FrancophonIA/ELRC3.0 huggingface dataset:
English: Pioglitazone Teva 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Pioglitazone Teva 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Danish: Du skal også kontakte din læge hurtigst muligt, hvis du allerede har sløret syn, og symptomerne forværres.
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Danish: Kontakt hurtigst muligt din læge, hvis du oplever nogle af disse bivirkninger, særligt hvis du er over 65 år.
English: Each Pioglitazone Teva 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Teva 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: The tablets are white to off-white, round, convex and debossed with the number ‘15' on one side and ‘TEVA' on the other side.
Danish: Tabletterne er hvide til grålig hvide, runde, konvekse og mærket med ‘15' på den ene side og ‘TEVA' på den anden side.
English: If you experience this side effect, talk to your doctor as soon as possible.
Danish: Kontakt hurtigst muligt din læge, hvis du oplever denne bivirkning.
English: - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Danish: - hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV) - nedsat leverfunktion - diabetisk ketoacidose - aktuel blærecancer eller blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi.
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: dobbeltblindede kliniske forsøg med over 8.100 patienter på pioglitazon og 7.400 patienter på komparator, der blev behandlet i op til 3,5 år, blev der set en forøget incidens af frakturer hos kvinder.
English: Cardiac disorders heart failure3
Danish: Hjerte hjerteinsufficiens3
English: General disorders and administration site conditions oedema5
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Pioglitazone Teva should be used every day to work properly.
Danish: For at opnå den ønskede virkning skal du tage Pioglitazone Teva hver dag.
English: ** Based on historical comparison.
Danish: ** Baseret på historisk sammenligning.
English: No deaths were reported.
Danish: Der blev ikke rapporteret om dødsfald.
English: An alternate reliable method of contraception is recommended.
Danish: En alternativ pålidelig kontraceptionsmetode anbefales.
English: In some patients additional factor VIII was given.
Danish: Hos nogle patienter blev der givet yderligere faktor VIII.
English: Such changes may in part be linked to the disease control and life style.
Danish: Sådanne forandringer kan til dels være forbundet med sygdomskontrol og livsstil.
English: These could be symptoms of a serious heart problem.
Danish: Det kan være symptomer på et alvorligt hjerteproblem.
English: Date of first authorisation: 22 August 2016
Danish: Dato for første markedsføringstilladelse: 22 august 2016
English: In the prepartum period, additional monitoring should be considered.
Danish: I præpartum-perioden bør yderligere monitorering overvejes.
English: Without tenofovir
Danish: Uden tenofovir
English: Week 96
Danish: Uge 96
English: It is normally used in combination with other anti-HIV medicines.
Danish: Det anvendes normalt i kombination med anden medicin mod HIV.
English: Week 48
Danish: Uge 48
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Typisk observeres sådanne reaktioner inden for de første få uger eller måneder efter påbegyndelsen af CART.
English: You may continue to develop infections or other illnesses linked to HIV infection.
Danish: Du kan fortsat udvikle infektioner eller andre sygdomme, som er forbundet med HIV-infektion.
English: This side effect is usually not dangerous in adults and infants older than 3 months of age; but it might be a symptom of a serious problem.
Danish: Denne bivirkning er normalt ikke farlig for voksne eller spædbørn, der er ældre end 3 måneder; men den kan være et symptom på et alvorligt problem.
English: A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Danish: En årsagssammenhæng er antydet, selvom virkningsmekanismen ikke er klarlagt.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Der bør træffes foranstaltninger med henblik på at forebygge overførsel i overensstemmelse med nationale retningslinjer.
English: The clinical relevance of these non-clinical data is unknown.
Danish: Den kliniske relevans af disse prækliniske data er ukendt.
English: There were no clinically important pharmacokinetic differences based on age or gender.
Danish: Der var ingen klinisk vigtige farmakokinetiske forskelle baseret på alder eller køn.
English: Biosciences, South San Francisco, California, USA)
Danish: (Monogram Biosciences, South San Francisco, Californien, USA).
English: Caution should be exercised.
Danish: Der skal udvises forsigtighed.
English: Your child's doctor will decide this.
Danish: Dit barns læge vil beslutte, hvorvidt dette er nødvendigt.
English: Your doctor will test for these changes.
Danish: Lægen vil holde øje med disse ændringer.
English: The best results in managing these events come from early diagnosis and immediate interruption of any suspect medicines.
