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).
Croatian: Zbog slabog antikoagulantnog učinka natrijeva pentozanpolisulfata, bolesnike koji se istovremeno liječe antikoagulansima, derivatima heparina, trombolitičkim lijekovima ili lijekovima protiv agregacije trombocita, uključujući acetilsalicilatnu kiselinu, ili nesteroidnim protuupalnim lijekovima treba pregledati zbog mogućeg krvarenja kako bi se prilagodilo dozu ako je potrebno (vidjeti dio 4.4).
English: How to take elmiron
Croatian: Kako uzimati elmiron
English: Stop taking elmiron if side effects occur, until they disappear.
Croatian: Ako se pojave nuspojave prestanite uzimati elmiron dok nuspojave ne prestanu.
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.
Croatian: Provedena je skupna analiza prethodno navedenih podataka iz placebom kontroliranih kliničkih ispitivanja kako bi s procijenilo jesu li bolesnici koji su peroralno uzimali natrijev pentozanpolisulfat imali jasnu korist od liječenja.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti” (EXP).
English: Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.
Croatian: Natrijev pentozanpolisulfat ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Nuspojave prijavljene tijekom liječenja natrijevim pentozanpolisulfatom mogu se usporediti s nuspojavama prijavljenim tijekom liječenja placebom u pogledu vrste i broja.
English: Av. improvement* (*Mean ± SD)
Croatian: Prosj. poboljšanja*
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.
Croatian: Učinak na bol i urgenciju ocjenjivan je putem istog upitnika kao i primarna mjera ishoda, pri čemu je ispitanik s odgovorom na liječenje definiran kao bolesnik koji je imao barem umjereno (50 %) poboljšanje u usporedbi s početnom točkom.
English: Overall, the reported systemic bioavailability after oral administration of pentosan polysulfate sodium is below 1%.
Croatian: Sveukupno, zabilježena sustavna bioraspoloživost natrijeva pentozanpolisulfata nakon peroralne primjene manja je od 1 %.
English: Pack size of 300 (3 bottles x 100) capsules.
Croatian: Pakiranje od 300 (3 bočice x 100) kapsula.
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.
Croatian: Četvrto ispitivanje bilo je dvostruko slijepo, s dvostrukim placebom, multifaktorijalnog dizajna za ocjenjivanje učinaka natrijeva pentozanpolisulfata i hidroksizina u jednom ispitivanju.
English: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Croatian: Anemija, ekhimoza, krvarenje, leukopenija, trombocitopenija
English: The apparent plasma half-life of pentosan polysulfate sodium depends on the route of administration.
Croatian: Prividni poluvijek natrijeva pentozanpolisulfata u plazmi ovisi o putu primjene.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Croatian: 5.1. Farmakodinamička svojstva
English: Pregnancy and breast-feeding elmiron is not recommended during pregnancy or breast-feeding.
Croatian: Primjena lijeka elmiron ne preporučuje se tijekom trudnoće ili dojenja.
English: 300 (3x100) hard capsules
Croatian: 300°(3°x°100) tvrdih kapsula
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.
Croatian: U znanstvenoj literaturi objavljena su ukupno četiri randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja koja su prospektivno uključivala bolesnike sa sindromom bolnog mjehura dijagnosticiranim pomoću cistoskopskog pregleda s hidrodistenzijom mjehura ili bez nje u kojima je ocjenjivana djelotvornost oralnog liječenja natrijevim pentozanpolisulfatom.
English: Indigestion, vomiting, mouth ulcer, flatulence, constipation
Croatian: Probavne smetnje, povraćanje, ulceracije u ustima, flatulencija, konstipacija
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.
Croatian: Nadalje, utjecaj na bol i urgenciju ocjenjivan je na ljestvici od 1 do 5, pri čemu je ispitanik s odgovorom na liječenje definiran kao bolesnik čije se stanje poboljšalo barem za 1 bod u usporedbi s početnim stanjem.
English: Therefore, pentosan polysulfate sodium should not be used during breast-feeding.
Croatian: Stoga se natrijev pentozanpolisulfat ne smije primjenjivati tijekom dojenja.
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.
Croatian: Budući da postoje dokazi o doprinosu bubrega i jetre na eliminaciju natrijeva pentozanpolisulfata, oštećenje bubrega ili jetre može utjecati na farmakokinetiku natrijeva pentozanpolisulfata.
English: • reduced liver or kidney function
Croatian: • imate smanjenu funkciju jetre ili bubrega
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.
Croatian: Djelotvornost liječenja ocijenjena je na temelju poboljšanja koje su bolesnici prijavili u pogledu četiri tipična simptoma sindroma bolnog mjehura: bol, urgencija, učestalost mokrenja i nokturija.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti" (EXP).
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.
Croatian: Elmiron se primjenjuje u odraslih osoba za liječenje sindroma bolnog mjehura kojeg karakteriziraju mnoga sitna krvarenja ili karakteristična oštećenja na stijenci mjehura te umjerena do jaka bol i učestali nagon za mokrenjem.
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.
Croatian: Smatralo se da je bolesnik pozitivno odgovorio na liječenje ako je nakon 3 mjeseca liječenja prijavljeno 50 % poboljšanja određenog simptoma u usporedbi s početnim stanjem.
English: bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET bene-Arzneimittel GmbH, PO Box 710269, 81452 München, Njemačka
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.
Croatian: Dokazana je statistički značajna korist primjene natrijeva pentozanpolisulfata u odnosu na primjenu placeba u pogledu primarne mjere ishoda, ocjene cjelokupnog poboljšanja koju su odredili bolesnici, kao i cjelokupne ocjene ispitivača.
English: The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over design evaluating pentosan polysulfate sodium versus placebo.
Croatian: Prvo provedeno ispitivanje bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s planiranim ukriženim dizajnom u kojem se ocjenjivao učinak natrijeva pentozanpolisulfata u odnosu na placebo.
English: Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium.
Croatian: Bolesnike s relevantnom insuficijencijom bubrega ili jetre treba pažljivo pratiti tijekom liječenja natrijevim pentozanpolisulfatom.
English: • The active substance is pentosan polysulfate sodium.
Croatian: • Djelatna tvar je natrijev pentozanpolisulfat.
English: Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use.
Croatian: Prijavljeni su rijetki slučajevi pigmentne makulopatije uz primjenu natrijevog pentozanpolisulfata, a naročito nakon njegove dugotrajne primjene.
English: 90 hard capsules
Croatian: 100 tvrdih kapsula
English: In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained.
Croatian: Kod bolesnika koji odgovaraju na liječenje natrijevim pentozanpolisulfatom liječenje se treba nastaviti kronično sve dok postoji odgovor.
English: After oral administration unabsorbed pentosan polysulfate sodium is excreted predominantly unchanged in the faeces.
Croatian: Nakon peroralne primjene neapsorbirani natrijev pentozanpolisulfat pretežno se izlučuje nepromijenjen u fecesu.
English: No information on a potential impact of pentosane polysulfate sodium on fertility is available.
Croatian: Plodnost Podaci o mogućem utjecaju natrijeva pentozanpolisulfata na plodnost nisu dostupni.
English: The patients in both studies were treated for three months with either 3x100 mg pentosan polysulfate sodium or placebo.
Croatian: Bolesnici u oba ispitivanja liječeni su tri mjeseca natrijevim pentozanpolisulfatom od 3 x 100 mg ili placebom.
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.
Croatian: U zdravih dobrovoljaca jedna parenteralna primjena radioaktivno obilježenog natrijeva pentozanpolisulfata dovela je do progresivnog unosa ukupne radioaktivnosti u jetru, slezenu i bubrege (50 min nakon 1 mg/kg i.v.: 60 % doze u jetri, 7,7 % u slezeni; 3 h nakon doze: 60 % u jetri i slezeni te 13 % u mjehuru).
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.
Croatian: Nakon kritičkog balansiranja rizika liječenje se treba nastaviti preporučenom dozom.
