FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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.
English: - The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
Slovenian: - Druge sestavine zdravila so natrijev stearilfumarat, silicizirana mikrokristalna celuloza in kopolimer bazičnega butilmetakrilata.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Slovenian: Zdravilo Siklos je na voljo v plastenkah, ki vsebujejo 60, 90 ali 120 tablet.
English: Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-glycoprotein.
Slovenian: Zato v primeru sočasnega dajanja s snovmi, ki so substrati citokromov P450 ali P-glikoproteina, ni pričakovati medsebojnega delovanja.
English: 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.
Slovenian: 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.
English: Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Slovenian: Hidroksikarbamid povzroča makrocitozo, kar pa lahko prikrije naključno pomanjkanje folne kisline in vitamina B12.
English: Because of the potential for serious adverse reactions in infants, breast-feeding must be discontinued while taking Siklos.
Slovenian: Zaradi potencialno hudih neželenih učinkov pri dojenčkih, med jemanjem zdravila Siklos prenehajte z dojenjem.
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).
Slovenian: 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).
English: Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Slovenian: Zmanjšano število rdečih krvničk (anemija), nizko število krvnih ploščic, glavobol, kožne reakcije, vnetje ali razjede v ustih (oralni mukozitis).
English: In patients with leg ulcers, Siklos should be used with caution.
Slovenian: Pri bolnikih z ulkusi na nogah je treba zdravilo uporabljati previdno.
English: The active substance of Siklos passes into human breast-milk.
Slovenian: Zdravilna učinkovina zdravila Siklos prehaja v materino mleko.
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.
Slovenian: 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
English: Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Slovenian: Srpastocelični sindrom je dedna bolezen, ki vpliva na rdeče krvne celice v obliki ploščice.
English: An effective method of contraception is strongly recommended in women of childbearing potential.
Slovenian: Pri ženskah v rodni dobi je zelo priporočljiva uporaba učinkovite kontracepcije.
English: Male and female patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Slovenian: Moški in ženske, ki želijo zanositi oz. spočeti otroka, morajo z zdravljenjem prekiniti 3 do 6 mesecev preden je možna zanositev.
English: The specific mechanism of action of hydroxycarbamide is not fully understood.
Slovenian: Specifični mehanizem delovanja hidroksikarbamida zaenkrat še ni povsem jasen.
English: Specific interaction studies have not been performed with hydroxycarbamide.
Slovenian: Specifičnih študij o medsebojnem delovanju s hikdroksikarbamidom niso opravili.
English: Leg ulcers are a common complication of Sickle Cell Syndrome, 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: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Siklos 1000 mg film-coated tablets EU/1/07/397/001
Slovenian: Siklos 1000 mg filmsko obložene tablete EU/1/07/397/001
English: How to take Siklos
Slovenian: Kako jemati zdravilo Siklos
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.
Slovenian: Klinični podatki, zbrani pri bolnikih s srpastoceličnim sindromom, ne kažejo, da bi imel hidroksikarbamid neželene učinke na jetrno in ledvično funkcijo.
English: Siklos 100 mg film-coated tablets EU/1/07/397/002
Slovenian: Siklos 100 mg filmsko obložene tablete EU/1/07/397/002
English: • As soon as the tablet is disintegrated, swallow the content of the teaspoon.
Slovenian: • Ko ste tableta razpusti, zaužijte celotno vsebino čajne žličke.
English: 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.
Slovenian: 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.
English: What Siklos looks like and contents of the pack
Slovenian: Izgled zdravila Siklos in vsebina pakiranja
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: In-use
Slovenian: V uporabi
English: 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.
Slovenian: Najpogosteje ugotovljeni neželeni učinki, ugotovljeni v predkliničnih študijah toksičnosti, so depresija kostnega mozga, atrofija limfoidnega tkiva in degenerativne spremembe epitela tankega in debelega črevesa.
English: The tablet can be divided into two equal parts.
Slovenian: Tableto je možno razdeliti na dve enaki polovici.
English: In patients receiving long-term hydroxycarbamide for myeloproliferative disorders, secondary leukaemia has been reported.
