FrancophonIA/ELRC3.0 huggingface dataset:
English: Improvements also were demonstrated in components of the NCI-WG response criteria.
Croatian: Poboljšanja su pokazana i u segmentima NCI-WG kriterija odgovora.
English: Classical biotransformation studies have not been performed.
Croatian: Klasična ispitivanja biotransformacije nisu provedena.
English: A risk to newborns/infants cannot be excluded.
Croatian: Rizik za novorođenčad/dojenčad se ne može isključiti.
English: The lymphocytes multiply too quickly and live too long, so there are too many of them circulating in your blood.
Croatian: Limfociti se prebrzo dijele i žive predugo tako da ih previše cirkulira Vašom krvi.
English: Date of first authorisation: 19 April 2010 Date of latest renewal: 17 February 2015
Croatian: Datum posljednje obnove odobrenja: 17. veljače 2015.
English: Probability of Progression-free Survival
Croatian: Vjerojatnost preživljenja bez progresije
English: Medicines given before each infusion
Croatian: Lijekovi koji se daju prije svake infuzije
English: • the bone marrow failing to produce enough red or white blood cells
Croatian: • nemogućnost koštane srži da proizvede dovoljno crvenih ili bijelih krvnih stanica
English: They are more likely during the first treatment.
Croatian: Vjerojatnije će se pojaviti tijekom prve terapije.
English: Your doctor may treat you with a suitable anti-viral medicine to help prevent this.
Croatian: Liječnik će Vas možda liječiti odgovarajućim antivirusnim lijekom kako bi to spriječio.
English: You must not be given Arzerra:
Croatian: Ne smije Vam se dati lijek Arzerra:
English: Time of Progression-free Survival (Months)
Croatian: Vrijeme preživljenja bez progresije (mjeseci)
English: Post-natal recovery has therefore not been demonstrated.
Croatian: Stoga nije dokazan postnatalni oporavak.
English: Pregnancy, breast-feeding and fertility Arzerra is not usually recommended for use during pregnancy.
Croatian: Trudnoća, dojenje i plodnost Arzerra se obično ne preporučuje tijekom trudnoće.
English: Store and transport refrigerated.
Croatian: Čuvati i prevoziti na hladnom.
English: 1) Cycle for which the pharmacokinetic parameters are presented in this table.
Croatian: 1) Ciklus za koji su prikazani farmakokinetički podaci u ovoj tablici.
English: Your doctor may treat you if any electrolyte imbalance is detected.
Croatian: Liječnik će Vas možda liječiti ako se uoči bilo kakva neravnoteža elektrolita.
English: These could be symptoms of a blockage in the bowel, especially during the early stages of your treatment.
Croatian: To mogu biti simptomi začepljenja crijeva, pogotovo tijekom ranijih stadija Vašeg liječenja.
English: There are no adequate and well-controlled studies in pregnant women to inform a product-associated risk.
Croatian: Nema prikladnih i dobro kontroliranih ispitivanja u trudnica koja bi dala podatke o rizicima povezanima s lijekom.
English: This includes herbal medicines and other medicines you can obtain without a prescription.
Croatian: To uključuje i biljne lijekove te druge lijekove koje ste nabavili bez recepta.
English: Time after start of infusion (minutes)
Croatian: Vrijeme nakon početka infuzije (minute)
English: You will be given an initial infusion followed by a second infusion 7 days later.
Croatian: Nakon što primite prvu infuziju, drugu infuziju ćete primiti 7 dana kasnije.
English: Preclinical data reveal no special hazards for humans.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude.
English: Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
Croatian: Obavijestite svog liječnika odmah ukoliko imate gubitak pamćenja, poteškoće sa razmišljanjem, hodanjem ili gubitak vida.
English: Pre- and post-natal development studies have not been performed.
Croatian: Pre- i postnatalna razvojna ispitivanja nisu provedena.
English: Arzerra and chlorambucil (N=221)
Croatian: Arzerra i klorambucil (N=221)
English: If you notice these symptoms, contact your doctor as soon as possible.
Croatian: Ako primijetite ove simptome, kontaktirajte svog liječnika što je prije moguće.
English: If you have had hepatitis B, Arzerra could cause it to become active again.
Croatian: Ako ste ikada imali hepatitis B, Arzerra može uzrokovati njegovu ponovnu aktivaciju.
English: Before each infusion of Arzerra, you will be given pre-medication - medicines which help to reduce any infusion reactions.
Croatian: Prije svake infuzije lijeka Arzerra, dobit ćete premedikaciju - lijekove koji će pomoći u smanjivanju bilo kakvih reakcija na infuziju.
English: Talk to your doctor or nurse before you are given Arzerra:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego što dobijete lijek Arzerra:
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su svrstane prema smanjenju ozbiljnosti.
English: You will be given an infusion once a week for eight weeks.
Croatian: Primat ćete infuziju jednom tjedno tijekom osam tjedana.
English: Vial 3 years.
Croatian: Bočica 3 godine.
English: The majority of infusion-related reactions were Grade 1 or Grade 2 in severity.
Croatian: Većina reakcija povezanih s infuzijom bila je 1. ili 2. stupnja težine.
English: • problems with blood clotting
Croatian: • problemi sa zgrušavanjem krvi
English: st infusion (300 mg)
Croatian: 1. infuzija (300 mg)
English: See section 5.1 for further information.
Croatian: Za dodatne informacije vidjeti dio 5.1.
English: These included bacterial, viral and fungal infections.
Croatian: Infekcije su uključivale bakterijske, virusne i gljivične infekcije.
English: How it is given Arzerra is given into a vein (intravenously) as an infusion (a drip) over several hours.
Croatian: Kako se primjenjuje Arzerra se daje u venu (intravenski) kao infuzija (drip) tijekom nekoliko sati.
English: Store and transport refrigerated (2 C - 8C).
Croatian: Čuvati i prevoziti na hladnom (2C - 8C).
English: The median number of cycles completed in patients was 6 (total Arzerra dose of 6300 mg).
Croatian: Medijan broja ciklusa koje su bolesnici dovršili iznosio je 6 (ukupna doza lijeka Arzerra: 6300 mg).
English: • Do not shake; mix diluted solution by gentle inversion.
Croatian: • Ne tresite; promiješajte razrijeđenu otopinu nježnim okretanjem.
English: No case of overdose has been reported.
Croatian: Nema prijavljenih slučaja predoziranja.
English: HBV reactivation has been reported up to 12 months following completion of therapy.
Croatian: Reaktivacija HBV-a prijavljivana je do 12 mjeseci nakon završetka liječenja.
English: A corresponding increase in reticulocyte counts seen in these monkeys was indicative of a regenerative response in the bone marrow.
Croatian: Odgovarajući porast broja retikulocita u tih majmuna ukazuje na regenerativni odgovor u koštanoj srži.
English: Other medicines and Arzerra
Croatian: Drugi lijekovi i Arzerra
English: Two percent of the infusion-related reactions led to discontinuation of treatment.
Croatian: Dva posto reakcija povezanih s infuzijom zahtijevalo je prekid liječenja.
English: Administer using an intravenous infusion pump.
Croatian: Primijenite koristeći intravensku infuzijsku pumpu.
English: Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation.
Croatian: Objavljeni podaci ukazuju da unos mlijeka dojenjem u novorođenčadi i dojenčadi ne rezultira značajnom apsorpcijom ovih majčinih antitijela u cirkulaciju.
English: • if you have lung disease,
Croatian: • ako imate bolest pluća,
English: Chemical and physical in-use stability has been demonstrated for 48 hours at ambient conditions (less than 25°C).
Croatian: Razrijeđena infuzijska otopina Dokazana kemijska i fizikalna stabilnost u primjeni je 48 sati pri sobnoj temperaturi (manje od 25°C).
English: Lymphocyte count ≥50% decrease Normalisation (≤4x10
Croatian: Broj limfocita ≥50% smanjenje Normalizacija (≤4x10
English: Efficacy endpoint or haematological parameter a
Croatian: Mjera ishoda djelotvornosti ili hematološki parametar a
English: In a few animals, increased red cell destruction occurred, presumably as a result of monkey anti-drug antibodies coating the red cells.
Croatian: U nekoliko je životinja došlo do povećanog razaranja crvenih krvnih stanica, vjerojatno kao rezultat majmunskih antitijela na lijek koja obavijaju crvene krvne stanice.
English: Ofatumumab should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Croatian: Ofatumumab se trudnicama ne smije primjenjivati osim u slučajevima kada korist za majku premašuje mogući rizik za fetus.
English: swelling of the face or the mouth (angioedema) causing difficulty breathing and collapse
Croatian: (koprivnjača), oticanje lica ili usta (angioedem) koje otežava disanje i uzrokuje kolaps
English: Patients should receive the following pre-medication medicinal products 30 minutes to 2 hours prior to each Arzerra infusion according to the following dosing schedules:
Croatian: Bolesnici trebaju primiti sljedeće premedikacijske lijekove 30 minuta do 2 sata prije svake infuzije lijeka Arzerra sukladno sljedećim rasporedima doziranja:
English: Time after start of infusion
Croatian: Vrijeme nakon početka infuzije
English: Patients received treatment for a maximum of 6 cycles.
Croatian: Bolesnici su primali liječenje do najviše 6 ciklusa.
English: • blocked nose.
Croatian: • začepljen nos.
English: The recommended dose and schedule is 12 doses administered as follows:
Croatian: Preporučena doza i raspored je 12 doza primijenjenih na sljedeći način:
English: Patients received a median of 5 prior therapies, including rituximab (57%).
Croatian: Bolesnici su primili medijan od 5 ranijih terapija, uključujući rituksimab (57%).
English: First and second infusions
Croatian: Prva i druga infuzija
English: Effects on male and female fertility have not been evaluated in animal studies.
Croatian: Djelovanje na mušku i žensku plodnost nije se procjenjivalo u ispitivanjima na životinjama.
English: Baseline cytogenetic (FISH) data were available for 209 patients.
Croatian: Početni citogenetički (FISH) podaci postojali su za 209 bolesnika.
English: These reactions may result in temporary interruption or withdrawal of treatment.
Croatian: Te reakcije mogu uzrokovati privremen ili trajan prekid terapije.
English: More than half of the patients (56%) with CR were MRD negative following the completion of study treatment.
Croatian: Više od polovice bolesnika (56%) koji su postigli CR imalo je negativan nalaz na MRD nakon završetka liječenja u sklopu ispitivanja.
English: It is not known whether Arzerra works in children and adolescents.
Croatian: Nije poznato djeluje li Arzerra u djece i adolescenata.
English: At 6 months after the last dose, the median reductions in B-cell counts were >99%.
Croatian: Šest mjeseci nakon posljednje doze medijan smanjenja broja B-stanica iznosio je >99%.
English: Premedication schedule for Arzerra
Croatian: Premedikacijski raspored za Arzerru
English: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX United Kingdom
Croatian: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX Ujedinjeno Kraljevstvo
English: • low levels of red blood cells (anaemia).
Croatian: • smanjen broj crvenih krvnih stanica (anemija).
English: As anticipated, a reduction in the IgG humoral immune response to keyhole limpet haemocyanin was noted, but there were no effects on delayed-type hypersensitivity responses.
Croatian: Kao što se i očekivalo, zabilježeno je smanjenje IgG humoralnog imunološkog odgovora na protein keyhole limpet haemocyanin, ali nije bilo učinaka na odgovor odgođene preosjetljivosti.
English: Do not use the Arzerra concentrate if there is discolouration.
Croatian: Ne koristite Arzerra koncentrat ako postoji promjena u boji.
English: Median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 9 and 31% of patients had a CIRS-G >10.
Croatian: Cumulative Illness Rating Score for Geriatrics, CIRS-G) iznosio je 9, a 31% bolesnika imalo je CIRS-G rezultat > 10.
English: The duration of response was 16 weeks (CI: 13, 19) and the time to next CLL therapy was 52.4 weeks (CI: 36.9 - non-estimable).
