FrancophonIA/ELRC3.0 huggingface dataset:
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Croatian: Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR“ na jednoj strani i „VEL“ na drugoj strani.
English: EU/1/09/569/019 280 film-coated tablets
Croatian: EU/1/09/569/019 280 filmom obloženih tableta
English: EU/1/09/569/030 98 film-coated tablets
Croatian: EU/1/09/569/030 98 filmom obloženih tableta
English: EU/1/09/569/052 56 film-coated tablets
Croatian: EU/1/09/569/052 56 filmom obloženih tableta
English: EU/1/09/569/001 14 film-coated tablets
Croatian: EU/1/09/569/001 14 filmom obloženih tableta
English: EU/1/09/569/005 90 film-coated tablets
Croatian: EU/1/09/569/005 90 filmom obloženih tableta
English: EU/1/09/569/025 14 film-coated tablets
Croatian: EU/1/09/569/025 14 filmom obloženih tableta
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Croatian: Zbog ograničenog broja dostupnih podataka u ovoj populaciji bolesnika, u starijih bolesnika se preporučuje oprez, uključujući češće praćenje krvnog tlaka, posebno pri najvišoj dozi Exforge HCT-a, 10 mg/320 mg/25 mg.
English: EU/1/09/569/003 30 film-coated tablets
Croatian: EU/1/09/569/003 30 filmom obloženih tableta
English: EU/1/09/569/053 90 film-coated tablets
Croatian: EU/1/09/569/053 90 filmom obloženih tableta
English: EU/1/09/569/029 90 film-coated tablets
Croatian: EU/1/09/569/029 90 filmom obloženih tableta
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: EU/1/09/569/017 90 film-coated tablets
Croatian: EU/1/09/569/017 90 filmom obloženih tableta
English: EU/1/09/569/049 14 film-coated tablets
Croatian: EU/1/09/569/049 14 filmom obloženih tableta
English: EU/1/09/569/037 14 film-coated tablets
Croatian: EU/1/09/569/037 14 filmom obloženih tableta
English: EU/1/09/569/014 28 film-coated tablets
Croatian: EU/1/09/569/014 28 filmom obloženih tableta
English: EU/1/09/569/015 30 film-coated tablets
Croatian: EU/1/09/569/015 30 filmom obloženih tableta
English: EU/1/09/569/051 30 film-coated tablets
Croatian: EU/1/09/569/051 30 filmom obloženih tableta
English: EU/1/09/569/002 28 film-coated tablets
Croatian: EU/1/09/569/002 28 filmom obloženih tableta
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Croatian: Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VHL“ na drugoj strani.
English: EU/1/09/569/039 30 film-coated tablets
Croatian: EU/1/09/569/039 30 filmom obloženih tableta
English: EU/1/09/569/044 56 x 1 film-coated tablet (unit dose) EU/1/09/569/045 98 x 1 film-coated tablet (unit dose) EU/1/09/569/046 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/569/044 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/046 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/569/008 56 x 1 film-coated tablet (unit dose) EU/1/09/569/009 98 x 1 film-coated tablet (unit dose) EU/1/09/569/010 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/569/008 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/010 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/569/056 56 x 1 film-coated tablet (unit dose) EU/1/09/569/057 98 x 1 film-coated tablet (unit dose) EU/1/09/569/058 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/569/056 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/058 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/569/032 56 x 1 film-coated tablet (unit dose) EU/1/09/569/033 98 x 1 film-coated tablet (unit dose) EU/1/09/569/034 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/569/032 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/034 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/569/013 14 film-coated tablets
Croatian: EU/1/09/569/013 14 filmom obloženih tableta
English: EU/1/09/569/050 28 film-coated tablets
Croatian: EU/1/09/569/050 28 filmom obloženih tableta
English: EU/1/09/569/028 56 film-coated tablets
Croatian: EU/1/09/569/028 56 filmom obloženih tableta
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
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)
Croatian: EU/1/09/569/020 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/022 280 x 1 filmom obloženih tableta (jedinična doza)
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
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)
Croatian: EU/1/09/569/048 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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)
Croatian: EU/1/09/569/012 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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)
Croatian: EU/1/09/569/060 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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)
Croatian: EU/1/09/569/036 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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)
Croatian: EU/1/09/569/024 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/023 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: No dose adjustment of Exforge HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m 2) dozu Exforge
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).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Each bottle contains 60 tablets.
Croatian: Jedna boca sadrži 60 tableta.
English: The tablets may be taken with or without food.
Croatian: Tablete se mogu uzimati s hranom ili bez nje.
English: No formal interaction studies with other medicinal products have been conducted.
Croatian: Nisu provedena službena ispitivanja interakcija s drugim lijekovima.
English: What Nityr looks like and contents of the pack
Croatian: Kako Nityr izgleda i sadržaj pakiranja
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.
Croatian: Za bolesnike kojima je potrebna dodatna jačina (tj. jačina između višekratnika 10 mg ili manja od 10 mg) dostupni su drugi lijekovi slabije jačine.
English: Other medicines and Nityr
Croatian: Drugi lijekovi i Nityr
English: For paediatric patients who have difficulties swallowing tablets, other pharmaceutical forms are available.
Croatian: Za pedijatrijske bolesnike koji imaju poteškoća s gutanjem tableta dostupni su drugi farmaceutski oblici.
English: What Nityr is and what it is used for
Croatian: Što je Nityr i za što se koristi
English: However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Croatian: Ipak, ako osjetite nuspojave koje utječu na vid, ne smijete upravljati vozilima ili raditi sa strojevima dok Vam vid ponovo ne postane normalan (vidjeti dio 4 „Moguće nuspojave“).
English: Tablets are not suitable for breaking to make up additional strengths.
Croatian: Tablete nisu pogodne za lomljenje kako bi se dobila dodatna jačina.
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).
Croatian: U 23 zdrava dobrovoljca nakon primjene pojedinačne doze tableta Nityr (10 mg) terminalni poluvijek (medijan) nitizinona u plazmi bio je 59 sati (u rasponu od 41 do 74 sata).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 tablets
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 tableta
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon prvog otvaranja lijeka, vidjeti dio 6.3.
English: Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Croatian: Nityr se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje nitizinonom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Croatian: Datum prvog odobrenja: 26. srpnja 2018
English: Contact your doctor immediately for an eye examination.
Croatian: Odmah se obratite svom liječniku radi pregleda očiju.
English: Probability of no HCC (95% confidence interval) at Start 2 years 4 years 6 years 2 years
Croatian: Vjerojatnost da se HCC neće pojaviti (interval pouzdanosti 95%) nakon na početku nakon 2 godine nakon 4 godine nakon 6 godina
English: If you take more Nityr than you should
Croatian: Ako uzmete više lijeka Nityr nego što ste trebali
English: Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Croatian: Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Nemojte uzimati Nityr“.
English: Each tablet contains less than 120 mg of lactose (as monohydrate).
Croatian: Jedna tableta sadrži manje od 120 mg laktoze (u obliku laktoza hidrata).
English: Shelf life after first opening - 2 months Open date:
Croatian: Rok valjanosti nakon prvog otvaranja - 2 mjeseca Datum otvaranja:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1290/001
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.
Croatian: Dostupni podaci iz kliničkih studija ukazuju da se sukcinilaceton u mokraći normalizirao u više od 90% bolesnika tijekom prvog tjedna liječenja.
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Croatian: Na temelju in vitro studija ne očekuje se da će nitizinon inhibirati metabolizam posredovan CYP 1A2, 2C9, 2C19, 2D6, 2E1 ili 3A4.
English: Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Croatian: Nityr s hranom Nityr se može uzimati s hranom ili bez nje za čitavo vrijeme trajanja
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment.
Croatian: Preporučuje se pregled očiju procjepnom svjetiljkom prije početka liječenja nitizinonom.
English: Elms Industrial Estate
Croatian: Elms Industrial Estate Bedford
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Croatian: Vjerojatnosti preživljenja nakon 2, 4 i 6 godina liječenja nitizinonom prikazane su u sljedećoj tablici.
English: The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Croatian: Ispitivanjem je utvrđeno da se Nityr može uzimati s hranom ili bez nje bez učinka na njegovu bioraspoloživost.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Laktoza Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: The clinical study was open-labelled and uncontrolled.
Croatian: Kliničko je ispitivanje bilo otvorenog tipa i bez kontrolne skupine.
English: Once the bottle is opened, the medicine can be stored for a period of 2 months, after which it must be discarded.
Croatian: Nakon otvaranja lijek se može čuvati u razdoblju od 2 mjeseca, a nakon toga mora se baciti.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
Croatian: Ovaj se lijek primjenjuje u liječenju rijetke bolesti zvane nasljedna tirozinemija tipa 1 u odraslih, adolescenata i djece.
English: If you stop taking Nityr
Croatian: Ako prestanete uzimati Nityr
English: There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Croatian: Posebne populacije Nema specifičnih preporuka za dozu u starijih ili bolesnika s oštećenjem bubrega ili jetre.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX04.
Croatian: Farmakoterapijska skupina: Drugi lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16A X04.
English: Nityr blocks the breakdown of tyrosine and the harmful substances are not formed.
Croatian: Nityr blokira razgradnju tirozina te ne nastaju štetne tvari.
English: What Nityr contains - The active substance is nitisinone.
Croatian: Što Nityr sadrži - Djelatna tvar je nitizinon.
English: No patient had detectable succinylacetone (SA) levels at the end of the once-daily treatment period.
Croatian: Nijedan bolesnik nije imao mjerljive razine sukcinilacetona (SA) na kraju razdoblja liječenja uz doziranje jednom dnevno.
