FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Slovenian: Neželeni učinki, ki so navedeni spodaj in so razvrščene na podlagi organskih sistemov in absolutne pogostnosti, temeljijo na podatkih iz kliničnega preskušanja in uporabe v obdobju trženja.
English: Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Slovenian: Matere, ki jemljejo nitizinon, ne smejo dojiti, ker tveganja za dojenčka ne moremo izključiti (glejte poglavji 4.3 in 5.3).
English: 2 years
Slovenian: 2 letih
English: Nitisinone MDK blocks the breakdown of tyrosine and the harmful substances are not formed.
Slovenian: MDK zaustavi razgraditev tirozina in prepreči nastanek škodljivih snovi.
English: 6 years
Slovenian: 6 letih
English: ≤ 2 months ≤ 6 months
Slovenian: ≤ 2 meseca ≤ 6 mesecev > 6 mesecev celokupna
English: Age at onset of symptoms 1 year 2 years < 2 months
Slovenian: Starost pri pojavu simptomov 1 leto 2 leti < 2 meseca 2-6 mesecev > 6 mesecev
English: Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Slovenian: Zdravljenje odraslih in pediatričnih bolnikov (vseh starosti) s potrjeno diagnozo dedne tirozinemije tipa 1 (HT-1 - »hereditary tyrosinemia type 1«), ki so hkrati na dieti z nizko vsebnostjo tirozina in fenilalanina.
English: Succinylacetone inhibits the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate.
Slovenian: Sukcinilaceton zavira proces sinteze porfirina in povzroča akumulacijo 5-aminolevulinata.
English: It is recommended that platelet and WBC counts are monitored regularly, as a few cases of reversible thrombocytopenia and leucopenia were observed during clinical evaluation.
Slovenian: Priporočljivo je redno spremljanje števila trombocitov in belih krvnih celic, ker so med kliničnim ocenjevanjem opazili nekaj primerov reverzibilne trombocitopenije in levkopenije.
English: By its mode of action, nitisinone increases tyrosine levels in all nitisinone treated patients.
Slovenian: Nitizinon s svojim načinom delovanja povečuje ravni tirozina pri vseh bolnikih, zdravljenih z nitizinonom.
English: Nitisinone is a weak inducer of CYP2E1 (30% decrease in chlorzoxazone AUC) and a weak inhibitor of OAT1 and OAT3 (1.7-fold increase in AUC of furosemide), whereas nitisinone did not inhibit CYP2D6 (see section 5.2).
Slovenian: Nitizinon je šibek induktor encima CYP 2E1 (znižanje AUC klorzoksazona za 30 %) in šibek zaviralec OAT1 in OAT3 (1,7-kratno zvišanje AUC furosemida), medtem ko nitizinon ni zaviral encima CYP 2D6 (glejte poglavje 5.2).
English: Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport.
Slovenian: Ni pričakovati, da bi koncentracija nitizinona v plazmi, dosežena v kliničnem okolju, zavirala transport, ki deluje preko OATP1B1, OATP1B3.
English: The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
Slovenian: starih 24 mesecev ali manj na začetku zdravljenja, in pri bolnikih, starih več kot 24 mesecev na začetku zdravljenja, je prikazana v naslednji preglednici:
English: Restriction of tyrosine and phenylalanine in the diet should limit the toxicity associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
Slovenian: Omejitev tirozina in fenilalanina v prehrani bi morala omejiti toksičnost, ki je povezana s tem tipom tirozinemije z zniževanjem ravni tirozina (glejte poglavje 4.4).
English: - The active substance is nitisinone.
Slovenian: - Učinkovina je nitizinon.
English: Nitisinone is a moderate CYP2C9 inhibitor.
Slovenian: Nitizinon je zmerni zaviralec encima CYP 2C9.
English: Patients with increasing alpha-fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Slovenian: Pri bolnikih s povečanim alfa-fetoproteinom ali znaki vozlov na jetrih je treba oceniti možnost, da na jetrih nastane maligna tvorba.
