FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Namuscla are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Namuscla pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Namuscla must also not be used in patients with various heart problems, or together with certain medicines.
Croatian: Namuscla se ne smije primjenjivati ni u bolesnika s raznim srčanim problemima ili zajedno s drugim lijekovima.
English: The most common side effects with Namuscla (which may affect more than 1 in 10 people) are abdominal (belly) pain and insomnia (difficulty sleeping).
Croatian: Najčešće nuspojave lijeka Namuscla (koje se mogu javiti u više od 1 na 10 osoba) jesu bol u abdomenu (trbuhu) i nesanica (otežano spavanje).
English: Namuscla must not be used in patients who are hypersensitive (allergic) to the active substance, mexiletine, to any other ingredients of the medicine, or to local anaesthetics (medicines that block out sensation used to prevent pain in a part of the body).
Croatian: Namuscla se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar, meksiletin, na bilo koji drugi sastojak lijeka ili na lokalne anestetike (lijekove koji blokiraju osjećaj kojim se sprječava bol u određenom dijelu tijela).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Namuscla have also 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 Namuscla nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency therefore decided that Namuscla's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Namuscla nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: In one study involving 25 patients with non-dystrophic myotonia, Namuscla was shown to be more effective than placebo (a dummy treatment) at reducing muscle stiffness.
Croatian: U jednom ispitivanju koje je obuhvatilo 25 bolesnika s nedistrofičnom miotonijom, lijek Namuscla pokazao se učinkovitijim od placeba (prividnog liječenja) u smanjenju ukočenosti mišića.
English: An overview of Namuscla and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Namuscla i zašto je odobren u EU-u
English: As for all medicines, data on the use of Namuscla are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Namuscla kontinuirano se prate.
English: The safety profile of Namuscla is well known and its side effects affecting the heart are considered to be manageable with restrictions in use and monitoring during treatment.
Croatian: Namuscla dobro je poznat, a smatra se da se nuspojave lijeka povezane sa srcem mogu kontrolirati, uz ograničenja u primjeni i praćenje tijekom liječenja.
English: These sodium channels play a role in the contraction and relaxation of muscles and are hyperactive in patients with myotonic disorders, causing excessive contractions and stiffness.
Croatian: Ti kanali natrija igraju ulogu u kontrakciji i opuštanju mišića te su hiperaktivni kod bolesnika s poremećajima miotonije, pri čemu uzrokuju prekomjerne kontrakcije i ukočenost.
English: Namuscla is available as capsules to be taken by mouth.
Croatian: Lijek Namuscla dostupan je u obliku kapsula koje se uzimaju na usta.
English: Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction.
Croatian: Bolesnici koji pate od nedistrofičnih poremećaja miotonije osjećaju ukočenost mišića jer su im se mišići presporo opuštaju nakon kontrakcije.
English: For more information about using Namuscla, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Namuscla pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Namuscla?
Croatian: Koji su rizici povezani s lijekom Namuscla?
English: Other information about Namuscla
Croatian: Ostale informacije o lijeku Namuscla
English: The active substance in Namuscla, mexiletine, works by blocking channels in muscle cells that allow sodium ions (electrically charged particles) to pass in and out.
Croatian: Djelatna tvar u lijeku Namuscla je meksiletin koji djeluje tako da blokira kanale u mišićnim stanicama koji omogućuju prolazak natrijevih iona (električki nabijene čestice).
English: What is Namuscla and what is it used for?
Croatian: Što je Namuscla i za što se primjenjuje?
English: Namuscla was shown to be effective at easing the symptoms of myotonia in patients with nondystrophic myotonic disorders, thus improving their quality of life.
Croatian: Lijek Namuscla pokazao se učinkovitim u ublažavanju simptoma miotonije u bolesnika s nedistrofičnim poremećajima miotonije jer je pridonio poboljšanju kvalitete života.
English: Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with nondystrophic myotonic disorders, a group of inherited muscle disorders.
Croatian: Namuscla je lijek za liječenje simptoma miotonije (ukočenosti mišića) u bolesnika s nedistrofičnim poremećajima miotonije, skupinom naslijeđenih mišićnih poremećaja.
English: How does Namuscla work?
Croatian: Kako djeluje Namuscla?
English: What benefits of Namuscla have been shown in studies?
Croatian: Koje su koristi od lijeka Namuscla utvrđene u ispitivanjima?
English: Namuscla can only be obtained with a prescription.
Croatian: Namuscla se izdaje samo na liječnički recept.
English: Non-dystrophic means no muscle wasting occurs in patients affected by the condition.
Croatian: „Nedistrofičan” znači da u bolesnika s tim stanjem ne dolazi do pojave propadanja mišića.
English: For the full list of side effects of Namuscla, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Namuscla potražite u uputi o lijeku.
English: How is Namuscla used?
Croatian: Kako se Namuscla primjenjuje?
English: Muscle stiffness was self-assessed by each patient before and after treatment, and scored on a scale running from 0 to 100 (most severe).
Croatian: Svaki je bolesnik proveo samoprocjenu ukočenosti mišića prije i nakon liječenja i ocijenio je na ljestvici od 0 do 100 (najteži oblik).
English: Long-term safety:
Croatian: Dugoročna sigurnost:
English: Not to be sold separately.
Croatian: Ne smije se odvojeno prodavati.
English: - if you notice skin changes.
Croatian: - ako primijetite promjene na koži.
English: This is a long-term treatment.
Croatian: Ovo je dugoročno liječenje.
English: Tuberculosis e
Croatian: Tuberkuloza e
English: Your doctor will also regularly check the level of lipids (fat) in your blood.
Croatian: Vaš liječnik će također redovito provjeravati razinu lipida (masnoća) u Vašoj krvi.
English: Both key secondary endpoints were also met.
Croatian: Obje ključne mjere sekundarnih ishoda također su ispunjene.
English: (see section 4.2).
Croatian: (vidjeti dio 4.2).
English: Comparative data regarding long-term survival and incidence of disease complications is missing.
Croatian: Komparativni podaci o dugoročnom preživljenju i incidenciji komplikacija bolesti nedostaju.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Croatian: Ovo mogu biti znakovi ozbiljne infekcije mozga i Vaš liječnik može predložiti daljnje pretrage i praćenje.
English: The median age was 60 years (range 33 to 90 years).
Croatian: Medijan dobi bio je 60 godina (raspon 33 do 90 godina).
English: Patients should be assessed for the risk of developing serious infections.
Croatian: Bolesnike treba procijeniti s obzirom na rizik od razvoja ozbiljnih infekcija.
English: Your doctor will tell you if you should take one or two doses and how many tablets to take for each dose.
Croatian: Liječnik će Vam reći trebate li uzeti jednu ili dvije doze i koliko tableta trebate uzeti za svaku dozu.
English: Effects of age, gender or race
Croatian: Utjecaj dobi, spola ili rase
English: The safety and efficacy of Jakavi in children and adolescents aged up to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Jakavija u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: They may differ from the general information contained in this leaflet.
Croatian: One se mogu razlikovati od općenitih informacija navedenih u ovoj uputi.
English: (64.2% versus 38.5%).
Croatian: (64,2% u odnosu na 38,5%).
English: The majority of patients (68.4%) were treated for at least 9 months.
Croatian: Većina bolesnika (68,4%) liječila se najmanje 9 mjeseci.
English: This medicine is not intended for use by children or adolescents aged below 18 years because it has not been studied in this age group.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina zato što nije ispitivan u toj dobnoj skupini.
English: - if you have or have ever had any liver problems.
Croatian: - ako imate ili ste ikada imali poteškoća s jetrom.
English: What Jakavi is and what it is used for
Croatian: Što je Jakavi i za što se koristi
English: You should take Jakavi every day at the same time, either with or without food.
Croatian: Jakavi trebate uzimati svaki dan u isto vrijeme, bilo uz obrok ili bez obroka.