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.
Croatian: Unutar roka valjanosti bolesnici mogu čuvati bocu nakon prvog otvaranja u razdoblju od 2 mjeseca, nakon čega se lijek mora baciti.
English: Nityr contains lactose
Croatian: Nityr sadrži laktoza
English: Store in the original bottle to protect from light.
Croatian: Čuvati u originalnoj boci radi zaštite od svjetlosti.
English: Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Croatian: Upala očnog kapka (blefaritis) je manje česta nuspojava (javlja se u do 1 na 100 osoba).
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.
Croatian: Studije prenatalnog i postnatalnog razvoja u miševa pokazale su statistički značajna smanjenja preživljenja mladunčadi te njihovog rasta tijekom razdoblja odbijanja od sise pri razinama doza 125, odnosno 25 puta većim od maksimalnih preporučenih doza u ljudi, s trendom negativnog učinka na preživljenje mladunčeta počevši od doze 5 mg/kg/dan.
English: Nityr has minor influence on the ability to drive and use machines.
Croatian: Nityr malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Marketing Authorisation Holder Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
English: If you forget to take Nityr
Croatian: Ako ste zaboravili uzeti Nityr
English: A food effect study has been conducted with Nityr.
Croatian: Provedeno je ispitivanje učinka uzimanja hrane s lijekom Nityr.
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.
Croatian: Tablete su bijele do bež boje, okrugle, plosnate te mogu imati svijetlo žute do smeđe točkice, s oznakom „L” na jednoj strani i oznakom „10” na drugoj strani.
English: The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Croatian: Preporučena početna doza u pedijatrijskoj i odrasloj populaciji iznosi 1 mg/kg tjelesne težine koja se primjenjuje peroralno.
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.
Croatian: Česte nuspojave na očima (javljaju se u više od 1 na 10 osoba) uzrokovane povišenim razinama tirozina su upala oka (konjunktivitis), zamućenje i upala rožnice (keratitis), osjetljivost na svjetlo (fotofobija) i bol u očima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg nitisinone.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 10 mg nitizinona.
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.
Croatian: Liječenje odraslih i pedijatrijskih bolesnika (bilo koje dobi) s potvrđenom dijagnozom nasljedne tirozinemije tipa 1 (HT-1) u kombinaciji s ograničenjem unosa tirozina i fenilalanina hranom.
English: SPECIAL STORAGE CONDITIONS Store in the original bottle in order to protect from light.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnoj boci radi zaštite od svjetlosti.
English: UNITED KINGDOM
Croatian: Ujedinjena Kraljevina
English: Contains lactose
Croatian: Sadrži laktozu.
English: Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
Croatian: Liječenje nitizinonom mora započeti i nadzirati liječnik iskusan u liječenju bolesnika s HT-1.
English: - if you get red eyes or any other signs of effects on the eyes.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Nityr, - ako Vam oči postanu crvene ili uočite bilo koje druge znakove učinka na oči.
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.
Croatian: Tablete bijele do bež boje, okrugle (7 x 2,3 mm), plosnate, mogu imati svijetložute do smeđe točkice, s oznakom „10” na jednoj strani i oznakom „L” na drugoj strani.
English: The active ingredient of Nityr is nitisinone.
Croatian: Djelatna tvar lijeka Nityr je nitizinon.
English: INFORMATION IN BRAILLE Nityr 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nityr 10 mg
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.
Croatian: Biokemijski defekt u nasljednoj tirozinemiji tipa 1 (HT-1) je nedostatak fumarilacetoacetat hidrolaze, koja je krajnji enzim kataboličkog puta tirozina.
English: Fertility There are no data on nitisinone affecting fertility.
Croatian: Nema podataka o utjecaju nitizinona na plodnost.
English: - The other ingredients are glycerol dibehenate, and lactose monohydrate (see section 2 under
Croatian: - Ostali sastojci su gliceroldibehenat i laktoza hidrat (vidjeti dio 2. „Nityr sadrži laktozu”).
English: - Each tablet contains 10 mg nitisinone.
Croatian: - Jedna tableta sadrži 10 mg nitizinona.
English: < 2 months > 2-6 months > 6 months
Croatian: Dob pri nastupu simptoma 1 godina 2 godine < 2 mjeseca > 2-6 mjeseci > 6 mjeseci
English: How to take Nityr
Croatian: Kako uzimati Nityr
English: Name and address of the manufacturer(s) responsible for batch release Central Pharma (Contract Packing) Limited Caxton Road
Croatian: Central Pharma (Contract Packing) Limited Caxton Road
English: How to store Nityr
Croatian: Kako čuvati Nityr
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI
English: The recommended total daily dose is 1 mg/kg body administered orally weight.
Croatian: Preporučena ukupna dnevna doza je 1 mg/kg tjelesne težine i uzima se kroz usta.