natgillin/translations-raw huggingface dataset:
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Najčešći nalaz u ispitivanjima ponovljenih doza bio je povećana primarna spongioza u metafizama dugih kostiju životinja u razvoju kod gotovo svih doza, što je odraz farmakološkog antiresorptivne aktivnosti tvari.
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Tablica 6: Nuspojave opažene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta Poremećaji živčanog sustava često:
Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Zoledronatna kiselina djeluje tako što se spaja na kost i usporava brzinu pregradnje kosti.
* Includes vertebral and non-vertebral fractures
* Uključuje prijelome kralježaka i drugih kostiju.
Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Bolesnici moraju biti dobro hidrirani prije i nakon primjene Zoledronatne kiseline Hospira.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Faktori koji mogu povećati potencijal propadanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje bubrega, višestruke cikluse primjene zoledronatne kiseline ili drugih bisfosfonata kao i istodobnu primjenu nefrotoksičnih lijekova ili kraće trajanje infuzije od trenutno preporučenog.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Pri donošenju odluke da se liječe bolesnici s koštanim metastazama radi prevencije koštanih događaja, treba uzeti u obzir da učinak liječenja nastupa nakon 2-3 mjeseca.
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.
Zoledronatna kiselina Hospira sa hranom i pićem Svakako pijte dovoljno tekućine (barem jednu ili dvije čaše) prije i nakon liječenja Zoledronatnom kiselinom Hospira, kako Vas je uputio Vaš liječnik.
Zoledronic Acid Recommended Dose* 4.0 mg zoledronic acid
Preporučena doza zoledronatne kiseline* 4,0 mg zoledronatne kiseline
- Zoledronic Acid Hospira 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
- Zoledronatna kiselina Hospira 4 mg/100 ml otopina za infuziju sadrži 4 mg zoledronatne kiseline u 100 ml otopine za infuziju za neposrednu primjenu u bolesnika s normalnom funkcijom bubrega.
100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
Polipropilenske vrećice od 100 ml s polipropilenskim zatvaračem s pričvršćenim poklopcem s poliesterskim/polipropilenskim omotom.
The following properties have been demonstrated in preclinical studies:
U nekliničkim ispitivanjima pokazala je sljedeća svojstva:
In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic Acid Hospira administration (see section 4.4).
U bolesnika s Pagetovom bolešću, snažno se preporučuje osigurati uzimanje odgovarajućeg nadomjestka kalcija, koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput dnevno, tijekom najmanje 10 dana nakon primjene Zoledronatne kiseline Hospira (vidjeti dio 4.4).
Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Zoledronatna kiselina je ispitivana u bolesnika oba spola koji su bili stariji od 30 godina i u kojih je radiološki potvrđena primarno blaga do umjerena Pagetova bolest kosti (u vrijeme ulaska u kliničko ispitivanje medijan razine alkalne fosfataze u serumu bio je 2,6 - 3,0 puta veći od gornje granice normalnog referentnog raspona specifičnog za tu dob).
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Nositelj odobrenja mora osigurati uvođenje kartice-podsjetnika za bolesnika u svezi osteonekroze čeljusti.
The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Sljedeće nuspojave navedene u Tablici 2 prikupljene su iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet, uglavnom kod kroničnog liječenja s 4 mg zoledronatne kiseline:
It is unknown whether zoledronic acid is excreted into human milk.
Nepoznato je izlučuje li se zoledronatna kiselina u majčino mlijeko.
Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Opaženo je oštećenje bubrega nakon primjene zoledronatne kiseline (vidjeti dio 4.8) pogotovo u bolesnika s postojećom disfunkcijom bubrega i drugim rizicima, uključujući uznapredovalu dob, istodobnu primjenu nefrotoksičnih lijekova i istodobnu primjenu diuretske terapije (vidjeti dio 4.5) ili dehidracije nakon primjene zoledronatne kiseline.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic Acid Hospira.
Vaš liječnik bi trebao napraviti pretrage krvi kako bi provjerio Vašu funckiju bubrega prije svake doze Zoledronatne kiseline Hospira.
Uncommon: Blurred vision, scleritis and orbital inflammation Rare:
zamagljen vid, skleritis i upala orbite rijetko:
Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Zoledronatnu kiselinu Hospira (5 mg/100 ml otopina spremna za infuziju) treba primijeniti putem infuzijske linije konstantnom brzinom infuzije.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
U razdoblju nakon stavljanja lijeka u promet prijavljeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji su uzimali zoledronatnu kiselinu
The use of zoledronic acid in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Primjena zoledronatne kiseline u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 35 ml/min), kontraindicirana je zbog povećanog rizika od zatajenja bubrega u toj populaciji.
