natgillin/translations-raw huggingface dataset:
Excipient with known effect: Each tablet contains 1.2 mg of sucrose.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 1,2 mg saharoze.
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 filmsko obloženih tablet EU/1/11/706/024 30 filmsko obloženih tablet EU/1/11/706/025 100 filmsko obloženih tablet EU/1/11/706/026 130 filmsko obloženih tablet EU/1/11/706/027 175 filmsko obloženih tablet EU/1/11/706/028 250 filmsko obloženih tablet
Excipient with known effect: Each tablet contains 1.4 mg of sucrose.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 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 filmsko obloženih tablet EU/1/11/706/008 30 filmsko obloženih tablet EU/1/11/706/009 100 filmsko obloženih tablet EU/1/11/706/010 130 filmsko obloženih tablet EU/1/11/706/011 175 filmsko obloženih tablet
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 filmsko obloženih tablet EU/1/11/706/035 30 filmsko obloženih tablet EU/1/11/706/036 100 filmsko obloženih tablet EU/1/11/706/037 130 filmsko obloženih tablet EU/1/11/706/038 175 filmsko obloženih tablet
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
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 filmsko obloženih tablet EU/1/11/706/030 30 filmsko obloženih tablet EU/1/11/706/031 100 filmsko obloženih tablet EU/1/11/706/032 130 filmsko obloženih tablet EU/1/11/706/033 175 filmsko obloženih tablet
Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet).
Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo (2,3 mg/tableto).
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 filmsko obloženih tablet EU/1/11/706/002 30 filmsko obloženih tablet EU/1/11/706/003 100 filmsko obloženih tablet EU/1/11/706/004 130 filmsko obloženih tablet EU/1/11/706/005 175 filmsko obloženih tablet EU/1/11/706/006 250 filmsko obloženih tablet
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 filmsko obloženih tablet EU/1/11/706/019 30 filmsko obloženih tablet EU/1/11/706/020 100 filmsko obloženih tablet EU/1/11/706/021 130 filmsko obloženih tablet EU/1/11/706/022 175 filmsko obloženih tablet
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 filmsko obloženih tablet EU/1/11/706/013 30 filmsko obloženih tablet EU/1/11/706/014 100 filmsko obloženih tablet EU/1/11/706/015 130 filmsko obloženih tablet EU/1/11/706/016 175 filmsko obloženih tablet EU/1/11/706/017 250 filmsko obloženih tablet
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Malaise
šibkost
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet).
Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo (1,9 mg/tableto).
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet).
Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo (1,6 mg/tableto).
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Zdravilo Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg so rjavkaste ali sivkastordečkaste filmsko obložene ovalne tablete brez zareze, z oznako »LCE 100« na eni strani.
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Urinary tract infection
okužba sečil
What Levodopa/Carbidopa/Entacapone Orion contains
Kaj vsebuje zdravilo Levodopa/Carbidopa/Entacapone Orion
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Levodopa/Carbidopa/Entacapone Orion.
Okvara jeter: Pri bolnikih z blago do zmerno okvaro jeter se priporoča previdnost pri uporabi zdravila Levodopa/Carbidopa/Entacapone Orion.
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet).
Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo (1,4 mg/tableto).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet).
Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo (1,2 mg/tableto).
Eye disorders Common:
Očesne bolezni Pogosti:
The doses of other antiparkinsonian medicinal products may need to be adjusted when Levodopa/Carbidopa/Entacapone Orion treatment is substituted for a patient currently not treated with entacapone.
Zdravnik, ki predpisuje zdravilo, mora biti previden, kadar bolniku, ki se je do nedavnega zdravil z zdravilom Levodopa/Carbidopa/Entacapone Orion, to terapijo nadomešča z levodopo/zaviralci DDK brez etakapona ali z drugo dopaminergično terapijo.
How to store Levodopa/Carbidopa/Entacapone Orion
Shranjevanje zdravila Levodopa/Carbidopa/Entacapone Orion
- 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.
Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg je 8 tablet na dan in zdravila Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg 7 tablet dnevno.
- For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
- Da ne bi prišlo do čezmerne izgube telesne mase, je pri bolnikih z diarejo priporočljivo spremljanje telesne mase.
There is evidence that breast-feeding is suppressed during treatment with levodopa.
Zdravljenje z levodopo dokazano suprimira laktacijo.
1 ml (125 mg/ml) 4 pre-filled pens
1 ml (125 mg/ml) 4 napolnjeni injekcijski peresniki
1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
1 ml (125 mg/ml) 12 (3 x 4) napolnjenih injekcijskih peresnikov (skupno pakiranje)
Date of first authorisation: 24 August 2017
Datum prve odobritve: 24. avgust 2017
NTBC study (N=250)
Študija NTBC (N=250)
Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Podatki iz študije, uporabljeni kot pretekle kontrolne vrednosti (van Spronsen et al., 1994), so pokazali naslednjo verjetnost preživetja.
The dosing frequency in the study was twice daily.
Pogostnost odmerjanja v študiji je bila dvakrat dnevno.
The study indicates that once daily administration is safe and efficacious across all ages of patients.
Študija kaže, da je enkrat dnevno jemanje varno in učinkovito pri bolnikih vseh starosti.
The capsules are packaged in plastic bottles.
Kapsule so pakirane v plastenkah.
Store in the original bottle in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Velika Britanija
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Velika Britanija
These substances are accumulated in your body.
Te snovi se kopičijo v vašem telesu.
Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Obisk monitorja naj bi bil izveden vsakih šest mesecev, krajši razmiki med posameznimi obiski so priporočljivi v primeru neželenih učinkov.
- if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na nitizinon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
Med zdravljenjem vam bodo pregledali kri, da lahko zdravnik ugotovi, ali je zdravljenje ustrezno, in zagotovi, da ne pride do neželenih učinkov, ki bi povzročili bolezni krvi.
Date when removed from refrigerator:
Datum odvzema zdravila iz hladilnika:
You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
Med uporabo tega zdravila morate upoštevati posebno dieto, ker bo tirozin ostal v vašem telesu.
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.
Zdravljenje vseh genotipov bolezni je treba začeti čim prej, da se poveča možnost preživetja in se preprečijo zapleti, kot so odpoved jeter, rak na jetrih in bolezni ledvic.
Do not change the dose or stop the treatment without talking to your doctor.
Ne spreminjajte odmerka in ne prekinjajte zdravljenja, ne da bi se prej posvetovali z zdravnikom.
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
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.
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”).
Če pa se pri jemanju pojavijo neželeni učinki, ki vplivajo na vid, ne smete voziti ali upravljati strojev, dokler se vaš vid ne normalizira (glejte poglavje 4 »Možni neželeni učinki«).
Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Neželeni učinki na oči (glejte poglavje 4.8) lahko vplivajo na vid.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake »EXP«.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
Ne pozabite na plastenki označiti datuma, ko ste zdravilo vzeli iz hladilnika.
In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
V kliničnih študijah je bila granulocitopenija le občasno težka (<0,5x109/l) in ni bila povezana z okužbami.
A study to evaluate the PK, efficacy and safety of once daily dosing compared to twice daily dosing was performed in 19 patients with HT-1.
Študija za oceno PK ter učinkovitosti in varnosti enkrat dnevnega odmerjanja v primerjavi z dvakrat dnevnim odmerjanjem je bila opravljena pri 19 bolnikih s HT-1.
It is recommended to administer the dose once daily.
Priporočljivo je dajanje odmerka enkrat dnevno.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
There are no adequate data from the use of nitisinone in pregnant women.
Ni zadostnih podatkov o uporabi nitizinona pri nosečnicah.
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.
