FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Stoga ako se smatra da je istovremena primjena neizbježna radi sastavljanja odgovarajućeg režima liječenja za MDR-TB preporučuje se vrlo često praćenje EKG-a, tijekom cijelog razdoblja liječenja delamanidom.
English: Pharmacokinetic data in animals have shown excretion of delamanid /metabolites into breast milk.
Croatian: Farmakokinetički podaci na životinjama pokazali su izlučivanje delamanida/metabolita u majčino mlijeko.
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.
Croatian: U bolesnika koji su u kliničkim ispitivanjima faze 2 i 3 primali delamanid u ukupnoj dnevnoj dozi od 200 mg, srednja vrijednost povećanja QTcF u odnosu na početnu vrijednost korigiranog za placebo bila je u rasponu od 4,7 do 7,6 ms u 1. mjesecu odnosno od 5,3 ms do 12,1 ms u 2. mjesecu.
English: Activity against specific pathogens Delamanid has no in vitro activity against bacterial species other than mycobacteria.
Croatian: Delamanid ne posjeduje in vitro aktivnost protiv drugih bakterijskih vrsta osim mikobakterija.
English: Deltyba 50 mg film-coated tablets are round, and yellow.
Croatian: Deltyba 50 mg filmom obložene tablete su okrugle i žute.
English: In the second trial (Trial 213), delamanid was administered orally at 100 mg BID as an add-on therapy to an OBR for 2 months followed by 200 mg once daily for 4 months.
Croatian: U drugom ispitivanju (Ispitivanje 213), delamanid je primjenjivan peroralno u dozi od 100 mg dvaput dnevno kao dodatna terapija OOR-u tijekom 2 mjeseca, a nakon toga u dozi od 200 mg jedanput dnevno tijekom 4 mjeseca.
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).
Croatian: - Ostali sastojci su hipromelozaftalat, povidon, sav-rac-α-tokoferol, mikrokristalična celuloza, natrijev škroboglikolat, karmelozakalcij, silicijev dioksid koloidni, hidratizirani, magnezijev stearat, laktoza hidrat, hipromeloza, makrogol 8000, titanijev dioksid, talk, željezov oksid (E172).
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.
Croatian: Da bi dodatno ispitao primjenu delamanida u različitim režimima kombiniranog liječenja kao i njegovu sigurnost, nositelj odobrenja za stavljanje lijeka u promet mora podnijeti rezultate ispitivanja „endTB (Evaluating Newly approved Drugs for multi drugresistantTB)“, randomiziranog kontroliranog ispitivanja faze III u odraslih i adolescenata s multirezistentnom tuberkulozom koje provodi Médecins Sans Frontières (MSF),
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.
Croatian: Budući da je za oba lijeka poznato da produljuju QTc-interval, od nositelja odobrenja za stavljanje lijeka u promet traži se da ažurira sažetak opisa svojstava lijeka i uputu o lijeku za delamanid te navede bedakilin kao jedan od istodobno primjenjivanih lijekova za koji je poznato da produljuje QTcinterval.
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).
Croatian: - ako uzimate išta od sljedećeg: cisaprid (za liječenje želučanih poremećaja), droperidol (koristi se protiv povraćanja i migrene), domperidon (koristi se protiv mučnine i povraćanja), difemanil (koristi se za liječenje želučanih poremećaja ili prekomjernog znojenja), probukol (snižava razinu kolesterola u krvi), levometadil ili metadon (koristi se za liječenje ovisnosti o opijatima), vinka alkaloide (lijekove protiv raka) ili arsenov trioksid (koristi se za liječenje određenih tipova leukemije).
English: • Swallowing problems
Croatian: • problemi s gutanjem
English: The complete metabolic profile of delamanid in man has not yet been fully elucidated (see sections 4.5 and 5.2).
Croatian: Kompletni metabolički profil delamanida u čovjeka još nije u potpunosti razjašnjen (vidjeti dijelove 4.5 i 5.2).
English: Effects of other medicinal products on Deltyba
Croatian: Učinci drugih lijekova na lijek Deltyba
English: The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see sections 4.4 and 5.2)
Croatian: Kompletan metabolički profil i način eliminacije delamanida još nije u potpunosti razjašnjen (vidjeti dijelove 4.4 i 5.2).
English: Herpes zoster Oropharyngeal candidiasis Tinea versicolor*
Croatian: Infekcije i infestacije herpes zoster orofaringealna kandidijaza tinea versicolor*
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment.
Croatian: Delamanid se ne preporučuje u bolesnika s umjerenim do teškim oštećenjem jetre.
English: Delamanid resistance (defined as MIC ≥ 0.2 µg/ml) has been observed at baseline in 2 of 316 patients in
Croatian: Rezistencija na delamanid (definirana kao MIC ≥ 0,2 µg/ml) opažena je na početku ispitivanja u 2 od
English: Co-administration of delamanid with quinolones
Croatian: Istovremena primjena delamanida s kinolonima
English: No cases of delamanid overdose have been observed in clinical trials.
Croatian: U kliničkim ispitivanjima nisu opaženi slučajevi predoziranja delamanidom.
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).
Croatian: U prvom ispitivanju (Ispitivanje 204), u 64/141 (45,4 %) bolesnika randomiziranih da primaju delamanid u dozi od 100 mg dvaput dnevno + OOR i u 37/125 (29,6 %) bolesnika randomiziranih da primaju placebo + OOR postigla se konverzija kulture sputuma nakon 2 mjeseca (tj.
English: Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (type A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate
Croatian: Jezgra tablete hipromelozaftalat povidon sav-rac-α-tokoferol celuloza, mikrokristalična natrijev škroboglikolat (tip A) karmelozakalcij silicijev dioksid, koloidni, hidratizirani magnezijev stearat laktoza hidrat
English: Table: Adverse drug reactions to delamanid System Organ
Croatian: Tablica: Nuspojave na delamanid Klasifikacija organskih sustava
English: • Increased blood uric acid level
Croatian: • povišena razina mokraćne kiseline u krvi
English: carbamazepine).
Croatian: vorikonazol).
English: Co-administration of moxifloxacin and delamanid in MDR-TB patients has not been studied.
Croatian: Istovremena primjena moksifloksacina i delamanida u bolesnika s MDR-TB
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).
Croatian: Deltyba je indicirana za primjenu kao sastavni dio odgovarajućeg kombiniranog režima za plućnu multirezistentnu tuberkulozu (engl. multi-drug resistant tuberculosis, MDR-TB) u odraslih bolesnika kada se djelotvoran režim liječenja ne može drugačije sastaviti zbog rezistencije ili podnošljivosti (vidjeti dijelove
English: There are no clinical data on the use of delamanid as part of combination regimens used to treat drug susceptible M. tuberculosis.
Croatian: Nema kliničkih podataka o primjeni delamanida kao sastavnog dijela kombiniranih režima za liječenje
English: • Pain in bones
Croatian: • bol u kostima
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.
Croatian: Incidencija QTcF intervala > 500 ms bila je u rasponu od 0,6 % (1/161) do 2,1 % (7/341) u bolesnika koji su primali delamanid u ukupnoj dnevnoj dozi od 200 mg naspram 0 % (0/160) do 1,2 % (2/170) bolesnika koji su primali placebo
English: - Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
Croatian: - Neuroleptike (npr. fenotiazine, sertindol, sultoprid, klorpromazin, haloperidol, mezoridazin, pimozid ili tioridazin), antidepresive.
English: • Abnormal values for blood investigations related to coagulation (prolonged APPT)
Croatian: • poremećene vrijednosti krvnih pretraga povezanih s koagulacijom (produljeno APTV; aktivirano parcijalno tromboplastinsko vrijeme)
English: • Blood in urine
Croatian: • krv u mokraći • vrućica
English: Repeat-dose toxicity studies in rabbits revealed an inhibitory effect of delamanid and/or its metabolites on vitamin K-dependent blood clotting.
Croatian: Ispitivanja toksičnosti ponovljene doze u kunića otkrile su inhibitorni učinak delamanida i/ili njegovih metabolita na zgrušavanje krvi ovisno o vitaminu K. U reproduktivnim ispitivanjima na kunićima opažena je embriofetalna toksičnost pri dozama koje su bile toksične za majku.
English: Deltyba 50 mg film-coated tablets delamanid
Croatian: Deltyba 50 mg filmom obložene tablete delamanid
English: Deltyba 50 mg film-coated tablets
Croatian: Deltyba 50 mg filmom obložene tablete
English: • Difficulties with falling or staying asleep
Croatian: • otežano uspavljivanje i održavanje sna
English: • Allergic conjunctivitis
Croatian: • regionalna bol • alergijski konjunktivitis
English: Therefore no dose adjustment is needed for patients with mild or moderate renal impairment.
Croatian: Stoga nije potrebna prilagodba doze za bolesnike s blagim ili umjerenim oštećenjem bubrega.
English: - One film-coated tablet contains 50 mg of the active substance delamanid.
Croatian: - Jedna filmom obložena tableta sadrži 50 mg djelatne tvari delamanida.
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.
Croatian: Da bi dodatno opisao farmakokinetički/farmakodinamički odnos delamanida, nositelj odobrenja za stavljanje lijeka u promet treba provesti in vitro ispitivanje pomoću HFSTB modela i podnijeti rezultate tog ispitivanja.
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).
Croatian: Nema podataka o primjeni delamanida u bolesnika s teškim oštećenjem bubrega, te se njegova primjena ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: • Muscular weakness
Croatian: • slabost u mišićima
English: Each film-coated tablet contains: 50 mg delamanid
Croatian: Jedna filmom obložena tableta sadrži: 50 mg delamanida
English: • you have liver disease or kidney disease.
Croatian: • ako imate bolest jetre ili bubrega.
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.
Croatian: Lijekovi protiv tuberkuloze U kliničkim ispitivanjima interakcija lijekova u zdravih ispitanika, delamanid je primijenjen sam (200 mg dnevno) i sa rifampicinom/izoniazidom/pirazinamidom (300/720/1800 mg dnevno) ili etambutolom (1100 mg dnevno) tijekom 15 dana.
English: • Foot, leg or ankle swelling
Croatian: • oticanje stopala, noge ili gležnja
English: Anti-HIV medicines
Croatian: Lijekovi protiv HIV-a
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Delamanid se ne preporučuje u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: It is also recommended that serum electrolytes, e.g. potassium, are obtained at baseline and corrected if abnormal.
Croatian: Također se preporučuje da se serumski elektroliti, primjerice kalij, odrede na početku liječenja, te korigiraju ako su vrijednosti poremećene.
English: • Drug use during breast feeding.
Croatian: • Upotreba lijeka tijekom dojenja.
English: Moxifloxacin is not recommended for use in patients treated with delamanid
Croatian: Primjena moksifloksacina se ne preporučuje u bolesnika liječenih delamanidom.
English: Side effects very commonly reported in clinical studies with Deltyba were:
Croatian: Nuspojave vrlo često prijavljene u kliničkim ispitivanjima s lijekom Deltyba bile su:
English: • Low blood calcium level
Croatian: • niska razina kalcija u krvi
English: How to take Deltyba
Croatian: Kako uzimati lijek Deltyba
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).
Croatian: - Serumski albumin < 2,8 g/dL (vidjeti dio 4.4 o primjeni u bolesnika sa serumskim albuminom
English: The time to SCC for the group randomised to 100 mg BID was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056).
Croatian: Također je pronađeno da je vrijeme do konverzije kulture sputuma bilo kraće u skupini randomiziranoj da prima 100 mg dvaput dnevno nego u skupini randomiziranoj da prima placebo + OOR (p = 0,0056).
English: • Increased values for blood investigations for the hormone cortisol
Croatian: • povišene vrijednosti hormona kortizola u krvnim pretragama
English: Each film-coated tablet contains 50 mg delamanid.
Croatian: Jedna filmom obložena tableta sadrži 50 mg delamanida.
English: Iron oxide yellow (E172)
Croatian: Film ovojnica hipromeloza makrogol 8000 titanijev dioksid talk željezov oksid, žuti (E172)
English: Alopecia*
Croatian: hematurija*
English: Hepatic impairment Deltyba is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and
Croatian: Deltyba se ne preporučuje u bolesnika s umjerenim do jakim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i
English: • Low blood platelets count (thrombocytopaenia)
Croatian: • nizak broj trombocita (trombocitopenija)
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).
Croatian: U kliničkim ispitivanjima interakcija lijekova u zdravih ispitanika, delamanid je primijenjen sam (100 mg dvaput dnevno) i sa tenofovirdizoproksilom (245 mg dnevno) ili lopinavirom/ritonavirom (400/100 mg dnevno) tijekom 14 dana i sa efavirenzom tijekom 10 dana (600 mg dnevno).
English: The adverse drug reactions are listed by MedDRA System Organ Class and Preferred Term.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i standardnim pojmovima.
English: Frequency common
Croatian: Učestalost često
English: • Lethargy
Croatian: • letargija
English: • Painful urination
Croatian: • bolno mokrenje
English: Paraesthesia oral Abdominal tenderness*
Croatian: Poremećaji probavnog sustava disfagija oralna parestezija osjetljivost abdomena*
English: • Problems with sleeping
Croatian: • mentalna aberacija • problemi sa spavanjem
English: Reticulocytosis
Croatian: retikulocitoza
English: In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (100 mg twice daily) and tenofovir disoproxil (245 mg daily), lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Croatian: U kliničkim ispitivanjima interakcija lijekova u zdravih ispitanika, delamanid je primijenjen sam (100 mg dvaput dnevno) i sa tenofovirdizoproksilom (245 mg dnevno), lopinavirom/ritonavirom (400/100 mg dnevno) tijekom 14 dana i sa efavirenzom tijekom 10 dana (600 mg dnevno).
