FrancophonIA/ELRC3.0 huggingface dataset:
English: Parenteral nutrition products2 containing amino acids and/or lipids with or without admixture of vitamins and/or trace elements - Adverse outcomes in neonates treated with solutions not protected from light (EPITT no 19423)
Croatian: Lijekovi za parenteralnu prehranu2 koji sadrže aminokiseline i/ili lipide, a kojima se dodaju ili ne dodaju vitamini i/ili elementi u tragovima
English: When used in neonates and children below 2 years, <product name> should be protected from ambient light until administration is completed (see sections 4.2, 6.3 and 6.6).
Croatian: Kada se primjenjuje u novorođenčadi i djece mlađe od 2 godine, <naziv lijeka> je potrebno zaštititi od svjetlosti iz okoline sve do završetka primjene (vidjeti dijelove 4.2, 6.3 i 6.6).
English: When used in neonates and children below 2 years, <product name> should be protected from ambient light until administration is completed.
Croatian: Kada se primjenjuje u novorođenčadi i djece mlađe od 2 godine, <naziv lijeka> je potrebno zaštititi od svjetlosti iz okoline sve do završetka primjene.
English: When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed.
Croatian: Kada se primjenjuje u <novorođenčadi i *> djece mlađe od 2 godine, otopinu (u vrećicama i setovima za primjenu) je potrebno zaštititi od izlaganja svjetlosti sve do završetka primjene.
English: When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2).
Croatian: Kada se primjenjuje u <novorođenčadi i *> djece mlađe od 2 godine, otopinu (u vrećicama i setovima za primjenu) je potrebno zaštititi od izlaganja svjetlosti sve do završetka primjene (vidjeti dio 2).
English: When used in <neonates and *> children below 2 years, protect from light exposure, until administration is completed.
Croatian: Kada se primjenjuje u <novorođenčadi i *> djece mlađe od 2 godine, otopinu treba zaštititi od izlaganja svjetlosti sve do završetka primjene.
English: Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.
Croatian: [Za lijekove indicirane u novorođenčadi (do 28 dana starosti)] Ako se otopina za intravensku parenteralnu prehranu izloži svjetlosti, posebno nakon dodavanja elemenata u tragovima i/ili vitamina, to može imati štetne učinke na klinički ishod u novorođenčadi zbog stvaranja peroksida i drugih produkata degradacije.
English: What you need to know before you take Inlyta
Croatian: Što morate znati prije nego počnete uzimati lijek Inlyta Upozorenja i mjere opreza
English: When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see sections 4.4, 6.3 and
Croatian: Kada se primjenjuje u <novorođenčadi i *> djece mlađe od 2 godine, otopinu (u vrećicama i setovima za primjenu) je potrebno zaštititi od izlaganja svjetlosti sve do završetka primjene (vidjeti dijelove 4.4, 6.3 i 6.6).
English: When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see sections 4.2, 4.4 and
Croatian: Kada se primjenjuje u <novorođenčadi i *> djece mlađe od 2 godine, otopinu (u vrećicama i setovima za primjenu) je potrebno zaštititi od izlaganja svjetlosti sve do završetka primjene (vidjeti dijelove 4.2, 4.4 i 6.6).
English: If you have high blood pressure (only applicable for products containing nintedanib and vandetanib as for the rest of the products, this warning is already included) If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: ako imate visok krvni tlak (primjenjivo samo za lijekove koji sadržavaju nintedanib i vandetanib.
English: Before initiating axitinib therapy in patients with pre-existing aneurysms, this risk should be carefully considered.
Croatian: U bolesnika s postojećom aneurizmom potrebno je pažljivo razmotriti ovaj rizik prije uvođenja terapije aksitinibom.
English: Aortic aneurysms and dissections
Croatian: Posebna upozorenja i mjere opreza pri uporabi Aneurizme i disekcije aorte
English: Patients should be monitored at least every six months.
Croatian: Bolesnici trebaju doći na kontrolu najmanje svakih šest mjeseci.
English: The recommended starting dose is 1 mg per kilogram body weight per day.
Croatian: Preporučena početna doza iznosi 1 mg po kilogramu tjelesne težine dnevno.
English: nitisinone
Croatian: nitizinon
English: The capsules are usually swallowed whole, but they may be opened and their contents mixed into a small amount of water or formula just before swallowing.
Croatian: Kapsule se obično progutaju cijele, ali mogu se otvoriti i njihov se sadržaj može pomiješati s malom količinom vode ili formule netom prije nego što se proguta.
