FrancophonIA/ELRC3.0 huggingface dataset:
English: In a repeated dose study in adult patients with Sickle Cell Syndrome approximately 60% of the hydroxycarbamide dose was detected in urine at steady state.
Croatian: U studiji ponovljene doze na odraslim bolesnicima sa sindromom srpastih stanica oko 60% doze hidroksikarbamida pronađeno je u urinu u stanju dinamičke ravnoteže.
English: Due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Croatian: Radi sigurnosnih pitanja Siklos je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.3 i 4.4).
English: Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Croatian: Istodobno uzimanje hidroksikarbamida i ostalih mijelosupresivnih lijekova ili terapije zračenjem mogu povećati stupanj depresije koštane srži, izazvati gastrointestinalne poremećaje ili mukozitis.
English: There are no data that support specific guidance for dose adjustment in patients with hepatic impairment, but, due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Ne postoje podaci koji podupiru specifične smjernice za prilagođavanje doze kod bolesnika s oštećenjem funkcije jetre ali je, iz sigurnosnih razloga, Siklos kontraindiciran kod bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.3).
English: Close monitoring of blood parameters is advised in these patients.
Croatian: Kod ovih se pacijenata savjetuje strogo praćenje parametara vrijednosti krvne slike.
English: Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Croatian: Hidroksikarbamid uzrokuje makrocitozu, koja može prikriti razvoj nedostatka folne kiseline i vitamina B12.
English: Haematologic recovery usually occurs within two weeks.
Croatian: Krvna se slika obično oporavlja unutar dva tjedna.
English: Treatment with Siklos should be initiated by a physician experienced in the management of Sickle Cell Syndrome.
Croatian: Terapiju Siklosom treba propisati liječnik s iskustvom u liječenju sindroma srpastih stanica.
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, javili su se u bolesnika s mijeloproliferativnim poremećajima tijekom terapije hidroksikarbamidom.
English: How to take Siklos
Croatian: Kako uzimati Siklos
English: Severe renal impairment (creatinine clearance < 30 ml/min).
Croatian: Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min).
English: Siklos may hence decrease the ability of men to father children.
Croatian: Siklos stoga može smanjiti plodnost kod muškaraca.
English: In patients, whose CrCl was below 60 ml/min or patients with end-stage renal disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.
Croatian: Kod bolesnika čiji je CrCl bio niži od 60 ml/min ili bolesnika u završnom stadiju bolesti bubrega srednja vrijednost izloženosti hidroksikarbamidu bila je oko 64% viša nego kod bolesnika s normalnom bubrežnom funkcijom.
English: Acute chest syndrome is a frequent life-threatening complication of Sickle Cell Syndrome and is characterised by chest pain or fever or dyspnoea with recent infiltrate on chest X-ray.
Croatian: Akutni prsni sindrom česta je komplikacija sindroma srpastih stanica koja može ugroziti život i koju karakterizira bol u prsnom košu ili vrućica ili dispneja uz novonastali infiltrat uočen na rendgenskoj snimci prsnog koša.
English: A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Croatian: Održana klinička korist uočena je u bolesnika liječenih hidroksikarbamidom kod kojih je terapija trajala i do 8 godina.
English: Bone marrow depression is the dose-limiting toxic effect of hydroxycarbamide.
Croatian: Depresija koštane srži predstavlja toksični učinak hidroksikarbamida koji ograničava dozu.
English: The duration of treatment is the responsibility of the treating physician and should be based on the clinical and haematological status of the individual patient.
Croatian: Za trajanje terapije odgovoran je liječnik bolesnika i ona bi se trebala temeljiti na kliničkom statusu i nalazu krvne slike svakog pojedinog bolesnika.
English: Specific interaction studies have not been performed with hydroxycarbamide.
Croatian: S hidroksikarbamidom nisu provedene posebne studije interakcije.
English: Impaired fertility has been observed in male rats (see section 5.3).
Croatian: Poremećaj plodnosti primijećen je kod mužjaka štakora (vidjeti dio 5.3).
English: - The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
Croatian: - Ostali sastojci su natrijev stearilfumarat, silificirana mikrokristalična celuloza i lužnati kopoli (butadien/metakrilat).
English: How to store Siklos
Croatian: Kako čuvati Siklos
English: 2 The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
Croatian: 2 Makrocitoza uzrokovana hidroksikarbamidom ne ovisi o vitaminu B12 niti o folnoj kiselini.