English: Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Croatian: Prije početka liječenja, kod bolesnika je potrebno procijeniti postojanje aktivne i inaktivne („latentne“) tuberkuloze, prema lokalnim preporukama.
English: Your doctor may want to gradually reduce the amount of Jakavi taken each day, before stopping it completely.
Croatian: Liječnik će Vam možda htjeti postupno smanjiti količinu Jakavija koju uzimate svaki dan prije nego što ga potpuno prestanete uzimati.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Croatian: Ako postoji sumnja na PML, daljnje doziranje treba obustaviti dok se PML ne isključi.
English: Appropriate supportive treatment should be given.
Croatian: Treba primijeniti odgovarajuću suportivnu terapiju.
English: The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals.
Croatian: Početna doza ne smije se povećavati u roku od prva četiri tjedna liječenja, a nakon toga ne češće nego u razdobljima od 2 tjedna.
English: It is important that you tell your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Croatian: Važno je da obavijestite svog liječnika ako ste ikada imali tuberkulozu ili ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
English: It is unknown whether the increased metabolite exposure is of safety concern.
Croatian: Nije poznato je li povećana izloženost metabolitima sigurnosni problem.
English: - if you are taking other medicines (see section “Other medicines and Jakavi”).
Croatian: - ako uzimate bilo koje druge lijekove (vidjeti dio „Drugi lijekovi i Jakavi“).
English: Elderly patients (≥65 years) No additional dose adjustments are recommended for elderly patients.
Croatian: Starije osobe (≥65 godina) Ne preporučuju se dodatna prilagođavanja doze za starije osobe.
English: This may require further observation, as certain types of skin cancer (non-melanoma) have been reported.
Croatian: To bi moglo zahtijevati daljnje promatranje, budući da su zabilježene određene vrste raka kože (nemelanomske).
English: Frequency is based on laboratory values.
Croatian: Učestalost se temelji na laboratorijskim vrijednostima.
English: c grade 1 and 2
Croatian: c stupanj 1 i 2
English: It is important that you tell your doctor if you have ever had hepatitis B. - if you have any kidney problems.
Croatian: Važno je da obavijestite svog liječnika ako ste ikada imali hepatitis B. - ako imate ikakvih poteškoća s bubrezima.
English: If you forgot to take Jakavi simply take your next dose at the scheduled time.
Croatian: Ako ste zaboravili uzeti Jakavi jednostavno uzmite sljedeću dozu u planirano vrijeme.
English: JAK mutation status
Croatian: Status JAK mutacije
English: However the treatment should be discontinued after 6 months if there has been no reduction in spleen size or improvement in symptoms since initiation of therapy.
Croatian: Međutim, liječenje treba prekinuti nakon 6 mjeseci ako nije došlo do smanjenja veličine slezene ili poboljšanja simptoma od početka liječenja.
English: 168 tablets (3x56)
Croatian: 168 tableta (3x56)
English: depending on your blood cell count.
Croatian: ovisno o Vašoj krvnoj slici.
English: Infections generally associated with immunosuppression were noted in dogs.
Croatian: Infekcije općenito povezane s imunosupresijom bile su uočene u pasa.
English: Your doctor may need to adjust the dose or stop treatment.
Croatian: Liječnik će Vam možda trebati prilagoditi dozu ili prekinuti liječenje.
English: Your doctor will always tell you exactly how many Jakavi tablets to take.
Croatian: Liječnik će Vam uvijek reći koliko točno tableta Jakavija trebate uzeti.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Croatian: Preporučuju se periodični pregledi kože za bolesnike s povećanim rizikom od raka kože.
English: You should continue taking Jakavi for as long as your doctor tells you to.
Croatian: Trebate nastaviti uzimati Jakavi dokle god Vam liječnik to kaže.
English: Your doctor may perform tests to see if you have tuberculosis or any other infections.
Croatian: Vaš liječnik može provesti pretrage kako bi provjerio imate li tuberkulozu ili neku drugu infekciju.
English: If you take more Jakavi than you should
Croatian: Ako uzmete više Jakavija nego što ste trebali
English: The blood becomes thicker as a result of the increased red blood cells.