English: Treatment should
Croatian: Terapija se mora započeti
English: The full EPAR for Nitisinone MDK can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Nitisinone MDK nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari, pa se stoga očekuje da imaju jednak učinak.
English: This summary was last updated in 10-2017.
Croatian: Sažetak je posljednji put ažuriran u 10.2017.
English: These amino acids are normally found in proteins in foods and drinks.
Croatian: Te se aminokiseline obično nalaze u bjelančevinama u hrani i piću.
English: Nitisinone MDK is available as capsules (2 mg, 5 mg and 10 mg).
Croatian: Lijek Nitisinone MDK dostupan je u obliku kapsula (2 mg, 5 mg i 10 mg).
English: Tyrosine is broken down in the body by a number of enzymes.
Croatian: Tirozin u tijelu razgrađuju određeni enzimi.
English: Previously known as Nitisinone MendeliKABS
Croatian: Prethodno poznat pod nazivom Nitisinone MendeliKABS
English: This means that Nitisinone MDK contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Orfadin.
Croatian: To znači da Nitisinone MDK sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Orfadin.
English: The name of the medicine was changed to Nitisinone MDK on 3 October 2017.
Croatian: Ime lijeka izmijenjeno je u Nitisinone MDK 3. travanj 2017.
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and harmful substances are formed, causing serious liver problems and liver cancer.
Croatian: To je rijetka bolest pri kojoj tijelo nije u mogućnosti do kraja razgraditi aminokiselinu tirozin i dolazi do nastanka štetnih tvari koje uzrokuju teške probleme s jetrom i rak jetre.
English: As for every medicine, the company provided studies on the quality of Nitisinone MDK.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Nitisinone MDK.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nitisinone MendeliKABS on 24 August 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi za lijek Nitisinone MendeliKABS u Europskoj uniji od 24. kolovoza 2017.
English: This is a summary of the European public assessment report (EPAR) for Nitisinone MDK.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Nitisinone MDK.
English: However, as the unconverted tyrosine remains in the body during Nitisinone MDK treatment, patients need to eat a special diet low in tyrosine.
Croatian: Međutim, budući da nerazgrađeni tirozin ostaje u tijelu tijekom terapije lijekom Nitisinone MDK, bolesnici moraju imati posebnu prehranu s niskim razinama tirozina.
English: Because Nitisinone MDK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Nitisinone MDK generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is transformed into harmful substances.
Croatian: Bolesnicima koji boluju od nasljedne hipertirozinemije tipa 1 (HT-1) nedostaje jedan od tih enzima pa se tirozin ne izlučuje na ispravan način, nego se pretvara u štetne tvari.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Nitisinone MDK has been shown to have comparable quality and to be bioequivalent to Orfadin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Nitisinone MDK dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Orfadin.
English: Nitisinone MDK is a ‘generic medicine'.
Croatian: Nitisinone MDK je „generički lijek”.
English: The diet also needs to be low in phenylalanine, as this is converted into tyrosine in the body.
Croatian: Ta prehrana mora imati i niske razine fenilalanina jer se on u tijelu pretvara u tirozin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nitisinone MDK have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Nitisinone MDK nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nitisinone MDK.
Croatian: Ispitivanja omjera koristi i rizika djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Orfadin i ne treba ih ponavljati za lijek Nitisinone MDK.
English: be started as early as possible and the dose of Nitisinone MDK adjusted according to the patient's response and body weight.
Croatian: što je prije moguće, a doza lijeka Nitisinone MDK određuje se ovisno o odgovoru bolesnika i tjelesnoj težini.
English: What measures are being taken to ensure the safe and effective use of Nitisinone MDK?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nitisinone MDK?
English: Nitisinone MDK can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Croatian: Nitisinone MDK izdaje se samo na recept, a terapiju mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika koji boluju od nasljedne hipertirozinemije tipa 1 (HT-1).
English: The active substance in Nitisinone MDK, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Croatian: Djelatna tvar u lijeku Nitisinone MDK, nitizinon, blokira enzim koji tirozin pretvara u štetne tvari.
English: The Agency recommended that Nitisinone MDK be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Nitisinone MDK u promet u EU-u.
English: Nitisinone MDK is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Croatian: Nitisinone MDK je lijek za liječenje nasljedne hipertirozinemije tipa 1 (HT-1).
English: For more information about treatment with Nitisinone MDK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Nitisinone MDK pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for Orfadin, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Orfadin.
English: What is Nitisinone MDK and what is it used for?
Croatian: Što je Nitisinone MDK i za što se koristi?
