FrancophonIA/ELRC3.0 huggingface dataset:
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3 % of plasma AUC.
Maltese: Prodotti metaboliċi oħrajn instabu fil-plażma, l-awrina u l-ippurgar, li jissarfu f`anqas minn jew daqs 3% talplażma AUC.
English: Levviax tablets are presented in blister packs.
Maltese: Id-dehra tal Levviax u d-daqs tal-pakkett
English: As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of Levviax with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
Maltese: Minħabba li, bħall-makrolidi jista jtawwal l-intervall tal-QT, Levviax għandu jintuża bir-reqqa f'pazjenti li jbatu b'mard koronarju tal-qalb, li għandhom passat ta' taħbit irregolari tal-ventrikoli talqalb, livell baxx u mhux korrett tal-potassium u / jew tal-magnesium fid-demm, bradikardja
English: Flush Palpitations
Maltese: Ħmura tal-wiċċ palpitazzjonijiet
English: Uncommon or rare side effects (1 out of 10,000 to less than 1 out of 100 patients) which may occur with Levviax are:
Maltese: Effetti oħra mhux komuni, jew rari (1 minn kull 10,000 pazjent sa anqas minn 1 kull 100 pazjent) li jistgħu iseħħu b`Levviax huma:
English: Benzodiazepins
Maltese: Acinetobacter
English: The holder of this marketing Authorisation will have to submit PSURs every 6 months.
Maltese: Id-detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq għandu jissottometti PSURs kull 6 xhur.
English: Levviax is indicated for the treatment of the following infections:
Maltese: Levviax huwa indikat għall-kura ta' l-infezzjonijiet imsemmija hawn taħt :
English: Concomitant administration of Levviax and any of these medicinal products is contraindicated (see section 4.3).
Maltese: Epatite severa u insuffiċjenza tal-fwied (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets.
Maltese: TAL-PRODOTT MEDIĊINALI Levviax pilloli ta' 400 mg miksija b'rita.
English: Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Maltese: Ir-rapporti inkludew imwiet u indeboliment akut fil-funzjoni respiratorja, li tista' tkun fatali, ikkaratterizzata b'bidu mgħaġġel (ara sezzjoni 4.8).
English: Malta sanofi-aventis Malta Ltd. Tel: +356 21493022
Maltese: Ελλάδα sanofi-aventis AEBE Τηλ.: +30 210 900 16 00
English: - Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics.
Maltese: − Dijarrea severa, persistenti jew bid-demm, flimkien ma` wġigħ ta' żaqq jew deni, jistgħu jkunu sinjali ta' infjammazzjoni serja tal-musrana, li tista' isseħħ rari ħafna wara kura bl-antibijotiċi.
English: -Paediatric patients
Maltese: - Pazjenti pedjatriċi
English: Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
Maltese: Telithromycin huwa metabolizzat minn iżoenżimi ta' CYP450, kif ukoll minn enżimi li mhumiex tattip CYP.
English: Repeated dose toxicity studies of 1, 3 and 6 months duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes, and histological evidence of damage.
Maltese: Studji dwar l-effetti tossiċi b`dożi ripetuti ta` telithromycin li damu 1, 3 u 6 xhur fuq il-far, il-kelb u xxadina, urew li l-fwied kien l-organu prinċipali li ntlaqat minn effetti tossiċi, b'livelli għolja t'enżimi tal-fwied, u evidenza ħistoloġika ta' dannu.
English: Rare cases of transient loss of consciousness (fainting), which may be preceded by vagal symptoms (malaise, gastrointestinal distress), have been reported.
Maltese: Każijiet rari transitorji ta' telf mis-sensi (ħass ħażin), li jistgħu jkunu preċeduti minn sintomi tan-nervaturi tal-vagus (telqa, disturbi gastro-intestinali), kienu irrapportati.
English: Organon Hellas S.A. 122, Vouliagmenis Av. Helliniko
Maltese: Organon Hellas S.A. 122, Vouliagmenis Av.
English: Somnolence1, 4 Sedation1, 4
Maltese: Sonnolenza1, 4 Sedazzjoni1, 4
English: • the antidepressant nefazodone.
Maltese: • anti-depressant imsejjaħ nefazodone.