Iz kliničnih študij in podatkov v obdobju trženja zdravila se pri nobeni indikaciji ne pokaže različen varnostni profil pri različnih podskupinah pediatričnih bolnikov ali drugačen varnostni profil glede na odrasle bolnike.
Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Povečanje koncentracije alfa-fetoproteina je lahko znak neustreznega zdravljenja.
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.
V mednarodni študiji pri bolnikih s HT-1 o zdravljenju zgolj s predpisano dieto so ugotovili, da je bila diagnoza HCK postavljena pri 18 % vseh bolnikov, starih dve leti in več.
The dose recommendation in mg/kg body weight is the same in children and adults.
Priporočeni odmerek v mg/kg telesne mase je enak za otroke in odrasle.
Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Populacijske farmakokinetične analize so bile izvedene na skupini 207 bolnikov s HT-1.
It was found that the early initiation of treatment resulted in a further reduced risk for the development of hepatocellular carcinoma.
Odkrili so, da je zgodnji začetek zdravljenja še bolj zmanjšal tveganje za razvoj hepatocelularnega karcinoma.
The dose of nitisinone should be adjusted individually.
Odmerek nitizinona je treba prilagoditi posamezniku.
Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Za pediatrične bolnike, ki imajo težave pri požiranju kapsul, so na voljo tudi druge farmacevtske oblike.
If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
V primeru ugodne biokemične reakcije je treba odmerek prilagoditi le v skladu s povečanjem telesne mase.
Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Formalnih študij absorpcije, porazdelitve, presnove in izločanja nitizinona niso izvedli.
Data is, however, limited in patients with body weight <20 kg.
Vendar pa so podatki pri bolnikih s telesno maso < 20 kg omejeni.
In this disease your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances.
Pri tej bolezni vaše telo ni sposobno popolnoma razgraditi aminokisline tirozin (aminokisline so gradniki beljakovin) in tvori škodljive snovi.
Start age > 24 months
Začetna starost > 24 mesecev
It is unknown whether nitisinone is excreted in human breast milk.
Ni znano, ali se nitizinon izloča v materino mleko.
This dose should be considered as a maximal dose for all patients.
To je za vse bolnike največji dovoljeni odmerek.
If the vision is affected the patient should not drive or use machines until the event has subsided.
Če je prizadet vid, naj bolnik ne vozi in ne upravlja strojev, dokler neželeni učinek ne izzveni.
It is recommended to also monitor serum alpha-fetoprotein concentrations.
Priporočljivo je tudi spremljanje koncentracij alfa-fetoproteina v serumu.
Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Študije na živalih so pokazale neželene poporodne učinke zaradi izpostavljenosti nitizinonu v mleku.
60 capsules
60 kapsul
Follow-up by your doctor should be performed every 6 months.
Vsakih šest mesecev mora zdravnik opraviti kontrolni pregled.
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.
Če imate težave s požiranjem kapsul, jih lahko odprete, prašek pa zamešate v malo vode ali v predpisano dieto, tik preden jo zaužijete.
Monitoring of plasma tyrosine levels
Nadziranje ravni tirozina v plazmi
This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
To zdravilo se uporablja za zdravljenje redke bolezni, imenovane dedna tirozinemija tipa 1 pri odraslih, mladostnikih in otrocih (vseh starosti).
Nitisinone MDK should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Nitisinone MDK ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje z nitizinonom.
Your doctor will adjust the dose individually.
Vaš zdravnik bo prilagodil odmerek vašemu stanju.
HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Plastenka iz HDPE s plastičnim pokrovčkom iz LDPE, ki vsebuje 60 kapsul.
No information about specific treatment of overdose is available.
Ni podatkov o posebnosti zdravljenja v primeru prevelikega odmerjanja.
If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination.
Če ste opazili, da imate rdeče oči ali katere koli druge znake učinka na oči, nemudoma obiščite zdravnika, da vam pregleda oči.
