FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the weak anticoagulant effect of pentosan polpysulfate sodium, patients, who are concomitantly treated with anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal anti-inflammatory medicinal products should be evaluated for any haemorrhagic event in order to adapt the dose if needed (see section 4.4).
Danish: På grund af pentosanpolysulfatnatriums svagt antikoagulerende virkning bør patienter, der samtidig er i behandling med antikoagulantia, heparinderivater, trombolytiske eller trombocytfunktionshæmmende lægemidler, herunder acetylsalicylsyre og andre nonsteroide antiinflammatoriske lægemidler, evalueres for blødningshændelser for om nødvendigt at justere dosis (se pkt.
English: Increased sweating, insomnia, hyperkinesia, paraesthesia
Danish: Øget svedtendens, søvnløshed, hyperkinesi, paræstesi
English: After oral administration unabsorbed pentosan polysulfate sodium is excreted predominantly unchanged in the faeces.
Danish: Efter oral administration udskilles ikke-absorberet pentosanpolysulfatnatrium hovedsageligt uomdannet i fæces.
English: Pack size of 90 capsules.
Danish: Pakningsstørrelse: 90 kapsler.
English: Av. improvement* (*Mean ± SD)
Danish: Gennemsnitlig procentvis forbedring* (*Gennemsnitlig ± SD)
English: • loss of appetite, weight gain or loss
Danish: • appetitløshed, vægtstigning eller vægttab
English: Secondary outcome measures included the O'Leary-Sant IC Symptom and Problem Index, the University of Wisconsin Symptom score, patient reported symptoms of pain/discomfort and urgency, and results of a 24-hour voiding diary.
Danish: Sekundære resultatmål omfattede O'Leary-Sant IC Symptom and Problem Index, University of Wisconsin Symptom score,
English: Depending on which institution the patients attended they were treated with either 3x100 mg or 2x200 mg PPS per day.
Danish: Afhængigt af hvilken klinik patienterne blev behandlet på, fik de enten 3 x 100 mg eller 2 x 200 mg pentosanpolysulfatnatrium pr. dag.
English: Because there is evidence of hepatic and renal contribution to the elimination of pentosan polysulfate sodium, hepatic or renal impairment may have an impact on the pharmacokinetics of pentosan polysulfate sodium.
Danish: Da der er evidens for, at nyrerne og leveren medvirker til elimination af pentosanpolysulfatnatrium, kan lever- eller nyreinsufficiens have en indvirkning på pentosanpolysulfatnatriums farmakokinetik.
English: 300 (3x100) hard capsules
Danish: 300 (3°x°100) kapsler, hårde
English: What you need to know before you take elmiron Do not take elmiron if you are
Danish: Det skal du vide, før du begynder at tage elmiron Tag ikke elmiron:
English: • The active substance is pentosan polysulfate sodium.
Danish: • Aktivt stof: pentosanpolysulfatnatrium.
English: Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium.
Danish: Patienter med relevant lever- eller nyreinsufficiens bør overvåges nøje under behandling med pentosanpolysulfatnatrium.
English: Stop taking elmiron if side effects occur, until they disappear.
Danish: Hvis du oplever bivirkninger, skal du holde op med at tage elmiron, indtil de er forsvundet igen.
English: Package leaflet: Information for the patient elmiron 100 mg hard capsules pentosan polysulfate sodium
Danish: Indlægsseddel: Information til patienten elmiron 100 mg hårde kapsler pentosanpolysulfatnatrium
English: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Danish: Anæmi, ekkymose, blødning, leukopeni, trombocytopeni
English: Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
Danish: Patienter, der tidligere har haft heparin- eller pentosanpolysulfatnatriuminduceret trombocytopeni, bør overvåges nøje under behandlingen med pentosanpolysulfatnatrium.
English: • joint or muscle pain
Danish: • led- eller muskelsmerter
English: A total of four randomised placebo-controlled, double-blind clinical studies prospectively enrolling patients with bladder pain syndrome diagnosed via cystoscopic examination with or without bladder hydrodistension evaluating the efficacy of oral treatment with pentosan polysulfate sodium were published in scientific literature.
Danish: Der er i litteraturen beskrevet i alt fire randomiserede, placebokontrollerede, dobbeltblinde kliniske studier, der prospektivt inkluderede patienter med smertefuldt blæresyndrom diagnosticeret ved cystoskopi med eller uden blære-hydrodistension, og som undersøgte virkningen af behandling med oralt pentosanpolysulfatnatrium.
English: The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium.
Danish: I nedenstående afsnit anføres de bivirkninger, der er beskrevet i litteraturen efter kliniske studier med pentosanpolysulfatnatrium.
English: In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained.
Danish: Hos de patienter, der responderer på behandlingen, bør behandlingen fortsættes kronisk, så længe responsen fastholdes.
English: In case of adverse reactions, treatment might be paused until the symptoms abate and treatment should be continued at the recommended dose after a critical balancing of the risks thereafter.
Danish: Behandlingen bør genoptages ved den anbefalede dosis efter en kritisk vurdering af risici.
English: administration, the apparent plasma half-life after oral administration is in the range of 24-34 hours.
Danish: Mens pentosanpolysulfatnatrium hurtigt fjernes fra cirkulationen efter intravenøs indgift, er den tilsyneladende plasma-halveringstid efter oral administration 24-34 timer.
English: HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
Danish: HDPE-beholder med et forseglet og børnesikret PP-låg med 100 kapsler.
English: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Danish: Kvalme, diarré, dyspepsi, abdominalsmerter, udspilet abdomen, rektalblødning
English: Efficacy of treatment was evaluated based on the patient reported improvement on four typical symptoms of bladder pain syndrome: pain, urgency, frequency, and nocturia, no primary endpoint was defined.
Danish: Virkningen af behandlingen blev vurderet på grundlag af patientrapporteret forbedring af fire typiske symptomer på smertefuldt blæresyndrom: smerte, imperiøs vandladning, øget vandladningshyppighed og nykturi.
English: Peripheral oedema, alopecia Uncommon Rash, increased mole size
Danish: Perifert ødem, alopeci Ikke almindelig Udslæt, voksende modermærker
English: In healthy volunteers, a single parenteral administration of radioactively labelled pentosan polysulfate sodium leads to a progressive up-take of total radioactivity by the liver, spleen, and kidney (50 min after 1 mg/kg i.v.
Danish: Hos raske frivillige forsøgspersoner resulterede en enkelt parenteral administration af radioaktivt mærket pentosanpolysulfatnatrium i en progressiv optagelse af al radioaktivitet i lever, milt og nyrer (50 min. efter 1 mg/kg intravenøst: 60 % af dosen i leveren, 7,7 % i milten; 3 timer efter administration: 60 % i leveren + milten og 13 % i blæren).
English: A trend for better efficacy under pentosan polysulfate sodium was observed for improved sexual intercourse:
Danish: Der sås en tendens til bedre virkning ved pentosanpolysulfatnatrium, hvad angår forbedring af samleje.
English: HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
Danish: HDPE-beholder med et forseglet og børnesikret PP-låg med 90 kapsler.
English: The patients in both studies were treated for three months with either 3x100 mg pentosan polysulfate sodium or placebo.
Danish: I begge studier fik patienterne enten 3 x 100 mg pentosanpolysulfatnatrium eller placebo i tre måneder.
English: No. responders / total (%) Av. % improvement* Urgency
Danish: Antal respondere/totalt (%) Gennemsnitlig procentvis forbedring*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BLISTRE
English: 90 hard capsules 3 bottles
Danish: 90 kapsler, hårde 3°beholdere
English: Immune system disorder
Danish: Immunsystemet
English: How to take elmiron
Danish: Sådan skal du tage elmiron
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: FARMAKOLOGISKE EGENSKABER 5.1.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1.
English: elmiron 100 mg hard capsules pentosan polysulfate sodium
Danish: elmiron 100 mg, hårde kapsler pentosanpolysulfatnatrium
English: • reduced liver or kidney function
Danish: • hvis du har nedsat lever- eller nyrefunktion.
English: 90 hard capsules 100 hard capsules
Danish: 90 kapsler, hårde 100 kapsler, hårde
English: Pack size of 300 (3 bottles x 100) capsules.
Danish: Pakningsstørrelse: 300°(3°beholdere°x°100) kapsler.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner's lesions in adults with moderate to severe pain, urgency and frequency of micturition (see section 4.4).
Danish: Terapeutiske indikationer elmiron er indiceret til behandling af smertefuldt blæresyndrom hos voksne, karakteriseret ved enten glomerulationer eller Hunners læsioner, moderate til svære smerter, imperiøs vandladning og øget vandladningshyppighed (se pkt.
English: • abnormal liver function
Danish: Unormale leverfunktionstest
English: 90 hard capsules
Danish: 90 kapsler, hårde
English: It is hypothesized, that a potential barrier function of pentosan polysulfate sodium instead of the damaged urothelial mucus might play a role as well the antiinflammatory activity of pentosan polysulfate sodium.
Danish: Det antages, at der ud over pentosanpolysulfatnatriums antiinflammatoriske aktivitet kan være tale om en potentiel barrierefunktion i forhold til den beskadigede uroteliale slimhinde.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BEHOLDER
English: No. responders (%)
Danish: Antal randomiserede patienter Antal respondere (%)
English: • to undergo surgery
Danish: • hvis du skal opereres
English: • abnormal sensation such as prickling, tingling and itchiness
Danish: • unormal prikkende eller stikkende fornemmelse i huden og kløe
English: • nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
Danish: • kvalme, fordøjelsesbesvær, diarré, mavesmerter, udspilet mave
English: For storage conditions after first opening of the bottle, see section 6.3.
Danish: Opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: • blood clotting disorders
Danish: • blødning fra endetarmen
English: Each capsule contains 100 mg of pentosan polysulfate sodium.
Danish: Hver kapsel indeholder 100 mg pentosanpolysulfatnatrium.
English: • weakness, pelvic (lower abdomen) pain
Danish: • tåreflåd, synsnedsættelse (dovne øjne − amblyopi)
English: D-81479 Munich tel: ++49 (0) 89 / 7 49 87-0 fax: ++49 (0) 89 / 7 49 87-142 e-mail: contact@bene-arzneimittel.de
Danish: D-81479 München Tlf.: +49 (0) 89 / 7 49 87-0
English: • skin rash, increased mole size
Danish: • hududslæt, voksende modermærker
English: One hard capsule contains 100 mg pentosan polysulfate sodium.
Danish: En hård kapsel indeholder 100 mg pentosanpolysulfatnatrium.
English: If you take more elmiron than you should
Danish: Hvis du har taget for meget elmiron
English: Each hard capsule contains 100 mg of pentosan polysulfate sodium.
Danish: Hver hård kapsel indeholder 100 mg pentosanpolysulfatnatrium.
English: • headache, back pain
Danish: • hovedpine, rygsmerter
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene-arzneimittel.de
Danish: D-81479 München Tlf.: +49 (0)89 749870
English: Posology
Danish: Nykturi
English: Changes from baseline voiding characteristics Mean volume per void (cc)
Danish: Ændringer fra baseline i vandladningskarakteristika
English: No. randomized
Danish: Nyrer og urinveje
English: No. responders / total (%) Av. % improvement* Frequency
Danish: Vandladningshyppighed Antal respondere/totalt (%) Gennemsnitlig procentvis forbedring
English: • mouth ulcer
Danish: • mundsår
English: 6.6 Special precautions for disposal
Danish: Regler for bortskaffelse
English: • indigestion, vomiting, wind, difficultiy passing stools
Danish: • fordøjelsesbesvær, opkastning, luft i maven, afføringsbesvær
English: Name and address of the manufacturer responsible for batch release bene-Arzneimittel GmbH Herterichstr.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse bene-Arzneimittel GmbH Herterichstrasse 1 - 3 81479 München Tyskland
English: The effect of pentosan polysulfate sodium on reproductive and developmental toxicity has not been investigated.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet.
English: Indigestion, vomiting, mouth ulcer, flatulence, constipation
Danish: Fordøjelsesbesvær, opkastning, mundsår, luft i maven, forstoppelse
English: Urinary frequency
Danish: Øget vandladningshyppighed
English: This applies to both men and women.
Danish: Dette gælder både mænd og kvinder.
English: Longer periods of monitoring may be required.
Danish: Længere overvågningsperioder kan være påkrævet.
English: After 18 months
Danish: Efter 18 måneder
English: (listed in section 6).
Danish: (angivet i punkt 6).
English: There were no deaths reported in the study.
Danish: Der blev ikke rapporteret om dødsfald i studiet.
English: Number of events / patient/ year
Danish: Antal hændelser/patient/år
English: Bioavailability is complete or nearly complete in cancer patients.
Danish: Biotilgængeligheden er komplet eller næsten komplet hos kræftpatienter.
English: Results of this study are presented in Tables 2 and 3 below.
Danish: Resultaterne af dette studie er vist i tabel 2 og 3 nedenfor.
English: These disorders are also associated with the underlying disease.
Danish: Disse forstyrrelser er også forbundet med den underliggende sygdom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1366/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1366/001
English: Furthermore, findings from these pivotal studies are supported by observational studies including some long-term follow up.
Danish: Desuden understøttes fundene fra disse pivotale studier af observationsstudier, hvoraf nogle omfattede langvarig opfølgning.