Abdominal pain Musculoskeletal and connective tissue disorders Common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva često:
Eye disorders Common:
Poremećaji oka često:
The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Rezultati su pokazali usporednu djelotvornost zoledronatne kiseline u dozi od 4 mg i 90 mg pamidronata u prevenciji koštanih događaja.
Caution is advised when Zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Savjetuje se oprez kod primjene zoledronatne kiseline s lijekovima za koje je poznato da uzrokuju hipokalcemiju budući da mogu imati sinergistički učinak s posljedičnom teškom hipokalcemijom (vidjeti dio 4.5).
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Kada su rezultati bili objedinjeni, nakon 6 mjeseci opaženo je slično sniženje u težini boli i zbrojeva interferencije boli u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Ispitivanja utjecaja zoledronatne kiseline na reproduktivnost životinja pokazala su da postoji reproduktivna toksičnost uključujući malformacije (vidjeti dio 5.3).
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
- ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Hospira i obavijestite svog liječnika o Vašem liječenju kod zubara.
Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Savjetuje se oprez kod primjene bisfosfonata s aminoglikozidima, kalcitoninom ili diureticima Henleove petlje budući da tijekom duljeg razdoblja ti lijekovi mogu imati aditivan učinak i sniziti razinu kalcija u serumu kroz dulje razdoblje nego što je potrebno (vidjeti dio 4.4).
Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Jednokratne i višekratne infuzije zoledronatne kiseline u dozi od 2, 4, 8 i 16 mg u trajanju od 5 i 15 minuta u 64 bolesnika s koštanim metastazama dale su sljedeće farmakokinetičke podatke, za koje se pokazalo da ne ovise o dozi.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
U bolesnika s koštanim metastazama koji prije početka terapije imaju blago do umjereno oštećenje bubrega koje se za ovu populaciju definira kao CLcr od 30 do 60 ml/min, preporučuje se sljedeća doza zoledronatne kiseline (vidjeti također dio 4.4):
In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
U drugom ispitivanju u bolesnika sa solidnim tumorima, izuzev raka dojke ili prostate, zoledronatna kiselina u dozi od 4 mg značajno je smanjila udio bolesnika s koštanim događajima, produljila medijan vremena do prvog koštanog događaja za > 2 mjeseca i smanjila stopu koštanog pobola.
− The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
- Otopina koja sadrži zoledronatnu kiselinu ne smije se dodatno razrjeđivati niti miješati s drugim infuzijskim otopinama.
− The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
- Otopina koja sadrži zoledronatnu kiselinu daje se kao jednokratna 15-minutna intravenska infuzija kroz zasebnu infuzijsku liniju.
− Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
- Zoledronatna kiselina Hospira se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
Each pack contains one bag which contains 4 mg of zoledronic acid.
Svako pakiranje sadrži jednu vrećicu sa 4 mg zoledronatne kisline.
Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira.
Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Hospira.
Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Nepravilan rad srca (srčana aritmija), napadaji, grčevi i trzanje mišića (tetanija) prijavljeni su kao posljedica teške hipokalcemije.
Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira.
Bolesnici moraju biti prikladno hidrirani prije primjene Zoledronatne kiseline Hospira.
Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Prije primjene, 5,0 ml koncentrata iz jedne bočice ili izvučen potreban volumen koncentrata mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (otopina natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili 5%-tna m/V otopina glukoze).
Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Zoledronatna kiselina pripada skupini bisfosfonata koji sadrže dušik i djeluje prvenstveno na kost.
After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Nakon razrjeđivanja: s mikrobiološkog stajališta, razrijeđenu otopinu za infuziju treba odmah primijeniti.
Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronatnu kiselinu Hospira bolesnicima smiju propisivati i primjenjivati samo zdravstveni radnici s iskustvom u intravenskoj primjeni bisfosfonata.
This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Rezultati su pokazali pojačane farmakološke učinke za koje se smatra da su povezani s inhibicijom metabolizma kalcija u kostima koju ta tvar izaziva s posljedičnom hipokalcemijom u vrijeme parturicije, što je učinak svojstven skupini bisfosfonata, s distocijom i ranim prekidom ispitivanja.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid Hospira.
Vaš liječnik bi trebao napraviti pretrage krvi radi provjere bubrežne funkcije (razine kreatinina) prije svake doze Zoledronatne kiseline Hospira.
In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
U HORIZON-Pivotal Fracture Trial [PFT] ispitivanju (vidjeti dio 5.1) ukupna incidencija atrijske fibrilacije iznosila je 2,5% (96 od 3862) i 1,9% (75 od 3852) u bolesnika koji su primali zoledronatnu kiselinu, odnosno placebo.
Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Populacijska analiza pokazala je da bi odgovarajući predviđeni klirens zoledronatne kiseline u bolesnika s klirensom kreatinina od 20 ml/min (teško oštećenje bubrega) bio 37%, odnosno u bolesnika s klirensom kreatinina od 50 ml/min (umjereno oštećenje) 72% onoga kakav postoji u bolesnika s klirensom kreatinina od 84 ml/min.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Propadanje funkcije bubrega koje napreduje do zatajenja bubrega i dijalize, prijavljeno je u bolesnika i nakon početne jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, Interstitial lung disease.
oštećenje bubrega, osteonekroza čeljusti, reakcija akutne faze, hipokalcijemija, fibrilacija atrija, anafilaksija, intersticijska bolest pluća.
Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
omaglica, parestezija, disgeuzija, hipoestezija, hiperestezija, tremor, somnolencija vrlo rijetko:
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Manje često (mogu se javiti u do 1 na 100 osoba): gripa, infekcije gornjih dišnih puteva, snžen broj crvenih krvnih stanica, gubitak apetita, nesanica, pospanost koja može uključivati smanjenu pažnju i svijest, trnci ili ukočenost, krajnji umor, drhtanje, privremeni gubitak svijesti, infekcije oka ili iritacija ili upala uz bol i crvenilo, osjećaj vrtnje, povišeni krvni tlak, navale vrućine, kašalj, nedostatak zraka, nelagoda u trbuhu, bol u trbuhu, zatvor, suhoća usta, žgaravica, kožni osip, pojačano znojenje, svrbež, crvenilo kože, bol u vratu, krutost mišića, kostiju i/ili zglobova, oticanje zgloba, grčevi mišića, bol u ramenu, bol u Vašim prsnim mišićima i rebrima, upala zgloba, mišićna slabost, odstupanja u rezultatima bubrežnih testova, neuobičajeno često mokrenje, oticanje dlanova, gležnjeva ili stopala, žeđ, zubobolja, poremećaji okusa.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis.
Nuspojava koja se zove osteonekroza čeljusti (ONČ) (oštećenje čeljusne kosti) zabilježena je nakon stavljanja lijek u promet u bolesnika koji su primali zoledronatnu kiselinu za osteoporozu.
Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Preporuča se adekvatan unos kalcija i vitamina D s primjenom zoledronatne kiseline.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Obavijestite svog liječnika i stomatologa odmah ako imate takve simptome tijekom ili nakon liječenja Zoledronatnom kiselinom Hospira.
How Zoledronic Acid Hospira is given - Zoledronic Acid Hospira is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Kako se daje Zoledronatna kiselina Hospira - Zoledronatna kiselina Hospira se daje u venu kao infuzija u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Bolesnicima treba provjeriti razinu kreatinina u serumu prije primjene svake doze zoledronatne kiseline.
For storage conditions of the diluted solution for infusion, see section 6.3.
Uvjete čuvanja razrijeđene otopine za infuziju vidjeti u dijelu 6.3.
The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Farmakokinetički parametri zoledronatne kiseline, viđenih i kod drugih bisfosfonata, uvelike se razlikuju između pojedinih bolesnika.
Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Tablica 1: Priprema sniženih doza Zoledronatne kiseline Hospira 4 mg/100 ml otopine za infuziju
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
U jednom randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 3 godine u kojem se ocjenjivala djelotvornost i sigurnost zoledronatne kiseline u dozi od 5 mg jednom godišnje naspram placeba u liječenju osteoporoze u postmenopauzi, ukupna incidencija fibrilacije atrija bila je 2,5% (96 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg, odnosno 1,9% (75 od 3852) u onih koje su primale placebo.
Zoledronic Acid Hospira is not recommended for use in adolescents and children below the age of 18 years.
Ne preporučuje se primjena Zoledronatne kiseline Hospira u adolescenata i djece mlađe od 18 godina.
The following conventional classification is used: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Za to se koristila sljedeća uobičajena klasifikacija: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Osteonecrosis of the jaw has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet u bolesnika koji su se liječili zoledronatnom kiselinom.
Aseptic techniques must be followed during preparation of the infusion.
Tijekom pripreme infuzije moraju se koristiti aseptičke tehnike.
− The bag does not require any specific storage conditions.
- Vrećica ne zahtijeva posebne uvjete čuvanja.
Skeletal morbidity rate p-value
p-vrijednost stopa koštanog pobola
Zoledronic acid is not recommended in women of childbearing potential.
Zoledronatna kiselina se ne proporučuje ženama u reproduktivnoj dobi.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Tijekom liječenja zoledronatnom kiselinom sve bolesnike se mora poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke kontrole i odmah prijave bilo koji oralni simptom kao što je pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Liječenje bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje bubrega zoledronatnom kiselinom dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Prema analizi višestrukih događaja, zoledronatna kiselina u dozi od 4 mg smanjila je rizik od koštanog događaja za 41% (omjer rizika =0,59, p=0,019) naspram placeba.