FrancophonIA/ELRC3.0 huggingface dataset:
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):
Maltese: It-tqabbil ta' dawk il-pazjenti li jirċievu pentosan polysulfate sodium ma' dawk li ma jirċivux pentosan polysulfate sodium (irrispettivament mill-kura b'idrossiżina orali) ma wera l-ebda differenza statistikament sinifikanti bejn iż-żewġ gruppi, iżda ġiet osservata tendenza għal effikaċja aħjar għall-punt aħħari primarju f'dawk il-pazjenti kkurati b'pentosan polysulfate sodium (jew waħdu jew flimkien ma' idrossiżina) (20 minn 59, 34 %) meta mqabbel ma' dawk il-pazjenti li ma jirċivux pentosan polysulfate sodium, iżda li jistgħu jirċievu idrossiżina (11 minn 62, 18 %, p0.
English: EU/1/17/1189/001 90 hard capsules EU/1/17/1189/003 300 (3 bottles x 100) hard capsules
Maltese: EU/1/17/1189/003 300 (3 fliexken x 100) kapsula iebsa
English: Tel.: +49 (0)951 6043-0, info@dr-pfleger.de
Maltese: +49 (0)951 6043-0, info@dr-pfleger.de
English: Pentosan polysulfate sodium is a weak anticoagulant.
Maltese: Pentosan polysulfate sodium huwa antikoagulant dgħajjef.
English: Increase of ≥ 20 cc (% pts) Total daily urine volume (cc)
Maltese: Żieda ta' ≥ 20 cc (% pti) Volum totali ta' awrina kuljum (cc)
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.
Maltese: Il-pazjenti ġew randomizzati għal erba' gruppi ta' kura u ġew ikkurati għal sitt xhur b'3x100 mg pentosan polysulfate sodium, 1x50 mg idrossiżina, iż-żewġ kuri attivi jew bil-plaċebo.
English: Marketing Authorisation Holder and Manufacturer bene-Arzneimittel GmbH Herterichstrasse 1-3
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur bene-Arzneimittel GmbH Herterichstrasse 1-3
English: Tel.: +43 (0) 1 330 06 71-0, mail@sigmapharm.at
Maltese: 1 330 06 71-0, mail@sigmapharm.at
English: Each carton contains 300 (3 bottles x 100) capsules.
Maltese: Kull kartuna fiha 300 (3 fliexken x 100) kapsula.
English: Other medicines and elmiron
Maltese: Mediċini oħra u elmiron
English: Pack size of 300 (3 bottles x 100) capsules.
Maltese: Daqs tal-pakkett ta' 300 (3 fliexken x 100) kapsula.
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)
Maltese: Nru. randomizzati Nru. ta' dawk li rrispondew (%) Nru. ta' data sħiħa ta' punt aħħari sekondarju (%) Punteġġ medju tal-uġigħ ± SD (0-9) Punteġġ medju tal-urġenza ± SD (0-9) Frekwenza medja ta' 24h ± SD Indiċi medju ta' sintomi
English: Each carton contains 90 capsules.
Maltese: Kull kartuna fiha 90 kapsula.
English: Asthenia, pelvic pain
Maltese: Astenija, uġigħ fil-pelvi
English: Name and address of the manufacturer responsible for batch release bene-Arzneimittel GmbH Herterichstr.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott bene-Arzneimittel GmbH Herterichstr.
English: Overall, the reported systemic bioavailability after oral administration of pentosan polysulfate sodium is below 1%.
Maltese: B'mod globali, il-bijodisponibilità sistemika rrappurtata wara għoti orali ta' pentosan polysulfate sodium hija taħt 1 %.
English: 3 voids less per day (% pts)
Maltese: 3 tbattil inqas kull jum (% pti)
English: The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium.
Maltese: Is-sezzjoni li jmiss telenka avvenimenti avversi rrappurtati mil-letteratura minn studji kliniċi b'pentosan polysulfate sodium.
English: Adverse events are listed below by MedDRA body system organ class and by frequency.
Maltese: L-avvenimenti avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi ta' MedDRA u skont il-frekwenza.