English: Parvovirus B19 infection
Danish: Parvovirus B19-infektion
English: This can cause acute pain crises and organ damage.
Danish: Det kan give akutte smertefulde kriser og organskade.
English: After first opening: 12 weeks.
Danish: Efter første åbning: 12 uger.
English: The non-inferiority margin was 15 cm/s.
Danish: Noninferioritetsmarginen var 15 cm/s.
English: At the first scheduled interim analysis, non-inferiority was shown and the sponsor terminated the study.
Danish: Ved den første planlagte interimanalyse sås noninferioritet, og sponsoren standsede studiet.
English: You can take this medicine with or after meals at any time of the day.
Danish: Du kan tage denne medicin sammen med mad eller efter et måltid når som helst på dagen.
English: Please contact your doctor immediately if you think you may be pregnant.
Danish: Kontakt lægen med det samme, hvis du tror, du er gravid.
English: Xromi may be taken with or after meals at any time of the day but patients should standardise the method of administration and time of day.
Danish: Xromi kan tages sammen med eller efter måltider når som helst på dagen, men den enkelte patient bør standardisere administrationsmetoden og -tidspunktet.
English: If necessary, blood should be transfused.
Danish: Der bør om nødvendigt foretages blodtransfusion.
English: In adults without swallowing difficulties, solid oral formulations may be more appropriate and convenient.
Danish: Hos voksne patienter, der ikke har svært ved at synke, kan en fast oral formulering være mere hensigtsmæssig og bekvem.
English: - Depending on the dose you take, these tests may be performed initially every two weeks and then every 2-3 months.
Danish: - Alt efter din dosis vil disse prøver indledningsvis blive taget hver anden uge og derefter hver 2.
English: Xromi with food and drink
Danish: Brug af Xromi sammen med mad og drikke
English: Remove the syringe from your mouth.
Danish: Tag sprøjten ud af munden.
English: Live vaccines are not recommended in immunosuppressed patients.
Danish: Levende vacciner anbefales ikke hos immunsupprimerede patienter.
English: Your doctor will also inspect your skin during routine follow-up visits.
Danish: Lægen vil også undersøge din hud ved de rutinemæssige opfølgningsbesøg.
English: Do not give this medicine to children from birth to 2 years of age because it is unlikely to be safe.
Danish: Dette lægemiddel må ikke anvendes til børn i alderen 0-2 år, da det formodentlig ikke vil være sikkert.
English: Open date: __________
Danish: Åbningsdato: __________
English: The primary outcome measure of the study was the number and duration of hospitalisations.
Danish: Det primære mål for virkning i studiet var antallet og varigheden af indlæggelser.
English: Results are presented in Table 4.
Danish: Resultaterne er vist i tabel 4.
English: The primary outcome was the decrease in the frequency of vasoocclusive crises per patient per year.
Danish: Det primære endepunkt var faldet i hyppigheden af vasookklusive kriser pr. patient årligt.
English: Xromi must not be used during pregnancy.
Danish: Xromi må ikke anvendes under graviditet.
English: There is also a serious risk of leukaemia and in the elderly, skin cancer, although the frequency is not known.
Danish: Der er også en alvorlig risiko for leukæmi og, hos ældre, for hudkræft, om end hyppigheden ikke kendes.
English: Other side effects which are not mentioned above are listed below.
Danish: Andre mulige bivirkninger end de ovenfor nævnte er anført nedenfor.
English: If you have kidney disease
Danish: Hvis du har en nyresygdom
English: Leukaemia, skin cancers (in elderly patients)
Danish: Leukæmi, hudkræft (hos ældre patienter)
English: There was no difference in life-threatening neurological events between the treatment groups.
Danish: Der sås ingen forskel mellem behandlingsgrupperne, hvad angår livstruende neurologiske hændelser.
English: The dose was increased to 25 mg/kg per day if change in HbF was <2% after 2 months.
Danish: Dosen blev øget til 25 mg/kg dagligt, hvis ændringen i HbF var < 2 % efter 2 måneder.
English: - After first opening of the bottle, discard any unused contents after 12 weeks.
Danish: - Efter første åbning af flasken skal ikke-anvendt produkt kasseres efter 12 uger.
English: Your doctor may need to give you a lower dose.
Danish: Lægen vil muligvis give dig en lavere dosis.
English: Fertility in males might be affected by treatment.
Danish: Fertiliteten hos mænd kan blive påvirket af behandlingen.
English: Xromi is for oral use.
Danish: Xromi er til oral anvendelse.
