FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic Acid Hexal was to be used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Danish: Ibandronic Acid Hexal skulle anvendes til forebyggelse af ‘knoglerelaterede hændelser' (frakturer [knoglebrud] eller knoglekomplikationer, der kræver behandling) hos patienter med brystkræft og knoglemetastaser (kræft, der har spredt sig til knoglerne).
English: On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.
Danish: Den 21. juli 2011 meddelte Hexal AG officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Ibandronic Acid Hexal til forebyggelse af forstyrrelser i knoglesystemet hos patienter med brystkræft og knoglemetastaser.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ibandronic Acid Hexal er af sammenlignelig kvalitet og er bioækvivalent med Bondronat.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Bondronat.
English: Because Ibandronic Acid Hexal was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Danish: Da Ibandronic Acid Hexal blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser, som er udført for at undersøge, hvorvidt det er ‘bioækvivalent' med referencelægemidlet.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Danish: hæmmende på osteoklasterne, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevæv.
English: Ibandronic Acid Hexal was developed as a ‘generic medicine'.
Danish: Ibandronic Acid Hexal blev udviklet som et “generisk lægemiddel”.
English: This means that Ibandronic Acid Hexal was intended to be similar to a ‘reference medicine' already authorised in the European Union called Bondronat.
Danish: Det betyder, at det var hensigten, at Ibandronic Acid Hexal skulle være identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Bondronat.
English: The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Ibandronic Acid Hexal og Bondronat, ibandronsyre, er et bisphosphonat.
English: Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat.
Danish: Ibandronic Acid Hexal forventes at virke på samme måde som referencelægemidlet Bondronat.
English: The Committee recommended that Ibandronic Acid Hexal be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ibandronic Acid Hexal.
English: Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid.
Danish: Ibandronic Acid Hexal er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: What is Ibandronic Acid Hexal?
Danish: Hvad er Ibandronic Acid Hexal?
English: What was Ibandronic Acid Hexal expected to be used for?
Danish: Hvad forventedes Ibandronic Acid Hexal anvendt til?
English: How is Ibandronic Acid Hexal expected to work?
Danish: Hvordan forventes Ibandronic Acid Hexal at virke?
English: Therefore pack sizes of 100g should be withdrawn from all EU member states where they are currently authorised.
Danish: Pakningsstørrelsen 100 g skal derfor trækkes tilbage i alle EUmedlemsstater, hvor den er godkendt.
English: National Competent Authorities of Member States or reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaterne sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
English: The maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use).
Danish: Den maksimale varighed af et behandlingsforløb med lægemidler indeholdende 0,01 vægtprocent estradiol til topisk anvendelse begrænses til fire uger (ikke gentagen anvendelse).
English: As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Danish: Da den maksimale varighed af et behandlingsforløb med lægemidler indeholdende 0,01 vægtprocent estradiol til topisk anvendelse er begrænset til fire uger (uden gentagen anvendelse) skal indehaverne af markedsføringstilladelse forelægge en detaljeret plan, herunder nøjagtige korte frister for tilpasning af den mindre pakningsstørrelse (25 g) og tilbagetrækning af 35 g og 50 g pakningsstørrelserne i alle EU-medlemsstater, hvor de er godkendt.
English: Packaging Content
Danish: Indhold Pakningsstørrelse
English: Oral use blister (PVC/alu)
Danish: Oral anvendelse Blisterpakning (PVC/alu)
English: 250 mg Capsule, hard
Danish: 250 mg Hård kapsel
English: capsules
Danish: 100 kapsler
English: 250 mg Powder for concentrate for solution for
Danish: 250 mg Pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning
English: Intravenous use Vial (glass)
Danish: Intravenøs anvendelse Hætteglas (glas) 10 hætteglas
English: Route of administration Packaging Package size
Danish: Pakningsstørrelse
English: • Risk Management Plan (RMP)
Danish: ● Risikostyringsplan (RMP)
English: • about what you can do to prevent dehydration
Danish: ● for at få at vide, hvad du kan gøre for at forebygge dehydrering
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: • if you have a severe infection
Danish: ● hvis du har en alvorlig infektion
English: • The other ingredients are:
Danish: ● Øvrige indholdsstoffer:
English: • medicines that contain alcohol.
Danish: ● medicin, der indeholder alkohol.
English: • It is best to take your tablet with a meal.
Danish: ● Det er bedst at tage tabletten i forbindelse med et måltid.
English: See section “Operations and X-rays”.
Danish: Se afsnittet ”Operationer og røntgen”
English: • common: a metallic taste (taste disturbance)
Danish: ● almindelig: en metallisk smag (smagsforstyrrelse)
English: • Try to take it at the same times each day.
Danish: ● Forsøg at tage tabletten til samme tid hver dag.
English: ‘shock' or breathing difficulties
Danish: ‘shock', eller vejrtrækningsbesvær
English: Operations and X-rays Tell your doctor you are taking Vokanamet if you are going to have:
Danish: Operationer og røntgenundersøgelser Fortæl lægen, at du tager Vokanamet, hvis du skal:
English: • The dose of Vokanamet is one tablet twice a day.
Danish: ● Dosis af Vokanamet er 1 tablet 2 gange dagligt
English: • if you have type 1 diabetes (your body does not produce any insulin).
Danish: ● hvis du har type 1-diabetes (hvor kroppen slet ikke producerer insulin).
English: • If you forget to take a dose, take it as soon as you remember.
Danish: ● Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: You may need to stop taking Vokanamet for a couple of days before and after the operation.
Danish: Du bliver måske nødt til at stoppe med at tage Vokanamet i nogle dage før og efter operationen
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: This happens more often in people with kidney problems.
Danish: Forekommer hyppigere hos folk med nyreproblemer.
English: See section “Look out for side effects” and section 4.
Danish: Se afsnittet ”Vær opmærksom på bivirkninger” og punkt 4.
English: • Swallow the tablet whole with at least a half glass of water.
Danish: ● Synk tabletten hel med et halvt glas vand
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: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed defineres i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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: This is because you are at an increased risk of getting a build-up of lactic acid in your blood (lactic acidosis) if you have too much alcohol.
Danish: Det skyldes, at du har en øget risiko for at ophobe mælkesyre i blodet (laktatacidose), hvis du får for meget alkohol.
English: In particular, tell your doctor if you are taking any of the following medicines:
Danish: Det er særlig vigtigt, at du fortæller det til lægen, hvis du tager et af følgende lægemidler:
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: ● at least two to four times a year in patients with eGFR (creatinine clearance) at the lower limit of normal and in elderly patients.
Danish: ● mindst to til fire gange om året hos patienter med eGFR (kreatininclearance) i den lave ende af normalområdet samt hos ældre patienter.
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: Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine.
Danish: Undgå at indtage store mængder alkohol eller medicin, der indeholder alkohol, mens du får dette lægemiddel.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: ● Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: • digoxin or digitoxin (medicines used for certain heart problems).
Danish: ● digoxin eller digitoxin (midler mod visse hjerteproblemer).
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine
Danish: ● hvis du er allergisk over for canagliflozin, metformin eller et af de øvrige indholdsstoffer i
English: • If your doctor has prescribed this medicine along with any medicine for lowering cholesterol such as cholestyramine you should take this medicine at least 1 hour before or 4 hours to
Danish: ● Hvis din læge har foreskrevet dette lægemiddel sammen med et middel til sænkning af kolesteroltallet, såsom colestyramin, skal du tage Vokanamet mindst 1 time før eller 4-6 timer efter det kolesterolsænkende lægemiddel
English: Stop taking Vokanamet and contact a doctor as soon as possible if you have any of the following serious side effects: Dehydration (uncommon, may affect up to 1 in 100 people)
Danish: Hold op med at tage Vokanamet og kontakt lægen snarest muligt, hvis du får en af følgende alvorlige bivirkninger: Dehydrering (ikke almindelig - kan berøre op til 1 ud af 100 personer)
English: • if you have kidney or liver problems
Danish: ● hvis du har nyre- eller leverproblemer
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Danish: ● alvorlig allergisk reaktion (kan omfatte hævelser af ansigt, læber, mund, tunge eller svælg, som kan gøre det vanskeligt at trække vejret eller synke)
English: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Danish: Laktatacidose er en sjælden, men alvorlig (høj mortalitet medmindre behandling iværksættes hurtigt), metabolisk komplikation, der kan forekomme ved akkumulering af metformin.