English: Nitisinone MDK is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Croatian: Nitisinone MDK primjenjuje se uz prehranu kojom se ograničava unos aminokiselina tirozina i fenilalanina.
English: It is not intended to provide practical advice on how to use Nitisinone MDK.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Nitisinone MDK.
English: Nitisinone MDK is intended for long-term use.
Croatian: Lijek Nitisinone MDK namijenjen je za dugoročnu primjenu.
English: What are the benefits and risks of Nitisinone MDK?
Croatian: Koje su koristi i rizici lijeka Nitisinone MDK?
English: For practical information about using Nitisinone MDK, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Nitisinone MDK bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Other information about Nitisinone MDK
Croatian: Ostale informacije lijeku Nitisinone MDK
English: Nitisinone MDK contains the active substance nitisinone.
Croatian: Nitisinone MDK sadrži djelatnu tvar nitizinon.
English: Why is Nitisinone MDK approved?
Croatian: Zašto je lijek Nitisinone MDK odobren?
English: How does Nitisinone MDK work?
Croatian: Kako djeluje Nitisinone MDK?
English: How is Nitisinone MDK used?
Croatian: Kako se Nitisinone MDK koristi?
English: How has Nitisinone MDK been studied?
Croatian: Kako je Nitisinone MDK ispitivan?
English: Final study report by:
Croatian: Završno izvješće o ispitivanju do:
English: November 20172019
Croatian: studenog 20172019.
English: February 2018 CMDh meeting
Croatian: Sastanak CMDh-a u veljači 2018.
English: The marketing authorisation holder(s) shall change the following condition(s) (new text underlined and in bold, deleted text strike through)
Croatian: Nositelji odobrenja za stavljanje lijeka u promet trebaju provesti izmjenu sljedećeg(ih) uvjeta (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan)
English: 06 June 2018
Croatian: 6. lipnja 2018.
English: The MAH(s) should provide within the risk management plan submission, a protocol for results of the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet trebaju dostaviti, u okviru podnošenja plana upravljanja rizikom, protokol za rezultate ispitivanja potrošnje lijeka kako bi se okarakterizirale prakse propisivanja lijekova tijekom tipične kliničke uporabe u reprezentativnim skupinama liječnika koji propisuju lijek i radi ocjenjivanja glavnih razloga propisivanja lijeka.
English: The PASS final study report submitted by the MAHs complies with their obligation to perform a survey among health care professionals to evaluate their knowledge and attitudes on prescribing conditions of thiocolchicoside containing medicinal products, as imposed during the Article 31 procedure EMEA/H/A
Croatian: Završno izvješće o PASS-u koje su podnijeli nositelji odobrenja za stavljanje lijeka u promet u skladu je s njihovom obvezom provedbe istraživanja među zdravstvenim djelatnicima radi procjene njihova znanja i stavova u pogledu uvjeta za propisivanje lijekova koji sadrže tiokolhikozid, kako je određeno tijekom postupka EMEA/H/A-1361, vođenom prema članku 31.
English: Therefore, in view of available data regarding the PASS survey final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: Stoga je PRAC, s obzirom na dostupne podatke u pogledu završnog izvješća o PASS-u, zaključio da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za rezultate ispitivanja za lijek(ove) koji sadrži(e) djelatnu tvar tiokolhikozid i koji su obuhvaćeni završnim izvješćem o PASS-u, CMDh smatra da je omjer koristi i rizika prethodno navedenih lijekova nepromijenjen, uz predložene izmjene informacija o lijeku.
English: 07 April 2018
Croatian: 7. travnja 2018.
English: The final results of the complementary drug utilization study using databases, which allows a dual approach to assessing the effectiveness of the risk minimisation measures imposed on thiocolchicoside containing medicinal products, are expected in 2019, and this new due date should be reflected in the conditions of the Marketing Authorisation.
