FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
Danish: Den mulige forbindelse mellem disse bivirkninger og behandlingen med pentosanpolysulfatnatrium er ikke diskuteret i de pågældende publikationer.
English: • allergic to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for pentosanpolysulfatnatrium eller et af de øvrige indholdsstoffer i elmiron (angivet i punkt 6)
English: The apparent plasma half-life of pentosan polysulfate sodium depends on the route of administration.
Danish: Den tilsyneladende plasma-halveringstid for pentosanpolysulfatnatrium afhænger af administrationsvejen.
English: Contents of the pack and other information What elmiron contains
Danish: Pakningsstørrelser og yderligere oplysninger elmiron indeholder:
English: Pentosan polysulfate sodium is a weak anticoagulant.
Danish: Pentosanpolysulfatnatrium er en svag antikoagulans.
English: EU/1/17/1189/001 90 hard capsules EU/1/17/1189/003 300 (3 bottles x 100) hard capsules
Danish: EU/1/17/1189/001 90 kapsler, hårde EU/1/17/1189/003 300 (3°beholdere°x°100) kapsler, hårde
English: All studies describe very low systemic availability of unchanged pentosan polysulfate sodium after oral administration.
Danish: Alle studier beskriver meget lav systemisk tilgængelighed af uomdannet pentosanpolysulfatnatrium efter oral administration.
English: Common: may affect up to 1 in 10 people
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 behandlede):
English: Comparison of those patients receiving pentosan polysulfate sodium with those not receiving pentosan polysulfate sodium (irrespective of treatment with oral hydroxyzine) revealed no statistically significant difference between the two group, but a trend for better efficacy was observed for the primary endpoint in those patients treated with pentosan polysulfate sodium (either alone or in combination with hydroxyzine) (20 of 59, 34%) compared to the those patients not receiving pentosan polysulfate sodium, but who might receive hydroxyzine (11 of 62, 18%, p0.064):
Danish: Sammenligning af de patienter, der fik pentosanpolysulfatnatrium, og de patienter, der ikke fik pentosanpolysulfatnatrium (uanset, om de samtidig fik oralt hydroxyzin), viste ingen statistisk signifikant forskel mellem de to grupper, men der sås en tendens til bedre virkning for det primære endepunkt hos de patienter, der blev behandlet med pentosanpolysulfatnatrium (enten alene eller i kombination med hydroxyzin) (20 ud af 59, 34 %) sammenholdt med dem, der ikke fik pentosanpolysulfatnatrium, men som muligvis fik hydroxyzin (11 ud af 62, 18 %; p = 0,064).
English: Animal studies with respect to reproductive toxicity were not conducted.
Danish: Der er ikke gennemført dyrestudier for at undersøge reproduktionstoksicitet.
English: The following two studies were conducted following very comparable double-blind, randomized, placebo-controlled multicentre study designs.
Danish: Nedenstående to studier havde næsten samme design, idet de begge var dobbeltblinde, randomiserede og placebokontrollerede multicenterstudier.
English: What you need to know before you take elmiron 3.
Danish: Det skal du vide, før du begynder at tage elmiron 3.
English: If you forget to take elmiron
Danish: Hvis du har glemt at tage elmiron
English: The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established.
Danish: Pentosanpolysulfatnatriums sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: • a blood clotting disorder or increased risks of bleeding, such as using a medicine that inhibits blood clotting
Danish: • hvis du har en forstyrrelse i blodets størkning eller øget risiko for blødning (f.eks. hvis du bruger et lægemiddel, der hæmmer blodets størkningsevne)
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron (especially after long term use).
Danish: Der er indberettet sjældne tilfælde af nethindelidelser (pigmentær makulopati) ved brug af elmiron (især efter lang tids brug).
English: About 6% of the administered dose of pentosan polysulfate sodium were excreted via urine after desulfation and depolymerisation.
Danish: Cirka 6 % af den administrerede dosis af pentosanpolysulfatnatrium udskilles via urinen efter desulfatering og depolymerisation.
English: Capsule content Microcrystalline cellulose Magnesium stearate
Danish: Kapselindhold Mikrokrystallinsk cellulose Magnesiumstearat
English: Uncommon Tinnitus
Danish: Ikke almindelig Tinnitus
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: • infections, flu
Danish: • infektioner, influenza
English: A study in healthy subjects revealed no pharmacokinetic or pharmacodynamic interactions between therapeutic doses of warfarin and pentosan polysulfate sodium.
