FrancophonIA/ELRC3.0 huggingface dataset:
English: • Shaking (tremor)
Slovenian: • tresenje (tremor)
English: There are very limited data from the use of delamanid in pregnant women.
Slovenian: Podatki o uporabi delamanida pri nosečnicah so zelo omejeni.
English: Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 100 mg laktoze (v obliki laktoze monohidrata).
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.
Slovenian: Analize konverzije kulture izpljunka (SCC, sputum culture conversion) so bile izvedene na modificirani populaciji z namenom zdravljenja (angl. intent to treat), ki je vključevala bolnike, ki so imeli ob izhodišču zdravljenja pozitivne kulture, izolat pa je bil odporen na izoniazid in rifampicin, tj. so imeli MDR TB.
English: The complete metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with other co-administered medications, if significant unknown metabolites are discovered.
Slovenian: Celotnega presnovnega profila delamanida še niso pojasnili, zato obstaja možnost za medsebojno delovanje z drugimi sočasno uporabljenimi zdravili, če se odkrijejo znatni neznani presnovki.
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.
Slovenian: Pri mikobakteriji so bile pogostnosti spontane odpornosti na delamanid in vitro podobne kot pri isoniazidu ter višje kot pri rifampicinu.
English: Deltyba contains lactose monohydrate.
Slovenian: Zdravilo Deltyba vsebuje laktozo monohidrat.
English: There are no clinical data on the effects of delamanid on fertility in humans.
Slovenian: Ni kliničnih podatkov o vplivu delamanida na plodnost pri ljudeh.
English: Anti-HIV medicines
Slovenian: Zdravila proti HIV-u
English: Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB.
Slovenian: Delamanid so ovrednotili v dveh dvojno slepih, s placebom nadzorovanih preskušanjih za zdravljenje MDR TB.
English: Such patients should receive very frequent monitoring of ECG throughout the full delamanid treatment period.
Slovenian: Te bolnike je treba zelo pogosto spremljati s pomočjo EKG-ja v celotnem obdobju zdravljenja z delamanidom.
English: What you need to know before you take Deltyba Do not take Deltyba:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Deltyba Ne jemljite zdravila Deltyba:
English: • Papules (small skin elevations)
Slovenian: • papule (dvig majhnega dela kože nad ravnjo kože)
English: Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required.
Slovenian: Zdravljenje prevelikega odmerjanja mora vključevat takojšnje ukrepe za odstranitev delamanida iz prebavil in podporno nego, kot je potrebno.
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.
Slovenian: Pri bolnikih, ki so prejemali 100 mg delamanida + OBR dvakrat na dan je bila pogostnost 8,1 % (kategorija pogostnosti pogosti) v primerjavi s pogostnostjo 6,3 % pri bolnikih, ki so prejemali placebo + OBR dvakrat na dan.
English: Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.
Slovenian: Zdravilo Deltyba je na voljo v pakiranjih po 48 filmsko obloženih tablet v aluminij/aluminij pretisnih omotih.
English: In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 7H11 medium.
Slovenian: V kliničnih preskušanjih so odpornost na delamanid opredelili kot vsakršno rast v prisotnosti koncentracije delamanida 0,2 μg/ml, ki je večja kot 1 % pri kontrolnih kulturah brez učinkovine v gojišču Middlebrook
English: Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Slovenian: Zdravljenje z delamanidom mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi na več zdravil odporne Mycobacterium tuberculosis.
English: It is also recommended that serum electrolytes, e.g. potassium, are obtained at baseline and corrected if abnormal.
Slovenian: Priporoča se tudi, da se ob izhodišču pridobijo vrednosti elektrolitov v serumu, npr. kalija, ki jih je treba popraviti, če so nenormalne.
English: - if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir.
Slovenian: - če jemljete zdravila za zdravljenje okužbe s HIV-om, ki vsebujejo lopinavir/ritonavir ali sakvinavir.
English: • Urine retention
Slovenian: • zadrževanje urina
English: All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use.
Slovenian: Sočasna uporaba delamanida s kinoloni Vsa podaljšanja QTcF za več kot 60 ms so bila povezana s sočasno uporabo fluorokinolonov.
