FrancophonIA/ELRC3.0 huggingface dataset:
English: The results are supportive of fluconazole as an appropriate treatment for mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Danish: Resultaterne understøtter fluconazol som en relevant behandling af candidainfektion i slimhinder, herunder orofaryngeal, øsofageal candidiasis, candiduria og kronisk mukokutan candidiasis.
English: • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Danish: • Candidiasis i slimhinder, herunder orofaryngeal, øsofageal candidiasis, candiduria og kronisk mukokutan candidiasis.
English: Section 4.2 - Posology and method of administration
Danish: Punkt 4.2 - Dosering og indgivelsesmåde
English: Recently, the Infectious Diseases Society of America (IDSA: Pappas et al 2009) published updated guidance for use of antifungal agents including the prevention indication where fluconazole is recommended for prevention.
Danish: For nylig har Infectious Diseases Society of America (IDSA: Pappas et al 2009) publiceret en opdateret vejledning i anvendelse af antimykotika, herunder profylakseindikationen, hvor fluconazol er anbefalet til forebyggelse.CHMP var enigt i de fremlagte data og var af den opfattelse, at fluconazol er effektivt som profylakse af candidainfektioner hos patienter med langvarig neutropeni.
English: Fluconazole is available also for intravenous (IV) use in the 2 mg/mL saline solution formulation.
Danish: anvendelse i en formulering med 2 mg/ml saltvandsopløsning.
English: However as the first line treatment of this candidiasis is the topical application, the one 150 mg capsule presentation is specifically indicated for the above genital candidiasis indications in adults when local therapy is not appropriate.
Danish: En kapsel med 150 mg er specifikt indiceret til ovennævnte indikationer ved genital candidiasis hos voksne, når lokal behandling ikke er velegnet.
English: Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia; however, drug-related adverse events were more frequent with amphotericin B. The CHMP concluded that fluconazole is a safe and effective medicinal product in prophylaxis or treatment for invasive candidiasis compared to other therapies.
Danish: Men lægemiddelrelaterede uønskede hændelser var hyppigere med amphotericin B. CHMP konkluderede, at fluconazol er et sikkert og effektivt lægemiddel ved profylakse eller behandling af invasiv candidiasis sammenlignet med andre behandlinger.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Diflucan and associated names (see Annex I).
Danish: anbefalede CHMP ændringen af de markedsføringstilladelser, for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Diflucan og relaterede navne (se bilag I).
English: Oral use
Danish: Indlægsseddel
English: Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines.
Danish: Det understøttes af data fra kliniske undersøgelser og anbefales i kliniske retningslinjer.
English: Fluconazole, administered at doses of 1 mg/Kg/day and 3 mg/Kg/day was more effective than the active comparator at preventing fungal infections.
Danish: mg/kg/dag var mere effektivt end det aktive stof, der blev anvendt til sammenligning, ved forebyggelse af svampeinfektioner.
English: For the one 150 mg capsule presentation the section 4.1 of the SPC is agreed by the CHMP as follows:
Danish: For formuleringen en 150 mg kapsel har CHMP vedtaget ordlyden i pkt.
English: Intravenous use
Danish: Anvendelse til børn
English: The CHMP noted that adolescent posology had been omitted; none of the national SPCs described the posology for this age group.
Danish: CHMP bemærkede, at doseringen for unge var udeladt.
English: Package Leaflet
Danish: BILAG II
English: Member State EU/EEA
Danish: Orale eller i.v.
English: Do not worry.
Danish: Her er ingen grund til bekymring.
English: Safety features will be implemented until 9/2/2019.
Danish: Sikkerhedsforanstaltninger vil blive implementeret indtil 09/02/2019
English: Once daily.
Danish: Én gang dagligt.
English: Date of first authorisation: 12 September 2008 Date of latest renewal: 9 April 2013
Danish: Dato for første markedsføringstilladelse: 12 september 2008 Dato for seneste fornyelse: 9 april 2013
English: The absolute bioavailability is greater than 90%.
Danish: Den absolutte biotilgængelighed er større end 90%.
English: The frequency category is probably not greater than "uncommon".
Danish: Hyppighedskategorien er formentlig ikke større end "ikke almindelig".
English: The three strips are marked with "Week 1", "Week 2" and "Week 3".
