FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: Rari ħafna:
English: What Micardis looks like and contents of the pack Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.
Maltese: Il-pilloli Micardis 80 mg huma bojod, b'forma oblunga u mnaqqxa bin-numru tal-kodiċi ‘52H' fuq naħa waħda u bil-logo tal-kumpanija fuq in-naħa l-oħra.
English: Treatment of essential hypertension in adults.
Maltese: Issinifikat u r-rilevanza klinika mhumiex magħrufa.
English: Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Maltese: Micardis jista' jżid l-effett ta' tnaqqis tal-pressjoni tad-demm ta' mediċini oħra li jintużaw għall-kura ta' pressjoni tad-demm għolja jew ta' mediċini b'potenzjal li jbaxxu l-pressjoni tad-demm (eż. baclofen, amifostine).
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Maltese: Telmisartan jieħu post angiotensin II b'affinità għolja ħafna mis-sit fejn jeħel fis sottotip tar-riċettur AT1, li hu responsabbli għall-azzjonijiet magħrufa ta' angiotensin II.
English: What Micardis looks like and contents of the pack Micardis 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Maltese: Il-pilloli Micardis 20 mg huma bojod, b'forma tonda u mnaqqxa bin-numru tal-kodiċi ‘50H' fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Maltese: Micardis għandu jintuża biss bl-attenzjoni f'pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat.
English: NAME OF THE MEDICINAL PRODUCT Micardis 40 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Micardis 40 mg pilloli Telmisartan
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 302 28 00
Maltese: Boehringer Ingelheim Pharma Ges mbH Reprezentanţa din România Tel: +4 021 302 28 00
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Maltese: antagonisti tar-riċettur ta' angiotensin II, NSAIDs (mediċini mhux sterojdi kontra linfjammazzjoni, eż. aspirina jew ibuprofen), eparina, immunosoppressivi (eż. cyclosporin jew tacrolimus), u l-antibijotiku trimethoprim.
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti mill-attività tassistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta' l-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema bħal telmisartan, kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b'mod rari ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side.
Maltese: Pilloli bojod ta' 4.6 mm b'forma oblunga li fuqhom hemm imnaqqax in-numru tal-kodiċi ‘52H' fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Maltese: Infezzjonijiet fl-apparat urinarju, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (eż. uġigħ filgriżmejn, sinuses infjammati, riħ komuni), tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija), livelli għolja ta' potassium, diffikultà biex torqod, tħossok imdejjaq/imdejqa (dipressjoni), ħass ħażin (sinkope), sensazzjoni li kollox qed idur bik (sturdament), taħbit tal-qalb bil-mod (bradikardija), pressjoni tad-demm baxxa (ipotensjoni) f'persuni kkurati għal pressjoni tad-demm għolja, sturdament meta wieħed iqum bilwieqfa (ipotensjoni ortostatika), qtugħ ta' nifs, sogħla, uġigħ ta' żaqq, dijarea, skonfort fiż-żaqq, nefħa fiż-żaqq, rimettar, ħakk, żieda fl-għaraq, raxx minħabba l-mediċina, uġigħ fid-dahar, bugħawwieġ fil-muskoli, uġigħ fil-muskoli (majalġja), indeboliment fil-kliewi li jinkludi insuffiċjenza akuta tal-kliewi, uġigħ fis-sider, sensazzjoni ta' dgħufija, u żieda fil-livell ta' krejatinina fid-demm.
English: NAME OF THE MEDICINAL PRODUCT Micardis 80 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Micardis 80 mg pilloli Telmisartan
English: White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side.
Maltese: Pilloli bojod ta' 3.8 mm b'forma oblunga li fuqhom hemm imnaqqax in-numru tal-kodiċi ‘51H' fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Maltese: L-effetti ta' Micardis jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra linfjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Maltese: - Dijabete mellitus, indeboliment renali, età (> 70 sena) - Kumbinazzjoni ma' prodott mediċinali wieħed jew aktar li jaffettwaw is-sistema renin angiotensin-aldosterone u/jew is-supplimenti tal-potassium.
English: Micardis belongs to a class of medicines known as angiotensin II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Micardis 20 mg pilloli Telmisartan
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Maltese: Sepsis* (ta' spiss imsejħa "avvelenament tad-demm", hi infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li tista' twassal għal mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (reazzjoni anafilattika), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fit-togħma (tibdil fis-sens tat-togħma), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dan l-effett sekondarju), nefħa mgħaġġla tal-ġilda u tal-mukuża li tista wkoll twassal għal mewt (anġjoedema wkoll b'riżultat fatali), ekżema (disturb tal-ġilda), ħmura tal-ġilda, urtikarja (ħorriqija), raxx sever minħabba l-mediċina, uġigħ fil-gogi (artralġja), uġigħ fl-estremitajiet, uġigħ fittendini, mard li jixbah l-influwenza, tnaqqis fl-emoglobina (proteina fid-demm), żieda fil-livelli taluric acid, żieda fl-enzimi epatiċi jew ta' creatine phosphokinase fid-demm.
English: Children and adolescents The use of Micardis in children and adolescents up to the age of 18 years is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Micardis fit-tfal u fl-adolexxenti sal-età ta' 18-il sena mhuwiex rakkomandat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Micardis 20 mg tablets
Maltese: U KWANTITATTIVA Micardis 20 mg pilloli
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg
Maltese: PAKKETTI TA' 90 X 1 PILLOLA) BUNDLED - LI JINKLUDU L-KAXXA L-BLU - 80 mg
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Maltese: L-iktar manifestazzjonijiet prominenti ta' doża eċċessiva ta' telmisartan kienu pressjoni tad-demm baxxa ħafna u takikardja; il-bradikardija, sturdament, żieda fil-livell tal-krejatinina fis-serum u insuffiċjenza renali akuta kienu osservati wkoll.
English: Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-0
Maltese: Boehringer Ingelheim Pharma Podružnica Ljubljana Tel: +386 1 586 40 00
English: Micardis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Maltese: Micardis m'għandux jingħata lil pazjenti b'kolestasi, b'disturbi ostruttivi tal-marrara jew li għandhom indeboliment sever epatiku (ara sezzjoni 4.3), għax telmisartan huwa eliminat fil-biċċa l-kbira tiegħu mal-bili.
English: (It is also better to avoid Micardis in early pregnancy see pregnancy section.)
Maltese: Micardis kmieni fit-tqala - ara ssezzjoni dwar it-tqala.)
English: Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas
Maltese: Boehringer Ingelheim Pharma GmbH Fióktelepe Tel.:
English: The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Micardis fit-tfal u l-adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Maltese: • jekk għandek problemi severi tal-fwied bħal kolestasi jew ostruzzjoni biljari (problemi fittnixxija tal-bila mill-fwied u mill-bużżieqa tal-marrara) jew kwalunkwe mard sever ieħor talfwied.
English: The absolute bioavailability is 75%.
Maltese: Il-bijodisponibilità assoluta hija ta' 75%.
English: See section 4.
Maltese: Ara sesezzjoni 4.
English: Tolerability and safety
Maltese: Tolleranza u sigurtà
English: ECT (electroconvulsive therapy)
Maltese: ECT (terapija elettrokonvulżiva)
English: Date of first authorisation: 18 December 2013 Date of latest renewal: 20 November 2018
Maltese: Data tal-aħħar tiġdid: 20 ta' Novembru 2018
English: Hypromellose Macrogol 400
Maltese: Macrogol 400
English: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX).
Maltese: F'studji kliniċi, id-disfunzjoni sesswali ġiet evalwata permezz tal-Arizona Sexual Experience Scale (ASEX).
English: Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate
Maltese: Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (tip A) Magnesium stearate
English: Each drop contains 4.25 mg of ethanol.
Maltese: Kull qatra fiha 4.25 mg ta' ethanol.
English: The mean elimination half-life and oral clearance are 66 hours and 33 L/h, respectively.
Maltese: Il-half-life medja tal-eliminazzjoni u t-tneħħija orali huma ta' 66 siegħa u 33 L/h, rispettivament.
English: The mean volume of distribution (Vss) is 2,600 L, indicating extensive extravascular distribution.
Maltese: Il-volum medju ta' distribuzzjoni (Vss) huwa ta' 2,600 L, li jindika distribuzzjoni ekstravaskulari estensiva.
English: Tel: +45 36301311(Dānija)
Maltese: 36301311(Dānija)
English: Brintellix contains ethanol.
Maltese: Brintellix fih ethanol.
English: 20 mg corresponding to 20 drops.
Maltese: 20 mg jikkorrispondu għal 20 qatra.
English: - moclobemide (a medicine to treat depression).
Maltese: - moclobemide (mediċina għall-kura tad-depressjoni).
English: Lundbeck SAS Tél: + 33 1 79 41 29 00
Maltese: Tél: + 33 1 79 41 29 00
English: 5 mg corresponding to 5 drops.
Maltese: 5 mg jikkorrispondu għal 5 qatriet.
English: The pharmacokinetics are linear and time independent in the dose range studied (2.5 to 60 mg/day).
Maltese: Il-farmakokinetika hija lineari u indipendenti mill-ħin fil-firxa ta' dożi studjati (2.5 sa 60 mg/kuljum).
English: The reactions were usually transient and did not generally lead to cessation of therapy.
Maltese: Irreazzjonijiet normalment kienu temporanji u ġeneralment ma wasslux għat-twaqqif tat-terapija.
English: - have had mania.
Maltese: - kellek manija
English: Tél/Tel: +32 2 535 7979
Maltese: Tél: +32 2 535 7979
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)
Maltese: Sindrome ta' Serotonin (SS) jew Sindrome Newrolettiku Malinn (NMS - Neuroleptic Malignant Syndrome)
English: 10 mg corresponding to 10 drops.
Maltese: 10 mg jikkorrispondu għal 10 qatriet.
English: The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
Maltese: Ir-riskju ta' SS jew NMS jiżdied bl-użu fl-istess waqt ta' sustanzi attivi serotonerġiċi (inkluż triptans), prodotti mediċinali li jfixklu l-metaboliżmu ta' serotonin (inkluż MAOIs), antipsikotiċi, u antagonisti oħrajn ta' dopamine.
English: - have had fits (seizures).
Maltese: - kellek aċċessjonijiet (konvulżjonijiet).
English: Each ml of solution contains vortioxetine (D,L)-lactate equivalent to 20 mg vortioxetine.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fiha vortioxetine (D,L)-lactate ekwivalenti għal 20 mg vortioxetine.
English: Nonclinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems.
Maltese: Tagħrif mhux kliniku jindika li vortioxetine huwa antagonist tar-riċetturi 5-HT3, 5-HT7, u 5-HT1D, agonist parzjali tar-riċettur 5-HT1B, agonist tar-riċettur 5-HT1A u inibitur tat-trasportatur ta' 5-HT, li jwassal għallmodulazzjoni tan-newrotrasmissjoni f'ħafna sistemi, li jinkludi l-iżjed is-sistemi ta' serotonin iżda wisq probabbli wkoll ta' norepinephrine, dopamine, histamine, acetylcholine, GABA u glutamate.
English: Seizures are a potential risk with antidepressants.
Maltese: Aċċessjonijiet huma riskju potenzjali b'antidepressanti.
English: Following multiple dosing of 5, 10, or 20 mg/day, mean Cmax values of 9 to 33 ng/mL were observed.
Maltese: Wara dożaġġ multiplu ta' 5, 10, jew 20 mg/kuljum, kienu osservati valuri medji ta' Cmax ta' 9 sa 33 ng/mL.
English: - lithium (a medicine to treat depression an d mental disorders) or tryptophan.
Maltese: - lithium (mediċina għall-kura tad-depressjoni u ta' disturbi mentali) jew tryptophan.
English: The major metabolite of vortioxetine is pharmacologically inactive.
Maltese: Il-metabolit prinċipali ta' vortioxetine huwa farmakoloġikament inattiv.
English: Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets
Maltese: Brintellix 5 mg pilloli miksija b'rita Brintellix 10 mg pilloli miksija b'rita Brintellix 15 mg pilloli miksija b'rita Brintellix 20 mg pilloli miksija b'rita
English: Brintellix with alcohol
Maltese: Brintellix mal-alkoħol
English: Following multiple doses of vortioxetine, no inhibitory effect was observed in healthy subjects for the cytochrome P450 isozymes CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (caffeine) or CYP2D6 (dextromethorphan).
Maltese: Wara dożi multipli ta' vortioxetine, ma kien osservat l-ebda effett inibitorju f'individwi f'saħħithom għall-isoenzimi taċ-ċitokromju P450 CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol,midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (kaffeina), jew CYP2D6 (dextromethorphan).
English: 4 years.
Maltese: 3 snin
English: - St John's wort (hypericum perforatum)(a medicine to treat depression).
Maltese: - St John's wort (hipericum perforatum) (mediċina għall-kura tad-depressjoni) - quinidine (mediċina għall-kura ta' disturbi fir-ritmu tal-qalb)
English: For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively)(see section 4.4).
Maltese: Għal dożi ta' 20 mg vortioxetine darba kuljum, l-inċidenzi ta' dardir u stitikezza kienu ogħla f'pazjenti ta' età ≥65 sena (42% u 15%, rispettivament) milli f'pazjenti ta' età <65 sena (27% u 4%, rispettivament)(ara sezzjoni 4.4).
English: Brintellix is indicated for the treatment of major depressive episodes in adults.
Maltese: Brintellix huwa indikat għall-kura ta' episodji depressivi maġġuri fl-adulti.
English: CYP2D6 inhibitors
Maltese: Inibituri ta' CYP2D6
English: [outer carton only]
Maltese: [kartuna ta' barra biss]
English: In accordance with the half-life, the accumulation index is 5 to 6 based on AUC0-24h following multiple doses of 5 to 20 mg/day.
Maltese: Skont il-half-life, l-indiċi ta' akkumulazzjoni huwa ta' 5 sa 6 ibbażat fuq l-AUC0-24h wara dożi multipli ta' 5 sa 20 mg/kuljum.
English: Dizziness Not known * Serotonin Syndrome
Maltese: Sturdament Mhux magħruf* Sindromu ta' Serotonin
English: - selegiline, rasagiline (medicines to treat Parkinson's disease).
Maltese: - selegiline, rasagiline (mediċini għall-kura tal-marda ta' Parkinson). - linezolid (mediċina għall-kura ta' infezzjonijiet ikkawżati mill-batterja).
English: No data are available (see section 4.4).
Maltese: Dejta mhux disponibbli (ara sezzjoni 4.4).
English: Brintellix contains the active substance vortioxetine.
Maltese: X'fih Brintellix - Is-sustanza attiva hi vortioxetine.
English: Brintellix 20 mg/ml [outer carton only]
Maltese: Brintellix 20 mg/ml [kartuna ta' barra biss]
English: Brintellix is used to treat major depressive episodes in adults.
Maltese: Brintellix jintuża biex jikkura episodji depressivi maġġuri f'adulti.
English: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Maltese: Iponatrimja, probabbilment ikkawżata minn sekrezzjoni mhux xierqa tal-ormon antidijuretiku (SIADH), kienet irrappurtata b'mod rari bl-użu ta' antidepressanti b'effett serotonerġiku (SSRIs, SNRIs).
English: Each drop contains vortioxetine (D,L)-lactate equivalent to 1 mg vortioxetine.
Maltese: Kull qatra fiha (D,L)-lactate ekwivalenti għal 1 mg vortioxetine.
English: Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5).
Maltese: Użu fl-istess ħin ma' inibituri mhux selettivi ta' monoamine oxidase (MAOIs ) jew inibituri selettivi MAO-A (ara sezzjoni 4.5).
English: In humans, two positron emission tomography (PET) studies have been conducted using 5-HT transporter ligands (11C-MADAM or 11C-DASB) to quantify the 5-HT transporter occupancy in the brain across different dose levels.
Maltese: Fil-bnedmin, saru żewġ studji ta' tomografija ta' emissjoni ta' pożitroni (PET - positron emission tomography) bl-użu ta' ligandi trasportaturi ta' 5-HT (11C-MADAM jew 11C-DASB) biex tiġi kkwantifikata l-okkupazzjoni tat-trasportatur ta' 5-HT fil-moħħ f'livelli ta' dożi differenti.
English: H. Lundbeck AS Tlf: +47 91 300 800
Maltese: Tlf: +47 91 300 800
English: For information on undesirable effects, see section 4.8.
Maltese: Għall-informazzjoni dwar l-effetti mhux mixtieqa, ara sezzjoni 4.8.
English: The efficacy of vortioxetine is supported by the pooled responder analysis, in which the proportion of responders ranged from 46% to 49% for vortioxetine versus 34% for placebo (p <0.01; NRI analysis).
Maltese: L-effikaċja ta' vortioxetine hija sostnuta minn analiżi ta' grupp ta' pazjenti li rrispondew fejn ilproporzjon ta' dawk li rrispondew kien ivarja minn 46% sa 49% għal vortioxetine kontra 34% għall placebo (p <0.01; analiżi
English: This was supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in the Clinical Global Impression - Global Improvement (CGI-I) score.
Maltese: Clinical Global Impression - Global Improvement).
English: No inhibitory or inducing effect of vortioxetine was observed in the drug-drug interaction studies for the CYP isozymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 (see section 4.5).
Maltese: Ma kien osservat l-ebda effett inibitorju jew ta' induzzjoni ta' vortioxetine fl-istudji ta' interazzjoni bejn mediċina u mediċina għall-isoenzimi ta' CYP, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A4/5.
English: Vortioxetine was not genotoxic in a standard battery of in vitro and in vivo tests.
Maltese: Vortioxetine ma kellux effett tossiku fuq il-ġeni f'sensiela standard ta' testijiet in vitro u in vivo.
English: - linezolid (a medicine to treat bacterial infections) .
Maltese: - linezolid (mediċina għall-kura ta' infezzjonijiet ikkawżati mill-batterja).
English: Vortioxetine is highly bound to plasma proteins (98 to 99%) and the binding appears to be independent of vortioxetine plasma concentrations.
Maltese: Vortioxetine jeħel ħafna mal-proteini fil-plażma (98 sa 99%) u l-irbit jidher li huwa indipendenti mill-konċentrazzjonijiet ta' vortioxetine fil-plażma.
English: In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P450 isozymes (see section 5.2).
Maltese: In vitro, vortioxetine ma wera l-ebda potenzjal rilevanti għall-inibizzjoni jew induzzjoni ta' isoenzimi taċ-ċitokromu P450 (ara sezzjoni 5.2).
English: Each drop contains 1 mg vortioxetine (as (D,L)- lactate)
Maltese: Kull taqtira fiha 1 mg vortioxetine (bħala (d,L)-lactate