natgillin/translations-raw huggingface dataset:
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.
V zadnjem času se je pokazalo, da je hidroksikarbamid povezan z nastajanjem dušikovega oksida, kar kaže na to, da dušikov oksid spodbuja proizvodnjo cikličnega gvanozin monofosfata (cGMP), ki nato aktivira proteinsko kinazo in poveča nastajanje HbF.
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.
Dokler se bolnik na terapijo bodisi klinično bodisi hematološko (npr. zvišanje koncentracije fetalnega hemoglobina F (HbF), povprečnega volumna eritrocitov (PVE), števila nevtrofilnih levkocitov) odziva, je treba odmerek zdravila Siklos vzdrževati.
Hydroxycarbamide may decrease sperm production in male patients while they are being treated.
Hidroksikarbamid lahko zmanjša nastajanje sperme pri moških bolnikih, medtem ko se zdravijo.
These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy.
O teh toksičnih vaskulitisih so najpogosteje poročali pri bolnikih, ki so bili v preteklosti ali takrat zdravljeni z interferonom.
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.
Zaradi potencialno hudih kliničnih izidov kožnih vaskulitičnih ulkusov, o katerih so poročali pri bolnikih z mieloproliferativno boleznijo, je treba zdravljenje s hidroksikabamidom prekiniti in/ali znižati njegov odmerek, če pride do nastanka kožnih vaskulitičnih ulkusov.
Anyone handling Siklos should wash their hands before and after contact with the tablets.
Vsi, ki rokujejo z zdravilom Siklos, si morajo pred stikom s tabletami in po njem umiti roke.
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.
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, da naj med zdravljenjem s hidroksikarbamidom ustrezno poskrbijo za preprečevanje zanositve, in da naj takoj obvestijo lečečega zdravnika, če zanosijo.
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.
Zdravilo Siklos se uporablja za preprečevanje bolečih kriz, vključno z nenadno bolečino v prsih, ki so posledica srpastoceličnega sindroma, pri odraslih, mladostnikih in otrocih, starejših od 2 let.
Each quarter of tablet is embossed “T” on one side.
Vsaka četrtina tablete ima na eni strani izbočeno črko "T".
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.
Bolniki z normalno (očistek kreatinina CrCl > 80 ml/min), blago (CrCl 60 - 80 ml/min), zmerno (CrCl 30 - < 60 ml/min) ali hudo (< 30 ml/min) okvaro ledvic so prejeli hidroksikarbamid v obliki enkratnega odmerka 15 mg/kg TM, z uporabo 200 mg, 300 mg ali 400 mg kapsul.
Prophylactic administration of folic acid is recommended.
Priporočljivo je preventivno dajanje folne kisline.
Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Sočasna uporaba hidroksikarbamida in drugih mielosupresivnih zdravil ali rentgenske terapije lahko poveča depresijo kostnega mozga, motnje prebavil ali mukozitis.
Treatment with Siklos should be initiated by a physician experienced in the management of Sickle Cell Syndrome.
Zdravljenje z zdravilom Siklos mora začeti zdravnik, izkušen v obravnavanju srpastoceličnega sindroma.
These adverse reactions are expected based on the pharmacology of hydroxycarbamide.
Te neželene učinke se pričakuje na podlagi farmakologije hidroksikarbamida.
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.
Kot so ugotovili v nadaljnji študiji, je bila pri bolnikih s CrCl < 60 ml/min površina pod krivuljo za približno 51 % višja kot pri bolnikih s CrCl ≥ 60 ml/min, kar kaže na to, da je pri bolnikih s CrCl < 60 ml/min primerno zmanjšati odmerek hidroksikarbamida za 50 %.
Due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Zaradi skrbi glede varnosti je Siklos kontraindiciran pri bolnikih s hudo jetrno okvaro (glejte poglavji 4.3 in 4.4).
Wash your hands before and after contact with the tablets.
Pred stikom s tabletami in po njem si umijte roke.
This leaflet was last approved in
Navodilo je bilo nazadnje revidirano dne.
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.
Pri bolnikih, katerih CrCl je bil pod 60 ml/min, ali pri bolnikih z ledvično boleznijo v zadnjem stadiju je bila povprečna izpostavljenost hidroksikarbamidu za približno 64 % višja kot pri bolnikih z normalno ledvično funkcijo.
These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect).
To vodi do zmanjšanja števila krožečih rdečih in belih krvničk ter krvnih ploščic (mielosupresivni učinek).
Since there is no available data in patients with mild to moderate liver impairment, Siklos should be used with caution (see section 4.2).