Danish: De tre ark er markeret med ”Uge 1”, ”Uge 2” og ”Uge 3”.
English: - Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Danish: - Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift.
English: In this case, you will have to take the tablets only once or twice a day.
Danish: I så fald skal du kun tage tabletter en eller to gange daglig.
English: Maintenance of efficacy was shown in patients treated for 33 weeks.
Danish: Virkningen blev påvist bevaret hos patienter behandlet i 33 uger.
English: Out of these 87 patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
Danish: Ud af disse 87 patienter, fik 82,8% uændret dosis, 13,8% fik forøget dosis og 3,4% fik nedsat dosis.
English: - Strong impulse to gamble excessively despite serious personal or family consequences.
Danish: - Stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser.
English: If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.
Danish: Hvis du gør det, er der risiko for overdosering, da medicinen derved kan blive frigivet for hurtigt i kroppen.
English: Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Danish: Augmentation blev specielt undersøgt i et kontrolleret klinisk forsøg på 26 uger.
English: Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Danish: Derfor er interaktioner med andre lægemidler, der påvirker plasmaproteinbinding eller elimination ved biotransformation, usandsynlig.
English: Inform your doctor if you find tablet pieces in your faeces.
Danish: Fortæl det til lægen, hvis du finder tabletstykker i din afføring.
English: The increase in Cmax is not considered clinically relevant.
Danish: Stigningen i Cmax vurderes ikke at være klinisk relevant.
English: - Uncontrollable excessive shopping or spending.
Danish: - Ukontrollerbart overdrevent indkøbsmønster og forbrug.
English: Caution should be exercised and careful assessment of therapeutic response and tolerability should be made before increasing to daily dosing after one week.
Danish: Forsigtighed bør udvises, og omhyggelig vurdering af det terapeutiske respons samt tolerabilitet bør foretages inden dosis optrappes til dosering hver dag efter 1 uge.
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Danish: Med 95% sikkerhed er frekvenskategorien ikke højere end “ikke almindelig” og kan være lavere.
English: The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Danish: Den potentielle virkning af pramipexol på den reproduktive funktion er blevet undersøgt i rotter og kaniner.
English: Table 1: Parkinson's disease Body System Very common
Danish: Tabel 1: Parkinsons sygdom Kropssystem Meget almindelig
English: If patients report such an observation, the physician should reassess patient's response to therapy.
Danish: Hvis patienter indberetter sådan en observation, skal lægen revurdere patientens behandlingsrespons.
English: The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Danish: Den absolutte biotilgængelighed er større end 90%, og maksimal plasmakoncentration opnås efter 1-3 timer.
English: The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Danish: Sidstnævnte fund blev hverken observeret i pigmenterede rotter eller i albinomus i et karcinogenitetsstudie over 2 år eller hos nogen anden undersøgt dyreart.
English: If this happens, your doctor may want to change your medication.
Danish: Hvis dette sker, kan det være, at lægen vil ændre din medicin.
English: The daily dose you take of Oprymea increases each week.
Danish: Den daglige dosis, du tager af Oprymea, øges hver uge.
English: If renal function declines during maintenance therapy, the recommendations given above should be followed.
Danish: Hvis nyrefunktionen aftager under vedligeholdelsesbehandlingen, bør ovennævnte anbefalinger følges.
English: This side effect has been observed in post-marketing experience.
Danish: Denne bivirkning er observeret efter markedsføring.
English: Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Danish: Derfor bør du ikke tage Oprymea, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
English: Your doctor will then discuss with you if you should continue to take Oprymea.
Danish: Din læge vil tale med dig, om du skal fortsætte med at tage Oprymea.
English: BOX for blisters
Danish: ÆSKE TIL BLISTRE
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Danish: Tilfælde af pludseligt opstået søvn under daglige aktiviteter, i nogle tilfælde uden nogen form for advarsel, har været rapporteret.
English: In half of the 16 patients who did not meet the criterion for maintained efficacy on UPDRS Part II+III score, the change from baseline was considered not clinically relevant.
Danish: Hos halvdelen af de 16 patienter, som ikke opfyldte kriteriet for vedvarende virkning i UPDRS del II+III-score, blev ændringen fra baseline betragtet som ikke klinisk relevant.
English: Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Danish: Kaplan-Meier analyse af tid til augmentation viste ingen signifikant forskel mellem pramipexol- og placebogruppen.
English: The Oprymea treatment initiation pack contains three blister strips of tablets - one strip for each of the first three weeks of your treatment.
Danish: Oprymea behandlingsstart pakken indeholder tre blisterark med tabletter - et ark for hver af de første tre uger af din behandling.
English: A decreased body weight by 30 kg results in an increase in Cmax of 45%.
Danish: Et vægtab på 30 kg viste en Cmax-stigning på 45%.
English: Patients with kidney disease If you have severe kidney disease, Oprymea may not be a suitable treatment for you.
Danish: Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er Oprymea måske ikke den egnede behandling for dig.
English: Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Danish: Farmakoterapeutisk klassifikation: Anti-Parkinson lægemiddel, dopaminreceptoragonist, ATC kode: N04BC05
English: Rare to
Danish: Meget sjælden
English: Oprymea should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Danish: Oprymea bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
English: The total clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 ml/min.
Danish: Den totale clearance for pramipexol er omkring 500 ml/min og den renale clearance er omkring 400 ml/min.
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Danish: Literaturen rapporterer, at behandling af restless legs syndrom med dopaminerge lægemidler kan resultere i augmentation.
English: Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Danish: Hypotension kan forekomme i begyndelsen af behandlingen, specielt hvis pramipexol optitreres for hurtigt.
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Danish: Det anbefales at monitorere blodtrykket, særlig i starten af behandlingen, pga. risikoen for hypotention i forbindelse med dopaminbehandling.
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 Oprymea.
English: Warnings and precautions Talk to your doctor before taking Oprymea.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Oprymea.
English: Very common: - Nausea (sickness).
Danish: Meget almindelig: - Kvalme
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl din læge, hvis du eller din familie/pårørende bemærker, at du er ved at udvikle trang til at opføre dig på måder, der er usædvanlige for dig, og du ikke kan modstå trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
English: Clinical efficacy and safety in Parkinson's disease
Danish: Klinisk virkning og sikkerhed ved Parkinsons sygdom
English: Table 2: Restless legs syndrome Body System Very common
Danish: Tabel 2: Restless legs syndrom Kropssystem Meget almindelig
English: Hallucinations or somnolence can occur.
Danish: Der kan opstå hallucinationer, døsighed eller somnolens.
English: The Oprymea treatment initiation pack is only to be used for the beginning of the treatment with Oprymea.
Danish: Oprymea behandlingsstart pakken skal kun anvendes i begyndelsen af behandlingen med Oprymea.
English: Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of patients in the placebo group (N = 149).
Danish: Augmentation blev observeret hos 11,8% af patienterne i pramipexolgruppen (N = 152) og hos 9,4% af patienterne i placebogruppen (N = 149).
English: The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Danish: Den samlede incidens af hallucinationer og døsighed var generelt højere i optitreringsfase for pramipexol gruppen.
English: You may experience the following side effects:
Danish: Du kan få følgende bivirkninger:
English: Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Danish: Pga. de valgte dyrearter og det begrænsede antal undersøgte parametre er pramipexols bivirkninger i forbindelse med graviditet og mandlig fertilitet ikke fuldt belyst.
English: Do not take Oprymea: - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Oprymea - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i Oprymea (angivet i punkt 6.1).
English: The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
Danish: Den justerede gennemsnitsforskel var -4,3 point (CI 95% -6,4; -2,1 procent, p-værdi <0,0001).
English: In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
Danish: I et farmakoepidemiologisk forsøg var brug af pramipexol associeret med en øget risiko for hjertesvigt sammenlignet med ikke-brug af pramipexol (observeret risikoratio 1,86; 95% CI
English: Pregelatinised maize starch Povidone K25
Danish: Pregelatineret majsstivelse Povidon K25
English: Common (≥1/100 to
Danish: Almindelig (≥1/100 til
English: The use of Oprymea tablets should be considered.
Danish: Anvendelse af Oprymea tabletter bør overvejes i stedet.
English: Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Danish: Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med Oprymea (henholdsvis 20,8% og 10,5%) sammenlignet med mandlige patienter (henholdsvis 6,7% og 7,3%).
English: The tablets should be swallowed whole with water, and must not be chewed, divided or crushed.
Danish: Tabletterne bør synkes hele med vand og må ikke tygges, deles eller knuses.
English: Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a hypotensive effect was discerned in the monkey.