English: Nitisinone is not expected to inhibit P-gp, BCRP or OCT2-mediated transport.
Slovenian: Ni pričakovati, da bi nitizinon zaviral transport, ki deluje preko P-gp, BCRP ali OCT2.
English: Nitisinone does not inhibit CYP2D6 since metoprolol AUC∞ was not affected by the administration of nitisinone.
Slovenian: Nitizinon ne zavira encima CYP 2D6, ker dajanje nitizinona ni vplivalo na AUC∞ metoprolola.
English: Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Slovenian: - zmanjšano število trombocitov (trombocitopenija) in belih krvnih celic (levkopenija), pomanjkanje nekaterih belih krvnih celic (granulocitopenija).
English: 4 years
Slovenian: 4 letih
English: Capsule content ˗ Pregelatinised starch (maize)
Slovenian: Vsebina kapsule - predgeliran (koruzni) škrob
English: Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Slovenian: Nitizinon se in vitro presnavlja z encimom CYP 3A4, zato bo v primeru dajanja nitizinona skupaj z inhibitorji ali induktorji tega encima morda treba prilagoditi odmerek.
English: Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Slovenian: Zmanjšanje količine tirozina in fenilalanina v dieti bi morale zmanjšati toksičnosti, povezane s to vrsto tirozinemije.
English: No patient had detectable succinylacetone (SA) levels at the end of the once-daily treatment period.
Slovenian: Ob koncu obdobja zdravljenja enkrat na dan ni imel noben bolnik merljivih ravni sukcinilacetona (SA).
English: Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Slovenian: Farmakodinamični učinki Zdravljenje z nitizinonom omogoča, da se vzpostavi normala presnova porfirina z normalnim delovanjem eritrocitne porfobilinogen-sintaze in 5-aminolevulinatom v urinu, da se zmanjša izločanje sukcinilacetona z urinom, poveča koncentracija tirozina v plazmi in tudi odvajanje fenola z urinom.
English: Fertility There are no data on nitisinone affecting fertility.
Slovenian: Plodnost Podatkov o vplivu nitizinona na plodnost ni.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Slovenian: Pri bolnikih s HT-1 se ta intermediata pretvorita v toksična presnovka sukcinilaceton in sukcinilacetoacetat.
English: Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1.
Slovenian: Nitizinon je povzročil znižanje AUC∞ klorzoksazona za približno 30 %, ki kaže na šibko indukcijo encima CYP 2E1.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
Slovenian: Razpoložljivi podatki klinične študije so pokazali, da se je sukcinilaceton v urinu pri več kot 90 %
English: The active ingredient of Nitisinone MDK is nitisinone.
Slovenian: Zdravilna učinkovina v zdravilu Nitisinone MDK je nitizinon.
English: During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Slovenian: Prilagoditev odmerka Med rednim nadzorovanjem je treba spremljati sukcinilaceton v urinu, teste delovanja jeter in raven alfa-fetoproteina (glejte poglavje 4.4).
English: A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist.
Slovenian: Če se pri bolniku med zdravljenjem z nitizinonom pojavijo motnje vida, mora nemudoma opraviti okulistični pregled.
English: In rats, exposure via milk resulted in reduced mean pup weight and corneal lesions.
Slovenian: Pri podganah se je izpostavljenost prek mleka pokazala v zmanjšani povprečni telesni masi mladiča in lezijah roženice.
English: If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination.
Slovenian: Če opazite neželene učinke, povezane z očmi, se takoj dogovorite z zdravnikom za očesni pregled.
English: Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).
Slovenian: Poleg zdravljenja z nitizinonom je potrebna dieta z nizko vsebnostjo fenilalanina in tirozina, pri čemer je treba nadzorovati aminokisline v plazmi (glejte poglavji 4.4 in 4.8).
English: If you become pregnant you should contact your doctor immediately.