Ker ni podatkov za bolnike z blago do zmerno jetrno okvaro, je treba zdravilo Siklos uporabljati previdno (glejte poglavje 4.2).
The extent of protein binding of hydroxycarbamide is unknown.
Obseg vezave hidroksikarbamida na proteine ni znan.
Embryotoxicity was characterized by decreased foetal viability, reduced live litter sizes, and developmental delays.
Za embriotoksičnost so bili značilni zmanjšanje viabilnosti plodu, zmanjšano število živih mladičev v leglu in upočasnitve razvoja.
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, ki so ga dali podganjim samcem v odmerku 60 mg/kg TM/dan (približno dvakratni odmerek priporočenega najvišjega odmerka za ljudi), je povzročil atrofijo mod, zmanjšanje spermatogeneze in signifikantno zmanjšano sposobnost za oploditev samic.
Haemoglobin < 4.5 g/dl
< 4,5 g/dl retikulociti
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.
Najpogostejši simptomi za prevelik odmerek zdravila Siklos so: - Pordela koža, - Občutljivost (dotik je boleč) in otekanje dlani in podplatov, kateremu sledi luščenje rok in stopal, - Koža postane močno pigmentirana (lokalne spremembe barve), - Občutljivost in otekline v ustih.
Treatment with Siklos should be discontinued if bone marrow function is markedly depressed.
Zdravljenje z zdravilom Siklos je treba prekiniti, če je delovanje kostnega mozga opazno zavrto.
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.
Po peroralnem dajanju 20 mg/kg hidroksikarbamida se opazi hitra absorbcija z najvišjimi vrednostmi v plazmi okrog 30 mg/l do katerih pride po 0,75 h pri otrocih in 1,2 h pri odraslih bolnikih s srpastoceličnim sindromom.
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.
Akutni sindrom bolečine v prsih je pogost življenjsko nevaren zaplet srpastoceličnega sindroma, zanj pa so značilni bolečina v prsih ali povišana telesna temperatura ali dispneja z infiltratom, videnim na zadnji rentgenski sliki prsnega koša.
- 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.
- če imate jetrno bolezen, - če imate ledvično bolezen, - če imate ulkuse (razjede) na nogah, - če jemljete druga mielosupresivna zdravila (zmanjšujejo tvorbo rdečih ali belih krvničk ali krvnih ploščic) ali vas zdravijo z obsevanjem (radioterapijo), - če imate znano pomanjkanje vitamina B12 ali folatov.
2 The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
2 Makrocitoza, ki je posledica hidroksikarbamida, ni odvisna od vitamina B12 ali folne kisline.
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.
V študiji s ponavljajočimi odmerki pri odraslih bolnikih s srpastoceličnim sindromom so v stanju dinamičnega ravnovesja približno 60 % hidroksikarbamida odkrili v urinu.
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.
Posamezni primeri malignih bolezni krvnih celic (levkemija), kožni rak pri starejših bolnikih, virusne okužbe s Parvovirus B19, krvavitev, prebavne motnje, bruhanje, suha koža, povišana telesna temperatura, izostanek menstrualnih ciklov (amenoreja) in povečana telesna masa.
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).
Pri bolnikih s srpastoceličnim sindromom so v posameznih primerih prevelikega odmerjanja hidroksikarbamida (1,43-krat in 8,57-krat višji odmerek od priporočenega odmerka 35 mg/kg TM/dan) poročali o nevtropeniji.
- The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
- Druge sestavine zdravila so natrijev stearilfumarat, silicizirana mikrokristalna celuloza in kopolimer bazičnega butilmetakrilata.
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.
Pri odraslih je celotni očistek, prilagojen glede na biološko uporabnost, znašal 9,89 l/h (0,16 l/h/kg), od tega 5,64 l/h z ledvičnim in 4,25 l/h z neledvičnim očistkom.
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.
stavudin in indinavir (lahko pride do upadanja števila belih krvničk), - mielosupresivna zdravila (zmanjšujejo proizvodnjo rdečih ali belih krvničk ali krvnih ploščic) in terapija z obsevanjem, - nekatera cepiva.
Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Zdravilo Siklos je na voljo v plastenkah, ki vsebujejo 60, 90 ali 120 tablet.
Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-glycoprotein.
Zato v primeru sočasnega dajanja s snovmi, ki so substrati citokromov P450 ali P-glikoproteina, ni pričakovati medsebojnega delovanja.
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.
Če med jemanjem zdravila Siklos zanosite ali načrtujete nosečnost, se bo zdravnik z vami pogovoril o potencialnih koristih in tveganjih nadaljevanja zdravljenja z zdravilom Siklos.
Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Hidroksikarbamid povzroča makrocitozo, kar pa lahko prikrije naključno pomanjkanje folne kisline in vitamina B12.
Because of the potential for serious adverse reactions in infants, breast-feeding must be discontinued while taking Siklos.
Zaradi potencialno hudih neželenih učinkov pri dojenčkih, med jemanjem zdravila Siklos prenehajte z dojenjem.
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).
Volumen porazdelitve v stanju dinamičnega ravnovesja, prilagojen glede na biološko uporabnost, znaša pri bolnikih s srpastoceličnim sindromom 0,57 l/kg (to predstavlja približno 72 l pri otrocih in 90 l pri odraslih).
Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Zmanjšano število rdečih krvničk (anemija), nizko število krvnih ploščic, glavobol, kožne reakcije, vnetje ali razjede v ustih (oralni mukozitis).
In patients with leg ulcers, Siklos should be used with caution.
Pri bolnikih z ulkusi na nogah je treba zdravilo uporabljati previdno.
The active substance of Siklos passes into human breast-milk.
Zdravilna učinkovina zdravila Siklos prehaja v materino mleko.
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.
Če ste moški bolnik, ki jemlje zdravilo Siklos, in vaša partnerica zanosi ali načrtuje nosečnost, se bo zdravnik z vami pogovoril o potencialnih koristih in tveganjih nadaljevanja zdravljenja z zdravilom
Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Srpastocelični sindrom je dedna bolezen, ki vpliva na rdeče krvne celice v obliki ploščice.
An effective method of contraception is strongly recommended in women of childbearing potential.
Pri ženskah v rodni dobi je zelo priporočljiva uporaba učinkovite kontracepcije.
Male and female patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Moški in ženske, ki želijo zanositi oz. spočeti otroka, morajo z zdravljenjem prekiniti 3 do 6 mesecev preden je možna zanositev.
The specific mechanism of action of hydroxycarbamide is not fully understood.
Specifični mehanizem delovanja hidroksikarbamida zaenkrat še ni povsem jasen.
Specific interaction studies have not been performed with hydroxycarbamide.
Specifičnih študij o medsebojnem delovanju s hikdroksikarbamidom niso opravili.
Leg ulcers are a common complication of Sickle Cell Syndrome, but have also been reported in patients treated with hydroxycarbamide.
Ulkusi na nogah so pogost zaplet pri srpastoceličnem sindromu, o njih pa so poročali tudi pri bolnikih, zdravljenih s hidroksikarbamidom.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Siklos 1000 mg film-coated tablets EU/1/07/397/001
Siklos 1000 mg filmsko obložene tablete EU/1/07/397/001
How to take Siklos
Kako jemati zdravilo Siklos
The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse reactions of hydroxycarbamide on hepatic and renal function.
Klinični podatki, zbrani pri bolnikih s srpastoceličnim sindromom, ne kažejo, da bi imel hidroksikarbamid neželene učinke na jetrno in ledvično funkcijo.
Siklos 100 mg film-coated tablets EU/1/07/397/002
Siklos 100 mg filmsko obložene tablete EU/1/07/397/002
• As soon as the tablet is disintegrated, swallow the content of the teaspoon.
• Ko ste tableta razpusti, zaužijte celotno vsebino čajne žličke.
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.
Ustrezna vrednost za celoten očistek je pri otrocih znašala 7,25 l/h (0,20 l/h/kg), z 2,91 l/h po ledvični poti in 4,34 l/h po neledvični poti.
What Siklos looks like and contents of the pack
Izgled zdravila Siklos in vsebina pakiranja
Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Hidroksikarbamid se pri 30, 100 in 300 µM s sistemom citokroma P450 jetrnih mikrosomov in vitro ne presnavlja.
In-use
V uporabi
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.
Najpogosteje ugotovljeni neželeni učinki, ugotovljeni v predkliničnih študijah toksičnosti, so depresija kostnega mozga, atrofija limfoidnega tkiva in degenerativne spremembe epitela tankega in debelega črevesa.
The tablet can be divided into two equal parts.
Tableto je možno razdeliti na dve enaki polovici.
In patients receiving long-term hydroxycarbamide for myeloproliferative disorders, secondary leukaemia has been reported.
Pri bolnikih, ki so dolgoročno prejemali hidroksikarbamid za zdravljenje mieloproliferativnih motenj, so poročali o pojavu sekundarne levkemije.
Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP. Store below 30°C.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki poleg oznake "EXP".
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.
Pri pediatričnih in odraslih bolnikih s srpastoceličnim sindromom je bila izpostavljenost hidroksikarbamidu, pri vzpostavljenem ravnotežju zdravila, po površini pod krivuljo podobna.
• Patient information pack
• Komplet z informacijami za bolnika
Siklos is a cytotoxic medicine that must be handled with care.
Siklos je citotoksično zdravilo, s katerim je treba ravnati previdno.
In all clinical studies, there was a significant increase in HbF from baseline after hydroxycarbamide use.
Pri vseh kliničnih študijah so po uporabi hidroksikarbamida opazili znaten porast HbF v primerjavi z izhodiščno točko,
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.
Zdravilo Siklos zmanjšuje tako število bolečih kriz kot tudi potrebo po hospitalizaciji, povezani z boleznijo.
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
Neznana pogostnost: okužba s parvovirusom B19 Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Neznana pogostnost: levkemija pri starejših bolnikih, kožni raki Bolezni krvi in limfatičnega sistema: Zelo pogosti: depresija kostnega mozga1 vključno z nevtropenijo (< 2,0 x 109/l), retikulocitopenija (< 80 x 109/l), makrocitoza2 Pogosti: trombocitopenija (< 80 x 109/l), anemija (hemoglobin < 4,5 g/dl)3 Bolezni živčevja: Pogosti: glavobol Občasni: omotica Žilne bolezni: Neznana pogostnost: krvavitve
The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment.
Pred zdravljenjem in večkrat med zdravljenjem je treba opredeliti tako hematološki status bolnika kot tudi ledvične in jetrne funkcije.
High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit.
Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno zaporko s sušilnim sredstvom.
Siklos 1000 mg is supplied in plastic bottles containing 30 tablets.
Zdravilo Siklos je na voljo v plastenkah, ki vsebujejo 30 tablet.
What you need to know before you take Siklos Do not take Siklos
Kaj morate vedeti, preden boste vzeli zdravilo Siklos 3.
In Sickle Cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.
Pri srpastoceličnem sindromu hidroksikarbamid pomaga preprečevati nastanek nenormalne oblike rdečih krvničk.
Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Siklos 1000 mg filmsko obložene tablete so sivobele tablete v obliki kapsul, označene s tremi zarezami na obeh straneh.
A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Pri bolnikih, ki so hidroksikarbamido jemali do 8 let, so se pokazale trajnostne klinične koristi.
Bone marrow depression is the dose-limiting toxic effect of hydroxycarbamide.
Depresija kostnega mozga je neželeni učinek, katerega posledica je omejitev odmerka hidroksikarbamida.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Addmedica
Hydroxycarbamide is excreted in human milk.
Hidroksikarbamid se izloča v materino mleko.
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.
Dokazali so, da je v višini terapevtskega odmerka za ljudi ali pod njim potentno teratogen in embriotoksičen za mnogo vrst živalskih modelov.
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.
Opazili so občutljivost, vijolični eritem, edeme na dlaneh in podplatih, katerim sledi luščenje rok in stopal, hudo generalizirano hiperpigmentacijo kože in stomatitis.
- A severe infection, - Tiredness and/or looking pale, - Unexplained bruising (accumulation of blood under the skin) or bleeding, - Unusual headache, - Difficulties in breathing.
Takoj obvestite svojega zdravnika, če opazite kateregakoli od sledečih resnih neželenih učinkov: - Huda okužba, - Utrujenost in/ali bleda koža, - Nepojasnjene modrice (kopičenje krvi pod kožo) ali krvavitve, - Neobičajen glavobol, - Težave pri dihanju.
Skin cancer has also been reported in patients receiving long-term hydroxycarbamide.
Pri bolnikih, ki so dolgoročno prejemali hidroksikarbamid, so poročali tudi o kožnem raku.
As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of Siklos in patients with renal impairment.
Ker je ledvično izločanje pot eliminacije, je treba pri bolnikih z ledvično okvaro premisliti o znižanju odmerka zdravila Siklos.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 tablet
Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out.
Prašek, ki slučajno nastane pri lomljenju tablete, je treba pobrisati z vlažno brisačo za enkratno uporabo in brisačo zavreči.
- 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”).
- če je pri vas izražena mielosupresija (če imate zmanjšano tvorbo rdečih ali belih krvničk ali krvnih ploščic), kot je opisano v poglavju 3 "Kako jemati zdravilo Siklos, spremljanje zdravljenja", - če dojite (glejte poglavje "Nosečnost in, dojenje in plodnost").