Nitisinone MDK may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Zdravilo Nitisinone MDK lahko vpliva na delovanje drugih zdravil, kot so: - zdravila za epilepsijo (kot je fenitoin) - zdravila proti strjevanju krvi (kot je varfarin)
Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Vnetje vek (blefaritis) je občasen neželen učinek (pojavi se lahko pri največ 1 od 100 bolnikov).
However, in addition to the tests above, during the initiation of therapy, switch from twice daily to once daily dosing or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Poleg zgoraj navedenih testov bo med začetkom zdravljenja, pri prehodu z dajanja dvakrat na dan na dajanje enkrat na dan ali v primeru poslabšanja morda treba podrobneje spremljati vse razpoložljive biokemične parametre (npr. sukcinilaceton v plazmi, 5-aminolevulinat (ALA) v urinu in delovanje eritrocitne porfobilinogen-sintaze (PBG).
There were no clinically important differences in AEs or other safety assessments between once and twice daily dosing.
Klinično pomembnih razlik v neželenih učinkih ali drugih ocenah varnosti med odmerjanjem enkrat na dan in odmerjanjem dvakrat na dan ni bilo.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
• Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Med jemanjem tega zdravila ne dojite, glejte poglavje »Nosečnost in dojenje«.
Nitisinone has minor influence on the ability to drive and use machines.
Nitizinon ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The clinical study was open-labelled and uncontrolled.
Klinična učinkovitost in varnost Klinična študija je bila odprta in nenadzorovana.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16A X04.
The liver function should be monitored regularly by liver function tests and liver imaging.
Delovanje jeter je treba redno spremljati s testi delovanja jeter in slikanjem.
The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Očistek zdravila je bil 0,0956 l/kg telesne mase na dan, razpolovni čas pa 52,1 ure.
Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Morda bo potrebna prilagoditev odmerka sočasno dajanih zdravil (glejte poglavje 4.5).
The safety of this medicine has not been studied in pregnant and breast-feeding women.
Študije o varnosti tega zdravila pri nosečnicah in doječih materah niso bile izvedene.
Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
Verjetnosti preživetja po 2, 4 in 6 letih zdravljenja z nitizinonom so povzete v spodnji preglednici.
Exfoliative dermatitis may occur uncommonly.
Eksfoliativni dermatitis se lahko pojavi občasno.
It should be established that the patient is adhering to his/her dietary regimen and the plasma tyrosine concentration should be measured.
Zdravnik mora ugotoviti, ali se bolnik drži dietnega režima, in izmeriti koncentracijo tirozina v plazmi.
This special diet is based on low tyrosine and phenylalanine (another amino acid) content.
Ta posebna dieta temelji na nizki vsebnosti tirozina in fenilalanina (druga aminokislina).
Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
AUC∞ furosemida se je zvišala za 1,7-krat, kar kaže na šibko zaviranje OAT1/OAT3 (glejte poglavji 4.4 in 4.5).
The safety profile is mainly based on the paediatric population since nitisinone treatment should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been established.
Pediatrična populacija Varnostni profil v glavnem temelji na pediatričnih bolnikih, ker je treba zdravljenje z nitizinonom začeti takoj, ko je ugotovljena diagnoza dedne tirozinemije tipa 1 (HT-1).
It is not recommended to lower the plasma tyrosine concentration by reduction or discontinuation of nitisinone, since the metabolic defect may result in deterioration of the patient's clinical condition.
Koncentracije tirozina v plazmi ni priporočljivo zniževati z zmanjšanjem ali prekinitvijo dajanja nitizinona, ker lahko presnovna motnja poslabša bolnikovo klinično stanje.
This medicine has minor influence on the ability to drive and use machines.
To zdravilo ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
Kapsula se lahko odpre, vsebina pa se tik pred zaužitjem raztopi v manjši količini vode ali predpisani dieti.
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.
Vendar se zaradi omejenih podatkov pri bolnikih s telesno maso < 20 kg pri tej populaciji bolnikov priporoča razdelitev skupnega dnevnega odmerka na dva odmerka na dan.