English: These adverse reactions are expected based on the pharmacology of hydroxycarbamide.
Croatian: Ove se nuspojave očekuju na temelju farmakologije hidroksikarbamida.
English: In patients receiving long-term hydroxycarbamide for myeloproliferative disorders, secondary leukaemia has been reported.
Croatian: U bolesnika koji su na dugotrajnoj terapiji hidroksikarbamidom radi mijeloproliferativnih poremećaja, prijavljen je razvoj sekundarne leukemije.
English: The volume of distribution at steady state adjusted for bioavailability is 0.57 L/kg in patients with Sickle Cell Syndrome (amounting to approximately 72 and 90 L in children and adults, respectively).
Croatian: Volumen distribucije u stanju dinamičke ravnoteže prilagođen prema bioraspoloživosti iznosi 0,57 L/kg u bolesnika sa sindromom srpastih stanica (i doseže do 72 L kod djece i 90 L kod odraslih).
English: Date of first authorisation: 29/06/2007 Date of latest renewal: 24/04/2017
Croatian: Datum posljednje obnove odobrenja: 24.04.2017
English: In paediatric and adult patients with Sickle Cell Syndrome the systemic exposure to hydroxycarbamide at steady state was similar by means of the area under the curve.
Croatian: Kod pedijatrijskih i odraslih bolesnika sa sindromom srpastih stanica sistemska izloženost hidroksikarbamidu u stanju dinamičke ravnoteže bila je slična s obzirom na površinu ispod krivulje.
English: In-use
Croatian: U uporabi
English: EXP: In-use shelf life of broken tablets: 3 months
Croatian: Rok valjanosti izlomljenih tableta u uporabi: 3 mjeseca
English: The most common symptoms of overdose with Siklos are: - Redness of the skin, - Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly, - Skin becoming strongly pigmented (locally changes of colour), - Soreness or swelling in the mouth.
Croatian: Najčešći simptomi predoziranja Siklosom su sljedeći: - Crvenilo kože, - Bolnost (bol na dodir) i oticanje dlanova i tabana popraćeno ljuštenjem kože šaka i stopala, - Jaka pigmentacija kože (lokalne promjene boje), - Bolnost ili oticanje u ustima.
English: The evaluation of the risk-benefit ratio should be made on an individual basis outweighing the respective risk of hydroxycarbamide therapy against the switch to a blood transfusion programme.
Croatian: Procjena omjera rizika i koristi potrebno je učiniti za za svakog bolesnika / svaku bolesnicu individualno i odvagnuti rizik terapije hidroksikarbamidom naspram programa transfuzije krvi.
English: The active substance of Siklos, hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells.
Croatian: Djelatna tvar Siklosa je hidroksikarbamid, to je tvar koja sprječava rast i širenje nekih stanica, primjerice krvnih stanica.
English: Siklos 100 mg film-coated tablets Pack sizes of 60, 90 or 120 tablets.
Croatian: Siklos 100 mg filmom obložene tablete Veličine pakiranja od 60, 90 ili 120 tableta.
English: The dose of Siklos may then be increased again under close haematological monitoring.
Croatian: Doza Siklosa može se potom ponovno povećati uz strogo praćenje krvne slike.
English: Siklos 1000 mg film-coated tablets EU/1/07/397/001
Croatian: Siklos 1000 mg filmom obložene tablete EU/1/07/397/001
English: Hydroxycarbamide crosses the placenta barrier and has been demonstrated to be a potent teratogen and embryotoxic in a wide variety of animal models at or below the human therapeutic dose.
Croatian: Hidroksikarbamid prolazi kroz placentu i kod mnogih se životinja pokazalo da je potencijalno teratogen i embriotoksičan, u dozama jednakima ili nižima od doziranja kod ljudi.
English: Leg ulcers are a common complication of Sickle Cell Syndrome, but have also been reported in patients treated with hydroxycarbamide.
Croatian: Ulkusi nogu uobičajena su komplikacija kod sindroma anemije srpastih stanica, ali su zabilježeni i kod bolesnika liječenih hidroksikarbamidom.
English: Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP. Store below 30°C.
Croatian: Siklos se ne smije upotrijebiti nakon isteka roka valjanosti navedenoga na kutiji i boci nakon „Rok valjanosti“.
English: Siklos 100 mg film-coated tablets EU/1/07/397/002
Croatian: Siklos 100 mg filmom obložene tablete EU/1/07/397/002
English: In adults, the total clearance adjusted for bioavailability was 9.89 L/h (0.16 L/h/kg) thereof 5.64 and 4.25 L/h by renal and non-renal clearance, respectively.
