natgillin/translations-raw huggingface dataset:
Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too weak, or if you experience possible side effects.
Razgovarajte sa svojim liječnikom ili ljekarnikom ako mislite da je učinak Levodopa/Carbidopa/Entacapone
Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 50 mg levodope, 12,5 mg karbidope i 200 mg entakapona.
Initiation of Levodopa/Carbidopa/Entacapone Orion may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/DDC inhibitor treatment.
U nekih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama na kraju intervala doziranja, koji nisu stabilizirani trenutnim liječenjem levodopom/DDC-inhibitorom sa standardnim oslobađanjem, može se razmotriti uvođenje Levodopa/Carbidopa/Entacapone Oriona u dozama odgovarajućim trenutnoj terapiji.
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Orion 175 mg/43,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 100 mg levodope, 25 mg karbidope i 200 mg entakapona.
levodopa/carbidopa/entacapone orion 200/50/200 mg [carton only]
levodopa/carbidopa/entacapone orion 200/50/200 mg [samo kutija]
Therefore, do not take Levodopa/Carbidopa/Entacapone Orion and iron supplements at the same time.
Stoga ne uzimajte istodobno Levodopa/Carbidopa/Entacapone
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Nisu objavljena posebna ispitivanja farmakokinetike levodope i karbidope kod bolesnika s bubrežnom insuficijencijom, pa se stoga terapija Levodopa/Carbidopa/Entacapone
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Orion 75 mg/18,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 75" na jednoj strani.
Urinary retention
Prijavljivanje nuspojava
Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 150 mg levodope, 37,5 mg karbidope i 200 mg entakapona.
Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
Excipient with known effect: Each tablet contains 1.6 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 1,6 mg saharoze.
Excipient with known effect: Each tablet contains 1.2 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 1,2 mg saharoze.
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Orion 50 mg/12,5 mg/200 mg: smećkasto ili sivkasto-crvene, okrugle, konveksne filmom obložene tablete, bez ureza, s oznakom "LCE 50" na jednoj strani.
How to take Levodopa/Carbidopa/Entacapone Orion
Kako uzimati Levodopa/Carbidopa/Entacapone Orion
Always leave at least an hour between Levodopa/Carbidopa/Entacapone Orion tablets, to avoid possible side effects.
Orion tableta uvijek mora proći najmanje jedan sat, kako bi se izbjegle moguće nuspojave.
EU/1/11/706/023 10 film-coated tablets EU/1/11/706/024 30 film-coated tablets EU/1/11/706/025 100 film-coated tablets EU/1/11/706/026 130 film-coated tablets EU/1/11/706/027 175 film-coated tablets EU/1/11/706/028 250 film-coated tablets
EU/1/11/706/023 10 filmom obloženih tableta EU/1/11/706/024 30 filmom obloženih tableta EU/1/11/706/025 100 filmom obloženih tableta EU/1/11/706/026 130 filmom obloženih tableta EU/1/11/706/027 175 filmom obloženih tableta EU/1/11/706/028 250 filmom obloženih tableta
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 50 mg/12,5 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone
Excipient with known effect: Each tablet contains 1.4 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 1,4 mg saharoze.
EU/1/11/706/007 10 film-coated tablets EU/1/11/706/008 30 film-coated tablets EU/1/11/706/009 100 film-coated tablets EU/1/11/706/010 130 film-coated tablets EU/1/11/706/011 175 film-coated tablets
EU/1/11/706/007 10 filmom obloženih tableta EU/1/11/706/008 30 filmom obloženih tableta EU/1/11/706/009 100 filmom obloženih tableta EU/1/11/706/010 130 filmom obloženih tableta EU/1/11/706/011 175 filmom obloženih tableta
According to this daily carbidopa dose, the maximum recommended daily dose of Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75
Prema ovoj dnevnoj dozi karbidope, najviša preporučena dnevna doza Levodopa/Carbidopa/Entacapone
EU/1/11/706/034 10 film-coated tablets EU/1/11/706/035 30 film-coated tablets EU/1/11/706/036 100 film-coated tablets EU/1/11/706/037 130 film-coated tablets EU/1/11/706/038 175 film-coated tablets
EU/1/11/706/034 10 filmom obloženih tableta EU/1/11/706/035 30 filmom obloženih tableta EU/1/11/706/036 100 filmom obloženih tableta EU/1/11/706/037 130 filmom obloženih tableta EU/1/11/706/038 175 filmom obloženih tableta
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
- Drugi sastojci u ovojnici tablete su glicerol (85 postotni) (E422), hipromeloza, magnezijev stearat, polisorbat 80, željezov oksid crveni (E172), saharoza, titanijev dioksid (E171).