Croatian: Završni rezultati dopunskog ispitivanja potrošnje lijeka uz uporabu baza podataka, što omogućava dvostruki pristup ocjenjivanju učinkovitosti mjera minimizacije rizika koje se zahtijevaju za lijekove koji sadrže tiokolhikozid, očekuju se 2019. godine.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Croatian: Stajalište je CMDh-a da je potrebna izmjena odobrenja za stavljanje lijeka u promet za lijekove obuhvaćene ovim završnim izvješćem o PASS-u.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance thiocolchicoside concerned by the noninterventional imposed PASS final report
Croatian: Potrebne izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijekove koji sadrže djelatnu tvar tiokolhikozid i koji su obuhvaćeni završnim izvješćem o zatraženom neintervencijskom PASS-u
English: The following changes to the conditions of the marketing authorisation(s) of medicinal products containing the active substance thiocolchicoside concerned by the PASS final report are recommended:
Croatian: Preporučuju se sljedeće izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijekove koji sadrže djelatnu tvar tiokolhikozid i koji su obuhvaćeni završnim izvješćem o PASS-u:
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the scientific conclusions are as follows:
Croatian: Post-authorisation safety study, PASS) za lijekove koji sadrže djelatnu tvar tiokolhikozid i koji su obuhvaćeni završnim izvješćem o PASS-u, znanstveni zaključci su sljedeći:
English: • At the request of the European Medicines Agency;
Croatian: ● na zahtjev Europske agencije za lijekove;
English: - This medicine has been prescribed for you only.
Croatian: - Ovaj lijek je propisan samo Vama.
English: - Augmentation.
Croatian: - Augmentacija.
English: MIRAPEXIN can cause hallucinations (seeing, hearing or feeling things that are not there).
Croatian: MIRAPEXIN može izazvati halucinacije (možete vidjeti, čuti ili osjećati stvari koje nisu prisutne).
English: If you have advanced
Croatian: Ako imate uznapredovalu
English: Most hallucinations are visual.
Croatian: Većina halucinacija su vidne.
English: Total exposure (AUC) was not affected by concomitant food intake.
Croatian: Ukupna ekspozicija (AUC) nije bila pogođena istovremenim unosom hrane.
English: The absolute bioavailability is greater than 90%.
Croatian: Apsolutna bioraspoloživost je veća od 90%.
English: - Strong impulse to gamble excessively despite serious personal or family consequences.
Croatian: - snažan nagon za pretjeranim kockanjem usprkos teškim posljedicama za osobu ili obitelj.*
English: Date of latest renewal: 23 February 2008
Croatian: Datum posljednje obnove odobrenja: 23. veljače 2008.
English: If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.
Croatian: Ako to učinite, postoji rizik od predoziranja, jer može doći do prebrzog oslobađanja lijeka u tijelo.
English: 100 tablets
Croatian: 100 tableta
English: Do not try to make up for the missed dose.
Croatian: Nemojte pokušavati nadoknaditi propuštenu dozu.
English: - Binge eating (eating large amounts of food in a short time period) or compulsive eating
Croatian: - prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Croatian: OBLIK I SADRŽAJ 30 tableta
English: Tablets can be divided into equal halves.
Croatian: Tablete se mogu razdijeliti na jednake polovice.
English: Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Croatian: Budite oprezni ako primjenjujete lijekove za smirenje (imaju sedativni učinak) ili ako konzumirate alkohol.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: ● prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Swallow the tablets with water.
Croatian: Progutajte tabletu s vodom.
English: MIRAPEXIN should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Croatian: MIRAPEXIN se ne smije primjenjivati tijekom trudnoće osim ako je nužno potreban, tj. ako očekivana korist opravdava potencijalni rizik za fetus.
English: - Uncontrollable excessive shopping or spending*
Croatian: - pretjerano kupovanje ili trošenje koje se ne može kontrolirati*
English: The tablets may be taken either with or without food and should be taken each day at about the same time.
Croatian: Tablete se mogu uzimati sa ili bez hrane, te se uzimaju svaki dan, otprilike u isto vrijeme.
English: Simply leave out that dose completely and then take your next dose at the right time.
Croatian: Jednostavno izostavite tu dozu u cijelosti i zatim uzmite sljedeću dozu u točno vrijeme.
English: OPA/aluminium/PVC-aluminium blisters.
Croatian: OPA/aluminij/PVC-aluminijski blisteri.
English: The effect of MIRAPEXIN on the unborn child is not known.
Croatian: Učinak MIRAPEXINA na nerođeno dijete nije poznat.
English: Do not take MIRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati MIRAPEXIN: - ako ste alergični na pramipeksol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Folding box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Preklopiva kutija
English: Evaluation of these side effects is based on the following frequencies:
Croatian: Ocjena ovih nuspojava zasniva se na sljedećim učestalostima: Vrlo često:
English: If patients report such an observation, the physician should reassess patient's response to therapy.
Croatian: Ukoliko bolesnici prijave takvo opažanje, liječnik treba ponovno procijeniti bolesnikov odgovor na terapiju.
English: - Severe heart or blood vessels disease.
Croatian: - Teška bolest srca ili krvnih žila.