Danish: Et studie hos raske forsøgspersoner viste ikke nogen farmakokinetiske eller farmakodynamiske interaktioner ved terapeutiske doser af warfarin og pentosanpolysulfatnatrium.
English: A statistically significant benefit of pentosan polysulfate sodium over placebo was demonstrated over the primary endpoint, the patients overall-assessment of improvement as well as on the investigators overall assessment.
Danish: En statistisk signifikant fordel ved pentosanpolysulfatnatrium over for placebo blev påvist for det primære endepunkt, patienternes samlede vurdering af forbedring, og for investigatorernes samlede vurdering.
English: There are no data from the use of pentosan polysulfate sodium in pregnant women.
Danish: Der er ingen data fra anvendelse af pentosanpolysulfatnatrium til gravide kvinder.
English: Bladder pain syndrome is a diagnosis of exclusion and other urologic disorders should be eliminated by the prescriber, such as urinary tract infection or bladder cancer.
Danish: Smertefuldt blæresyndrom er en udelukkelsesdiagnose, og den ordinerende læge skal udelukke andre urologiske lidelser som f.eks. urinvejsinfektion eller blærekræft.
English: The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily.
Danish: Den anbefalede dosis pentosanpolysulfatnatrium er 300 mg oralt dagligt administreret som en kapsel på 100 mg tre gange dagligt.
English: Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in patients who actively bleed.
Danish: På grund af pentosanpolysulfatnatriums svagt antikoagulerende virkning må elmiron ikke anvendes hos patienter med en aktuel blødning.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 behandlede):
English: Uncommon Dyspnoea
Danish: Ikke almindelig Dyspnø
English: Pentosan polysulfate sodium has not been specifically studied in special patient populations like elderly or patients with renal or hepatic impairment (see section 4.4).
Danish: Pentosanpolysulfatnatrium er ikke specifikt undersøgt hos særlige patientpopulationer som f.eks. ældre eller patienter med nedsat nyre- eller leverfunktion (se pkt.
English: elmiron 100 mg hard capsules
Danish: elmiron 100 mg hårde kapsler
English: • accumulation of fluid in arms or legs
Danish: • væskeophobning i arme og/eller ben
English: The fourth study was following a double-blind, double-dummy, multifactorial design and evaluated the effects of pentosan polysulfate sodium and hydroxyzine in one study.
Danish: Det fjerde studie havde et dobbeltblindt, multifaktorielt dobbelt-dummy-design og undersøgte virkningerne af pentosanpolysulfatnatrium og hydroxyzin i ét studie.
English: • severe mood swings or depression
Danish: • alvorlige humørsvingninger eller depression
English: Total daily urine volume (cc)
Danish: Samlet daglig urinmængde (ml)
English: All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with longterm use of PPS.
Danish: Alle patienter bør have regelmæssige oftalmiske undersøgelser med henblik på tidlig påvisning af pigmentær makulopati, især ved langtidsbrug af PPS. I sådanne situationer bør behandlingsophør overvejes.
English: Back pain Uncommon Myalgia, Arthralgia
Danish: Rygsmerter Ikke almindelig Myalgi, artralgi
English: In the case of an accidental overdose, patients should be evaluated for potential adverse effects of pentosan polysulfate sodium like gastrointestinal symptoms or bleeding.
Danish: I tilfælde af overdosering skal patienterne undersøges for eventuelle bivirkninger af pentosanpolysulfatnatrium som f.eks. gastrointestinale symptomer eller blødning.
English: Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use.
Danish: Sjældne tilfælde af pigmentær makulopati er blevet rapporteret ved brug af pentosanpolysulfatnatrium (PPS), og især efter lang tids brug.
English: Less than 10% of orally administered pentosan polysulfate sodium are slowly absorbed from the gastrointestinal tract and are available in systemic circulation in the form of unchanged pentosan polysulfate sodium or it's metabolites.
Danish: Mindre end 10 % af oralt administreret pentosanpolysulfatnatrium optages langsomt fra mave-tarmkanalen og er tilgængeligt i det systemiske kredsløb i form af uomdannet pentosanpolysulfatnatrium eller metabolitter deraf.
