FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Slovenian: Sočasna uporaba hidroksikarbamida in drugih mielosupresivnih zdravil ali radioterapije lahko poveča depresijo kostnega mozga, motnje prebavil ali mukozitis.
English: If Xromi comes into contact with skin, eyes or nose, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če zdravilo Xromi pride v stik s kožo, očmi ali nosom, predel takoj in temeljito umijte z milom in vodo.
English: The usual starting dose of hydroxycarbamide is 15 mg/kg/day and usual maintenance dose is between 20-25 mg/kg.
Slovenian: Običajni začetni odmerek hidroksikarbamida je 15 mg/kg na dan, običajni vzdrževalni odmerek pa je 20-25 mg/kg.
English: Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-gp.
Slovenian: Zato v primeru sočasnega dajanja s snovmi, ki so substrati citokromov P450 ali P-gp, ni pričakovati medsebojnega delovanja.
English: An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Slovenian: Eritem, ki je posledica radioterapije, se lahko zaradi hidroksikarbamida poslabša.
English: - After first opening of the bottle, discard any unused contents after 12 weeks.
Slovenian: - Neporabljeno vsebino zavrzite po 12 tednih po prvem odprtju steklenice.
English: Hydroxycarbamide must not be administered to patients with severe renal impairment (CrCl < 30 ml/min) (see sections 4.3, 4.4, and 5.2).
Slovenian: Hidroksikarbamid se ne sme dajati bolnikom s hudo ledvično okvaro (CrCl < 30 ml/min) (glejte poglavja 4.3, 4.4 in 5.2).
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Varno ravnanje
English: In addition patients should conduct self-inspection of the skin during the treatment and after discontinuation of the therapy with hydroxycarbamide and be screened for secondary malignancies during routine follow-up visits.
Slovenian: Poleg tega si morajo bolniki med zdravljenjem in po prenehanju zdravljenja s hidroksikarbamidom sami pregledovati kožo, med rutinskimi kontrolnimi pregledi pa jih je treba pregledati glede sekundarnih malignomov.
English: Generally, the patient's antibody response to vaccines may be decreased.
Slovenian: Bolnikov odziv protiteles na cepivo je lahko na splošno zmanjšan.
English: HIV patients
Slovenian: Bolniki, okuženi z virusom HIV
English: After oral administration hydroxycarbamide is readily absorbed from the gastrointestinal tract.
Slovenian: Po peroralni uporabi se hidroksikarbamid brez težav absorbira iz gastrointestinalnega trakta.
English: Subjects assigned to standard treatment (n = 61) continued to receive monthly blood transfusions to maintain 30% HbS or lower, while those assigned to the alternative treatment (n = 60), after having received blood transfusions for a mean duration of 4.5 years (±2.8), started oral hydroxycarbamide at 20 mg/kg/day, which was escalated to each participant's maximum tolerated dose.
Slovenian: Bolniki, ki so bili zdravljeni s standardno terapijo (n = 61), so še naprej prejemali mesečne transfuzije krvi za ohranjanje 30 % HbS ali manj, medtem ko so bolniki, ki so bili zdravljeni z alternativno terapijo (n = 60) in so transfuzije krvi prejemali povprečno 4,5 leta (± 2,8), začeli peroralno prejemati dnevni odmerek hidroksikarbamida 20 mg/kg, ki se je stopnjeval do najvišjega dovoljenega odmerka za posameznika.
English: Patients should be advised not to drive or operate machines, if dizziness is experienced while taking hydroxycarbamide.
Slovenian: Bolnikom je treba odsvetovati vožnjo ali upravljanje strojev, če se med jemanjem hidroksikarbamida počutijo omotične.
English: Fatal hepatic events were reported most often in patients treated with the combination of hydroxycarbamide, didanosine, and stavudine.
Slovenian: O jetrnih zapletih s smrtnim izidom so najpogosteje poročali pri bolnikih, ki so se zdravili s kombinacijo hidroksikarbamida, didanozina in stavudina.
English: This medicinal product contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Slovenian: To zdravilo vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (tudi zapoznele).