Croatian: Trajanje odgovora bilo je 16 tjedana (CI: 13, 19) i vrijeme do iduće terapije za KLL bilo je 52,4 tjedna (CI: 36,9 - ne može se procijeniti).
English: If you have been previously treated for CLL but the disease returns you will have a maximum of 7 infusions.
Croatian: Ako ste prethodno primili liječenje za KLL, ali se bolest vratila, primit ćete najviše 7 infuzija.
English: As a result, ofatumumab clearance values were lower and t½ values were significantly larger after later infusions than after the initial infusion; during repeated weekly infusions, ofatumumab AUC and Cmax values increased more than the expected accumulation based on first infusion data.
Croatian: Kao rezultat toga, vrijednosti klirensa ofatumumaba nakon kasnijih infuzija bile su niže, a vrijednosti t½ znatno više od onih nakon prvotne infuzije; tijekom ponavljanih tjednih infuzija, vrijednosti AUC i Cmax za ofatumumab su se povisile više od očekivane akumulacije procijenjene temeljem podataka o prvoj infuziji.
English: • low blood pressure (can cause light-headedness when you stand up)
Croatian: • sniženi krvni tlak (može uzrokovati ošamućenost kod ustajanja)
English: The results of this study demonstrated that Arzerra in combination with bendamustine is an effective therapy providing an ORR of 95% (95% CI: 85, 99) and a CR of 43%.
Croatian: Rezultati ovog ispitivanja pokazali su da je Arzerra u kombinaciji s bendamustinom djelotvorna terapija kojom se postiže ORR od 95% (95% CI: 85, 99) i CR od 43%.
English: Approximately 90% of patients received 3-6 cycles of ofatumumab and 66% completed 6 cycles.
Croatian: Otprilike 90% bolesnika primilo je 3-6 ciklusa ofatumumaba i 66% je završilo 6 ciklusa.
English: cells available for the antibody to bind at subsequent infusions.
Croatian: stanica na raspolaganju za vezanje antitijela u sljedećim infuzijama.
English: Laboratory monitoring
Croatian: Laboratorijsko praćenje
English: What you need to know before you are given Arzerra
Croatian: Što morate znati prije nego što dobijete lijek Arzerra
English: Infusion-related reactions occur predominantly during the first infusion and tend to decrease with subsequent infusions.
Croatian: Reakcije povezane s infuzijom pretežno se javljaju tijekom prve infuzije i imaju tendenciju smanjenja sa sljedećim infuzijama.
English: Although limited formal drug-drug interaction data exist for ofatumumab, there are no known clinically significant interactions with other medicinal products.
Croatian: Iako postoje ograničeni podaci iz službenih ispitivanja interakcija lijekova s ofatumumabom, nema poznatih klinički značajnih interakcija s drugim lijekovima.
English: Common side effects that may show up in your blood tests: • low levels of platelets in the blood (cells that help blood to clot).
Croatian: Česte nuspojave koje se mogu pokazati u krvnim pretragama: • smanjen broj trombocita u krvi (stanica koje pomažu zgrušavanje krvi)
English: Patients received treatment for a minimum of 3 months until best response or up to a maximum of 12 cycles.
Croatian: Bolesnici su primali liječenje tijekom najmanje 3 mjeseca, do postizanja najboljeg odgovora ili tijekom najviše 12 ciklusa.
English: What Arzerra is and what it is used for What you need to know before you are given Arzerra How Arzerra is given
Croatian: Što je Arzerra i za što se koristi Što morate znati prije nego što dobijete lijek Arzerra
English: Intravenous corticosteroid (prednisolone or equivalent)
Croatian: Intravenski kortikosteroid (prednizolon ili ekvivalent)
English: The B-cell tumours include CLL (generally associated with lower levels of CD20 expression) and non-Hodgkin's lymphomas (where >90% of tumours have high levels of CD20 expression).
Croatian: B-stanični tumori uključuju KLL (općenito povezana s nižom razinom ekspresije CD20) i nonHodgkinove limfome (pri čemu > 90% tumora ima visoke razine ekspresije CD20).
