FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Slovenian: Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet”.
English: It is not known whether delamanid and metabolites will be significantly removed by haemodialysis or peritoneal dialysis.
Slovenian: Ni znano, ali hemodializa ali peritonealna dializa delamanid in njegove presnovke odstrani v pomembnem obsegu.
English: Trial 204 and 2 of 511 patients in Trial 213 (4 of 827 patients [0.48%]).
Slovenian: Odpornost na delamanid (opredeljeno kot MIK ≥ 0,2 µg/ml) so v izhodišču opazili pri 2 od 316 bolnikov v preskušanju 204 in pri 2 od 511 bolnikih pri preskušanju 213 (4 od 827 bolnikov [0,48 %]).
English: What Deltyba looks like and contents of the pack
Slovenian: Izgled zdravila Deltyba in vsebina pakiranja
English: • Hearing a persistent sound in your ear when no sound exists (tinnitus)
Slovenian: • zvenjenje v ušesih (tinitus)
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.
Slovenian: Farmakološki način delovanja delamanida vključuje zaviranje sinteze sestavin celične stene mikobakterij,
English: Exposure of concomitant anti-TB drugs (rifampicin [R]/ isoniazid [H]/ pyrazinamide [Z]) was not affected.
Slovenian: To ni vplivalo na izpostavljenost sočasnim zdravilom proti-TB (rifampicin [R]/ izoniazid
English: Eye disorders Conjunctivitis allergic*
Slovenian: Očesne bolezni alergijski konjunktivitis *
English: • High blood cholesterol level
Slovenian: • visoka raven holesterola v krvi
English: QT prolongation has been observed in patients treated with delamanid.
Slovenian: QTc pri bolnikih, zdravljenih z delamanidom.
English: The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see sections 4.4 and 5.2)
Slovenian: Celoten presnovni profil in način izločanja delamanida še nista bila v celoti pojasnjena (glejte poglavji 4.4
English: It is not known if delamanid passes into breast milk in humans.
Slovenian: Ni znano, ali se delamanid izloča v materino mleko.
English: Deltyba 50 mg film-coated tablets are round, and yellow.
Slovenian: Zdravilo Deltyba 50 mg filmsko obložene tablete so okrogle in rumene.
English: In order to further investigate the use of delamanid in different combination treatment regimens as well as safety, the MAH should submit the results of the endTB (Evaluating Newly approved Drugs for multidrug-resistant TB) study, a randomized, controlled Phase III trial in adults and adolescents with multi-drug-resistant tuberculosis conducted by Médecins Sans Frontières, including an additional analysis of the data with a focus on the evaluation of delamanid based on an agreed statistical analysis plan.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za potrebe nadaljnjega raziskovanja uporabe delamanida v različnih kombiniranih režimih zdravljenja in raziskovanja varnosti predložiti rezultate študije endTB (Evaluating Newly approved Drugs for multidrug-resistant TB (Ocenjevanje na novo odobrenih zdravil za multirezistentno tuberkulozo)), ki je randomizirano, kontrolirano preskušanje III. faze pri odraslih in mladostnikih z multirezistentno tuberkulozo, ki ga je izvedla organizacija Médecins
English: How to take Deltyba
Slovenian: Kako jemati zdravilo Deltyba
English: No cases of delamanid overdose have been observed in clinical trials.
Slovenian: V kliničnih preskušanjih niso opazili primerov prevelikega odmerjanja delamanida.
English: - if you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine) - if you are taking any of the following: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), diphemanil (used to treat stomach disorders or excessive sweating), probucol (lowers the level of cholesterol in the bloodstream), levomethadyl or methadone (used for the treatment of opiate addiction), vinca alkaloids (anti-cancer medicines), or arsenic trioxide (used to treat certain types of leukaemia).
Slovenian: - če jemljete kaj od naslednjega: cisaprid (uporablja se za zdravljenje bolezni želodca), droperidol (uporablja se proti bruhanju in migreni), domperidon (uporablja se proti slabosti in bruhanju), difemanil (uporablja se za zdravljenje bolezni želodca ali pretirano znojenje), probukol (znižuje raven holesterola v krvnem obtoku), levometadil ali metadon (uporablja se za zdravljenje odvisnosti od opiatov), vinka alkaloide (zdravila proti raku) ali arzenov trioksid (uporablja se za zdravljenje nekaterih vrst levkemije).