Croatian: Krv postaje gušća kao rezultat povećane razine crvenih krvnih stanica.
English: Best available therapy (N=72)
Croatian: Najbolja dostupna terapija (N=72)
English: This pattern was observed in patients regardless of whether they had received transfusion during therapy.
Croatian: Ovaj je obrazac bio uočen u bolesnika bez obzira na to jesu li primili transfuziju tijekom liječenja.
English: After 48 weeks
Croatian: Nakon 48 tjedana
English: Individual components of primary response at week 32
Croatian: Pojedinačne komponente primarnog odgovora u 32. tjednu
English: Unchanged parent substance accounted for less than 1% of the excreted total radioactivity.
Croatian: Nepromijenjena početna tvar činila je manje od 1% izlučene ukupne radioaktivnosti.
English: It is possible that the potential inhibition of P-gp and BCRP in the intestine can be minimised if the time between administrations is kept apart as long as possible.
Croatian: Moguće je da se potencijalna inhibicija P-gp i BCRP-a u crijevima može smanjiti ako je vrijeme između primjena što je duže moguće.
English: If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Croatian: Ako propusti dozu, bolesnik ne smije uzeti dodatnu dozu već treba uzeti sljedeću uobičajenu propisanu dozu.
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 minimalizacije rizika).
English: Treatment may be continued as long as the benefit-risk remains positive.
Croatian: Liječenje se može nastaviti dokle god je omjer koristi i rizika pozitivan.
English: Single doses up to 200 mg have been given with acceptable acute tolerability.
Croatian: Jednokratne doze do 200 mg primjenjivale su se uz prihvatljivu akutnu podnošljivost.
English: Most patients (>80%) had received at least two phlebotomies in the last 24 weeks prior to screening.
Croatian: Većina bolesnika (>80%) primila je najmanje dvije flebotomije u posljednja 24 tjedna prije probira.
English: Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi.
Croatian: Vaš liječnik će pažljivo provjeriti imate li bilo kakve znakove ili simptome infekcije prije započinjanja i tijekom liječenja Jakavijem.
English: Do not take Jakavi - if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Jakavi - ako ste alergični na ruksolitinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Treatment with Jakavi should not be started until active serious infections have resolved.
Croatian: Liječenje Jakavijem ne smije se započeti dok ne prođu aktivne ozbiljne infekcije.
English: Date of first authorisation: 23 August 2012 Date of latest renewal: 24 April 2017
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2017.
English: Two major and active metabolites are present in plasma representing 25% and 11% of parent AUC.
Croatian: Dva glavna i aktivna metabolita prisutna su u plazmi i predstavljaju 25% i 11% AUC-a početne tvari.
English: - Rifabutin or rifampicin, medicines used to treat tuberculosis (TB).
Croatian: - Rifabutin ili rifampicin, lijekovi koji se upotrebljavaju za liječenje tuberkuloze (TB).
English: It may be necessary to treat your infection before starting Jakavi.
Croatian: Možda će biti potrebno liječiti Vašu infekciju prije početka uzimanja Jakavija.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Jakavi - if you have any infections.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Jakavi - ako imate ikakve infekcije.
English: Your doctor will regularly monitor your condition to make sure that the treatment is having the desired effect.
Croatian: Vaše stanje kako bi bio siguran da liječenje ima željeni učinak.
English: Patients developing anaemia may require blood transfusions.
Croatian: Bolesnici kod kojih se razvije anemija možda će trebati transfuzije krvi.
English: Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Propisivači se upozoravaju na rizik od lažno negativnog tuberkulinskog kožnog testa, posebno u bolesnika koji su teško bolesni ili imunokompromitirani.
English: Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs).
Croatian: Liječnici moraju posebno paziti na simptome koji upućuju na PML, a koje bolesnici možda neće primijetiti (npr. kognitivni, neurološki ili psihijatrijski simptomi ili znakovi).
English: It is particularly important that you mention any of the following medicines containing any of the following active substances, as your doctor may need to adjust the Jakavi dose for you.
Croatian: Osobito je važno da spomenete lijekove u nastavku koji sadrže bilo koju od niže navedenih djelatnih tvari, budući da će Vam liječnik možda morati prilagoditi dozu Jakavija.
English: However, this could be related to the high ruxolitinib dose resulting in pharmacodynamic effects near Emax.
Croatian: Međutim, to bi moglo biti povezano s visokom dozom ruksolitiniba koja rezultira farmakodinamičkim učincima blizu Emax.
English: Before you start treatment with Jakavi, your doctor will perform blood tests to determine the best starting dose for you.
Croatian: Prije nego započnete liječenje Jakavijem, liječnik će Vam obaviti krvne pretrage kako bi se utvrdilo koja je najbolja doza za Vas.
English: There have been cases of patients discontinuing Jakavi who sustained more severe events, particularly in the presence of acute intercurrent illness.
Croatian: Bilo je slučajeva bolesnika koji su prestali uzimati Jakavi i koji su doživjeli teže događaje, osobito u prisutnosti akutne interkurentne bolesti.
English: One patient (0.3%) discontinued treatment because of anaemia.
Croatian: Jedan je bolesnik (0,3%) prekinuo terapiju zbog anemije.
English: Activating mutations in JAK2 (V617F or exon 12) are found in >95% of PV patients.
Croatian: Aktivirajuće mutacije u JAK2 (V617F ili ekson 12) nalaze se u >95% bolesnika s PV-om.
English: Dosing only on dialysis days reduces the metabolite exposure, but also the pharmacodynamic effect, especially on the days between dialysis.
Croatian: Primjena doze samo u dane dijalize smanjuje izloženost metabolitima, ali i farmakodinamički učinak, osobito u dane između dijalize.
English: Frequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755)
Croatian: Učestalost se temelji na svim bolesnicima izloženima ruksolitinibu u kliničkim ispitivanjima (N=4755)
English: Thus, medicinal products inhibiting these enzymes can give rise to increased ruxolitinib exposure.
Croatian: Stoga lijekovi koji inhibiraju te enzime mogu uzrokovati povećanu izloženost ruksolitinibu.
English: Most of the side effects of Jakavi are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Croatian: Većina nuspojava Jakavija blage je do umjerene prirode i općenito nestane nakon nekoliko dana do nekoliko tjedana liječenja.
English: Uncommon (may affect up to 1 in 100 people): - tuberculosis
Croatian: Manje česte (mogu se javiti u manje od 1 na 100 ljudi): - tuberkuloza
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: 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).
Croatian: Osim toga, odgovarajuća kategorija učestalosti za svaku nuspojavu na lijek određena je na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged.
Croatian: Patološka koštana srž više ne može stvarati dovoljno normalnih krvnih stanica i zbog toga se slezena značajno poveća.
English: Dose proportionality was demonstrated in the single and multiple dose studies.
Croatian: Proporcionalnost doze dokazana je u ispitivanjima s jednokratnim i višekratnim dozama.
English: The sum total of all active metabolites contributes to 18% of the overall pharmacodynamics of ruxolitinib.
Croatian: Ukupni zbroj svih aktivnih metabolita doprinosi do 18% ukupne farmakodinamike ruksolitiniba.
English: Jakavi has no or negligible sedating effect.
Croatian: Jakavi nema nikakav ili ima zanemariv sedirajući učinak.
English: When adjusted for exposure, the adverse events rates were generally comparable with those observed during the comparative periods of the randomised studies.
Croatian: Kada se prilagode za izloženost, stope štetnih događaja općenito su bile usporedive s onima uočenima tijekom komparativnih razdoblja randomizacije ispitivanja.
English: Tell your doctor immediately if you experience any of the following side effects.
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih nuspojava.
English: There was no evidence of a teratogenic effect in rats and rabbits.
Croatian: Nije bilo dokaza teratogenog učinka u štakora i zečeva.
English: Do not take Jakavi during pregnancy.
Croatian: Ne uzimajte Jakavi tijekom trudnoće.