FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/569/020 56 x 1 film-coated tablet (unit dose) EU/1/09/569/021 98 x 1 film-coated tablet (unit dose) EU/1/09/569/022 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/569/020 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/021 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/022 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Exforge HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Exforge HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: if you experience dizziness and/or fainting during treatment with Exforge HCT, tell your doctor as soon as possible.
Slovenian: V tem primeru zdravila Exforge HCT nikoli več ne smete več jemati; če med zdravljenjem z zdravilom Exforge HCT pride do omotičnosti in/ali izgube zavesti, čimprej obvestite zdravnika; če se vam poslabša vid ali vas začne boleti oko.
English: EU/1/09/569/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/569/036 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/035 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
English: EU/1/09/569/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/569/048 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/047 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
English: EU/1/09/569/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/569/012 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/011 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
English: EU/1/09/569/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/569/060 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/059 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
English: EU/1/09/569/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/569/024 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/023 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
English: What Exforge HCT looks like and contents of the pack Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Slovenian: Exforge HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR” na eni strani in “VCL” na drugi.
English: • anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);
Slovenian: • mišičnih relaksantov (zdravil za sproščanje mišic, ki jih uporabljajo med operacijami); nitroglicerina in drugih nitratov ter učinkovin, ki jih imenujemo “vazodilatatorji”; drugih zdravil za zdravljenje visokega krvnega tlaka, vključno z metildopo; rifampicina (ki ga uporabljamo za zdravljenje npr. tuberkuloze); eritromicin, klaritromicin (antibiotiki); šentjanževke; dantrolen (zdravilo v infuziji pri hudih odstopanjih telesne temperature); vitamina D in kalcijevih soli.
English: Frequency is 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: Pogostnost neželenih učinkov je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki, <1/10.000, neznana (ni mogoče oceniti iz razpoložljivih podatkov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1290/001
English: The tablets may be taken with or without food.
Slovenian: Tablete se lahko jemljejo s hrano ali brez nje.
English: Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Slovenian: Obisk monitorja naj bi bil izveden vsakih 6 mesecev, krajši razmiki med posameznimi obiski so priporočljivi v primeru neželenih dogodkov.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Slovenian: Datum prve odobritve: 26. julij 2018
English: This medicine does not require any special temperature storage conditions.
Slovenian: To zdravilo ne zahteva posebnih temperaturnih pogojev shranjevanja.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalised during the first week of treatment.
Slovenian: Razpoložljivi podatki klinične študije so pokazali, da se je sukcinilaceton v urinu pri več kot 90 % bolnikov normaliziral v prvem tednu zdravljenja.
English: Start age ≤ 24 months Start age > 24 months
Slovenian: Začetna starost ≤ 24 mesecev Začetna starost > 24 mesecev
English: For patients who require additional strengths (i.e. between multiples of 10 mg or lower than 10 mg) other medicinal products with lower strengths are available.
Slovenian: Za bolnike, ki potrebujejo drugačne jakosti (npr. med večkratniki 10 mg ali nižje od 10 mg), so na voljo druga zdravila z nižjimi jakostmi.
English: Probability of no HCC (95% confidence interval) at Start 2 years 4 years 6 years 2 years
Slovenian: Verjetnost za nepojav HCK (95 % interval zaupanja) po na začetku po 2 letih po 4 letih po 6 letih
English: For paediatric patients who have difficulties swallowing tablets, other pharmaceutical forms are available.
Slovenian: Za pediatrične bolnike, ki imajo težave s požiranjem tablet, so na voljo druge farmacevtske oblike.
English: Each carton contains 1 bottle.
Slovenian: Ena kartonska škatla vsebuje 1 plastenko.
English: Each tablet contains less than 120 mg of lactose (as monohydrate).
Slovenian: Ena tableta vsebuje manj kot 120 mg laktoze (v obliki monohidrata).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intolerance za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
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: 2-, 4- in 6-letna verjetnost, da se HCK med zdravljenjem z nitizinonom ne bo pojavil pri bolnikih, 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: Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Slovenian: Zdravila Nityr ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje z nitizinonom.
English: In 23 healthy volunteers, after administration of a single dose of Nityr tablets (10 mg) the terminal half-life (median) of nitisinone in plasma was 59 hours (ranging from 41 to 74 hours).
Slovenian: Pri 23 zdravih prostovoljcih je bil končni razpolovni čas (mediana) nitizinona v plazmi po zaužitju tablet Nityr (10 mg) 59 ur (od 41 do 74 ur).
English: Each bottle contains 60 tablets.
Slovenian: Ena plastenka vsebuje 60 tablet.
English: What Nityr is and what it is used for
Slovenian: Kaj je zdravilo Nityr in za kaj ga uporabljamo
English: Excipient with known effect
Slovenian: Pomožna snov z znanim učinkom.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
Slovenian: To zdravilo se uporablja za zdravljenje redke bolezni, imenovane dedna tirozinemija tipa 1 pri odraslih, mladostnikih in otrocih.
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Slovenian: Verjetnosti preživetja po 2, 4 in 6 letih zdravljenja z nitizinonom so povzete v spodnji preglednici.
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 zdravilo Nityr, ne smejo dojiti, ker tveganja za dojenčka ni mogoče izključiti (glejte poglavji 4.3 in 5.3).
English: Patients who have problems swallowing Nityr tablets whole, are recommended to take alternative nitisinone formulations.
Slovenian: Bolnikom, ki imajo težave s požiranjem celih tablet zdravila Nityr, se priporoča jemanje drugačnih formulacij nitizinona.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko prirojeno intoleranco na galaktozo, popolnim pomanjkanjem laktaze ali motnjo absorpcije glukoze-galaktoze tega zdravila ne smejo jemati.
English: The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Slovenian: Pokazale so, da se zdravilo Nityr lahko jemlje s hrano ali brez nje, ne da bi to vplivalo na njegovo biološko uporabnost.
English: Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Slovenian: Med jemanjem tega zdravila ne smete dojiti, glejte poglavje »Ne jemljite zdravila Nityr«.
English: 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).
Slovenian: 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)
English: Once the bottle is opened, the medicine can be stored for a period of 2 months, after which it must be discarded.
Slovenian: Po prvem odprtju plastenke se lahko zdravilo shranjuje dva meseca, potem pa ga je treba zavreči.
English: Other medicines and Nityr
Slovenian: Druga zdravila in zdravilo Nityr
English: Elms Industrial Estate
Slovenian: Elms Industrial Estate Bedford
English: Contact your doctor immediately for an eye examination.
Slovenian: Nemudoma obiščite zdravnika, da vam pregleda oči.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 tablet
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Slovenian: Študije in vitro so pokazale, da nitizonon ne bi smel zavirati presnove, ki deluje preko encimov CYP 1A2, 2C9, 2C19, 2D6, 2E1 ali 3A4.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX04.
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16A X04.
English: A food effect study has been conducted with Nityr.
Slovenian: Opravljene so bile študije učinka hrane na zdravilo Nityr.
English: Store in the original bottle to protect from light.
Slovenian: Shranjujte v originalni plastenki zaradi zaščite pred svetlobo.
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, so pokazale omejeno presnovo preko encima CY P3A4.
English: All patients
Slovenian: Število bolnikov
English: Nityr blocks the breakdown of tyrosine and the harmful substances are not formed.
Slovenian: Zdravilo Nityr zaustavi razgraditev tirozina in prepreči nastanek škodljivih snovi.
English: What you need to know before you take Nityr
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Nityr
English: Marketing Authorisation Holder Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Slovenian: Imetnik dovoljenja za promet z zdravilom Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
English: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Slovenian: V 26-tedenski študiji kancerogenosti pri transgenskih miših (TgrasH2) nitizinon ni pokazal kancerogenega potenciala.
English: Tablets are not suitable for breaking to make up additional strengths.
Slovenian: Tablete niso primerne za delitev z namenom, da se dobi drugačna jakost.
English: Common eye related side effects (may affect more than 1 in 10 people) are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Slovenian: Pogosti neželeni učinki, povezani z očmi, (pojavijo se lahko pri več kot 1 od 10 bolnikov), ki jih povzročijo višje ravni tirozina, so vnetje v očesu (konjunktivitis), motnjava in vnetje roženice (keratitis), občutljivost za svetlobo (fotofobija) in bolečine v očeh.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študije o medsebojnem delovanju z drugimi zdravili niso bile izvedene.
English: If you forget to take Nityr
Slovenian: Če ste pozabili vzeti zdravilo Nityr
English: During the shelf life, the patient may store the bottle after first opening for a period of 2 months, after which the medicinal product must be discarded.
Slovenian: Med rokom uporabnosti lahko bolnik plastenko po prvem odprtju shranjuje dva meseca, potem pa mora zdravilo zavreči.
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: 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: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Slovenian: Pri inhibiciji normalnega katabolizma tirozina pri bolnikih, ki imajo HT-1, nitizinon prepreči akumulacijo toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
English: INFORMATION IN BRAILLE Nityr 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Nityr 10 mg
English: If you stop taking Nityr
Slovenian: Če ste prenehali jemati zdravilo Nityr
English: Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common.
Slovenian: Neželeni učinki, povezani z očmi, kot so konjunktivitis, motnjava roženice, keratitis, fotofobija in bolečine v očeh, povezane s povečanimi ravnmi tirozina, so zato pogosti.
English: Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Slovenian: Zdravilo Nityr skupaj s hrano Zdravilo Nityr se lahko ves čas zdravljenja jemlje s hrano ali brez nje.
English: Shelf life after first opening - 2 months Open date:
Slovenian: Rok uporabnosti po prvem odprtju: 2 meseca Datum odprtja:
English: White to beige, round (7 x 2.3 mm), flat tablets which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side.
Slovenian: Bele do bež, okrogle (7 x 2,3 mm), ploščate tablete, posejane s svetlorumenimi do rjavimi pikami, z oznako „10“ na eni strani in oznako „L“ na drugi.
English: Nityr has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Nityr ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Contains lactose
Slovenian: Vsebuje laktozo.
English: A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, then 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: 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: Treatment of adult and paediatric 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: The tablets are packaged in plastic square bottles with a tamper-evident child-resistant closure.
Slovenian: Tablete so pakirane v plastično, pravokotno plastenko, ki ima za otroke varno zaporko s pečatom proti nedovoljenemu odpiranju.
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 Nityr, kot bi smeli Če ste vzeli prevelik odmerek tega zdravila, se čim prej posvetujte z zdravnikom ali farmacevtom.
English: HDPE 75 mL square bottles with a tamper-evident child-resistant closure of polypropylene (PP).
Slovenian: Pravokotna plastenka iz HDPE velikosti 75 ml z za otroke varno zaporko s pečatom proti nedovoljenemu odpiranju iz polipropilena (PP).
English: Fertility There are no data on nitisinone affecting fertility.
Slovenian: Podatkov o vplivu nitizinona na plodnost ni.
English: The active ingredient of Nityr is nitisinone.
Slovenian: Zdravilna učinkovina v zdravilu Nityr je nitizinon.
English: What Nityr looks like and contents of the pack
Slovenian: Izgled zdravila Nityr in vsebina pakiranja
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Slovenian: Nitizinon je kompetitivni inhibitor encima 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: Biokemična motnja pri dedni tirozinemiji tipa 1 (HT-1) je pomanjkanje fumarilacetoacetat-hidrolaze, ki je končni encim v katabolni poti tirozina.
English: Name and address of the manufacturer(s) responsible for batch release Central Pharma (Contract Packing) Limited Caxton Road
Slovenian: Central Pharma (Contract Packing) Limited Caxton Road
English: The recommended total daily dose is 1 mg/kg body administered orally weight.
Slovenian: Priporočeni celotni dnevni odmerek je 1 mg/kg telesne mase, ki se daje peroralno.
English: < 2 months > 2-6 months > 6 months
Slovenian: Starost pri pojavu simptomov 1 leto 2 leti < 2 meseca > 2-6 mesecev > 6 mesecev
English: - Each tablet contains 10 mg nitisinone.
Slovenian: Ena tableta vsebuje 10 mg nitizinona.
English: The tablets are white to beige, round, flat which may display light yellow to brown speckles marked with “L” on one side and “10” on the other side.
Slovenian: Tablete so bele do bež barve, okrogle, ploščate, posejane s svetlorumenimi do rjavimi pikami, z oznako „L“ na eni strani in oznako „10“ na drugi.
English: How to take Nityr
Slovenian: Kako jemati zdravilo Nityr
English: Breastfeeding (see sections 4.6 and 5.3).
Slovenian: Matere, ki jemljejo nitizinon, ne smejo dojiti (glejte poglavji 4.6 in 5.3).
English: Nityr contains lactose
Slovenian: Zdravilo Nityr vsebuje laktoza
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Nityr Vsebina pakiranja in dodatne informacije
English: The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Slovenian: Priporočeni začetni odmerek za otroke in odrasle je 1 mg/kg telesne mase, ki se jemlje peroralno.
English: - The other ingredients are glycerol dibehenate, and lactose monohydrate (see section 2 under
Slovenian: Drugi sestavini zdravila sta glicerol dibehenat in laktoza (v obliki monohidrata) (glejte poglavje 2 „Zdravilo Nityr vsebuje laktozo“)
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Slovenian: Pogosti konjunktivitis, motnjava roženice, keratitis, fotofobija, bolečine v očeh
English: Do not take Nityr: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section - Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Slovenian: Ne jemljite zdravila Nityr - če ste alergični na nitizinon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: ≤ 2 months ≤ 6 months > 6 months Overall
Slovenian: Starost na začetku zdravljenja 2 leti 4 leta 6 let ≤ 2 meseca ≤ 6 mesecev > 6 mesecev celokupna
English: Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Slovenian: Drugi pogosti neželeni učinki - zmanjšano število trombocitov (trombocitopenija) in belih krvnih celic (levkopenija),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nityr 10 mg tablets nitisinone oral use
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Nityr 10 mg tablete nitizinon peroralna uporaba
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets nitisinone
Slovenian: IME ZDRAVILA Nityr 10 mg tablete nitizinon
English: If you have the impression that the medicine is not working properly, talk to your doctor.
Slovenian: Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom.
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment.
Slovenian: Pred začetkom zdravljenja z nitizinonom je priporočljivo opraviti pregled oči s špranjsko svetilko.
English: MedDRA system organ class
Slovenian: Organski sistem
English: How to store Nityr
Slovenian: Shranjevanje zdravila Nityr
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg nitisinone.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg nitizinona.
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
Slovenian: Če raven tirozina v plazmi presega 500 mikromolov/l, je treba z dieto še bolj zmanjšati vnos tirozina in fenilalanina.
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH NALEPKA NA VSEBNIKU