natgillin/translations-raw huggingface dataset:
For patients who are not able to swallow the tablets, these can be disintegrated immediately before use in a small quantity of water in a teaspoon.
Bolesnici koji ne mogu progutati tabletu mogu je neposredno prije uzimanja otopiti u maloj količini vode u čajnoj žličici.
Each half of tablet is embossed “H” on one side.
Svaka polovica tablete ima otisnuto slovo „H“ na jednoj strani.
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Detaljnijee informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
When the maximum tolerated dose is not reached transient myelotoxicity usually occurs in less than 10% of patients, while under the maximum tolerated dose more than 50% can experience reversible bone marrow suppression.
Kada nije postignuta maksimalna podnošljiva doza, prolazna mijelotoksičnost obično se javlja u manje od 10% bolesnika, dok je kod maksimalno podnošljive doze kod više od 50% bolesnika zabilježena reverzibilna supresija koštane srži.
The maximum plasma levels and the apparent volume of distribution related to body weight were well comparable between age groups.
Maksimalne plazmatske koncentracije i prividni volumen distribucije prema težini tijela bili su usporedivi između dobnih skupina.
• Treatment guide for physicians
• Vodič za terapiju namijenjen liječnicima
Siklos has minor influence on the ability to drive and use machines.
Siklos malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Luxembourg/Luxemburg
Luxembourg/Luxemburg Addmedica
Very rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (frequency cannot be estimated from the available data):
Vrlo rijetke nuspojave (mogu se javiti kod do 1 na 10 000 osoba) ili nuspojave nepoznate učestalosti (učestalost nije moguće procijeniti na temelju dostupnih podataka):
In patients with a creatinine clearance ≤ 60 ml/min the initial Siklos dose should be decreased by 50%.
Kod bolesnika s klirensom kreatinina ≤ 60 ml/min početnu dozu Siklosa treba smanjiti za 50%.
Also, in rats testicular atrophy with decreased spermatogenesis occurred, while in dogs reversible spermatogenic arrest was noted.
Kod štakora se osim toga pojavila atrofija testisa sa smanjenjem spermatogeneze, dok je kod pasa zabilježen reverzibilan zastoj spermatogeneze.
Siklos must not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
Siklos se ne smije primjenjivati bolesnicima s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.3, 4.4 i 5.2).
The estimated volume of distribution of hydroxycarbamide approximates total body water.
Procijenjeni volumen distribucije hidroksikarbamida približan je ukupnom volumenu vode u tijelu.
Beside the inconstant correlation between reduction of crisis rate and the increase in HbF, the cytoreductive effect of hydroxycarbamide, particularly the drop of neutrophils, was the factor with the strongest correlation to a reduced crisis rate.
Osim nepostojane korelacije između smanjenja učestalosti kriza i povećanja HbF, citoredukcijski učinak hidroksikarbamida, a naročito pad neutrofila, predstavlja faktor koji je u najjačoj korelaciji sa smanjenjem učestalosti kriza.
3 Mainly due to an infection with Parvovirus or a splenic sequestration.
3 Većinom radi infekcije parvovirusom ili sekvestracije u slezeni.
People who are not taking Siklos and in particular pregnant women should avoid being in contact with hydroxycarbamide.
Ljudi koji ne uzimaju Siklos, a naročito trudnice, moraju izbjegavati doticaj s hidroksikarbamidom.
You can add a drop of syrup or mix the content with food to mask a possible bitter taste.
Možete dodati kapljicu sirupa ili lijek pomiješati s hranom kako biste prikrili mogući gorak okus.
In case the prescribed dose requires breaking the tablet in halves or quarters, this should be done out of the reach of food.
Ako zbog propisane doze tabletu treba prelomiti na dva ili četiri dijela, to je potrebno učiniti podalje od hrane.
Treatment with Siklos requires close clinical monitoring.
Terapija Siklosom zahtijeva strogo kliničko praćenje.
Patients treated with hydroxycarbamide in combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/mm3.
Kod bolesnika liječenih hidroksikarbamidom u kombinaciji s didanozinom, stavudinom i indinavirom primijećen je medijan smanjenja CD4 stanica od oko 100/mm3.
Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints.
Upala kože koja uzrokuje crvene ljuskave mrlj e i može se pojaviti zajedno s boli u zglobovima.
There are no data that support specific dose adjustments in patients with hepatic impairment.
Ne postoje podaci koji podupiru specifično prilagođavanje doze kod bolesnika sa oštećenjem jetre.
Specifically, the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults over 13 years and 352 children older than 2 years and adolescents up to 12 years.
