natgillin/translations-raw huggingface dataset:
• Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
• Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, je bila dokazana na podlagi primernih podatkov v skladu z zahtevami člena 10 Direktive 2001/83/ES (npr. primerjalne bioekvivalenčne študije z referenčnim zdravilom, odobrenim v EU).
For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Za preklic začasnega umika dovoljenj za promet z zdravilom, navedenih v Prilogi IB, morajo pristojni organi zagotoviti, da je/so imetnik(-i) dovoljenj(a) za promet z zdravilom izpolnil(-i) spodnje pogoje.
Annex III Conditions for lifting the suspension of the marketing authorisation(s)
Priloga III Pogoji za preklic začasnega umika dovoljenj(a) za promet z zdravilom
Date of first authorisation: 5 September 2017
Datum prve odobritve: 5. september 2017
Not known (frequency cannot be estimated from available data)
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
This medicine is for long-term use.
Zdravilo je namenjeno dolgotrajni uporabi.
Frequencies are 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).
Pogostnost 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).
EU/1/17/1199/001 72 film-coated tablets EU/1/17/1199/002 96 film-coated tablets
EU/1/17/1199/001 72 filmsko obloženih tablet EU/1/17/1199/002 96 filmsko obloženih tablet
Just take your next dose at its regularly scheduled time.
Vzemite le naslednji predvideni odmerek ob običajnem času.
However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.
Ni pa bilo mogoče določiti, ali je bil vzrok reakcije jemanje trientina ali predhodno zdravljenje s penicilaminom.
This means that the small amounts of copper from food and drink build up to excessive levels and can lead to liver damage and problems in the nervous system.
To pomeni, da se majhne količine bakra v hrani in pijači nakopičijo do čezmernih ravni in lahko povzročijo poškodbo jeter in težave z živčevjem.
However, no food interaction studies have been performed and so the extent of the food effect on systemic trientine exposure is unknown.
Vendar pa ni bila izvedena nobena študija o medsebojnem delovanju s hrano in je tako obseg učinka hrane na sistemsko izpostavljenost trientinu neznan.
Do not stop your treatment without the advice of your doctor even if you feel better because Wilson's disease is a life-long condition.
Tudi če se boste počutili boljše, zdravljenja ne prekinite brez zdravnikovega nasveta, saj je Wilsonova bolezen doživljenjska.
• Periodic safety update reports
• Redna posodobljena poročila o varnosti zdravila
Your doctor will tell you how many tablets you should take and how often in the day.
Zdravnik bo določil, koliko tablet morate jemati in kako pogosto jih morate jemati.
Your symptoms may initially get worse after starting the treatment.
Simptomi se bodo ob začetku zdravljenja morda poslabšali.
The film-coated tablets should be swallowed with water.
Filmsko obložene tablete je treba pogoltniti z vodo.
In cases up to 20 g of trientine base there were no apparent adverse effects reported.
V primerih odmerkov do 20 g trientinijeve baze niso poročali o očitnih neželenih učinkih.
The trientine plasma concentration then declined in a multiphasic manner, initially rapidly, followed by a slower elimination phase.
Plazemska koncentracija trientina je nato večfazno upadla, sprva hitro, čemur je sledila počasnejša faza izločanja.
Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could still be detected in the plasma after 20 hours.
Trientin in njegovi presnovki se z urinom hitro izločajo, vendar so lahko nizke ravni trientina v plazmi zaznavne še po 20 urah.
Factors which need to be born in mind include the risks associated with the disease itself, the risk of those alternative treatments which are available and the possible teratogenic effects of trientine (see section 5.3).
Dejavniki, ki jih je treba upoštevati, so tveganja, povezana s samo boleznijo, tveganja alternativnega zdravljenja, ki je na voljo, in možni teratogeni učinki trientina (glejte poglavje 5.3).
The aim of maintenance treatment is to maintain free copper levels in the serum within acceptable limits.
Cilj vzdrževalnega zdravljenja je ohranjanje ravni prostega bakra v serumu v sprejemljivih mejah.
Do not take Cuprior If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Cuprior, če ste alergični na trientin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The most reliable index for monitoring therapy is the determination of serum free copper which is calculated using the difference between the total copper and the ceruloplasmin-bound copper (normal level of free copper in the serum is usually 100 to 150 microgram/L).
Najzanesljivejši kazalnik za spremljanje zdravljenja je določitev ravni prostega bakra v krvi, ki se izračuna kot razlika med celotnim bakrom in na ceruloplazmin vezanim bakrom (normalna raven prostega bakra v serumu je običajno od 100 do 150 mikrogramov/l).
What you need to know before you take Cuprior 3.
Kaj morate vedeti, preden boste vzeli zdravilo Cuprior 3.
This medicine may also reduce the level of iron in your blood and your doctor may prescribe iron supplements (see section “Other medicines and Cuprior” below).
Zdravilo lahko zmanjša tudi raven železa v krvi, zato vam bo zdravnik morda predpisal dodatke železa (glejte poglavje „Druga zdravila in zdravilo Cuprior“ spodaj).
The safety and efficacy of trientine in children aged < 5 years have not been established.
Varnost in učinkovitost trientina pri otrocih, mlajših od 5 let, še nista bili dokazani.
In particular, you must tell your doctor if you are already taking iron supplements or if you take indigestion remedies (medicines that reduce discomfort after eating).
Posebej pomembno je, da zdravnika opozorite, če že jemljete dodatke železa ali če jemljete zdravila za slabo prebavo (zdravila, ki zmanjšujejo nelagodje po jedi).
Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use as follows:
S trientinom pridobljeni predklinični podatki so pokazali neželene učinke, ki v kliničnih študijah niso bili opaženi, opaženi pa so bili pri živalih ob ravni izpostavljenosti, ki je bila podobna izpostavljenosti pri klinični uporabi in z možnim pomenom za klinično uporabo, kot sledi:
Since iron and trientine may inhibit absorption of each other, iron supplements should be taken after at least two hours have elapsed from the administration of trientine.
Ker lahko železo in trientin zavirata absorpcijo drug drugega, je treba dodatke železa jemati vsaj dve uri po jemanju trientina.
If this happens, you must tell your doctor.
Če pride do tega, o tem obvestite zdravnika.
If you take these medicines you may need to take Cuprior at a different time in the day because otherwise Cuprior may not be as effective.
Če jemljete ta zdravila, boste morda morali zdravilo Cuprior vzeti ob drugem času, ker sicer ne bo dovolj učinkovito.
Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration.
Čeprav ni nobenih dokazov, da kalcijevi ali magnezijevi antacidi spremenijo učinkovitost trientina, se priporoča, da se jemljejo ločeno.
The microscopic changes in lung were considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells.
Mikroskopske spremembe pljuč so nakazovale persistentno vnetno reakcijo ali persistenten toksični učinek na alveolarne celice.
When your baby is born, the copper level in the baby's blood will also be monitored.
Ko se bo otrok rodil, bodo kontrolirali tudi ravni bakra v otrokovi krvi.
Your doctor will carry out checks more frequently to ensure your copper levels are maintained at a suitable level for normal growth and mental development.
Zdravnik bo pogosteje opravljal kontrole, da bo zagotovil, da so vaše ravni bakra zadosti visoke za normalno rast in duševni razvoj.
Cuprior has no or negligible influence on the ability to drive and use machines.
Zdravilo Cuprior nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Monitoring for manifestations of overtreatment should be undertaken, particularly when copper requirements may change, such as in pregnancy (see section 4.6) and in children where appropriate control of copper levels are required to ensure proper growth and mental development.
Pozorno je treba spremljati morebitne znake preveč intenzivnega zdravljenja, zlasti v primeru, da se potrebe po bakru spremenijo, npr. v nosečnosti (glejte poglavje 4.6) in pri otrocih, pri katerih je za zagotovitev primerne rasti in duševnega razvoja treba zagotoviti ustrezen nadzor ravni bakra.
The starting dose in paediatrics is lower than for adults and depends on age and body weight.
Začetni odmerek pri pediatrični populaciji je nižji kot pri odraslih in je odvisen od starosti in telesne mase.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
FARMACEVTSKA OBLIKA IN VSEBINA Filmsko obložena tableta
Not known: duodenitis, colitis (including severe colitis).
Neznani: duodenitis, kolitis (vključno s hudim kolitisom).
The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4).
