FrancophonIA/ELRC3.0 huggingface dataset:
English: • swelling (typically in ankles or feet) caused by fluid retention (oedema)
Maltese: • nefħa (tipikament fl-għakiesi u fis-saqajn) ikkawżat minn ritenzjoni ta' fluwidi (edema)
English: The applicant/MAH was therefore asked to provide support for the cut-off at 40 ml/min as the range is normally defined as 30- 50 ml/min (moderate renal impairment).
Maltese: Għalhekk l-applikant/Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq intalab għalhekk sabiex jipprovdi sostenn għall-cut-off ta' 40 ml/min billi l-medda ġeneralment hija definita bħala 30-50 ml/min (indeboliment moderat tal-kliewi).
English: • feeling elated or emotionally ‘high' (mania)
Maltese: • tħossok ferħan iżżejjed jew emozzjonalment ‘high' (manija)
English: Remeron 15 mg/ml oral solution contains 15 mg mirtazapine per ml solution.
Maltese: Remeron 15 mg/ml soluzzjoni orali fih 15 mg mirtazapine għal kull ml soluzzjoni.
English: Each Remeron 30 mg film-coated tablet contains 217 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita Remeron 30 mg fiha 217 mg lattosju (bħala monoidrat).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Remeron oral solution contains 15 mg of mirtazapine.
Maltese: U KWANTITATTIVA 1 ml mis-soluzzjoni orali Remeron fiha 15 mg ta' mirtazapine.
English: The following pack sizes are available for each strength: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6) and 180 (10x18 (3x6)) orodispersible tablets.
Maltese: Is-segwenti daqsijiet ta' pakketti huma disponibbli għal kull qawwa: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) u 96 (16x6) u 180 (10x18) (3x6) pillola li tinħall fil-ħalq.
English: Each Remeron 30 mg orodispersible tablet contains 9.30 mg aspartame and 56 mg sucrose.
Maltese: Kull pillola li tinħall fil-ħalq Remeron 30 mg fiha 9.30 mg aspartame u 56 mg zokkor tal-kannamieli.
English: Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Maltese: Għaldaqstant, kienet rakkomandata l-kitba segwenti dwar l-interazzjonijiet faramakodinamiċi għal Sezzjoni 4.5 tal-SPC:
English: Mirtazapine Zispin SolTab 30mg orodispersible tablet
Maltese: Mirtazapine Zispin SolTab 30mg orodiskullsible pillola
English: Box 20, NL - 5340 BH Oss, The Netherlands
Maltese: Organon Europe B.V., Kloosterstraat 6, 5349AB Oss, The Netherlands
English: Arthralgia Myalgia Back pain1
Maltese: Arthralgia Uġigħ filmuskoli (Myalgia) Uġigħ fiddahar1
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 provi kliniċi wera riskju ikbar ta' imġieba suwiċidali f'adulti ta' eta` inqas minn 25 sena b'kundizzjonijiet psikjatriċi li ġew trattati b'antidipressanti.
English: Tablet core: maize starch, hyprolose, magnesium stearate, silica, colloidal anhydrous, lactose monohydrate
Maltese: Il-qalba tal-pillola: maize starch, hyprolose, magnesium stearate, silica, colloidal anhydrous, lactose monohydrate Il-kisja tal-pillola: hypromellose, Macrogol 8000, titanium dioxide (E171).
English: - Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably most antipsychotics, antihistamine H1 antagonists, opioids).
Maltese: - Mirtazapine tista żżid il-proprjetajiet sedattivi ta' benzodiazepines u sedattivi oħrajn (notevolment ħafna mill-antisikotiċi, opioids anti-istaminiċi
English: - renal impairment: Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance < 40 ml/min) and severe (creatinine clearance ≤ 10 ml/min) renal impairment the clearance of mirtazapine was about 30 % and 50 % decreased respectively, compared to normal subjects.
Maltese: Wara doża orali waħda ta' 15 mg ta' mirtazapine, f'pazjenti b'indeboliment renali moderata (tneħħija ta' creatinine <40 ml/min) u qawwija (tneħħija ta' creatinine ≤10 ml/min) it-tneħħija ta' mirtazapine kien imnaqqas b'madwar 30 % u 50 % rispettivament pparagunati ma' suġġetti normali.
English: 6 orodispersible tablets 18 orodispersible tablets 30 orodispersible tablets 48 orodispersible tablets 96 orodispersible tablets
Maltese: 6 pilloli li jinħallu fil-ħalq 18-il pillola li jinħallu fil-ħalq 30 pillola li jinħallu fil-ħalq 48 pillola li jinħallu fil-ħalq 96 pillola li jinħallu fil-ħalq
English: Pharmacokinetic interactions - Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about twofold, resulting in a decrease in average plasma mirtazapine concentration of 60 % and 45 %, respectively.
Maltese: Interazzjonijiet farmakokinetiċi - Carbamazepine u phenytoin, indutturi CYP3A4, żiedu t-tneħħija ta'mirtazapine madwar darbtejn, b'riżultat ta' tnaqqis tal-medja tal-konċentrazzjonijiet ta' plażma mirtazapine ta' 60% u 45% rispettivament.
English: Treatment of episodes of major depression.
Maltese: Episodji ta' dipressjoni qawwija.
English: Mirtazapine Zispin SolTab 45mg orodispersible tablet
Maltese: Mirtazapine Zispin SolTab 45mg orodiskullsible pillola
English: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Maltese: Is-segwenti daqsijiet ta' pakketti huma disponibbli għal pilloli ta' 30 mg fi strixxi: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) u 500 (50x10) pilloli miksija b'rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b'rita.
English: Like with other antidepressants, the following should be taken into account: - Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified.
Maltese: - Jista jkun hemm tiħżin ta' sintomi psikotiċi meta anti-dipressanti huma amministrati lil pazjenti bi skiżofrenja jew disturbi psikotiċi oħrajn; ħsibijiet paranojiċi jistgħu jiġu intensifikati.
English: These do not include hereditary deficiencies of amino acid (phenylalanine) metabolism, such as phenylketonuria.
Maltese: Dawn ma jinkludux defiċjenzi ereditarji tal-metaboliżmu ta' l-aċidu amminiku (phenylalanine), bħall-fenilketonurja.
English: The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties.
Maltese: H1-antagonistika ta' mirtazapine hija assoċċjata mal-proprjetajiet sedattivi.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
Maltese: 10 pilloli miksija b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita 200 pillola miksija b'rita 500 pillola miksija b'rita
English: The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.
Maltese: Ilmetabolit demetil huwa attiv farmakoloġikament u jidher li għandu l-istess profil farmakokinetiku bħall-kompost oriġinali.
English: • lethargy
Maltese: • iremettar
English: For Remeron 45 mg film-coated tablets in blisters the following pack sizes are available: 10, 20, 30, 50, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 45 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Maltese: Għal pilloli miksija b'rita Remeron 45 mg fi strixxi huma disponibbli s-segwenti daqsijiet ta' pakketti: 10, 20, 30, 50, 100, 200 u 500 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b'rita Remeron 45 mg fi fliexken huwa disponibbli daqs ta' pakkett ta' 250 pillola (mhux id-daqsijiet kollha talpakketti jistgħu jiġu mqiegħda fuq is-suq).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fruttosju, malassorbiment ta' glukows-galaktosju jew insuffiċjenza ta' sucraseisomaltase m'għandhomx jieħdu din il-mediċina.
English: Group 4 Severe renal insufficiency with a GFR <10 ml/min/1.73 m2
Maltese: Grupp 2 Insuffiċjenza renali ħafifa b'GFR ta' 40-79 ml/min/1.73 m2
English: Patients who are sensitive to phenylalanine are usually aiming for low phenylalanine levels (e.g. through diet), not complete abstinence of this source.
Maltese: Il-pazjenti li huma sensittivi għal phenylalanine ġeneralment jimmiraw għal livelli baxxi ta' phenylalanine (eż. permezz ta' dieta), u mhux astinenza totali ta' dan is-sors.
English: For Remeron 30 mg film-coated tablets in blisters the following pack sizes are available: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 30 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Maltese: Għal pilloli miksija b'rita Remeron 30 mg fi strixxi huma disponibbli s-segwenti daqsijiet ta' pakketti: 10, 20, 30, 50, 60, 90, 100, 200 u 500 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b'rita Remeron 30mg fi fliexken huwa disponibbli daqs ta' pakkett ta' 250 pillola (mhux id-daqsijiet kollha tal-pakketti jistgħu jiġu mqiegħda fuq is-suq).
English: Mirtazapine is extensively metabolized and eliminated via the urine and faeces within a few days.
Maltese: Mirtazapine hija metabolizzata estensivament u eliminata via l-awrina u l-ippurgar fi żmien ftit ġranet.
English: • medicines for anxiety or insomnia such as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine.
Maltese: • mediċini għall-anzjeta` jew insomnja bħal benzodiazepines; mediċini għal skizofrenja bħal olanzapine; mediċini għall-allerġiji bħal cetrizine; mediċini għal uġigħ qawwi bħal morfina.
English: • abnormal sensations in the mouth (oral paraesthesia)
Maltese: • sensazzjoni anormali fil-ħalq (parastażija orali)
English: 2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
Maltese: 2Fi provi kliniċi dawn l-eventi seħħew iktar frekwentement waqt trattament bi plaċebo milli b'Remeron, iżda mhux bi frekwenza iktar sinjifikanti statistikament.
English: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine.
Maltese: Iponatrimija, probabbilment minħabba sekrezzjoni mhux adattata ta' l-ormon antidijuretiku (SIADH), ġiet irrappurtata b'mod rari bl-użu ta' mirtazapine.
English: Each Remeron 45 mg film-coated tablet contains 325 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita Remeron 45 mg fiha 325 mg lattosju (bħala monoidrat).
English: Oval, biconvex, white and marked with ‘Organon' on one side-and a code on the other side (TZ/7).
Maltese: Ovali, konvessa miż-żewġ naħat, bajda u mmarkata ‘Organon' fuq naħa waħda u kodiċi fuq in-naħa loħra (TZ/7).
English: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Maltese: Is-segwenti daqsijiet ta' pakketti huma disponibbli għal pilloli ta' 45 mg fi strixxi: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) u 500 (50x10) pilloli miksija b'rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b'rita.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galaktosju, id-defiċjenza Lapp lactase jew malassorbiment ta' glukows-galaktosju m'għandhomx jieħdu din il-mediċina.
English: Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
Maltese: Dipressjoni fil-mudullun tal-għadam (granuloċitopen ija, agranuloċitożi, anemija aplastika u tromboċitopenij a) eosinofilija.
English: - Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
Maltese: - Ko-amministrazzjoni tal-inibitur potenti CYP3A4 ketoconazole żied l-ogħla livelli plażma u lAUC ta' mirtazapine b'madwar 40 % u 50 % rispettivament.
English: - Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma levels and the AUC of mirtazapine by approximately 40 % and 50 % respectively.
Maltese: - Ko-amministrazzjoni tal-inibitur potenti CYP3A4 ketoconazole żied l-ogħla livelli plażma u lAUC ta' mirtazapine b'madwar 40% u 50% rispettivament.
English: • antidepressants such as SSRIs,venlafaxine and L-tryptophan, or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. John's Wort - Hypericum perforatum preparations (a herbal remedy for depression).
Maltese: • antidepressanti bħal SSRIs, venlafaxine u L-tryptophan jew triptans (użati biex jikkuraw lemigranja), tramadol (itaffi l-uġigħ), linezolid (antibijotiku), lithium (użat biex jikkura xi kundizzjonijiet psikjatriċi) u St.
English: MAO-inhibitors
Maltese: Inibituri MAO
English: For Remeron 15 mg film-coated tablets in blisters the following pack sizes are available: 30, 60, 90 and 100 tablets; 14, 28, 56 and 70 tablets; for Remeron 15 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Maltese: Għal pilloli miksija b'rita Remeron 15 mg fi strixxi huma disponibbli s-segwenti daqsijiet ta' pakketti: 30, 60, 90 u 100 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b'rita Remeron 15 mg fi fliexken huwa disponibbli daqs ta' pakkett ta' 250 pillola (mhux id-daqsijiet kollha tal-pakketti jistgħu jiġu mqiegħda fuq is-suq).
English: Caution should be exercised and the dose may have to be decreased when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.
Maltese: Għandha tintuża attenzjoni u d-doża jista' jkun li jkollha titnaqqas meta mirtazapine jingħata flimkien ma' impedituri qawwija tas-CYP3A4, impedituri HIV tal-protease, antifungali azole, erythromycin, cimetidine jew nefazodone.
English: • antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. Johns Wort - Hypericum perforatum preparations (a herbal remedy for depression).
Maltese: • antidipressanti bħal SSRIs, venlafaxine u L-tryptophan jew triptans (użati biex jikkuraw lemigranja), tramadol (joqtol l-uġigħ), linezolid (antibijotiku), lithium (użat għat-trattament ta' xi kundizzjonijiet psikjatriċi) u preparazzjonijiet tas-St.
English: Mirtazapine Remeron 15 mg/ml 15 mg/ml
Maltese: Mirtazapine Mirtazapine 15mg/ml
English: Each Remeron 15 mg film-coated tablet contains 109 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita Remeron 15 mg fiha 109 mg lattosju (bħala monoidrat).
English: - cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered.
Maltese: - mard kardijaku bħal disturbi tal-konduzzjoni, angina pectoris u infart mijokardjali riċenti, fejn għandhom jittieħdu prekawzjonijiet normali u mediċini konkomitanti għandhom jiġu amministrati b'attenzjoni.
English: Take the oral solution orally.
Maltese: U KONTENUT Soluzzjoni orali
English: Mirtazapine displays linear pharmacokinetics within the recommended dose range.
Maltese: Mirtazapine turi farmakokinetika lineari fil-medda taddoża rrakomandata.
English: Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172) (15 and 30 mg film-coated tablets only) red iron oxide (E172)
Maltese: Il-kisja tal-pilloli miksija b'rita Remeron 30 mg fihom ukoll yellow iron oxide (E172) u red iron oxide (E172).
English: Hepatic impairment
Maltese: Irrekwitezza psikomutur
English: In each subgroup 10 subjects were included.
Maltese: F'kull sottogrupp kienu inklużi 10 individwi.
English: akathisia, hyperkinesia)
Maltese: Akathisia, iperkinesia)
English: The referral was triggered by the applicant and aims to harmonise major areas of discrepancy between the EU member states, with regard to the Summary of Product Characteristics (SPCs), Package Leaflets (PLs), labelling and Module 3 of the following products containing the active substance mirtazapine:
Maltese: Ir-riferiment sar mill-applikant u għandu l-mira li jarmonizza oqsma prinċipali ta' diskrepanza bejn l-Istati Membri ta' l-UE, fir-rigward tas-Sommarju tal-Karatteristiċi tal-Prodott (SPCs), il-Fuljetti ta' Tagħrif (PLs), it-Tikketti u Modulu 3 tal-prodotti segwenti li fihom is-sustanza attiva mirtazapine:
English: All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Maltese: Il-provi kollha plaċebo-kontrollati għallarieda f'pazjenti (inkluż indikazzjonijiet oħrajn apparti minn diżordni dipressiv qawwi), ġew evalwati għal effetti mhux mixtieqa ta' Remeron.
English: That is the reason for the cut-off value of 40 ml/min/1.73 m2.
Maltese: Dik hija r-raġuni għall-valur ta' qtugħ il-linja ta' 40 ml/min/1.73 m2.
English: In this study, subjects were divided into 4 categories using the following cut-off values: Group 1 Normal healthy controls with a glomerular filtration rate (GFR) of >80 ml/min/1.73 m2 Group 2 Mild renal insufficiency with a GFR of 40-79 ml/min/1.73 m2
Maltese: Grupp 1 Kontrolli normali b'saħħithom b'rata ta' filtrazzjoni glomerulari (GFR) ta' >80 ml/min/1.73 m2
English: • medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIVprotease inhibitors).
Maltese: • mediċini għall-infezzjonijiet: mediċini għal infezzjonijiet batteriċi (bħal erythromycin), mediċini għat-trattament ta' infezzjonijiet fungali (bħal ketoconazole) u mediċini għal HIV/AIDS (bħal inibituri HIV-protease).
English: Mirtazapine Zispin SolTab 15mg orodispersible tablet
Maltese: Mirtazapine Zispin SolTab 15mg orodiskullsible pillola
English: The most commonly reported adverse reactions, occurring in more than 5 % of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
Maltese: L-iktar effett mhux mixtieq illi ġie rrapurtat, li seħħ f'iktar minn 5 % mill-pazjenti trattati b'Remeron fi provi plaċebo-kontrollati għallarieda (ara isfel) kienu sonnolenza, sedazzjoni, ħalq xott, żieda fil-piż, żieda fl-aptit, sturdament u għejja.
English: • nightmares
Maltese: • nawsja
English: - When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50 %.
Maltese: - Meta cimetidine (impeditur dgħajjef ta' CYP1A2, CYP2D6 u CYP3A4) jingħata ma' mirtazapine, il-medja ta' konċentrazzjoni tal-plażma ta' mirtazapine tista' tiżdied aktar minn 50 %.
English: Remeron contains aspartame, a source of phenylalanine.
Maltese: Remeron fih l-aspartame li huwa sors ta' fenilalanin.
English: • hallucinations
Maltese: • iponatrimija
English: • rash or skin eruptions (exanthema)
Maltese: • raxx jew eruzzjonijiet fil-ġilda (exanthema)
English: From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8).
Maltese: Minn esperjenza wara ttqegħid fuq is-suq , jidher illi serotonin syndrome iseħħ rarament ħafna f'pazjenti trattati b'Remeron waħdu (ara sezzjoni 4.8).
English: Additionally, the CHMP considered that the clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min).
Maltese: It-tneħħija ta' mirtazapine jista jkun imnaqqas f'pazjenti b'indeboliment renali moderata għal qawwija (tneħħija ta' creatinine <40 ml/min).
English: • Uncommon:
Maltese: • Mhux komuni:
English: Mirtazapine MirtazapinImi Pharma
Maltese: Mirtazapine Mirtazapin STADA
English: The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials.
Maltese: Il-frekwenzi tal-effetti mhux mixtieqa minn rapporti spontanji huma bbażati fuq ir-rata ta' rapportaġġ ta' dawn l-eventi fi provi kliniċi.
English: LIST OF EXCIPIENTS Maltitol liquid
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Maltitol likwidu
English: This medicinal product contains maltitol liquid.
Maltese: Dan il-prodott mediċinali fih il-maltitol likwidu.
English: Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions.
Maltese: Każijiet ta' dożi eċċessivi għandhom jirċievu terapija approprijata sintomatika u ta' appoġġ għal funzjonijiet vitali.
English: • hyponatraemia
Maltese: • letarġija
English: Dry mouth
Maltese: Qatta tul
English: - Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity).
Maltese: - Għanda tingħata attenzjoni f'pazjenti b'disturbi ta' micturition bħal ipertrofija tal-prostata u f'pazjenti glawkoma akuta narrow-angle u żieda fil-pressjoni intra-okulari (għalkemm il possibilita` ta' problemi b'Remeron hija żgħira minħabba li l-attivita` antikolinerġenika hijadgħajfa ħafna).
English: Therefore, the addition of a cross reference to section 4.3 of the SPC in section 4.5 (after the wording related to the interaction with MAOIs) was recommended, in line with the harmonised SPC for SSRIs and in line with the SPC for venlafaxine - a SNRI.
Maltese: Għalhekk, kienet rakkomandata ż-żieda ta' cross reference għal sezzjoni 4.3 tal-SPC f'sezzjoni 4.5 (wara l-kliem relatat ma' l-interazzjoni mal-MAOIs), b'mod konformi mal-SPC armonizzat għas-SSRIs u konformi mal-SPC għal venlafaxine - SNRI.
English: - No significant pharmacokinetic interactions are expected between mirtazapine and other psychotropic active substances because most psychotropic active substances are metabolized by multiple cytochrome P450 (CYP) iso-enzymes and one metabolic pathway will compensate for the other in case of inhibition of one or more CYP iso-enzymes.
Maltese: - Mhumiex mistennija interazzjonijiet farmakokinetiċi sinifikanti bejn mirtazapine u sustanzi psikotropiċi attivi oħra minħabba li l-maġġoranza tas-sustanzi psikotropiċi attivi jiġu metabolizzati minn diversi isoenzimi taċ-ċitokromu P450 (CYP) u passaġġ metaboliku wieħed jikkumpensa għall-ieħor f'każ ta' inibizzjoni ta' waħda jew aktar mill-isoenzimi CYP. Mirtazapine ma jinibixxix u ma jinduċix b'mod sinifikanti l-isoenzimi CYP. - L-istudji ta' l-interazzjoni ma indikaw ebda effetti farmakokinetiċi sinifikanti fuq it-trattament simultanju ta' mirtazapine ma' paroxetine, amitriptyline, jew risperidone jew lithium.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġieba relatata ma' suwiċidju (attentat ta' suwiċidju u ħsibijiet suwiċidali), u ostilita` (il-biċċa l-kbira laggressjoni, imġieba antagonistika u rabja) kienu osservati iktar frekwentement fil-provi kliniċi fi tfal u addoloxxenti trattati bl-anti-depressanti pparagunati ma' dawk trattati bil-plaċebo.