hjerteproblemer).
English: 211 patients from the clinical study in older patients participated in a body composition substudy using DXA body composition analysis.
Danish: 211 patienter fra det kliniske studie med ældre patienter deltog i et delstudie, der undersøgte kroppens sammensætning ved hjælp af DXA-analyse.
English: Canagliflozin should not be used.
Danish: Canagliflozin bør ikke anvendes.
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Danish: Der opstod moderate stigninger (generelt < 400 ml til 500 ml) i det daglige urinvolumen, som blev dæmpet efter behandling i flere dage.
English: These changes are not likely to be clinically relevant.
Danish: Disse forandringer har sandsynligvis ingen klinisk relevans.
English: Vokanamet is used when your blood sugar cannot be adequately controlled by metformin alone or together with other diabetes medicines.
Danish: Vokanamet anvendes, når blodsukkeret ikke er velkontrolleret med metformin alene eller sammen med andre midler mod diabetes.
English: • if you have or have recently had heart failure.
Danish: • hvis du har eller for nyligt har haft hjertesvigt
English: Before initiating Vokanamet, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Før indledning af behandling med Vokanamet skal faktorer i patientens anamnese, som kan prædisponere for ketoacidose, tages i betragtning.
English: Vokanamet has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Danish: Vokanamet er ikke undersøgt hos patienter med type 1-diabetes og kan derfor ikke anbefales til denne patientgruppe.
English: Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel og under behandlingen:
English: Vokanamet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Vokanamet kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
English: Most reports of vulvovaginal candidiasis occurred during the first four months of treatment with canagliflozin.
Danish: De fleste tilfælde af vulvovaginal candidiasis forekom i løbet af de første fire måneders behandling med canagliflozin.
English: Food decreases the extent and slightly delays the absorption of metformin.
Danish: Fødeindtagelse nedsætter omfanget af og medfører en mindre forsinkelse i absorption af metformin.
English: At the recommended metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/mL.
Danish: Ved de anbefalede metformin-doser og doseringsskemaer nås steady state-plasmakoncentration i løbet af 24-48 timer, og den ligger generelt under 1 mikrogram/ml.
English: Other side effects when taking canagliflozin alone: Very common (may affect more than 1 in 10 people)
Danish: Andre bivirkninger, der er set ved behandling med canagliflozin alene: Meget almindelige (kan berøre flere end 1 ud af 10 personer)
English: A study in juvenile rats administered canagliflozin from day 1 through day 90 postnatal did not show increased sensitivity compared to effects observed in adults rats.
Danish: Et studie med unge rotter, der fik canagliflozin postnatalt fra dag 1 til dag 90, viste ingen øget følsomhed sammenlignet med de virkninger, der var observeret hos voksne rotter.
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Danish: Tal med lægen snarest muligt, hvis du får en eller flere af følgende bivirkninger: Hypoglykæmi (meget almindelig - kan berøre flere end 1 ud af 10 personer)
English: The Leydig cell tumours are associated with an increase in luteinising hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Danish: Leydig-celletumorerne associeres med stigning i luteiniserende hormon (LH), som er en kendt mekanisme bag dannelse af Leydig-celletumorer hos rotter.
English: • if you have severely reduced kidney function
Danish: • hvis du har alvorligt nedsat nyrefunktion
English: However, if it is nearly time for the next dose, skip the missed dose.
Danish: Hvis det næsten er tid til næste dosis, skal du springe den glemte dosis over
English: Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.
Danish: Tal med din læge om at holde op med at tage medicinen eller stoppe med at amme.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Peak-værdier i blod er lavere end i plasma og nås på omtrent samme tidspunkt.
English: Table 5: Efficacy results from active-controlled clinical studiesa
Danish: Tabel 5: Effektresultater fra aktivt kontrollerede kliniske studiera
English: Vokanamet should not be used during pregnancy.
Danish: Vokanamet bør ikke anvendes under graviditet.
English: This demonstrated that approximately two-thirds of the weight loss associated with canagliflozin was due to loss of fat mass relative to placebo.
Danish: Den viste, at ca. to tredjedel af vægttabet associeret med canagliflozin i forhold til placebo skyldtes tab af fedtmasse.
English: Canagliflozin, one of the ingredients in Vokanamet, should not be used during pregnancy.
Danish: Canagliflozin, et af stofferne i Vokanamet, må normalt ikke anvendes under graviditet.
English: In a pooled analysis of eight placebo-controlled and active-controlled studies, the safety profile of canagliflozin in elderly patients was generally consistent with younger patients.
Danish: I en poolet analyse af otte placebokontrollerede og aktivt kontrollerede studier svarede sikkerheds profilen hos ældre patienter generelt til profilen hos yngre patienter.
English: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Danish: Det observerede farmakokinetiske og farmakodynamiske respons stemte overens med det, der sås hos voksne forsøgspersoner.
English: Inhibition of BCRP by canagliflozin cannot be excluded at an intestinal level and increased exposure may therefore occur for medicinal products transported by BCRP, e.g., certain statins like rosuvastatin and some anti-cancer medicinal products.
Danish: Det kan ikke udelukkes, at canagliflozin hæmmer BCRP i tarmsystemet, og der kan derfor være øget eksponering for lægemidler, der transporteres af BCRP, f.eks. visse statiner såsom rosuvastatin og visse lægemidler mod cancer.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive randomiserede studie (UKPDS) har påvist langtidsfordelene ved intensiv glykæmisk kontrol ved type 2-diabetes.
English: The reductions in RTG and increases in UGE were sustained over a 26-week dosing period in patients with type 2 diabetes.
Danish: Faldene i RTG og stigningerne i UGE blev opretholdt over en behandlingsperiode på 26 uger hos patienter med type 2-diabetes.
English: Due to canagliflozin's mechanism of action, patients taking Vokanamet will test positive for glucose in their urine.
Danish: På grund af canagliflozins virkningsmekanisme vil patienter, der tager Vokanamet, testes positive for glucose i urinen.
English: Metformin partitions into erythrocytes.
Danish: Metformin optages i erytrocytter.
English: It is unknown whether ossification delays can be attributed to effects of canagliflozin on calcium homeostasis observed in adult rats.
Danish: Det vides ikke, om forsinkelser i ossifikation kan tilskrives canagliflozins observerede virkninger på calciumhomeostasen hos voksne rotter.