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 < 400-500 ml) i det daglige urinvolumen, som blev dæmpet efter behandling i flere dage.
English: This can be followed by acidotic dyspnea, abdominal pain, hypothermia and coma.
Danish: Derefter kan følge acidotisk dyspnø, abdominalsmerter, hypotermi og koma.
English: ● at least annually in patients with normal renal function
Danish: ● mindst én gang om året hos patienter med normal nyrefunktion
English: -0.60b (-0.792; -0.407) N/Ac
Danish: -0,60b (-0,792; -0,407) Ikke relevantc
English: You will need to stop taking Vokanamet before, or at the time of the X-ray and for 2 or more days after.
Danish: Du er nødt til at stoppe med Vokanamet før eller på tidspunktet for røntgenundersøgelsen og i mindst 2 dage derefter.
English: • efavirenz or ritonavir (medicines used to treat HIV infection)
Danish: ● efavirenz eller ritonavir (midler til at behandle hiv-infektion)
English: Possible signs of losing too much fluid from your body are listed under “Dehydration” in section 4.
Danish: Se listen over mulige tegn på for stort væsketab fra kroppen i punkt 4 under “Dehydrering”
English: Before taking Vokanamet again, your kidney function should be tested.
Danish: Før du begynder at tage Vokanamet igen, skal du have kontrolleret din nyrefunktion
English: As Vokanamet contains metformin, therapy must be discontinued 48 hours before elective surgery with general, spinal, or peridural anaesthesia.
Danish: Eftersom Vokanamet indeholder metformin, skal behandlingen seponeres 48 timer før elektiv kirurgi under universel, spinal eller epidural anæstesi.
English: • very rare: decreased vitamin B12 levels (may cause anaemia - low count of red blood cells),
Danish: ● meget sjældne: nedsat indhold af B12-vitamin (kan give anæmi - lavt antal røde blodlegemer),
English: • if you have or have recently had heart failure.
Danish: ● hvis du har eller for nyligt har haft hjertesvigt
English: As metformin is excreted by the kidney, and metformin accumulation may precipitate lactic acidosis, eGFR or creatinine clearance should be determined before initiating treatment and regularly thereafter:
Danish: Da metformin udskilles gennem nyrerne, og akkumulering af metformin kan udløse laktatacidose, skal eGFR eller kreatininclearance bestemmes før behandlingsstart og derefter regelmæssigt:
English: • if you have recently had a heart attack or have severe blood circulation problems, such as
Danish: ● hvis du for nylig har haft et hjerteanfald eller har alvorlige kredsløbsproblemer, for eksempel
English: These symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Symptomerne kan være tegn på “diabetisk ketoacidose”, som er en komplikation, du kan få ved sukkersyge på grund af de forhøjet niveau af “ketonstoffer” i urinen eller blodet.
English: This may induce metformin accumulation which may increase the risk for lactic acidosis.
Danish: Dette kan inducere akkumulering af metformin, hvilket kan øge risikoen for laktatacidose.
English: • kidney failure (mainly as a consequence of loss of too much fluid from your body).
Danish: ● nyresvigt (hovedsageligt som en konsekvens af et forhøjet væsketab fra kroppen)
English: • changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
Danish: ● ændringer i vandladning (herunder hyppigere vandladning eller større urinmængde, akut trang til at lade vandet, natlig trang til at lade vandet)
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 poolede analyse af de fire 26-ugers placebokontrollerede studier (N=2.313) beskrevet ovenfor.
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Danish: ● carbamazepin, phenytoin eller phenobarbital (midler til kontrol af epilepsi)
English: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Danish: Canagliflozins gennemsnitlige fordelingsvolumen (Vd) ved steady state efter en enkelt intravenøs infusion til raske forsøgspersoner var 119 liter, hvilket tyder på omfattende fordeling i væv.
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: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation)
Danish: ● dabigatran (blodfortyndende middel, der nedsætter risikoen for blodpropper)
English: Combinations requiring precautions for use
Danish: Kombinationer, der skal anvendes med forsigtighed
English: • blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
Danish: ● blodprøver kan vise forandringer i nyrefunktionen (forhøjet kreatinin eller urinstof) eller forhøjet kalium
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: 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Danish: 9,3 % versus 1,3 %; non-HDL-kolesterol 2,2 % og 4,4 % versus 0,7 %; triglycerider 2,4 % og 0,0 % versus 7,6 %.
English: • blood tests may show increases in your blood phosphate level
Danish: ● blodprøver kan vise forhøjet indhold af fosfat i blodet
English: • if you have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, feeling sick [nausea], or being sick [vomiting])
Danish: ● hvis du har diabetisk ketoacidose (en følgesygdom til diabetes med højt blodsukker, hurtigt vægttab, kvalme eller opkastning)
English: Lactic acidosis may also be caused by excessive alcohol intake or prolonged fasting.
Danish: Laktatacidose kan også skyldes indtagelse af store mængder alkohol eller langvarig faste.
English: • rifampicin (an antibiotic used to treat tuberculosis)
Danish: ● rifampicin (antibiotikum til at behandle tuberkulose)
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 metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient should be hospitalised immediately (see section 4.9).
Danish: Ved mistanke om metabolisk acidose bør lægemidlet seponeres, og patienten skal hasteindlægges (se pkt.
English: The safety and efficacy of canagliflozin in patients with type 1 diabetes have not been established and Vokanamet should not be used for treatment of patients with type 1 diabetes.
Danish: Vokanamets sikkerhed og virkning af canagliflozin hos patienter med type 1-diabetes er ikke blevet klarlagt, og Vokanamet bør ikke anvendes til patienter med type 1-diabetes.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund omfatter nedsat pH i blodet, plasmalaktat over 5 mmol/l og forhøjet anion-gap og laktat/pyruvat-forhold.
English: The intravascular administration of iodinated contrast agents in radiologic studies can lead to renal failure.
Danish: Intravaskulær administration af iodholdige kontraststoffer i forbindelse med radiologiske undersøgelser kan føre til nyresvigt.
English: 1 x 20 film-coated tablets 1 x 60 film-coated tablets 180 (3 x 60) film-coated tablets.
Danish: 1 x 20 filmovertrukne tabletter 1 x 60 filmovertrukne tabletter 180 (3 x 60) filmovertrukne tabletter
English: • insulin or a sulphonylurea (such as glimepiride or glipizide) for diabetes - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
Danish: ● insulin eller et sulfonylurinstof (f.eks. glimepirid eller glipizid) mod diabetes - i så fald vil lægen måske nedsætte din dosis for at undgå, at dit blodsukker bliver alt for lavt (hypoglykæmi)
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in the amount of red blood cells in your blood (haematocrit).
Danish: ● blodprøver kan vise ændringer i blodets fedtindhold (kolesteroltal) og et øget antal røde blodlegemer i blodet (forhøjet hæmatokrit)
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N=9,439) of patients from eight controlled phase 3 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større poolet analyse (N=9.439) af patienter fra otte kontrollerede fase 3-studier, der omfattede begge doser af canagliflozin.
English: • The active substances are canagliflozin and metformin hydrochloride.
Danish: ● Aktive stoffer: canagliflozin og metforminhydrochlorid.
English: • very common: feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache, and loss of appetite
Danish: ● meget almindelig: kvalme, opkastning, diaré, mavepine og appetitmangel
English: The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment, and any conditions associated with hypoxia.
Danish: Incidensen af laktatacidose kan og bør reduceres ved også at vurdere andre risikofaktorer såsom dårligt kontrolleret diabetes, ketose, langvarig faste, et voldsomt alkoholforbrug, nedsat leverfunktion og tilstande associeret med hypoksi.