FrancophonIA/ELRC3.0 huggingface dataset:
English: Dipropyleneglycol monomethyl ether
Slovenian: 6.1 Seznam pomožnih snovi butilhidroksitoluen, Dipropilenglikol monometil eter, Isopropilni alkohol
English: Pipettes with yellow caps contain 0.25 ml of product and deliver 15 mg selamectin and 2.5 mg sarolaner Pipettes with orange caps contain 0.5 ml of product and deliver 30 mg selamectin and 5 mg sarolaner Pipettes with green caps contain 1 ml of product and deliver 60 mg selamectin and 10 mg sarolaner
Slovenian: - merilna kapalka z oranžnim pokrovčkom vsebuje 0,5 ml raztopine in sprosti 30 mg selamektina in 5 mg sarolanerja.
English: Keep away from heat, sparks, open flame or other sources of ignition.
Slovenian: Izdelek je lahko vnetljiv, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
English: These effects do not affect the safety or efficacy of the veterinary medicinal product.
Slovenian: Ti učinki običajno izginejo v 24 urah po nanosu in ne vplivajo na varnost niti na učinkovitost zdravila.
English: PACKAGE SIZE
Slovenian: Vsebnost tube
English: A single dose of the product should be administered.
Slovenian: Za zdravljenje zadostuje enkraten odmerek.
English: Treatment of biting lice A single dose of the product should be administered.
Slovenian: Zdravljenje infestacij z ušmi Za zdravljenje zadostuje enkraten odmerek.
English: PHARMACEUTICAL FORM Spot-on solution.
Slovenian: Zdravilo ne učinkuje na odrasle oblike
English: PACKAGE LEAFLET Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Slovenian: Stronghold Plus 15 mg/2.5 mg raztopina kožnih kapljic za mačke ≤2.5 kg Stronghold Plus 30 mg/5 mg raztopina kožnih kapljic za mačke >2.5-5 kg Stronghold Plus 60 mg/10 mg raztopina kožnih kapljic za mačke >5-10 kg
English: PIPETTE
Slovenian: Odmerjanje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Slovenian: NAVODILO ZA UPORABO Stronghold Plus 15 mg/2.5 mg raztopina kožnih kapljic za mačke ≤2.5 kg Stronghold Plus 30 mg/5 mg raztopina kožnih kapljic za mačke >2.5-5 kg Stronghold Plus 60 mg/10 mg raztopina kožnih kapljic za mačke >5-10 kg
English: Selamectin may adversely affect aquatic organisms.
Slovenian: Selamektin učinkovito uniči tudi razvojne oblike Dirofilarie immitis.
English: Treatment schedule
Slovenian: FARMACEVTSKI PODATKI
English: Overdose (symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi)
English: Keep out of the sight and reach of children.
Slovenian: Izogibajte se dotikanja oči z rokami.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg Selamectin/sarolaner
Slovenian: Stronghold Plus 15 mg/2,5 mg kožni nanos, raztopina za mačke ≤ 2,5 kg Stronghold Plus 30 mg/5 mg kožni nanos, raztopina za mačke > 2,5-5 kg Stronghold Plus 60 mg/10 mg kožni nanos, raztopina za mačke > 5-10 kg
English: EU Procedure number Invented name Strength Pharmaceutical Form
Slovenian: Številka EU Izmišljeno ime Jakost Farmacevtska oblika Način uporabe zdravila
English: Most (61%) had a normal outcome with regard to term and normal birth.
Slovenian: Večina (61 %) je imela normalen izid z ozirom na trajanje in normalno rojstvo.
English: • Then drink a large glass of water or any other drink.
Slovenian: • Nato spijte velik kozarec vode ali drugega napitka.
English: Depending on the dose you take, these tests may be performed every two weeks or every two months.
Slovenian: Odvisno od odmerka, ki ga jemljete, bodo te teste opravljali vsaka dva tedna ali vsaka dva meseca.
English: This can cause acute pain crises and organ damage.
Slovenian: To lahko povzroči akutno bolečo krizo in poškodovanje organov.
English: Children less than 2 years of age
Slovenian: Posebne populacije Otroci, mlajši od 2 let
English: Date of first authorisation: 29/06/2007 Date of latest renewal: 24/04/2017
Slovenian: Datum prve odobritve: 29/06/2007 Datum zadnjega podaljšanja: 24/04/2017
English: It can be taken with a glass of water or a very small amount of food.
Slovenian: Lahko ga vzamete s kozarcem vode ali z zelo majhno količino hrane.
English: Do not stop your treatment unless advised by your doctor.
Slovenian: Ne prekinite zdravljenja, razen če vam tako svetuje zdravnik.
English: • Need for contraception
Slovenian: • Potreba po kontracepciji
English: E-mail : contact@addmedica.com
Slovenian: Elektronska pošta: contact@addmedica.com
English: In the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice.
Slovenian: V drugih primerih z znanim potekom je bila nosečnost prekinjena bodisi prostovoljno ali po nasvetu zdravnikov.
English: If you cannot swallow the tablets, you can disintegrate them in water immediately before use:
Slovenian: Če tablet ne morete pogoltniti, jih lahko raztopite v vodi tik pred uporabo:
English: • Risk of medication error due to the availability of two different strengths
Slovenian: • Tveganje za napake pri odmerjanju zdravila zaradi dveh različnih jakosti.
English: An updated RMP shall be submitted on a yearly basis.
Slovenian: Posodobljen RMP je treba predložiti na letni osnovi.
English: The use of effective contraception is strongly recommended.
Slovenian: Zelo priporočljiva je uporaba učinkovite kontracepcije.
English: The same decrease was observed for the number of hospital admissions and the number of days of hospitalisation in the treated groups.
Slovenian: Enako zmanjšanje so opazili pri številu sprejemov v bolnišnico in številu dni hospitalizacije pri zdravljeni skupini.
English: It is currently unknown how long patients should be treated with Siklos.
Slovenian: Trenutno ni znano, kako dolgo je treba bolnike zdraviti z zdravilom Siklos.
English: Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Slovenian: Odsotnost ali nizka količina semenčic v spermi (azoospermija ali oligospermija).
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ta izobraževalni načrt uvesti nacionalno pred začetkom trženja, in kot je dogovorjeno s pristojnimi organi države članice.
English: Patients who are stable on lower doses should be monitored every 2 months.
Slovenian: Bolnike, ki jemljejo nižje odmerke in so stabilni, je treba kontrolirati vsaka dva meseca.
English: Neutropenia is generally the first and most common manifestation of haematological suppression.
Slovenian: Nevtropenija je navadno prva in najpogostejša manifestacija hematološke supresije.
English: 4 Oligospermia and azoospermia are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
Slovenian: 4 Oligospermija in azoospermija sta na splošno reverzibilni, vendar ju je treba upoštevati, kadar obstaja želja po očetovstvu (glejte poglavje 5.3).
English: These disorders are also associated with the underlying disease.
Slovenian: Ti dve motnji sta prav tako povezani z boleznijo.
English: A dose producing haematological toxicity should not be tried more than two times.
Slovenian: Zdravljenje z odmerkom, ki povzroča hematološko toksičnost, se ne sme poskusiti več kot dvakrat.
English: No information is available regarding pharmacokinetic differences due to age (except paediatric patients), gender or race.
Slovenian: Podatki glede farmakokinetičnih razlik zaradi starosti (razen pri pediatričnih bolnikih), spola ali rase niso na voljo.
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.
Slovenian: Trajanje zdravljenja je odgovornost lečečega zdravnika in mora temeljiti na kliničnem in hematološkem statusu posameznega bolnika.
English: 5 Weight gain may be an effect of improved general conditions.
Slovenian: 5 Porast telesne mase je lahko posledica splošnega izboljšanja počutja.
English: Depending on these results your doctor will adjust your dose of Siklos.
Slovenian: Glede na te rezultate bo zdravnik prilagodil vaš odmerek zdravila Siklos.
English: Geriatric, gender, race
Slovenian: Starost, spol, rasa
English: Continue as normal when it is time to take the next dose as prescribed by your doctor.
Slovenian: Z jemanjem nadaljujte normalno, ko je čas za naslednji odmerek, kot vam je to predpisal zdravnik.
English: Conforming to the individual dose, the tablet or the half or quarter of the tablet should be taken once daily, preferably in the morning before breakfast and, where necessary, with a glass of water or a very small amount of food.
Slovenian: Skladno z individualnim odmerkom je treba vzeti eno tableto ali polovico ali četrtino tablete enkrat na dan, po možnosti zjutraj pred zajtrkom in, če je potrebno, s kozarcem vode ali z zelo majhno količino hrane.
English: Severe hepatic impairment (Child-Pugh classification C).
Slovenian: Huda jetrna okvara (Child-Pughova klasifikacija C).
English: Treatment with Siklos and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks.