English: The identified metabolites of delamanid do not show anti-mycobacterial activity.
Slovenian: Opredeljeni presnovki delamanida niso pokazali antimikobakterijskega delovanja.
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.
Slovenian: Ker možnega tveganja za dojenega otroka zaradi zdravljenja z delamanidom ni mogoče izključiti, ženske med zdravljenjem z zdravilom Deltyba ne smejo dojiti.
English: • Increase of certain white blood cells (eosinophilia)
Slovenian: • zvišanje nekaterih belih krvnih celic (eozinofilija)
English: Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.
Slovenian: Zdravilo Deltyba vsebuje zdravilno učinkovino delamanid, antibiotik za zdravljenje tuberkuloze pljuč, ki jo povzroča bakterija, ki je drugi antibiotiki, ki se najpogosteje uporabljajo za zdravljenje tuberkuloze, ne morejo uničiti.
English: Special Considerations Cardiac risk factors
Slovenian: Dejavniki tveganja za srce
English: • Balance disorder
Slovenian: • motnje ravnotežja
English: • Aggression
Slovenian: • agresija
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.
Slovenian: Sočasna uporaba delamanida z močnimi zaviralci CYP3A4 (lopinavir/ritonavir) je bila povezana s 30 % višjo izpostavljenostjo presnovku DM-6705, kar je povezano s podaljšanjem QTc.
English: Deltyba is not recommended in pregnant women or in women of childbearing potential unless they are using a reliable form of contraception.
Slovenian: Zdravila Deltyba ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, razen če uporabljajo učinkovito metodo kontracepcije.
English: - Taking medicinal products that are known to prolong the QTc interval.
Slovenian: - Jemanje zdravil, za katera je znano, da podaljšujejo interval QTc.
English: - if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
Slovenian: - če jemljete nekatera zdravila za zdravljenje alergijskih reakcij (npr. terfenadin, astemizol, mizolastin).
English: If you take more Deltyba than you should
Slovenian: Če ste vzeli večji odmerek zdravila Deltyba, kot bi smeli
English: • Problems with sleeping
Slovenian: • težave z uspavanjem in spanjem
English: • you have liver disease or kidney disease.
Slovenian: • če imate bolezen jeter ali bolezen ledvic
English: Cytochrome P450 3A4 inducers
Slovenian: Induktorji citokroma P450 3A4
English: Care must be taken in using delamanid in patients already receiving medicines associated with QT prolongation (see section 4.4).
Slovenian: Pri uporabi delamanida pri bolnikih, ki že uporabljajo zdravila, povezana s podaljšanjem intervala QT, je potrebna previdnost (glejte poglavje 4.4).
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%).
Slovenian: Neželeni učinki, ki so jih pri bolnikih, zdravljenih z delamanidom v kombinaciji z optimirano osnovno shemo zdravljenja (OBR, Optimised Background Regimen), najpogosteje opazili (tj. incidenca > 10 %), so navzea (32,9 %), bruhanje (29,9 %), glavobol (27,6 %), nespečnost (27,3 %), omotica (22,4 %), tinitus (16,5 %), hipokaliemija (16,2 %), gastritis (15,0 %), zmanjšan apetit (13,1 %) in astenija (11,3 %).
English: • Decreased tolerability of the eyes for bright light
Slovenian: • zmanjšana toleranca oči za močno svetlobo • bolečine v ušesu
English: There are no clinical data on the use of delamanid as part of combination regimens used to treat drug susceptible M. tuberculosis.
Slovenian: Ni kliničnih podatkov o uporabi delamanida kot dela kombiniranega režima za zdravljenje M. tuberculosis, dovzetne na zdravljenje.
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.
Slovenian: Delamanid se lahko uporablja le kot ustrezni kombinirani režim za zdravljenje MDR-TB po priporočilih SZO za preprečitev razvoja odpornosti na delamanid.
English: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München Germany
Slovenian: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München
English: Since both medications are known to prolong the QT interval, the MAH is asked to update the SmPC and PL of delamanid to list bedaquiline as one of the concomitant drugs known to prolong the QTc interval.