EU/1/11/706/029 10 film-coated tablets EU/1/11/706/030 30 film-coated tablets EU/1/11/706/031 100 film-coated tablets EU/1/11/706/032 130 film-coated tablets EU/1/11/706/033 175 film-coated tablets
EU/1/11/706/029 10 filmom obloženih tableta EU/1/11/706/030 30 filmom obloženih tableta EU/1/11/706/031 100 filmom obloženih tableta EU/1/11/706/032 130 filmom obloženih tableta EU/1/11/706/033 175 filmom obloženih tableta
- The active substances of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
Međutim, izravni prijelaz sa levodope/DDC-inhibitora na Levodopa/Carbidopa/Entacapone
EU/1/11/706/001 10 film-coated tablets EU/1/11/706/002 30 film-coated tablets EU/1/11/706/003 100 film-coated tablets EU/1/11/706/004 130 film-coated tablets EU/1/11/706/005 175 film-coated tablets EU/1/11/706/006 250 film-coated tablets
EU/1/11/706/001 10 filmom obloženih tableta EU/1/11/706/002 30 filmom obloženih tableta EU/1/11/706/003 100 filmom obloženih tableta EU/1/11/706/004 130 filmom obloženih tableta EU/1/11/706/005 175 filmom obloženih tableta EU/1/11/706/006 250 filmom obloženih tableta
EU/1/11/706/018 10 film-coated tablets EU/1/11/706/019 30 film-coated tablets EU/1/11/706/020 100 film-coated tablets EU/1/11/706/021 130 film-coated tablets EU/1/11/706/022 175 film-coated tablets
EU/1/11/706/018 10 filmom obloženih tableta EU/1/11/706/019 30 filmom obloženih tableta EU/1/11/706/020 100 filmom obloženih tableta EU/1/11/706/021 130 filmom obloženih tableta EU/1/11/706/022 175 filmom obloženih tableta
The possibility that the patient has taken other active substances in addition to Levodopa/Carbidopa/Entacapone Orion should be taken into consideration.
Mora se uzeti u obzir mogućnost da je bolesnik uz Levodopa/Carbidopa/Entacapone
Do not take Levodopa/Carbidopa/Entacapone Orion if you:
Nemojte uzimati Levodopa/Carbidopa/Entacapone Orion
EU/1/11/706/012 10 film-coated tablets EU/1/11/706/013 30 film-coated tablets EU/1/11/706/014 100 film-coated tablets EU/1/11/706/015 130 film-coated tablets EU/1/11/706/016 175 film-coated tablets EU/1/11/706/017 250 film-coated tablets
EU/1/11/706/012 10 filmom obloženih tableta EU/1/11/706/013 30 filmom obloženih tableta EU/1/11/706/014 100 filmom obloženih tableta EU/1/11/706/015 130 filmom obloženih tableta EU/1/11/706/016 175 filmom obloženih tableta EU/1/11/706/017 250 filmom obloženih tableta
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 175 mg/43,75 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone
No adverse reactions on fertility were observed in preclinical studies with entacapone, carbidopa or levodopa alone.
U pretkliničkim ispitivanjima samo s entakaponom, karbidopom ili levadopom nisu uočene neželjene reakcije na plodnost.
How to store Levodopa/Carbidopa/Entacapone Orion
Kako čuvati Levodopa/Carbidopa/Entacapone Orion
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 75 mg/18,75 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone
Carton
Serija
How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Levodopa/Carbidopa/Entacapone Orion a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Levodopa/Carbidopa/Entacapone Orion tablet strengths can be directly transferred to corresponding Levodopa/Carbidopa/Entacapone Orion tablets.
Bolesnici koji su trenutno liječeni entakaponom i levodopom/karbidopom sa standardnim oslobađanjem u dozama koje su jednake jačinama Levodopa/Carbidopa/Entacapone
- Each Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Orion 75 mg/18,75 mg/200 mg tableta sadrži 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
- Drugi sastojci u ovojnici tablete su glicerol (85 postotni) (E 422), hipromeloza, magnezijev stearat, polisorbat 80, crveni željezov oksid (E 172), saharoza, titanijev dioksid (E 171) i žuti željezov oksid(E 172).
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 150 mg/37,5 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 125 mg/31,25 mg/200 mg filmom obložene tablete Levodopa/Carbidopa/Entacapone
Ten tablets of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Oriona 150 mg/37,5 mg/200 mg odgovara 375 mg karbidope dnevno.