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.
Croatian: Pretpostavlja se da ulogu može imati potencijalna funkcija natrijeva pentozanpolisulfata kao barijere umjesto oštećene urotelne sluznice, kao i protuupalno djelovanje natrijeva pentozanpolisulfata.
English: Back pain Uncommon Myalgia, Arthralgia
Croatian: Bol u leđima Manje često Mijalgija, artralgija
English: Marketing Authorisation Holder and Manufacturer bene-Arzneimittel GmbH Herterichstrasse 1-3
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač bene-Arzneimittel GmbH Herterichstrasse 1-3
English: 110 patients were enrolled and treated for three months in the first of the two very comparable studies.
Croatian: U prvom od dva vrlo usporediva ispitivanja uključeno je 110 ispitanika i liječeno tri mjeseca.
English: Immune system disorder
Croatian: Poremećaji imunološkog sustava
English: Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
Croatian: Bolesnike koji imaju anamnezu trombocitopenije inducirane heparinom ili natrijevim pentozanpolisulfatom treba pažljivo pratiti tijekom liječenja natrijevim pentozanpolisulfatom.
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).
Croatian: Elmiron je indiciran za liječenje sindroma bolnog mjehura koji karakteriziraju glomerulacije ili Hunnerove lezije u odraslih bolesnika sa srednjom do jakom boli, urgencijom i učestalim mokrenjem (vidjeti dio 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOČICU
English: elmiron 100 mg hard capsules
Croatian: NAZIV LIJEKA elmiron 100 mg tvrde kapsule
English: Uncommon Tinnitus
Croatian: Manje često Tinitus
English: • indigestion, vomiting, wind, difficultiy passing stools
Croatian: • probavne smetnje, povraćanje, vjetrovi, problemi s pražnjenjem stolice
English: • abnormal sensation such as prickling, tingling and itchiness
Croatian: • neuobičajen osjećaj peckanja, trnaca i svrbeža
English: HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
Croatian: Plastična (HDPE) bočica sa polipropilenskim zatvaračem s evidencijom otvaranja sigurnim za djecu koja sadrži 100 kapsula.
English: No. responders / total (%) Av. % improvement* Urgency
Croatian: Prosj. % poboljšanja* Urgencija
English: Pack size of 90 capsules.
Croatian: Pakiranje od 90 kapsula.
English: Peripheral oedema, alopecia Uncommon Rash, increased mole size
Croatian: Periferni edemi, alopecija Manje često Osip, povećanje veličine madeža
English: How to store elmiron
Croatian: Kako čuvati elmiron
English: HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
Croatian: Plastična (HDPE) bočica sa polipropilenskim zatvaračem s evidencijom otvaranja sigurnim za djecu koja sadrži 90 kapsula.
English: Pentosan polysulfate sodium is metabolised extensively by desulfation in liver and spleen and depolymerisation in the kidney.
Croatian: Natrijev pentozanpolisulfat uvelike se metabolizira desulfatacijom u jetri i slezeni te depolimerizacijom u bubrezima.
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.
Croatian: Štoviše, u ocjeni bolesnika o poboljšanju boli i urgencije primijećen je trend veće djelotvornosti natrijeva pentozanpolisulfata, unatoč odstupanjima koja su primijećena u ocjenama urgencije.
English: Package leaflet: Information for the patient elmiron 100 mg hard capsules pentosan polysulfate sodium
Croatian: Uputa o lijeku: Informacije za bolesnika elmiron 100 mg tvrde kapsule natrijev pentozanpolisulfat
English: What elmiron is and what it is used for elmiron is a medicine that contains the active substance pentosan polysulfate sodium.
Croatian: Elmiron je lijek koji sadrži djelatnu tvar natrijev pentozanpolisulfat.
English: It is unknown whether pentosane polysulfate sodium or metabolites are excreted in human milk.
Croatian: Dojenje Nije poznato izlučuju li se natrijev pentozanpolisulfat ili njegovi metaboliti u majčino mlijeko.
