FrancophonIA/ELRC3.0 huggingface dataset:
English: • excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
Croatian: • prekomjerno vaginalno krvarenje ubrzo nakon poroda (poslijeporođajno krvarenje) • padovi (najčešće u starijih ljudi), poremećen hod.
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Croatian: Hrana odgađa vrijeme do postizanja vršne koncentracije sa 6
English: The 40 mg capsules are orange and blue and are printed with '40 mg' and the code ‘9545'.
Croatian: Kapsule od 40 mg su narančaste i plave boje s otisnutom oznakom „40 mg“ i oznakom „9545“.
English: 56 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Croatian: 56 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
English: Caution is advisable if YENTREVE is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Croatian: YENTREVE primjenjuje istodobno sa serotoninergičkim lijekovima poput SSRI-ja, SNRI-ja, tricikličkih antidepresiva poput klomipramina ili amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
English: The 20 mg capsules are blue and are printed with '20 mg' and the code ‘9544'.
Croatian: Kapsule od 20 mg su plave boje s otisnutom oznakom „20 mg“ i oznakom „9544“.
English: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Croatian: Podaci o farmakokinetici duloksetina u bolesnica s blagim ili umjerenim oštećenjem bubrežne funkcije su ograničeni.
English: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),
Croatian: • zatajenje jetre, žutilo kože ili bjeloočnica (žutica) • Stevens-Johnsonov sindrom (ozbiljna bolest sa stvaranjem mjehurića na koži, ustima, očima i genitalijama), ozbiljna alergijska reakcija koja uzrokuje oticanje lica ili grla (angioedem),
English: The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
Croatian: Djelotvornost lijeka YENTREVE dodatno se pospješuje u kombinaciji s programom vježbi za jačanje mišića donjeg dijela zdjelice.
English: Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Croatian: Apsorpcija: duloksetin se nakon peroralne primjene dobro apsorbira, pri čemu se Cmax postiže
English: Feeling abnormal Feeling cold Thirst
Croatian: neuobičajeno osjećanje osjećaj hladnoće žeđ malaksalost osjećaj vrućine smetnje hoda
English: • suicidal behaviour, suicidal thoughts, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
Croatian: • samoubilačko ponašanje, samoubilačke misli, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes • "serotoninski sindrom" (rijetka reakcija koja može uzrokovati osjećaj velike sreće,
English: • weakness, shivering
Croatian: • slabost, drhtanje
English: Black iron oxide - synthetic (E172) Propylene glycol
Croatian: Jestiva tinta: željezov oksid, crni - sintetski (E172) propilenglikol šelak
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštana bol stezanje mišića spazam mišića trizmus trzanje mišića
English: The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Croatian: Klinička korist lijeka YENTREVE u usporedbi s placebom nije pokazana u žena s blagom
English: • muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle
Croatian: • bol u mišićima, stezanje mišića, grčevi mišića, stezanje mišića čeljusti
English: EU/1/04/280/002(28 hard gastro-resistant capsules) EU/1/04/280/003 (56 hard gastro-resistant capsules) EU/1/04/280/004 (98 hard gastro-resistant capsules) EU/1/04/280/005 (140 hard gastro-resistant capsules)
Croatian: EU/1/04/280/004 (98 tvrdih želučanootpornih kapsula) EU/1/04/280/005 (140 tvrdih želučanootpornih kapsula)
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Croatian: • smanjena aktivnost štitnjače koja može uzrokovati umor ili dobivanje na tjelesnoj težini
English: It is recommended that consideration be given to concomitant PFMT.
Croatian: Preporučuje se razmotriti istodobno uvođenje programa jačanja mišića donjeg dijela zdjelice.
English: The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
Croatian: U placebom kontroliranim ispitivanjima djelotvornost lijeka YENTREVE nije ocijenjena za razdoblje dulje od 3 mjeseca.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Croatian: Farmakokinetika duloksetina pokazuje veliku interindividualnu varijabilnost (općenito 50-60%),
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Croatian: Oštećenje bubrežne funkcije U bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koje su na hemodijalizi koncentracije duloksetina u plazmi su povećane.