Sama sigurnost primjene hidroksikarbamida ispitivala se retroaktivno u kohorti od 123 odrasla bolesnika tijekom 13 godina i u 352 djece starije od 2 godine i adolescenta tijekom do 12 godina.
In paediatric patients, the half-life was slightly longer and the total clearance related to body weight slightly higher than in adult patients (see section 4.2).
Kod pedijatrijskih bolesnika poluvijek je bio nešto duži, a ukupni klirens u odnosu na težinu tijela blago povišen u usporedbi s odraslim bolesnicima vidjeti dio 4.2).
Siklos therapy can then be re-initiated at a lower dose (see section 4.2).
Terapiju Siklosom moguće je nakon toga ponovno uvesti u smanjenoj dozi (vidjeti dio 4.2).
The oral bioavailability of hydroxycarbamide is almost complete as assessed in indications other than Sickle Cell Syndrome.
Oralna bioraspoloživost hidroksikarbamida je gotovo potpuna kako je procijenjeno u drugim indikacijama osim sindroma srpastih stanica.
In the human, according to a retrospective analysis of a cohort of 123 adult patients treated with hydroxycarbamide, twenty-three pregnancies have been reported from 15 women treated with hydroxycarbamide and partners of 3 men treated with hydroxycarbamide.
Kod ljudi su, na temelju retrospektivne analize kohorte od 123 odrasla bolesnika koji su liječeni hidroksikarbamidom, zabilježene 23 trudnoće kod 15 žena liječenih hidroksikarbamidom i kod partnerica trojice muškaraca koji su primali hidroksikarbamid.
Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia.
Neke stanice postaju abnormalne, krute i poprimaju oblik mjeseca odnosno postaju srpaste što dovodi do anemije.
During treatment with Siklos, blood counts must be monitored every two weeks at treatment initiation (i.e. for the first two months) and if the daily dose of hydroxycarbamide is up to 35 mg/kg b.w.
Tijekom terapije Siklosom broj krvnih stanica mora se redovito kontrolirati svaka dva tjedna na početku terapije (tj. tijekom prva dva mjeseca) i ako dnevna doza hidroksikarbamida iznosi do 35 mg/kg tjelesne težine/dnevno.
In nearly all clinical studies conducted in Sickle Cell Syndrome, hydroxycarbamide reduced the frequency of vaso-occlusive episodes by 66% to 80%, in children and in adults.
U gotovo svim kliničkim studijama provedenima kod sindroma srpastih stanica, hidroksikarbamid je smanjio učestalost vazookluzivnih epizoda za 66% do 80% kod djece i odraslih.
Long-term data on the continued use of hydroxycarbamide in patients with Sickle Cell Syndrome are available in children and adolescents, with a follow-up of 12 years in children and adolescents and over 13 years in adults.
Dugoročni podaci o kontinuiranoj primjeni hidroksikarbamida u bolesnika sa sindromom anemije srpastih stanica dostupni su za djecu i adolescente, uz razdoblje praćenja do 12 godina za djecu i adolescente i više od 13 godina za odrasle.
HbF interferes with the polymerisation of HbS and thus impedes the sickling of red blood cell.
HbF interferira s polimerizacijom HbS i na taj način sprječava deformacije eritrocita.
In patients with Sickle Cell Syndrome, neutropenia was reported in isolated cases of hydroxycarbamide overdose (1.43 times and 8.57 times of the maximum recommended dose of 35 mg/kg b.w./day).
U bolesnika sa sindromom srpastih stanica neutropenija je zabilježena u izoliranim slučajevima predoziranja hidroksikarbamidom (1,43 puta i 8,57 puta više od maksimalne preporučene doze od 35 mg/kg tjelesne težine/dnevno).
Urea is one metabolite of hydroxycarbamide.
Urea je jedan od metabolita hidroksikarbamida.
Each quarter of tablet is embossed “T” on one side.
Svaka četvrtina tablete ima otisnuto slovo „T“ na jednoj strani.
Treatment of overdose consists of gastric lavage, followed by symptomatic treatment and control of bone marrow function.
Liječenje predoziranja sastoji se od ispiranja želuca nakon čega slijedi simptomatsko liječenje i kontrola funkcije koštane srži.
• Need for periodic blood counts
• Potrebu za periodičnim krvnim pretragama
Hydroxycarbamide may decrease sperm production in male patients while they are being treated.
Hidroksikarbamid može smanjiti proizvodnju spermija kod muških bolesnika, za vrijeme liječenja.