Slovenian: Če zanosite, morate o tem takoj obvestiti zdravnika.
English: Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171)
Slovenian: Ovojnica kapsule - želatina - titanov dioksid (E 171)
English: Contents of the pack and other information What Nitisinone MDK contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nitisinone MDK
English: Elevated tyrosine levels
Slovenian: Zelo pogosti povečane ravni tirozina
English: The recommended total daily dose is 1 mg/kg body weight administered orally.
Slovenian: Priporočeni celotni dnevni odmerek je 1 mg/kg telesne mase, ki se daje peroralno.
English: It is recommended that if nitisinone treatment is initiated with food, this should be maintained on a routine basis, see section 4.5.
Slovenian: Če se zdravljenje z nitizinonom začne ob hrani, se priporoča, da se to vzdržuje rutinsko, glejte poglavje 4.5.
English: What Nitisinone MDK is and what it is used for
Slovenian: Kaj je zdravilo Nitisinone MDK in za kaj ga uporabljamo
English: Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Slovenian: Neželeni učinki, ki vplivajo na organske sisteme v skupini bolezni krvi in limfatičnega sistema, so pri nadaljnjem zdravljenju z nitizinonom izzveneli.
English: Nitisinone treatment leads to elevated tyrosine levels.
Slovenian: Zdravljenje z nitizinonom vodi v zvišane ravni tirozina.
English: Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
Slovenian: Zdravljenje z nitizinonom zato lahko povzroči zvišane plazemske koncentracije sočasno dajanih zdravil, ki se presnavljajo predvsem preko encima CYP 2C9.
English: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Slovenian: 26-tedenski študiji kancerogenosti pri transgenskih miših (TgrasH2) nitizinon ni pokazal kancerogenega potenciala.
English: Liver monitoring
Slovenian: Spremljanje jeter
English: The capsule contains a white to off-white powder.
Slovenian: Kapsula vsebuje bel do belkast prašek.
English: There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Slovenian: Za starejše bolnike ali bolnike z ledvično ali jetrno okvaro ni posebnih priporočil glede odmerjanja.
English: Treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease (hereditary tyrosinemia type 1).
Slovenian: Zdravljenje s tem zdravilom lahko začne in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni (dedna tirozinemija tipa 1).
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Slovenian: Drugi občasni neželeni učinki - povečano število belih krvnih celic (levkocitoza), - srbečica (pruritus), vnetje kože (eksfoliativni dermatitis), izpuščaj.
English: If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Nitisinone MDK, kot bi smeli Če ste vzeli prevelik odmerek tega zdravila, se čim prej posvetujte z zdravnikom ali farmacevtom.
English: Therefore, it is recommended that if nitisinone treatment with Nitisinone MDK hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Slovenian: Če se zdravljenje z nitizinonom z zdravilom Nitisinone MDK trde kapsule začne ob hrani, se priporoča, da se to vzdržuje rutinsko, glejte poglavje 4.2.
English: Blepharitis
Slovenian: Občasni blefaritis
English: - Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment.
Slovenian: - Oftalmolog bo vaše oči pregledal pred zdravljenjem z nitizinonom in nato v rednih intervalih.
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels.
Slovenian: Nitizinon je pri kliničnih odmerkih pokazal znake embriofetalne toksičnosti pri miših in kuncih.
English: A pre- and postnatal development study in the mouse showed statistically significant reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher,
Slovenian: Študije o pre- in postnatalnem razvoju pri miših so pokazale statistično značilno zmanjšano preživetje mladičev, izpostavljenih 125-krat večjim odmerkom, in zmanjšanje rasti mladičev po odstavitvi pri 25-krat večjih odmerkih v primerjavi z največjim priporočenim odmerkom za človeka.
English: If you experience any side effects, shorter intervals are recommended.
Slovenian: Če se pojavijo kakršni koli neželeni učinki, so priporočljivi pogostejši kontrolni pregledi.
