FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution
Croatian: NAZIV LIJEKA Xromi 100 mg/ml oralna otopina
English: To decrease the risk of exposure disposable gloves should be used when handling Xromi.
Croatian: Kako bi se smanjio rizik od izloženosti, potrebno je nositi jednokratne rukavice prilikom rukovanja lijekom Xromi.
English: Also rates of acute chest syndrome were decreased in those taking hydroxycarbamide when compared with those taking placebo; RR 0.44 (95% CI 0.28 to 0.68) (p < 0.001).
Croatian: Također su se smanjile stope akutnog sindroma prsnog koša u osoba koje su uzimale hidroksikarbamid u usporedbi s osobama koje su uzimale placebo; RR 0,44 (95 % CI 0,28 do
English: Treatment with hydroxycarbamide and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks (see section 4.4).
Croatian: Liječenje hidroksikarbamidom uz istodobnu imunizaciju cjepivima sa živim virusima trebalo bi provoditi samo ako prednosti značajno nadmašuju potencijalne rizike
English: Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 ml of oral solution.
Croatian: Bočica od smeđeg stakla tipa III sa zatvaračem sigurnim za djecu s evidencijom otvaranja (polietilen visoke gustoće (HDPE) s proširenim polietilenskim obrubom) koja sadrži 150 ml oralne otopine.
English: Put the cap back on the bottle with the adaptor left in place.
Croatian: 11. Vratite zatvarač na bočicu s tim da nastavak i dalje ostane na svom mjestu.
English: In Sickle Cell Disease, hydroxycarbamide also helps to prevent red blood cells from taking the abnormal sickle shape.
Croatian: Kod bolesti srpastih stanica hidroksikarbamid pomaže u sprečavanju nastanka abnormalnog srpastog oblika crvenih krvnih stanica.
English: LIST OF EXCIPIENTS Also contains: methyl parahydroxybenzoate (E218).
Croatian: POPIS POMOĆNIH TVARI Također sadrži: metilparahidroksibenzoat (E218).
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Croatian: Ako niste sigurni odnosi li se nešto od prethodno navedenog na vas, prije uzimanja lijeka Xromi obratite se liječniku ili ljekarniku.
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).
Croatian: Također je između skupine koja je primala hidroksikarbamid i skupine koja je primala placebo zabilježena značajna razlika u broju transfuzija krvi, srednja vrijednost razlike -1.85 (95 % CI -2.18 do -1.52) (p < 0.00001), u broju hospitalizacija, srednja vrijednost razlike -8,89 (95 % CI -10,04 do -7,74) (p < 0,00001), te u trajanju hospitalizacije, srednja vrijednost razlike -4,00 dana (95 % CI -4,87 do -3,13) (p < 0,00001).
English: If hydroxycarbamide comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako hidroksikarbamid dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito oprati vodom i sapunom.
English: One ml of solution contains 0.5 mg methyl hydroxybenzoate.
Croatian: Jedan ml otopine sadrži 0,5 mg metilhidroksibenzoata.
English: At the first scheduled interim analysis, non-inferiority was shown and the sponsor terminated the study.
Croatian: Sponzor je prekinuo ispitivanje nakon što je u prvoj planiranoj interim analizi utvrđena neinferiornost.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Supresija koštane srži
English: If appropriate, hydroxycarbamide should be re-started at a lower dose.
Croatian: Prema potrebi, liječenje treba ponovno započeti nižom dozom hidroksikarbamida.
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
Croatian: - Neobjašnjive modrice (nakupljanja krvi ispod kože) ili krvarenje - Rane (otvorene kožne infekcije) na koži
English: EXP:
Croatian: Raspon:
English: Do not breastfeed while taking Xromi.
Croatian: Tijekom uzimanja lijeka Xromi nemojte dojiti.
English: Gently put the tip of the syringe into your mouth and to the inside of your cheek.
Croatian: 7. Pažljivo stavite vrh štrcaljke u usta i usmjerite je prema unutrašnjoj strani obraza.
English: Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Croatian: Kožna vaskulitična toksičnost, uključujući i vaskulitične ulceracije i gangrenu, pojavila se u bolesnika s mijeloproliferativnim poremećajima tijekom terapije hidroksikarbamidom.
English: To minimise air bubbles, do not shake the bottle before administering a dose.
Croatian: Kako bi se mjehurići zraka sveli na najmanju moguću mjeru, nemojte tresti bočicu prije primjene doze.
English: Hydroxycarbamide contact with skin or mucous membrane must be avoided.
Croatian: Potrebno je izbjeći kontakt hidroksikarbamida s kožom ili sluznicom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Weight gain observed during treatment with hydroxycarbamide may be an effect of improved general conditions.
Croatian: Porast težine uočen tijekom liječenja hidroksikarbamidom mogao bi biti posljedica oporavka općeg stanja organizma.
English: The Patient/carer guide shall contain the following key elements:
Croatian: • Vodič za liječenje za bolesnika/njegovatelja Vodič za liječenje za bolesnika/njegovatelja mora sadržavati sljedeće ključne elemente:
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).
Croatian: Vaše pakiranje lijeka Xromi sadrži bočicu lijeka, zatvarač, nastavak za bočicu i dvije štrcaljke za doziranje (crvena štrcaljka od 3 ml i bijela štrcaljka od 12 ml).
English: At lower doses, mild, transient and reversible cytopenias are commonly reported in Sickle Cell Disease patients which is expected based on the pharmacology of hydroxycarbamide.
Croatian: Često su prijavljene blage, prolazne i reverzibilne citopenije pri primjeni nižih doza u bolesnika s bolešću srpastih stanica, što se očekuje na temelju farmakologije hidroksikarbamida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 100 mg hydroxycarbamide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 100 mg hidroksikarbamida.
English: Due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see sections 4.3 and
Croatian: Zbog sigurnosnih razloga hidroksikarbamid je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove
English: PHARMACEUTICAL FORM Oral solution.
Croatian: OBLIK Oralna otopina.
English: These effects lead to a reduction of circulating red, white and coagulation blood cells.
Croatian: To dovodi do smanjenja broja crvenih krvnih stanica, bijelih krvnih stanica i krvnih pločica u cirkulaciji.
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.
Croatian: Cijepljenja Istodobna primjena hidroksikarbamida i cjepiva sa živim virusima može potencirati replikaciju virusa iz cjepiva i/ili pojačati neke od nuspojava na virus cjepiva jer normalni obrambeni mehanizmi mogu biti potisnuti zbog terapije hidroksikarbamidom.
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.
Croatian: Nakon što se krvna slika oporavi treba ponovno započeti liječenje hidroksikarbamidom u dozi koja je za 5 mg/kg/dan niža od doze koja se primjenjivala prije pojave citopenija.
English: Fatal and non-fatal pancreatitis has occurred in HIV-infected patients during therapy with hydroxycarbamide and didanosine, with or without stavudine.
Croatian: Pankreatitis sa smrtnim ishodom ili bez smrtnog ishoda pojavio se u bolesnika zaraženih HIV-om tijekom terapije hidroksikarbamidom u kombinaciji s didanozinom, sa stavudinom ili bez njega.
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.
Croatian: Istodobna primjena hidroksikarbamida i cjepiva sa živim virusima može potencirati replikaciju virusa iz cjepiva i/ili pojačati nuspojavu na virus cjepiva jer normalni obrambeni mehanizmi mogu biti potisnuti zbog terapije hidroksikarbamidom.
English: Do not take Xromi - if you are allergic (hypersensitive) to hydroxycarbamide or any of the other ingredients of Xromi
Croatian: - ako ste alergični (pretjerano osjetljivi) na hidroksikarbamid ili bilo koji drugi sastojak lijeka
English: Hydroxycarbamide is presumed to be a transspecies carcinogen (see section 5.3).
Croatian: Hidroksikarbamid se smatra kancerogenim za različite vrste (vidjeti dio 5.3.).
English: (listed in section 6).
Croatian: (vidjeti dio 6.6.).
English: Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.
Croatian: Uočena je bolnost, ljubičasti eritem, edem dlanova i tabana s ljuštenjem kože na šakama i stopalima, teška generalizirana hiperpigmentacija kože i teški akutni stomatitis.
English: Strawberry flavour Methyl parahydroxybenzoate (E218) Sodium hydroxide (E524) Purified water
Croatian: Metilparahidroksibenzoat (E218) Natrijev hidroksid (E524)
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
Croatian: bijelih krvnih stanica ili krvnih pločica) - terapiju zračenjem ili kemoterapiju - bilo koji lijek za liječenje raka, posebno terapiju interferonom - pri primjeni u kombinaciji s lijekom Xromi povećana je mogućnost nastanka nuspojava kao što je anemija - antiretrovirusne lijekove (koji sprečavaju ili uništavaju retrovirus poput HIV-a), npr. didanozin,
English: Any unused product should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek potrebno je zbrinuti sukladno nacionalnim propisima.
English: Close monitoring of blood parameters is advised in patients with hepatic impairment.
Croatian: Preporučuje se pomno praćenje krvnih parametara u bolesnika s oštećenjem funkcije jetre.
English: There was a statistically significant difference between the hydroxycarbamide group and placebo group in the mean annual crisis rate (all crises), mean difference -2.80 (95% CI -4.74 to -0.86) (p = 0.005), and for crises requiring hospitalisation, mean difference -1.50 (95% CI -2.58 to -0.42) (p = 0.007).
Croatian: Zabilježena je statistički značajna razlika između skupine koja je primala hidroksikarbamid i skupine koja je primala placebo u srednjoj vrijednosti godišnje stope krize (sve krize), srednja vrijednost razlike -2,80 (95 % CI -4,74 do -0,86) (p = 0,005), te u krizama koje zahtijevaju hospitalizaciju, srednja vrijednost razlike -1,50 (95 % CI -2,58 do -0,42) (p = 0,007).
English: Women of childbearing potential/Contraception in males and females Medicinal products which affect DNA synthesis, such as hydroxycarbamide, may be potent mutagenic active substances.
Croatian: Lijekovi koji utječu na sintezu DNK, kao što je hidroksikarbamid, mogu biti djelatne tvari snažnog mutagenog djelovanja.
English: Stomatitis, diarrhoea, vomiting
Croatian: Stomatitis, proljev,
English: It appears that nitroxyl, the corresponding carboxylic acid and nitric oxide are metabolites: Urea has also been shown to be a metabolite of hydroxycarbamide.
Croatian: Čini se da su nitroksil, odgovarajuća karboksilna kiselina i dušikov oksid metaboliti.
English: Other
Croatian: Drugo
English: Thrombocytopenia and anaemia occur less often and are seldom seen without a preceding leukopenia.
Croatian: Rjeđe dolazi do trombocitopenije i anemije, a uglavnom im prethodi leukopenija.
English: Clear, colourless to pale yellow viscous liquid.
Croatian: Bistra, bezbojna do blijedožuta viskozna tekućina.
English: Your doctor or pharmacist will advise you of the correct syringe to use, either the 3 ml (red syringe) or the 12 ml (white syringe) in order to give the correct dose.
Croatian: Liječnik ili ljekarnik savjetovat će vas o tome koju štrcaljku upotrijebiti, od 3 ml (crvena štrcaljka) ili od 12 ml
English: Hydroxycarbamide (n=22)
Croatian: Hidroksikarbamid (n = 22)
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).
Croatian: (2,76 mjeseci u skupini koja je primala hidroksikarbamid, u usporedbi s 1,35 mjeseci u skupini koja je primala placebo (p = 0,014)), do druge bolne krize (6,58 mjeseci u skupini koja je primala hidroksikarbamid, u usporedbi s 4,13 mjeseci u skupini koja je primala placebo (p < 0,0024)) i do treće bolne krize (11,9 mjeseci u skupini koja je primala hidroksikarbamid u usporedbi sa 7,04
English: Common: may affect up to 1 in 10 people - Nausea - Headache - Dizziness - Constipation - Darkening of the skin, nails and mouth - Dry skin - Hair loss
Croatian: - Glavobolja - Omaglica - Zatvor - Zatamnjenje kože, noktiju i usta - Suha koža - Gubitak kose
English: • Full blood cell count with white cell differential and reticulocyte count to be monitored at least every 4 weeks when adjusting dosage.
Croatian: • Kod prilagodbe doze treba pratiti kompletnu krvnu sliku s diferencijalnom bijelom krvnom slikom i brojem retikulocita najmanje svaka četiri tjedna.
English: Fertility in males might be affected by treatment.
Croatian: Terapija može utjecati na plodnost muškaraca.
English: Xromi contains methyl parahydroxybenzoate (E218) Xromi contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Croatian: Xromi sadrži metilparahidroksibenzoat (E218) koji može uzrokovati alergijske reakcije (moguće i odgođene reakcije).