English: • dizziness
Maltese: • aġitazzjoni
English: D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene-arzneimittel.de
Maltese: +49 (0) 89 749870 fax: +49 (0) 89 74987142 e-mail: contact@bene-arzneimittel.de
English: 90 hard capsules
Maltese: 100 kapsula iebsa
English: Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron (especially after long term use).
Maltese: Każijiet rari ta' disturbi fir-retina (makulopatija pigmentarja) ġew irrappurtati bl-użu ta' elmiron (speċjalment wara użu fit-tul).
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.
Maltese: Inqas minn 10 % ta' pentosan polysulfate sodium mogħti oralment jiġi assorbit bil-mod mill-apparat gastrointestinali u huwa disponibbli f'ċirkolazzjoni sistemika fil-forma ta' pentosan polysulfate sodium mhux mibdul jew tal-metaboliti tiegħu.
English: The patients were asked whether they felt improved overall since the start of treatment, and if so, whether the improvement was “slight” 25%, “moderate “50%, “great” 75% or “complete cure” 100%.
Maltese: Il-pazjenti ngħataw ilmistoqsija jekk ħassewhomx li titjiebu b'mod globali mill-bidu tal-kura, u jekk hu hekk, jekk it-titjib kienx “ftit” 25%, “moderat” “50 %, “kbir” 75 % jew “kura sħiħa” 100 %.
English: • blister
Maltese: • sturdament
English: Accordingly, oral administration of pentosan polysulfate sodium 3-times daily is expected to lead to accumulation of pentosan polysulfate sodium over the first 7 days of administration (accumulation factor 5-6.7).
Maltese: B'mod xieraq, għoti orali ta' pentosan polysulfate sodium 3 darbiet kuljum huwa mistenni li jwassal għal akkumulazzjoni ta' pentosan polysulfate sodium matul l-ewwel 7 ijiem tal-għoti (fattur ta' akkumulazzjoni 5-6.7).
English: Increased sweating, insomnia, hyperkinesia, paraesthesia
Maltese: Żieda fl-għaraq, insomnja, iperkinesija, parasteżija
English: White opaque capsules size 2.
Maltese: Kapsuli bojod opaki ta' daqs 2.
English: Uncommon Lacrimation, amblyopia
Maltese: Mhux komuni Lakrimazzjoni, amblijopija
English: The hard capsules are white and non-transparent, provided in a plastic bottle with child resistant closure or plastic/aluminium blisters, packed in a carton.
Maltese: Il-kapsuli iebsa huma bojod u mhux trasparenti, li jiġu pprovduti fi flixkun tal-plastik b'għeluq reżistenti għat-tfal jew f'folji tal-plastik/aluminju, ippakkjati f'kartuna.
English: 5.2 Pharmacokinetic properties
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
English: Date of first authorisation: 2 June 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 02 ta' Ġunju 2017
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1.
English: Peripheral oedema, alopecia Uncommon Rash, increased mole size
Maltese: Edema periferika, alopeċja ta' taħt il-ġilda
English: Patients who reported at least moderate (50%) improvement were counted as responders.
Maltese: Il-pazjenti li rrappurtaw talinqas titjib moderat (50 %) ingħaddew bħala dawk li rrispondew.
English: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Maltese: Nawsja, dijarea, dispepsja, uġigħ addominali, tkabbir tal-addome, emorraġija tar-rektum
English: elmiron 100 mg hard capsules
Maltese: IL-PRODOTT MEDIĊINALI elmiron 100 mg kapsuli iebsa
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja għallMediċini http://www.ema.europa.eu.
English: Pack size of 90 capsules.
Maltese: Daqs tal-pakkett ta' 90 kapsula.
English: The secondary efficacy endpoints included the investigators evaluation of improvement.
Maltese: Il-punti aħħarija tal-effikaċja sekondarji kienu jinkludu l-evalwazzjoni tal-investigaturi ta' titjib.
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.
Maltese: Il-pazjenti li jkunu għaddejjin minn proċeduri invażivi jew li jkollhom sinjali/sintomi ta' koagulopatija sottostanti jew riskju miżjud ieħor ta' fsada (minħabba kura ma' prodotti mediċinali oħra li jinfluwenzaw il-koagulazzjoni bħal antikoagulanti, derivattivi tal-eparina, aġenti trombolitiċi jew kontra l-pjastrini inkluż aċidu aċetilsaliċiliku, jew prodotti mediċinali antiinfjammatorji mhux sterojdi (ara sezzjoni 4.5)) għandhom jiġu evalwati għal avvenimenti ta' emorraġija.