English: No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Slovenian: Pri študijah in vitro niso opazili mutagenosti, temveč le rahlo klastogensko aktivnost.
English: What you need to know before you take Nitisinone MDK Do not take Nitisinone MDK:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Nitisinone MDK Ne jemljite zdravila Nitisinone MDK
English: 60 hard capsules
Slovenian: 60 trdih kapsul
English: If you forget to take a dose, contact your doctor or pharmacist.
Slovenian: Če ste pozabili vzeti odmerek zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9.
Slovenian: Klinična študija medsebojnega delovanja z nitizinonom 80 mg v stanju dinamičnega ravnovesja je pokazala, da je nitizinon povzročil 2,3-kratno zvišanje AUC∞ substrata CYP 2C9 tolbutamida, ki kaže na zmerno zaviranje encima CYP 2C9.
English: Other medicines and Nitisinone MDK
Slovenian: Druga zdravila in zdravilo Nitisinone MDK
English: If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Slovenian: Če en mesec po začetku zdravljenja z nitizinonom v urinu še vedno zasledite sukcinilaceton, je treba odmerek nitizinona povečati na 1,5 mg/kg telesne mase na dan. Na podlagi ocene biokemičnih parametrov bo morda potreben odmerek 2 mg/kg telesne mase na dan.
English: The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Slovenian: Priporočeni začetni dnevni odmerek za otroke in odrasle je 1 mg/kg telesne mase, ki se jemlje peroralno.
English: The medicine can be stored for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which it must be discarded.
Slovenian: Zdravilo lahko shranjujete zunaj hladilnika dva meseca, po prvem odprtju steklenico, pri temperaturi do 25 °C, potem ga je treba zavreči.
English: Elevated levels of tyrosine have been associated with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions.
Slovenian: Povečane ravni tirozina so povezane z neželenimi učinki, povezanimi z očmi, kot so motnjava roženice in hiperkeratozne lezije.
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5.
Slovenian: 1A2, 2C19 ali 3A4, ali inducirati encimov CYP 1A2, 2B6 ali 3A4/5.
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Slovenian: Težave z očmi, glejte poglavje 4, so lahko znak neustrezne diete.
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
Slovenian: Študije in vitro, pri katerih so uporabili človeške mikrosome jeter in s cDNA izražene encime P450,
English: Probability of no HCC (95% confidence interval) at
Slovenian: Verjetnost za nepojav HCK (95 % interval zaupanja) po na začetku po 2 letih po 4 letih po 6 letih
English: Can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Slovenian: Zdravilo lahko shranjujete dva meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
English: Thrombocytopenia, leucopenia, granulocytopenia
Slovenian: Pogosti trombocitopenija, levkopenija, granulocitopenija
English: Platelet and white blood cell (WBC) monitoring
Slovenian: Spremljanje trombocitov in belih krvnih celic
English: respectively, the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Slovenian: Trend negativnega učinka na preživetje mladičev se začne pri odmerku 5 mg/kg/dan.
English: Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted.
Slovenian: Pri ustrezno prilagojenem odmerku nitizinona se v urinu ali plazmi sukcinilaceton ne bi smel pojavljati.
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Slovenian: Pred začetkom zdravljenja z nitizinonom in nato redno, a vsaj enkrat na leto, je priporočljivo opraviti pregled oči s špranjsko svetilko.
English: Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.
Slovenian: Pri osebah, ki imajo normalno dieto brez omejitve tirozina in fenilalanina in pomotoma zaužijejo nitizinon, se bo raven tirozina povečala.
English: What Nitisinone MDK looks like and contents of the pack
Slovenian: Izgled zdravila Nitisinone MDK in vsebina pakiranja
English: If you start Nitisinone MDK treatment by taking it with food, it is recommended that you carry on taking it with food throughout your course of treatment.
Slovenian: Zdravilo Nitisinone MDK skupaj s hrano in pijačo Če boste zdravljenje začeli z jemanjem zdravila Nitisinone MDK s hrano, je priporočljivo, da tako nadaljujete ves čas zdravljenja.
English: During the shelf life, the patient may store the capsules for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which the medicinal product must be discarded.
Slovenian: 24 mesecev Med rokom uporabnosti lahko bolnik shranjuje kapsule pri temperaturi do 25 °C dva meseca, po prvem odprtju steklenico, potem pa jih mora zavreči.
English: Leukocytosis
Slovenian: Občasni levkocitoza
English: ≤ 24 months
Slovenian: Začetna starost ≤ 24 mesecev
English: Other common adverse reactions include thrombocytopenia, leucopenia, and granulocytopenia.
Slovenian: Drugi pogosti neželeni učinki vključujejo trombocitopenijo, levkopenijo in granulocitopenijo.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo Nitisinone MDK Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Nitisinone MDK capsules are 15.7 mm long, white, opaque, hard gelatin capsules, imprinted with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg”, in black.
Slovenian: Kapsule Nitisinone MDK so trde želatinske kapsule motno bele barve dolžine 15,7 mm, vtisnjen imajo napis »Nitisinone« in jakost »2 mg«, »5 mg«, ali »10 mg« v črni barvi.
English: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Slovenian: HT-1, nitizinon prepreči kopičenje toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
English: Exfoliative dermatitis, erythematous rash, pruritus
Slovenian: Občasni eksfoliativni dermatitis, kožni izpuščaji, pruritus
English: Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje z nitizinonom mora začeti in nadzorovati zdravnik, usposobljen za zdravljenje bolnikov z dedno tirozinemijo tipa 1.
English: Imprint ˗ Black iron oxide (E172) ˗ Shellac
Slovenian: Tiskarsko črnilo: črn železov oksid (E 172)
English: In the rabbit, nitisinone induced a dose-related increase in malformations (umbilical hernia and gastroschisis) from a dose level 2.5-fold higher than the maximum recommended human dose (2 mg/kg/day).
Slovenian: Pri kuncih je pri odmerkih, večjih od 2,5-kratnega največjega priporočenega odmerka za človeka (2 mg/kg/dan), povzročil od odmerka odvisno povečanje pogostosti malformacij (umbilikalne hernije in gastroshize).
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Slovenian: 4-hidroksifenilpiruvat-dioksigenaze, ki v katabolni poti tirozina katalizira stopnjo pred fumarilacetoacetat-hidrolazo.
English: The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Slovenian: Mehanizem delovanja Biokemična motnja pri dedni tirozinemiji tipa 1 (HT-1) je pomanjkanje fumarilacetoacetat-hidrolaze,
English: Capsule content: pregelatinised maize starch Capsule shell: gelatin, titanium dioxide (E171) Printing ink: black iron oxide (E172), shellac glaze
Slovenian: - Druge sestavine zdravila so: Vsebina kapsule: predgeliran (koruzni) škrob Ovojnica kapsule: želatina titanov dioksid (E 171)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Treatment with nitisinone was also found to result in reduced risk for the development of hepatocellular carcinoma compared to historical data on treatment with dietary restriction alone.
Slovenian: Poleg tega so odkrili, da zdravljenje z nitizinonom, v primerjavi s podatki o zdravljenju zgolj s predpisano dieto, zmanjšuje tveganje za razvoj hepatocelularnega karcinoma (HCK).
English: No formal food interactions studies have been performed with Nitisinone MDK hard capsules.
Slovenian: Formalnih študij interakcij zdravila Nitisinone MDK trde kapsule s hrano niso opravili, vendar so med zbiranjem podatkov o učinkovitosti in varnosti nitizinon dajali skupaj s hrano.
English: Nitisinone MDK 5 mg: Each capsule contains 5 mg nitisinone.
Slovenian: Nitisinone MDK 5 mg: ena kapsula vsebuje 5 mg nitizinona.
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Slovenian: Pogosti konjunktivitis, motnjava roženice, keratitis, fotofobija,