English: There were no fatal infusionrelated reactions (see section 4.4).
Croatian: Nije bilo reakcija povezanih s infuzijom sa smrtnim ishodom (vidjeti dio 4.4).
English: Relapsed CLL (ofatumumab + FC)
Croatian: Relapsni KLL (ofatumumab + FC)
English: • If you have persistent stomach pain, see your doctor as soon as possible.
Croatian: • Ako imate stalnu bol u trbuhu, obratite se svom liječniku što je prije moguće.
English: You need to take this into account if you are on a controlled sodium diet.
Croatian: Ovo trebate uzeti u obzir ako morate kontrolirati unos natrija u prehrani.
English: These may include anti-histamines, steroids and pain relievers.
Croatian: To može uključivati antihistaminike, steroide i lijekove protiv bolova.
English: If you had these symptoms prior to treatment with Arzerra, tell your doctor immediately about any changes in these symptoms.
Croatian: Ukoliko ste imali ove simptome i prije započinjanja liječenja lijekom Arzerra, recite svom liječniku odmah ako se ovi simptomi promijene.
English: With a median follow-up of approximately 34 months, 67 deaths (37%) in the OFA+FC arm and 69 deaths (38%) in the FC arm were reported.
Croatian: S medijanom praćenja od otprilike 34 mjeseca, zabilježeno je 67 smrti (37%) u skupini OFA+FC i 69 smrti (38%) u skupini FC.
English: • 2000 mg every 28 days for 4 doses (infusions 9 to 12)
Croatian: • 2000 mg svakih 28 dana sljedeće 4 doze (9. do 12. infuzija)
English: There are no data on the effects of ofatumumab on human fertility.
Croatian: Ne postoje podaci o učincima ofatumumaba na plodnost u ljudi.
English: IgG1 molecules such as ofatumumab are catabolised by ubiquitous proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of ofatumumab.
Croatian: IgG1 molekule poput ofatumumaba se razgrađuju proteolitičkim enzimima koji su svugdje prisutni i nisu ograničeni na tkivo jetre; stoga, nije vjerojatno da bi promjene jetrenih funkcija imale ikakvog utjecaja na eliminaciju ofatumumaba.
English: The majority of patients (81%) received 1-2 prior lines of treatments (of whom approximately 50% received 1 prior treatment) and 21% of patients had received prior rituximab.
Croatian: Većina bolesnika (81%) primila je 1-2 prethodne linije liječenja (od kojih je otprilike 50% primilo 1 prethodno liječenje), a 21% bolesnika je prethodno primilo rituksimab.
English: After this period, planning of a pregnancy in relation to the underlying disease, should be evaluated by the treating physician.
Croatian: Nakon tog razdoblja, liječnik treba procijeniti planiranje trudnoće s obzirom na osnovnu bolest.
English: Based on available safety and efficacy data in the elderly, no dose adjustment is required (see section 5.2).
Croatian: Temeljem dostupnih podataka o sigurnosti i djelotvornosti u starijih osoba, dozu nije potrebno prilagođavati (vidjeti dio 5.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arzerra in all subsets of the paediatric population in chronic lymphocytic leukaemia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Arzerra u svim podskupinama pedijatrijske populacije s kroničnom limfocitnom leukemijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: 50 to 100 mg***
Croatian: 50 do 100 mg***
English: • memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible symptoms of progressive multifocal leukoencephalopathy)
Croatian: • gubitak pamćenja, poteškoće u razmišljanju, i poteškoće s hodanjem ili gubitak vida (mogući simptomi progresivne multifokalne leukoencefalopatije)
English: The effect of ofatumumab on patients with prolonged QT intervals (e.g. acquired or congenital) is unknown.
Croatian: Učinak ofatumumaba na bolesnike s produljenim QT intervalom (npr. stečenim ili prirođenim) nije poznat.
English: • high blood pressure
Croatian: • povišeni krvni tlak
English: Oral paracetamol (acetaminophen) Oral or intravenous antihistamine
Croatian: Oralni paracetamol (acetaminofen) Oralni ili intravenski antihistaminik
English: Ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Croatian: Ofatumumab je protein za koji se očekuje metabolički put razgradnje do malih peptida i pojedinačnih aminokiselina posredstvom sveprisutnih proteolitičkih enzima.
