FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit to the patient of treatment with Yargesa should be evaluated on a regular basis (see section 4.4).
Slovenian: Koristi zdravljenja z zdravilom Yargesa je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
English: The efficacy of Yargesa in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Slovenian: Pediatrična populacija Učinkovitost zdravila Yargesa pri otrocih in mladostnikih, starih od 0 do 17 let, z Gaucherjevo boleznijo tipa 1, še ni bila dokazana.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Slovenian: Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija, glavobol, omotičnost
English: Miglustat has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Slovenian: Miglustat so v kliničnih preskušanjih uporabljali v odmerkih do 3000 mg/dan do šest mesecev pri bolnikih z okužbo z virusom HIV.
English: • For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Slovenian: • Za Niemann-Pickovo bolezen tipa C: Za odrasle in mladostnike (stare več kot 12 let) je običajni odmerek dve kapsuli (200 mg) trikrat dnevno (zjutraj, popoldan in zvečer).
English: There was no drug-related increase in tumour incidence in any other organ.
Slovenian: Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli organa ni bilo.
English: They could be signs of peripheral neuropathy, due to side effects of Yargesa or they could be due to existing conditions.
Slovenian: To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravilaYargesa, morda pa so vzrok zanje druge obstoječe bolezni.
English: Most serious side effects
Slovenian: Najresnejši neželeni učinki
English: There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Slovenian: Delovanje ledvic močno vpliva na očistek miglustata, izpostavljenost miglustatu je opazno višja pri bolnikih s hudo okvarjenim delovanjem ledvic (glejte poglavje 5.2).
English: Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, -30.7)] were observed between baseline and end of study.
Slovenian: Med izhodiščem in koncem študije so opazili majhno povprečno zmanjšanje hemoglobina [-0,95 g/dl (95-odstotni IZ: -1,38, -0,53)] in število trombocitov [-44,1 × 109/l (95-odstotni IZ: -57,6, -30,7)].
English: EU/1/17/1176/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1176/001
English: Contraceptive measures should be used by women of childbearing potential.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
English: Very common effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Slovenian: Zelo pogosti neželeni učinki - pojavijo se lahko pri več kot 1 od 10 bolnikov Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje teka.
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Slovenian: Opažali so povprečno povišanje koncentracije hemoglobina za 0,26 g/dl ter povprečno povečanje koncentracije trombocitov za 8,29 × 109/l.
English: Take the next capsule at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Yargesa Kapsulo vzemite ob običajnem času.
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Slovenian: Miglustat so proučevali v zvezi z indikacijami, pri katerih bi bili lahko nekateri neželeni učinki, kot so nevrološki in nevropsihološki simptomi/znaki, kognitivna disfunkcija in trombocitopenija, tudi posledica bolezni, zaradi katere se bolnik zdravi.
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>.
English: Male patients should maintain reliable contraceptive methods while taking Yargesa.
Slovenian: Bolniki moškega spola naj v času jemanja zdravila Yargesa uporabljajo zanesljive kontracepcijske metode.
English: Changes in lactation were observed in female rats in a 1-year study.
Slovenian: V enoletni študiji so opazili spremembe pri dojenju pri podganjih samicah.
English: Yargesa contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Slovenian: Zdravilo Yargesa vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
English: Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease.
Slovenian: Tega zdravila ne dajajte otrokom in mladostnikom (mlajšim od 18 let) z Gaucherjevo boleznijo tipa 1,
English: The benefit of treatment with Yargesa for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be reappraised after at least 1 year of treatment with Yargesa.
Slovenian: Koristi zdravljenja z zdravilom Yargesa pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Yargesa.
English: Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Slovenian: Miglustat je zaviralec glukozilceramid-sintaze, ki je odgovoren za prvi korak v sintezi večine glikolipidov.
English: Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters, and reduces fertility (see sections 4.6 and 5.3).
Slovenian: Študije na podganah so pokazale, da miglustat neželeno vpliva na spermatogenezo in parametre spermijev ter zmanjšuje plodnost (glejte poglavji 4.6 in 5.3).
English: In patients with type 1 Gaucher disease, monitoring of platelet counts is recommended.
