FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Danish: I kliniske forsøg med pioglitazon var der tegn på dosisrelateret vægtøgning, hvilket kan skyldes fedtophobning og i nogle tilfælde, associeret med væskeretention.
English: The other side effects that have been experienced by some patients taking Pioglitazone Krka are:
Danish: Andre bivirkninger, der er forekommet hos nogle patienter, når de har taget Pioglitazone Krka:
English: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Danish: I PROactive, et kardiovaskulært outcome forsøg, blev 5.238 patienter med type 2-diabetes mellitus og betydende makrovaskulær sygdom, som blev randomiseret til pioglitazon eller placebo i tillæg til eksisterende antidiabetika og kardiovaskulær behandling i op til 3,5 år.
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Danish: almindelige (kan påvirke op til 1 ud af 10 personer) - luftvejsinfektion - synsforstyrrelser - vægtstigning - følelsesløshed ikke almindelige (kan påvirke op til1 ud af 100 personer) - bihulebetændelse (sinuitis) - søvnløshed (insomni)
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Danish: - impotens - rygsmerter - kortåndethed - mindre fald i de røde blodlegemer (blodmangel) - luftafgang fra tarmen ikke almindelige (kan påvirke op til 1 ud af 100 personer) - sukker i urinen, protein i urinen - forhøjede enzymtal - svimmelhed, hvor verden drejer rundt (vertigo) - svedudbrud - træthed - øget appetit
English: Talk to your doctor before taking Pioglitazone Krka: - if you retain water (fluid retention) or have heart failures problems in particular if you are over
Danish: Kontakt lægen, før du tager Pioglitazone Krka: - hvis du har vand i kroppen (ødemer) eller har problemer med hjertesvigt specielt hvis du er over 75 år.
English: In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Danish: I kliniske forsøg med pioglitazon var hyppigheden af et forhøjet ALAT, som var større end tre gange den øvre normalgrænse den samme som med placebo, men mindre end det observerede i sammenligningsgrupperne med metformin og sulfonylurinstof.
English: Eye disorders visual disturbance common common uncommon macular oedema not known not known not known not known not known
Danish: Øjne synsforstyrrelser almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Danish: I kontrollerede kliniske undersøgelser er hyppigheden af rapporteret hjerteinsufficiens ved pioglitazonbehandling den samme som for for placebo-, metformin- og sulfonylurinstof-grupperne, men var forøget ved kombinationsbehandling med insulin.
English: 14 tablets: EU/1/11/723/001 28 tablets: EU/1/11/723/002 30 tablets: EU/1/11/723/003 56 tablets: EU/1/11/723/004 60 tablets: EU/1/11/723/005 90 tablets: EU/1/11/723/006 98 tablets: EU/1/11/723/007
Danish: 14 tabletter: EU/1/11/723/001 28 tabletter: EU/1/11/723/002 30 tabletter: EU/1/11/723/003 56 tabletter: EU/1/11/723/004 60 tabletter: EU/1/11/723/005 90 tabletter: EU/1/11/723/006 98 tabletter: EU/1/11/723/007
English: 14 tablets: EU/1/11/723/015 28 tablets: EU/1/11/723/016 30 tablets: EU/1/11/723/017 56 tablets: EU/1/11/723/018 60 tablets: EU/1/11/723/019 90 tablets: EU/1/11/723/020 98 tablets: EU/1/11/723/021
Danish: 14 tabletter: EU/1/11/723/015 28 tabletter: EU/1/11/723/016 30 tabletter: EU/1/11/723/017 56 tabletter: EU/1/11/723/018 60 tabletter: EU/1/11/723/019 90 tabletter: EU/1/11/723/020 98 tabletter: EU/1/11/723/021
English: Alanine aminotransferase increased not known not known not known not known not known
Danish: Makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektion almindelig almindelig almindelig almindelig almindelig bronkitis almindelig sinusitis ikke almindelig ikke almindelig ikke almindelig ikke almindelig ikke almindelig
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - cardiac failure or history of cardiac failure (NYHA stages I to IV), - hepatic impairment, - diabetic ketoacidosis, - current bladder cancer or a history of bladder cancer, - uninvestigated macroscopic haematuria.
Danish: - overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt 6.1 - hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV) - nedsat leverfunktion - diabetisk ketoacidose - blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi
English: Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Danish: Synsforstyrrelse er primært blevet indberettet tidligt i behandlingsforløbet og er relateret til ændringer i blodglucoseværdier.