Slovenian: Zdravljenje z zdravilom Siklos in hkratno imunizacijo s cepivi z živim virusom se sme opravljati le, če koristi brez dvoma prevladajo nad potencialnimi tveganji.
English: Thrombocytopenia and anaemia occur less frequently, and are rarely seen without a preceding neutropenia.
Slovenian: Trombocitopenija in anemija se pojavita manj pogosto in se ju redko opazi brez predhodne nevtropenije.
English: The patient information pack should contain the following key elements:
Slovenian: Informacije za bolnika morajo vsebovati naslednje ključne elemente:
English: Recovery from myelosuppression is usually rapid when therapy is discontinued.
Slovenian: Okrevanje od mielosupresije je običajno hitro, če se terapijo prekine.
English: The biotransformation pathways as well as the metabolites are not fully characterised.
Slovenian: Tako poti biotransformacije kot tudi presnovki niso popolnoma karakterizirani.
English: • Risk to male and female fertility, potential risk to foetus and breast feeding
Slovenian: • Tveganje za plodnost moških in žensk, potencialno tveganje za plod in dojenje
English: For the full list of excipients, see section 6.1.
Slovenian: Za popoln seznam pomožnih snovi glejte poglavje 6.1.
English: Your doctor will tell you how long to take Siklos.
Slovenian: Vaš zdravnik vam bo povedal, kako dolgo jemljite zdravilo Siklos.
English: Your doctor will tell you how much of Siklos to take each day and will describe the dose in whole, half or quarter tablets.
Slovenian: Zdravnik vam bo povedal, koliko zdravila Siklos morate vzeti na dan, in definiral odmerek kot celo tableto, polovico ali četrtino tablete.
English: Gradual dose titration may help to diminish these effects (see section 4.2).
Slovenian: Postopno titriranje odmerka lahko pomaga te učinke zmanjšati (glejte poglavje 4.2).
English: Information sharing is especially required for - antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g. didanosine,
Slovenian: Izmenjava informacij je še posebej potrebna za - antiretrovirusna zdravila (zavirajo ali uničujejo retroviruse, kot npr. HIV), npr. didanozin,
English: In case of non-response (re-occurrence of crises or no decrease in crisis rate) the daily dose may be increased by steps of 2.5 to 5 mg/kg b.w./day using the most appropriate strength.
Slovenian: V primeru neodzivnosti (ponovni pojav kriz ali nezmanjšano število kriz) se dnevni odmerek lahko zviša v korakih po 2,5 do 5 mg/kg TM/dan z uporabo najustreznejše jakosti.
English: Thus, the data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/newborn.
Slovenian: Tako podatki na majhnem številu izpostavljenih nosečnosti ne kažejo nobenih neželenih učinkov na nosečnost ali zdravje plodu/novorojenčka,
English: Patients and/or parents or the legal responsible person must be able to follow directions regarding the administration of this medicine, their monitoring and care.
Slovenian: Bolniki in/ali starši ali zakoniti zastopniki morajo biti zmožni slediti navodilom, ki zadevajo dajanje tega zdravila, spremljanje zdravljenja in nego.
English: 3 Mainly due to an infection with Parvovirus or a splenic sequestration.
Slovenian: 3 V glavnem zaradi okužbe s parvovirusom ali sekvestracije vranice.
English: The prescribed dose of Siklos must be taken once daily, preferably in the morning before breakfast.
Slovenian: Predpisani odmerek zdravila Siklos je treba vzeti vsak dan ob isti uri, po možnosti zjutraj pred zajtrkom.
English: Siklos is not recommended during pregnancy.
Slovenian: Jemanje zdravila Siklos med nosečnostjo ni priporočljivo.
English: The toxic range may be characterised by the following results of blood tests: Neutrophils
Slovenian: Za toksično območje so značilni sledeči rezultati krvnih testov: nevtrofilni levkociti
English: 1 Haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
Slovenian: 1 Do hematološkega okrevanja ponavadi pride v roku dveh tednov od prekinitve jemanja hidroksikarbamida.
English: For the storage of unused broken tablets, see section 5 “How to store Siklos”.
Slovenian: Za shranjevanje neporabljenih prelomljenih tablet glejte poglavje 5 »Shranjevanje zdravila Siklos«.
English: Conventional long-term studies to evaluate the carcinogenic potential of hydroxycarbamide have not been performed.
Slovenian: Konvencionalnih dolgoročnih študij za ocenjevanje karcinogenega potenciala hidroksikarbamida niso izvedli.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu.
English: Always take Siklos exactly as your doctor has told you.
Slovenian: Zdravilo Siklos morate vedno jemati natančno tako, kot vam je naročil zdravnik.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Siklos, dobili komplet z informacijami za zdravnika, ki bodo vseboval naslednje:
English: If you experience (or have experienced) any of the above, please tell your doctor.
Slovenian: Če imate oz. opazite (ali ste imeli oz. opazili) karkoli od omenjenega, obvestite svojega zdravnika.
English: The time to reach maximum plasma concentration and the percentage of the dose excreted in urine were increased in children compared to adults.
Slovenian: Čas za dosego najvišje koncentracije v plazmi in odstotek z urinom izločenega odmerka sta bila pri otrocih, v primerjavi z odraslimi, zvišana.
English: Treatment may then be reinstituted at a reduced dose.
Slovenian: Takrat se zdravljenje, z zmanjšanim odmerkom, lahko ponovno vzpostavi.
English: 3 years.
Slovenian: 6.3 Rok uporabnosti 3 leti.
English: Frequencies are defined as very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so po pogostnosti opredeljeni kot zelo pogosti (> 1/10); pogosti (> 1/100, <1/10); občasni (> 1/1.000, < 1/100); redki (> 1/10.000, < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).V okviru vsake skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti :
English: The most frequently reported adverse reaction is myelosuppression with neutropenia as the most common manifestation.
Slovenian: Neželeni učinek, o katerem so največkrat poročali, je mielosupresija z nevtropenijo kot najbolj pogosta manifestacija.
English: Like all medicines, Siklos can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Siklos neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: In case the prescribed dose requires breaking the tablet in halves or quarters, this should be done out of the reach of food.
Slovenian: V primeru, da predpisani odmerek zahteva, da se tableto prelomi na pol ali na četrtine, je treba to storiti zunaj dosega hrane.
English: • Handling of broken tablets
Slovenian: • Ravnanje z zlomljenimi tabletami
English: Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia.
Slovenian: Nekatere celice postanejo nenormalne, toge in prevzamejo obliko polmeseca ali srpa, kar povzroči anemijo.
English: Reticulocytes < 80,000/mm3 if the haemoglobin concentration < 9 g/dl
Slovenian: < 80.000/mm3, če je koncentracija hemoglobina < 9 g/dl
English: When taking Siklos you will have regular blood tests and check your liver and kidney.
Slovenian: Med jemanjem zdravila Siklos vam bodo delali redne krvne teste in testirali delovanje vaših jeter in ledvic.
English: In patients with a creatinine clearance ≤ 60 ml/min the initial Siklos dose should be decreased by 50%.
Slovenian: Pri bolnikih z očistkom kreatinina ≤ 60 ml/min je treba začetni odmerek zdravila Siklos znižati za 50 %.
English: Beside the inconstant correlation between reduction of crisis rate and the increase in HbF, the cytoreductive effect of hydroxycarbamide, particularly the drop of neutrophils, was the factor with the strongest correlation to a reduced crisis rate.
Slovenian: Poleg nestalne korelacije med zmanjšanjem števila kriz in zvišanjem koncentracije HbF je bil citoreduktivni učinek hidroksikarbamida, še zlasti znižanje števila nevtrofilcev, dejavnik z najmočnejšo korelacijo z zmanjšanjem števila kriz.
English: The growth of children using Siklos should be regularly monitored by the treating doctor.
Slovenian: Rast otrok, ki uporabljajo zdravilo Siklos, mora redno nadzirati lečeči zdravnik.
English: Other medicines and Siklos
Slovenian: Druga zdravila in zdravilo Siklos
English: Because of the rarity of long term data on treatment with hydroxycarbamide in children less than 2 years of age, dose regimens have not been established and thus, in this population, the treatment with hydroxycarbamide is not recommended.
Slovenian: Zaradi redkosti dolgoročnih podatkov o zdravljenju s hidroksikarbamidom pri otrocih, mlajših od 2 let, režima odmerjanja še niso določili, zato pri tej skupini bolnikov zdravljenje s hidroksikarbamidom ni priporočljivo.
English: The adverse reactions are listed below by system organ class and absolute frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in absolutni pogostnosti.
English: In paediatric patients, the half-life was slightly longer and the total clearance related to body weight slightly higher than in adult patients (see section 4.2).
Slovenian: Pri pediatričnih bolnikih je bil razpolovni čas nekoliko daljši in celotni očistek, glede na telesno maso, nekoliko višji kot pri odraslih bolnikih (glejte poglavje 4.2).