Slovenian: Pri bolnikih, ki so dolgoročno prejemali hidroksikarbamid za zdravljenje mieloproliferativnih motenj, so poročali o pojavu sekundarne levkemije.
English: Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP. Store below 30°C.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki poleg oznake "EXP".
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.
Slovenian: Pri pediatričnih in odraslih bolnikih s srpastoceličnim sindromom je bila izpostavljenost hidroksikarbamidu, pri vzpostavljenem ravnotežju zdravila, po površini pod krivuljo podobna.
English: • Patient information pack
Slovenian: • Komplet z informacijami za bolnika
English: Siklos is a cytotoxic medicine that must be handled with care.
Slovenian: Siklos je citotoksično zdravilo, s katerim je treba ravnati previdno.
English: Addmedica Tel : +44-(0)203-695 9305
Slovenian: Tel : +44-(0)203-695 9305
English: In all clinical studies, there was a significant increase in HbF from baseline after hydroxycarbamide use.
Slovenian: Pri vseh kliničnih študijah so po uporabi hidroksikarbamida opazili znaten porast HbF v primerjavi z izhodiščno točko,
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.
Slovenian: Zdravilo Siklos zmanjšuje tako število bolečih kriz kot tudi potrebo po hospitalizaciji, povezani z boleznijo.
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
Slovenian: 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
English: The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment.
Slovenian: Pred zdravljenjem in večkrat med zdravljenjem je treba opredeliti tako hematološki status bolnika kot tudi ledvične in jetrne funkcije.
English: High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno zaporko s sušilnim sredstvom.
English: Siklos 1000 mg is supplied in plastic bottles containing 30 tablets.
Slovenian: Zdravilo Siklos je na voljo v plastenkah, ki vsebujejo 30 tablet.
English: What you need to know before you take Siklos Do not take Siklos
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Siklos 3.
English: Addmedica Tel : +353-(0)1-903 8043
Slovenian: Tel : +353-(0)1-903 8043
English: In Sickle Cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.
Slovenian: Pri srpastoceličnem sindromu hidroksikarbamid pomaga preprečevati nastanek nenormalne oblike rdečih krvničk.
English: Addmedica Tel : +31-(0)20-208 2161
Slovenian: Tel : +31-(0)20-208 2161
English: Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Slovenian: Siklos 1000 mg filmsko obložene tablete so sivobele tablete v obliki kapsul, označene s tremi zarezami na obeh straneh.
English: Addmedica Tel : +49-(0)30-8878 9408
Slovenian: Tel : +49-(0)30-8878 9408
English: A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Slovenian: Pri bolnikih, ki so hidroksikarbamido jemali do 8 let, so se pokazale trajnostne klinične koristi.
English: Bone marrow depression is the dose-limiting toxic effect of hydroxycarbamide.
Slovenian: Depresija kostnega mozga je neželeni učinek, katerega posledica je omejitev odmerka hidroksikarbamida.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Addmedica
English: Hydroxycarbamide is excreted in human milk.
Slovenian: Hidroksikarbamid se izloča v materino mleko.
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.
Slovenian: Dokazali so, da je v višini terapevtskega odmerka za ljudi ali pod njim potentno teratogen in embriotoksičen za mnogo vrst živalskih modelov.
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.
Slovenian: Opazili so občutljivost, vijolični eritem, edeme na dlaneh in podplatih, katerim sledi luščenje rok in stopal, hudo generalizirano hiperpigmentacijo kože in stomatitis.
English: Addmedica Tel : +32-(0)2-808 2973
Slovenian: Tel : +32-(0)2-808 2973
English: - A severe infection, - Tiredness and/or looking pale, - Unexplained bruising (accumulation of blood under the skin) or bleeding, - Unusual headache, - Difficulties in breathing.
Slovenian: 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.
English: Skin cancer has also been reported in patients receiving long-term hydroxycarbamide.
Slovenian: Pri bolnikih, ki so dolgoročno prejemali hidroksikarbamid, so poročali tudi o kožnem raku.
English: As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of Siklos in patients with renal impairment.