English: 14 tablets: EU/1/11/723/008 28 tablets: EU/1/11/723/009 30 tablets: EU/1/11/723/010 56 tablets: EU/1/11/723/011 60 tablets: EU/1/11/723/012 90 tablets: EU/1/11/723/013 98 tablets: EU/1/11/723/014
Danish: 14 tabletter: EU/1/11/723/008 28 tabletter: EU/1/11/723/009 30 tabletter: EU/1/11/723/010 56 tabletter: EU/1/11/723/011 60 tabletter: EU/1/11/723/012 90 tabletter: EU/1/11/723/013 98 tabletter: EU/1/11/723/014
English: Excipient with known effect: Each tablet contains 264.68 mg of lactose (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 264,68 mg lactose (se pkt.
English: In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 - 3 kg over one year.
Danish: I kontrollerede kliniske forsøg med aktive stoffer som sammenligning var den gennemsnitlige vægtøgning 2-3 kg i løbet af et år med pioglitazon givet som monoterapi.
English: Since insulin and pioglitazone are both associated with fluid retention,
Danish: Da insulin og pioglitazon begge er associeret med væskeretention, kan samtidig indgift måske øge risikoen for ødemer.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Pioglitazone Krka.
Danish: Knoglebrud har været almindeligt forekommende (kan påvirke op til 1 ud af 10 personer) hos kvinder, der tager Pioglitazone Krka.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Krka.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" (kan påvirke op til 1 ud af 100 personer) hos patienter, der tager Pioglitazone Krka.
English: What you need to know before you take Pioglitazone Krka
Danish: Det skal du vide, før du begynder at tage Pioglitazone Krka
English: as dual oral therapy in combination with - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
Danish: som oral behandling med to præparater, sammen med - et sulfonylurinstof hos voksne patienter med utilstrækkelig glykæmisk kontrol ved monoterapi med sulfonylurinstof på trods af maksimalt tolereret sulfonylurinstofdosis; dog kun hos patienter, der udviser intolerans over for metformin, eller for hvem metformin er kontraindiceret
English: Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Hjerteinsufficiens er hyppigere rapporteret, når pioglitazon bruges i kombinationsbehandling med insulin eller hos patienter med tidligere hjerteinsufficiens.
English: White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Danish: Hvide til næsten hvide, runde tabletter, med skrå kanter (diameter 8,0 mm)
English: If you stop taking Pioglitazone Krka
Danish: Hvis du holder op med at tage Pioglitazone Krka
English: - The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate (E572).
Danish: - Øvrige indholdsstoffer:lactosemonohydrat, hydoxypropylcellulose (E463), croscarmellosenatrium,
English: If you forget to take Pioglitazone Krka
Danish: Hvis du har glemt at tage Pioglitazone Krka
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Pioglitazone Krka, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Tabulated list of adverse reactions
Danish: Tabuleret sammendrag af bivirkninger
English: Your doctor will check whether Pioglitazone Krka is working 3 to 6 months after you start taking it.
Danish: Når du har taget Pioglitazone Krka i 3-6 måneder, vil din læge undersøge, om medicinen virker.
English: If you have the impression that the effect of Pioglitazone Krka is too weak, talk to your doctor.
Danish: Tal med lægen, hvis du har indtryk af, at effekten af Pioglitazone Krka er for svag.
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Danish: Dette sker fortrinsvis via cytochrom P450 2C8, selvom andre isoformer kan være involveret i mindre grad. Tre af de seks identificerede metabolitter er aktive (M-II, M-III og M-IV).
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Danish: I PROactive-forsøget (kardiovaskulært risiko-studie) som forløb over 3,5 år, fik 44/870 (5,1%; 1,0 frakturer pr. 100 patientår) af de pioglitazonbehandlede kvindelige patienter frakturer.
English: White to almost white round tablets with bevelled edges and with engraved "45" on one side of tablet (diameter 10.0 mm).
Danish: Hvide til næsten hvide, runde tabletter, med skrå kanter og præget med ”45” på den ene side af tabletten (diameter 10,0 mm).
English: White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Danish: Hvide til næsten hvide, runde tabletter, med skrå kanter og præget med ”15” på den ene side af tabletten (diameter 7,0 mm)
English: Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Danish: Undersøgelser øget vægt almindelig almindelig almindelig almindelig almindelig forhøjet kreatinphosphokinase almindelig forhøjet laktatdehydrogenase ikke almindelig forhøjet alaninaminotransferase ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common back pain common
Danish: Knogler, led, muskler og bindevæv knoglefraktur almindelig almindelig artralgi almindelig almindelig almindelig rygsmerter almindelig
English: Pioglitazone Krka 45 mg tablets
Danish: Pioglitazone Krka 45 mg tabletter
English: Pioglitazone Krka 30 mg tablets
Danish: Pioglitazone Krka 30 mg tabletter
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Danish: Der er rapporter om, at samtidig administration af pioglitazon og gemfibrozil (en hæmmer af cytochrom P450 2C8) har resulteret i en 3- gange stigning i AUC for pioglitazon.
English: Pioglitazone Krka 15 mg tablets
Danish: Pioglitazone Krka 15 mg tabletter
English: What Pioglitazone Krka is and what it is used for What you need to know before you take Pioglitazone Krka How to take Pioglitazone Krka Possible side effects
Danish: Det skal du vide, før du begynder at tage Pioglitazone Krka Sådan skal du tage Pioglitazone Krka Bivirkninger
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Danish: Der er set henholdsvis en øgning og en reduktion af plasmakoncentrationen af pioglitazon ved samtidig administration af pioglitazon og gemfibrozil (en hæmmer af cytochrom P450 2C8) eller rifampicin (en inducer af cytochrom P450 2C8) (se pkt.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon Respiratory, thoracic and mediastinal disorders dyspnoea common
Danish: cyster og polypper) blærecancer ikke ikke ikke almindelig ikke almindelig ikke almindelig
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Danish: Her viste glykæmiske kontrolmålinger( målt som middelændringer i HbA1c fra baseline), at de var omtrentlig de samme to grupper imellem efter et år.
English: How to take Pioglitazone Krka
Danish: Sådan skal du tage Pioglitazone Krka
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Danish: Udseende og pakningsstørrelser Hvide til næsten hvide, runde tabletter, med skrå kanter (diameter 8,0 mm)
English: General disorders and administration site conditions oedema very common fatigue uncommon
Danish: Almene symptomer og reaktioner på administrations stedet ødem meget almindelig træthed ikke almindelig
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Danish: I en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, kontrollerede, dobbeltblindede kliniske forsøg med over 8.100 patienter behandlet med pioglitazon og 7.400 patienter behandlet med komparator, der blev behandlet i op til 3,5 år, blev der set en forøget incidens af frakturer hos kvinder.
English: If you take more Pioglitazone Krka than you should If you accidentally take too many Pioglitazone Krka tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager din medicin.
English: Pioglitazone Krka 45 mg tablets Pioglitazone
Danish: Pioglitazone Krka 45 mg tabletter pioglitazon
English: CARTON FOLDING BOX
Danish: Mave-tarm kanalen flatulens almindelig
English: Pioglitazone Krka 30 mg tablets Pioglitazone
Danish: Pioglitazone Krka 30 mg tabletter pioglitazon
English: Pioglitazone Krka 15 mg tablets Pioglitazone
Danish: Pioglitazone Krka 15 mg tabletter pioglitazon
English: Ear and
Danish: <MM/ÅÅÅÅ>
English: Adverse reaction
Danish: Admininstration
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Danish: Immunsystemet Overfølsomhed og allergiske reaktioner
English: Not known: cannot be estimated from the available data
Danish: Ikke kendt: Kan ikke estimeres ud fra forhåndenværende data
English: Odds Ratio (95% CI)
Danish: Odds ratio (95 % KI)
English: Frequencies are defined as:
Danish: Hyppigheder er defineret som:
English: Therefore, administration of aprotinin is contraindicated in these patients.
Danish: Administration af aprotinin er derfor kontraindiceret hos disse patienter.
English: 4.7 Effects on ability to drive and use machines Not relevant.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Ikke relevant.
English: MedDRA Standard System organ class
Danish: MedDRA standard systemorganklasse
English: It is unknown whether aprotinin is excreted in human milk.
Danish: Det er ukendt, om aprotinin udskilles i human mælk.
English: Adult:
Danish: Voksne:
English: Most of the studies did not adequately account for these baseline differences in risk factors and the influence of these risk factors on the results is not known.
Danish: De fleste af disse studier gjorde ikke tilstrækkeligt rede for disse baseline-forskelle i risikofaktorer, og indflydelsen af disse risikofaktorer på resultaterne er ikke kendt.
English: The same lumen should not be used for the administration of any other medicinal product.
Danish: Anvend ikke samme lumen til administration af andre lægemidler.
English: Aprotinin should be used throughout pregnancy only if the potential benefit justifies the potential risk.
Danish: Aprotinin bør kun anvendes under graviditet, hvis de potentielle fordele retfærdiggør den potentielle risiko.
English: Therefore interpretation of these observational studies is limited and an association between aprotinin use and increased mortality can neither be established nor refuted.
Danish: Derfor er forståelsen af disse observationsstudier begrænset, og en sammenhæng mellem brug af aprotinin og øget mortalitet kan hverken be- eller afkræftes.
English: The placenta is probably not absolutely impermeable to aprotinin, but permeation appears to take a very slow course.
Danish: Placenta er sandsynligvis ikke absolut inpermeabel for aprotinin, men permeationen synes at være meget langsomt.
English: Adequate anticoagulation with heparin must be assured (see also above).
Danish: Tilstrækkelig antikoagulation med heparin skal sikres (se også ovenfor).
English: Metabolism, elimination and excretion
Danish: Metabolisme, elimination og udskillelse
English: The safety of aprotinin has been evaluated in more than forty five phase II and phase III studies including more than 3800 patients exposed to aprotinin.
Danish: Aprotinins sikkerhed er blevet vurderet i mere end 45 fase II- og fase III-studier med mere end 3.800 patienter, der er blevet eksponeret for aprotinin.
English: • Determination of Heparin Levels
Danish: • Bestemmelse af heparin-niveauer
English: In the majority of instances, post-operative renal dysfunction was not severe and reversible.
Danish: I størstedelen af tilfældene var den postoperative renale dysfunktion ikke alvorlig, og den var reversibel.
English: These metabolites lacked enzyme-inhibitory activity.
Danish: Disse metabolitter manglede enzymhæmmende aktivitet.
English: Aminoglycosides are a risk factor for renal dysfunction.
Danish: Aminoglykosider er en risikofaktor for renal dysfunktion.
English: Assessment of potential for allergic reactions
Danish: Vurdering af risikoen for allergiske reaktioner
English: - Your kidneys do not work properly.
Danish: - Dine nyrer fungerer ikke normalt.
English: Important: aprotinin is not a heparin-sparing agent.
Danish: Vigtigt: Aprotinin er ikke et heparinbesparende middel.
English: When using a multi-lumen central catheter a separate catheter is not required.
Danish: Hvis der anvendes et multi-lumen-centralkateter, er et separat kateter ikke påkrævet.
English: Anaphylactic shock (potentially life threatening)
Danish: Anafylaktisk shock (potentielt livstruende)
English: <Aprotinin-containing medicinal product> belongs to a group of medicines called anti-fibrinolytics, i.e. medicines to prevent blood loss.
Danish: <Lægemidler, der indholder aprotinin> tilhører en gruppe lægemidler, der kaldes antifibrinolytika, dvs. lægemidler, der forebygger blodtab.
English: In general, the total amount of aprotinin administered per treatment course should not exceed 7 million KIU.
Danish: Generelt bør den totale dosis aprotinin, der administreres pr. behandlingscyklus, ikke overstige 7 millioner KIE.
English: However, due to several methodological deficiencies no firm conclusion on cardiovascular risks can be made on the BART study results.
Danish: Dog kan der på grund af flere metodiske mangler ikke drages nogen sikker konklusion om de kardiovaskulære risici på basis af BART-studiets resultater.
English: Re-exposure to aprotinin
Danish: Reeksponering for aprotinin
English: In man, urinary excretion of active aprotinin accounts for less than 5 % of the dose.
Danish: Hos mennesket udgør urinudskillelse af aktivt aprotinin mindre end 5 % af dosis.
English: It is also used to reduce the need for a blood transfusion during and after heart surgery.
Danish: Det anvendes også til at mindske behovet for blodtransfusion under og efter en hjerteoperation.
English: A trend of increased incidence of MI in association with aprotinin was observed in some studies, while other studies showed a lower incidence compared to placebo.
Danish: I nogle studier sås en tendens til øget incidens af MI i forbindelse med aprotinin, mens andre studier viste en lavere incidens sammenlignet med placebo.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, tror, at du kan være gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Your doctor will discuss with you the risks and benefits of using this medicine.
Danish: Din læge vil diskutere fordele og risici ved at anvende dette lægemiddel med dig.
English: Consult the manufacturer of the ACT test regarding the interpretation of the assay in the presence of aprotinin.
Danish: Kontakt forhandleren af ACT-testen vedrørende fortolkning af testen ved tilstedeværelse af aprotinin.
English: Arterial thrombosis (and its organ specific manifestations that might occur in vital organs such as kidney, lung or brain)
Danish: Arteriel trombose (og de organspecifikke manifestationer, der kan vise sig i vitale organer som f.eks. nyrer, lunger eller hjerne)
English: In total, about 11% of aprotinin-treated patients experienced adverse reactions.
Danish: I alt oplevede omkring 11% af de patienter, der blev behandlet med aprotinin, bivirkninger.
English: It also inhibits the contact phase activation of coagulation which both initiates coagulation and promotes fibrinolysis.
Danish: Aprotinin hæmmer også kontaktfaseaktiveringen af koagulationen, som både initierer koagulation og fremmer fibrinolyse.
English: Elderly Reported clinical experience has not identified differences in responses in elderly patients.
Danish: Ældre Klinisk erfaring har ikke identificeret forskelle i responset hos ældre patienter.
English: In these studies, aprotinin was usually administered to patients who had more risk factors for increased mortality before surgery than patients in the other treatment groups.
Danish: I disse studier blev aprotinin som regel givet til patienter, der havde flere risikofaktorer for øget mortalitet før operationen end patienter i de andre behandlingsgrupper.