Danish: Fald i det diastoliske og systoliske blodtryk og hjerterytmen blev fundet i minigrise, og en tendens til en hypotensiv virkning blev set i aber.
English: Do not take a double dose to make up for a forgotten tablet dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Danish: Inhibitorer/kompetitiv hæmmere af den renale eliminationsvej Cimetidin reducerer den renale clearance af pramipexol med ca. 34%, antagelig ved en hæmning af det kationiske sekretionstransportsystem i de renale tubuli.
English: Total exposure (AUC) was not affected by concomitant food intake.
Danish: Det samlede AUC blev ikke påvirket ved samtidig fødeindtagelse.
English: Efficacy was maintained in 87 of 103 patients switched to pramipexole prolonged-release tablets.
Danish: Virkningen blev bevaret hos 87 ud af 103 patienter, som skiftede til pramipexol depottabletter.
English: There is no pharmacokinetic interaction with selegiline and levodopa.
Danish: Der er ingen pharmakokinetisk interaktion med selegelin og levodopa.
English: Take your Oprymea (immediate release) tablets as normal the day before you switch.
Danish: Tag dine almindelige Oprymea tabletter som normalt dagen før, du skifter.
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Danish: Således kan symptomerne optræde tidligere på aftenen (eller tilmed om eftermiddagen), og symptomerne kan forværres og kan involvere andre ekstremiteter.
English: 3-week treatment initiation pack
Danish: 3 ugers behandlingsstart pakke
English: Furthermore a reduction of dose or termination of therapy may be considered.
Danish: En reduktion af dosis eller ophør med behandling kan overvejes.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel dig personligt.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Danish: Patienter, som har oplevet døsighed, somnolens og/eller en episode med pludseligt opstået søvn, må ikke køre bil eller betjene maskiner.
English: The effect of Oprymea on the unborn child is not known.
Danish: Det er ukendt, hvilken virkning Oprymea kan have på det ufødte barn.
English: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Danish: Oprymea kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom).
English: If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Danish: Hvis du har restless legs syndrom, kan du muligvis få følgende bivirkninger:
English: This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Danish: Denne forsinkelse af motoriske komplikationer med pramipexol skal opvejes imod en større bedring af den motoriske funktion med levodopa (målt ved den gennemsnitlige ændring i UPDRS-score).
English: What Oprymea contains - The active substance is pramipexole.
Danish: Oprymea indeholder - Det aktive stof er pramipexol.
English: Concomitant administration with food does generally not affect the bioavailability of pramipexole.
Danish: Samtidig indtagelse af mad påvirker generelt ikke biotilgængeligheden af pramipexol.
English: A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats.
Danish: Forsinket kønsudvikling er observeret hos rotter (dvs. forsinket præputial separation og forsinket vaginalåbning).
English: In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Danish: Hos rotter var koncentrationen af lægemidlet højere i modermælken end i plasma.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Neuroleptic malignant syndrome
Danish: Malignt neuroleptika syndrom
English: The use of pramipexole has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Danish: Brugen af pramipexol har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
English: Steady state of exposure is reached at the latest after 5 days of continuous dosing.
Danish: Steady-state koncentration opnås senest 5 dage efter kontinuerlig dosering.
English: In early and advanced Parkinson's disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
Danish: Ved tidlig og fremskreden Parkinsons sygdom blev virkningen af pramipexol i de kontrollerede kliniske undersøgelser bevaret i ca. 6 måneder.
English: Oprymea should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Danish: Oprymea bør ikke anvendes til børn og unge med Tourettes sygdom på grund af en negativ balance mellem fordele og ulemper ved denne sygdom (se pkt.
English: While body weight has no impact on the AUC, it was found to influence the volume of distribution and therefore the peak concentrations Cmax.
Danish: AUC bliver ikke påvirket af kropsvægten, men det gør fordelingsvolumen og dermed Cmax.
English: In the Phase III studies that established safety and efficacy of pramipexole prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Danish: I de fase-III forsøg, hvor sikkerhed og virkning af pramipexol depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse.
English: If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Danish: I tilfælde af, at centralnervesystemet synes at være stimuleret, kan et neuroleptisk middel anvendes.
English: Approximately 90% of C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Danish: Ca. 90% af en 14C-mærket dosis udskilles via nyrerne og mindre end 2% via fæces.