Slovenian: Pri bolnikih z Gaucherjevo boleznijo tipa 1 se priporoča nadziranje števila trombocitov.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Piramal Critical Care B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Piramal Critical Care B.V.
English: Your doctor will perform some tests before and during treatment with Yargesa to assess this (see section 2).
Slovenian: Zdravnik bo to ocenil z nekaj preskusi pred zdravljenjem z zdravilom Yargesa in med zdravljenjem (glejte poglavje 2).
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Yargesa (see section 4).
Slovenian: Vaš zdravnik lahko zmanjša odmerek, npr. na eno kapsulo (100 mg) enkrat ali dvakrat dnevno, če imate med jemanjem zdravila
English: Yargesa works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Slovenian: Zdravilo Yargesa deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
English: Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Slovenian: Zaradi visoke prevalence pomanjkanja vitamin B12 pri bolnikih z Gaucherjevo boleznijo tipa 1 se priporoča redno spremljanje ravni vitamina B12.
English: Depression, insomnia, libido decreased Nervous system disorders Very common
Slovenian: Pogosto depresija, insomnia, zmanjšan libido
English: Sometimes your doctor will need to reduce the dose or stop Yargesa treatment to stop the tremor.
Slovenian: Lahko se zgodi, da bo moral zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Yargesa ali prekiniti zdravljenje z njim.
English: All patients should undergo baseline and repeat neurological evaluation.
Slovenian: Vse bolnike je treba ob izhodišču in kasneje ponovno nevrološko oceniti.
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Slovenian: Pri več kot 80 % bolnikov so na začetku zdravljenja ali občasno med zdravljenjem opažali neželene učinke na prebavila, zlasti drisko (glejte poglavje 4.8).
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Slovenian: Pri bolnikih s prilagojenim očistkom kreatinina 50-70 ml/min/1,73 m2 uporabo začnemo z odmerkom 100 mg dvakrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1 in z odmerkom 200 mg dvakrat dnevno (prilagojeno na površino telesa pri bolnikih, starih manj kot 12 let) pri bolnikih z Niemann-Pickovo boleznijo tipa C.
English: Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno z distocijo (glejte poglavje 5.3).
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Yargesa and maintain reliable contraceptive methods for 3 months thereafter.
Slovenian: Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred zaploditvijo prenehajo uporabljati zdravilo Yargesa in še tri mesece potem uporabljajo zanesljivo metodo kontracepcije.
English: A total daily dose of 300 mg miglustat administered in three divided doses was used in the above two studies.
Slovenian: V dveh zgoraj omenjenih študijah so jemali skupni dnevni odmerek 300 mg miglustata, razdeljen na tri ločene odmerke.
English: The benefit of treatment with Yargesa for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be reappraised after at least 1 year of treatment with Yargesa, (see section 4.4).
Slovenian: Koristi zdravljenja z zdravilom Yargesa pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Yargesa (glejte poglavje 4.4).
English: Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Slovenian: Študije pri podganah so pokazale, da miglustat negativno vpliva na parametre sperme (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
English: If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Slovenian: Če med zdravljenjem z zdravilom Yargesa izkusite blag tremor, običajno tresenje rok, to čim prej sporočite svojemu zdravniku.
English: The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Slovenian: Zaviralno delovanje na glukozilceramid-sintazo je podlaga za zdravljenje z zmanjšanjem substrata pri
English: What Yargesa contains
Slovenian: Kaj vsebuje zdravilo Yargesa
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: Pack size of 84 capsules.
Slovenian: Velikost pakiranja: 84 kapsul.
English: Each hard capsule contains 100 mg miglustat.
Slovenian: Ena trda kapsula vsebuje 100 mg miglustata.
English: A second open, controlled study of miglustat randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
Slovenian: 36 bolnikov, ki so se že vsaj dve leti zdravili z ERT: nadaljevanje zdravljenja z imiglucerazo, kombinacija imigluceraze in miglustata ali prehod na miglustat.
English: • Yargesa is used to treat mild to moderate type 1 Gaucher disease in adults.
Slovenian: • Zdravilo Yargesa se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
English: • measurement of vitamin B12 levels
Slovenian: - pregled živcev v vaših rokah in nogah - meritev ravni vitamina B12
English: Ask your pharmacist how to throw away medicines you no longer take.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with NiemannPick type C disease is 200 mg three times a day.
Slovenian: Pediatrična populacija Priporočeni odmerek za zdravljenje mladostnikov (starih 12 let in več) z Niemann-Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
English: INFORMATION IN BRAILLE Yargesa 100 mg
Slovenian: Yargesa 100 mg
English: Miglustat has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Slovenian: Miglustata pri bolnikih z anamnezo pomembnega obolenja prebavil, vključno z vnetno črevesno boleznijo, niso vrednotili.
English: 4.4 Special warnings and precautions for use
Slovenian: Opozorila in previdnostni ukrepi
English: There was no drug-related increase in tumour incidence in male or female rats in any other organ.
Slovenian: Drugih z zdravilom povezanih povišanj incidenc tumorjev kateregakoli drugega organa pri samcih ali samicah podgan ni bilo.
English: Male patients should maintain reliable contraceptive methods while taking Yargesa (see sections 4.4 and 5.3).
Slovenian: Moški morajo ves čas uporabe zdravila Yargesa uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
English: Elderly There is no experience with the use of Yargesa in patients over the age of 70.
Slovenian: Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom Yargesa.
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Slovenian: Povprečno povečanje koncentracije trombocitov je bilo 22,2 × 109/l, povprečno povišanje koncentracije hemoglobina pa 0,95 g/dl.
English: Marketing Authorisation Holder and Manufacturer Piramal Critical Care B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec: Piramal Critical Care B.V.
English: • monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
Slovenian: - nadziranje rasti, če ste otrok ali mladostnik z Niemann-Pickovo boleznijo tipa C - nadziranje števila trombocitov v krvi.
English: Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Slovenian: Opaženi neželeni učinki so bili granulocitopenija, omotičnost in parestezija.
English: The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and Niemann-Pick type C disease patients when compared to healthy subjects.
Slovenian: Farmakokinetika miglustata je podobna pri odraslnih bolnikih z Gaucherjevo boleznijo tipa 1 in bolenikih z Niemann-Pickovo boleznijo tipa C, primerjano pri odraslih osebah.
English: Carcinomas in the large intestine occurred occasionally at all doses with a statistically significant increase in the high dose group.
Slovenian: Karcinomi debelega črevesa so se pojavili občasno pri vseh odmerkih, s statistično pomembnim povečanjem pri največjem odmerku.Pomembnost teh ugotovitev za človeka ni mogoče izključiti.
English: Other medicines and Yargesa Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Dosage in Niemann-Pick type C disease
Slovenian: Odmerjanje pri Niemann-Pickovi bolezni tipa C
English: Psychiatric disorders Common
Slovenian: Psihiatrične motnje
English: There is limited experience with the use of Yargesa in Niemann-Pick type C disease patients under the age of 4 years.
Slovenian: Izkušenj z zdravljenjem z zdravilom Yargesa pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
English: 6.6 Special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
Slovenian: Pri nekaterih bolnikih bo morda zaradi driske treba začasno znižati odmerek na 100 mg enkrat ali dvakrat dnevno.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Slovenian: Manifestacije Gaucherjeve bolezni tipa 1 na kosteh so bile ocenjene v treh odprtih kliničnih študijah pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do dve leti (n = 72).
English: Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Slovenian: Pri bolnikih, zdravljenih z miglustatom, s sočasnim stanjem, kot sta pomanjkanje vitamina B12 in monoklonska gamopatija, ali brez teh stanj, so opazili primere periferne nevropatije.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Slovenian: Oznaka ATC: A16AX06.
English: Driving and using machines Yargesa may make you feel dizzy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Yargesa ste lahko omotični.
English: In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
Slovenian: V nekontrolirano podštudijo je bilo za celokupno povprečno obdobje 3,1 leta in do 4,4 let vključenih 12
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Slovenian: starih 3 do 15 let, in pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih 5-16 let.
English: This can result in liver and spleen enlargement, changes in the blood and bone disease.