English: • low levels of white blood cells (neutropenia)
Croatian: • smanjen broj bijelih krvnih stanica (neutropenija)
English: A diagnosis of PML should be considered in any Arzerra patient who reports the new onset of or changes in pre-existing neurological signs and symptoms.
Croatian: Dijagnozu PML treba razmotriti u svakog bolesnika koji dobiva lijek Arzerra i prijavi pojavu novih ili promjene već postojećih neuroloških znakova i simptoma.
English: 65 (6%) of the 1,168 patients experienced a fatal infection.
Croatian: 65 (6%) od 1168 bolesnika imalo je infekciju sa smrtnim ishodom.
English: Electrolyte abnormalities should be corrected.
Croatian: Odstupanja u vrijednostima elektrolita moraju se korigirati.
English: Serum samples from more than 1,000 patients across the CLL clinical programme were tested for anti-ofatumumab antibodies during and after treatment periods ranging from 8 weeks to 2 years.
Croatian: Uzorci seruma prikupljeni u više od 1000 bolesnika u kliničkom programu liječenja KLL-a testirani su na protutijela na ofatumumab tijekom i nakon razdoblja liječenja koja su trajala od 8 tjedana do 2 godine.
English: Medicines of this type (monoclonal antibodies) can cause infusion-related reactions, which are occasionally severe, and can cause death.
Croatian: Ova vrsta lijekova (monoklonska protutijela) može izazvati reakcije povezane s infuzijom, koje ponekad mogu biti teške i uzrokovati smrt.
English: For relapsed CLL, the recommended dosage and schedule is:
Croatian: Za relapsni KLL, preporučena doza i raspored su:
English: Diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
Croatian: Difenhidramin 50 mg ili cetirizin 10 mg (ili ekvivalent)
English: • 300 mg on day 1 followed 1 week later by
Croatian: • 300 mg 1. dana, a zatim tjedan dana kasnije
English: Table 5 Ofatumumab pharmacokinetic parameters (geometric mean)
Croatian: Tablica 5 Farmakokinetički parametri ofatumumaba (geometrijska srednja vrijednost)
English: CLL is a cancer of the blood which affects a type of white blood cell called lymphocytes.
Croatian: KLL je rak krvi koji pogađa jednu vrstu bijelih krvnih stanica nazvanih limfociti.
English: Cycle
Croatian: Ciklus
English: Formation of anti-ofatumumab antibodies was observed for less than 0.5% of patients with CLL after treatment with ofatumumab.
Croatian: Stvaranje protutijela na ofatumumab uočeno je u manje od 0,5% bolesnika s KLL-om nakon liječenja ofatumumabom.
English: Thus, the benefit of such a new combination over a rituximab based regimen is unknown.
Croatian: Stoga nije poznata korist takve nove kombinacije u odnosu na liječenje utemeljeno na rituksimabu.
English: A dose-ranging study (Hx-CD20-402) was conducted in 33 patients with relapsed or refractory CLL.
Croatian: Ispitivanje raspona doze (Hx-CD20-402) provedeno je na 33 bolesnika s ponovljenim ili refraktornim KLL-om.
English: The excretion of ofatumumab in milk has not been studied in animals.
Croatian: Izlučivanje ofatumumaba u mlijeko se nije ispitivalo na životinjama.
English: Excludes patients' visits from date of first transfusion, treatment with erythropoietin, or treatment with growth factors.
Croatian: Isključuje posjete bolesnika od datuma prve transfuzije, terapije eritropoetinom, ili terapije čimbenicima rasta.
English: Spleen weights decreased by approximately 15% in the low-dose group and by approximately 30% in the high-dose group, compared with control values.
Croatian: Masa slezene se smanjila za otprilike 15% u skupini koja je primala nisku dozu i za otprilike 30% u skupini koja je primala visoku dozu, u usporedbi s kontrolnim vrijednostima.