FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selectivenoradrenaline reuptake inhibitors, SNRI),
English: • abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk
Slovenian: • neobičajna menstruacija, vključno z močno, bolečo, neredno ali podaljšano menstruacijo, neobičajna blaga ali spuščena menstruacija, nenormalno nastajanje mleka v dojkah pri moških in ženskah • prekomerna krvavitev iz nožnice kmalu po porodu (poporodna krvavitev)
English: Suicidal behaviour5,6
Slovenian: konvulzije1,6
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies.
Slovenian: Pri bolnicah, ki jemljejo sredstva proti strjevanju krvi in/ali druga zdravila, za katera je znano, da vplivajo na delovanje trombocitov (npr. nesteroidne protivnetne učinkovine (NSAID) ali acetilsalicilna kislina
English: Česká republika Eli Lilly ČR, s.r.o.
Slovenian: Eli Lilly ČR, s.r.o.
English: Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily.
Slovenian: Nekaterim bolnicam lahko koristi začetno zdravljenje z odmerkom 20 mg dvakrat na dan za dva tedna pred zvišanjem na priporočeni odmerek 40 mg dvakrat na dan. Zviševanje odmerka lahko zmanjša, vendar ne odpravi tveganje za slabost in omotico.
English: YENTREVE with food, drink and alcohol
Slovenian: Zdravilo YENTREVE skupaj s hrano, pijačo in z alkoholom Zdravilo YENTREVE lahko vzamete s hrano ali brez nje.
English: Muscle spasm
Slovenian: propilenglikol šelak
English: If while on YENTREVE therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Slovenian: se je treba posvetovati s specialistom, depresija je namreč resno bolezensko stanje.
English: Eli Lilly Benelux S.A./N.V.
Slovenian: België/Belgique/Belgien S.A. Eli Lilly N.V.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastroresistant capsules)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU (20 mg trde gastrorezistentne kapsule)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence.
Slovenian: YENTREVE za vse skupine pediatrične populacije pri zdravljenju stresne urinske inkontinence.
English: Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE prescribed by your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila YENTREVE, kot bi smeli Če vzamete večjo količino zdravila YENTREVE, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
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.
Slovenian: definirano tako v randomiziranih preskušanjih kot tistih z IEF < 14 na teden, niso dokazali.
English: However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea).
Slovenian: Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih in so minili v
English: If you get any side effects, talk to your doctor of pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastroresistant capsules)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU (40 mg trde gastrorezistentne kapsule)
English: • diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided.
Slovenian: • bolečine zaradi diabetične nevropatije, depresije, anksioznosti in urinske inkontinence
English: YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
Slovenian: YENTREVE 20 mg trde gastrorezistentne kapsule duloksetin
English: YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
Slovenian: YENTREVE 40 mg trde gastrorezistentne kapsule duloksetin
English: • low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
Slovenian: oslabelosti, zmedenosti, zaspanosti ali močne utrujenosti, slabost; resnejši simptomi so lahko omedlevica, epileptični napad ali padci), sindrom nezadostnega izločanja antidiuretičnega hormona (SIADH - syndrome of inadequate secretion of anti-diuretic hormone)
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
Slovenian: • serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), epileptični napadi, nenadni nehoteni gibi mišic ali mišično trzanje, občutek nemira ali nezmožnosti sedenja ali stanja pri miru, težave z nadziranjem gibov, npr. slaba koordinacija ali nehoteni gibi mišic, sindrom nemirnih nog
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina napetost mišic mišični krč trizem trzanje mišic
English: How to store YENTREVE Keep this medicine out of the sight and reach of children.
Slovenian: SHRANJEVANJE ZDRAVILA YENTREVE Zdravilo shranjujte nedosegljivo otrokom!
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).
Slovenian: denimo, klomipraminom ali amitriptilinom, z MAOI, denimo moklobemidom ali linezolidom, s šentjanževko (Hypericum perforatum), triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost (glejte poglavje 4.4).