English: / Τηλ / Sími / Tel.: +49 (0)89 749870, contact@bene-arzneimittel.de
Maltese: +49 (0)89 749870, contact@bene-arzneimittel.de
English: The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over design evaluating pentosan polysulfate sodium versus placebo.
Maltese: L-ewwel studju kien studju double-blind, randomizzat, ikkontrollat bil-plaċebo bi tfassil ta' qlib ippjanat li jevalwa pentosan polysulfate sodium kontra l-plaċebo.
English: Indigestion, vomiting, mouth ulcer, flatulence, constipation
Maltese: Indiġestjoni, remettar, ulċeri fil-ħalq, flatulenza, stitikezza
English: • skin rash, increased mole size
Maltese: • raxx tal-ġilda, żieda fid-daqs tal-felul
English: A study in healthy subjects revealed no pharmacokinetic or pharmacodynamic interactions between therapeutic doses of warfarin and pentosan polysulfate sodium.
Maltese: Studju f'individwi b'saħħithom ma wera l-ebda interazzjoni farmakokinetika jew farmakodinmaika bejn dożi terapewtiċi ta' warfarina u pentosan polysulfate sodium.
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).
Maltese: Pentosan polysulfate sodium ma ġiex studjat speċifikament f'popolazzjonijiet tal-pazjenti speċjali bħal anzjani jew pazjenti b'indeboliment tal-kliewi jew tal-fwied (ara sezzjoni 4.4).
English: PC: {number} SN: {number} NN: {number}
Maltese: • telf ta' xagħar
English: Pain
Maltese: FOLJA
English: The following two studies were conducted following very comparable double-blind, randomized, placebo-controlled multicentre study designs.
Maltese: Iż-żewġ studji li ġejjin twettqu wara tfassil ta' studju kumparabbli ħafna, double-blind, randomizzat, ikkontrollat bil-plaċebo, multiċentriku.
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
Maltese: D-81479 Munich telefon: ++49 (0) 89 / 7 49 87-0
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.
Maltese: L-avvenimenti avversi l-aktar komuni rrappurtati mill-istudji kliniċi huma uġigħ ta' ras, sturdament u avvenimenti gastrointestinali bħal dijareja, nawsja, uġigħ ta' żaqq u fsada ġor-rektum.
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).
Maltese: Minħabba l-effett antikoagulanti baxx ta' pentosan polysulfate sodium, il-pazjenti li jiġu kkurati flistess ħin b'antikoagulanti, derivattivi tal-eparina, aġenti trombolitiċi jew kontra l-pjastrini inkluż aċidu aċetilsaliċiliku, jew prodotti mediċinali antiinfjammatorji mhux sterojdi għandhom jiġu evalwati għal kwalunkwe avveniment ta' emorraġija sabiex jekk ikun meħtieġ, id-doża tiġi adattata (ara sezzjoni 4.4).
English: About 6% of the administered dose of pentosan polysulfate sodium were excreted via urine after desulfation and depolymerisation.
Maltese: Madwar 6 % tad-doża mogħtija ta' pentosan polysulfate sodium ġiet eliminata permezz tal-awrina wara desulfation u depolimerizzazzjoni.
English: bene-Arzneimittel GmbH
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ bene-Arzneimittel GmbH
English: How to store elmiron
Maltese: Tiħux elmiron:
English: Tel: +44 (0)20 3751 1888, infouk@consilienthealth.com
Maltese: 3751 1888, infouk@consilienthealth.com
English: • abnormal sensation such as prickling, tingling and itchiness
Maltese: • sensazzjoni anormali bħal tingiż, tnemnim u ħakk
English: This leaflet was last revised in <{MM/YYYY}>.
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: Blister 21 months
Maltese: 21 xahar
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.
Maltese: Fil-letteratura xjentifika b'kollox ġew ippubblikati erba' studji kliniċi randomizzati, ikkontrollati bi plaċebo, double-blind li rreġistraw pazjenti b'sindrome ta' uġigħ fil-bużżieqa tal-awrina dijanjostikat permezz ta' eżami ċistoskopiku b'idrodistensjoni tal-bużżieqa tal-awrina jew mingħajrha li evalwaw leffikaċja ta' kura orali b'pentosan polysulfate sodium.