English: The hypothetic mechanism of action of pentosan polysulfate sodium includes a local effect in the bladder after systemic administration and excretion into the urine by binding of glycosaminoglycans to the deficient mucous of the bladder.
Danish: Pentosanpolysulfatnatriums formodede virkningsmekanisme omfatter en lokal effekt i blæren efter systemisk administration og udskillelse i urinen ved binding af glykosaminoglykaner til blærens beskadigede slimhinde.
English: Visual symptoms might include complaints of reading difficulty and slow adjustment to low or reduced light environments.
Danish: Visuelle symptomer kan omfatte læsebesvær og forlængelse af justering til dæmpet eller reduceret lys.
English: elmiron is used in adults to treat bladder pain syndrome characterised by many tiny bleeds or distinctive lesions on the bladder wall and moderate to severe pain and a frequent urge to urinate.
Danish: elmiron anvendes hos voksne til at behandle smertefuldt blæresyndrom, der er karakteriseret ved mange små blødninger eller karakteristiske skader (læsioner) på blærevæggen, moderate til kraftige smerter og hyppig trang til at lade vandet.
English: In case no improvement is reached 6 months after treatment initiation, treatment with pentosan polysulfate sodium should be stopped.
Danish: Hvis der ikke ses nogen bedring 6 måneder efter behandlingsstart, bør pentosanpolysulfatnatrium seponeres.
English: The most common adverse events reported from the clinical studies are headache, dizziness and gastro-intestinal events like diarrhoea, nausea, abdominal pain and rectal bleeding.
Danish: De hyppigste bivirkninger, der er rapporteret i kliniske studier, er hovedpine, svimmelhed og gastrointestinale bivirkninger som f.eks. diarré, kvalme, abdominalsmerter og rektalblødning.
English: For early detection of retinal disorders, eye examination will be performed regularly.
Danish: Øjenundersøgelse vil blive udført regelmæssigt for tidligt at kunne påvise nethindelidelser.
English: bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany
Danish: bene-Arzneimittel GmbH, PO Box 710269, 81452 München, Tyskland
English: Pentosan polysulfate sodium is metabolised extensively by desulfation in liver and spleen and depolymerisation in the kidney.
Danish: Pentosanpolysulfatnatrium metaboliseres i vid udstrækning ved desulfatering i leveren og milten og depolymerisation i nyrerne.
English: Furthermore a trend for better efficacy of pentosane polysulfate sodium was observed for the patients self-assessment of an improvement of pain and urgency, despite a deviating effect observed for the evaluation of urgency via the scale.
Danish: Desuden sås der en tendens til bedre virkning ved behandling med pentosanpolysulfatnatrium i patienternes egenvurdering af forbedring i smerter og vandladningstrang, selvom der blev observeret en afvigelse i vurderingen af vandladningstrang ved brug af skalaen.
English: Uncommon Lacrimation, amblyopia
Danish: Ikke almindelig Øget tåreflåd, amblyopi
English: What elmiron is and what it is used for elmiron is a medicine that contains the active substance pentosan polysulfate sodium.
Danish: Virkning og anvendelse elmiron er et lægemiddel, der indeholder det aktive stof pentosanpolysulfatnatrium.
English: No information on a potential impact of pentosane polysulfate sodium on fertility is available.
Danish: Der foreligger ingen oplysninger om en eventuel indvirkning af pentosanpolysulfatnatrium på fertilitet.
English: In addition the impact on pain and urgency was evaluated via a 5 score scale, where a responder was defined as a patient experiencing at least a 1-point improvement compared to baseline.
Danish: Derudover blev virkningen på smerter og imperiøs vandladning vurderet ved hjælp af en 5-punkts-skala, hvor en responder blev defineret som en patient, der oplevede en forbedring på minimum 1 point i forhold til baseline.
English: Marketing Authorisation Holder and Manufacturer bene-Arzneimittel GmbH Herterichstrasse 1-3
Danish: Indehaver af markedsføringstilladelsen og fremstiller bene-Arzneimittel GmbH Herterichstrasse 1-3
English: Uncommon Anorexia, weight gain, weight loss
Danish: Ikke almindelig Anoreksi, vægtstigning, vægttab
English: In all of these studies, patients reported a better subjective improvement of bladder pain syndrome under treatment with pentosan polysulfate sodium compared to placebo.