English: • dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Slovenian: • zvišan tlak v očesu (glavkom) • omotica, občutek omotičnosti ali omedlevice ob prehitrem vstajanju, občutek mraza v prstih in/ali prstih na nogah • napeto grlo, krvavitve iz nosu
English: YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules
Slovenian: YENTREVE 20 mg trde gastrorezistentne kapsule YENTREVE 40 mg trde gastrorezistentne kapsule
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni laringitis
English: Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 20 ali 40 mg duloksetina (v obliki klorida).
English: • muscle twitching
Slovenian: • mišično trzanje
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: S svojim zdravnikom preverite,
English: Edible ink:
Slovenian: Okvarjeno delovanje ledvic:
English: YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Slovenian: Neprozorno oranžno telo z vtisnjenim napisom ‘40 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9545'.
English: YENTREVE contains sucrose
Slovenian: Zdravilo YENTREVE vsebuje saharozo
English: Incontinence Episode Frequency: In all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group.
Slovenian: 50 % ali večje mediano znižanje IEF v primerjavi s 33 % v skupini, ki je prejemala placebo.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
Slovenian: YENTREVE 20 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
English: • weight loss, weight gain
Slovenian: • izguba telesne mase, zvečanje telesne mase
English: Black iron oxide - synthetic (E172) Propylene glycol
Slovenian: Užitno črnilo: črni železov oksid - sintetični (E172)
English: YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Slovenian: Neprozorno oranžno telo z vtisnjenim napisom ‘20 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9544'.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 40 MG TRDE GASTROREZISTENTNE KAPSULE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 20 MG TRDE GASTROREZISTENTNE KAPSULE
English: EU/1/04/280/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/280/006
English: The active substance is duloxetine.
Slovenian: Kaj vsebuje zdravilo YENTREVE Učinkovina je duloksetin.
English: Eli Lilly Danmark A/S Tlf: +45 45 26 60 00
Slovenian: Eli Lilly Danmark A/S, Útibú á Íslandi Tel: + 354 520 34 00
English: YENTREVE contains sucrose.
Slovenian: Zdravilo YENTREVE vsebuje saharozo.
English: Hepatic impairment
Slovenian: ušesna bolečina
English: Laryngitis
Slovenian: trietilcitrat
English: Gynaecological haemorrhage Menopausal symptoms
Slovenian: Motnje reprodukcije in dojk ginekološka krvavitev menopavzalni simptomi motnje menstruacije galaktoreja hiperprolaktinemija
English: What you need to know before you take YENTREVE DO NOT take YENTREVE if you:
Slovenian: Pred jemanjem zdravila YENTREVE se posvetujte s svojim zdravnikom, če:
English: Adverse reactions may be more common during concomitant use of YENTREVE and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila YENTREVE in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: Diarrhoea Abdominal pain Vomiting Dyspepsia
Slovenian: Bolezni imunskega sistema preobčutljivost anafilaktična reakcija
English: EU/1/04/280/001 (56 hard gastro-resistant capsules) EU/1/04/280/007 (28 hard gastro-resistant capsules) EU/1/04/280/008 (98 hard gastro-resistant capsules)
Slovenian: EU/1/04/280/008 (98 trdih gastrorezistentnih kapsul)
English: Each capsule contains 40 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 40 mg duloksetina (v obliki klorida).
English: YENTREVE is a hard gastro-resistant capsule.
Slovenian: Izgled zdravila YENTREVE in vsebina pakiranja Zdravilo YENTREVE je trda gastrorezistentna kapsula.
English: • chest pain, feeling cold, thirst, feeling hot
Slovenian: • neobičajna vaginalna krvavitev, menopavzalni simptomi • bolečina v prsnem košu, občutek mraza, žeja, občutek vročine
English: Each capsule contains 20 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 20 mg duloksetina (v obliki klorida).
English: • diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion
Slovenian: • driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava • povečano znojenje
English: Dermatitis contact Cold sweat Increased tendency to bruise
Slovenian: Bolezni kože in podkožja povečano znojenje izpuščaj povečano nočno znojenje urtikarija kontaktni dermatitis hladen znoj nagnjenje k modricam
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2).
Slovenian: V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila
English: Asthenia Chills
Slovenian: KLINIČNI PODATKI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. avgust 2004
English: Extra-pyramidal symptoms6
Slovenian: psihomotorični nemir6 ekstrapiramidni simptomi6 diskinezija sindrom nemirnih nog
English: Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis
Slovenian: Bolezni prebavil navzea suha usta zaprtje driska bolečina v trebuhu bruhanje dispepsija gastrointestinalna krvavitev7 gastroenteritis stomatitis kolcanje gastritis disfagija napenjanje slab zadah hematohezija mikroskopski kolitis9
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov) • vnetje grla, ki povzroči hripav glas
English: Agitation
Slovenian: • utrujenost
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips
Slovenian: Redki neželeni učinki (se lahko pojavijo pri največ 1 od 1.000 bolnikov) • resne alergične reakcije, ki povzročajo težave pri dihanju ali omotico z oteklim jezikom ali ustnicami
English: Feeling abnormal Feeling cold Thirst
Slovenian: neobičajno počutje občutek mraza žeja bolehnost občutek vročine motnja hoje poporodna krvavitev6
English: YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
Slovenian: NAVODILO ZA UPORABO YENTREVE 40 mg trde gastrorezistentne kapsule YENTREVE 20 mg trde gastrorezistentne kapsule duloksetin (v obliki klorida)
English: Caution is advised if YENTREVE is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Slovenian: triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin)
English: Throat tightness Epistaxis Interstitial lung disease10
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zehanje stisnjeno grlo epistaksa intersticijska bolezen pljuč10
English: Vascular disorders
Slovenian: Okvarjeno delovanje jeter
English: SIADH6
Slovenian: Tako CYP2D6
English: Pollakiuria Urine odour abnormal
Slovenian: Bolezni sečil odlašanje uriniranja disurija nokturija polakiurija nenormalen vonj urina zastajanje urina6 poliurija slabši curek urina
English: • falls (mostly in elderly people), abnormal gait
Slovenian: • nizka raven natrija v krvi (predvsem pri starejših; simptomi so lahko občutek vrtoglavice,
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Slovenian: Tel: + 31(0)30 6025800
English: Blurred vision Mydriasis Visual impairment
Slovenian: Očesne bolezni zamegljen vid midriaza okvara vida suho oko glavkom
English: 56 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 98 trdnih gastrorezistentnih kapsul
English: 64331 Weiterstadt Germany
Slovenian: 64331 Weiterstadt Nemčija
English: Overall summary of the scientific evaluation of Norsed Combi D and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Norsed Combi D in z njim povezanih imen (glejte Prilogo I)
English: Scientific conclusions and grounds for positive opinion
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE
English: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine France
Slovenian: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Francija
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicants and marketing authorisation holder in the Member States
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exceptional cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”.
Slovenian: V skladu s Smernico CHMP za kombinirana zdravila so „kombinirana pakiranja sprejemljiva le v izjemnih primerih, ko obstajajo jasne koristi za javno zdravje zaradi režima zdravljenja in/ali upoštevanja navodil, če upoštevamo zahtevane utemeljitve v 5. poglavju omenjene smernice“.
English: The Applicant submitted an application for mutual recognition of the marketing authorisation granted by Sweden in 2006 for Norsed Combi D, a combination product consisting of risedronate sodium 35 mg film-coated tablets together with 1000 mg calcium carbonate and 880 IU colecalciferol effervescent granules.
Slovenian: Predlagatelj je predložil vlogo za postopek z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je odobrila Švedska leta 2006 za zdravilo Norsed Combi D, kombinirano zdravilo iz risedronat natrija 35 mg filmsko obložene tablete in 1000 mg kalcijevega karbonata ter 880 i.e. holekalciferola šumeča zrnca.
English: The objecting CMS considered the benefit-risk balance of Norsed Combi D to be unfavourable and presented specific points for objection to the application.
Slovenian: Nasprotujoča zadevna država članica je upoštevala, da je razmerje koristi in tveganj za zdravilo Norsed Combi D neugodno ter predstavila specifične zadržke do vloge.