English: In patients with Sickle Cell Disease, 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 body weight/ day).
Slovenian: Pri bolnikih s srpastoceličnim sindromom so v posameznih primerih prevelikega odmerjanja hidroksikarbamida (1,43-krat in 8,57-krat višji odmerek od priporočenega dnevnega odmerka 35 mg/kg telesne mase) poročali o nevtropeniji.
English: Iron overload improved more in the hydroxycarbamide than the transfusion arm, with a greater average change in serum ferritin (-1805 versus -38 ng/mL; p < 0.0001) and liver iron concentration (average = -1.9 mg/g versus +2.4 mg/g dry weight liver; p = 0.0011).
Slovenian: Preobremenitev z železom se je bolj izboljšala v skupini, ki je prejemala hidroksikarbamid, kot v skupini, ki je prejemala transfuzije, in sicer z večjo povprečno spremembo serumskega feritina (-1.805 proti -38 ng/ml; p < 0,0001) in koncentracijo železa v jetrih (povprečno = -1,9 mg/g proti +2,4 mg/g suhe teže jeter; p = 0,0011).
English: The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
Slovenian: Makrocitoza, ki je posledica hidroksikarbamida, ni odvisna od vitamina B12 ali folne kisline.
English: Concomitant anti-retroviral medicinal products for HIV disease (see sections 4.4 and 4.5)
Slovenian: Hkratna uporaba protiretrovirusnih zdravil pri okužbi z virusom HIV (glejte poglavji 4.4 in 4.5).
English: Table 3: Mean Haematologic Values Before and After 6 Months of Treatment with hydroxycarbamide (Ferster et al, 1996)
Slovenian: Preglednica 3: Povprečne hematološke vrednosti pred šestmesečnim zdravljenjem s hidroksikarbamidom in po njem (Ferster et al 1996) Pred zdravljenjem s hidroksikarbamidom
English: stavudine, and indinavir (a drop in your white cell count may occur) - live vaccines, e.g. measles, mumps, rubella (MMR), chicken pox
Slovenian: stavudin in indinavir (pride lahko do upadanja števila belih krvničk), - živa cepiva, npr. proti ošpicam, mumpsu in rdečkam (OMR) ter noricam.
English: Xromi is used to prevent the complications of blocked blood vessels caused by Sickle Cell Disease in patients over 2 years of age.
Slovenian: Zdravilo Xromi se uporablja za preprečevanje zapletov zamašenih krvnih žil, ki jih pri bolnikih, starejših od dveh let, povzroča srpastocelični sindrom.
English: Patients on hydroxycarbamide should be made aware of the theoretical risks to the foetus.
Slovenian: Bolnice, ki se zdravijo s hidroksikarbamidom, je treba opozoriti na teoretično tveganje za plod.
English: If hydroxycarbamide comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če hidroksikarbamid pride v stik s kožo ali sluznico, jo takoj in temeljito umijte z milom in vodo.
English: The recovery from myelosuppression is rapid when hydroxycarbamide therapy is interrupted.
Slovenian: Okrevanje po mielosupresiji je hitro, če se zdravljenje s hidroksikarbamidom prekine.
English: The full blood cell count with white cell differential, reticulate count, and platelet count should be monitored regularly (see section 4.2).
Slovenian: Redno je treba spremljati število vseh krvnih celic, vključno z diferencialno belo krvno sliko, številom retikulocitov in številom trombocitov (glejte poglavje 4.2).
English: It is recommended that the healthcare professional advises the patient or carer which syringe to use to ensure that the correct volume is administered.
Slovenian: da zdravstveni delavec svetuje bolniku ali skrbniku, katero brizgo naj uporabi, da odmeri pravilen volumen.
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle after
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Wigston, Leicester LE18 4YL
Slovenian: Nova Laboratories Limited Martin House Gloucester Crescent Wigston, Leicester LE18 4YL
English: The smaller 3 ml syringe (red), marked from 0.5 ml to 3 ml, is for measuring doses of less than or equal to 3 ml.