English: Open date: ______
Danish: Åbningsdato: ______
English: Peak plasma concentrations are reached within 2 hours and by 24 hours the serum concentrations are virtually zero.
Danish: Den maksimale plasmakoncentration nås i løbet af 2 timer, og efter 24 timer er serumkoncentrationen så godt som nul.
English: Sometimes the doctor may change your dose of Xromi, for example as a result of different tests.
Danish: Nogle gange kan lægen ændre din dosis af Xromi, eksempelvis på baggrund af forskellige testresultater.
English: Suite 2, Stafford House Strand Road Portmarnock Co. Dublin
Danish: MIAS Pharma Limited Suite 2, Stafford House Strand Road Portmarnock Co. Dublin
English: Therefore it must not be administered to patients who are pregnant.
Danish: Det må derfor ikke gives til gravide patienter.
English: HIV patients
Danish: Hiv-patienter
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet (se punkt 5.3).
English: If dose escalation is warranted based on clinical and laboratory findings, the following steps should be taken:
Danish: Hvis dosiseskalering vurderes relevant baseret på kliniske fund og laboratorieresultater, bør følgende fremgangsmåde følges:
English: Bone marrow depression including neutropenia, reticulocytopenia, macrocytosis
Danish: Knoglemarvsdepression, herunder neutropeni, retikulocytopeni, makrocytose
English: Non-inferiority (p = 8.82×10-16) and post-hoc superiority (p = 0.023) were met.
Danish: Noninferioritet (p = 8,82 x 10-16) og post hoc superioritet (p = 0,023) blev opnået.
English: Patients should be advised to protect skin from sun exposure.
Danish: Patienterne bør oplyses om, at de skal beskytte huden mod sollys.
English: Not significant
Danish: Ikke signifikant
English: The patient should be instructed to immediately contact a doctor in case of suspected pregnancy.
Danish: Patienterne skal oplyses om, at de straks skal kontakte lægen ved formodet graviditet.
English: Oligospermia, azoospermia
Danish: Oligospermi, azoospermi
English: Xromi will decrease the number of painful crises as well as the need for hospitalisation as a result of the disease.
Danish: Xromi vil nedsætte antallet af smertefulde kriser og behovet for indlæggelse i forbindelse med sygdommen.
English: There is an increased risk of severe or fatal infections with the concomitant use of live vaccines.
Danish: Der er øget risiko for svære og letale infektioner ved samtidig anvendelse af levende vacciner.
English: This possibility should be carefully considered before administering this medicinal product to male or female patients who may contemplate conception.
Danish: Der bør tages nøje hensyn til dette forhold, før lægemidlet administreres til mandlige eller kvindelige patienter, der overvejer at få børn.
English: Syringes should be rinsed and washed with cold or warm water and dried completely before the next use.
Danish: Sprøjterne skal skylles og rengøres med koldt eller varmt vand og tørres helt inden næste anvendelse.
English: Continuous follow-up of the growth of treated children and adolescents is recommended.
Danish: Væksten hos behandlede børn og unge bør overvåges kontinuerligt.
English: • Increases in dose to be continued until mild myelosuppression (absolute neutrophil count
Danish: • Dosen bør fortsat øges, indtil der opnås mild myelosuppression (absolut neutrofiltal på 2.000
English: The primary objective of this study was to examine if hydroxycarbamide could maintain TCD velocities after an initial period of transfusions as effectively as chronic blood transfusions.
Danish: Studiets primære formål var at undersøge, om hydroxycarbamid kunne opretholde TCD-hastigheden, efter en indledende periode med transfusioner, lige så effektivt som kroniske blodtransfusioner.
English: Speak to your doctor if you are concerned by any of these side effects.
Danish: Tal med lægen, hvis du er bekymret over en bivirkning.
English: Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-gp.
Danish: Der forventes således ingen interaktion ved samtidig administration af stoffer, der er substrater for cytokrom P450-systemet eller P-gp.
English: Secondary leukaemia and skin cancer
Danish: Sekundær leukæmi og hudkræft
English: Pull the plunger back to the point on the scale that corresponds to the dose prescribed (figure 4).
Danish: Træk stemplet tilbage til det punkt på skalaen, der svarer til den ordinerede dosis (figur 4).
English: Thrombocytopenia and anaemia occur less often and are seldom seen without a preceding leukopenia.
Danish: Trombocytopeni og anæmi optræder mindre ofte og ses sjældent uden forudgående leukopeni.
English: The maximum dose is 35 mg/kg/day.
Danish: Den maksimale dosis er 35 mg/kg/dag.