English: Immeuble Optima 10 rue Godefroy 92821 PUTEAUX Cedex France
Maltese: 10 rue Godefroy 92821 PUTEAUX Cedex France
English: Delegation of power: Organon België n.v., Terhulpsesteenweg 166, 1170 Brussels , Belgium
Maltese: Organon België n.v., Terhulpsesteenweg 166, 1170 Brussels , Belgium
English: IMI Pharma AS, Literbuen 9, DK- 2740 Skovlunde, Denmark
Maltese: IMI Pharma AS, Literbuen 9, DK- 2740
English: Organon Española, S.A. Ctra.
Maltese: Organon Española, S.A.
English: United Kingdom Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
Maltese: Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
English: Cambridge, CB4 0FL
Maltese: Cambridge, CB4 0FL United Kingdom
English: Organon GmbH Mittenheimer Straße 62 85764 Oberschleißheim Germany
Maltese: Organon GmbH Mittenheimer Straße 62 85764
English: • The active substance is mirtazapine.
Maltese: • Is-sustanza attiva hi mirtzapine.
English: C.A.Papaellinas & Co Ltd 179 Yiannos Kranidiotis Avenue,
Maltese: Ltd 179 Yiannos Kranidiotis Avenue,
English: • monoamine oxidase inhibitors (MAO inhibitors).
Maltese: • inibituri monoamine oxidase (inibituri MAO).
English: Steady state is reached after 3-4 days, after which there is no further accumulation.
Maltese: Stat stabbli huwa milħuq wara 3-4 ijiem, li wara ma jkunx hemm iżjed akkumulazzjoni.
English: System organ class
Maltese: Klassi tas-sistema organika
English: Luxembourg Organon Europe B.V. Kloosterstraat 6,
Maltese: Lussemburgu Organon Europe B.V. Kloosterstraat 6,
English: Suicidal ideation6 Suicidal behaviour6
Maltese: Ideazzjoni suwiċidali6 Imġieba suwiċidali6
English: A-1050 Wien Austria
Maltese: A-1050
English: Remeron oral solution contains 0.3 % v/v ethanol.
Maltese: Remeron soluzzjoni orali għandu 3 % v/v ta' ethanol.
English: Organon (Ireland) Limited, PO Box 2857,
Maltese: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co.
English: 1 ml of Remeron oral solution contains 700 mg maltitol liquid.
Maltese: 1 ml mis-soluzzjoni orali Remeron fiha 700 mg maltitol likwidu.
English: Insomnia3, 5
Maltese: Insomnja3, 5
English: SPC Section 4.3 Contraindications
Maltese: SPC Sezzjoni 4.3 Kontra-indikazzjonijiet
English: Maltitol liquid
Maltese: Maltitol Likwidu
English: Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16-B -2º 1070-159 Lisboa Portugal
Maltese: José Malhoa, 16-B -2º 1070-159 Lisboa Portugal
English: Hallucinations Psychomotor restlessness (incl.
Maltese: Irrekwitezza psikomutur (inkl.
English: Common (≥1/100 to
Maltese: Komuni (≥1/100 sa <1/10)
English: Pharmacokinetic interactions.
Maltese: Interazzjonijiet farmakokinetiċi.
English: • medicines to prevent blood clotting such as warfarin.
Maltese: • mediċini kontra t-tgħaqqid tad-demm bħal warfarin.
English: Elevations in serum transaminase activities
Maltese: Elevazzjonijie t fl-attivita` ta' serum transaminases
English: 15 mg 1 press 30 mg 2 presses 45 mg 3 presses
Maltese: 15 mg għafsa 1 30 mg 2 għafsiet 45 mg 3 għafsiet
English: • Rare:
Maltese: • Rari:
English: N.V. Organon, Kloosterstraat 6, P.O.
Maltese: N.V. Organon, Kloosterstraat 6, P.O. Box
English: Tear off one tablet pocket along the dotted lines (Figure 1).
Maltese: Qatta qartas ta' pillola waħda tul il-linji ittikkjati (Figura 1).
English: • fainting (syncope)
Maltese: • ħass ħażin (sinkope)
English: In Sections 4.3 (Contra-indications) and 4.5 (Interaction with other medicinal products and forms of interaction) of the SPC, the interaction with MAOIs concerns an absolute contra-indication in accordance with the SPCs for SSRIs and SNRIs.
Maltese: F'sezzjoni 4.3 (Kontra-indikazzjonijiet) u 4.5 (Interazzjoni ma' prodotti mediċinali oħra u forom ta' interazzjoni) tal-SPC, l-interazzjoni mal-MAOIs tirrigwarda kontra-indikazzjoni assoluta skond isSPCs għas-SSRIs u s-SNRIs.
English: Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Maltese: L-użu ta' mirtazapine flimkien ma' impedituri ta' monoamine oxidase (MAO) (ara sezzjoni 4.5).
English: NL 5340 AB Oss, The Netherlands
Maltese: 5349AB Oss, The Netherlands
English: • medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.
Maltese: • mediċini għall-epilessija bħal carbamazepine u phenytoin, u mediċini għat-tuberkolożi bħal rifampicin.
English: Maistraatinportti 2 00240 Helsinki, Finland
Maltese: Oy Organon Ab Maistraatinportti 2 00240
English: 6.1 List of excipients sugar spheres hypromellose povidone K30 magnesium stearate basic butylated methacrylate copolymer aspartame (E951) citric acid, anhydrous crospovidone (type A) mannitol (E421) microcrystalline cellulose natural and artificial orange flavour (No. SN027512) sodium hydrogen carbonate
Maltese: 6.1 Lista ta' sustanzi mhux attivi sugar spheres hypromellose povidone K30 magnesium stearate basic butylated methacrylate copolymer aspartame (E951) citric acid, anhydrous crospovidone (type A) mannitol (E421) microcrystalline cellulose natural and artificial orange flavour (No. SN027512) sodium hydrogen carbonate
English: Mirtazapine Mirtazapine orodispergeerbare tabletten
Maltese: Mirtazapine Mirtazapine orodiskullgeerbare pillolaten
English: In very rare cases these can be signs of serotonin syndrome.
Maltese: F'każijiet rari ħafna dawn jistgħu jkunu sinjali ta' serotonin syndrome.
English: L-methionine sodium benzoate (E211) saccharin sodium (E954) citric acid monohydrate (E330) glycerol (E422) maltitol liquid (E965) orange tangerine flavour No. PHL-132597 (contains ethanol) purified water
Maltese: L-methionine sodium benzoate (E211) saccharin sodium (E954) citric acid monohydrate (E330) glycerol (E422) maltitol liquid (E965) orange tangerine flavour No. PHL-132597 (fih ethanol) ilma ppurifikat
English: Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ml
Maltese: Remeron pilloli 15, 30 u 45 mg Remeron pilloli li jinħallu fil-ħalq 15, 30 u 45 mg Remeron soluzzjoni orali 15 mg/ml
English: The plastic films contain: PVC (polyvinyl chloride), polyamide and polyester.
Maltese: Ir-riti tal-plastik fihom: PVC (polimer ta' kloridu tal-vinil), poliamide u poliester.
English: Nausea3
Maltese: Nawsja3
English: • pain in your joints (arthralgia) or muscles (myalgia)
Maltese: • uġigħ fil-ġogi (arthralgia) jew muskoli (myalgia)
English: Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson's disease).
Maltese: Eżempji ta' inibituri MAO huma moclobemide, tranylcypromine (it-tnejn huma antidepressanti) u selegiline (użat għall-marda tal-Parkinsons).
English: • Common:
Maltese: • Komuni:
English: The applicant/ MAH also agreed to include the interaction with MAOIs in section 4.3 of the SPC:
Maltese: L-applikant/ Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq qablu wkoll li jinkludu l-interazzjoni mal-MAOIs f'sezzjoni 4.3 tal-SPC:
English: Mirtazapine Remeron-S smeltetabletter
Maltese: Mirtazapine Remeron-S smeltepillolater
English: The Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006) and the above mentioned guideline (CHMP/463/00) indicate which excipients and information should appear in the labelling.
Maltese: Il-Linja gwida dwar issustanzi mhux attivi fil-faxxiklu għall-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq ta' prodott mediċinali (EMEA/CHMP/QWP/396951/2006) u l-linja gwida msemmija qabel (CHMP/463/00) jindikaw liema sustanzi mhux attivi u informazzjoni għandhom jidhru fit-tikketti.
English: Outer carton and label, 15 mg/ml
Maltese: Kartuna ta' barra u tikketta, 15 mg/ml
English: The average plasma concentration of mirtazapine was about 55 % and 115 % increased respectively.
Maltese: Il-konċentrazzjoni medja tal-plażma ta' mirtazapine żdiedet b'madwar 55 % u 115 % rispettivament.
English: Hence it is proposed not to include MAO-inhibitors as absolute contraindication in section 4.3.
Maltese: Għaldaqstant huwa propost li l-inibituri MAO ma jiġux inklużi bħala kontra-indikazzjoni assoluta f'sezzjoni 4.3.
English: During the last PSUR period (01 Sep 2004 to 01 Sep 2007), 36 cases of hyponatraemia and 8 cases of SIADH were reported for mirtazapine (Remeron).
Maltese: Matul l-aħħar perjodu tal-PSUR (01 ta' Settembru 2004 sal-1 ta' Settembru 2007), ġew irrappurtati 36 każ ta' iponatremija u 8 każi ta' SIADH għal mirtazapine (Remeron).
English: Pharmacotherapeutic group: other antidepressants, ATC code: N06AX11
Maltese: Anti-depressanti, Kodiċi ATC:
English: Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine, respectively.
Maltese: Kull pillola ta' 15 mg , 30 mg u 45 mg mirtazapine tikkorispondi għal 2.6 mg, 5.2 mg u 7.8 mg fenilalanin rispettivament, Jista jkun ta' ħsara għal pazjenti b'fenilketonurja.
English: Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Maltese: Sintomi ta' serotonin syndrome jistgħu jkunu ipertermija, riġidita`, instabilita` awtonomika possibilment bi tmewwiġ rapidu tas-sinjali vitali, bdil fl-istat mentali li jista' jinkludi konfużjoni, irritabilita` u aġitazzjoni estrema li twassal għal delirju u koma.
English: Oedema peripheral1 Fatigue
Maltese: Edema periferali1 għejja
English: In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
Maltese: Tagħrif in vitro mill-mikrosomi tal-fwied uman jindika illi ċitokromju P450 enżimi CYP2D6 u CYP1A2 huma involuti fil-formazzjoni tal-metabolit 8-hydroxy ta' mirtazapine, filwaqt illi CYP3A4 huwa kkunsidrat bħala responsabbli għall-formazzjoni tal-metaboliti
English: On 14 February 2007 a combined renewal via MRP was concluded for Remeron film-coated tablets 45 mg, Remeron 15, 30, 45 mg, Remeron oral solution 15 mg/ml, Mirtazapine orodispersible tablets 15, 30, 45 mg., involving in total 8 Member States, including the Reference Member State (RMS).
Maltese: Fl-14 ta' Frar 2007 ġie konkluż tiġdid kombinat permezz tal-MRP għal Remeron pilloli miksijin b'rita 45 mg, Remeron 15, 30, 45 mg, Remeron soluzzjoni orali 15 mg/ml, Mirtazapine pilloli li jinħallu filħalq 15, 30, 45 mg., li b'kollox kien jinvolvi 8 Stati Membri, fosthom l-Istat Membru ta' Referenza (RMS).
English: • muscle twitching or contractions (myoclonus)
Maltese: • ġbid tal-muskoli jew kontrazzjonijiet (mijoklonus)
English: - Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
Maltese: - Ma ġewx osservati effetti farmakokinetiċi rilevanti fi trattament konkorrenti b'mirtazapine ma' paroxetine, amitriptyline, risperidone jew litju.
English: Convulsions (insults) Serotonin syndrome Oral paraesthesia
Maltese: Paraesteżija2 Aġitazzjoni fir-riġlejn sinkope mijoklonus konvulżjoniji et (insulti) serotonin syndrome paraesteżija orali
English: Mirtazapine is a centrally active presynaptic α2-antagonist, which increases central noradrenergic and serotonergic neurotransmission.
Maltese: Mirtazapine hija α2-antagonist presinattiku attiv ċentralment, li żżid in-newrotrażmissjoni noradrenerġika u serotonerġika ċentrali.
English: Headache2
Maltese: Doża
English: -seizures (epilepsy).
Maltese: • attakk epilettiku (aċċessjonijiet).
English: It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Maltese: Huwa rrakkomandat illi t-trattament b'mirtazapine jitwaqqaf b'mod gradwali sabiex jiġu evitati sintomi ta' rtirar (ara sezjoni 4.4).
English: Each Remeron 45 mg orodispersible tablet contains 13.95 mg aspartame and 84 mg sucrose.
Maltese: Kull pillola li tinħall fil-ħalq Remeron 45 mg fiha 13.95 mg aspartame u 84 mg zokkor tal-kannamieli.
English: • The other ingredients are L-methionine, sodium benzoate (E211), saccharin sodium (E954), citric acid monohydrate (E330), glycerol (E422), maltitol liquid (E965), orange tangerine flavour No.: PHL-132597 (contains ethanol) and purified water.
Maltese: • Is-sustanzi l-oħra huma L-methionine, sodium benzoate (E211), saccharin sodium (E954), citric acid monohydrate (E330), glycerol (E422), maltitol liquid (E965), orange tangerine flavour No.: PHL-132597 (fih ethanol) u ilma ppurifikat.
English: A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Maltese: Meta-analiżi ta' provi kliniċi kontrollati bi plaċebo ta' mediċinali anti-depressanti f'adulti b'mard psikjatriku wera riskju ikbar ta' imġieba suwiċidali b'anti-depressanti meta pparagunat ma' plaċebo f'pazjenti ta' taħt il-25 sena.
English: Sugar spheres (containing sucrose) and aspartame (E951) See leaflet for further information.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Sugar spheres (fihom sucrose) u aspartame (E951) Ara l-fuljett għal aktar informazzjoni.
English: BN
Maltese: MG
English: Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).
Maltese: Interazzjoni ma' sustanzi attivi serotonerġiċi: jista jseħħ serotonin syndrome meta serotonin reuptake inhibitors selettivi (SSRIs) jingħataw f'kumbinazzjoni ma' sustanzi attivi serotonerġiċi oħrajn (ara sezzjoni 4.5).
English: If there is no response within a further 2-4 weeks, then treatment should be stopped.
Maltese: Jekk ma jkunx hemm rispons fi żmien 2-4 ġimgħat oħra, it-trattament għandu jitwaqqaf.
English: After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. one hour.
Maltese: Wara amministrazzjoni orali ta' Remeron, is-sustanza attiva mirtazapine hija assorbita rapidament u tajjeb (bijodisponibilita` ≈ 50 %), tilħaq l-ogħla livelli plażma wara madwar sagħtejn.
English: In laboratory evaluations in clinical trials transient increases in transaminases and gammaglutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
Maltese: F'evalwazzjonijiet fil-laboratorju fi provi kliniċi ġew osservati żidiet għaddiena fi transaminases u gamma-glutamyltransferase (iżda ma ġewx irrapurtati eventi avversi assoċjati statistikament sinjifikanti iktar frekwenti b'Remeron milli bi plaċebo).
English: SPC 4.8 Undesirable Effects
Maltese: SPC 4.8 Effetti mhux mixtieqa
English: SPC Section 4.1 Therapeutic Indications
Maltese: SPC Sezzjoni 4.1 Indikazzjonijiet Terapewtiċi
English: INFORMATION IN BRAILLE Remeron 45
Maltese: INFORMAZZJONI BIL-BRAILLE Remeron 45
English: Mania Agitation2
Maltese: Manija Aġitazzjoni2
English: Do not take Remeron
Maltese: Tieħux Remeron
English: Exanthema2
Maltese: Inkubi2
English: INFORMATION IN BRAILLE Remeron
Maltese: INFORMAZZJONI BIL-BRAILLE Remeron
English: This medicinal product is authorised in the Member States of the EEA under the following names [not applicable for art 30 referral]
Maltese: [mhux applikabbli għal art 30 referenza]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of oral solution contains 15 mg mirtazapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 ml tas-soluzzjoni orali fih 15 mg mirtazapine
English: • The other ingredients are sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butylated methacrylate copolymer, aspartame (E951), anhydrous citric acid, crospovidone (type A), mannitol (E421), microcrystalline cellulose, natural and artificial orange flavour (No. SN027512) and sodium hydrogen carbonate.
Maltese: • L-ingredjenti l-oħrajn huma sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butylated methacrylate copolymer, aspartame (E951), anhydrous citric acid, crospovidone (type A), mannitol (E421), microcrystalline cellulose, natural u artificial orange flavour (No.
English: Mirtazapine Mirtazapine 30mg Tablets
Maltese: Mirtazapine Mirtazapine 30mg Pillolas
English: Group 3 Moderate/marked renal insufficiency with a GFR 10-39 ml/min/1.73 m2
Maltese: Grupp 3 Insuffiċjenza renali moderata/evidenti b'GFR ta' 10-39 ml/min/1.73 m2 Grupp 4 Insuffiċjenza renali akuta b'GFR ta' <10 ml/min/1.73 m2
English: Remeron (mirtazapine) has been referred for the harmonisation of Summary of Product Characteristics, in accordance with Article 30 (1) of Directive 2001/83/EC.
Maltese: Remeron (mirtazapine) ġie riferut għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott, skond l-Artikolu 30(1) tad-Direttiva 2001/83/KE. Mirtazapine huwa indikat għal episodji ta' depressjoni kbira.
English: INFORMATION IN BRAILLE Remeron 30
Maltese: INFORMAZZJONI BIL-BRAILLE Remeron 30
English: 45 mg Film coated tablets
Maltese: 45 mg Film coated pillolas
English: - Mirtazapine may increase the CNS depressant effect of alcohol.
Maltese: - Mirtazapine jista' jżid l-effett dipressanti CNS ta' l-alkoħol.
English: 15 mg Film coated tablets
Maltese: 15 mg Film coated pillolas
English: 30 mg Film coated tablets
Maltese: 30 mg Film coated pillolas
English: Mirtazapine Mirtazapine 45mg Tablets
Maltese: Mirtazapine Mirtazapine 45mg Pillolas
English: With an insufficient response, the dose can be increased up to the maximum dose.
Maltese: B'rispons insuffiċjenti, d-doża tista tiżdied sad-doża massima.
English: The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo.
Maltese: Il-meta-analiżi kkonċernat 20 prova, b'durata ta' trattament ippjanata sa 12-il ġimgħa, b'1501 pazjent (134 sena ta' persuni) li irċevew dożi ta' mirtazapine sa 60 mg u 850 pazjent (79 sena ta' persuni) li rċevew plaċebo.
English: Mirtazapine Mirtazapine 15mg Tablets
Maltese: Mirtazapine Mirtazapine 15mg Pillolas
English: Binding of mirtazapine to plasma proteins is approx. 85 %.
Maltese: L-irbit ta' mirtazapine mal-proteini tal-plażma huwa ta' madwar 85 %.
English: Mirtazapine Zispin® Soltab® orodispersible tablets
Maltese: ID-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: INFORMATION IN BRAILLE Remeron 15
Maltese: INFORMAZZJONI BIL-BRAILLE Remeron 15
English: Each Remeron 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose.
Maltese: Kull pillola li tinħall fil-ħalq Remeron 15 mg fiha 4.65 mg aspartame u 28 mg zokkor tal-kannamieli.
English: For Remeron 15, 30 and 45 mg orodispersible tablets the following pack sizes are available: 6, 18, 30, 48, 90, 96 and 180 orodispersible tablets (not all pack sizes may be marketed).
Maltese: Għal pilloli li jinħallu fil-ħalq Remeron 15, 30 u 45 mg huma disponibbli s-segwenti daqsijiet: 6, 18, 30, 48, 90, 96 u 180 pilloli li jinħallu fil-ħalq (mhux id-daqsijiet kollha tal-pakketti jistgħu jitqiegħdu fuq is-suq).
English: The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.
Maltese: It-tkabbir ta' newrotrażmissjoni serotonerġiku huwa speċifikament medjat via riċetturi 5-HT1, peress illi r-riċetturi 5-HT2 u 5-HT3 huma imblukkati b'mirtazapine.