Danish: I alle studierne rapporterede patienterne en større subjektiv forbedring af smertefuldt blæresyndrom ved behandling med pentosanpolysulfatnatrium sammenholdt med placebo.
English: Pregnancy and breast-feeding elmiron is not recommended during pregnancy or breast-feeding.
Danish: Graviditet og amning elmiron anbefales ikke under graviditet eller amning.
English: Driving and using machines elmiron has no or negligible influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed elmiron påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: A patient was counted as a responder to treatment in case a 50% improvement compared to baseline was reported for a specific symptom after 3 months of treatment.
Danish: En patient blev anset som responder på behandlingen, hvis han/hun efter tre måneders behandling oplevede en forbedring af et specifikt symptom på 50 % i forhold til baseline.
English: A pooled analysis of the data described above from placebo-controlled clinical studies was conducted to evaluate, whether patients taking oral pentosane polysulfate sodium have clear benefit from the treatment.
Danish: En samlet analyse af de ovenfor beskrevne data fra placebokontrollerede kliniske studier blev gennemført for at vurdere, om patienter, der tager oralt pentosanpolysulfatnatrium, har en klar fordel ved behandlingen.
English: The impact on pain and urgency was evaluated via the same questionnaire as the primary endpoint with a responder defined as a patient experiencing an at least moderate (50%) improvement compared to baseline.
Danish: Virkningen på smerter og imperiøs vandladning blev evalueret ved hjælp af det samme spørgeskema som det primære endepunkt, og en responder blev defineret som en patient, der oplevede en som minimum moderat forbedring (50 %) i forhold til baseline.
English: Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.
Danish: Pentosanpolysulfatnatrium påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Hepatic or renal insufficiency elmiron has not been studied in patients with hepatic or renal insufficiency.
Danish: Lever- eller nyreinsufficiens elmiron er ikke undersøgt hos patienter med lever- eller nyreinsufficiens.
English: The second of the two very comparable studies enrolled 148 patients and demonstrated a statistically significant benefit pentosan polysulfate sodium over placebo was demonstrated on the patient reported overall improvement evaluated as primary endpoint and an the investigator-assessed overall improvement, all evaluations on pain and urgency.
Danish: I det andet af de to meget ens studier deltog 148 patienter, og der blev påvist en statistisk signifikant fordel ved pentosanpolysulfatnatrium over for placebo i forhold til den samlede patientvurderede forbedring af smerte og vandladningstrang, som var det primære endepunkt, og den samlede investigatorvurderede forbedring.
English: After first opening: use within 45 days.
Danish: Anvendes inden 45 dage efter anbrud.
English: Increase of ≥ 20 cc (% pts) Total daily urine volume (cc)
Danish: Stigning ≥ 20 ml (% af patienterne) Samlet daglig urinmængde (ml)
English: It is unknown whether pentosane polysulfate sodium or metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om pentosanpolysulfatnatrium/metabolitter udskilles i human mælk.
English: This pooled analysis showed that the percentage of patients responding to treatment with pentosan polysulfate sodium with a clinically relevant improvement in their overall assessment, pain and urgency was approximately 2-fold higher than the respective responder rates under placebo:
Danish: Den samlede analyse viste, at procentdelen af patienter, der responderede på behandlingen med pentosanpolysulfatnatrium med en klinisk relevant forbedring i deres samlede vurdering af smerter og vandladningstrang, var ca. 2 gange højere end de tilsvarende responderfrekvenser ved placebo.
English: • increased sweating, sleeplessness
Danish: • øget svedtendens, søvnløshed
English: Voids per day ns
Danish: Antal vandladninger pr. dag ns
English: Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to treatment with other medicinal products influencing coagulation such as anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal antiinflammatory medicinal products (see section 4.5)) should be evaluated for haemorrhagic events.
Danish: Patienter, der skal gennemgå en invasiv procedure, eller som har symptomer på underliggende koagulopati eller anden øget risiko for blødning (behandling med andre lægemidler, der indvirker på koagulationen, f.eks. antikoagulantia, heparinderivater, trombolytiske eller trombocytfunktionshæmmende lægemidler, herunder acetylsalicylsyre og andre nonsteroide antiinflammatoriske lægemidler (se pkt.
