FrancophonIA/ELRC3.0 huggingface dataset:
English: - Taking medicinal products that are known to prolong the QTc interval.
Croatian: - Uzimanje lijekova za koje je poznato da produljuju QTc interval.
English: There is evidence in the last PSUR to suspect the possibility of a causal relationship of liver disorders with delamanid, but the scientific evidence is insufficient to conclude that the association is causal.
Croatian: Zadnji PSUR sadrži dokaze zbog kojih se sumnja na mogućnost uzročno-posljedične povezanosti poremećaja jetre s delamanidom, ali nema dovoljno znanstvenih dokaza iz kojih bi se moglo zaključiti kako se radi o uzročno-posljedičnoj povezanosti.
English: Special Considerations Cardiac risk factors
Croatian: Faktori rizika za srce
English: Delamanid is contraindicated in patients with albumin <2.8 g/dL (see section 4.3).
Croatian: Delamanid je kontraindiciran u bolesnika s albuminom < 2,8 g/dL (vidjeti dio 4.3).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/Aluminium
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Aluminij/aluminij
English: There are no clinical data on the effects of delamanid on fertility in humans.
Croatian: Nema kliničkih podataka o učincima delamanida na plodnost u ljudi.
English: Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Croatian: Liječenje delamanidom mora započeti i pratiti liječnik s iskustvom u zbrinjavanju multirezistentne Mycobacterium tuberculosis.
English: Frequent ECG monitoring should be performed.
Croatian: Mora se provoditi učestalo EKG praćenje.
English: However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily.
Croatian: Međutim, dodatni klinički podaci pokazali su da u bolesnika koji su primali 200 mg dvaput dnevno, što znači ukupno 400 mg delamanida na dan, sveukupni sigurnosni profil je bio usporediv s onim u bolesnika koji su primali preporučenu dozu od 100 mg dvaput dnevno.
English: In mycobacteria, the in vitro frequencies of spontaneous resistance to delamanid were similar to those for isoniazid, and were higher than those for rifampicin.
Croatian: In vitro učestalosti spontane rezistencije na delamanid u mikobakterija bile su slične onima za izoniazid, te više od onih za rifampicin.
English: - Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Croatian: - Bilo koja predisponirajuća srčana stanja za aritmiju kao što su teška hipertenzija, hipertrofija lijeve klijetke (uključujući hipertrofičnu kardiomiopatiju) ili kongestivno zatajenje srca praćeno smanjenom istisnom frakcijom lijeve klijetke.
English: • Changes found in investigations (electrocardiogram, ECG) of the heart
Croatian: • iskašljavanje krvi • promjene u nalazima pretraga (elektrokardiogram, EKG) srca
English: Two sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis using “bookending” methodology (which required that the previous and subsequent cultures were both observed negative cultures to impute a negative result, otherwise a positive result was imputed).
Croatian: (engl. last-observation-carried-forward, LOCF) i analiza pomoću „bookending“ metode (gdje je bilo potrebno da i prethodna i kasnije kulture budu negativne da bi se upisao negativni rezultat; u suprotnom,
English: QTc prolongation is very closely correlated with the major delamanid metabolite DM-6705.
Croatian: Produljenje QTc u vrlo je uskoj vezi s glavnim metabolitom delamanida DM-6705.
English: Depression and depressed mood
Croatian: depresija i depresivno raspoloženje nemir
English: The analyses of SCC were conducted on the modified intent to treat population which included patients who had positive cultures at baseline and the isolate was resistant to both isoniazid and rifampicin, i.e., had MDR TB.
Croatian: Analize konverzije kulture iskašljaja provedene su na modificiranoj populaciji planiranoj za liječenje koja je uključivala bolesnike s pozitivnim kulturama na početku ispitivanja i izolat je bio rezistentan i na izoniazid i na rifampicin, tj. one koji su imali MDR-TB.
English: In a clinical study, the presence of hypoalbuminaemia was associated with an increased risk of prolongation of the QTc interval in delamanid treated patients.
Croatian: U kliničkom ispitivanju, prisutnost hipoalbuminemije je bila povezana s povećanim rizikom produljenja QTc intervala u bolesnika liječenih delamanidom.
English: Posology The recommended dose for adults is 100 mg twice daily for 24 weeks.
Croatian: Preporučena doza za odrasle iznosi 100 mg dva puta dnevno, tijekom 24 tjedna.
English: In lactating rats, the Cmax for delamanid in breast milk was 4-fold higher than that of the blood.
Croatian: U štakora u periodu laktacije, Cmax delamanida u majčinom mlijeku bio je 4 puta veći od onog u krvi.
English: Patients who commence delamanid with serum albumin <3.4 g/dL or experience a fall in serum albumin into this range during treatment should receive very frequent monitoring of ECGs throughout the full delamanid treatment period.
Croatian: Bolesnicima koji su započeli liječenje delamanidom, a imaju serumski albumin < 3,4 g/dL ili u kojih je došlo do pada serumskog albumina u taj raspon tijekom liječenja, mora se vrlo često pratiti EKG tijekom cijelog razdoblja liječenja delamanidom.
English: Cytochrome P450 3A4 inducers
Croatian: Induktori citokroma P450 3A4
English: • Heart rhythm problems
Croatian: • problemi sa srčanim ritmom
English: Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold compared to fasting conditions.
Croatian: Apsorpcija Oralna bioraspoloživost delamanida poboljšava se uz primjenu standardnog obroka, za otprilike 2,7 puta u usporedbi s uvjetima natašte.
English: - if you are taking medicines that strongly induce a certain liver enzyme called “CYP450 3A4” (e.g.
Croatian: − ako uzimate lijekove koji jako potiču jetreni enzim koji se zove “CYP450 3A4”(npr. karbamazepin).
English: • Shaking (tremor)
Croatian: • drhtavica (tremor)
English: Plasma albumin and CYP3A4 regulate the formation and metabolism of DM-6705 respectively (see Special Considerations below).
Croatian: Plazmatski albumini i CYP3A4 reguliraju stvaranje odnosno metabolizam DM-6705 (vidjeti niže Posebne okolnosti).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Deltyba in one or more subsets of the paediatric population in {treatment in multi-drug resistant tuberculosis} (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Deltyba u jednoj ili više podskupina pedijatrijske populacije u liječenju tuberkuloze rezistentne na više lijekova (vidjeti dio 4.2
English: On the basis of the scientific conclusions for delamanid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing delamanid is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za delamanid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) delamanid nepromijenjen, uz predložene izmjene informacija o lijeku.
English: • Yeast infection of the skin (tinea versicolor)
Croatian: • ranica u ustima • gljivična infekcija kože (tinea versicolor)
English: Other medicines and Deltyba
Croatian: Drugi lijekovi i Deltyba
English: General recommendations
Croatian: Opće preporuke
English: In the dog, foamy macrophages were observed in lymphoid tissue of various organs during repeat-dose toxicity studies.
Croatian: U pasa su uočeni pjenasti makrofagi u limfoidnom tkivu različitih organa tijekom ispitivanja toksičnosti ponovljene doze.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka na sposobnost upravljanja vozilima i rada na strojevima.
English: • Adjustment disorder with depressed mood
Croatian: • poremećaj prilagođavanja s depresivnim raspoloženjem
English: Delamanid given in combination with the anti-HIV-medicines, tenofovir disoproxil, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal products.
Croatian: Delamanid primijenjen u kombinaciji s lijekovima protiv HIV-a, tenofovirdizoproksilom, lopinavirom/ritonavirom i efavirenzom nije utjecao na ekspoziciju ovim lijekovima.
English: The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial cell wall components, methoxy-mycolic and keto-mycolic acid.
Croatian: Način djelovanja Farmakološki način djelovanja delamanida uključuje inhibiciju sinteze komponenti stanične stijenke mikobakterija, metoksi-mikolne i keto-mikolne kiseline.
English: Because a potential risk to the breast-feeding infant cannot be ruled out , it is recommended that women should not breastfeed during treatment with Deltyba.
Croatian: Budući da se mogući rizik za dojenče ne može isključiti, žene ne smiju dojiti tijekom liječenja lijekom
English: • Panic attacks
Croatian: • napadaji panike
English: What you need to know before you take Deltyba 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Deltyba
English: Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: svaka filmom obložena tableta sadrži 100 mg laktoze (u obliku hidrata).
English: • A tingling, burning or pricking sensation or numbness of the skin (paresthesia)
Croatian: • osjećaj trnaca, žarenja ili bockanja ili obamrlost kože (parestezija)
English: • Risk of QT interval prolongation
Croatian: • Rizik za produljenje QT intervala
English: In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(pgp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of approximately 5 to 20 fold greater than the Cmax at steady state.
Croatian: MDR1(p-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 i BSEP, u koncentracijama približno 5 do 20 puta većim od Cmax u stanju dinamičke ravnoteže.
English: Effects of Deltyba on other medicinal products
Croatian: Učinci lijeka Deltyba na druge lijekove
English: Eye disorders Conjunctivitis allergic*
Croatian: Poremećaji oka alergijski konjunktivitis*
English: Frequency very common
Croatian: Učestalost vrlo često
English: - if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
Croatian: - ako uzimate određene lijekove za liječenje alergijskih reakcija (npr. terfenadin, astemizol, mizolastin).
English: - if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir.
Croatian: - ako uzimate lijekove protiv HIV-a koji sadrže lopinavir/ritonavir ili sakinavir.
English: • Abnormal blood values related to the function of the liver, biliary system or pancreas
Croatian: • poremećene vrijednosti krvnih pretraga vezanih za funkciju jetre, žučnog sustava ili gušterače
English: • Balance disorder
Croatian: • poremećaj ravnoteže
English: Co-administration with delamanid significantly increased steady state plasma concentrations of ethambutol by approximately 25%, the clinical relevance is unknown.
Croatian: Istovremena primjena s delamanidom značajno je povećala plazmatske koncentracije etambutola u stanju dinamičke ravnoteže za približno 25% dok klinička važnost ovih nalaza nije poznata.
English: Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) (see sections 4.4 and 5.1).
Croatian: Delamanid se mora uvijek primijeniti kao dio odgovarajućeg kombiniranog režima liječenja tuberkuloze otporne na više lijekova (MDR-TB) (vidjeti dijelove 4.4 i 5.1).
English: It is recommended that electrocardiograms (ECG) should be obtained before initiation of treatment and monthly during the full course of treatment with delamanid.
Croatian: Elektrokardiogrami (EKG) se moraju snimiti prije početka liječenja te jednom mjesečno tijekom punog ciklusa liječenja delamanidom.
English: Therefore the potential for drug-drug interactions of clinical significance to occur with delamanid and the possible consequences, including the total effect on the QTc interval, cannot be predicted with confidence.
Croatian: Stoga se ne može sa sigurnošću predvidjeti potencijal pojavljivanja klinički značajnih interakcija lijekova s delamanidom i moguće posljedice, uključujući ukupni učinak na QTc interval.
English: It is not known if delamanid passes into breast milk in humans.
Croatian: Nije poznato prelazi li delamanid u majčino mlijeko u ljudi.
English: Delamanid must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by WHO to prevent development of resistance to delamanid.
Croatian: Delamanid se mora koristiti samo u odgovarajućem kombiniranom režimu za liječenje MDR-TB prema preporuci SZO za prevenciju razvoja rezistencije na delamanid.
English: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München Germany
Croatian: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nakon toga, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom
English: Co-administration of delamanid with a strong inhibitor of CYP3A4 (lopinavir/ritonavir) was associated with a 30% higher exposure to the metabolite DM-6705, which has been associated with QTc prolongation.
Croatian: Istovremena primjena delamanida s jakim inhibitorom CYP3A4 (lopinavir/ritonavir) vezana je za 30% višu izloženost metabolitu DM-6705, što se povezuje s QTc produljenjem.
English: Delamanid is not excreted in urine.
Croatian: Delamanid se ne izlučuje u mokraći.
English: • Aggression
Croatian: • agresija
English: • Neurosis
Croatian: • neuroza
English: * The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the placebo plus OBR group.
Croatian: * Učestalost ovih događaja bila je niža u skupini koja je primala kombinaciju delamanida s OOR-om u usporedbi sa skupinom koja je primala placebo s OOR-om.
English: Both showed a 13-day shorter median time to SCC in the delamanid + OBR group (p=0.0281 for LOCF and p=0.0052 for “bookending”).
Croatian: Obje su pokazale 13 dana kraći medijan vremena do konverzije kulture sputuma u skupini liječenoj delamanidom + OOR (p = 0,0281 za LOCF i p = 0,0052 za “bookending”).
English: Co-administration with strong inhibitors of CYP3A4
Croatian: Istovremena primjena s jakim inhibitorima CYP3A4
English: The most frequently observed adverse drug reactions in patients treated with delamanid + Optimised Background Regimen (OBR) (i.e. incidence > 10%) are nausea (32,9%), vomiting (29,9%), headache (27.6%), insomnia (27.3%), dizziness (22.4%), tinnitus (16.5%), hypokalaemia (16.2%), gastritis (15.0%), decreased appetite (13.1%), and asthenia (11.3%).
Croatian: (OOR) (tj. incidencija > 10 %) su mučnina (32,9 %), povraćanje (29,9 %), glavobolja (27,6 %), nesanica (27,3 %), omaglica (22,4 %), tinitus (16,5 %), hipokalemija (16,2 %), gastritis (15,0 %), smanjeni apetit (13,1 %) i astenija (11,3 %).
English: • Dry throat
Croatian: • suho grlo
English: These include (but are not limited to): - Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Croatian: Ovo uključuje (ali nije ograničeno na): - Antiaritmike (npr. amiodaron, dizopiramid, dofetilid, ibutilid, prokainamid, kinidin, hidrokinidin, sotalol).
English: The list of adverse drug reactions and frequencies are based on the results from 2 double-blind placebo controlled clinical trials (delamanid plus OBR, n = 662 vs placebo plus OBR n = 330).
Croatian: Tablični popis nuspojava Popis nuspojava i učestalosti temelji se na rezultatima 2 dvostruko slijepa, placebom kontrolirana klinička ispitivanja (delamanid plus OOR, n = 662 naspram placebo plus OOR n = 330).
English: • Increase of blood pressure (hypertension)
Croatian: • povišenje krvnog tlaka (hipertenzija)
English: Delamanid exposure remained unchanged (<25% difference) with anti-HIV medicines tenofovir disoproxil and efavirenz but was slightly increased with the combination anti-HIV medicine containing lopinavir/ritonavir.
Croatian: Izloženost delamanidu je ostala nepromijenjena (< 25% razlike) s lijekovima protiv HIV-a, tenofovirdizoproksilom i efavirenzom, ali je blago povećana u kombinaciji s lijekovima protiv HIV-a koji sadrže lopinavir/ritonavir.
English: Breast-feeding is not recommended during treatment with Deltyba.
Croatian: Dojenje se ne preporučuje tijekom liječenja lijekom Deltyba.
English: • Pain in arms or legs
Croatian: • bol u rukama ili nogama
English: There are very limited data from the use of delamanid in pregnant women.
Croatian: Podaci o primjeni delamanida u trudnica su vrlo ograničeni.
English: Deltyba film-coated tablets contain lactose.
Croatian: Deltyba filmom obložene tablete sadrže laktozu.
English: Exposure of concomitant anti-TB drugs (rifampicin [R]/ isoniazid [H]/ pyrazinamide [Z]) was not affected.
Croatian: Nije bilo utjecaja na izloženost istodobno primjenjivanim lijekovima protiv tuberkuloze (rifampicin [R]/izoniazid [H]/pirazinamid [Z]).
English: The identified metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM6705.
Croatian: Identificirani metaboliti ne pokazuju antimikobakterijsku aktivnost ali neki doprinose produljenju QTc, uglavnom metabolit DM
English: • Low white blood cell count (leukopenia)
Croatian: • nizak broj bijelih krvnih stanica (leukopenija)
English: The proportion of patients achieving SCC (sputum culture conversion) after the 6-month treatment period was 87.6% (198/226) in the delamanid + OBR treatment group compared to 86.1% (87/101) in the placebo + OBR treatment group (p=0.7131).
Croatian: Udio bolesnika u kojih je postignuta konverzija kulture sputuma nakon 6-mjesečnog razdoblja liječenja iznosio je 87,6 % (198/226) u skupini liječenoj delamanidom + OOR u usporedbi s 86,1 % (87/101) u skupini koja je primala placebo + OOR (p = 0,7131).
English: • Increase in immature red blood cells
Croatian: • porast razine nezrelih crvenih krvnih stanica
English: It is unknown whether this medicinal product or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se ovaj lijek ili njegovi metaboliti u majčino mlijeko u ljudi.
English: The MAH should agree the educational material with the Member States, prior to launch.
Croatian: Nositelj odobrenja će se dogovoriti o edukacijskim materijalima s državama članicama, prije puštanja lijeka u promet.
English: Atrioventricular block first degree Ventricular extrasystoles* Supraventricular extrasystoles
Croatian: Srčani poremećaji atrioventrikularni blok prvog stupnja ventrikularne ekstrasistole* supraventrikularne ekstrasistole palpitacije
English: Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB.
Croatian: Delamanid je procijenjen u dva dvostruko slijepa, placebom kontrolirana klinička ispitivanja liječenja
English: • Decrease of blood pressure (hypotension)
Croatian: • sniženje krvnog tlaka (hipotenzija)
English: - Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Croatian: - Cisaprid, droperidol, domperidon, bepridil, difemanil, probukol, levometadil, metadon, vinka alkaloide, arsenov trioksid.
English: Resistance to delamanid has been documented to occur during treatment (see section 4.4).
Croatian: Dokumentirana je rezistencija na delamanid koja se pojavljuje tijekom liječenja (vidjeti dio 4.4).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovoga lijeka, obratite se svojem liječniku ili ljekarniku.
English: • Increase of certain white blood cells (eosinophilia)
Croatian: • povišene razine određenih bijelih krvnih stanica (eozinofilija)
English: • Psychotic disorder
Croatian: • psihotični poremećaj
English: The median time to SCC was 51 days in the delamanid + OBR group compared with 57 days in the PLC + OBR group (p = 0.0562 using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test).
Croatian: Medijan vremena do konverzije kulture sputuma iznosio je 51 dan u skupini koja je primala delamanid + OOR u usporedbi s 57 dana u skupini koja je primala placebo + OOR (p = 0,0562 prema stratificiranoj modificiranoj Peto-Peto modifikaciji Gehanovog Wilcoxonovog testa sume rangova).
English: • High blood cholesterol level
Croatian: • visoka razina kolesterola u krvi
English: Therefore if co-administration of delamanid with any strong inhibitor of CYP3A4 is considered necessary it is recommended that there is very frequent monitoring of ECGs, throughout the full delamanid treatment period.
Croatian: Prema tome ako se smatra da je istovremena primjena delamanida s nekim jakim inhibitorom CYP3A4 neophodna, preporučuje se vrlo često praćenje EKG-a, tijekom cijelog razdoblja liječenja delamanidom.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Deltyba Lijek čuvajte izvan pogleda i dohvata djece.
English: No clinically relevant reduction in delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg daily for 10 days in combination with delamanid 100 mg twice daily.
Croatian: Nije opaženo klinički značajno smanjenje izloženosti delamanidu sa slabim induktorom efavirenzom kod primjene u dozi od 600 mg dnevno tijekom 10 dana u kombinaciji s delamanidom 100 mg dvaput dnevno.
English: Such patients should receive very frequent monitoring of ECG throughout the full delamanid treatment period.
Croatian: U tih se bolesnika mora provoditi vrlo često EKG praćenje tijekom cijelog razdoblja liječenja delamanidom.
English: The educational material for Patients to be provided via the HCPs to reinforce and supplement the information provided in the patient information leaflet.
Croatian: Edukacijske materijale za bolesnike će davati zdravstveni djelatnici kako bi se osnažile i proširile informacije dane u uputi o lijeku: Informacija za bolesnika.
English: If you stop taking Deltyba
Croatian: Ako prestanete uzimati lijek Deltyba
English: See the end of section 4 for how to report side effects.
Croatian: pogledajte kraj dijela 4.
English: If you forget to take Deltyba
Croatian: Ako ste zaboravili uzeti lijek Deltyba
English: For patients receiving 100 mg delamanid + OBR twice daily, the frequency was 8.1% (frequency category common) in comparison to a frequency of 6.3% in patients receiving placebo + OBR twice daily.
Croatian: U bolesnika koji su primali 100 mg delamanida + OOR dvaput dnevno, učestalost je bila 8,1% (česta kategorija učestalosti) u usporedbi s učestalošću od 6,3% u bolesnika koji su primali placebo + OOR dvaput dnevno.
English: Available pharmacokinetic data in animals have shown excretion of delamanid and/or its metabolites in milk.
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se delamanid i/ili njegovi metaboliti izlučuju u mlijeko.