Slovenian: Ker je ledvično izločanje pot eliminacije, je treba pri bolnikih z ledvično okvaro premisliti o znižanju odmerka zdravila Siklos.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 tablet
English: Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out.
Slovenian: Prašek, ki slučajno nastane pri lomljenju tablete, je treba pobrisati z vlažno brisačo za enkratno uporabo in brisačo zavreči.
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”).
Slovenian: - 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").
English: All pack sizes may not be marketed.
Slovenian: Ta trgu morda ni vseh navedenih pakiranj.
English: Rarely, ulcers are caused by leukocytoclastic vasculitis.
Slovenian: Levkocitoklastični vaskulitis redko povzroča ulkuse.
English: Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13
Slovenian: Faks: +33 1 73 72 94 13
English: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Syndrome (see section 5.1).
Slovenian: Zdravilo Siklos je indicirano za preprečevanje ponavljajočih se bolečih vazookluzivnih kriz, vključno z akutnim sindromom bolečine v prsih pri odraslih bolnikih in otrocih, starih več kot 2 leti, ki imajo simptomatični srpastocelični sindrom.
English: and the usual dose is between 15 and 30 mg/kg b.w./day.
Slovenian: 30 mg/kg TM/dan.
English: Infections and infestations: Not known:
Slovenian: Infekcijske in parazitske bolezni:
English: Siklos 100 mg tablets hydroxycarbamide Oral use
Slovenian: Siklos 100 mg tablet hidroksikarbamid peroralna uporaba
English: You can add a drop of syrup or mix the content with food to mask a possible bitter taste.
Slovenian: dodajte kapljico sirupa ali vsebino premešajte s hrano.
English: 60 tablets 90 tablets 120 tablets
Slovenian: 120 tablet
English: Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides.
Slovenian: Siklos 100 mg filmsko obložene tablete so sivobele podolgovate tablete z zarezo na obeh straneh.
English: However, hydroxycarbamide is presumed to be a transspecies carcinogen.
Slovenian: Vendar pa domnevajo, da je hidroksikarbamid karcinogen za različne vrste.
English: Renal impairment As renal excretion is a main pathway of elimination, dose reduction of Siklos should be considered in patients with renal impairment.
Slovenian: Ker je ledvično izločanje glavna pot eliminacije, je treba pri bolnikih z ledvično okvaro razmisliti o zmanjšanju odmerka zdravila Siklos.
English: Off-white oblong-shaped, film-coated tablet with half-scoring on both sides.
Slovenian: Sivobela, podolgovata, filmsko obložena tableta z zarezo na polovici na obeh straneh.
English: If you have any question, please ask your doctor or pharmacist or nurse.
Slovenian: Če imate kakršno koli vprašanje, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: Very rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (frequency cannot be estimated from the available data):
Slovenian: Zelo redki neželeni učinki ali neznana pogostnost:
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxycarbamide in combination with antiretroviral medicinal products, particularly didanosine plus stavudine.
Slovenian: Pri bolnikih, okuženih z virusom HIV, ki so prejemali hidroksikarbamid v kombinaciji z antiretroviralnimi zdravili, zlasti z didanozinom in s stavudinom, so poročali o pankreatitisu in hepatotosičnosti s potencialno smrtnim izidom in hudi periferni nevropatiji.
English: The starting dose of hydroxycarbamide is 15 mg/kg b.w.
Slovenian: Začetni odmerek hidroksikarbamida je 15 mg/kg TM, običajni odmerek znaša med 15 in
English: Cytotoxic Addmedica
Slovenian: Magyarország Addmedica
English: Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at doses several times above the therapeutic dose.
Slovenian: Pri bolnikih, ki so prejemali hidroksikarbamid v nekajkrat višjih odmerkih od terapevtskega odmerka, so poročali o akutni mukokutani toksičnosti.
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.
Slovenian: Čimprej obvestite svojega zdravnika, če opazite kateregakoli od sledečih neželenih učinkov zdravila: - Povišana telesna temperatura ali mrzlica, - Občutek slabosti ali splošno slabo počutje, - Izpuščaj (srbeči rdeči kožni izpuščaj), - Ulkusi (razjede) ali rane na nogah, - Rane (odprte kožne okužbe) na koži, - Zmedenost (konfuznost) in omotičnost.