English: • the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Norsed Combi D and associated names (see Annex I).
Slovenian: CHMP je priporočil odobritev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku koordinacijske skupine in navedenim v Prilogi III za zdravilo Norsed Combi D in povezanih imen (glejte Prilogo I).
English: Italy sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan Italy
Slovenian: viale Luigi Bodio, 37/B 20158 Milan Italija
English: Sweden sanofi-aventis S.p.A. Viale Luigi Bodio, 37/b 20158 Milano Italy
Slovenian: Viale Luigi Bodio, 37/b 20158 Milano Italija
English: Adopted at the 7-10 September 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 7. in 10. septembrom 2015
English: What you need to know before you <take> <use> X:
Slovenian: Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X:
English: EMA/PRAC/590265/2015
Slovenian: EMA/PRAC/618068/2015 Corr1
English: Possible side effects Tell your doctor immediately if you experience:
Slovenian: Možni neželeni učinki Nemudoma obvestite svojega zdravnika, če opazite:
English: Frequency ‘not known': pulmonary hypertension
Slovenian: Pogostost »neznana«:: pljučna 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)
Slovenian: Bisfosfonati (alendronska kislina; alendronska kislina, holekalciferol; klodronska kislina; etidronska kislina; ibandronska kislina; neridronska kislina; pamidronska kislina; risedronska kislina; tiludronska kislina; zoledronska kislina) - Osteonekroza zunanjega slušnega kanala (EPITT št. 18256)
English: Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Slovenian: Poglavje 4.8 - Neželeni učinki: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Slovenian: Pljučni simptomi, npr. kašelj in dispneja, so lahko razlog za prekinitev zdravljenja in nadaljnjo preiskavo, če je to potrebno.
English: - a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
Slovenian: - kašelj ali oteženo dihanje, ki lahko nakazujeta težave s pljuči vnetje pljuč (intersticijska bolezen pljuč ali pljučna hipertenzija);
English: Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Slovenian: Poglavje 4.8 Zelo redki: Osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov).
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.
Slovenian: Alel HLA-DRB1*04:03 (razmerje obetov za dovzetnost za IAS: 1,6) je prisoten zlasti pri belcih, z večjo razširjenostjo v južni Evropi kot v severni, alel HLA-DRB1*04:06 (razmerje obetov za dovzetnost za IAS: 56,6) pa je zlasti prisoten pri japonskih in korejskih bolnikih.
English: The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Slovenian: Tveganje za njen njun pojav je lahko povečano pri bolnikih z anamnezo intersticijske bolezni pljuč.
English: IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
Slovenian: IAS je treba upoštevati pri diferencialni diagnozi spontane hipoglikemije pri bolnikih, ki uporabljajo tioktično kislino (glejte poglavje 4.8).
English: Leflunomide - Pulmonary hypertension (EPITT no 18221)
Slovenian: Leflunomid1 - Pljučna hipertenzija (EPITT št. 18221)
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: • V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.
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.
Slovenian: Bolniki z določenim genotipom humanega levkocitnega antigena (ki je pogostejši pri japonskih in korejskih bolnikih, vendar je prisoten tudi pri belcih) so bolj dovzetni za nastanek insulinskega avtoimunega sindroma (motnja hormonov za uravnavanje glukoze v krvi z izrazitim znižanjem koncentracije sladkorja v krvi) med zdravljenjem s tioktično kislino.
English: Frequency unknown: insulin autoimmune syndrome (see section 4.4)
Slovenian: Neznana pogostnost: insulinski avtoimuni sindrom (glejte poglavje 4.4)
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.
Slovenian: Bolniki z genotipom humanega levkocitnega antigena, kot sta alela HLA-DRB1*04:06 in HLA-DRB1*04:03, so bolj dovzetni za nastanek IAS med zdravljenjem s tioktično kislino.
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Slovenian: Neznana pogostnost: Motnja hormonov za uravnavanje glukoze v krvi z izrazitim znižanjem koncentracije sladkorja v krvi (insulinski avtoimuni sindrom).