English: Psychotic disorder Agitation
Croatian: Psihijatrijski poremećaji agresija deluzioni poremećaj,
English: Side effects uncommonly reported in clinical studies with Deltyba were:
Croatian: Nuspojave prijavljene manje često u kliničkim ispitivanjima s lijekom Deltyba bile su:
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
Croatian: Nema kliničkih podataka o primjeni delamanida u liječenju - izvanplućne tuberkuloze (npr. središnjeg živčanog sustava, kostiju)
English: ECG QT interval prolongation
Croatian: Produljenje QT intervala
English: - if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
Croatian: - ako uzimate lijekove za liječenje gljivičnih infekcija koji sadrže triazol (npr. flukonazol, itrakonazol,
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava leukopenija trombocitopenija anemija* eozinofilija*
English: How to store Deltyba
Croatian: Kako čuvati lijek Deltyba
English: Dehydration Hypocalcaemia Hypercholesterolaemia
Croatian: Poremećaji metabolizma i prehrane dehidracija hipokalcemija hiperkolesterolemija hipertrigliceridemija hipokalemija smanjen apetit hiperuricemija*
English: Package leaflet: Information for the patient Deltyba 50 mg film-coated tablets delamanid This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku:Informacije za bolesnika Deltyba 50 mg filmom obložene tablete delamanid
English: Hypertension Hypotension Haematoma* Hot flush*
Croatian: Krvožilni poremećaji hipertenzija hipotenzija hematom*
English: Constipation* Abdominal pain Abdominal pain lower Dyspepsia
Croatian: gastritis* konstipacija* bol u abdomenu bol u donjem dijelu abdomena dispepsija nelagoda u abdomenu povraćanje proljev*
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).
Croatian: 45% nakon 15 dana istodobne primjene jakog induktora citokroma P450 (CYP) 3A4 (Rifampicin 300 mg dnevno) s delamanidom (200 mg dnevno).
English: • Increased blood tryglycerides
Croatian: • povišeni trigliceridi u krvi
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove:
English: Oropharyngeal pain Throat irritation Dry throat* Rhinorrhoea*
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja kašalj orofaringealna bol iritacija grla suho grlo* rinoreja*
English: Susceptibility testing breakpoints
Croatian: Testiranje granične koncentracije osjetljivosti
English: • Hot flushes
Croatian: • navale vrućine
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji bubrega i mokraćnog retencija mokraće dizurija*
English: • Reduced sensation
Croatian: • smanjen osjet
English: • Drug- resistance
Croatian: • Rezistenciju na lijek
English: The PRAC noted the recurrent concomitant use of delamanid with bedaquiline in patients experiencing QTc prolongation.
Croatian: PRAC je zabilježio rekurentnu istodobnu primjenu delamanida s bedakilinom u bolesnika s produljenjem
English: No dose adjustment is considered necessary in patients with mild or moderate renal impairment.
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: Tablet core
Croatian: sustava nokturija
English: Rash maculo-papular* Rash*
Croatian: pruritus* makulopapulozni osip* osip* akne hiperhidroza
English: Tinnitus
Croatian: astenija
English: • SmPC
Croatian: • omaglica
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.
Croatian: - Anamneza simptomatskih srčanih aritmija ili klinički relevantna bradikardija.
English: Eosinophilic pustular folliculitis* Pruritus generalised* Rash erythematous
Croatian: Poremećaji kože i potkožnog tkiva alopecija* eozinofilni pustularni folikulitis* generalizirani pruritus* eritematozni osip dermatitis urtikarija pruritični osip*
English: Abdominal pain upper
Croatian: mučnina bol u gornjem dijelu abdomena
English: • Drowsiness
Croatian: • omamljenost
English: Tel: +39 (0)2 00632710
Croatian: Otsuka Pharmaceutical Italy S.r.l. Tel: +39 (0)2 00632710
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije upotrebe pročitajte uputu o lijeku.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta bol u uhu tinitus
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).
Croatian: Obavijestite svog liječnika... - ako uzimate ili ste nedavno uzimali ili biste mogli uzimati druge lijekove uključujući lijekove ili biljne lijekove dobivene bez recepta,
English: Feeling hot
Croatian: navala vrućine*
English: Anti-Tuberculosis medicines
Croatian: FARMACEUTSKI PODACI
English: • Decreased values for blood investigations for the hormone cortisol
Croatian: • smanjene vrijednosti hormona kortizola u krvnim pretragama • povišeni krvni tlak
English: Osteochondrosis Muscular weakness Musculoskeletal pain* Flank pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva osteohondroza mišićna slabost bol u mišićno-koštanom sustavu* bol u slabinama bol u ekstremitetima artralgija* mialgija*
English: Haemoptysis
Croatian: hemoptiza
English: Side effects commonly reported in clinical studies with Deltyba were:
Croatian: Nuspojave često prijavljene u kliničkim ispitivanjima s lijekom Deltyba bile su: • anemija
English: • Acne
Croatian: • osip • akne
English: No dose adjustment is considered necessary in patients with mild hepatic impairment.
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem funkcije jetre.
English: • Stomach pain
Croatian: • herpes zoster