English: Urea is one metabolite of hydroxycarbamide.
Slovenian: Sečnina je eden od presnovkov hidroksikarbamida.
English: Cutaneous dryness Reproductive system and breast disorders: Very common: Oligospermia , azoospermia4 Not known:
Slovenian: Zelo pogosti : oligospermija, azoospermija4 Neznana pogostnost: amenoreja Splošne težave in spremembe na mestu aplikacije: Neznana pogostnost: povišana telesna temperatura
English: How to store Siklos
Slovenian: Shranjevanje zdravila Siklos
English: Hydroxycarbamide is presumed to be a transspecies carcinogen.
Slovenian: Domnevajo, da je hidroksikarbamid karcinogen za različne vrste.
English: Siklos 100 mg film-coated tablets Pack sizes of 60, 90 or 120 tablets.
Slovenian: Velikosti pakiranj: 60, 90 ali 120 tablet.
English: Addmedica, 37 rue de Caumartin, 75009 Paris, France
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Addmedica, 37 rue de Caumartin - 75009 Pariz, Francija
English: Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Slovenian: Pri bolnikih z mieloproliferativnimi motnjami so se med terapijo s hidroksikarbamidom pojavili toksični kožni vaskulitisi, vključno z vaskulitičnimi ulkusi in gangreno.
English: Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide.
Slovenian: Ena Siklos 100 mg filmsko obložena tableta vsebuje 100 mg hidroksikarbamida.
English: Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
Slovenian: Če med jemanjem zdravila Siklos postanete omotični, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
English: Please contact your doctor if you think you may be pregnant.
Slovenian: Če menite, da bi lahko bili noseči, se posvetujte z zdravnikom.
English: Each Siklos 1000 mg film-coated tablet contains 1,000 mg hydroxycarbamide.
Slovenian: Ena Siklos 1000 mg filmsko obložena tableta vsebuje 1.000 mg hidroksikarbamida.
English: Off-white, capsule-shaped, film-coated tablet with triple scoring on both sides.
Slovenian: Sivobela, filmsko obložena tableta v obliki kapsule s tremi zarezami na obeh straneh.
English: Package leaflet: information for the user Siklos 100 mg film-coated tablets Siklos 1000 mg film-coated tablets hydroxycarbamide
Slovenian: Navodilo za uporabo Siklos 100 mg filmsko obložene tablete Siklos 1000 mg filmsko obložene tablete hidroksikarbamid
English: Siklos 100 mg film-coated tablets.
Slovenian: Siklos 100 mg filmsko obložene tablete.
English: Siklos 1000 mg film-coated tablets
Slovenian: Siklos 1000 mg filmsko obložene tablete
English: Adding a drop of syrup or mixing with food can mask a possible bitter taste.
Slovenian: Če želite prekriti možen grenak okus,
English: 5 How to store Siklos Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Siklos 100 mg film-coated tablets
Slovenian: Siklos 100 mg filmsko obložene tablete
English: Siklos 1000 mg film-coated tablets.
Slovenian: Siklos 1000 mg filmsko obložene tablete.
English: Elevated liver enzymes Skin and subcutaneous tissue disorders: Common Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis.
Slovenian: Občasni: navzea Neznana pogostnost: prebavne motnje, bruhanje, gastrointestinalna razjeda, huda hipomagneziemija Bolezni jeter, žolčnika in žolčevodov Redki: zvišane vrednosti jetrnih encimov Bolezni kože in podkožja: Pogosti: kožne reakcije (na primer pigmentacija ust, nohtov in kože) in oralni mukozitis.
English: 2D barcode carrying the unique identifier included
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
English: Siklos 1000 mg tablets hydroxycarbamide
Slovenian: Siklos 1000 mg tablete hidroksikarbamid
English: Siklos 1000 mg film-coated tablets Each film-coated tablet contains 1,000 mg of hydroxycarbamide.
Slovenian: Siklos 1000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1000 mg hidroksikarbamida.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU