natgillin/translations-raw huggingface dataset:
In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide. 
V nekaterih primerih bo zdravnik lahko predpisal zdravilo proti driski, na primer loperamid.
Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose. 
Levkopenijo in nevtropenijo so opazili pri podobni skupini bolnikov, ki so jemali 800 mg/dan ali več.
Thirteen patients discontinued treatment due to an adverse event. 
Trinajst bolnikov je zdravljenje zaključilo zaradi neželenega učinka.
The terminal half-life of radioactivity in plasma was 150 h suggesting the presence of one or more metabolites with very long half-life. 
Končna razpolovna doba radioaktivnosti v plazmi je bila 150 h, kar kaže na prisotnost enega ali več presnovkov z zelo dolgo razpolovno dobo.
The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Yargesa (see section 4 for further details). 
Te preiskave bodo zdravniku v pomoč pri presoji, ali so ti učinki posledica vaše bolezni ali drugega obstoječega stanja ali posledica neželenih učinkov zdravila Yargesa (za dodatne informacije glejte poglavje 4).
In case of overdose general medical care is recommended. 
Ravnanje Pri prevelikem odmerjanju se priporoča splošna zdravstvena nega.
Do not stop taking Yargesa without talking to your doctor. 
Ne prenehajte uporabljati zdravilaYargesa, ne da se o tem pogovorite z zdravnikom.
This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase. 
Ta študija je tudi pokazala, da miglustat nima ali ima le majhen učinek na farmakokinetiko imigluceraze.
The systemic exposure at the lowest dose was below or comparable to that observed in humans (based on AUC0-∞) at the recommended human dose. 
Sistemska izpostavljenost pri najnižjem odmerku je bila pod tisto, ki so jo opazili pri ljudeh (na podlagi AUC0-∞) ob priporočenem odmerjanju, ali primerljiva z njo.
Your doctor can give you more information. 
Več informacij lahko dobite pri zdravniku.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Yargesa can be taken with or without food. 
Zdravilo Yargesa se lahko jemlje s hrano ali brez nje.
Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests. 
Miglustat ni pokazal nobenega potenciala za mutagene ali klastogene učinke v standardnem nizu testov genotoksičnosti.
There were no events of bone crisis, avascular necrosis or fracture during the treatment period. 
Ni bilo primerov kostne krize, avaskularne nekroze ali zloma v času zdravljenja.
Most cases are mild and disappear quite quickly. 
Večina neželenih učinkov je blagih in kmalu izzvenijo.
Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000). 
Neželeni učinki zdravila iz kliničnih preskušanj in spontanega poročanja, ki so se pojavili pri > 1 % bolnikov, so navedeni v spodnji preglednici, razvrščeni po organskem sistemu in pogostnosti (zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 < 1/10, občasni: ≥1/1.000 do <1/100, redki: ≥1/10.000 do <1/1.000,
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• na zahtevo Evropske agencije za zdravila; • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Twenty-one patients completed 24 months of miglustat treatment. 
Enaindvajset bolnikov je zaključilo 24-mesečno zdravljenje z miglustatom.
Mechanistic studies revealed a rat specific mechanism which is considered to be of low relevance for humans. 
Študije mehanizmov so pokazale mehanizem, specifičen za podgano, ki je običajno majhnega pomena za človeka.
Miglustat crosses the placenta and should not be used during pregnancy. 
Miglustat prehaja skozi placento in ga med nosečnostjo ne smemo uporabljati.
The kinetics of miglustat appear to be dose linear and time independent. 
Kinetika miglustata je videti linearno odvisna od odmerka in neodvisna od časa.
Clinical benefit has been assessed at 24 and 36 months in 13 patients. 
Po 24 in 36 mesecih so pri 13 bolnikih ocenili klinično korist.
Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years. 
Oba niza podatkov sta vključevala pediatrične bolnike, mladostnike in odrasle bolnike, pri čemer je bil starostni razpon od 1 do 43 let.
Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose. 
Miglustat se pretežno izloča skozi ledvice, pri čemer znaša rekuperacija nespremenjenega zdravila v urinu 70-80 % odmerka.
The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years. 
V klinično preskušanje je bilo vključenih 29 odraslih bolnikov in mladostnikov v 12-mesečnem kontroliranem obdobju, ki mu je sledil podaljšek zdravljenja s povprečnim skupnim trajanjem 3,9 let in do 5,6 let.
Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces. 
Po uporabi enega odmerka 100 mg14C-miglustata pri zdravih prostovoljcih je bilo 83 % radioaktivno označenega zdravila izločenega z urinom in 12 % z blatom.
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Yargesa. 
Obvestite zdravnika, če jemljete zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilomYargesa.
Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at Month 24. 
Med njimi je bilo 18 bolnikov ob izhodišču znotraj uveljavljenih terapevtskih ciljev za volumen jeter in vranice, ravni hemoglobina in število trombocitov, 16 bolnikov pa je ostalo znotraj vseh teh terapevtskih ciljev v 24. mesecu.
Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required. 
Običajno lahko znižanje odmerka tremor v nekaj dneh zmanjša, včasih pa je potrebna prekinitev zdravljenja.
Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility. 
Druge študije so odkrile spremembe v parametrih spermijev (gibljivost in morfologija), skladne z opažanim zmanjšanjem plodnosti.
Over the range of data available, no significant relationships or trends were noted between miglustat pharmacokinetic parameters and demographic variables (age, BMI, gender or race). 
V območju razpoložljivih podatkov ni opaziti pomembnih razmerij ali usmeritev med farmakokinetičnimi parametri miglustata in demografskimi spremenljivkami (starost, indeks telesne mase, spol ali rasa).
For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease. 
Za otroke, stare manj kot 12 let, bo zdravnik odmerek prilagodil za Niemann-Pickovo bolezen tipa C.
Several metabolites were identified in urine and faeces. 
V urinu in blatu so bili identificirani številni presnovki.
Gastrointestinal disturbances 
Gastrointestinalne motnje
What Yargesa is and what it is used for 
Kaj je zdravilo Yargesa in za kaj ga uporabljamo
Separate at perforations 
Ločite po perforaciji.
The tremor often disappears without needing to stop the treatment. 
Tremor pogosto izgine brez potrebe prekinitve zdravljenja z zdravilom Yargesa.
In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands. 
Pri Gaucherjevi bolezni tipa 1 so bili ti tremorji so opisovali kot pretirano fiziološko tresenje rok.
The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease. 
Učinkovitost in varnost miglustata nista bili posebej ocenjeni pri bolnikih s hudo Gaucherjevo boleznijo.
Niemann-Pick type C disease is a very rare, invariably progressive and eventually fatal neurodegenerative disorder characterised by impaired intracellular lipid trafficking. 
Niemann-Pickova bolezen tipa C je zelo redka, vedno progresivna in končno smrtna nevrodegenerativna bolezen, za katero je značilno zmanjšano intracelično prehajanje maščob.
Data to support safety and efficacy of Yargesa in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey. 
Podatki, ki podpirajo varnost in učinkovitost zdravila Yargesa pri Niemann-Pickovi bolezni tipa C so bili zbrani v prospektivnem odprtem kliničnem preskušanju in v retrospektivni analizi.
The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state. 
Presnovek, ki to povzroča, ni bil opredeljen, vendar se lahko kopiči in doseže koncentracije, ki presežejo koncentracije miglustata v stanju dinamičnega ravnovesja.
When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively). 
V primerjavi z meritvami pri šestih mesecih je bil nadzor bolezni po 18 in 24 mesecih monoterapije z miglustatom nespremenjen (20 oziroma 6 bolnikov).
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy. 
To študijo so izpeljali v šestmesečnem randomiziranem primerjalnem obdobju, ki mu je sledilo 18-mesečno podaljšanje, v katerem so vsi bolniki prejemali monoterapijo z miglustatom.
This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures. 
To lahko povzroči motnje nevroloških funkcij kot so počasno gibanje očesa, ravnotežje, požiranje, spomin in epileptične napade.
If you take more capsules than you were told to, consult your doctor immediately. 
Če ste vzeli večji odmerek zdravilaYargesa, kot bi smeli Če ste vzeli več kapsul, kot vam je bilo naročeno, se takoj posvetujte z zdravnikom.
No patient showed rapid deterioration of type 1 Gaucher disease following the switch to miglustat monotherapy. 
Noben od bolnikov ni kazal hitrega poslabšanja stanja Gaucherjeve bolezni vrste 1 po prehodu na monoterapijo z miglustatom.
Do not take this medicine after the expiry date which is stated on the blister and carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »Uporabno do«.
Pharmacokinetic data indicate increased systemic exposure to miglustat in patients with renal impairment. 
Farmakokinetični podatki kažejo povečano sistemsko izpostavljenost miglustatu pri bolnikih z okvarjenim delovanjem ledvic.
PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil containing 21 capsules. 
PVC in poliklorotrifluoroetilenski (PCTFE) pretisni omot, zavarjen z aluminijevo folijo, ki vsebuje 21 kapsul.
An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg. 
Dodatno so izvedli študijo z monoterapijo pri 18 bolnikih, ki so prejemali skupni dnevni odmerek 150 mg, rezultati pa kažejo na zmanjšano učinkovitost v primerjavi s skupnim dnevnim odmerkom 300 mg.