English: What you need to know before you take elmiron 3.
Maltese: X'għandek tkun taf qabel ma tieħu elmiron 3.
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.
Maltese: Benefiċċju sinfikanti statistikament ta' pentosan polysulfate sodium fuq il-plaċebo ntwera fil-punt aħħari primarju, fil-valutazzjoni globali tal-pazjenti ta' titjib kif ukoll fil-valutazzjoni globali talinevstigaturi.
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.
Maltese: L-effikaċja tal-kura ġiet evalwata abbażi ta' titjib irrappurtat mill-pazjent dwar erba' sintomi tipiċi ta' sindrome ta' uġigħ fil-bużżieqa tal-awrina: uġigħ, urġenza, frekwenza, u nokturja, l-ebda punt aħħari ma ġie definit.
English: • bottle
Maltese: • flixkun
English: • nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
Maltese: • nawsja, indiġestjoni, dijarea, uġigħ addominali, tkabbir tal-addome
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.
Maltese: It-tieni studju miż-żewġ studji kumparabbli ħafna rreġistra 148 pazjent u wera benefiċċju statistikament sinfikanti ta' pentosan polysulfate sodium fuq il-plaċebo u dan intwera fuq it-titjib globali rrappurtat mill-pazjent evalwat bħala punt aħħari primarju u fuq it-titjib globali vvalutat minn investigatur, l-evalwazzjonijiet kollha dwar l-uġigħ u l-urġenza.
English: Pentosan polysulfate sodium is metabolised extensively by desulfation in liver and spleen and depolymerisation in the kidney.
Maltese: Pentosan polysulfate sodium jiġi metabolizzat b'mod estensiv minn tneħħija ta' sulfur fil-fwied u filmilsa u minn depolimerizzazzjoni fil-kliewi.
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.
Maltese: Ir-raba' studju sar wara tfassil double-blind, double-dummy, multifattorjali u evalwa l-effetti ta' pentosan polysulfate sodium u ta' idrossiżina fi studju wieħed.
English: Total daily urine volume (cc)
Maltese: Volum totali ta' awrina kuljum (cc)
English: A trend for better efficacy under pentosan polysulfate sodium was observed for improved sexual intercourse:
Maltese: Ġiet osservata tendenza għal effikaċja aħjar taħt pentosan polysulfate sodium għal sess imtejjeb:
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).
Maltese: Indikazzjonijiet terapewtiċi elmiron huwa indikat għall-kura ta' sindrome ta' uġigħ fil-bużżieqa tal-awrina kkaratterizzat minn jew glomerulazzjonijiet jew leżjonijiet ta' Hunner f'adulti b'uġigħ moderat sa sever, urġenza u frekwenza biex wieħed jgħaddi l-awrina (ara sezzjoni 4.4).
English: No information on a potential impact of pentosane polysulfate sodium on fertility is available.
Maltese: L-ebda informazzjoni dwar impatt potenzjali ta' pentosan polysulfate sodium fuq il-fertilità mhi disponibbli.
English: Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use.
Maltese: Ġew irrappurtati każijiet rari ta' makulopatija pigmentarja bl-użu ta' pentosan polysulfate sodium (PPS), speċjalment wara użu fit-tul.
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.
Maltese: Il-miżuri tal-eżitu sekondarju kienu jinkludu s-Sintomu u l-Indiċi tal-Problema IC ta' O'Leary-Sant, il-punteġġ tassintomi tal-Università ta' Wisconsin, sintomi rrappurtati mill-pazjenti ta' uġigħ/skumdità u urġenza, u riżultati ta' djarju ta' tbattil ta' 24 siegħa.
English: Pharmacotherapeutic group: Urologicals, other urologicals, ATC code: G04BX15.
Maltese: Uroloġiċi, uroloġiċi oħra, Kodiċi ATC:
English: • weakness, pelvic (lower abdomen) pain
Maltese: • dgħufija, uġigħ fil-pelvi (il-parti t'isfel tal-addome)
English: • restlessness
Maltese: • reazzjonijiet allerġiċi
English: What elmiron is and what it is used for elmiron is a medicine that contains the active substance pentosan polysulfate sodium.
Maltese: X'inhu elmiron u għal xiex jintuża elmiron huwa mediċina li fiha s-sustanza attiva pentosan polysulfate sodium.
English: elmiron 100 mg hard capsules pentosan polysulfate sodium
Maltese: TAL-PRODOTT MEDIĊINALI elmiron 100°mg kapsuli iebsa pentosan polysulfate sodium
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.
Maltese: F'voluntiera b'saħħithom, għoti parenterali waħdieni ta' pentosan polysulfate sodium immarkat b'mod radjuattiv iwassal għal teħid progressiv ta' radjoattività totali mill-fwied, il-milsa u l-kliewi (50 min wara 1mg/kg i.v: 60 % tad-doża fil-fwied, 7.7 % fil-milsa; 3 sigħat wara d-dożaġġ: 60 % fil-fwied u lmilsa, u 13 % fil-bużżieqa tal-awrina).
English: Package leaflet: Information for the patient elmiron 100 mg hard capsules pentosan polysulfate sodium
Maltese: Informazzjoni għall-pazjent elmiron 100 mg kapsuli iebsa pentosan polysulfate sodium
English: • joint or muscle pain
Maltese: • uġigħ fil-ġogi jew fil-muskoli
English: The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily.
Maltese: Id-doża rakkomandata ta' pentosan polysulfate sodium hija ta' 300 mg/jum li tittieħed bħala kapsula waħda ta' 100 mg mill-ħalq tliet darbiet kuljum.
English: 90 hard capsules 100 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 90 kapsula iebsa
English: The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' pentosan polysulfate sodium fit-tfal u fl-adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Capsule content Microcrystalline cellulose Magnesium stearate
Maltese: Armi kwalunkwe kapsuli li jkun għad fadal wara dan ilperjodu.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf: ma tistax tittieħed stima mid-data disponibbli
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)
Maltese: Dawk li rrispondew rigward l-uġigħ u l-urġenza Uġigħ (titjib moderat/ta' 50 %) Skala ta' uġigħ (titjib ta' punt 1) Pressjoni biex jgħaddu l-awrina (titjib moderat/50 %) Dawk li rrispondew rigward l-uġigħ u l-urġenza Sess imtejjeb Bidliet mill-volum ta' tbattil fil-linja bażi Volum medju għal kull tbattil (cc)
English: • abnormal liver function
Maltese: • funzjoni anormali tal-fwied
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi fil-ġilda u fit-tessuti
English: • increased sweating, sleeplessness
Maltese: • fluss ta' dmugħ, amblijopija
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.
Maltese: Jingħad li funzjoni ta' barriera potenzjali ta' pentosan polysulfate sodium minflok il-mukus tal-apparat tal-awrina li ssirlu l-ħsara kif ukoll lattività antiinfjammatorja ta' pentosan polysulfate sodium jista' jkollha rwol x'taqdi.
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.
Maltese: Minħabba l-effett antikoagulanti baxx ta' pentosan polysulfate sodium, elmiron m'għandux jintuża minn pazjenti li jinfarġu b'mod attiv.
English: Menstruation is no contraindication.
Maltese: Il-menstruwazzjoni mhijiex kontraindikazzjoni.
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.
Maltese: Minħabba li hemm evidenza ta' kontribut tal-fwied u tal-kliewi fl-eliminazzjoni ta' pentosan polysulfate sodium, lindeboliment tal-fwied jew tal-kliewi jista' jkollu impatt fuq il-farmakokinetiċi ta' pentosan polysulfate sodium.
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.
Maltese: F'każ ta' doża eċċessiva aċċidentali, il-pazjenti għandhom jiġu evalwati għal effetti avversi potenzjali ta' pentosan polysulfate sodium bħal sintomi gastrointestinali jew fsada.
English: One hard capsule contains 100 mg pentosan polysulfate sodium.
Maltese: Kull kapsula iebsa fiha 100 mg ta' pentosan polysulfate sodium.
English: Blister
Maltese: Pożoloġija
English: Uncommon Photosensitivity Not known
Maltese: Mhux komuni Fotosensittività Mhux magħruf Reazzjonijiet allerġiċi