FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the reported systemic bioavailability after oral administration of pentosan polysulfate sodium is below 1%.
Slovenian: Splošno je poročana sistemska biološka uporabnost natrijevega pentozan polisulfata po peroralnem dajanju manjša od 1 %.
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.
Slovenian: Bolniki so bili randomizirani v štiri skupine zdravljenja in so bili zdravljeni šest mesecev s 3 x 100 mg natrijevega pentozan polisulfata, 1 x 50 mg hidroksizina, obema učinkovinama ali placebom.
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.
Slovenian: Hipotetični mehanizem delovanja natrijevega pentozan polisulfata vključuje lokalni učinek na mehur po sistemski uporabi in izločanje v urin z vezavo glikozaminoglikanov na okvarjeno sluznico mehurja.
English: There are no data from the use of pentosan polysulfate sodium in pregnant women.
Slovenian: Podatkov o uporabi natrijevega pentozan polisulfata pri nosečnicah ni.
English: • breathing difficulties
Slovenian: • oteženo dihanje;
English: The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over design evaluating pentosan polysulfate sodium versus placebo.
Slovenian: Prva študija je bila dvojno slepa, randomizirana, s placebom kontrolirana študija z načrtovano navzkrižno zasnovo, v kateri so ocenjevali natrijev pentozan polisulfat v primerjavi s placebom.
English: What elmiron looks like and contents of the pack
Slovenian: Izgled zdravila elmiron in vsebina pakiranja
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.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah, so glavobol, omotica in motnje prebavil in dihal, kot so driska, navzea, bolečine v trebuhu in krvavitev iz danke.
English: Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium.
Slovenian: Bolnike s pomembno jetrno ali ledvično insuficienco je treba med zdravljenjem z natrijevim pentozan polisulfatom skrbno spremljati.
English: What you need to know before you take elmiron 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo elmiron
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.
Slovenian: Statistično značilna korist natrijevega pentozan polisulfata v primerjavi s placebom je bila dokazana v primarnem cilju študije, pri splošni oceni izboljšanja, o kateri so poročali bolniki, ter pri splošni oceni preiskovalcev.
English: elmiron is not recommended during pregnancy.
Slovenian: Zdravilo elmiron ni priporočljivo med nosečnostjo ali dojenjem.
English: The patients in both studies were treated for three months with either 3x100 mg pentosan polysulfate sodium or placebo.
Slovenian: Bolniki v obeh študijah so se tri mesece zdravili s 3 x 100 mg natrijevega pentozan polisulfata ali placebom.
English: Furthermore volume voiding profiles over three days and the impact of treatment on pain and urgency were evaluated as secondary endpoints.
Slovenian: Nadalje so kot sekundarni cilj študije ocenjevali profil volumna praznjenja v treh dneh in učinek zdravljenja na bolečino in nujnost.
English: • The active substance is pentosan polysulfate sodium.
Slovenian: • Učinkovina je natrijev pentozan polisulfat.
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)
Slovenian: Odzivni bolniki na osnovi samoocene splošnega izboljšanja Odzivni bolniki na osnovi ocene splošnega izboljšanja, o katerem so poročali preiskovalci Odzivni bolniki glede bolečine in nujnosti Bolečina (zmerno/50-odstotno izboljšanje) Lestvica bolečine (izboljšanje za 1 točko) Siljenje k uriniranju (zmerno/50-odstotno izboljšanje) Lestvica nujnosti (izboljšanje za 1 točko)
English: No information on a potential impact of pentosane polysulfate sodium on fertility is available.
Slovenian: Plodnost Informacije o morebitnem vplivu natrijevega pentozan polisulfata na plodnost niso na voljo.
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.
Slovenian: Dodatno so učinek na bolečino in nujnost ocenjevali z lestvico od 1 do 5, pri čemer je za odzivnega bolnika štel bolnik z izboljšanjem za najmanj eno stopnjo v primerjavi z izhodiščem.
English: • accumulation of fluid in arms or legs
Slovenian: • kopičenje tekočine v rokah ali nogah;
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.