English: • abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk
Croatian: • nenormalne mjesečnice, uključujući obilne, bolne, neredovite ili produljene mjesečnice,
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Croatian: Najčešće prijavljene reakcije su omaglica, senzorni poremećaji (uključujući paresteziju ili osjete nalik elektrošoku, osobito u glavi), poremećaji spavanja (uključujući nesanicu i intenzivne snove), umor, somnolencija, agitacija ili anksioznost, mučnina i/ili povraćanje, tremor, glavobolja,
English: • difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased urine flow
Croatian: • otežano ili nemogućnost mokrenja, pojačana potreba za mokrenjem, smanjen protok mokraće
English: Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Croatian: Epidemiološki podaci pokazali su da primjena SSRI-a u trudnoći, osobito u visokom stupnju trudnoće,
English: No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
Croatian: U drugom ispitivanju u kojem se ispitivala viša doza različite soli duloksetina nisu uočene malformacije.
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Croatian: Za bolesnice s teškim oštećenjem bubrežne funkcije vidjeti dio 4.3. Vidjeti dio 4.2 za informacije o bolesnicama s blagim ili umjerenim poremećajem bubrežne funkcije.
English: YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
Croatian: YENTREVE 20 mg tvrde želučanootporne kapsule duloksetin
English: YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Croatian: Neprozirno tijelo plave boje s otisnutom oznakom „20 mg“ i neprozirna plava kapica s otisnutom oznakom „9544“.
English: YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
Croatian: YENTREVE 40 mg tvrde želučanootporne kapsule duloksetin
English: Orthostatic hypotension2 Peripheral coldness
Croatian: hipertenzivna kriza3 ortostatska hipotenzija2
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Red iron oxide (E172) Yellow iron oxide (E172) Edible black ink
Croatian: YENTREVE 40 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, crveni (E172) željezov oksid, žuti (E172) crna tinta, jestiva
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with YENTREVE (see section 4.4).
Croatian: inhibitor i ne smije se davati bolesnicima koji se liječe lijekom YENTREVE (vidjeti dio 4.4).
English: YENTREVE and Prior Continence Surgery: There are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
Croatian: YENTREVE nisu umanjene u žena sa stresnom urinarnom inkontinencijom koje su prethodno bile podvrgnute kirurškom liječenju inkontinencije.
English: Stevens-Johnson Syndrome6
Croatian: Stevens-Johnsonov sindrom6 angioneurotski edem6 reakcije fotoosjetljivosti kutani vaskulitis
English: Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
Croatian: INR-a kada se duloksetin primjenjivao istodobno u bolesnica liječenih varfarinom.
English: Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Croatian: hemoperfuzija i izmjena perfuzijom (peritonealna dijaliza) vjerojatno ne bi bile korisne.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
Croatian: YENTREVE 20 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) crna tinta, jestiva
English: Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 20 ili 40 mg duloksetina (u obliku duloksetinklorida).
English: YENTREVE contains the active substance duloxetine.
Croatian: Što je YENTREVE i za što se koristi YENTREVE sadrži djelatnu tvar duloksetin.
English: • diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion
Croatian: • proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe
English: Urine flow decreased
Croatian: poliurija smanjen protok mokraće
English: Hyperglycaemia (reported especially in diabetic patients) Hyponatraemia
Croatian: Poremećaji metabolizma i prehrane smanjen apetit dehidracija hiperglikemija (prijavljena posebno u bolesnica sa šećernom bolešću)
English: YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Croatian: Neprozirno tijelo narančaste boje s otisnutom oznakom „40 mg“ i neprozirna plava kapica s otisnutom oznakom „9545“.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV YENTREVE 20 mg
English: YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules
Croatian: YENTREVE 20 mg tvrde želučanootporne kapsule YENTREVE 40 mg tvrde želučanootporne kapsule
English: 8 Falls were more common in the elderly (≥65 years old).
Croatian: Padovi su bili češći u starijih osoba (≥ 65 godina starosti) 9 Učestalost procijenjena na temelju svih podataka iz kliničkih ispitivanja.
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Croatian: Kod primjene selektivnih inhibitora ponovne pohrane serotonina (SSRI) i inhibitora ponovne pohrane serotonina i noradrenalina (SNRI), uključujući duloksetin, bilo je izvješća o abnormalnim krvarenjima,
English: YENTREVE is for oral use.
Croatian: YENTREVE se uzima kroz usta.
English: Asthenia Chills
Croatian: KLINIČKI PODACI
English: Eli Lilly Norge A.S Tlf: +47 22 88 18 00
Croatian: Tlf: +47 22 88 18 00
English: EU/1/04/280/006
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/280/006
English: - are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and YENTREVE') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Croatian: − ako uzimate ili ste unutar zadnjih 14 dana uzimali drugi lijek koji je poznat kao inhibitor monoaminooksidaze (MAOI) (pogledajte „Drugi lijekovi i YENTREVE“)
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Croatian: Istodobna primjena duloksetina (40 mg dvaput dnevno) povećava AUC tolterodina (2 mg dvaput dnevno) u stanju dinamičke ravnoteže za
English: Do not take more than the daily amount of YENTREVE that has been prescribed for you in one day.