Slovenian: Ker je znano, da obe zdravili podaljšujeta interval QT, mora imetnik dovoljenja za promet z zdravilom posodobiti povzetek glavnih značilnosti zdravila in navodilo za uporabo delamanida tako, da navede bedakilin kot eno od sočasnih zdravil, za katera je znano, da podaljšujejo interval QTc.
English: In the dog, foamy macrophages were observed in lymphoid tissue of various organs during repeat-dose toxicity studies.
Slovenian: Pri psih so v limfoidnem tkivu različnih organov v študijah toksičnosti pri ponavljajočih odmerkih opazili penaste makrofage.
English: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Deltyba je indicirano kot del ustreznega kombiniranega režima zdravljenja pljučne tuberkuloze, odporne na več zdravil (MDR-TB, multi-drug resistant tubercolosis) pri odraslih bolnikih, če učinkovitega režima zdravljenja sicer ni mogoče sestaviti zaradi odpornosti ali prenašanja (glejte poglavja 4.2, 4.4 in 5.1).
English: • Dry throat
Slovenian: • suho grlo
English: • Increase of blood pressure (hypertension)
Slovenian: • zvišanje krvnega tlaka (hipertenzija)
English: If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital.
Slovenian: Če ste vzeli več tablet, kot je predpisani odmerek, se takoj posvetujte z zdravnikom ali pojdite v najbližjo zdravstveno ustanovo.
English: • Pain in the mouth or throat
Slovenian: • bolečina v ustih ali žrelu
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).
Slovenian: Tabelarični seznam neželenih učinkov Seznam neželenih učinkov in pogostnosti zdravil temelji na rezultatih 2 dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih (delamanid plus OBR, n = 662, v primerjavi s placebom plus OBR,
English: Other medicines and Deltyba
Slovenian: Druga zdravila in zdravilo Deltyba
English: Atrioventricular block first degree Ventricular extrasystoles* Supraventricular extrasystoles
Slovenian: Srčne bolezni atrioventrikularni blok prve stopnje ventrikularne ekstrasistole* supraventrikularne ekstrasistole palpitacije
English: The adverse drug reactions are listed by MedDRA System Organ Class and Preferred Term.
Slovenian: Neželeni učinki so našteti po MedDRA razvrstitvi organskih sistemov in priporočenem izrazu.
English: Deltyba film-coated tablets contain lactose.
Slovenian: Zdravilo Deltyba filmsko obložene tablete vsebujejo laktozo.
English: • Decrease of blood pressure (hypotension)
Slovenian: • znižanje krvnega tlaka (hipotenzija)
English: These include (but are not limited to): - Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Slovenian: Ta vključujejo (vendar niso omejena na): - antiaritmike (npr. amiodaron, dizopiramid, dofetilid, ibutilid, prokainamid, kinidin,
English: The incidence of a QTcF interval > 500 ms ranged from 0.6% (1/161) - 2.1% (7/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 1.2% (2/170) of patients receiving placebo + OBR, while the incidence of QTcF change from baseline > 60ms ranged from 3.1% (5/161) - 10.3% (35/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 7.1% (12/170) in patients receiving placebo.
Slovenian: Incidenca intervala QTcF > 500 ms je znašala od 0,6 % (1/161) do 2,1 % (7/341) pri bolnikih, ki so prejemali 200 mg skupnega dnevnega odmerka delamanida, v primerjavi z od 0 % (0/160) do 1,2 % (2/170 ) bolnikov, ki so prejemali placebo + OBR, medtem ko se je incidenca spremembe QTcF od izhodišča > 60 ms gibala med 3,1 % (5/161) in 10,3 % (35/341) pri bolnikih, ki so prejemali 200 mg skupnega dnevnega odmerka delamanida v primerjavi z od 0 % (0/160) do 7,1 % (12/170) pri bolnikih, ki so prejemali placebo.