If you forget to take Siklos
Ako ste zaboravili uzeti Siklos
In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.
Osim toga, hidroksikarbamid izaziva trenutačnu inhibiciju sinteze DNK jer djeluje kao inhibitor ribonukleotidne reduktaze, bez utjecaja na sintezu ribonukleinske kiseline ili proteina.
Thrombocytopenia (< 80 x 109/L), anaemia (haemoglobin < 4.5 g/dl)3
trombocitopenija (< 80 x 109/L), anemija (hemoglobin < 4,5 g/dl)3
Treatment with Siklos should be discontinued if bone marrow function is markedly depressed.
Liječenje Siklosom treba prekinuti ako se funkcija koštane srži znatno smanji.
Male and female patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Bolesnici i bolesnice koji uzimaju hidroksikarbamid, a žele začeti dijete, terapiju moraju prekinuti 3 do 6 mjeseci prije moguće trudnoće.
Rarely, ulcers are caused by leukocytoclastic vasculitis.
U rijetkim slučajevima ulkuse su uzrokovani leukocitoklastičnim vaskulitisom.
The most frequently reported adverse reaction is myelosuppression with neutropenia as the most common manifestation.
Najčešće zabilježena nuspojava je mijelosupresija najčešće manifestirana kao neutropenija.
Patients and/or parents or the legal responsible person must be able to follow directions regarding the administration of this medicine, their monitoring and care.
Bolesnici i/ili roditelji ili zakonski skrbnici bolesnika moraju biti u stanju slijediti upute o primjeni ovog lijeka, redovitim kontrolama i njezi.
Parvovirus B19 infection Neoplasms, benign, malignant and unspecified Not known:
infekcija parvovirusom B19 Dobroćudne, zloćudne i nespecificirane novotvorine Nepoznato:
Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Syndrome (see section 5.1).
Siklos je indiciran u prevenciji rekurentnih bolnih vazookluzivnih kriza koje uključuju akutni prsni sindrom kod odraslih, adolescenata i djece starije od 2 godine koji boluju od simptomatskog sindroma srpastih stanica (vidjeti dio 5.1).
Cardiovascular effects and haematological changes were observed in some species.
Kod nekih vrsta primijećeni su kardiovaskularni učinci i hematološke promjene.
Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13
Telefon: +33 1 72 69 01 86 Faks: +33 1 73 72 94 13
Haemoglobin < 4.5 g/dl
Hemoglobin < 4,5 g/dl Retikulociti
Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide should be discontinued and/or its dose reduced if cutaneous vasculitic ulcerations develop.
Zbog potencijalno teških kliničkih ishoda kožnih vaskulitičnih ulkusa prijavljenih u bolesnika s mijeloproliferativnim bolestima, hidroksikarbamid treba prekinuti i/ili smanjiti dozu, ako se razviju kožne vaskulitične ulceracije.
Low blood cell counts (myelosuppression), enlargement of red blood cells, decreased resistance to infections.
Smanjeni broj krvnih stanica (mijelosupresija), povećanje veličine crvenih krvnih stanica, smanjena otpornost na infekcije.
Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxycarbamide in combination with antiretroviral medicinal products, particularly didanosine plus stavudine.
Potencijalno fatalni pankreatitis i hepatotoksičnost te teška periferna neuropatija zabilježeni su u bolesnika zaraženih virusom HIV koji su primali hidroksikarbamid u kombinaciji s antiretrovirusnim lijekovima i to naročito didanozinom i stavudinom.
In the event a patient does still not respond when treated with the maximum dose of hydroxycarbamide (35 mg/kg b.w./day) over three to six months, permanent discontinuation of Siklos should be considered.
Ako bolesnik i dalje ne odgovara na liječenje s maksimalnom dozom hidroksikarbamida (35 mg/kg tjelesne težine/dnevno) u trajanju od tri do šest mjeseci, potrebno je razmisliti o trajnom prekidu terapije Siklosom.
Because of the potential for serious adverse reactions in infants, breast-feeding must be discontinued while taking Siklos.
Zbog potencijalnih ozbiljnih nuspojava u dojenčadi, dojenje se tijekom uzimanja Siklosa mora prekinuti.
Wash your hands before and after contact with the tablets.
Prije i nakon doticaja s tabletama operite ruke.
Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Bolest srpastih stanica je nasljedni poremećaj krvi koji pogađa crvene krvne stanice u obliku diska.
As long as the patient responds to therapy either clinically or haematologically (e.g. increase of haemoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrophil count) the dose of Siklos should be maintained.