- Each Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Orion 175 mg/43,75 mg/200 mg tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 100 mg/25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Orion 50 mg/12,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
- Each Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Orion 125 mg/31,25 mg/200 mg tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Orion 200 mg/50 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Levodopa/Carbidopa/Entacapone Orion strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Oriona iznosi 10 tableta na dan za jačine od 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg i 150 mg/37,5 mg/200 mg.
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Orion 150 mg/37,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
- Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of drug-induced extrapyramidal reactions.
Orion se ne preporučuje za liječenje ekstrapiramidnih reakcija izazvanih lijekovima.
Tablet core:
Orion tablete.
- If general anaesthesia is required, therapy with Levodopa/Carbidopa/Entacapone Orion may be continued for as long as the patient is permitted to take fluids and medicinal products by mouth.
Orionom može se nastaviti tako dugo dok bolesnik smije uzimati tekućinu i lijekove na usta.
Management of acute overdose with Levodopa/Carbidopa/Entacapone Orion therapy is similar to acute overdose with levodopa.
Zbrinjavanje akutnog predoziranja tijekom terapije Levodopa/Carbidopa/Entacapone
Patients taking these medicinal products with Levodopa/Carbidopa/Entacapone Orion should be carefully observed for loss of therapeutic response.
Orionom mora se pažljivo pratiti radi gubitka terapijskog odgovora.
1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
1 ml (125 mg/ml) 12 (4 x 3) napunjenih brizgalica (višestruko pakiranje)
1 ml (125 mg/ml) 4 pre-filled pens
1 ml (125 mg/ml) 4 napunjene brizgalice
Date of first authorisation: 24 August 2017
Datum prvog odobrenja: 24. kolovoza 2017.
This dose should be considered as a maximal dose for all patients.
Ta se doza mora smatrati maksimalnom dozom za sve bolesnike.
Store in the original bottle in order to protect from light.
Čuvati u originalnoj bočici radi zaštite od svjetlosti.
The capsules are packaged in plastic bottles.
Kapsule su pakirane u plastične boce.
Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Podaci iz ispitivanja koji su se koristili kao povijesna kontrola (van Spronsen i sur., 1994) pokazali su sljedeće vjerojatnosti preživljenja.
Please contact your doctor if you plan to become pregnant.
Obratite se svom liječniku ako planirate trudnoću.
No information about specific treatment of overdose is available.
Nisu dostupne informacije o specifičnom liječenju predoziranja.
Do not change the dose or stop the treatment without talking to your doctor.
Nemojte mijenjati dozu ili prekidati liječenje bez razgovora sa svojim liječnikom.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
Ne zaboravite naznačiti na boci datum vađenja iz hladnjaka.
Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Drugi farmaceutski oblici dostupni su za pedijatrijske bolesnike koji imaju poteškoća s gutanjem kapsula.
Follow-up by your doctor should be performed every 6 months.
Vaš će liječnik provoditi kontrole svakih 6 mjeseci.
During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.
Tijekom liječenja uzimat će se uzorci Vaše krvi kako bi liječnik provjerio je li liječenje za Vas odgovarajuće te da bi se pobrinuo da nema mogućih nuspojava koje uzrokuju poremećaje krvi.
A dose of 2 mg/kg body weight/day may be needed based on the evaluation of all biochemical parameters.
Možda će biti potrebna doza od 2 mg/kg tjelesne težine/dan na temelju procjene svih biokemijskih parametara.
Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Posjete radi praćenja potrebno je provoditi svakih 6 mjeseci; u slučaju štetnih događaja preporučuju se kraći razmaci između posjeta.
Date when removed from refrigerator:
Datum vađenja iz hladnjaka:
- if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na nitizinon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Ako je biokemijski odgovor zadovoljavajući, doza se mora prilagođavati samo sukladno povećanju tjelesne težine.
These substances are accumulated in your body.
Te se tvari nakupljaju u Vašem tijelu.
Age at onset of symptoms 1 year 2 years < 2 months
Dob pri nastupu simptoma 1 godina 2 godine < 2 mjeseca
Each bottle contains 60 capsules.
Jedna boca sadrži 60 kapsula.
Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Analiza populacijske farmakokinetike provedena je na skupini od 207 HT-1 bolesnika.
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Ujedinjeno Kraljevstvo
You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
Morate se pridržavati posebne dijete dok uzimate ovaj lijek, jer će tirozin zaostati u Vašem tijelu.
Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Nuspojave koje zahvaćaju oči (vidjeti dio 4.8) mogu utjecati na vid.
NTBC study (N=250)
Ispitivanje NTBC (N=250)
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”).
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”).
If you have the impression that the medicine is not working properly, talk to your doctor.
Ako imate dojam da lijek ne djeluje ispravno, obratite se svom liječniku.
Your doctor will adjust the dose individually.
Vaš će liječnik prilagoditi dozu Vašim individualnim potrebama.
It is recommended to administer the dose once daily.
Preporučuje se primjenjivati dozu jednom dnevno.
In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
U kliničkim ispitivanjima granulocitopenija je bila manje često teška (<0,5x109/l) i nije bila povezana s infekcijama.
In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
U međunarodnom ispitivanju bolesnika s HT-1 koji se liječe samo uz ograničenja u prehrani, pronašlo se da je HCC bio dijagnosticiran u 18% svih bolesnika u dobi od 2 godine i naviše.
Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Liječenje svih genotipova bolesti mora se započeti čim je prije moguće, kako bi se povećalo ukupno preživljenje i izbjegle komplikacije poput zatajenja jetre, raka jetre i bolesti bubrega.
Concomitant use with other medicinal products
Istodobna primjena s drugim lijekovima
Each carton pack contains one bottle.
Jedno kartonsko pakiranje sadrži jednu bocu.
However, nitisinone has been co-administered with food during the generation of efficacy and safety data.
Međutim, nitizinon se primjenjivao istodobno s hranom tijekom prikupljanja podataka o djelotvornosti i sigurnosti.
60 capsules
60 kapsula
There are no adequate data from the use of nitisinone in pregnant women.
Nema odgovarajućih podataka o uporabi nitizinona u trudnica.
The safety of this medicine has not been studied in pregnant and breast-feeding women.
Sigurnost ovog lijeka nije ispitivana u trudnica i dojilja.
Eye problems could be a sign of inadequate dietary control (see section 4).
Problemi s očima mogu biti znak neodgovarajuće kontrole prehranom (pogledajte dio 4).
From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Podaci iz kliničkih ispitivanja i primjene nakon stavljanja lijeka u promet ne ukazuju na to da se sigurnosni profil razlikuje u različitih podskupina pedijatrijske populacije ili da se razlikuje od sigurnosnog profila u odraslih bolesnika.
If you become pregnant you should contact your doctor immediately.
Ako zatrudnite, odmah se obratite svom liječniku.
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.
Preporučuje se pregled očiju procjepnom svjetiljkom prije početka liječenja nitizinonom , a zatim redovito, najmanje jednom godišnje.
Nitisinone MDK with food and drink
Nitisinone MDK s hranom i pićem
2 - 6 months > 6 months
2-6 mjeseci > 6 mjeseci
Blepharitis
Blefaritis
In 10 healthy male volunteers, after administration of a single dose of nitisinone capsules (1 mg/kg body weight) the terminal half-life (median) of nitisinone in plasma was 54 hours (ranging from 39 to 86 hours).
U 10 zdravih muških dobrovoljaca nakon primjene pojedinačne doze kapsula nitizinona (1 mg/kg tjelesne težine) terminalni poluvijek (medijan) nitizinona u plazmi bilo je 54 sata (u rasponu od 39 do 86 sati).
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Ujedinjena Kraljevina
Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Nitizinon nije pokazao kancerogeni potencijal u 26-tjednom ispitivanju kancerogenosti na transgeničnim miševima (TgrasH2).
Nitisinone MDK should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Nitisinone MDK ne smije se primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje nitizinonom.
Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Može biti potrebna prilagodba doze tih istodobno primjenjivanih lijekova (vidjeti dio 4.5).
The dose recommendation in mg/kg body weight is the same in children and adults.
Preporučena doza u mg/kg tjelesne težine jednaka je u djece i odraslih.
6 years
6 godina
If you have problems with swallowing the capsules, you may open the capsule and mix the powder with a small amount of water or formula diet just before you take it.
Ako imate problema s gutanjem kapsula, možete otvoriti kapsulu i pomiješati prašak s malo vode ili dijetetskim pripravkom neposredno prije uzimanja.
The study indicates that once daily administration is safe and efficacious across all ages of patients.
Ispitivanje pokazuje da je primjena jednom dnevno sigurna i djelotvorna u svim dobnim skupinama bolesnika.
However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.
Međutim, zbog ograničenih podataka za bolesnike tjelesne težine <20 kg, u toj se populaciji bolesnika preporučuje razdijeliti ukupnu dnevnu dozu i primijeniti je u dva dijela.
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.
Ako započnete liječenje lijekom Nitisinone MDK uzimajući ga s hranom, preporučuje se da ga nastavite uzimati s hranom tijekom liječenja.
It was found that the early initiation of treatment resulted in a further reduced risk for the development of hepatocellular carcinoma.
Otkriveno je da je rani početak liječenja rezultirao u daljnjem smanjenju rizika od razvoja hepatocelularnog karcinoma.