Croatian: Kod odraslih bolesnika ukupni klirens prilagođen prema bioraspoloživosti bio je 9,89 L/h (0,16 L/h/kg) od čega se 5,64 L/h odnosilo na renalni klirens, a 4,25 L/h na nerenalni klirens.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse reactions of hydroxycarbamide on hepatic and renal function.
Croatian: Klinički podaci prikupljeni od bolesnika sa sindromom anemije srpastih stanica ne ukazuju na nuspojave hidroksikarbamida vezane uz funkciju jetre i bubrega.
English: After oral administration of 20 mg/kg of hydroxycarbamide, a rapid absorption is observed with peak plasma levels of about 30 mg/L occurring after 0.75 and 1.2 h in children and adult patients with Sickle Cell Syndrome, respectively.
Croatian: Nakon peroralnog uzimanja 20 mg/kg hidroksikarbamida, zabilježena je brza apsorpcija s vršnim vrijednostima u plazmi od oko 30 mg/L koja je nastupila nakon 45 minuta kod djece i 72 minute kod odraslih bolesnika sa sindromom srpastih stanica.
English: The growth of children using Siklos should be regularly monitored by the treating doctor.
Croatian: Liječnik mora redovno pratiti rast djece koja uzimaju Siklos.
English: Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections.
Croatian: Cijepljenje živim cjepivom bolesnika koji prima hidroksikarbamid može za posljedicu imati teške infekcije.
English: Siklos is a medicinal product that must be handled with care.
Croatian: Siklos je lijek kojim se mora pažljivo rukovati.
English: Delpharm Lille Z.I de Roubaix Est Rue de Toufflers 59390 Lys-Lez-Lannoy France
Croatian: Proizvođač Delpharm Lille Z.I de Roubaix Est Rue de Toufflers
English: Siklos 1000 mg is supplied in plastic bottles containing 30 tablets.
Croatian: Siklos 1000 mg dostupan je u plastičnoj boci od 30 tableta.
English: Siklos is a cytotoxic medicine that must be handled with care.
Croatian: Siklos je citotoksični lijek s kojim se mora rukovati vrlo pažljivo.
English: For male patients taking Siklos, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
Croatian: S muškim bolesnicima koji primaju terapiju Siklosom, a čije partnerice ostanu trudne ili planiraju zatrudnjeti, liječnik će raspraviti potencijalne koristi i rizike nastavka terapije Siklosom.
English: Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out.
Croatian: Prašak od prelamanja tablete treba obrisati vlažnim ubrusom za jednokratnu uporabu kojeg se mora odmah baciti.
English: • Growth follow-up of treated children
Croatian: • Praćenje rasta djece koja dobivaju terapiju
English: Addmedica Tel : +44-(0)203-695 9305
Croatian: Tel : +44-(0)203-695 9305
English: Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Croatian: Smanjeni broj crvenih krvnih stanica (anemija), nizak broj krvnih pločica, glavobolja, kožne reakcije, upala ili nastajanje ranica usne šupljine (upala sluznice).
English: In all clinical studies, there was a significant increase in HbF from baseline after hydroxycarbamide use.
Croatian: U svim kliničkim studijama nakon primjene hidroksikarbamida nastupilo je značajno povećanje razine HbF u odnosu na početnu vrijednost.
English: These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect).
Croatian: To dovodi do smanjenja broja crvenih krvnih stanica, bijelih krvnih stanica i krvnih pločica u cirkulaciji (mijelosupresijski učinak).
English: The active substance of Siklos passes into human breast-milk.
Croatian: Djelatna tvar Siklosa se izlučuje u majčino mlijeko.
English: Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Croatian: Siklos 1000 mg filmom obložene tablete su gotovo bijele tablete oblika kapsule, s tri razdjelna ureza na obje strane.
English: High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit.
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu i sredstvom za sušenje.
English: Addmedica Tel : +353-(0)1-903 8043
Croatian: Tel : +353-(0)1-903 8043
English: Addmedica Tel : +31-(0)20-208 2161
Croatian: Tel : +31-(0)20-208 2161
English: - A severe infection, - Tiredness and/or looking pale, - Unexplained bruising (accumulation of blood under the skin) or bleeding, - Unusual headache, - Difficulties in breathing.
Croatian: Odmah se obratite liječniku ako primijetite neku od sljedećih ozbiljnih nuspojava: - Tešku infekciju, - Umor i/ili bljedilo, - Neobjašnjive modrice (nakupljanja krvi ispod kože) ili krvarenje, - Neuobičajene glavobolje, - Teškoće s disanjem.
English: Posology
Croatian: E-pošta
English: Addmedica Tel : +49-(0)30-8878 9408
Croatian: Tel : +49-(0)30-8878 9408
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 tableta
English: Soreness, violet erythema, oedema on palms and soles followed by scaling of hand and feet, severe generalised hyperpigmentation of the skin and stomatitis have been observed.
Croatian: Uočena je bolnost, ljubičasti eritem, edem dlanova i tabana s ljuštenjem kože na šakama i stopalima, teška generalizirana hiperpigmentacija kože i stomatitis.
English: Package leaflet: information for the user Siklos 100 mg film-coated tablets Siklos 1000 mg film-coated tablets hydroxycarbamide
Croatian: Uputa o lijeku: Informacije za korisnika Siklos 100 mg filmom obložene tablete Siklos 1000 mg filmom obložene tablete hidroksikarbamid
English: The adverse reactions are listed below by system organ class and absolute frequency.
Croatian: Nuspojave su navedene u nastavku, prema organskim sustavima i apsolutnoj učestalosti.
English: As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of Siklos in patients with renal impairment.
Croatian: Budući da je put eliminacije izlučivanje bubrezima, potrebno je voditi računa o smanjenju doze Siklosa kod bolesnika s oštećenjem bubrega.
English: Leukaemia and in elderly patients, skin cancers Blood and lymphatic system disorders: Very common: Bone marrow depression1 including neutropenia (< 2.0 x 109/L), reticulocytopenia (< 80 x 109/L), macrocytosis2
Croatian: depresija koštane srži1 uključujući neutropeniju (< 2,0 x 109/L), retikulocitopeniju (< 80 x 109/L), makrocitozu2
English: 60 tablets 90 tablets 120 tablets
Croatian: 120 tableta
English: Addmedica Tel : +32-(0)2-808 2973
Croatian: Tel : +32-(0)2-808 2973
English: - if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6), - if you suffer from severe liver disease, - if you suffer from severe kidney disease, - if you are myelosuppressed (if you have decreased production of red, white, or coagulating blood cells) as described in section 3 “How to take Siklos, Treatment follow-up”, - if you are breast-feeding (see section “Pregnancy,breast-feeding and fertility”).
Croatian: - ako patite od mijelosupresije (imate smanjeno stvaranje crvenih krvnih stanica, bijelih krvnih stanica ili krvnih pločica) kako je opisano u dijelu 3 “Kako uzimati Siklos, Praćenje tijekom liječenja“, - ako dojite (pogledajte dio „Trudnoća , dojenje i plodnost“).
English: Addmedica, 37 rue de Caumartin, 75009 Paris, France
Croatian: Addmedica, 37 rue de Caumartin - 75009 Paris - Francuska
English: For severe painful crises, most patients require hospitalisation.Siklos will decrease the number of painful crises as well as the need for hospitalisation linked with the disease.
Croatian: U slučaju teških bolnih kriza, većini bolesnika je potreban prijem u bolnicu.
English: If you have any question, please ask your doctor or pharmacist or nurse.
Croatian: Ako imate bilo kakvo pitanje molimo obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Close monitoring of blood parameters is advised in patients with hepatic impairment.
Croatian: Strogo praćenje krvne slike preporučuje se kod bolesnika s oštećenjem funkcije jetre.
English: - if you have a liver disease, - if you have a kidney disease, - if you have leg ulcers, - if you are taking other myelosuppressive medicines (decrease production of red, white, or coagulating blood cells) or receiving radiation therapy, - if you have a known lack of vitamin B12 or folate.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Siklos - ako imate bolest jetre, - ako imate bolest bubrega, - ako imate ulkuse (rane) na nogama, - ako uzimate neke druge mijelosupresivne lijekove (koji uzrokuju smanjeno stvaranje crvenih krvnih stanica, bijelih krvnih stanica ili krvnih pločica) ili ste podvrgnuti terapiji zračenjem, - ako imate utvrđen manjak vitamina B12 ili folata.
English: Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides.
Croatian: Siklos 100 mg su gotovo bijele ovalne filmom obložene tablete s razdjelnom linijom na obje strane.
English: Siklos 1000 mg film-coated tablets Pack size of 30 tablets.
