natgillin/translations-raw huggingface dataset:
The efficacy of Zavesca in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Djelotvornost Zavesce kod djece i adolescenata u dobi 0 do 17 godina s Gaucherovom bolesti tipa 1 nije ustanovljena.
Capsule shell Gelatin,
Ovojnica kapsule Želatina,
Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Kutija s 4 blister stripa, svaki blister strip sadrži 21 kapsulu što je ukupno 84 kapsule.
The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Metabolit u najvećoj količini u urinu bio je miglustat glukuronid koji je činio 5% doze.
The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Glavni učinci kod svih vrsta bili su gubitak tjelesne težine i proljev, a pri višim dozama, oštećenje gastrointestinalne sluznice (erozije i ulceracije).
Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Zavescu (vidjeti dijelove 4.4 i 5.3).
There is no experience with the use of Zavesca in patients over the age of 70.
Nema iskustava s primjenom Zavesce u bolesnika starijih od 70 godina.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state.
Metabolit uzročnik toga nije određen, ali se može akumulirati i dosegnuti koncentracije koje nadilaze one u miglustatu pri stanju dinamičke ravnoteže.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODACI NA KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
Data to support safety and efficacy of Zavesca in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Podatci koji podupiru sigurnost i djelotvornost Zavesce u Niemann-Pickovoj bolesti tipa C potječu iz prospektivnog otvorenog kliničkog ispitivanja i retrospektivne analize.
Eighteen patients then continued to receive Zavesca under an optional extended treatment protocol.
Osamnaest bolesnika je tada nastavilo primati Zavescu u neobaveznom protokolu proširenog liječenja.
Blood and lymphatic system disorders Common
Poremećaji krvi i limfnog sustava
Limited data suggest that co-administration of Zavesca and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Ograničeni podatci ukazuju na to da istovremena primjena Zavesce i enzimskog nadomjestka s imiglucerazom u bolesnika s Gaucherovom bolesti tipa 1 može za posljedicu imati smanjenu izloženost miglustatu (približno smanjenje od 22% u Cmax i 14% u AUC zabilježeno u malom ispitivanju s paralelnim skupinama).
In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
U prikupljenoj analizi nekontroliranih podataka su Z-vrijednosti mineralne gustoće kosti lumbalne kralježnice i vrata bedrene kosti povećane za više od 0,1 jedinice od početka u 27 (57%) i 28 (65%) bolesnika s longitudinalnim mjerenjima gustoće kostiju.
This can result in liver and spleen enlargement, changes in the blood, and bone disease.
To za posljedicu može imati povećanje jetre i slezene, promjene u krvi i bolest kostiju.
In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 µM.
In vitro, miglustat inhibira glukozilceramid sintazu sa IC50 koji iznosi 20-37 µM.
In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Osim toga, inhibitorsko djelovanje nelizosomalne glikozilceramidaze eksperimentalno se pokazalo in vitro.
The efficacy and safety of Zavesca has not been specifically evaluated in patients with severe Gaucher disease.
Djelotvornost i sigurnost Zavesce nije posebno procjenjivana kod bolesnika s teškom Gaucherovom bolesti.
Growth should be monitored in paediatric and adolescent patients during treatment with Zavesca; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
U tijeku liječenja Zavescom treba pratiti rast pedijatrijskih bolesnika i adolescenata; omjer koristi/rizika treba ponovo individualno procjenjivati za nastavak liječenja.
The survey included a case series of 66 patients treated with Zavesca outside of the clinical trial for a mean duration of 1.5 years.
Analiza je uključivala seriju slučajeva od 66 bolesnika liječenih Zavescom izvan kliničkog ispitivanja u prosječnom trajanju od 1,5 godine.
Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Primjena Zavesce kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min/1,73 m2) se ne preporučuje.
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Ograničeni podatci za bolesnike s Fabrijevom bolesti i poremećajem funkcije bubrega pokazuju da CL/F opada sa slabljenjem funkcije bubrega.
Capsule, hard White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Kapsula, tvrda Bijele kapsule s “OGT 918” otisnutim crnom bojom na kapici i “100” otisnutim crnom bojom na tijelu.
Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Kod više od 80% bolesnika primijećeni su gastrointestinalni poremećaji, uglavnom proljev, bilo u početku liječenja ili na mahove tijekom liječenja (vidjeti dio 4.8).
Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Zavesca je indicirana za liječenje progresivne neurološke manifestacije u odraslih bolesnika i pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C (vidjeti dijelove 4.4 i 5.1).
Male patients should maintain reliable contraceptive methods while taking Zavesca.
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Zavescu.
The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).
Najčešća ozbiljna nuspojava zabilježena liječenjem Zavescom u kliničkim ispitivanjima bila je periferna neuropatija (vidjeti dio 4.4).
Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Približno 37% bolesnika u kliničkim ispitivanjima kod Gaucherove bolesti tipa 1 i 58% bolesnika u kliničkim ispitivanjima kod Niemann-Pickove bolesti tipa C izvijestilo je o tremoru tijekom liječenja.
The systemic exposure at the lowest dose was below or comparable to that observed in humans (based on AUC0-∞) at the recommended human dose.
Sistemska izloženost pri najnižoj dozi bila je niža ili se mogla usporediti s onom zapaženom kod ljudi (na osnovu
In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking Zavesca between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
U kliničkoj praksi, primijećene su gastrointestinalne pojave potaknute miglustatom, kao odgovor na individualiziranu prilagodbu prehrane (na primjer smanjeno uzimanje saharoze, laktoze i drugih ugljikohidrata), uzimanje Zavesce između obroka, i/ili na lijekove protiv proljeva poput loperamida.
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Zavesca together with food, or to temporarily reduce your dose.
Ako imate proljev liječnik može zatražiti prilagodbu prehrane kako biste smanjili uzimanje laktoze i drugih ugljikohidrata kao što je saharoza (šećer iz trske), ili neuzimanje Zavesce s hranom ili privremeno smanjenje doze.
Dizziness has been reported as a common adverse reaction, and patients suffering from dizziness should not drive or use machines.
Omaglica je zabilježena kao česta nuspojava, pa bolesnici koji pate od omaglice ne bi smjeli upravljati vozilom ili raditi sa strojevima.
ACLAR/ALU blister strips supplied as a box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
ACLAR/Al blister stripovi pakirani u kutiju s 4 blister stripa, svaki blister strip sadrži 21 kapsulu što je ukupno 84 kapsule.
Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Doze koje se temelje na mg/kg/dan i korigirane za razlike pri izlučivanju fecesom, odgovaraju 8, 16 i 33/19 puta višim dozama od najviše preporučene doze za ljude (200 mg triput dnevno).
Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Zavesca se smije koristiti samo u liječenju bolesnika kod kojih enzimska nadomjesna terapija nije prikladna (vidjeti dijelove 4.4 i 5.1).
Black iron oxide (E172) Shellac.
Željezov oksid, crni (E172) Šelak
Zavesca should not be taken during breast-feeding.
Zavesca se ne smije uzimati tijekom dojenja.
No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.
Niti jedan bolesnik nije pokazao brzo pogoršanje Gaucherove bolesti tipa 1 nakon prelaska na monoterapiju Zavescom.
Overall the data show that treatment with Zavesca can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Ukupni podatci pokazuju da liječenje Zavescom može smanjiti progresiju klinički relevantnih neuroloških simptoma u bolesnika s Niemann-Pickove bolesti tipa C.
In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
pedijatrijskih bolesnika bilo je uključeno u nekontrolirano podispitivanje u ukupnom prosječnom trajanju od 3,1 godine pa do 4,4 godine.
Package leaflet: Information for the user Zavesca 100 mg capsules
Uputa o lijeku: Informacija za korisnika Zavesca 100 mg kapsule miglustat
Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Zavesca se primjenjuje samo kada se bolesnik smatra nepodobnim za enzimsko nadomjesno liječenje.
They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions.
To mogu biti znakovi periferne neuropatije, koji se javljaju zbog nuspojava Zavesce ili su se javili zbog postojeće bolesti.
Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Ostala su ispitivanja otkrila promjene u parametrima sperme (pokretljivost i morfologija) sukladne opažanjima smanjene plodnosti.
Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Čini se da je periferna neuropatija češća u bolesnika s Gaucherovom bolesti tipa 1 u usporedbi s ostalom populacijom.
Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Miglustat se uglavnom eliminira kroz bubrege, pri čemu se u urinu pronašlo 70-80% doze neizmijenjenog lijeka.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Kod bolesnika uključenih u kliničko ispitivanje, 40%-50% bolesnika broj trombocita na početku bio je ispod donje granice normale.
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Zavesca.
Razlog za te pretrage je taj što što su neki bolesnici, dok su uzimali Zavescu, osjećali trnce ili obamrlost u šakama i stopalima ili im se smanjila tjelesna težina.
Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4).
npr. na jednu kapsulu (100 mg) jednom ili dvaput dnevno, ako imate proljev dok uzimate Zavescu (vidjeti dio 4).
The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Najčešće nuspojave zabilježene u kliničkim ispitivanjima sa Zavescom bile su proljev, flatulencija, bol u trbuhu, gubitak težine i tremor (vidjeti dio 4.4).
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received Zavesca monotherapy.
To je ispitivanje provedeno u 6-mjesečnom randomiziranom komparativnom razdoblju nakon čega je slijedilo 18 mjesečno produljenje u kojem su svi bolesnici primali monoterapiju Zavescom.
Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
≥ 1/100 < 1/10, manje često: ≥ 1/1000 do < 1/100, rijetko: ≥ 1/10 000 do < 1/1000, vrlo rijetko:
The kinetics of miglustat appear to be dose linear and time independent.
Pokazalo se da je kinetika miglustata linearno ovisna o dozi a neovisna o vremenu.
Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Gaucherova bolest je nasljedni poremećaj metabolizma uzrokovan nemogućnošću razgradnje glukozilceramida posljedica čega su pohranjivanje tog materijala u lizosomima i raširena patologija.
Zavesca has negligible influence on the ability to drive and use machines.
Zavesca zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Adverse reactions were generally of mild to moderate severity and occurred with similar frequency across indications and dosages tested.
Nuspojave su uglavnom bile blage do umjerene težine i javljale su se sličnom učestalošću kod svih ispitivanih indikacija i doziranja.
Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain.
Pedijatrijska populacija Kod nekih pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C zabilježeno je smanjenje rasta u ranoj fazi liječenja miglustatom kada početno smanjeno dobivanje na težini može biti popraćeno smanjenjem rasta ili ono može uslijediti kasnije.
Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Primjena miglustata kod muških i ženskih Sprague-Dawley štakora oralnom sondom tijekom 2 godine u dozama od 30, 60 i 180 mg/kg/dan za rezultat je imala povećanu incidenciju hiperplazije testikularnih intersticijskih stanica (Leydigovih stanica) i adenome u muških štakora pri svim razinama doza.
Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas,
Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili malo više od kliničkih razina izloženosti, bili su: promjene na limfoidnim organima u svih ispitanih vrsta, promjene vrijednosti transaminaza, vakuolizacija štitnjače i gušterače, katarakta, nefropatije i promjene miokarda u štakora.
Contraceptive measures should be used by women of childbearing potential.
Metode kontracepcije trebaju koristiti i žene u razdoblju plodnosti.
There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Postoji ograničeno iskustvo u primjeni Zavesce kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
Zavesca has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Zavesca je ispitivana na indikacijama kod kojih su neki događaji zabilježeni kao nuspojave, poput neuroloških i neurofizioloških simptoma/znakova, kognitivne disfunkcije i trombocitopenije mogli biti posljedica bolesti od koje se bolesnik liječi.
Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Zavesca sadrži djelatnu tvar miglustat koja pripada skupini lijekova koji djeluju na metabolizam.
Cases of peripheral neuropathy have been reported in patients treated with Zavesca with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Kod bolesnika liječenih Zavescom zabilježeni su slučajevi periferne neuropatije prisutne samostalno ili praćene stanjima kao što su, pomanjkanje vitamina B12 i monoklonalna gamopatija.
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Miglustat je inhibitor glukozilceramid sintaze, enzima odgovornog za prvi korak u sintezi večine glikolipida.
A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent.
nije ustanovljena i učinak nije bio ovisan o dozi.
Zavesca 100 mg capsules
Zavesca 100 mg kapsule
- If you have any further questions, please ask your doctor or pharmacist.
Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Zavesca je bijela kapsula od 100 mg sa “OGT 918” otisnutim crnom bojom na kapici i “100” otisnutim crnom bojom na tijelu.
Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Zavesca nije procjenjivana kod bolesnika s težom gastrointestinalnom bolesti u anamnezi, uključujući i upalnu bolest crijeva.
It is not known if miglustat is secreted in breast milk.
Nije poznato izlučuje li se miglustat u majčino mlijeko.
Until further information is available, before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for a further 3 months.
Do dostupnosti daljnjih informacija, prije pokušaja začeća djeteta, muški bolesnici trebaju prekinuti uzimanje Zavesce i primjenjivati pouzdane metode kontracepcije daljnja 3 mjeseca.
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Ako imate Niemann-Pickovu bolest tipa C, masti kao što su glikosfingolipidi nakupljaju se u stanicama
Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters, and reduces fertility (see sections 4.6 and 5.3).
Ispitivanja na štakorima su pokazala da miglustat štetno djeluje na spermatogenezu i parametre sperme, te da umanjuje plodnost (vidjeti dijelove 4.6 i 5.3).
In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50200 mg t.i.d.
U 11 kliničkih ispitivanja s različitim indikacijama 247 bolesnika je liječeno Zavescom u dozama od 50200 mg triput dnevno, u prosječnom trajanju od 2,1 godine.
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
Kod nekih će bolesnika možda biti potrebno privremeno smanjenje doze na 100 mg jednom ili dvaput dnevno, zbog proljeva.
Sodium starch glycollate, Povidone (K30), Magnesium stearate.
Natrijev škroboglikolat, Povidon (K30), Magnezijev stearat
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije tijekom liječenja Zavescom, te tijekom 3 mjeseca nakon završetka liječenja.
Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
< 30 ml/min/1,73 m2) se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka, obratite se svojem liječniku ili ljekarniku.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
Psychiatric disorders Common
Psihijatrijski poremećaji Često
Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Zavesca djeluje kao inhibitor enzima 'glukozilceramid sintaze', odgovornog za prvi korak u sintezi većine glikosfingolipida.
Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Ispitivanja na štakorima su pokazala da miglustat štetno djeluje na parametre sperme (mobilnost i morfologiju), te umanjuje plodnost (vidjeti dijelove 4.4 i 5.3).
The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section
Potrebno je redovito procjenjivati korist za bolesnika od liječenja Zavescom (vidjeti dio 4.4).
Depression, insomnia, libido decreased Nervous system disorders Very common
Depresija, nesanica, oslabljen libido
The active substance is miglustat 100 mg.
Djelatna tvar je miglustat 100 mg.
The usual dose of Zavesca in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Uobičajena doza Zavesce u odraslih bolesnika bila je 200 mg triput dnevno, a kod pedijatrijskih bolesnika je bila prilagođena veličini površine tijela.
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Inhibitorsko djelovanje na glukozilceramid sintazu podloga je za liječenje sa smanjenjem supstrata kod
• Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults.
• Zavesca se primjenjuje za liječenje blage do umjerene Gaucherove bolesti tipa 1 u odraslih.
Do not drive or use any tools or machines if you feel dizzy.
Ako osjećate omaglicu nemojte voziti niti raditi sa strojem.
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Mučnina, povraćanje, abdominalna distenzija/nelagoda, konstipacija,
The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day.
Preporučena početna doza za liječenje odraslih bolesnika s Gaucherovom bolesti tipa 1 je 100 mg triput dnevno.
Most serious side effects:
Najozbiljnije nuspojave
Small mean reductions in haemoglobin [0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, -30.7)] were observed between baseline and end of study.
Između početka i kraja ispitivanja uočeno je malo prosječno smanjenje hemoglobina [-0,95 g/dL (95% CI: -1,38, -0,53)]i broja trombocita [-44,1 × 109/L
6.6 Special precautions for disposal
6.6 Posebne mjere opreza za zbrinjavanje