Začetni odmerek običajno ustreza najnižjemu odmerku v razponu in ga je treba naknadno prilagoditi glede na bolnikov klinični odziv (glejte poglavje 4.4).
Wilson's disease is an inherited condition in which the body cannot transport copper around the body in the normal way or remove copper in the normal way as a secretion from the liver into the gut.
Wilsonova bolezen je dedna bolezen, pri kateri telo ne more po telesu normalno prenašati bakra ali ga normalno odstranjevati kot izloček iz jeter v črevo.
If you have kidney problems, your doctor will regularly check that the treatment dose is appropriate and does not affect the functioning of your kidney.
Če imate težave z ledvicami, bo zdravnik redno preverjal, ali je odmerek primeren in ne vpliva na delovanje ledvic.
The absorption of trientine following oral administration is low and variable in patients with Wilson disease.
Absorpcija trientina po peroralnem dajanju je pri bolnikih z Wilsonovo boleznijo nizka in spremenljiva.
Once you have started the treatment, your doctor may adjust the dose based on the response to treatment.
Po začetku zdravljenja bo zdravnik odmerek morda prilagodil glede na odziv na zdravljenje.
Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron supplements may be required.
Ugotovljeno je bilo, da trientin zmanjša serumske ravni železa, morda tako, da zmanjša njegovo absorpcijo, in je zato potrebno dodajanje železa.
It is very important to continue treatment to reduce copper during pregnancy.
Zelo pomembno je, da v nosečnosti z zdravljenjem še naprej zmanjšujete raven bakra.
OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.
OPA/Alu/PVC-Alu-pretisni omoti; en pretisni omot vsebuje 8 filmsko obloženih tablet.
The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 600 mg and 750 mg trientine in healthy male and female subjects.
Farmakokinetični profil zdravila Cuprior je bil ocenjen po enkratnem peroralnem odmerku 450 mg, 600 mg in 750 mg trientina pri zdravih preiskovancih in preiskovankah.
Cuprior is available in packs containing 72 or 96 film-coated tablets.
Zdravilo Cuprior je na voljo v pakiranjih, ki vsebujejo pakiranje po 72 ali 96 filmsko obloženih tablet.
Not known: iron deficiency anaemia.
Neznani: anemija zaradi pomanjkanja železa
The following side effects have been reported:
Poročali so tudi o naslednjih neželenih učinkih:
Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Študije na živalih so pokazale toksičnost za sposobnost razmnoževanja, ki je bila verjetno posledica s trientinom povzročenega pomanjkanja bakra (glejte poglavje 5.3).
Occasional cases of trientine overdose have been reported.
Občasno so poročali o primerih prevelikega odmerjanja trientina.
MAT may also participate to the overall clinical activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels remains to be determined.
K celotni klinični aktivnosti zdravila Cuprior morda prispeva tudi presnovek MAT, vendar je delež prispevka presnovka MAT k celotnemu učinku zdravila na ravni bakra še treba določiti.
Cuprior is a medicine used to treat Wilson's disease that contains the active substance trientine.
Zdravilo Cuprior je zdravilo, ki se uporablja za zdravljenje Wilsonove bolezni, ki vsebuje učinkovino trientin.
Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion.
Trientin je kelator bakra, katerega glavni mehanizem delovanja je odstranjevanje vezanega bakra iz telesa tako, da z bakrom tvori stabilen kompleks, ki se nato izloči z urinom.
When switching a patient from another formulation trientine, caution is advised because doses expressed in trientine base may not be equivalent (see section 4.2).
Kadar bolnik preide z zdravljenja z drugo obliko trientina, se priporoča previdnost, saj odmerek, izražen v količini trientina, morda ni enakovreden (glejte poglavje 4.2).
No specific dose adjustment is required in these patients (see section 4.4).
Pri teh bolnikih ni potrebnega posebnega prilagajanja odmerka (glejte poglavje 4.4).
In patients who were previously treated with D-penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Pri bolnikih, ki so se pred tem zdravili z D-penicilaminom, so pri zdravljenju s trientinom poročali o lupusu podobnih reakcijah, vendar ni mogoče določiti, ali obstaja vzročna povezanost s trientinom.