English: EU/1/17/1189/001 EU/1/17/1189/002
Danish: EU/1/17/1189/001 EU/1/17/1189/002 EU/1/17/1189/003
English: Other medicines and elmiron
Danish: Brug af anden medicin sammen med elmiron
English: Patients were randomized to four treatment group and were treated for six months with 3x100 mg pentosane polysulfate sodium, 1x50 mg hydroxyzine, both active treatments or placebo.
Danish: Patienterne blev randomiseret til fire behandlingsgrupper og fik 3 x 100 mg pentosanpolysulfatnatrium, 1 x 50 mg hydroxyzin, begge aktive stoffer eller placebo i seks måneder.
English: No. complete secondary end point data (%) Mean pain score ± SD (0-9) Mean urgency score ± SD (0-9) Mean 24-hr frequency ± SD Mean IC symptom index ± SD (0-20) Mean IC problem index ± SD (0-16) Mean Wisconsin IC score ± SD (0-42)
Danish: Gennemsnitligt IC-symptom-indeks ± SD (0-20) -2,6 ± 3,4 Gennemsnitligt IC-problem-indeks ± SD (0-16) Gennemsnitlig Wisconsin IC-score ± SD (0-42)
English: Increase of ≥ 20 cc (% pts)
Danish: Stigning ≥ 20 ml (% af patienterne)
English: An evaluation of all data generated in the study showed that for all four symptoms statistically significant more patients responded to pentosan polysulfate sodium treatment compared to placebo:
Danish: En vurdering af alle data fra studiet viste, at der for alle fire symptomer var statistisk signifikant flere patienter, som responderede på pentosanpolysulfatnatrium end på placebo.
English: EXP After first opening: use within 45 days.
Danish: EXP Anvendes inden 45 dage efter anbrud.
English: The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over design evaluating pentosan polysulfate sodium versus placebo.
Danish: Det første studie var et dobbeltblindt, randomiseret, placebokontrolleret studie med en planlagt overkrydsning til undersøgelse af pentosanpolysulfatnatrium over for placebo.
English: Therefore, pentosan polysulfate sodium should not be used during breast-feeding.
Danish: Pentosanpolysulfatnatrium bør derfor ikke anvendes under amning.
English: Responders based on patients self-evaluation of overall improvement Responders based on investigators evaluation of overall improvement Responders regarding pain and urgency Pain (moderate/50% improvement) Pain scale (1-point improvement) Pressure to urinate (moderate/50% improvement) Urgency scale (1-point improvement)
Danish: Respondere baseret på patienternes egenvurdering af samlet forbedring Respondere baseret på investigatorernes vurdering af samlet forbedring Respondere mht. smerter og vandladningstrang Smerter (moderat/op til 50 % forbedring) Smerteskala (1 points forbedring) Vandladningstrang (moderat/op til 50 % forbedring) Vandladningstrang (1 points forbedring)
English: The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity.
Danish: De bivirkninger, der blev rapporteret under behandling med pentosanpolysulfatnatrium, svarede til de bivirkninger, der blev rapporteret for placebo, hvad angår både art og antal.
English: Responders based on patients self-evaluation of overall improvement Responders based on investigators evaluation of overall improvement Responders regarding pain and urgency Pain (moderate/50% improvement) Pain scale (1-point improvement) Pressure to urinate (moderate/50% improvement) Responders regarding pain and urgency Improved sexual intercourse Changes from baseline voided volume Mean volume per void (cc)
Danish: Respondere baseret på patienternes egenvurdering af samlet forbedring Respondere baseret på investigatorernes vurdering af samlet forbedring Respondere mht. smerter og vandladningstrang Smerter (moderat/op til 50 % forbedring) Smerteskala (1 points forbedring) Vandladningstrang (moderat/op til 50 % forbedring) Respondere mht. smerter og vandladningstrang Forbedring af samleje Ændringer fra baseline i tømningsvolumen Middelvolumen pr. vandladning (ml)
English: Each carton contains 300 (3 bottles x 100) capsules.
Danish: Hver pakning indeholder 300°(3°beholdere°x°100) kapsler.
English: • breathing difficulties
Danish: • vejrtrækningsbesvær
English: A responder was defined as a patient assessed to be at least “good” compared to baseline.
Danish: En responder blev defineret som en patient med en som minimum god forbedring i forhold til baseline.