Sve dok bolesnik reagira na terapiju klinički ili hematološki (npr. povećanjem vrijednosti hemoglobina F (HbF), prosječnog volumena crvenih krvnih stanica (MCV), broja neutrofila) dozu Siklosa treba održavati.
Any person, in particular pregnant women, who are not taking Siklos should avoid direct contact with the parts when breaking a tablet.
Sve osobe koje ne uzimaju Siklos, a naročito trudnice, moraju izbjegavati neposredan doticaj s dijelovima lijeka kod lomljenja tablete.
In patients with leg ulcers, Siklos should be used with caution.
Kod bolesnika s ulkusima nogu Siklos treba primjenjivati s oprezom.
If you become pregnant or plan to become pregnant while taking Siklos, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
Ako tijekom uzimanja Siklosa ostanete trudni ili planirate zatrudnjeti, liječnik će s Vama raspraviti potencijalne koristi i rizike nastavka terapije Siklosom.
Women of childbearing potential/Contraception in males and females Women of childbearing age receiving hydroxycarbamide should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Žene reproduktivne dobi/Kontracepcija kod muškaraca i žena Žene reproduktivne dobi koje primaju hidroksikarbamid treba savjetovati da moraju izbjegavati trudnoću, a ako do začeća ipak dođe o tome moraju odmah obavijestiti liječnika.
At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (PGP), indicating that hydroxycarbamide is not a PGP substrate.
In vitro u koncentracijama u rasponu od 10 do 300 µM, hidroksikarbamid ne stimulira aktivnost ATPaze rekombinantnog humanog P glikoproteina (PGP), što ukazuje da hidroksikarbamid nije supstrat PGP-a.
Siklos is used to prevent painful crises, including sudden chest pain, caused by Sickle Cell disease, in adults, adolescents and children older than 2 years.
Siklos se uzima za prevenciju bolnih kriza, uključujući i iznenadnu bol u prsnom košu izazvanu bolešću srpastih stanica kod odraslih, adolescenata i djece starije od 2 godine.
Hydroxycarbamide administered to male rats at 60 mg/kg b.w./day (about double the recommended usual maximum dose in humans) produced testicular atrophy, decreased spermatogenesis and significantly reduced their ability to impregnate females.
Hidroksikarbamid koji se davao mužjacima štakora u dozi od 60 mg/kg tjelesne težine/dnevno (oko dvostruko više od preporučene maksimalne doze za ljude) izazvao je atrofiju testisa, smanjenje spermatogeneze i značajno smanjenje njihove sposobnosti da oplode ženke.
Depending on these results your doctor will adjust your dose of Siklos.
Ovisno o nalazima pretraga liječnik će prilagoditi dozu Siklosa.
The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment.
Krvnu sliku bolesnika kao i funkciju bubrega i jetre potrebno je utvrditi prije početka terapije i tijekom terapije redovito kontrolirati.
UNIQUE IDENTIFIER- HUMAN READABLE DATA
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at doses several times above the therapeutic dose.
Akutna mukokutana toksičnost zabilježena je u bolesnika koji primaju hidroksikarbamid u dozama nekoliko puta većim od terapijske doze.
Very common reversible oligo- and azoo-spermia have been observed in man, although these disorders are also associated with the underlying disease.
Vrlo često su kod muškaraca primijećene reverzibilna oligospermija i azoospermija iako se ti poremećaji mogu povezati i s već postojećom bolešću.
Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, viral infection with Parvovirus B19, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenorrhoea), and weight gain.
Izolirani slučajevi maligne bolesti krvnih stanica (leukemije), raka kože kod starijih bolesnika, virusne infekcije parvovirusom B19, krvarenje, probavne smetnje, povraćanje, suhoća kože, vrućica, izostanak menstrualnog ciklusa (amenoreja) i porast tjelesne težine.
Recently, hydroxycarbamide has shown to be associated with the generation of nitric oxide suggesting that nitric oxide stimulates cyclic guanosine monophosphatase (cGMP) production, which then activates a protein kinase and increases the production of HbF.
Nedavno je primijećeno da je hidroksikarbamid povezan sa nastankom dušikova oksida ukazujući na to da dušikov oksid stimulira stvaranje cikličke gvanozin monofosfataze (cGMP) koja zatim aktivira protein-kinazu i potiče stvaranje HbF.
One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients.
Jedan od mehanizama kojima hidroksikarbamid djeluje je povećanje koncentracije fetalnog hemoglobina (HbF) u bolesnika s anemijom srpastih stanica.