Slovenian: Manjša, 3-mililitrska brizga (rdeča), označena z lestvico od 0,5 ml do 3 ml, je namenjena odmerjanju odmerkov v jakosti 3 ml ali manj.
English: If bone marrow function is depressed, treatment with hydroxycarbamide should not be initiated.
Slovenian: Če je delovanje kostnega mozga zavrto, zdravljenja s hidroksikarbamidom ni dovoljeno začeti.
English: Preclinical toxicity studies have demonstrated the most commonly observed effects include bone marrow depression in rats, dogs and monkeys.
Slovenian: 5.3 Predklinični podatki o varnosti Najpogosteje opaženi učinki, ugotovljeni v predkliničnih študijah toksičnosti, vključujejo depresijo kostnega mozga pri podganah, psih in opicah.
English: Do not stop taking your medicine unless advised by your doctor.
Slovenian: Če ste prenehali jemati zdravilo Xromi Ne prenehajte jemati zdravila, razen če vam tako svetuje zdravnik.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Fertility in males might be affected by treatment.
Slovenian: Zdravljenje lahko vpliva na plodnost pri moških.
English: One ml of solution contains 0.5 mg methyl hydroxybenzoate.
Slovenian: 1 ml raztopine vsebuje 0,5 mg metilhidroksibenzoata.
English: - if you suffer from severe liver disease - if you suffer from severe kidney disease - if you have decreased production of red, white, or coagulating blood cells (‘myelosuppressed') as described in section 3 “How to take Xromi, Treatment follow-up” - if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
Slovenian: - če imate hudo okvaro jeter, - če imate hudo okvaro ledvic, - če imate zmanjšano tvorbo rdečih ali belih krvničk ali krvnih ploščic („mielosupresijo“), kot je opisano v poglavju 3 „Kako jemati zdravilo Xromi, spremljanje zdravljenja“,
English: Patients must not be treated with hydroxycarbamide and anti-retroviral medicinal products concurrently (see sections 4.3 and 4.4).
Slovenian: Bolniki se ne smejo hkrati zdraviti s hidroksikarbamidom in protiretrovirusnimi zdravili (glejte poglavji 4.3 in 4.4).
English: When blood counts have recovered, hydroxycarbamide should be reinstated at a dose 5 mg/kg/day lower than the dose given before onset of cytopenias.
Slovenian: Ko se krvna slika izboljša, je treba ponovno uvesti dnevni odmerek hidroksikarbamida, ki je za 5 mg/kg nižji od odmerka pred začetkom citopenije.
English: Because of the potential for serious adverse reactions in breast-feeding infants, breast-feeding must be discontinued while taking hydroxycarbamide.
Slovenian: Zaradi možnih resnih neželenih učinkov na dojene otroke je treba med jemanjem hidroksikarbamida dojenje prekiniti.
English: Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.
Slovenian: Zdravilo Xromi je indicirano za preprečevanje vazookluzivnih zapletov pri bolnikih, starejših od dveh let, ki imajo srpastocelični sindrom.
English: If, during treatment, anaemia occurs, correct without interrupting hydroxycarbamide therapy.
Slovenian: Če se anemija pojavi med zdravljenjem, jo je treba odpraviti brez prekinitve zdravljenja s hidroksikarbamidom.
English: Parents and care givers should avoid hydroxycarbamide contact with skin or mucous membrane.
Slovenian: Starši in skrbniki naj preprečijo stik hidroksikarbamida s kožo ali sluznico.
English: This syringe should be recommended for doses less than or equal to 3 ml (each graduation of 0.1 ml contains 10 mg of hydroxycarbamide).
Slovenian: Ta brizga se priporoča za odmerke manjše ali enake 3 ml (vsako povečanje za 0,1 ml vsebuje 10 mg hidroksikarbamida).
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution
Slovenian: IME ZDRAVILA Xromi 100 mg/ml peroralna raztopina
English: Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide should be discontinued if cutaneous vasculitic ulcerations develop.