Croatian: Nemojte u jednome danu uzeti više od propisane dnevne doze lijeka YENTREVE.
English: Skin and subcutaneous tissue disorders Sweating increased
Croatian: Poremećaji kože i potkožnog tkiva pojačano znojenje osip noćno znojenje urtikarija kontaktni dermatitis hladan znoj povećana sklonost stvaranju modrica
English: Diarrhoea Abdominal pain Vomiting Dyspepsia
Croatian: Poremećaji imunološkog sustava poremećaj preosjetljivosti anafilaktička reakcija
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u najviše 1 na 10 osoba):
English: Each capsule contains 40 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 40 mg duloksetina (u obliku duloksetinklorida).
English: How to store YENTREVE Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: Each capsule contains 20 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 20 mg duloksetina (u obliku duloksetinklorida).
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Croatian: Znakovi i simptomi predoziranja (samim duloksetinom ili u kombinaciji s drugim lijekovima) uključivali su somnolenciju,
English: Eructation Gastritis Dysphagia Flatulence Breath odour
Croatian: Poremećaji probavnog sustava mučnina suha usta konstipacija proljev bol u abdomenu povraćanje dispepsija gastrointestinalno krvarenje7 gastroenteritis stomatitis podrigivanje gastritis disfagija flatulencija zadah iz usta
English: Hypertension3,7 Flushing
Croatian: Krvožilni poremećaji hipertenzija3,7 crvenilo uz osjećaj vrućine sinkopa2 povišeni krvni tlak3
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Croatian: poremećaji spavanja (živopisni snovi, noćne more, nemogućnost spavanja), umor, pospanost, osjećaj nemira ili uznemirenosti, osjećaj tjeskobe, mučnina ili povraćanje, nevoljno drhtanje
English: Blurred vision Mydriasis Visual impairment
Croatian: Poremećaji oka zamućen vid midrijaza poremećaj vida suho oko glaukom
English: Clinical efficacy and safety
Croatian: UČINKOVITU PRIMJENU LIJEKA
English: • muscle twitching
Croatian: • trzanje mišića
English: • feeling sick (nausea), dry mouth, constipation • fatigue
Croatian: • mučnina, suha usta, zatvor
English: • throat tightness, nose bleeds
Croatian: • stezanje u grlu, krvarenja iz nosa
English: YENTREVE 20 mg hard gastro-resistant capsules.
Croatian: (20 mg tvrde želučanootporne kapsule)
English: Tremor
Croatian: OBLIK
English: YENTREVE 40 mg hard gastro-resistant capsules.
Croatian: KUTIJE ZA 40 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: Sugar spheres
Croatian: Gospina trava
English: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Croatian: Na temelju ispitivanja provedenom na 6 bolesnica u laktaciji koje nisu dojile svoju djecu pokazalo se da se duloksetin u majčino mlijeko izlučuje u vrlo maloj mjeri.
English: YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
Croatian: YENTREVE 40 mg tvrde želučanootporne kapsule YENTREVE 20 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
English: Eli Lilly Ges.m.b.H.
Croatian: Eli Lilly Norge A.S
English: Feeling hot
Croatian: periferna hladnoća
English: If you get any side effects, talk to your doctor of pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Dyskinesia Restless legs syndrome
Croatian: Antibiotik linezolid je reverzibilan neselektivan MAO
English: Gynaecological haemorrhage Menopausal symptoms
Croatian: Poremećaji reproduktivnog sustava i dojki ginekološko krvarenje simptomi menopauze menstrualni poremećaj galaktoreja hiperprolaktinemija poslijeporođajno krvarenje6
English: Haemorrhage
Croatian: • umor
English: Respiratory, thoracic and mediastinal disorders Yawning
Croatian: poput ekhimoza, purpure i gastrointestinalnih krvarenja.
English: Very rare
Croatian: Vrlo rijetko:
English: EMA/PRAC/590265/2015
Croatian: EMA/PRAC/618057/2015 Corr1
English: What you need to know before you <take> <use> X:
Croatian: Dio 2: Što morate znati prije nego počnete <uzimati> <primjenjivati> X
English: Adopted at the 7-10 September 2015 PRAC
Croatian: Usvojeno na sjednici PRAC-a 7. - 10. rujna 2015.
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: • Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: Section 4.4
Croatian: Dio 4.4:
English: Possible side effects Tell your doctor immediately if you experience:
Croatian: Dio 4.: Moguće nuspojave Odmah obavijestite svog liječniku u slučaju:
English: Frequency ‘not known': pulmonary hypertension
Croatian: Učestalost „nepoznato": plućna hipertenzija
English: Bisphosphonates (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - Osteonecrosis of the external auditory canal (EPITT no 18256)
Croatian: Bisfosfonati (alendronatna kiselina; alendronatna kiselina, kolekalciferol; klodronatna kiselina; etidronatna kiselina; ibandronatna kiselina; neridronatna kiselina; pamidronatna kiselina; risedronatna kiselina; tiludronatna kiselina; zoledronatna kiselina) - osteonekroza vanjskog slušnog kanala (EPITT br. 18256)
English: HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
Croatian: HLA-DRB1*04:03 alel (omjer izgleda podložnosti prema IAS: 1,6) posebno je prisutan u bijelaca, s većom prevalencijom na jugu u odnosu na sjever Europe i HLA-DRB1*04:06 alel (omjer izgleda podložnosti prema IAS: 56,6) posebno je prisutan u japanskih i korejskih bolesnika.
English: Leflunomide - Pulmonary hypertension (EPITT no 18221)
Croatian: Leflunomid1 - plućna hipertenzija (EPITT br. 18221)
English: - a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
Croatian: - kašlja ili problema s disanjem, jer to može upućivati na upalu probleme s plućima (intersticijska plućna bolest ili plućna hipertenzija),
English: Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Croatian: Učestalost „manje često": Slučajevi sumnje na sindrom kapilarnog curenja prijavljeni su s trabektedinom.
English: IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
Croatian: IAS je potrebno uzeti u obzir u diferencijalnoj dijagnozi spontane hipoglikemije u bolesnika koji koriste tioktatnu kiselinu (vidjeti dio 4.8.).
English: Patients with a certain human leukocyte antigen genotype (which is more frequent in Japanese and Korean patients, but is also found in Caucasians) are more prone to development of insulin autoimmune syndrome (disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels) when treated with thioctic acid.
Croatian: Bolesnisi s određenim genotipom humanog leukocitnog antigena (koji je češće prisutan u japanskih i korejskih bolesnika, no prisutan je i u bijelaca) podložniji su razvitku autoimunog inzulinskog sindroma (poremećaj hormona koji reguliraju glukozu u krvi sa značajnim sniženjem koncentracije šećera u krvi) kada se liječe tioktatnom kiselinom.
English: Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with thioctic acid.
Croatian: Insulin Autoimmune Syndrome, IAS) prijavljeni su tijekom liječenja tioktatnom kiselinom.
English: The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Croatian: Rizik od njezine njihove pojave može biti povećan je u bolesnika s intersticijskom plućnom bolesti u anamnezi.
English: Patients with human leukocyte antigen genotype such as HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles, are more susceptible to develop IAS when treated with thioctic acid.
Croatian: Bolesnici s genotipom humanog leukocitnog antigena poput HLA-DRB1*04:06 i HLA-DRB1*04:03 alela, podložniji su razvitku IAS-a kada se liječe tioktatnom kiselinom.
English: Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Croatian: Vrlo rijetko: Osteonekroza vanjskog slušnog kanala (nuspojava razreda bisfosfonata).
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Croatian: Nepoznata učestalost: Poremećaj hormona koji reguliraju glukozu u krvi sa značajnim sniženjem koncentracije šećera u krvi (autoimuni inzulinski sindrom).
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Croatian: Za vrijeme liječenja leflunomidom zabilježena je intersticijska plućna bolest, kao i rijetki slučajevi plućne hipertenzije (vidjeti dio 4.8.).
English: Frequency unknown: insulin autoimmune syndrome (see section 4.4)
Croatian: Učestalost nije poznata: autoimuni inzulinski sindrom (vidjeti dio 4.4.).
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility [...] may also occur with an unknown frequency.
Croatian: Također se mogu javiti druge nuspojave, poput zatajenja bubrega, smanjene koncentracije mokraćne kiseline u krvi, plućne hipertenzije, muške neplodnosti [...], ali je njihova učestalost nepoznata.
English: Trabectedin - Capillary leak syndrome (EPITT no 18115)
Croatian: Trabektedin - Sindrom kapilarnog curenja (EPITT br.
English: Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi
English: Thioctic acid - Insulin autoimmune syndrome (EPITT no
Croatian: Tioktatna kiselina - autoimuni inzulinski sindrom (EPITT br. 18406)