Dizziness has been reported as a common adverse reaction, and patients suffering from dizziness should not drive or use machines. 
Poročali so o omotičnosti kot o pogostem neželenem učinku, zato bolniki z omotičnostjo ne smejo voziti ali uporabljati strojev.
The survey included a case series of 66 patients treated with Yargesa outside of the clinical trial for a mean duration of 1.5 years. 
Študija je vključevala klinično serijo 66 bolnikov, zdravljenih z zdravilom Yargesa, izven kliničnega preskušanja s povprečnim trajanjem 1,5 let.
Eighteen patients then continued to receive miglustat under an optional extended treatment protocol. 
18 bolnikov je nato nadaljevalo jemanje miglustata v neobveznem podaljšanem programu zdravljenja.
The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose. 
V urinu je bilo največ presnovka miglustat glukuronida, ki je predstavljal 5 % odmerka.
In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements. 
V zbrani analizi nekontroliranih podatkov so se vrednosti Z mineralne gostote kosti ledvene hrbtenice in vratu stegnenice povečale za več kot 0,1 enote od izhodišča pri 27 (57 %) in 28 (65 %) bolnikov pri vzdolžni smeri merjenja gostote kosti.
The usual treatment for type 1 Gaucher disease is enzyme replacement therapy. 
Običajno zdravljenje Gaucherjeve bolezni tipa 1 je encimsko nadomestno zdravljenje.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline. 
Pri bolnikih, vključenih v klinično preskušanje, je 40 % - 50 % bolnikov imelo število trombocitov pod spodnjo mejo normalnega ob izhodišču.
Temporary dose reduction may be necessary in some patients because of diarrhoea. 
Začasno zmanjšanje odmerka je lahko potrebno pri nekaterih bolnikih zaradi driske.
The neurological manifestations are considered secondary to the abnormal accumulation of glycosphingolipids in neuronal and glial cells. 
Nevrološke manifestacije se obravnavajo kot sekundarne na nenormalno kopičenje glikosfingolipidov v nevronalnih in glialnih celicah.
In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged. 
Pri bolnikih, ki so prešli na miglustat, se prvih šest mesecev volumna jeter in vranice ter ravni hemoglobina niso spremenili.
This means a daily maximum of three capsules (300 mg). 
To pomeni največ tri kapsule (300 mg) dnevno.
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function. 
Malo podatkov za bolnike s Fabryjevo boleznijo in okvarjenim delovanjem ledvic je pokazalo, da se CL/F s slabšanjem ledvičnega delovanja zmanjšuje.
Weight loss has been reported in 55% of patients using miglustat. 
O izgubi telesne mase pri uporabi miglustata so poročali pri približno 55 % bolnikov.
- the other ingredients are sodium starch glycolate (type A), povidone (K-29/32), magnesium stearate, gelatin, purified water, titanium dioxide (E171), printing ink (shellac glaze, iron oxide black (E172), propylene glycol and concentrated ammonia solution) 
- druge sestavine zdravila so natrijev karboksimetilškrob (tipa A), povidon (K-29/32),magnezijev stearat, želatina, prečiščena voda, titanov dioksid (E171), tiskarsko črnilo (glazura šelaka, črni železov oksid (E172), propilenglikol in koncentrirana raztopina amoniaka).
At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma. 
V stanju dinamičnega ravnovesja je koncentracija miglustata v cerebrospinalni tekočini šestih bolnikov z Gaucherjevo bolezijo tipa 3 predstavljala 31,4-67,2% koncentracije v plazmi.
An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years. 
Odprta, neprimerjalna dvoletna študija z vključenimi 42 bolniki z Gaucherjevo boleznijo tipa 1, ki so vsaj tri leta prejemali ERT in so izpolnjevali merila za bolezen, stabilno vsaj dve leti.
Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study). 
Malo podatkov kaže, da lahko sočasna uporaba miglustata in nadomestka encima z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu (v majhni študiji z vzporednimi skupinami so opažali približno znižanje za 22 % Cmax in 14 % AUC).
In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that miglustat monotherapy may not maintain the same control of disease activity in all patients. 
Pri nekaterih bolnikih je prišlo do zmanjšanja koncentracije trombocitov in povečanja aktivnosti hitotriozidaze, kar kaže, da monoterapija z miglustatom morebiti ne zadostuje za vzdrževanje enakega nadzora nad boleznijo pri vseh bolnikih.
In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 µM. 
Glukozilceramid-sintazo in vitro zavira miglustat z IC50, ki je 20-37 µM.
Use of Yargesa in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended. 
Uporabe zdravila Yargesa pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo.
The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil. 
Kapsule so v PVC in poliklorotrifluoroetilenskem (PCTFE) pretisnem omotu, zavarjenem z aluminijasto folijo.
Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range. 
Podatki za hudo okvarjeno delovanje ledvic so omejeni na dva bolnika, ki sta imela očistek kreatinina v območju 1829 ml/min, zato podatkov ne moremo ekstrapolirati pod to območje.
This means a daily maximum of six capsules (600 mg). 
To pomeni največ šest kapsul zdravila dnevno (600 mg).
If you stop taking Yargesa 
Če ste prenehali jemati zdravilo Yargesa
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka}
In some patients, temporary dose reduction may be necessary. 
Pri nekaterih bolnikih bo morda treba začasno znižati odmerek.
Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain. 
Pri nekaterih pediatričnih bolnikih z Niemann-Pickovo boleznijo tipa C so poročali o zmanjšani rasti v zgodnji fazi zdravljenja z miglustatom, kjer lahko manjša rast spremlja začetno zmanjšano pridobitev teže ali ji sledi.
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Yargesa together with food, or to temporarily reduce your dose. 
Če boste imeli drisko, vam bo morda zdravnik svetoval, da spremenite prehrano tako, da zmanjšate vnos laktoze in ogljikovih hidratov, kot je saharoza (namizni sladkor), ali ne jemljete zdravila Yargesa skupaj s hrano ali začasno znižate odmerek.
Overall the data show that treatment with Yargesa can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease. 
Na splošno so podatki pokazali, da lahko zdravljenje z zdravilom Yargesa zmanjša napredovanje klinično značilnih nevroloških simptomov pri bolnikih z Niemann-Pickovo boleznijo tipa C.
Tremor Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment. 
Približno 37 % bolnikov v kliničnih preskušanjih z Gaucherjevo boleznijo tipa 1 in 58 % bolnikov v kliničnih preskušanjih z Niemann-Pickovo boleznijo tipa C je poročalo o tremorju med zdravljenjem.
The hard capsule consists of an opaque white cap and body with “708” printed in black on the body. 
Trda kapsula je sestavljena iz neprozornega belega pokrovčka in telesa kapsule, na katerem je s črno barvo natisnjeno „708“.
Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats. 
Poleg tega so tu še učinki, zabeleženi pri živalih pri odmerkih, ki povzročijo ravni izpostavljenosti, ki so podobne ali malo višje kot klinične ravni izpostavljenosti: spremembe v limfoidnih organih pri vseh testiranih vrstah, spremembe vrednosti transaminaz, vakuolizacija ščitnice in trebušne slinavke, katarakte, nefropatija ter spremembe miokarda pri podganah.
Capsule content sodium starch glycolate (Type A) povidone (K-29/32) magnesium stearate 
Vsebina kapsule natrijev karboksimetilškrob (tipa A), povidon (K-29/32), magnezijev stearat
Yargesa should not be taken during breast-feeding. 
Zdravila Yargesa se ne sme jemati v času dojenja.
Breast-feeding It is not known if miglustat is secreted in breast milk. 
Ni znano, ali se miglustat izloča v materino mleko.
Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1). 
Zdravilo Yargesa smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain. 
Če imate Niemann-Pickovo bolezen tipa C, se v celicah vaših možganov kopičijo maščobe kot so glikosfingolipidi.
Repeated-dose toxicity studies in rats showed effects on the seminiferous epithelium of the testes. 
Študije toksičnosti pri večkratnem odmerjanju na podganah so pokazale učinke na semenski epitelij v modih.
Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, postimplantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits. 
Miglustat je vplival na preživetje zarodkov/plodov pri podganah in zajcih, poročali so o distociji, povečale so se izgube po implantaciji in povečala se je incidenca žilnih nepravilnosti pri zajcih.
After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively. 
Po treh letih stalnega jemanja miglustata je bilo povprečno zmanjšanje volumna jeter 17,5 % in vranice 29,6 %.
While the numbers of subjects with mild and moderate renal impairment were very small, the data suggest an approximate decrease in CL/F of 40% and 60% respectively, in mild and moderate renal impairment (see section 4.2). 
Medtem ko je bilo število bolnikov z blago in zmerno okvarjenim delovanjem ledvic zelo majhno, podatki kažejo na zmanjšanje CL/F za približno 40 % pri blago in 60 % pri zmerno okvarjenem delovanju ledvic (glejte poglavje 4.2).
Growth should be monitored in paediatric and adolescent patients during treatment with Yargesa; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy. 
Med zdravljenjem z zdravilom Yargesa je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja.