FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Maltese: It-tagħrif farmakokinetiku fuq duloxetine huwa limitat f'pazjenti b'indeboliment renali ta' grad ħafif jew wieħed moderat.
English: Eli Lilly Sweden AB Tel: + 46-(0)8 7378800
Maltese: Tel: + 46-(0)8 7378800
English: Nocturia
Maltese: Stitikezza
English: The data analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse events typically occurred in the first week of therapy.
Maltese: ikkontrollati bil-plaċebo f'pazjenti b'SUI, li kienu jikkonsistu f'958 pazjent ikkurat b'duloxetine u f'955 pazjent ikkurat bil-plaċebo, urew li ġeneralment ir-reazzjonijiet avversi li kienu rrapportati jibdew fl-ewwel ġimgħa ta' terapija.
English: In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle.
Maltese: Fl-istudji fuq l-annimali, livelli ogħla ta' 5-HT u NA fil-kordun ċentrali nervuż sagro-spinali, iwasslu għall-żieda fis-saħħa muskolari uretrali permezz ta' stimulazzjoni aktar b'saħħitha tan-nerv tal pudenda għall-muskolu rrigat ta' l-isfinster ta' l-uretra u dan biss waqt il-fażi tal-ħażna ta' l-awrina fiċ ċiklu tal-passaġġ ta' l-awrina.
English: Throat tightness Epistaxis Interstitial lung disease10
Maltese: Mard talinterstizju talpulmun10
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Maltese: M'hemmx bżonn ta' tibdil fid-doża għall-pazjenti b'disfunzjoni renali ħafifa jew moderata (tneħħija tal-krejatinina 30 sa 80 ml/min).
English: When stopping treatment with YENTREVE the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Maltese: Meta l-kura b'YENTREVE tkun ser titwaqqaf id-doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta' mill-anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir-riskju ta' reazzjonijiet ta' rtirar (ara sezzjonijiet 4.4 u 4.8).
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
Maltese: Tagħrif minn studji kliniċi wera li hemm żieda fir-riskju ta' mġiba suwiċidali f'adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b'antidipressivi.
English: PC: SN: NN:
Maltese: X'fih YENTREVE:
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.
Maltese: Fl-erba' studji kollha l-grupp ikkurat b'duloxetine kellu tnaqqis medjan ta' 50% jew aktar fil-IEF meta mqabbel ma' 33% fil-grupp ikkurat bil-plaċebo.
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Maltese: CYP1A2, naqqas it-tneħħija tal-plażma apparenti ta' duloxetine b'madwar 77% u żied b'6 darbiet l
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Maltese: Il-farmakokinetika ta' duloxetine juru varjabiltà kbira bejn persuna u oħra (ġeneralment 50-60%), parti minħabba s-sess,
English: Other medicines and YENTREVE
Maltese: Kif taħżen YENTREVE
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.
Maltese: • sturdament, sensazzjonijiet ta' tniggiż jew sensazzjonijiet bħal meta tieħu xokk elettriku (speċjalment fir-ras), problemi ta' irqad(ħolm stramb, ħmar il-lejl, ma tkunx tista' torqod), għeja, tħossok li trid torqod, tħossok irrekwet u aġitat, tħossok ansjuż, tħossok ħażin (dardir) jew jagħmillek ħażin (rimettar), ċaqliq (tregħid), uġigħ ta' ras, uġigħ fil-muskoli, tħossok irritabbli, dijarea, għaraq esaġerat jew vertigo.
English: 9 Estimated frequency based on all clinical trial data.
Maltese: 9 Stima tal-frekwenza bbażata fuq tagħrif mill-provi kliniċi kollha.
English: Talk to your doctor before you take Yentreve if you: - are taking medicines to treat depression (see ‘Other medicines and YENTREVE') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage.
Maltese: għandek problemi f'għajnejk bħal xi tip ta' glawkoma (pressjoni għolja fl-għajn). għandek passat ta' emorraġija (tendenza li tiżviluppa tbenġil, speċjalment jekk inti tqila (ara ‘Tqala u treddigħ'). qiegħed/qiegħda f'riskju li jitbaxxielek il-livell ta' sodium(per eżempju jekk qiegħed/qiegħda tieħu d-dijuretiċi, speċjalment jekk inti anzjan/anzjana) qiegħed/qiegħda tirċievi fl-istess waqt kura b'mediċina oħra li tista' tikkawżalek ħsara fil fwied.
English: Hallucinations Aggression and anger4,6
Maltese: Aggressjoni u rabja4,6
English: Each capsule contains 40 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula għandha 40 mg ta' duloxetine (bħala hydrochloride).
English: Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Maltese: Huma komuni s-sintomi ta' rtirar meta l-kura tiġi mwaqqfa, partikolarment jekk it-twaqqif isir f'daqqa waħda (ara sezzjoni 4.8).
English: YENTREVE with food, drink and alcohol
Maltese: YENTREVE mal-ikel, max-xorb u mal-alkoħol
English: Tinnitus1 Ear pain
Maltese: Tinnitus1
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Maltese: B'duloxetine ġew irrappurtati każijiet ta' ħsara fil-fwied, fosthom żidiet b'mod serju ta' enzimi talfwied (>10 darbiet il-limitu ta' fuq tan-normal), epatite u suffejra (ara sezzjoni 4.8).
English: The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies that randomised 1913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo.
Maltese: studji randomised, double blind, ikkontrollati bil-plaċebo, b'1913-il mara (22 sa 83 sena) bis-SUI;
English: Chest pain7
Maltese: Uġigħ fis-sider7
English: Antacids and H2 antagonists: Co-administration of YENTREVE with aluminium- and magnesiumcontaining antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Maltese: Mediċini kontra l-aċtu fl-istonku u antagonisti ta' H2: It-teħid ta' YENTREVE flimkien ma' mediċini kontra l-aċtu fl-istonku li fihom aluminium u magnesium jew ma' famotidine ma kellhiex effett sinifikanti fuq ir-rata jew il-miżura ta' assorbiment ta' duloxetine wara li ngħatat doża orali ta' 40 mg.
English: Lactation did not influence duloxetine pharmacokinetics.
Maltese: Effett ta' duloxetine fuq prodotti mediċinali oħra
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).
Maltese: John's wort (Hypericum perforatum) jew triptans, tramadol, pethidine u tryptophan (ara sezzjoni 4.4).
English: Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: Firien tas-sess femminil li rċevew duloxetine, qabel u waqt li kienu qedgħin jgħammru u fil-bidu tat-tqala, kellhom tnaqqis fil-konsum ta' l-ikel matern u fil-piż, taqlib fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ ħajjin u fis-sopravivenza tal-ferħ ta' lannimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Maltese: • uġigħ newropatiku tad-dijabete, depressjoni ansjetà u inkontinenza awrinarja
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2).
Maltese: Huwa rakkomandat it-twaqqif gradwali ta' YENTREVE jekk tiġi meħuda d-deċisjoni li tinbeda kura farmakoloġika antidepressiva (ara Sezzjoni 4.2).
English: • blurred eyesight
Maltese: Vista mċajpra
English: Duloxetine may increase the risk of postpartum haemorrhage (see section 4.6).
Maltese: F'pazjenti b'ipertensjoni mhux ikkontrollata m'għandux jinbeda duloxetine (ara sezzjoni 4.3).
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Maltese: warfarin taħt kundizzjonijiet fissi, f'volontiera b'saħħithom, bħala parti minn studju ta' farmakoloġija klinika, ma rriżultax f'tibdil klinikament sinifikanti fl-INR mil-linja bażi jew fil-farmakokinetika tal
English: Hypertensive crisis3
Maltese: ANNESS III
English: Each capsule contains 20 mg of duloxetine (as hydrochloride)
Maltese: Kull kapsula fiha 20 mg ta' duloxetine (bħala hydrochloride)
English: Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of YENTREVE with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Maltese: Peress li CYP1A2 huwa involut fil-metaboliżmu ta' duloxetine, bl-użu fl-istess ħin ta' duloxetine ma' inibituri qawwija ta' CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta' duloxetine. Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta'
English: Each capsule contains 20 mg of duloxetine (as hydrochloride).
Maltese: YENTREVE 20 mg Kull kapsula għandha 20 mg ta' duloxetine (bħala hydrochloride).
English: Each capsule contains 40 mg of duloxetine (as hydrochloride)
Maltese: Kull kapsula fiha 40 mg ta' duloxetine (bħala hydrochloride)
English: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Maltese: Duloxetine huwa inibitur ta' ġbir mill-ġdid kemm tas-serotonin (5-HT) kif ukoll ta' noradrenaline
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Maltese: Bħal kull sustanza serotonerġika oħra, il-kura b'duloxetine tista' tikkawża s-sindromu ta' serotonin, kundizzjoni li tista' tkun ta' periklu għall-ħajja, speċjalment jekk fl-istess ħin ikunu qed jintużaw sustanzi serotonerġiċi oħra (li jinkludu SSRIs, antidipressivi triċikliċi SNRIsm jew triptans), sustanzi li jnaqqsu l-metaboliżmu ta' serotonin bħal MAOIs jew antipsikotiċi jew antagonisti oħra ta' dopamine li jistgħu jaffettwaw is-sistemi ta' newrotrasmissjoni seotonerġiċi (ara sezzjonijiet 4.3 u 4.5).
English: The other ingredients are:
Maltese: Stima ta' frekwenza:
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).
Maltese: Hu rrakkomandat li YENTREVE jingħata b'attenzjoni jekk jittieħed flimkien ma' prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: The concomitant use of YENTREVE with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' YENTREVE ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: Do not store above 30° C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Red iron oxide (E172) Yellow iron oxide (E172) Edible black ink
Maltese: Sodium lauryl sulfate Titanium dioxide (E171)
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Maltese: Duloxetine huwa użat taħt trejdmarks differenti f'ħafna indikazzjonijiet (kura ta' uġigħ newropatiku tad-dijabete, episodji depressivi maġġuri, disturb ta' ansjetà ġeneralizzata u l-inkontinenza ta' l-awrina minħabba sforz).
English: Muscle spasm
Maltese: Użu orali
English: YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Maltese: YENTREVE huwa indikat għan-nisa għall-kura ta' Inkontinenza Awrinarja minħabba Sforz - (SUI) ta' grad moderat għal wieħed gravi.
English: What is in this leaflet:
Maltese: Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with YENTREVE (see section 4.4).
Maltese: L-antibijotiku linezolid huwa MAOI riversibbli u mhux selettiv u m'għandux jingħata lill-pazjenti kkurati b'YENTREVE (ara sezzjoni 4.4).
English: YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women.
Maltese: qiegħed/qiegħda tieħu mediċini oħra biex tikkura d-depressjoni (ara ‘Mediċini oħra u YENTREVE').
English: Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 20 mg jew 40 mg ta' duloxetine (bħala hydrochloride).
English: Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Maltese: Duloxetine ma kienx ġenotossiku f'firxa ta' testijiet standard u ma kienx karċinoġenu fil-firien.
English: YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Maltese: Il-parti prinċipali ċelesti opak, stampat b''20 mg' u għatu ċelesti opak, stampat b' '9544'.
English: The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Maltese: Il-farmakokinetika ta' duloxetine u l-prodotti metaboliċi tiegħu ma kienux studjati f'pazjenti b'insuffiċjenza tal-fwied ħafifa jew severa.
English: Postpartum haemorrhage6
Maltese: Irrekwitezza psikomotorja6
English: The amount of duloxetine in breast milk is approximately 7 µg/day while on 40 mg twice daily dosing.
Maltese: duloxetine fil-ħalib ta' l-omm huwa bejn wieħed u ieħor ta' 7 µg/jum waqt li tkun fuq doża ta' 40 mg darbtejn kuljum.
English: Constipation
Maltese: Iponatrimja
English: Dry mouth
Maltese: Vaskulite kutanea
English: (Invented) Name
Maltese: Isem inventat
English: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine France
Maltese: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Franza
English: 64331 Weiterstadt Germany
Maltese: 64331 Weiterstadt Il-Ġermanja
English: Italy sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan Italy
Maltese: L-Italja sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan L-Italja
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.
Maltese: L-Applikant issottometta applikazzjoni għal rikonoxximent reċiproku talawtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Isvezja fl-2006 għal Norsed Combi D, prodott ta' kombinazzjoni magħmul minn pilloli ta' 35 mg risedronate sodium miksijin b'rita flimkien ma' 1000 mg karbonat tal-kalċju u 880 IU granuli effervexxenti ta' colecalciferol.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicants and marketing authorisation holder in the Member States
Maltese: TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, DETENTURI
English: Strength
Maltese: Billi
English: Overall summary of the scientific evaluation of Norsed Combi D and associated names (see Annex I)
Maltese: III għal Norsed Combi D u l-ismijiet assoċjati (ara l-Anness I).