Cuprior is given to adults, adolescents and children aged 5 years and over who cannot tolerate another medicine that is used to treat this disease, called penicillamine.
Zdravilo Cuprior se daje odraslim, mladostnikom in otrokom, starim 5 let ali več, ki ne morejo prenašati drugega zdravila za zdravljenje te bolezni, imenovanega penicilamin.
Overtreatment carries the risk of copper deficiency.
Preveč intenzivno zdravljenje pomeni tveganje za pomanjkanje bakra.
Plasma levels of trientine rose rapidly following administration with the median peak level reached after 1.25 to 2 hours.
Plazemske ravni trientina so se po dajanju hitro zvišale, pri čemer je bila srednja največja koncentracija dosežena po 1,25 do 2 urah.
Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Trientin se acetilira v dva glavna presnovka, N(1)-acetiltrietilentetramin (MAT) in N(1)N(10)diacetiltrietilentetramin (DAT).
Since chelation therapy leads to an increase in urinary copper levels, this may/will not give an accurate reflection of the excess copper load in the body but may be a useful measure of treatment compliance.
Ker kelacijsko zdravljenje povzroča zvišanje ravni bakra v urinu, ta (morda) ne bo natančno odražala presežka bakra v telesu, lahko pa se uporabi kot koristno merilo za spremljanje bolnikove kompliance.
The scored filmcoated tablet can be divided in two equal halves, if required, to provide a more precise dose or facilitate administration.
Filmsko obložena tableta z zarezo se lahko za natančnejše odmerjanje ali lažje dajanje po potrebi razdeli v dve enaki polovici.
No dose adjustment is required in elderly patients.
Pri starejših bolnikih odmerka ni treba prilagajati.
This maximises the absorption of trientine and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract.
S tem se poveča absorpcija trientina in zmanjša verjetnost vezave zdravila na kovine v prebavnem traktu.
Distribution Little is known on the distribution of trientine in organs and tissues.
Porazdelitev O porazdelitvi trientina v organih in tkivih je le malo znanega.
This medicine mainly works by attaching to copper in the body which then allows it to be removed in the urine instead, helping to lower copper levels.
To zdravilo deluje predvsem tako, da se veže na baker v telesu in tako omogoči odstranjevanje bakra z urinom, kar pomaga zniževati raven bakra.
As trientine is poorly absorbed following oral intake and the principal mechanism of action requires its systemic exposure (see section 5.1), it is important that the film-coated tablets are taken on empty stomach at least one hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section 4.2).
Ker se trientin pri peroralnem vnosu slabo absorbira in njegov glavni mehanizem delovanja zahteva sistemsko izpostavljenost (glejte poglavje 5.1), je pomembno, da se filmsko obložene tablete jemljejo na prazen želodec vsaj eno uro pred obrokom ali dve uri po njem in v razmiku vsaj ene ure od jemanja drugih zdravil, hrane ali mleka (glejte poglavje 4.2).
Cuprior should only be used in pregnancy after careful consideration of the benefits compared with the risks of treatment in the individual patient.
V nosečnosti se sme zdravilo Cuprior uporabljati le po natančni proučitvi razmerja med tveganji in koristmi zdravljenja pri posamezni bolnici.
Babies born to mothers being treated with trientine should be monitored for serum copper levels where appropriate.
Pri dojenčkih, ki se rodijo materam, zdravljenim s trientinom, je treba po potrebi spremljati serumske ravni bakra.
The overall pharmacokinetic profiles were similar between males and females, although males had higher levels of trientine.
Celotna farmakokinetična profila sta bila pri preiskovancih in preiskovankah podobna, čeprav so bile ravni trientina pri preiskovancih višje.
Your doctor will advise you which treatment and which dose is best in your situation.
Zdravnik vam bo svetoval, katero zdravljenje in kateri odmerek je za vas najprimernejši.
Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper.
Preveč intenzivno zdravljenje in čezmerno odstranjevanje bakra je mogoče spremljati z uporabo vrednosti izločenega bakra z urinom in na ceruloplazmin nevezanega bakra.
Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test and genotoxicity tests in mammalian cells.
V splošnem je trientin v in vitro študijah genotoksičnosti pokazal pozitivne učinke, vključno z Amesovim testom in testi genotoksičnosti pri sesalcih.
The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).
Priporočeni odmerek zdravila Cuprior je izražen v mg trientina (ne pa v mg soli trientinijevega tetraklorida).
Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
Zdravilo Cuprior je indicirano za zdravljenje Wilsonove bolezni pri odraslih, mladostnikih in otrocih, starih 5 let ali več, ki ne prenašajo zdravljenja z D-penicilaminom.
Tablets can be divided in half if needed.
Če je treba, lahko tablete razdelite na pol.
Special populations Elderly
Posebne skupine bolnikov Starejši
Close monitoring is required to optimise the dose or to adapt treatment if necessary.
Za optimizacijo odmerka ali morebitno prilagoditev zdravljenja je potrebno natančno spremljanje.
Linearity/non-linearity Plasma exposures in humans have shown a linear relationship with oral doses of trientine.
Linearnost/nelinearnost Plazemska izpostavljenost je pri človeku pokazala linearno razmerje s peroralnimi odmerki trientina.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX12.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX12
Repeat dose toxicity
Toksičnost pri ponavljajočih se odmerkih
Your doctor will regularly check your blood and urine to ensure that you receive the right dose of Cuprior to properly control your symptoms and copper levels.
Zdravnik bo redno preverjal vašo kri in urin, na podlagi česar bo lahko poskrbel, da boste prejemali primeren odmerek zdravila Cuprior za uspešno obvladovanje vaših simptomov in ravni bakra.
Pack size: 72 or 96 film-coated tablets.
Velikost pakiranja: 72 ali 96 filmsko obloženih tablet.
If you take iron supplements, take them at least two hours after taking a dose of Cuprior.
Če jemljete dodatke železa, jih vzemite vsaj dve uri po odmerku zdravila Cuprior.
Taking into account that trientine has irritating properties, it was estimated that the observed chronic interstitial pneumonitis was explained by a cytotoxic effect of trientine upon accumulation into bronchiolar epithelial cells and alveolar pneumocytes.
Ob upoštevanju dražilnih lastnosti trientina je bilo ocenjeno, da gre pri ugotovljenem kroničnem intersticijskem pnevmonitisu za citotoksični učinek trientina na kopičenje bronhialnih epitelijskih celic in alveolarnih pnevmocitov.
Iron supplements may be necessary in case of iron deficiency anaemia and should be administered at a different time (see section 4.5).
Pri anemiji zaradi pomanjkanja železa bodo morda potrebni dodatki železa, ki naj se dajejo ob drugem času (glejte poglavje 4.5).
Warnings and precautions Talk to your doctor or pharmacist before taking Cuprior.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Cuprior se posvetujte z zdravnikom ali farmacevtom.
Package leaflet online at QR code to be included http://www.cuprior.com Oral use.
Na spletu je navodilo za uporabo na voljo na Koda QR bo vstavljena poznejehttp://www.cuprior.com peroralna uporaba
What Cuprior is and what it is used for 2.
Kaj je zdravilo Cuprior in za kaj ga uporabljamo 2.
Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.
Kronično preveč intenzivno zdravljenje lahko povzroči pomanjkanje bakra in reverzibilno sideroblastno anemijo.
Children aged < 5 years
Otroci, starejši od 5 let
72 film-coated tablets
72 filmsko obloženih tablet
This daily total will be divided into 2 to 4 smaller doses to be taken during the day.
Skupni dnevni odmerek se razdeli v 2 do 4 manjše dnevne odmerke.
You can find the information also when flashing the QR code below with a smartphone or via the website QR code to be included http://www.cuprior.com
Informacije o tem zdravilu lahko dobite tudi, če s pametnim telefonom poskenirajte spodnjo kodo QR Koda QR bo vstavljena pozneje ali preko spletne strani http://www.cuprior.com
In rats administered oral trientines doses, up to 600 mg/kg/day for 26 weeks, histopathology revealed a dose-related incidence and severity of focal chronic interstitial pneumonitis accompanied by fibrosis of the alveolar wall.
Pri podganah, ki so 26 tednov peroralno prejemale trientin v odmerkih do 600 mg/kg/dan, je histopatologija pokazala z odmerkom povezano incidenco in resnost žariščnega kroničnega intersticijskega pnevmonitisa s fibrozo alveolarne stene.