English: • A tingling, burning or pricking sensation or numbness of the skin (paresthesia)
Slovenian: • občutek mravljinčenja, zbadanja, skelenja ali odrevenelost kože (parestezija)
English: • Heart rhythm problems
Slovenian: • težave s srčnim ritmom
English: Anti-Tuberculosis medicines
Slovenian: Zdravila za zdravljenje tuberkuloze
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.
Slovenian: Klinično pomembnega zmanjšanja izpostavljenosti delamanidu s šibkimi induktorji efavirenza niso opazili po 10-dnevnem dajanju odmerka 600 mg na dan v kombinaciji z delamanidom 100 mg dvakrat na dan.
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).
Slovenian: Delež bolnikov, ki so dosegli SCC po 6 mesecih zdravljenja, je bil v skupini zdravljenja z zdravilom delamanid + OBR 87,6 % (198/226) v primerjavi s 86,1 % (87/101) v skupini za zdravljenje s placebom + OBR (p = 0,7131).
English: Available pharmacokinetic data in animals have shown excretion of delamanid and/or its metabolites in milk.
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje delamanida in/ali njegovih presnovkov v mleko.
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.
Slovenian: Izpostavljenost delamanida je v kombinaciji z zdravili proti HIVu, ki vsebujejo tenofovir dizoproksil in efavirenz ostala nespremenjena (< 25 % razlika), nekoliko pa se je zvišala v kombinaciji z zdravili proti HIV-u, ki vsebujejo lopinavir/ritonavir.
English: If you stop taking Deltyba
Slovenian: Če prenehate jemati zdravilo Deltyba
English: Medicinal products with the potential to prolong QTc
Slovenian: Zdravila, ki lahko podaljšajo QTc
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA
English: Co-administration with strong inhibitors of CYP3A4
Slovenian: Sočasna uporaba z močnimi zaviralci CYP3A4
English: It is unknown whether this medicinal product or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se zdravilo ali njegovi presnovki izločajo v materino mleko.
English: The PRAC noted the recurrent concomitant use of delamanid with bedaquiline in patients experiencing QTc prolongation.
Slovenian: Odbor PRAC je opazil pogosto sočasno uporabo delamanida z bedakilinom pri bolnikih s podaljšanjem intervala QTc.
English: Pharmacokinetic data in animals have shown excretion of delamanid /metabolites into breast milk.
Slovenian: Farmakokinetični podatki pri živalih so pokazali izločanje delamanida/presnovkov v mleko.
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.
Slovenian: < 3,4 mg/dl ali ki so med zdravljenjem doživeli upad serumskega albumina v ta razpon, je treba zelo redno spremljati s pomočjo EKG-ja ves čas zdravljenja z delamanidom.
English: Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
Slovenian: Po končanem 24-tedenskem obdobju zdravljenja z delamanidom zdravljenje nadaljujte s kombiniranim režimom v skladu s smernicami SZO.
English: In the first trial (Trial 204), 64/141 (45.4%) patients randomised to receive delamanid 100 mg BID + OBR and 37/125 (29.6%) of patients randomised to receive placebo (PLC) + OBR achieved two-month sputum culture conversion (SCC) (i.e. growth of Mycobacterium tuberculosis to no growth over the first 2 months and maintained for 1 more month) (p=0.0083).
Slovenian: V prvem preskušanju (preskušanje 204) je 64/141 (45,4 %) bolnikov, randomiziranih za prejemanje delamanida 100 mg BID + OBR, in 37/125 (29,6 %) bolnikov, randomiziranih za prejemanje placeba (PLC) + OBR, doseglo dvomesečno konverzijo kulture izpljunka (SCC) (tj. rast bakterijMycobacterium tuberculosis na raven nerasti v prvih dveh mesecih in ohranitev še en mesec) (p = 0,0083).
English: - Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Slovenian: - cisaprid, droperidol, domperidon, bepridil, difemanil, probukol, levometadil, metadon, vinka alkaloide, arzenov trioksid.
English: Deltyba is not expected to have an influence on your ability to drive and use machines.
Slovenian: Ni za pričakovati, da bi zdravilo Deltybavplivalo na vašo sposobnost vožnje ali upravljanja strojev.
English: Activity against specific pathogens Delamanid has no in vitro activity against bacterial species other than mycobacteria.
Slovenian: Delamanid in vitro ne deluje proti drugim vrstam bakterij, razen proti mikobakterijam.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for delamanid, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za delamanid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Hyperhidrosis
Slovenian: akne hiperhidroza
English: Package leaflet: Information for the patient Deltyba 50 mg film-coated tablets delamanid This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Deltyba 50 mg filmsko obložene tablete delamanid Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: • Psychotic disorder
Slovenian: • psihotična motnja
English: Round, yellow, film-coated tablet.
Slovenian: filmsko obložene tablete (tablete) okrogla, rumena, filmsko obložena tableta
English: Therefore if coadministration is considered to be unavoidable in order to construct an adequate treatment regimen for MDRTB it is recommended that there is very frequent monitoring of ECGs throughout the full delamanid treatment period.
Slovenian: Če je sočasna uporaba za oblikovanje ustrezne sheme zdravljenja za MDR-TB neizogibna, se priporoča zelo redno spremljanje s pomočjo EKG-ja ves čas zdravljenja z delamanidom.
English: • Pain in bones
Slovenian: • bolečine v kosteh
English: If you forget to take Deltyba
Slovenian: Če ste pozabili vzeti zdravilo Deltyba
English: - The other ingredients are hypromellose phthalate, povidone, all-rac-α-tocopherol, microcrystalline cellulose, sodium starch glycolate, carmellose calcium, colloidal hydrated silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).
Slovenian: - Druge sestavine zdravila so hipromelozaftalat, povidon, vseracemni-alfa-tokoferol, mikrokristalna celuloza, natrijev karboksimetilškrob, kalcijev karmelozat, koloidni hidratirani silicijev dioksid, magnezijev stearat, laktoza monohidrat, hipromeloza, makrogol 8000, titanov dioksid, smukec, železov oksid (E172).
English: Transaminases increased* Activated partial thromboplastin time prolonged*
Slovenian: Preiskave depresija segmenta ST na elektrokardiogramu zvišanje transaminaz* podaljšan aktiviran parcialni tromboplastinski čas*
English: - if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
Slovenian: - če jemljete triazolne antimikotike (npr. flukonazol, itrakonazol, vorikonazol).
English: Non-clinical data reveal no specific hazard for humans based on conventional studies for genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij genotoksičnosti in kancerogenosti ne kažejo posebnega tveganja za človeka.
English: Co-administration with delamanid significantly increased steady state plasma concentrations of ethambutol by approximately 25%, the clinical relevance is unknown.
Slovenian: [H]/ pirazinamid [Z]).Sočasno dajanje z delamanidom je značilno zvišalo koncentracije etambutola v plazmi za približno 25 %, vendar klinični pomen ni znan.
English: Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (type A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate
Slovenian: Jedro tablete hipromelozaftalat povidon vseracemni-alfa-tokoferol mikrokristalna celuloza natrijevega karboksimetilškrob (vrsta A) kalcijev karmelozat koloidni hidratirani silicijev dioksid magnezijev stearat laktoza monohidrat
English: Delamanid should be taken with food.
Slovenian: Način uporabe peroralna uporaba Delamanid se jemlje s hrano.
English: Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up to 45% following 15 days of concomitant administration of the strong inducer of cytochrome P450 (CYP) 3A4 (Rifampicin 300 mg daily) with delamanid (200 mg daily).
Slovenian: Klinične študije medsebojnega delovanja zdravil pri zdravih osebah kažejo na zmanjšano izpostavljenost delamanidu za do 45 % po 15 dneh sočasnega dajanja močnega induktorja citokroma P450 (CYP) 3A4 (Rifampicin 300 mg na dan) z delamanidom (200 mg na dan).
English: Resistance to delamanid has been documented to occur during treatment (see section 4.4).
Slovenian: Med zdravljenjem so dokumentirali odpornost na delamanid (glejte poglavje 4.4).
English: Herpes zoster Oropharyngeal candidiasis Tinea versicolor*
Slovenian: Infekcijske in parazitske bolezni herpes zoster orofaringealna kandidiaza tinea versicolor*