English: Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic medicinal products; hydroxycarbamide should be used cautiously in such patients.
Croatian: Depresija koštane srži vjerojatnija je u bolesnika koji su prethodno liječeni radioterapijom ili citotoksičnim kemoterapijskim lijekovima za liječenje raka.
English: The patient information pack should contain:
Croatian: Informativni paket za bolesnika treba sadržavati sljedeće: • Uputu o lijeku
English: Other side effects which are not mentioned above are listed below.
Croatian: Ostale nuspojave navedene su u tekstu koji slijedi.
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution hydroxycarbamide
Croatian: NAZIV LIJEKA Xromi 100 mg/ml oralna otopina hidroksikarbamid
English: Close monitoring of blood parameters is advised (see section 4.2).
Croatian: Preporučuje se pomno praćenje krvnih parametara (vidjeti dio
English: Slowly and gently push the plunger down to gently squirt the medicine into the inside of your cheek and swallow it. DO NOT forcefully push down the plunger, or squirt the medicine to the back of your mouth or throat, as you may choke.
Croatian: NEMOJTE snažno potiskivati klip ili uštrcati lijek u stražnji dio usne šupljine ili u grlo jer to može izazvati gušenje.
English: Table 3: Mean Haematologic Values Before and After 6 Months of Treatment with hydroxycarbamide (Ferster et al, 1996)
Croatian: Tablica 3.: Srednje hematološke vrijednosti prije i nakon šest mjeseci liječenja hidroksikarbamidom
English: Rare: may affect up to 1 in 1000 people
Croatian: Manje česte nuspojave: mogu se javiti u do 1 na 100 osoba
English: The largest difference in the pharmacokinetic profile was a trend towards a shorter time to peak concentration following ingestion of the liquid compared with the capsule, but that difference did not reach statistical significance (0.74 versus 0.97 hours, p = 0.14).
Croatian: Najveća razlika u farmakokinetičkom profilu bila je tendencija smanjenja u vremenu postizanja vršne koncentracije nakon gutanja tekućine u usporedbi s kapsulom, ali ta razlika nije dosegla statističku značajnost
English: Put on disposable hand gloves before handling Xromi.
Croatian: Prije rukovanja lijekom Xromi navucite jednokratne rukavice.
English: Hepatotoxicity and hepatic failure resulting in death were reported during post-marketing surveillance in HIV-infected patients treated with hydroxycarbamide and other antiretroviral medicinal products.
Croatian: Tijekom nadzora nakon stavljanja lijeka u promet zabilježeni su slučajevi hepatotoksičnosti i zatajenja jetre sa smrtnim ishodom u bolesnika zaraženih HIV-om liječenih hidroksikarbamidom i drugim antiretrovirusnim lijekovima.
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.
Croatian: dana u skupini koja je primala hidroksikarbamid i 15,2 dana u skupini koja je primala placebo.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Sigurno rukovanje
English: This study used a non-inferiority trial design with a primary endpoint of TCD velocity at 24 months, controlling for baseline (enrollment) values.
Croatian: U pogledu izvedbe, korišteno je ispitivanje neinferiornosti, a mjera primarnog ishoda bila je brzina strujanja krvi utvrđena TCD pretragom nakon 24 mjeseca kojom se uzimaju u obzir početne vrijednosti (pristupanje ispitivanju).
English: Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections.
Croatian: Cijepljenje živim cjepivom u bolesnika koji prima hidroksikarbamid može za posljedicu imati teške infekcije.
English: Always use the syringes provided to take your medicine.
Croatian: Za primjenu lijeka uvijek upotrijebite priložene štrcaljke.
English: Hydroxycarbamide is excreted in human breast milk.
Croatian: Hidroksikarbamid se izlučuje u majčino mlijeko.
English: Xromi will decrease the number of painful crises as well as the need for hospitalisation as a result of the disease.
Croatian: Liječenjem lijekom Xromi smanjit će se broj bolnih kriza,
English: ‘EXP'.
Croatian: RMP-a.
English: Very common: may affect more than 1 in 10 people - Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Croatian: - Izostanak ili mali broj spermija u sjemenoj tekućini (azoospermija ili oligospermija).
English: (each graduation of 0.1 ml contains 10 mg of hydroxycarbamide).
Croatian: (svaka gradacija od 0,25 ml sadrži 25 mg hidroksikarbamida).