English: Furthermore volume voiding profiles over three days and the impact of treatment on pain and urgency were evaluated as secondary endpoints.
Croatian: Kao sekundarne mjere ishoda dodatno su se ocjenjivali profil volumen mokrenja tijekom tri dana te učinak liječenja na bol i urgenciju.
English: • abnormal liver function
Croatian: • poremećena funkcija jetre
English: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Croatian: Mučnina, proljev, dispepsija, bol u abdomenu, povećan abdomen, rektalno krvarenje
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
Croatian: ++49 (0) 89 / 7 49 87-0 Faks: ++49 (0) 89 / 7 49 87-142
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOČICI
English: Fertility
Croatian: Želatina
English: Uncommon Lacrimation, amblyopia
Croatian: Manje često Suzenje oka, ambliopija
English: Hepatic or renal insufficiency elmiron has not been studied in patients with hepatic or renal insufficiency.
Croatian: Elmiron nije ispitivan u bolesnika s insuficijencijom bubrega ili jetre.
English: • blood clotting disorders
Croatian: • poremećaji zgrušavanja krvi
English: Increase of ≥ 20 cc (% pts)
Croatian: Povećanje od ≥ 20 cm
English: Voids per day ns
Croatian: Broj mokrenja po danu
English: DATE OF REVISION OF THE TEXT
Croatian: 10 DATUM REVIZIJE TEKSTA {MM/GGGG}
English: • weakness, pelvic (lower abdomen) pain
Croatian: • slabost, bol u zdjelici (donji dio trbuha)
English: • to undergo surgery
Croatian: • morate na operaciju
English: • bottle
Croatian: • bočica
English: • Periodic Safety Update Reports
Croatian: • Periodičko izvješće o neškodljivosti lijeka
English: Adverse events are listed below by MedDRA body system organ class and by frequency.
Croatian: Nuspojave su navedene u nastavku prema organskim sustavima (MedDRA-i) i učestalosti.
English: A responder was defined as a patient assessed to be at least “good” compared to baseline.
Croatian: Kako bi ispitanik bio zabilježen kao bolesnik s odgovorom na liječenje trebao je biti barem u kategoriji „dobro” u usporedbi s početnom točkom.
English: All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with longterm use of PPS.
Croatian: Svim bolesnicima, a posebice onima koji natrijev pentozanpolisulfat primjenjuju dugotrajno, moraju se provoditi redoviti oftalmološki pregledi radi ranog otkrivanja pigmentne makulopatije.
English: administration, the apparent plasma half-life after oral administration is in the range of 24-34 hours.
Croatian: Iako se natrijev pentozanpolisulfat brzo eliminira iz cirkulacije nakon intravenske primjene, njegov prividni poluvijek u plazmi nakon peroralne primjene je u rasponu od 24 do 34 sata.
English: One hard capsule contains 100 mg pentosan polysulfate sodium.
Croatian: Jedna tvrda kapsula sadrži 100 mg natrijeva pentozanpolisulfata.
English: elmiron 100 mg hard capsules pentosan polysulfate sodium
Croatian: NAZIV LIJEKA elmiron 100 mg tvrde kapsule natrijev pentozanpolisulfat
English: • rectal bleeding
Croatian: • rektalno krvarenje
English: • flow of tears, lazy eye
Croatian: • suzenje oka, slabovidnost
English: Ear disorders
Croatian: Poremećaji uha
English: bene-Arzneimittel GmbH
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET bene-Arzneimittel GmbH
English: Uncommon Photosensitivity Not known
Croatian: Manje često Fotoosjetljivost
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: Popis pomoćnih tvari
English: • nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
Croatian: • mučnina, probavne smetnje, proljev, bol u trbuhu, povećanje trbuha
English: Depending on which institution the patients attended they were treated with either 3x100 mg or 2x200 mg PPS per day.
Croatian: Ovisno o ustanovi u kojoj su ispitanici sudjelovali u ispitivanju, primali su 3 x 100 mg ili 2 x 200 mg natrijeva pentozanpolisulfata (engl. pentosan polysulfate sodium, PPS) dnevno. 75 bolesnika bilo je randomizirano u ispitivanju, dok je njih 62 dovršilo ispitivanje.
English: NAME OF THE MEDICINAL PRODUCT
Croatian: 6. FARMACEUTSKI PODACI
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)
Croatian: Bolesnici koji su odgovorili na lijek na temelju vlastite ocjene cjelokupnog poboljšanja Bolesnici koji su odgovorili na lijek na temelju ocjene ispitivača o cjelokupnom poboljšanju Bolesnici koji su odgovorili na lijek u pogledu boli i urgencije
English: Uncommon Anorexia, weight gain, weight loss
Croatian: Manje često Anoreksija, debljanje, mršavljenje
English: • mouth ulcer
Croatian: • ranice u ustima
English: D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene-arzneimittel.de
Croatian: Faks: +49 (0)89 74987142
English: bene-Arzneimittel GmbH, D-81479 Munich,
Croatian: D-81479 München
English: Each capsule contains 100 mg of pentosan polysulfate sodium.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula sadrži 100 mg natrijeva pentozanpolisulfata.
English: 4.9 Overdose
Croatian: 4.1. Terapijske indikacije
English: LIST OF EXCIPIENTS
Croatian: Broj randomiziranih ispitanika
English: Changes from baseline voiding characteristics Mean volume per void (cc)
Croatian: Srednji volumen po mokrenju (cm
English: Method of administration
Croatian: Učestalost mokrenja
English: Contents of the pack and other information What elmiron contains
Croatian: Što elmiron sadrži
English: No. responders / total (%) Av. % improvement* Frequency
Croatian: Prosj. % poboljšanja*
English: Each hard capsule contains 100 mg of pentosan polysulfate sodium.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tvrda kapsula sadrži 100 mg natrijeva pentozanpolisulfata.
English: No. randomized
Croatian: Rok valjanosti
English: 90 hard capsules 100 hard capsules
Croatian: OBLIK I SADRŽAJ 90 tvrdih kapsula
English: After 18 months
Croatian: Nakon 18 mjeseci
English: This applies to both men and women.
Croatian: Ovo se odnosi i na muškarce i na žene.
English: Children less than 2 years of age
Croatian: Djeca u dobi manjoj od dvije godine
English: Do not give this medicine to children from birth to 2 years of age because it is unlikely to be safe.
Croatian: Nemojte davati ovaj lijek djeci u dobi od rođenja do dvije godine jer nije vjerojatno da je to sigurno.
English: - This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan samo vama.
English: Xromi may harm your sperm or eggs.
Croatian: Xromi može oštetiti vašu spermu ili jajašca.
English: Longer periods of monitoring may be required.
Croatian: Možda će biti potrebno duže razdoblje praćenja.
English: The non-inferiority margin was 15 cm/s.
Croatian: Granica neinferiornosti bila je 15 cm/s.
English: However, the choice of method and time of day should be consistent from day to day.
Croatian: Međutim, odabir načina primjene i doba dana treba biti dosljedan iz dana u dan.
English: After first opening: 12 weeks.
Croatian: Nakon prvog otvaranja: 12 tjedana
English: If necessary, blood should be transfused.
Croatian: Ako je to potrebno, treba napraviti transfuziju krvi.
English: Number of events / patient/ year
Croatian: Broj događaja / bolesnik / godina
English: This can cause acute pain crises and organ damage.
Croatian: To može uzrokovati akutne bolne krize i oštećenja organa.
English: - After first opening of the bottle, discard any unused contents after 12 weeks.
Croatian: Nakon prvog otvaranja bočice, bacite sav neiskorišteni sadržaj nakon 12 tjedana.
English: The primary outcome measure of the study was the number and duration of hospitalisations.
Croatian: Primarna mjera ishoda ispitivanja bila je broj i trajanje hospitalizacija.
English: Number of days in hospital
Croatian: Broj dana u bolnici