Croatian: Siklos 1000 mg filmom obložene tablete Veličina pakiranja od 30 tableta.
English: An effective method of contraception is strongly recommended in women of childbearing potential.
Croatian: Ženama koje mogu zatrudnjeti svakako se preporučuje korištenje učinkovite metode kontracepcije.
English: The yearly frequency of acute chest syndrome was also reduced by 25 to 33% under hydroxycarbamide in several studies.
Croatian: U nekoliko je studija i godišnja učestalost akutnog prsnog sindroma uz hidroksikarbamid smanjena za 25% do 33%.
English: Vascular disorders: Not known:
Croatian: Krvožilni poremećaji: Nepoznato:
English: Treatment follow-up
Croatian: Praćenje tijekom liječenja
English: Cytotoxic Addmedica
Croatian: Deutschland Addmedica
English: In Sickle Cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.
Croatian: Kod bolesti srpastih stanica, hidroksikarbamid pomaže u sprječavanju nastanka poremećenog oblika eritrocita.
English: However, hydroxycarbamide is presumed to be a transspecies carcinogen.
Croatian: Međutim, za hidroksikarbamid se smatra da je kancerogen za različite vrste.
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: Please contact your doctor if you think you may be pregnant.
Croatian: Ako mislite da ste trudni molimo obratite se liječniku.
English: Renal impairment As renal excretion is a main pathway of elimination, dose reduction of Siklos should be considered in patients with renal impairment.
Croatian: Glavni put eliminacije je izlučivanje bubregom pa kod bolesnika sa oštećenjem bubrega treba razmotriti smanjenje doze Siklosa.
English: Hydroxycarbamide is excreted in human milk.
Croatian: Hidroksikarbamid se izlučuje u majčino mlijeko.
English: Hepatobiliary disorders: Rare:
Croatian: Poremećaji jetre i žuči: Rijetko:
English: Elevated liver enzymes Skin and subcutaneous tissue disorders: Common Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis.
Croatian: kožne reakcije (primjerice pigmentacija usne šupljine, noktiju i kože) i oralni mukozitis.
English: DETAILS OF SIDE EFFECTS Very common side effects (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
English: - Fever or chills, - Feeling sick, or a general feeling of being unwell, - Rash (itching red eruption of the skin), - Ulcers or wounds on your legs, - Sore (open skin infection) on your skin, - Disorientation (confusion) and dizziness.
Croatian: Obratite se liječniku što je moguće brže ako primijetite bilo koju od sljedećih nuspojava: - Vrućicu ili zimicu, - Mučninu ili opće loše osjećanje, - Osip (izbijanje crvenih promjena na koži koje svrbe), - Čireve ili rane na nogama, - Rane (otvorene kožne infekcije) na koži, - Dezorijentiranost (smetenost) i omaglicu.
English: stavudine and indinavir (a drop in your white cell count may occur) , - myelosuppressive medicines (those that decrease production of red, white, or coagulating blood cells) and radiation therapy, - some vaccines.
Croatian: Posebice je potrebno dijeljenje informacija za - antiretrovirusne lijekove (koji sprječavaju ili uništavaju retrovirus poput HIV-a), primjerice didanozin, stavudin i indinavir (može se javiti pad broja leukocita), - mijelosupresivne lijekove (koji uzrokuju smanjeno stvaranje crvenih krvnih stanica, bijelih krvnih stanica ili krvnih pločica) i terapiju zračenjem, - neka cjepiva.
English: Some people may experience dizziness when using Siklos.
Croatian: Tijekom uzimanja Siklosa neke osobe mogu osjetiti omaglicu.
English: Store below 30 °C
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30°C
English: - The active substance is hydroxycarbamide.
Croatian: - Djelatna tvar je hidroksikarbamid.
English: Siklos 1000 mg tablets hydroxycarbamide
Croatian: Siklos 1000 mg tablete hidroksikarbamid
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Delpharm Lille
English: Leg ulcers
Croatian: ulkusi nogu
English: Siklos 1000 mg film-coated tablets
Croatian: Siklos 1000 mg filmom obložene tablete
English: Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide.
Croatian: Svaka Siklos 100 mg filmom obložena tableta sadrži 100 mg hidroksikarbamida.
English: Each Siklos 1000 mg film-coated tablet contains 1,000 mg hydroxycarbamide.
Croatian: Svaka Siklos 1000 mg filmom obložena tableta sadrži 1000 mg hidroksikarbamida.