Slovenian: Zaradi morebitnih hudih kliničnih izidov kožnih vaskulitičnih ulkusov, o katerih so poročali pri bolnikih z mieloproliferativno boleznijo, je treba v primeru nastanka kožnih vaskulitičnih ulkusov zdravljenje s hidroksikabamidom prekiniti.
English: - other myelosuppressive medicines (those that decrease production of red, white, or coagulating blood cells) - radiation therapy or chemotherapy - any medicines for cancer treatment, especially interferon therapy - when used with Xromi there is a greater chance of side effects, such as anaemia
Slovenian: - radioterapijo ali kemoterapijo, - katero koli zdravilo za zdravljenje raka, zlasti zdravljenje z interferonom - če se uporabljajo v kombinaciji z zdravilom Xromi, se poveča možnost za nastanek neželenih učinkov, kot je anemija,
English: P value2 Vaso-occlusive crises 12.13 ± 8.56 0.6 ± 1.37 11.46 ± 3.01 10.2 ± 3.24 0.10 <0.001 Blood transfusions 2.43 ± 0.69 0.13 ± 0.43 2.13 ± 0.98 1.98 ± 0.82 0.25 <0.001 Hospitalisations P value is for comparison between hydroxycarbamide and placebo groups at baseline P value is for comparison between hydroxycarbamide and placebo groups at 18 months Primary stroke prevention (TWiTCH study) Transcranial Doppler (TCD) with Transfusions Changing to Hydroxycarbamide (TWiTCH) was an
Slovenian: P-vrednost2 Vazookluzivne krize 12,13 ± 8,56 0,6 ± 1,37 11,46 ± 3,01 10,2 ± 3,24 0,10 < 0,001 Transfuzije krvi Hospitalizacije 10,13 ± 6,56 0,70 ± 1,28 9,56 ± 2,91 9,59 ± 2,94 P-vrednost je za primerjavo med skupinama s hidroksikarbamidom oziroma placebom v izhodišču.
English: Safe handling of the solution
Slovenian: Varno ravnanje z raztopino
English: Xromi is for oral use.
Slovenian: Zdravilo Xromi je namenjeno peroralni uporabi.
English: There was also significant difference between the hydroxycarbamide group and placebo groups in the number of blood transfusions, mean difference -1.85 (95% CI -2.18 to -1.52) (p < 0.00001), in the number of hospitalisations, mean difference -8.89 (95% CI -10.04 to -7.74) (p < 0.00001), and the duration of hospitalisation, mean difference -4.00 days (95% CI -4.87 to -3.13) (p < 0.00001).
Slovenian: Prav tako sta se bistveno razlikovali število transfuzij krvi v skupini, ki je prejemala hidroksikarbamid, in število transfuzij v skupini, ki je prejemala placebo; povprečna razlika -1,85 (95-odstotni interval zaupanja: od -2,18 do -1,52) (p < 0,00001), število hospitalizacij, povprečna razlika -8,89 (95-odstotni interval zaupanja: od -10,04 do -7,74) (p < 0.00001), in trajanje hospitalizacije, povprečna razlika -4,00 dneva (95-odstotni interval zaupanja: od -4,87 do -3,13) (p < 0,00001).
English: Weight gain observed during treatment with hydroxycarbamide may be an effect of improved general conditions.
Slovenian: Pridobivanje telesne mase, opaženo med zdravljenjem s hidroksikarbamidom, je lahko posledica splošnega izboljšanja počutja.
English: Gently put the tip of the syringe into your mouth and to the inside of your cheek.
Slovenian: Konico brizge si nežno namestite v usta in jo usmerite na notranjo stran lica.
English: Hydroxycarbamide, the active substance of Xromi, passes into human breast milk.
Slovenian: Hidroksikarbamid, učinkovina v zdravilu Xromi, prehaja v materino mleko.
English: Xromi should be stopped 3 to 6 months prior to becoming pregnant, if possible.
Slovenian: Če je možno, je treba zdravilo Xromi nehati jemati vsaj od tri do šest mesecev pred zanositvijo.
English: In addition, there was a reduction in mean hospital stay; 5.3 days in the hydroxycarbamide group and 15.2 days in the placebo group.
Slovenian: Poleg tega se je zmanjšalo povprečno število dni bivanja v bolnišnici; 5,3 dneva v skupini, ki je prejemala hidroksikarbamid, in
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Slovenian: Hidroksikarbamid se pri 30, 100 in 300 µm s sistemom citokroma P450 jetrnih mikrosomov in vitro ne presnavlja.
English: Your pack of Xromi contains a bottle of medicine, a cap, a bottle adaptor and two dosing syringes (a red 3 ml syringe and a white 12 ml syringe).
Slovenian: Škatla zdravila Xromi vsebuje steklenico z zdravilom, pokrovček, nastavek za steklenico in dve brizgi za odmerjanje (rdečo 3-mililitrsko brizgo in belo 12-mililitrsko brizgo).
English: Leg ulcers are a common complication of Sickle Cell Disease, but have also been reported in patients treated with hydroxycarbamide.
Slovenian: Ulkusi na nogah so pogost zaplet pri srpastoceličnem sindromu, o njih pa so poročali tudi pri bolnikih, zdravljenih s hidroksikarbamidom.
English: - Elevated liver enzymes Other side effects (the frequency is unknown)
Slovenian: Drugi neželeni učinki (neznana pogostnost)
English: Hydroxycarbamide is presumed to be a transspecies carcinogen (see section 5.3).
Slovenian: Domnevajo, da je hidroksikarbamid karcinogen za različne vrste (glejte poglavje 5.3).
English: Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase some of the adverse reactions of the vaccine virus because normal defence mechanisms may be suppressed by hydroxycarbamide.
Slovenian: Cepljenja Hkratna uporaba hidroksikarbamida z živimi cepivi lahko okrepi razmnoževanje virusa cepiva in/ali poveča nekatere neželene učinke virusa cepiva, ker lahko zdravljenje s hidroksikarbamidom zavira normalni obrambni mehanizem.
English: How to take Xromi
Slovenian: Kako jemati zdravilo Xromi
English: Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 ml of oral solution.
Slovenian: Rumeno-rjava steklenica iz stekla tipa III z za otroke varno zaporko s pripomočkom za zaščito pred poseganjem v ovojnino (iz polietilena visoke gostote (HDPE) z razširjenim vložkom iz polietilena), ki vsebuje 150 ml peroralne raztopine.
English: Hydroxycarbamide contact with skin or mucous membrane must be avoided.
Slovenian: Preprečevati je treba stik hidroksikarbamida s kožo ali sluznico.
English: Hydroxycarbamide is excreted in human breast milk.
Slovenian: Hidroksikarbamid se izloča v materino mleko.
English: 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.
Slovenian: Hkratna uporaba hidroksikarbamida z živimi cepivi lahko okrepi razmnoževanje virusa v cepivu in/ali poveča neželene učinke virusa v cepivu, ker lahko zdravljenje s hidroksikarbamidom zavira normalni obrambni mehanizem.
English: See section 2 “Xromi contains methyl parahydroxybenzoate”.
Slovenian: Xromi vsebuje metil parahidroksibenzoat“.
English: Your doctor or pharmacist will advise which syringe to use depending on the dose that has been prescribed.
Slovenian: Zdravnik ali farmacevt vam bo glede na predpisani odmerek svetoval, katero brizgo uporabite.
English: There is an increased risk of severe or fatal infections with the concomitant use of live vaccines.
Slovenian: Hkratna uporaba živih cepiv poveča tveganje za resne ali smrtne okužbe.
English: Similarly after six months of treatment, haemoglobin and MCV increased significantly whilst platelet count and white blood cells (WBC) decreased significantly in the hydroxycarbamide group.
Slovenian: Podobno se je v skupini, ki se je šest mesecev zdravila s hidroksikarbamidom, bistveno zvišala raven hemoglobina in povečal povprečni volumen eritrocita, medtem ko se je število trombocitov in belih krvničk (WBC - white blood cells) bistveno zmanjšalo.