Slovenian: spremembe v krvi in kostno bolezen.
English: Not applicable.
Slovenian: kot je ustrezno.
English: What you need to know before you take Yargesa
Slovenian: Kaj je zdravilo Yargesa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Yargesa Kako jemati zdravilo Yargesa
English: Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Slovenian: Dajanje miglustata samcem in samicam miši CD1 po sondi dve leti v odmerkih 210, 420 in 840/500 mg/kg/dan (zmanjšanje odmerka na pol leta) je povzročilo povišano incidenco vnetnih in in hiperplastičnih lezij v debelem črevesu pri obeh spolih.Odmerki, ki temeljijo na mg/kg/dan in korekciji zaradi razlik pri izločanju fecesa, ustrezajo 8, 16 in 33/19-kratnem najvišjem priporočenem odmerku pri človeku (200 mg trikrat dnevno).
English: Type 1 Gaucher disease
Slovenian: Gaucherjeva bolezen tipa 1
English: Male patients should use reliable birth control methods during their treatment with Yargesa and for 3 months after finishing treatment.
Slovenian: Bolniki moškega spola morajo med jemanjem zdravila Yargesa in tri mesece po prenehanju jemanja uporabljati zanesljivo metodo preprečitve zanositve.
English: Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Slovenian: Zdravilo Yargesa je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko
English: Renal Impairment
Slovenian: Okvarjeno delovanje ledvic
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia Musculoskeletal and connective tissue disorders Common
Slovenian: Pogosto navzea, bruhanje, trebušna distenzija/nelagodje v trebuhu, zaprtje, dispepsija Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosto mišični krči, oslabelost mišic Splošne težave in spremembe na mestu aplikacije
English: Hepatic Impairment Yargesa has not been evaluated in patients with hepatic impairment.
Slovenian: ZdravilaYargesa pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Dosage in type 1 Gaucher disease
Slovenian: Odmerjanje pri Gaucherjevi bolezni tipa 1 Odrasli
English: Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
Slovenian: Gaucherjeve bolezni tipa 1, študijo je zaključilo 22 bolnikov.
English: Weight loss, decreased appetite
Slovenian: Zelo pogosto izguba telesne mase, zmanjšan tek
English: Liver volume (primary efficacy variable) was unchanged from baseline to the end of treatment.
Slovenian: Bolniki so prešli iz monoterapije z miglustatom 100 mg dvakrat na dan. Jetrni volumen (primarna spremenljivka učinkovitosti) se od izhodišča do konca zdravljenja ni spremenil.
English: Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
Slovenian: Med temi bolniki jih je imelo 132 Gaucherjevo bolezen tipa 1 in 40 Niemann-Pickovo bolezen tipa C. Neželeni učinki so bili v glavnem blagi do zmerni in so se pojavljali s podobno pogostnostjo za vse preskušane indikacije in odmerke.
English: Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Slovenian: 180 mg/kg/dan je povzročilo povišano incidenco hiperplazije testikularnih intersticijskih (Leydigovih) celic in adenomov pri samcih pri vseh odmerkih.
English: Peel back paper at arrows
Slovenian: Pri puščici odluščite papir.
English: PHARMACEUTICAL FORM AND CONTENTS 84 x 1 hard capsules
Slovenian: 84 x1 trda kapsula
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules miglustat
Slovenian: Navodilo za uporabo Yargesa 100 mg trde kapsule miglustat
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Yargesa.
Slovenian: Pri nekaterih bolnikih z Niemann-Pickovo boleznijo tipa C, zdravljenih z zdravilom Yargesa, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules
Slovenian: Yargesa 100 mg trde kapsule
English: adjusted for body surface area resulted in Cmax and AUCτ values which were approximately twofold those attained after 100 mg t.i.d.
Slovenian: Odmerjanje 200 mg trikrat dnevno pri otrocih, prilagojeno na površino telesa, je povzročilo vrednosti Cmax in AUCτ, ki so bile približno dvakratne od tistih, pridobljenih po odmerku 100 mg trikrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1, kar je skladno z farmakokinetiko miglustata, linearno z odmerkom.