Slovenian: Učinek na bolečino in nujnost so ocenjevali z istim vprašalnikom kot primarni cilj študije, pri čemer je za odzivnega bolnika štel bolnik z najmanj zmernim (50-odstotnim) izboljšanjem v primerjavi z izhodiščem.
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).
Slovenian: Zaradi šibkega antikoagulacijskega učinka natrijevega pentozan polisulfata se bolnike, ki so se hkrati zdravili z antikoagulanti, derivati heparina, trombolitičnimi ali protitrombocitnimi zdravili, vključno z acetilsalicilno kislino, ali nesteroidnimi protivnetnimi zdravili, oceni glede možnosti pojava morebitnih hemoragičnih dogodkov, da se odmerek po potrebi prilagodi (glejte poglavje 4.4).
English: It is unknown whether pentosane polysulfate sodium or metabolites are excreted in human milk.
Slovenian: Dojenje Ni znano, ali se natrijev pentozan polisulfat ali njegovi presnovki izločajo v materino mleko.
English: All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with longterm use of PPS.
Slovenian: Vse bolnike, zlasti tiste, ki NPP uporabljajo dolgotrajno, mora redno pregledovati oftalmolog zaradi zgodnjega odkrivanja pigmentne makulopatije.
English: bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM bene-Arzneimittel GmbH, PO Box 710269, 81452 München, Nemčija
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.
Slovenian: Ker obstajajo dokazi, da jetra in ledvice sodelujejo pri izločanju natrijevega pentozan polisulfata, lahko jetrna ali ledvična okvara vpliva na farmakokinetiko natrijevega pentozan polisulfata.
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).
Slovenian: Zdravilo elmiron je indicirano za zdravljenje sindroma bolečega mehurja, za katerega so značilne glomerulacije ali Hunnerjeve lezije pri odraslih z zmerno do hudo bolečino, nujnostjo in pogostnostjo mikturicije (glejte poglavje 4.4).
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.
Slovenian: V znanstveni literaturi so bile objavljene skupno štiri randomizirane, s placebom kontrolirane, dvojno slepe klinične študije, v katerih so bili vključeni bolniki s sindromom bolečine v mehurju, ki je bil diagnosticiran s cistoskopskim pregledom s hidrodistenzijo mehurja ali brez nje, v katerih so ocenjevali učinkovitost peroralnega zdravljenja z natrijevim pentozan polisulfatom.
English: A responder was defined as a patient assessed to be at least “good” compared to baseline.
Slovenian: Za odzivnega bolnika je štel bolnik, ki je bil ocenjen z najmanj „dobro“ v primerjavi z izhodiščem.
English: Marketing Authorisation Holder and Manufacturer bene-Arzneimittel GmbH Herterichstrasse 1-3
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec bene-Arzneimittel GmbH Herterichstrasse 1-3
English: Pentosan polysulfate sodium is metabolised extensively by desulfation in liver and spleen and depolymerisation in the kidney.
Slovenian: Natrijev pentozan polisulfat se presnavlja predvsem z desulfacijo v jetrih in vranici ter depolimerizacijo v ledvicah.
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)
Slovenian: Odzivni bolniki na osnovi samoocene splošnega izboljšanja Odzivni bolniki na osnovi ocene splošnega izboljšanja, o katerem so poročali preiskovalci Odzivni bolniki glede bolečine in nujnosti Bolečina (zmerno/50-odstotno izboljšanje) Lestvica bolečine (izboljšanje za 1 točko) Siljenje k uriniranju (zmerno/50-odstotno izboljšanje) Odzivni bolniki glede bolečine in nujnosti Izboljšani spolni odnosi Spremembe količine praznjenja glede na izhodišče Povprečna količina praznjenja (cc)
English: • increased sweating, sleeplessness
Slovenian: • povečano potenje, nespečnost;
English: Pack size of 90 capsules.
Slovenian: Velikost pakiranja: 90 kapsul.
English: Depending on which institution the patients attended they were treated with either 3x100 mg or 2x200 mg PPS per day.
Slovenian: Bolniki so glede na institucijo, v kateri so se zdravili, prejemali 3 x 100 mg ali 2 x 200 mg natrijevega pentozan polisulfata dnevno.
English: HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
Slovenian: Plastenka iz HDPE z za otroke varno zaporko iz polipropilena z 90 kapsulami.