English: Frequency common
Slovenian: Pogostnost pogosti
English: Deltyba 50 mg film-coated tablets delamanid
Slovenian: Deltyba 50 mg filmsko obložene tablete delamanid
English: Side effects uncommonly reported in clinical studies with Deltyba were:
Slovenian: Neželeni učinki, o katerih so pogosto poročali v kliničnih študijah z zdravilom Deltyba, so bili:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR BLISTER PACKS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA PAKIRANJA PRETISNIH OMOTOV
English: The complete metabolic profile of delamanid in man has not yet been fully elucidated (see sections 4.5 and 5.2).
Slovenian: Celoten presnovni profil delamanida pri ljudeh še ni bil v celoti pojasnjen (glejte poglavji 4.4 in 5.2).
English: Deltyba had no effect on male or female fertility in animals (see section 5.3).
Slovenian: Zdravilo Deltyba ni imelo vpliva na sposobnost razmnoževanja samcev ali samic živali (glejte poglavje 5.3).
English: Deltyba 50 mg film-coated tablets
Slovenian: Deltyba 50 mg filmsko obložene tablete
English: Palpitations
Slovenian: Palpitacije
English: Plasma albumin and CYP3A4 regulate the formation and metabolism of DM-6705 respectively (see Special Considerations below).
Slovenian: Nastajanje DM-6705 uravnava albumin v plazmi, presnovo pa CYP3A4 (glejte spodaj Posebni dejavniki).
English: • Low blood calcium level
Slovenian: • nizka raven kalcija v krvi
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Deltyba Vsebina pakiranja in dodatne informacije
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Delamanid se ne priporoča pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
English: - Certain antimicrobial agents, including: - macrolides (e.g. erythromycin, clarithromycin) - moxifloxacin, sparfloxacin (see section 4.4 regarding use with other fluoroquinolones) - bedaquiline - triazole antifungal agents - pentamidine - saquinavir - Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine) - Certain antimalarials with QT-prolonging potential (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
Slovenian: - makrolide (npr. eritromicin, klaritromicin) - moksifloksacin, sparfloksacin (glejte poglavje 4.4 glede uporabe z drugimi fluorokinoloni) - bedakilin - triazolne antimikotike - pentamidin - sakvinavir - nekatere nesedativne antihistaminike (npr. terfenadin, astemizol, mizolastin).
English: Mutation in one of the 5 coenzyme F420 genes is suggested as the mechanism for resistance against delamanid in mycobacteria.
Slovenian: Kot mehanizem za odpornost mikobakterije proti delamanidu se nakazuje mutacija v enem od 5 genov koencima F420.
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).
Slovenian: Delamanid morate za zdravljenje tuberkuloze, odporne na več zdravil (MDR-TB - multidrug-resistant tuberculosis), vedno dajati kot del ustreznega kombiniranega režima (glejte poglavji 4.4 in 5.1).
English: Delamanid is primarily metabolised in plasma by albumin and to a lesser extent by CYP3A4.
Slovenian: Delamanid se primarno presnavlja v plazmi s pomočjo albumina in v manjši meri s pomočjo encima
English: In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (200 mg daily) and with rifampicin/isoniazid/pyrazinamide (300/720/1800 mg daily) or ethambutol (1100 mg daily) for 15 days.
Slovenian: V klinični študiji medsebojnega delovanja zdravil pri zdravih osebah so delamanid 15 dni dajali sam (200 mg na dan) in z rifampicinom/izoniazidom/pirazinamidom (300/720/1800 mg na dan) ali etambutolom (1.100 mg na dan).
English: In order to further characterise the PK/PD relationship of delamanid, the MAH should conduct and submit the results of an in vitro study using the HFS-TB model.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za potrebe nadaljnje opredelitve odnosa med farmakokinetiko in farmakodinamiko delamanida izvesti in predložiti rezultate študije in vitro s pomočjo modela HFS-TB.
English: Each film-coated tablet contains: 50 mg delamanid
Slovenian: Ena filmsko obložena tableta vsebuje: 50 mg delamanida
English: • Abnormal feeling in the mouth
Slovenian: • nenormalen občutek v ustih • občutljivost trebuha
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment.
Slovenian: Uporaba delamanida se pri bolnikih z zmerno ali hudo okvaro jeter ne priporoča.
English: Moxifloxacin is not recommended for use in patients treated with delamanid
Slovenian: Uporaba moksifloksacina se ne priporoča pri bolnikih, zdravljenih z delamanidom.
English: - Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval or QTc > 500 ms. - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
Slovenian: - Znano prirojeno podaljšanje intervala QTc ali katerega drugega kliničnega stanja, za katerega je znano, da podaljšuje interval QTc ali QTc > 500 ms.
English: Therefore no dose adjustment is needed for patients with mild or moderate renal impairment.
Slovenian: Zato pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati.
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • Low blood platelets count (thrombocytopaenia)
Slovenian: • nizko število krvnih ploščic (trombocitopenija)
English: • Drug use during breast feeding.
Slovenian: • uporaba zdravila med dojenjem
English: - Serum albumin < 2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL) - Taking medicinal products that are strong inducers of CYP3A4 (e.g. carbamazepine).
Slovenian: - Serumski albumin < 2,8 g/dl (za uporabo pri bolnikih s serumskim albuminom ≥ 2,8 g/dl glejte poglavje 4.4).
English: Repeat-dose toxicity studies in rabbits revealed an inhibitory effect of delamanid and/or its metabolites on vitamin K-dependent blood clotting.
Slovenian: Študije toksičnosti pri ponavljajočem odmerku pri kuncih so pokazale zaviralen učinek delamanida in/ali njegovih presnovkov na strjevanje krvi, odvisno od vitamina K. V študijah vpliva na razmnoževanje pri kuncih so v odmerkih, toksičnih za mater, opazili toksičnost za embrio/zarodek.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom.
English: • A bone disease called osteochondrosis
Slovenian: • bolezen kosti, ki se imenuje osteohondroza • oslabelost mišic
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.
Slovenian: Hipoalbuminemija V klinični študiji je bila prisotnost hipoalbuminemije povezana z večjim tveganjem podaljšanja intervala
English: • Reduced sensation
Slovenian: • zmanjšan tek
English: • Decreased values for blood investigations for the hormone cortisol
Slovenian: • znižane vrednosti hormona kortizola pri krvnih preiskavah • zvišan krvni tlak
English: Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold compared to fasting conditions.
Slovenian: Absorpcija Peroralna biološka razpoložljivost delamanida se pri uporabi s standardnim obrokom izboljša za približno
English: Each film-coated tablet contains 50 mg delamanid.
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg delamanida.
English: Iron oxide yellow (E172)
Slovenian: Filmska obloga hipromeloza makrogol 8000 titanov dioksid smukec rumeni železov oksid (E172)
English: • Increased blood tryglycerides
Slovenian: • povišani trigliceridi v krvi
English: There are no clinical data on the use of delamanid to treat - extra pulmonary tuberculosis (e.g. central nervous system, bone) - infections due to Mycobacterial species other than those of the M. tuberculosis complex - latent infection with M. tuberculosis
Slovenian: Ni kliničnih podatkov o uporabi delamanida za zdravljenje - zunajpljučne tuberkuloze (npr. osrednji živčni sistem, kosti)
English: • Risk of QT interval prolongation
Slovenian: • odpornost na zdravilo • tveganje za podaljšanje intervala QT
English: Breast-feeding is not recommended during treatment with Deltyba.
Slovenian: Med uporabo zdravila Deltyba se dojenje ne priporoča.
English: Hypertension Hypotension Haematoma* Hot flush*
Slovenian: Žilne bolezni hipertenzija hipotenzija hematom*
English: Osteochondrosis Muscular weakness Musculoskeletal pain* Flank pain
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva osteohondroza oslabelost mišic mišično-skeletne bolečine* bolečina v ledvenem predelu bolečine v okončinah artralgija* mialgija*
English: In patients receiving 200 mg delamanid total daily dose in the phase 2 and 3 trials, the mean placebo corrected increase in QTcF from baseline ranged from 4.7 - 7.6 ms at 1 month and 5.3 ms - 12.1 ms at 2 months, respectively.
Slovenian: Pri bolnikih, ki so prejemali 200 mg skupnega dnevnega odmerka delamanida v drugi in tretji fazi preskušanja, se je povprečna, s placebom korigirana vrednost intervala QTcF od izhodišča zvišala s 4,7 na
English: Haematuria*
Slovenian: pruritus*
English: • Lethargy
Slovenian: • letargija
English: • Swallowing problems
Slovenian: • težave pri požiranju
English: • Dry eye
Slovenian: suhe oči*
English: - One film-coated tablet contains 50 mg of the active substance delamanid.
Slovenian: - Ena filmsko obložena tableta vsebuje 50 mg zdravilne učinkovine delamanida.
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).
Slovenian: Deltyba za eno ali več podskupin pediatrične populacije za {zdravljenje tuberkuloze, odporne na več zdravil}
English: Reticulocytosis
Slovenian: retikulocitoza
English: In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg twice daily) and with tenofovir disoproxil (245 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Slovenian: V klinični študiji medsebojnega delovanja zdravil pri zdravih prostovoljcih so delamanid 14 dni dajali sam (100 mg dvakrat na dan) in s tenofovir dizoproksilom (245 mg na dan), lopinavirjem/ritonavirjem (400/100 mg na dan), 10 dni pa z efavirenzom (600 mg na dan).
English: Anxiety and anxiety disorder
Slovenian: psihotična motnja agitacija anksioznost in anksiozna motnja depresija in depresivno razpoloženje nemir nespečnost
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema levkopenija trombocitopenija anemija* eozinofilija*
English: • Feeling hot
Slovenian: • občutek vročine
English: Lethargy Balance disorder Radicular pain Poor quality sleep
Slovenian: Pogostnost zelo pogosti motnje ravnotežja radikularna bolečina slaba kakovost spanja zaspanost* hipoastezija glavobol parestezija tremor
English: Susceptibility testing breakpoints
Slovenian: Mejne vrednosti testiranja občutljivosti
English: Effects of other medicinal products on Deltyba
Slovenian: in 5.2) Učinki drugih zdravil na zdravilo Deltyba
English: Hepatic impairment Deltyba is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and
Slovenian: Okvara jeter Zdravilo Deltyba se ne priporoča pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavji 4.2 in 5.2).
English: • you have reduced levels of albumin, potassium, magnesium or calcium in the blood
Slovenian: Povejte zdravniku, če imate katero od spodaj navedenih stanj: • v krvi imate zmanjšane ravni albumina, kalija, magnezija ali kalcija
English: • Yeast infection of the skin (tinea versicolor)
Slovenian: • okužba kože s kvasovkami (tinea versicolor) • nizko število belih krvnih celic (levkopenija)
English: - Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
Slovenian: - če jemljete zdravila za zdravljenje psihoz (npr. fenotiazine, sertindol, sultoprid, klorpromazin, haloperidol, mesoridazin, pimozid ali tioridazin) ali depresijo.
English: Neuropathy peripheral Somnolence* Hypoaesthesia
Slovenian: Bolezni živčevja letargija periferna nevropatija omotica*
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.
Slovenian: Zato se priporoča zelo redno spremljanje s pomočjo EKG-ja, ves čas zdravljenja z delamanidom, če se razmišlja o sočasni uporabi delamanida s katerim koli močnim zaviralcem CYP3A4.
English: There are no data on the use of delamanid in patients with severe renal impairment and its use is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati Podatkov o uporabi delamanida pri bolnikih s hudo okvaro ledvic ni, zato se uporaba ne priporoča (glejte poglavji 4.4 in 5.2).
English: Rash maculo-papular* Rash*
Slovenian: makulopapulozni izpuščaj* izpuščaj*
English: • SmPC
Slovenian: • srbečica
English: Co-administration of moxifloxacin and delamanid in MDR-TB patients has not been studied.
Slovenian: Sočasne uporabe moksifloksacina in delamanida pri bolnikih z
English: Dehydration Hypocalcaemia Hypercholesterolaemia
Slovenian: Presnovne in prehranske motnje dehidracija hipokalciemija hiperholesterolemija hipertrigliceridemija hipokaliemija zmanjšan tek hiperurikemija*
English: Table: Adverse drug reactions to delamanid System Organ
Slovenian: Preglednica: Neželeni učinki delamanida
English: Feeling hot
Slovenian: vročinski oblivi*
English: • Nausea
Slovenian: • nemir
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.
Slovenian: Zadnje poročilo PSUR vsebuje dokaze za sum na možno vzročno povezavo bolezni jeter z delamanidom,
English: • Joint or muscle pain
Slovenian: • bolečine v sklepih ali mišicah
English: • Low blood potassium level
Slovenian: • nizka raven kalija v krvi
English: How to store Deltyba
Slovenian: Shranjevanje zdravila Deltyba
English: - if you are taking medicines to treat psychoses (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression - if you are taking certain antimicrobial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
Slovenian: - če jemljete nekatera protimikrobna zdravila (npr. eritromicin, klaritromicin, moksifloksacin, sparfloksacin, bedakilin ali pentamidin).
English: • Increased blood uric acid level
Slovenian: • zvišana raven sečne kisline v krvi
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).
Slovenian: V drugem preskušanju (preskušanje 213) so delamanid dajali peroralno, in sicer 100 mg dvakrat na dan kot dodatno zdravljenje k OBR v trajanju 2 mesecev, ki mu je sledilo 4-mesečno prejemanje odmerka 200 mg enkrat na dan. Srednji čas za SCC je bil 51 dni v skupini delamanid + OBR v primerjavi s 57 dni v skupini PLC + OBR (p = 0,0562 z uporabo stratificirane modificirane modifikacije Peto-Peto Gehan-Wilcoxonovega preizkusa vsot rangov).
English: The MAH should agree the educational material with the Member States, prior to launch.
Slovenian: Pred prihodom zdravila na trg se mora imetnik dovoljenja za promet z zdravilom z državo članico dogovoriti o izobraževalnem gradivu.
English: Tinnitus
Slovenian: astenija
English: Urinary retention Dysuria* Nocturia
Slovenian: Bolezni sečil zastoj urina disurija* nikturija hematurija*
English: Oropharyngeal pain Throat irritation Dry throat* Rhinorrhoea*
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja kašelj orofaringealna bolečina draženje grla suho grlo* izcedek iz nosu*
English: • Stomach pain
Slovenian: • bolečina v želodcu
English: Haemoptysis
Slovenian: hemoptiza
English: • Constipation
Slovenian: • vrtoglavica
English: • Throat irritation
Slovenian: • agitacija (vznemirjenje)
English: Mental disorder
Slovenian: • prebavne motnje
English: • Drowsiness
Slovenian: • zaspanost
English: • Blood in urine
Slovenian: • izkašljevanje krvi
English: Tell your doctor... - if you are taking, have recently taken or might take any other medicines, including medicines or herbal remedies obtained without prescription, - if you are taking medicines to treat an abnormal heart rhythm (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Slovenian: Obvestite zdravnika, - če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo ali zeliščni preparat, ki ste ga dobili brez recepta,
English: • Neurosis
Slovenian: • nevroza (nemir)
English: Skin and subcutaneous tissue disorders
Slovenian: žolčnika in žolčevodov nenormalno delovanje jeter
English: Gastritis*
Slovenian: gastritis* zaprtje*
English: Eosinophilic pustular folliculitis* Pruritus generalised* Rash erythematous
Slovenian: Bolezni kože in podkožja alopecija* ezinofilen pustulozen folikulitis* generalizirani pruritus*
English: Pharmacotherapeutic group: Antimycobacterials, antibiotics, ATC code: J04AK06.
Slovenian: ATC: J04AK06.
English: • Shortness of breath
Slovenian: • oteženo dihanje • kašelj
English: Ear and labyrinth disorders
Slovenian: vključno z motnjami labirinta bolečine v ušesu tinitus
English: Dizziness* Headache Paraesthesia Tremor
Slovenian: eritematozni izpuščaj dermatitis urtikarija srbeč izpuščaj*
English: ECG QT interval prolongation
Slovenian: Opis izbranih neželenih učinkov Podaljšanje intervala QT
English: Blood cortisol increased Electrocardiogra m QT prolonged
Slovenian: zvišana gamaglutamiltransferaza* znižan kortizol v krvi zvišan krvni tlak zvišan kortizol v krvi podaljšan QT na elektrokardiogramu
English: Description of selected adverse reactions
Slovenian: Aktivnost proti specifičnim povzročiteljem bolezni
English: • Foot, leg or ankle swelling
Slovenian: • nelagodje v prsih • otekanje stopal, nog ali gležnjev
English: Paraesthesia oral Abdominal tenderness*
Slovenian: Bolezni prebavil disfagija oralna parestezija občutljivost trebuha*
English: No dose adjustment is considered necessary for patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati.
English: Delamanid is contraindicated in patients with albumin <2.8 g/dL (see section 4.3).
Slovenian: < 2.8 g/dl (glejte poglavje 4.3).
English: • Restlessness
Slovenian: • slabokrvnost
English: • Hair loss
Slovenian: • draženje grla