English: Each pack contains one bottle, a bottle adaptor and two dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Croatian: Svako pakiranje sadrži jednu bočicu, nastavak za bočicu i dvije štrcaljke za doziranje (crvena štrcaljka graduirana do 3 ml i bijela štrcaljka graduirana do 12 ml).
English: Store syringes in a hygienic place with the medicine.
Croatian: Štrcaljke čuvajte na čistom mjestu zajedno s lijekom.
English: Mean corpuscular haemoglobin concentration (MCHC) (%)
Croatian: Srednja vrijednost koncentracije hemoglobina u eritrocitima (MCHC)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: NHLBI-funded Phase III multicenter, randomized clinical trial comparing 24 months of standard treatment (monthly blood transfusions) to alternative treatment (hydroxycarbamide) in 121 children aged 4-16 years with Sickle Cell Disease and abnormal TCD velocities (≥ 200 cm/s) who had received at least 12 months of chronic transfusions and did not have severe vasculopathy, documented clinical stroke, or transient ischaemic attack..
Croatian: Transcranial Doppler with Transfusions Changing to Hydroxycarbamide, TWiTCH) je multicentrično, randomizirano kliničko ispitivanje faze III koje je financirao Nacionalni institut za srce, pluća i krv (NHLBI), u kojem je uspoređeno 24 mjeseca standardnog liječenja (mjesečne transfuzije krvi) sa zamjenskim liječenjem (hidroksikarbamid) u 121 djeteta u dobi od 4 do 16 godina s bolešću srpastih stanica i abnormalnim brzinama strujanja krvi utvrđenima TCD pretragom (≥ 200
English: Hydroxycarbamide, the active substance of Xromi, passes into human breast milk.
Croatian: Hidroksikarbamid, djelatna tvar lijeka Xromi, izlučuje se u majčino mlijeko.
English: Each pack contains one bottle, an HDPE bottle adaptor and 2 polyethylene dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Croatian: Svako pakiranje sadrži jednu bočicu, HDPE nastavak za bočicu i dvije štrcaljke za doziranje od polietilena (crvena štrcaljka graduirana do 3 ml i bijela štrcaljka graduirana do 12 ml).
English: Store the syringe in a hygienic place with the medicine.
Croatian: Štrcaljku čuvajte na čistom mjestu zajedno s lijekom.
English: One ml of solution contains 100 mg of hydroxycarbamide.
Croatian: Jedan ml otopine sadrži 100 mg hidroksikarbamida.
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.
Croatian: Slično tome, u skupini koja je primala hidroksikarbamid nakon šest mjeseci liječenja zabilježeno je značajno povećanje vrijednosti hemoglobina i srednjeg staničnog volumena, dok je broj trombocita i bijelih krvnih stanica značajno smanjen.
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Croatian: U in vitro uvjetima citokromi P450 ljudskih mikrosoma jetre ne metaboliziraju hidroksikarbamid u koncentracijama od 30, 100 i 300 μM.
English: • Patient information pack
Croatian: • Materijali za obuku liječnika • Informativni paket za bolesnika
English: disease and it may cause treatment failure and toxicities (in some cases fatal) in HIV patients (see sections 4.3 and 4.5).
Croatian: Primjena hidroksikarbamida u bolesnika s HIV-om (vidjeti dijelove 4.3. i 4.5.) može uzrokovati neuspjeh liječenja i toksičnost (u nekim slučajevima sa smrtnim ishodom).
English: - Isolated cases of malignant disease of blood cells (leukaemia)
Croatian: Ostale nuspojave (učestalost nije poznata) - Izolirani slučajevi maligne bolesti krvnih stanica (leukemija)
English: 60 children (aged 5-18 years) with three or more blood transfusions or vaso-occlusive crises requiring hospitalisation per year, were randomised to fixed dose 10 mg/mg per day hydroxycarbamide (n=30) or to a matched placebo (n=30).
Croatian: U randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju provedenom u tercijarnoj bolnici u Indiji, 60 djece (u dobi od 5 do 18 godina) s tri ili više transfuzija krvi ili vazookluzivnih kriza godišnje zbog kojih je bila potrebna hospitalizacija randomizirano je u dvije skupine, od kojih je jedna primala fiksnu dozu od 10 mg/kg hidroksikarbamida dnevno (n = 30), a druga odgovarajući placebo (n = 30).