Danish: De bedste resultater i håndteringen af disse bivirkninger opnås ved tidlig diagnosticering og øjeblikkelig seponering af alle mistænkte lægemidler.
English: 15 to less than 35
Danish: 15 til mindre end 35
English: Includes patients with baseline resistance data.
Danish: d Inkluderer patienter med baseline resistens data.
English: Your doctor will decide the right dose based on your child's weight.
Danish: Lægen vil fastsætte den rigtige dosis afhængig af dit barns vægt.
English: Paediatric patients (less than 3 months of age)
Danish: Pædiatriske patienter (under 3 måneder)
English: Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
Danish: Derudover kan det i tilfælde af seponering af glukokortikoidet være nødvendigt med progressiv dosisreduktion over en længere periode.
English: Number of patients evaluable.
Danish: eAntal evaluerbare patienter.
English: Table 2: Interactions between atazanavir and other medicinal products
Danish: Tabel 2: Interaktioner mellem atazanavir og andre lægemidler
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Justering af midazolamdosis bør overvejes, specielt hvis der administreres mere end én dosis midazolam.
English: At baseline, 34% of patients were receiving a PI and 60% were receiving an NNRTI.
Danish: Ved baseline fik 34% af patienterne en PI og 60% fik en NNRTI.
English: In this instance, close clinical monitoring is warranted (see Interaction with other Medicinal Products below).
Danish: I dette tilfælde er tæt klinisk monitorering påkrævet (se Interaktion med andre lægemidler).
English: Consistent results were obtained with the last observation carried forward method of analysis (time-averaged difference of 0.11, 97.5% confidence interval [-0.15, 0.36]).
Danish: Der blev opnået samstemmede resultater ved en analysemetode, hvor sidste observation blev fremskrevet (tidsgennemsnitlig forskel på 0,11; 97,5% konfidensinterval [-0,15; 0,36]).
English: There is a trend toward a higher clearance in younger children when normalised for body weight.
Danish: Der er en lille tendens til højere clearance hos yngre børn, når der korrigeres for legemsvægt.
English: Thirty-two percent of patients in the study had a viral strain with fewer than two NRTI substitutions.
Danish: Toogtredive procent af patienterne i studiet havde en virusstamme med færre end to NRTIsubstitutioner.
English: Responders on LPV/RTV who completed treatment before Week 96 are excluded from Week 96 analysis.
Danish: Patienter, der responderede på LPV/RTV, og som fuldførte behandlingen inden uge 96, er ekskluderet fra uge 96 analysen.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: Some patients required hospitalization for additional management and some had complications.
Danish: Hos nogle patienter krævede dette hospitalsindlæggelse med yderligere behandling, og nogle patienter havde komplikationer.
English: 100 mg at least 35
Danish: 100 mg mindst 35
English: Consistent results were obtained with the last observation carried forward method of analysis.
Danish: Der blev opnået samstemmende resultater ved en analysemetode, hvor sidste observation blev fremskrevet.
English: During the second and third trimesters of pregnancy
Danish: Graviditetens andet og tredje trimester:
English: Subsequent 9 month oral toxicity studies in dogs showed no drug-related electrocardiographic changes.
Danish: Efterfølgende 9 måneders orale toksicitetsstudier af hunde viste ingen lægemiddelrelaterede elektrokardiografiske forandringer.
English: If you miss a dose, take the missed dose as soon as possible with food and then take your next scheduled dose at its regular time.
Danish: Hvis du glemmer en dosis, skal du tage den manglende dosis så hurtigt som muligt sammen med et måltid, og derefter tage næste planlagte dosis til sædvanlig tid.
English: More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised.
Danish: Hyppigere monitorering af den terapeutiske koncentration af disse lægemidler anbefales, indtil plasmaniveauerne er stabile.
English: There was no evidence of pathologic jaundice and six of 40 infants in this study received phototherapy for a maximum of 4 days.
Danish: Der var ikke tegn på patologisk gulsot, og 6 ud af 40 spædbørn i dette studie fik lysbehandling i maksimalt 4 dage.
English: Cmin is concentration 24 hours post-dose.
Danish: b Cmin er koncentrationen 24 timer efter dosering.
English: If available, 90% confidence intervals (CI) are shown in parentheses.
Danish: Hvis tilgængelige angives 90% konfidensintervaller (KI) i parentes.
English: The safety profile in this study was overall comparable to that seen in adults.
Danish: Sikkerhedsprofilen i dette studie var overordnet set sammenlignelig med den, der blev set for voksne.
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Danish: Dieselweg 25, 3752 LB Bunschoten Nederlandene
English: When treating HIV infection, it is not always easy to identify what side effects are caused by atazanavir, by the other medicines you are taking, or by the HIV infection itself.
Danish: Ved behandling af HIV-infektion er det ikke altid let at sige, hvilke bivirkninger der skyldes atazanavir, anden medicin du tager eller selve HIV-infektionen.
English: Although not studied, similar results are expected with other proton pump inhibitors.
Danish: Selvom det ikke er undersøgt, forventes lignende resultater med andre protonpumpehæmmere.
English: Age/gender
Danish: Alder/køn
English: Switching to capsules from other formulations is encouraged as soon as patients are able to consistently swallow capsules.
Danish: Det anbefales at skifte til kapsler fra andre formuleringer, så snart patienten konsekvent er i stand til at sluge kapsler.
English: The studies presented in Table 2 were conducted in healthy subjects unless otherwise noted.
Danish: Studierne, der refereres til i Tabel 2, er udført med raske frivillige medmindre andet er angivet.
English: These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication.
Danish: Denne slags medicin kontrollerer infektion med human immundefektvirus (HIV) ved at stoppe et protein, som HIV har brug for til at mangfoldiggøre sig.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selvom effektiv viral suppression med antiretroviral behandling har vist sig at nedsætte risikoen væsentligt for seksuel overførsel, kan en residual risiko ikke udelukkes.
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Danish: ALFA 1-ADRENERGE RECEPTORANTAGONISTER Alfuzosin
English: Frequency is defined using 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).
Danish: Hyppighed af bivirkninger er defineret i henhold til MedDRAkonventionen: 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).
English: Administration of activated charcoal may also be used to aid removal of unabsorbed drug.
Danish: Administration af aktivt kul kan også anvendes som middel til at fjerne uoptaget lægemiddel.
English: Therefore if the combination is unavoidable, the following recommendations are made according to the CYP2C19 status:
Danish: Hvis kombinationen ikke kan undgås, anbefales derfor følgende, afhængigt af CYP2C19-status:
English: No differences in frequency of bilirubin elevations were observed between these patients and those without viral hepatitis.
Danish: Der er ikke observeret forskel i hyppigheden af bilirubinforhøjelser mellem disse patienter og dem uden viral hepatitis.
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde fortsattes behandlingen med proteasehæmmere, eller behandlingen blev genoptaget hvis afbrudt.
English: If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.
Danish: Hvis du har leverproblemer, herunder hepatitis B eller C infektion, kan du opleve, at dine leverproblemer forværres.
English: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, France
Danish: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, Frankrig
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Danish: Grad 3 eller 4 forhøjelse af total bilirubin blev noteret hos 37% (6% grad 4).
English: Since there are limited data available and due to inter-patient variability during pregnancy, Therapeutic Drug Monitoring (TDM) may be considered to ensure adequate exposure.
Danish: Da der findes begrænsede data samt på grund af variabiliteten patienterne imellem under graviditet, kan det overvejes at anvende terapeutisk lægemiddelovervågning (TDM Therapeutic Drug Monitoring) for at sikre tilstrækkelig eksponering.
English: When transitioning between formulations, a change in dose may be needed.
Danish: Ved skift mellem to formuleringer kan det være nødvendigt at ændre dosis.
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Danish: Risiko for øget alfuzosinkoncentration, som kan medføre hypotension.
English: The potential for PR prolongation should be considered in cases of overdose (see section 4.9).
Danish: Potentialet for PR-forlængelse bør tages i betragtning i tilfælde af overdosering (se pkt.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling bør indledes af en læge med erfaring med behandling af HIV-infektion.
English: Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
Danish: Raske frivillige har indtaget enkeltdoser på op til 1.200 mg uden symptomatisk negativ effekt.
English: It is recommended that the International Normalised Ratio (INR) be monitored carefully during treatment with atazanavir, especially when commencing therapy.
Danish: Det anbefales at monitorere International Normaliseret Ratio (INR) omhyggeligt under behandling med atazanavir, særligt ved behandlingsstart.
English: This association was observed independently of exposure to tenofovir disoproxil.
Danish: Denne sammenhæng blev observeret uafhængig af eksponering for tenofovirdisoproxil.