English: Final model-based TCD velocities were 143 cm/s (95% CI 140-146) in children who received standard transfusions and 138 cm/s (95% CI 135-142) in those who received hydroxycarbamide, with a difference of 4.54 cm/s (95% CI 0.10-8.98).
Slovenian: (95-odstotni interval zaupanja: 140-146) pri otrocih, ki so prejemali standardne transfuzije, in 138 cm/s (95-odstotni interval zaupanja: 135-142) pri tistih, ki so prejemali hidroksikarbamid, razlika med njima je bila 4,54 cm/s (95-odstotni interval zaupanja: 0,10-8,98).
English: 3 ml and 12 ml dosing syringes.
Slovenian: Brizgi za odmerjanje s prostornino 3 ml in 12 ml.
English: The MSH study showed increased haematological toxicity resulting in a dose reduction in the hydroxycarbamide group as compared with placebo, but there were no infections related to neutropenia or bleeding episodes due to thrombocytopenia.
Slovenian: v primerjavi s skupino, ki je prejemala placebo, povečala hematološka toksičnost, zaradi katere je bilo treba zmanjšati odmerek, vendar ni bilo nobenih okužb, povezanih z nevtropenijo, ali krvavitev zaradi trombocitopenije.
English: - Low Vitamin D level in blood test - Low magnesium level in blood test
Slovenian: - gastrointestinalna razjeda zvišana telesna temperatura izostanek menstrualnih ciklov (amenoreja) pridobivanje telesne mase nizka raven vitamina D pri krvni preiskavi nizka raven magnezija pri krvni preiskavi krvavitve
English: Parents / care givers and patients should be advised to keep hydroxycarbamide out of the sight and reach of children.
Slovenian: Staršem/skrbnikom in bolnikom je treba svetovati, naj hidroksikarbamid shranjujejo nedosegljivo otrokom.
English: If you are not sure how much medicine to take, always ask your doctor or nurse.
Slovenian: koliko zdravila morate izčrpati v brizgo, se vedno posvetujte z zdravnikom ali medicinsko sestro.
English: The study also showed an increase in median time from the initiation of treatment to first painful crisis (2.76 months in the hydroxycarbamide arm compared with 1.35 months on placebo (p = 0.014), second painful crisis (6.58 months in the hydroxycarbamide group compared with 4.13 months on placebo (p < 0.0024), and third painful crisis (11.9 months in the hydroxycarbamide group compared with 7.04 months on placebo (p = 0.0002).
Slovenian: (2,76 meseca v skupini, ki je prejemala hidroksikarbamid, v primerjavi z 1,35 meseca v skupini, ki je prejemala placebo (p = 0,014)), druge boleče krize (6,58 meseca v skupini, ki je prejemala hidroksikarbamid, v primerjavi s 4,13 meseca v skupini, ki je prejemala placebo (p < 0,0024)) in tretje boleče krize (11,9 meseca v skupini, ki je prejemala hidroksikarbamid, v primerjavi s 7,04 meseca v skupini, ki je prejemala placebo (p = 0,0002)).
English: Leg ulcers In patients with leg ulcers, hydroxycarbamide should be used with caution.
Slovenian: Ulkusi na nogah Pri bolnikih z ulkusi na nogah je treba hidroksikarbamid uporabljati previdno.
English: In a study of children with Sickle Cell Disease, liquid and capsule formulations resulted in similar area under the curve, peak concentrations, and half-life.
Slovenian: V študiji pri otrocih s srpastoceličnim sindromom so bili rezultati glede površine pod krivuljo, najvišje koncentracije in razpolovnega časa pri tekoči farmacevtski obliki podobni rezultatom pri kapsulah.
English: Observations in monkeys have also shown lymphoid atrophy and degeneration of the small and large intestine.
Slovenian: Pri opicah so opazili tudi atrofijo limfoidnega tkiva ter degeneracijo tankega in debelega črevesa.
English: Common: may affect up to 1 in 10 people - Unexplained bruising (accumulation of blood under the skin) or bleeding - Sore (open skin infection) on your skin
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - nepojasnjene modrice (kopičenje krvi pod kožo) ali krvavitve