An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Eritem izazvan terapijom zračenjem može se zbog djelovanja hidroksikarbamida pogoršati.
Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Syndrome include decrease of neutrophils, increase of the water content of erythrocytes, increase of the deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Ostali poznati farmakološki učinci hidroksikarbamida koji mogu pridonijeti njegovim pozitivnim učincima kod sindroma srpaste anemije uključuju snižavanje neutrofila, povećanje sadržaja vode u eritrocitima, povećanje mogućnosti deformacije srpastih stanica i promjenu adhezije eritrocita na endotel.
• Information on growth follow-up of treated children for their parents
• Informacije za roditelje o načinu praćenja rasta djece koja dobivaju terapiju
In preclinical toxicity studies the most common effects noted included bone marrow depression, lymphoid atrophy and degenerative changes in the epithelium of the small and large intestines.
U pretkliničkim studijama toksičnosti najčešći zabilježeni učinci uključivali su depresiju koštane srži, atrofiju limfoidnog tkiva i degenerativne promjene epitela tankog i debelog crijeva.
Teratogenicity was characterised by partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae.
Teratogeni učinak karakteriziran je djelomičnim okoštavanjem kosti lubanje, odsustvom očnih duplji, hidrocefalijom, dvodijelne sternebre, nepostojećim slabinskim kralješcima.
Patients with normal (creatinine clearance CrCl>80 ml/min), mild (CrCl 60-80 ml/min), moderate (CrCl 30 - 60 ml/min), or severe (<30 ml/min) renal impairment received hydroxycarbamide as a single dose of 15 mg/kg b.w.
Bolesnici s normalnom funkcijom bubrega (klirens kreatinina CrCl>80 ml/min) te blagim (CrCl 60-80 ml/min), umjerenim (CrCl 30 - 60 ml/min) ili teškim (<30 ml/min) oštećenjem rada bubrega, primali su hidroksikarbamid u jednokratnoj dozi od 15 mg/kg tjelesne težine u kapsulama od po 200 mg, 300 mg, ili 400 mg.
Since there is no available data in patients with mild to moderate liver impairment, Siklos should be used with caution (see section 4.2).
Budući da nema dostupnih podataka u bolesnika s blagim do umjerenim oštećenjem jetre, Siklos treba uzimati s oprezom (vidjeti dio 4.2).
Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Siklos 100 mg dostupan je u plastičnim bocama koje sadrže 60, 90 ili 120 tableta.
These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy.
Te su vaskulitične toksičnosti zabilježene najčešće u bolesnika koji su ranije primali ili sada primaju terapiju interferonom.
Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase the adverse reaction of the vaccine virus, because normal defence mechanisms may be suppressed by hydroxycarbamide therapy.
Istodobna primjena hidroksikarbamida i cjepiva sa živim virusima može potencirati replikaciju virusa iz cjepiva i/ili pojačati nuspojavu na virus cjepiva, jer mogu biti potisnuti normalni obrambeni mehanizmi zbog terapije hidroksikarbamidom.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Unutar svake skupine učestalosti nuspojave su prikazane po redoslijedu od najozbiljnijih prema manje ozbiljnima :
In adults with Sickle Cell Syndrome, mean cumulative urinary hydroxycarbamide excretion was 62% of the administered dose at 8 hours, and thus higher than in cancer patients (35-40%).
Kod odraslih sa sindromom srpastih stanica srednja vrijednost kumulativnog izlučivanja hidroksikarbamida putem urina iznosila je 62% primijenjene doze tijekom 8 sati, što je više nego kod bolesnika koji boluju od raka (35-40%).
The respective value for total clearance in children was 7.25 L/h (0.20 L/h/kg) with 2.91 and 4.34 L/h by renal and non-renal pathways.
Vrijednost ukupnog klirensa kod djece bila je 7,25 L/h (0,20 L/h/kg) odnosno 2,91 za renalni i za 4,34 L/h nerenalni put uklanjanja.
As evaluated in a further study, in patients with a CrCl<60 ml/min the area under the curve was approximately 51% higher than in patients with a CrCl ≥60 ml/min, which suggests that a dose reduction of hydroxycarbamide by 50% may be appropriate in patients with a CrCl < 60 ml/min.
Daljnjom je studijom procijenjeno da je kod bolesnika sa CrCl<60 ml/min površina ispod krivulje bila oko 51% viša nego kod bolesnika čiji je CrCl ≥ 60 ml/min, što upućuje na činjenicu da smanjivanje doze hidroksikarbamida za 50% može biti prikladno za bolesnike kod kojih je CrCl < 60 ml/min.