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).
Maltese: • is-CHMP kien konvint mill-benefiċċji ċari għas-saħħa pubblika u mill-konformità mtejba li jirriżultaw minn dan il-prodott, is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li, is-sommarju talkaratteristiċi tal-prodott, it-tikketta u l-fuljett ta' tagħrif tiegħu jibqgħu skont il-verżjonjiet finali miksubin waqt il-proċedura tal-grupp ta' Koordinazzjoni kif imsemmi fl-Anness
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 September 2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24
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)
Maltese: Bifosfonati (aċidu alendroniku; aċidu alendroniku, kolekalċiferol; aċidu klodroniku; aċidu etidroniku; ibandroniku; aċidu neridroniku; aċidu pamidroniku; aċidu risedroniku; aċidu tiludroniku; aċidu żoledroniku)Osteonekrożi tal-kanal estern tas-smigħ (EPITT nru 18256)
English: Adopted at the 7-10 September 2015 PRAC
Maltese: September 2015
English: Leflunomide - Pulmonary hypertension (EPITT no 18221)
Maltese: 2. Leflunomide - Ipertensjoni pulmonari (EPITT nru 18221)
English: Frequency ‘not known': pulmonary hypertension
Maltese: Frekwenza 'mhux magħrufa': ipertensjoni pulmonari
English: Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Maltese: Sezzjoni 4.8 Rari ħafna: Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati).
English: Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Maltese: Frekwenza ‘mhux komuni': Każijiet ta' sindromu ta' tnixxija kapillari suspettata ġew irrapportati b'trabectedin.
English: Trabectedin - Capillary leak syndrome (EPITT no 18115)
Maltese: Trabectedin - Sindromu ta' tnixxija kapillari (EPITT nru 18115)
English: Frequency unknown: insulin autoimmune syndrome (see section 4.4)
Maltese: Frekwenza mhux magħrufa: sindrome awtoimmuni tal-insulina (ara sezzjoni 4.4)
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.
Maltese: 1.6) tinsab l-iktar fil-Kawkażi, bi prevalenza ogħla fin-Nofsinhar tal-Ewropa milli fit-Tramuntana u l-allel HLA-DRB1*04:06 (proporzjon ta' probabbiltà ta' suxxettibbiltà għal IAS: 56.6) tinsab l-iktar f'pazjenti Ġappuniżi u Koreani.
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.
Maltese: Effetti sekondarji oħrajn bħal insuffiċjenza tal-kliewi, tnaqqis fil-livelli tal-aċidu uriku fid-demm tiegħek, ipertensjoni pulmonari, infertilità fl-irġiel [...] jistgħu jseħħu wkoll bi frekwenza mhux magħrufa.
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Maltese: Marda tal-interstizju tal-pulmun hija marda potenzjalment fatali, li tista' sseħħ b'mod akut waqt it-terapija.
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Maltese: Mard tal-interstizju tal-pulmun, kif ukoll każijiet rari ta' ipertensjoni pulmonari ġiet ġew irrapportati waqt il-kura b'leflunomide (ara sezzjoni 4.8).
English: - a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
Maltese: - sogħla jew problemi fit-teħid tan-nifs peress li dawn jistgħu jindikaw problemi ta' infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun jew ipertensjoni pulmonari);
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.
Maltese: L-allel HLA-DRB1*04:03 (proporzjon ta' probabbiltà ta' suxxettibbiltà għal IAS:
English: IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
Maltese: IAS għandha tiġi kkunsidrata fid-dijanjosi differenzjali ta' ipogliċemija spontanja f'pazjenti li jkunu qed jużaw l-aċidu tijottiku (ara sezzjoni 4.8).
English: Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa:
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Maltese: Ġiet irrapportata osteonekrożi tal-kanal estern tas-smigħ bil-bifosfonati, prinċipalment assoċjata ma' terapija fit-tul.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Maltese: Il-possibbiltà ta' osteonekrożi tal-kanal estern tas-smigħ għandha tiġi kkunsidrata f'pazjenti li qegħdin jirċievu bifosfonati li jkollhom sintomi fil-widnejn inklużi infezzjonijiet kroniċi tal-widna.