English: Siklos must not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravila Siklos se ne sme dajati bolnikom s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) (glejte poglavja 4.3, 4.4 in 5.2).
English: In an open single-dose study in adult patients with Sickle Cell Syndrome (Yan JH et al, 2005) the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Slovenian: V odprti študiji z enkratnim odmerkom pri odraslih bolnikih s srpastoceličnim sindromom (Yan JH et al, 2005) so ugotovili vpliv ledvične funkcije na farmakokinetiko hidroksikarbamida.
English: Under exceptional circumstances a maximum dose of 35 mg/kg b.w./day might be justified under close haematological monitoring (see section 4.4).
Slovenian: Pod izjemnimi okoliščinami je lahko upravičeno dajanje največjega odmerka 35 mg/kg TM/dan, vendar pod skrbnim hematološkim nadziranjem (glejte poglavje 4.4).
English: Haemodialysis reduced the exposure to hydroxycarbamide by 33% (see sections 4.2 and 4.4).
Slovenian: Hemodializa je izpostavljenost hidroksikarbamida znižala za 33 % (glejte poglavji 4.2 in 4.4).
English: In nearly all clinical studies conducted in Sickle Cell Syndrome, hydroxycarbamide reduced the frequency of vaso-occlusive episodes by 66% to 80%, in children and in adults.
Slovenian: Pri skoraj vseh kliničnih študijah, ki so jih opravili pri srpastoceličnem sindromu, je hidroksikarbamid zmanjšal pogostnost vazookluzivnih epizod za 66 % do 80 % pri otrocih in odraslih.
English: If you take more Siklos than you should or if a child has taken any, contact your doctor or the nearest hospital immediately as you may need urgent medical treatment.
Slovenian: Če ste vzeli večji odmerek zdravila Siklos, kot bi smeli, ali je zdravilo vzel otrok, takoj obvestite svojega zdravnika ali najbližjo bolnišnico, saj boste morda potrebovali nujno medicinsko pomoč.
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Addmedica
English: What Siklos is and what it is used for
Slovenian: Kaj je zdravilo Siklos in za kaj ga uporabljamo
English: Hydroxycarbamide is unequivocally genotoxic in a wide range of test systems.
Slovenian: Hidroksikarbamid je nedvoumno genotoksičen pri širokem spektru testnih sistemov.
English: Treatment with Siklos requires close clinical monitoring.
Slovenian: Zdravljenje z zdravilom Siklos zahteva natančno klinično opazovanje.
English: Specifically, the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults over 13 years and 352 children older than 2 years and adolescents up to 12 years.
Slovenian: Preiskana je bila zlasti varnost hidroksikarbamida, retrospektivno iz kohort 123 odraslih, starih več kot 13 let, in 352 otrok, starih več kot 2 leti, ter mladostnikov, starih do 12 let.
English: The dose of Siklos may then be increased again under close haematological monitoring.
Slovenian: Odmerek zdravila Siklos se nato lahko zopet zviša pri natančnem hematološkem opazovanju.
English: • Need for periodic blood counts and dose adjustment
Slovenian: • Potreba po periodičnem preverjanju krvne slike in prilagoditvi odmerka
English: The maximum plasma levels and the apparent volume of distribution related to body weight were well comparable between age groups.
Slovenian: Najvišje vrednosti v plazmi in očitni volumen porazdelitve sta bila, glede na telesno maso, med starostnimi skupinami dobro primerljiva.
English: The treatment guide for physicians should contain the following key elements:
Slovenian: Vodnik za zdravljenje za zdravnika mora vsebovati naslednje ključne elemente:
English: Treatment follow-up
Slovenian: Spremljanje zdravljenja
English: The total exposure up to 24 h post-dose is 124 mg*h/L in children and adolescents and 135 mg*h/L in adult patients.
Slovenian: Popolna izpostavljenost do 24 h po odmerku znaša 124 mg*h/l pri otrocih in mladostnikih ter 135 mg*h/l pri odraslih bolnikih.
English: Delpharm Lille Z.I de Roubaix Est Rue de Toufflers 59390 Lys-Lez-Lannoy France
Slovenian: Delpharm Lille Z.I de Roubaix Est Rue de Toufflers 59390 Lys-Lez-Lannoy Francija
English: It is unknown whether this leukemogenic effect is secondary to hydroxycarbamide or is associated with the patient's underlying disease.
Slovenian: Ni znano, če je levkemogenski učinek sekundarna posledica hidroksikarbamida ali pa je povezan z bolnikovo boleznijo.