English: The primary endpoint was the time-averaged difference in change from baseline in HIV RNA through 48 weeks (Table 6).
Danish: Det primære endpoint var den tidsgennemsnitlige forskel i ændring fra baseline i HIV-RNA gennem 48 uger (tabel 6).
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Danish: Det bør erindres, at 2 ugentlige doser på 150 mg muligvis ikke giver en optimal eksponering for rifabutin med deraf følgende risiko for rifamycinresistens og behandlingssvigt.
English: The 24 hour concentration following a high fat meal was increased by approximately 33% due to delayed absorption; the median Tmax increased from 2.0 to 5.0 hours.
Danish: 24timerskoncentrationen efter et fedtrigt måltid steg med ca. 33% på grund af forsinket absorption; middel-Tmax steg fra 2,0 til 5,0 timer.
English: Per protocol analysis e
Danish: Per protokol analysee
English: Serum cholesterol and glucose were minimally to mildly increased in rats but not in mice or dogs.
Danish: Serum-kolesterol og glukose var minimalt til let forhøjet hos rotter, men ikke hos mus eller hunde.
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 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 til råds, før du tager dette lægemiddel.
English: Severe rash may be developed in association with other symptoms which could be serious.
Danish: Der kan udvikles alvorligt udslæt i forbindelse med andre symptomer, som kan være alvorlige.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med HIV, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: UNIKT ID - LÆSBAR DATA
English: Antacids and medicinal products containing buffers
Danish: Antacida og lægemidler indeholdende buffer
English: In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
Danish: I de fleste tilfælde blev gulsot rapporteret inden for et par dage til et par måneder efter indledningen af behandlingen (se pkt.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: UNIKT ID - 2D-STREGKODE
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Danish: Metabolitterne udskilles herefter i galden, enten som frie eller som glucuroniderede metabolitter.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette er til dels forbundet med forbedret helbredstilstand og med livsstil, og for lipidernes vedkommende sommetider med selve HIV-medicinen.
English: Atazanavir Mylan capsules may be used by adults and children 6 years of age and older.
Danish: Atazanavir Mylan -kapsler kan anvendes af voksne og børn, der er 6 år og ældre.
English: Consult the dosing table for the specific formulation (see relevant Summary of Product Characteristics).
Danish: Se doseringstabellen for den pågældende formulering (se relevant produktresume).
English: A dose reduction of buprenorphine may be considered
Danish: Reduktion af buprenorphindosis kan overvejes.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: 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/EC samt alle efterfølgende opdateringer og offentliggjort på den europæiske webportal for lægemidler.
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Danish: Elektrokardiografiske forandringer (sinusbradykardi, forlængelse af PR- interval, forlængelse af QT-interval og forlængelse af QRSkompleks) blev kun observeret i en indledende 2-ugers oral toksicitetsstudie udført på hunde.
English: Neither metabolite demonstrated in vitro antiviral activity.
Danish: Ingen af metabolitterne udviste in vitro-antiviral aktivitet.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (som skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din HIV-infektion.
English: At the time voriconazole treatment is required, a patient's CYP2C19 genotype should be performed if feasible.
Danish: Når behandling med voriconazol er påkrævet, bør patientens CYP2C19-genotype bestemmes, hvis muligt.
English: Atazanavir exhibits anti- HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Danish: Atazanavir udviser anti-HIV-1 (herunder alle testede grupper) og anti-HIV-2 aktivitet i cellekulturer.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis jirovecii pneumoni.
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the virus developing resistance to the treatment.
Danish: Sådan kan du være sikker på, at medicinen virker bedst muligt, og risikoen for, at viruset udvikler resistens over for behandlingen, er mindre.
English: The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; significant differences were observed between the two groups.
Danish: Farmakokinetik for atazanavir er evalueret hos raske, voksne frivillige og hos HIV-inficerede patienter; der er observeret væsentlige forskelle mellem de to grupper.
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryo-development study.
Danish: Der sås hos drægtige kaniner omfattende læsioner i mave og tarm hos døde eller moribunde hunner ved maternelle doser 2 og 4 gange den højeste dosis administreret i den endelige fosterudviklingsstudie.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Større effekt kan forventes ved inhalation af fluticasonpropionat.
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Danish: Hæmofilipatienter bør derfor være opmærksomme på risikoen for øget blødning.
English: Withdrawal of ritonavir only under restrictive conditions
Danish: Seponering af ritonavir udelukkende under restriktive omstændigheder