English: Each carton contains 300 (3 bottles x 100) capsules.
Slovenian: Ena škatla vsebuje 300°(3°plastenke°x°100) kapsul.
English: After oral administration unabsorbed pentosan polysulfate sodium is excreted predominantly unchanged in the faeces.
Slovenian: Po peroralnem dajanju se neabsorbiran natrijev pentozan polisulfat izloči večinoma nespremenjen z blatom.
English: The apparent plasma half-life of pentosan polysulfate sodium depends on the route of administration.
Slovenian: Navidezni razpolovni čas natrijevega pentozan polisulfata v plazmi je odvisen od načina dajanja zdravila.
English: • reduced liver or kidney function
Slovenian: • če imate zmanjšano delovanje jeter ali ledvic.
English: • abnormal sensation such as prickling, tingling and itchiness
Slovenian: • neobičajni občutki, kot so zbadanje, mravljinčenje in srbenje;
English: • loss of appetite, weight gain or loss
Slovenian: • izguba teka, pridobivanje ali izguba telesne mase;
English: HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
Slovenian: Plastenka iz HDPE z za otroke varno zaporko iz polipropilena z 100 kapsulami.
English: • indigestion, vomiting, wind, difficultiy passing stools
Slovenian: • prebavne motnje, bruhanje, vetrovi, oteženo izločanje blata;
English: GRA (95% CI) Pain (95% CI) Urgency (95% CI)
Slovenian: Placebo ocena globalnega odziva (95-odstotni interval zaupanja) bolečine (95-odstotni interval zaupanja) nujnost (95-odstotni interval zaupanja)
English: In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained.
Slovenian: Pri odzivnih bolnikih je treba zdravljenje z natrijevim pentozan polisulfatom trajno nadaljevati, dokler se bolniki nanj odzivajo.
English: 300 (3x100) hard capsules
Slovenian: 300°(3°x°100) trdih kapsul
English: Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
Slovenian: Bolnike, ki imajo anamnezo trombocitopenije zaradi heparina ali natrijevega pentozan polisulfata, je treba med zdravljenjem z natrijevim pentozan polisulfatom skrbno spremljati.
English: How to take elmiron
Slovenian: Kako jemati zdravilo elmiron
English: Talk to your doctor or pharmacist before taking elmiron if you have:
Slovenian: Pred začetkom jemanja zdravila elmiron se posvetujte z zdravnikom ali farmacevtom:
English: Pack size of 300 (3 bottles x 100) capsules.
Slovenian: Velikost pakiranja: 300°(3°plastenke°x°100) kapsul.
English: While pentosan polysulfate sodium is rapidly cleared from circulation of i.v.
Slovenian: Medtem ko se natrijev pentozan polisulfat pri i.v.
English: Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron (especially after long term use).
Slovenian: Pri uporabi elmirona (zlasti po dolgotrajni uporabi) so poročali o redkih primerih bolezni mrežnice (pigmentna makulopatija).
English: elmiron 100 mg hard capsules
Slovenian: IME ZDRAVILA elmiron 100 mg trde kapsule
English: • blood clotting disorders
Slovenian: • motnje strjevanja krvi;
English: • abnormal liver function
Slovenian: • nepravilno delovanje jeter.
English: • skin rash, increased mole size
Slovenian: • kožni izpuščaj, povečana kožna znamenja;
English: Uncommon Lacrimation, amblyopia
Slovenian: Očesne bolezni občasni solzenje, ambliopija
English: 5.2 Pharmacokinetic properties
Slovenian: Farmakokinetične lastnosti
English: No special requirements.
Slovenian: Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: bene-Arzneimittel GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM bene-Arzneimittel GmbH
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni dispneja
English: 90 hard capsules
Slovenian: 100 trdih kapsul
English: • weakness, pelvic (lower abdomen) pain
Slovenian: • šibkost, bolečina v predelu medenice (bolečina v spodnjem delu trebuha);
English: The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium.
Slovenian: V tem poglavju so navedeni neželeni učinki iz kliničnih študij z natrijevim pentozan polisulfatom, o katerih so poročali v literaturi.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: Vrsta ovojnine in vsebina
English: Increased sweating, insomnia, hyperkinesia, paraesthesia
Slovenian: Bolezni živčevja pogosti glavobol, omotica občasni povečano potenje, nespečnost, hiperkinezija, parestezija
English: One hard capsule contains 100 mg pentosan polysulfate sodium.
Slovenian: Ena trda kapsula vsebuje 100 mg natrijevega pentozan polisulfata.
English: elmiron 100 mg hard capsules pentosan polysulfate sodium
Slovenian: IME ZDRAVILA elmiron 100 mg trde kapsule natrijev pentozan polisulfat
English: • nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
Slovenian: • siljenje na bruhanje, prebavne motnje, driska, bolečine v trebuhu, povečan trebuh;
English: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Slovenian: Bolezni krvi in limfnega sistema občasni anemija, ekhimoza, krvavitve, levkopenija, trombocitopenija neznana pogostnost motnje strjevanja krvi
English: Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use.
Slovenian: Pri uporabi natrijevega pentozana polisulfata (NPP), zlasti po dolgotrajni uporabi, so poročali o redkih primerih pigmentne makulopatije.
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.
Slovenian: Predvideva se, da natrijev pentozan polisulfata lahko deluje kot pregrada namesto poškodovane sluznice mehurja in protivnetno zaradi svojega protivnetnega delovanja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
English: Tabulated summary of adverse events
Slovenian: Povzetek neželenih učinkov v obliki preglednice
English: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Slovenian: Bolezni prebavil pogosti navzea, driska, dispepsija, bolečine v trebuhu, razširjen trebuh, krvavitev iz danke občasni prebavne motnje, bruhanje, razjede v ustih, napenjanje, zaprtost
English: 3 years
Slovenian: 3°leta
English: • restlessness
Slovenian: • nemir;
English: Asthenia, pelvic pain
Slovenian: Natrijev pentozan polisulfat
English: How to store elmiron
Slovenian: Shranjevanje zdravila elmiron
English: Uncommon Anorexia, weight gain, weight loss
Slovenian: Presnovne in prehranske motnje občasni anoreksija, pridobivanje telesne mase, izguba telesne mase
English: • dizziness
Slovenian: • omotica;
English: Package leaflet: Information for the patient elmiron 100 mg hard capsules pentosan polysulfate sodium
Slovenian: Navodilo za uporabo elmiron 100 mg trde kapsule natrijev pentozan polisulfat
English: • joint or muscle pain
Slovenian: • bolečine v sklepih ali mišicah.
English: Voids per day ns
Slovenian: Število praznjenj dnevno
English: Infections, influenza
Slovenian: Infekcijske in parazitske bolezni pogosti okužbe, gripa
English: • blister
Slovenian: • Plastenka
English: • hair loss
Slovenian: • Pretisni omot
English: Liver function abnormalities
Slovenian: Preiskave neznana pogostnost nepravilno delovanje jeter
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
Slovenian: Faks: +49 (0) 89/7 49 87-142
English: If you take more elmiron than you should
Slovenian: Če ste vzeli večji odmerek zdravila elmiron, kot bi smeli Obvestite zdravnika, če ste vzeli prevelik odmerek.
English: D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene-arzneimittel.de
Slovenian: Faks: +49 (0)89 74987142
English: Blister
Slovenian: plastenka
English: • to undergo surgery
Slovenian: • če čakate na operacijo;
English: bene-Arzneimittel GmbH, D-81479 Munich,
Slovenian: D-81479 München
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: Povprečna količina praznjenja (cc)
English: Pain
Slovenian: Nokturija
English: Uncommon Tinnitus
Slovenian: Ušesne bolezni občasni tinitus
English: Mean reduction in pain score from baseline ns
Slovenian: Povprečno zmanjšanje ocene bolečine glede na izhodišče
English: Urinary frequency
Slovenian: Bolezni sečil pogosti pogosto uriniranje
English: No. responders / total (%) Av. % improvement* Frequency
Slovenian: Bolečine Št. odzivnih bolnikov/skupno (%) Povprečno izboljšanje v %* Nujnost Št. odzivnih bolnikov/skupno (%) Povprečno izboljšanje v %* Pogostnost Št. odzivnih bolnikov/skupno (%) Povprečno izboljšanje Nokturija Povprečno izboljšanje* (*Povprečje ± st.
English: Each hard capsule contains 100 mg of pentosan polysulfate sodium.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 100 mg natrijevega pentozan polisulfata.
English: 6.3 Shelf life
Slovenian: 3°plastenke
English: This applies to both men and women.
Slovenian: To velja za moške in ženske.
English: Children less than 2 years of age
Slovenian: Otroci, mlajši od dveh let
English: There were no deaths reported in the study.
Slovenian: V študiji niso poročali o smrtnih primerih.
English: Longer periods of monitoring may be required.
Slovenian: Potrebno je lahko daljše nadziranje.
English: After 18 months
Slovenian: Po 18 mesecih
English: The primary outcome measure of the study was the number and duration of hospitalisations.
Slovenian: Primarno merilo rezultatov v študiji sta bila število in trajanje hospitalizacij.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1366/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1366/001
English: Number of days in hospital
Slovenian: Število dni v bolnišnici
English: Furthermore, findings from these pivotal studies are supported by observational studies including some long-term follow up.
Slovenian: Poleg tega so ugotovitve navedenih ključnih študij podprte z opazovalnimi študijami, vključno z nekaterimi dolgoročnimi kontrolnimi pregledi.
English: Do not give this medicine to children from birth to 2 years of age because it is unlikely to be safe.
Slovenian: Tega zdravila ne dajajte otrokom, mlajšim od 2 let, ker verjetno ne bo varno.
English: This can cause acute pain crises and organ damage.
Slovenian: To lahko povzroči akutno bolečo krizo in poškoduje organe.
English: Remove the syringe from your mouth.
Slovenian: Odstranite brizgo iz ust.
English: These disorders are also associated with the underlying disease.
Slovenian: Ti motnji sta prav tako povezani z osnovno boleznijo.
English: (listed in section 6).
Slovenian: (navedeno v poglavju 6),
English: The non-inferiority margin was 15 cm/s.
Slovenian: Delež neinferiornosti je bil 15 cm/s.
English: Results of this study are presented in Tables 2 and 3 below.
Slovenian: Rezultati te študije so predstavljeni v spodnjih preglednicah 2 in 3.
English: After first opening: 12 weeks.
Slovenian: Po prvem odprtju: 12 tednov.
English: - Depending on the dose you take, these tests may be performed initially every two weeks and then every 2-3 months.
Slovenian: - Glede na vaš odmerek se lahko preiskave najprej izvajajo vsaka dva tedna in nato vsaka dva do tri mesece.
English: Open date: __________
Slovenian: Datum odprtja: __________
English: Do not shake the bottle.
Slovenian: Steklenice ne pretresajte.
English: Continuous follow-up of the growth of treated children and adolescents is recommended.
Slovenian: Priporočljivo je redno spremljanje rasti zdravljenih otrok in mladostnikov.
English: At the first scheduled interim analysis, non-inferiority was shown and the sponsor terminated the study.
Slovenian: Pri prvi načrtovani vmesni analizi se je pokazala neinferiornost, zato je naročnik končal študijo.
English: The primary outcome was the decrease in the frequency of vasoocclusive crises per patient per year.
Slovenian: Primarni rezultat je bilo zmanjšanje pogostosti vazookluzivnih kriz na bolnika na leto.
English: Number of hospitalisations
Slovenian: Število hospitalizacij
English: If necessary, blood should be transfused.
Slovenian: Po potrebi se opravi transfuzija krvi.
English: Results are presented in Table 4.
Slovenian: Rezultati so predstavljeni v preglednici 4.
English: Xromi may harm your sperm or eggs.
Slovenian: Zdravilo Xromi lahko škoduje vaši spermi oziroma jajčecem.
English: Patients should be advised to protect skin from sun exposure.
Slovenian: Bolnikom je treba svetovati, naj kožo zaščitijo pred izpostavljenostjo soncu.
English: 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Slovenian: občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: When you use the medicine follow the instructions below:
Slovenian: Pri uporabi zdravila upoštevajte spodnja navodila: