FrancophonIA/ELRC3.0 huggingface dataset:
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001).
Maltese: F'żewġ studji fuq 12-il ġimgħa, ikkontrollati bi plaċebo (200109 u 200110), iż-żieda ta' Incruse Ellipta ma' fluticasone furoate/vilanterol (FF/VI) (92/22 mikrogramma) darba kuljum f'pazjenti adulti b'dijanjożi klinika ta' COPD, irriżultat f'titjib statistikament u klinikament sinifikanti fil-punt ta' tmiem primarju l-aktar baxx ta' FEV1 fil-Jum 85 meta mqabbel mal-plaċebo flimkien ma' FF/VI (124 mL 95% CI: 93, 154; p<0.001 u 122 mL 95%CI:
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited logo
Maltese: GlaxoSmithKline (Ireland) Limited logo
English: 2 years
Maltese: 4 sekondi).
English: Vision blurred
Maltese: • Vista mċajpra
English: How to use Incruse Ellipta 4.
Maltese: Kif għandek tuża Incruse Ellipta 4.
English: c)
Maltese: NUMRU(I)
English: Other medicines and Incruse Ellipta
Maltese: Mediċina oħra u Incruse Ellipta
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Irekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta 'aġġornament għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kull aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients receiving Incruse Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Maltese: Il-pazjenti li kienu qed jirċievu Incruse Ellipta kellhom perċentwal ogħla ta' ġranet fejn ma kienx hemm il-ħtieġa li jieħdu mediċina ta' salvataġġ (medja ta' 31.1%) meta mqabbla ma' plaċebo (medja ta' 21.7%).
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with placebo (15%) in the 12-week study.
Maltese: Il-proporzjon ta' pazjenti li rrispondew b'mill-inqas id-differenza minima klinikament importanti (MCID) ta' unità 1 fil-punteġġ fokali tad-TDI fil-Ġimgħa 12 kien akbar għal Incruse Ellipta(38%) meta mqabbel ma' plaċebo (15%) fl-istudju fuq 12-il ġimgħa.
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals
Maltese: GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: Glaxo Wellcome Production
Maltese: Priory Street Ware
English: Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12week pivotal study.
Maltese: Incruse Elliptawera titjib statistikament sinifikanti akbar mil-linja bażi fl-FEV1 medju peżat wara 0-6 sigħat wara d-doża fil-Ġimgħa 12 meta mqabbel ma' plaċebo (166 ml (p<0.001)) fl-istudju pivotali fuq 12-il ġimgħa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Maltese: 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide).
English: What Incruse Ellipta is
Maltese: incruse ellipta
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Incruse Ellipta on COPD exacerbation rate.
Maltese: Il-perjodu qasir ta' dawn iż-żewġ studji u n-numru limitat ta' avvenimenti ta' aggravar, jipprekludi kwalunkwe konklużjoni dwar l-effett addizzjonali ta' Incruse Ellipta fuq ir-rata ta' aggravar ta' COPD.
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Maltese: Fl-istudju fuq 24-ġimgħa kkontrollat bi plaċebo f'pazjeni b'COPD sintomatiku, Incruse Ellipta naqqas ir riskju ta' aggravar ta' COPD moderat/sever b'40 % meta mqabbel ma' plaċebo (analiżi taż-żmien għallewwel aggravar; Proporzjoni tal-Periklu ta' 0.6; 95% CI: 0.4, 1.0, p=0.035*)).Il-probabbiltà ta' aggravar f'pazjenti li kienu qed jirċievu Incruse Ellipta fil-ġimgħa 24 kienet ta' 8.9% meta mqabbla ma' 13.7% għall plaċebo.
English: Incruse Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001
Maltese: Incruse Ellipta wera titjib akbar mil-linja bażi fl-FEV1 medju peżat wara 0-6 sigħat wara d-doża filĠimgħa 24 meta mqabbel ma' plaċebo (150 ml; p<0.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Maltese: Kull inalazzjoni waħdanija tipprovdi doża mogħtija (id-doża li toħroġ mill-biċċa tal-ħalq tal-inalatur) ta' 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide).
English: Incruse Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Maltese: George's (SGRQ) kif indikat bi tnaqqis fil-punteġġ totali ta' SGRQ fil-Ġimgħa 12 meta mqabbla ma' plaċebo (-7.90 unità, p≤0.001) fl-istudju fuq 12-il ġimgħa.
English: The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
Maltese: doża (provvista ta' 30 jum) jew għall-inalatur ta' 7 dożi (provvista ta' 7 ijiem).
English: INFORMATION IN BRAILLE incruse ellipta
Maltese: X'inhu Incruse Ellipta
English: An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Maltese: 1,412 pazjent li rċevew umeclidinium bromide).
English: Incruse Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Maltese: Incruse Ellipta fih is-sustanza attiva umeclidinium bromide, li tagħmel parti minn grupp ta' mediċini magħrufa bħala bronkodilaturi.
English: Infections and infestations Nasopharyngitis Upper respiratory tract infection Urinary tract infection
Maltese: Infezzjoni fl-apparat urinarju Sinusite
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study.
Maltese: Titjib statistikament sinifikanti meta mqabbel ma' plaċebo fil-punteġġ fokali tat-TDI fil-Ġimgħa 24 intwera għal Incruse Ellipta(1.0 unità,
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Maltese: Id-data “Armi sa” hija 6 ġimgħat mid-data meta tkun ftaħt ittrej.
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Maltese: Incruse Ellipta 55 mcg trab li jittieħed man-nifs umeclidinium (umeclidinium bromide)
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Maltese: Bl-istess mod, kien hemm proporzjon akbar ta' pazjenti li kisbu mill-inqas l-MCID għal Incruse Ellipta 55 mikrogramma fil-Ġimgħa 24 (44%) meta mqabbla ma' plaċebo (34%) fl istudju fuq 24-ġimgħa.
English: In the 12-week study, Incruse Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Maltese: salvataġġ b'salbutamol meta mqabbel ma' plaċebo (tnaqqis b'medja ta' 0.7 puffs kuljum matul il-Ġimgħat 112, p=0.025) u wera perċentwal ogħla ta' ġranet meta ma kienx hemm il-ħtieġa ta' xi mediċina ta' salvataġġ (medja ta' 46.3%) meta mqabbel ma' plaċebo (medja ta' 35.2%; l-ebda analiżi statistika formali ma twettqet fuq dan l-endpoint).
English: EXPIRY DATE EXP
Maltese: EXP
English: In the 24-week study treatment with Incruse Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Maltese: għal plaċebo u ta' -1.7 (0.16) għal Incruse Ellipta (Differenza = -0.3; 95%CI:
English: • constipation.
Maltese: glawkoma).
English: • Difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention
Maltese: • Diffikultà u uġigħ meta tgħaddi l-awrina - dawn jistgħu jkunu sinjali ta' ostruzzjoni tal-bużżieqa tal awrina jew ta' żamma tal-awrina • Sturdament
English: The clinical efficacy of Incruse Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Maltese: studju fuq 12-il ġimgħa (AC4115408) u studju fuq 24-ġimgħa (DB2113373).
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05).
Maltese: Fl-istudju fuq 12-il ġimgħa, ma ntweriex titjib statistikament sinifikanti meta mqabbel ma' plaċebo fil punteġġ fokali tat-TDI fil-Ġimgħa 12 għal Incruse Ellipta(1.0 unità, p=0.05).
English: Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Maltese: Incruse Ellipta 55 mikrogramma trab li jittieħed man-nifs, lest minn qabel umeclidinium (umeclidinium bromide)
English: Allergic reactions are uncommon (may affect up to 1 in 100 people).
Maltese: Reazzjonijiet allerġiċi mhumiex komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna).
English: • itching
Maltese: • stitikezza.
English: Excipients
Maltese: Inalatur
English: In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Maltese: Fi studju tal-Fażi III, li dam għaddej 6 xhur (DB2113373),Incruse Ellipta ipprovda titjib klinikament sinifikanti fuq plaċebo fil-funzjoni tal-pulmun (kif imkejjel bil-volum tal-arja sfurzat 'l barra f'sekonda 1
English: Inhalation powder, pre-dispensed.
Maltese: polycarbonate u stainless steel.
English: Deterioration of disease
Maltese: Infezzjonijiet u infestazzjonijiet
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Maltese: • Jekk il-counter tad-dożi ma jonqosx 'l isfel malli tisma l-“klikk”, l-inalatur ma jagħtix il mediċina.
English: Incruse Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
Maltese: Incruse Ellipta ma ġiex studjat f'pazjenti b'indeboliment epatiku sever u għandu jintuża b'kawtela (ara sezzjoni 5.2).
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Maltese: L-inalatur Ellipta jikkonsisti minn korp tal-plastik griż, għatu aħdar ċar tal-biċċa tal-ħalq u counter tad-dożi.
English: Magnesium stearate
Maltese: Fibrillazzjoni atrijali
English: Desiccant Tray
Maltese: Għatu tat-trej
English: Step-by-step instructions for use
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva
English: GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Maltese: GlaxoSmithKline d.o.o. Tel: +385 1 6051999
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/922/003
Maltese: EU/1/14/922/001 EU/1/14/922/002 EU/1/14/922/003
English: The primary endpoint was annual rate of ontreatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with FF/VI.
Maltese: Il-punt tat-tmiem primarju ken ir-rata annwali ta' aggravar moderat u sever meta l-pazjent kien fuq it-tratttament f'individwi ttrattati b'FF/UMC/VI meta mqabbel ma' FF/VI.
English: If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.
Maltese: Ma kien hemm ebda evidenza ta' takifilassi fl-effett ta' Incruse Elliptamaż-żmien.
English: ARICLAIM is indicated in adults.
Maltese: ARICLAIM huwa indikat għall-adulti.
English: Date of latest renewal: 24 June 2009
Maltese: Data tal-aħħar tiġdid: 24 ta' Ġunju 2009
English: • depression, anxiety and urinary incontinence
Maltese: • depressjoni, ansjetà u inkontinenza awrinarja
English: EU/1/04/283/012 (98 hard gastro-resistant capsules)
Maltese: EU/1/04/283/012 (98 kapsula gastro-reżistenti iebsa)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008 (7 hard gastro-resistant capsules) EU/1/04/283/009 (28 hard gastro-resistant capsules) EU/1/04/283/010 (98 hard gastro-resistant capsules)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/283/008 (7 kapsuli gastro-reżistenti ibsin) EU/1/04/283/009 (28 kapsula gastro-reżistenti iebsa) EU/1/04/283/010 (98 kapsula gastro-reżistenti iebsa)
English: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel:
English: ARICLAIM contains the active substance duloxetine.
Maltese: ARICLAIM fih is-sustanza attiva duloxetine.
English: ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: ARICLAIM iżid il-livelli ta' serotonin u ta' noradrenaline fis-sistema nervuża.
English: ARICLAIM is available in 2 strengths: 30 mg and 60 mg.
Maltese: ARICLAIM issibu f'2 dożi: 30 mg u 60 mg
English: Other medicines and ARICLAIM
Maltese: Mediċini oħra u ARICLAIM
English: ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
Maltese: ARICLAIM 60 mg issibu f'pakketti ta' 28 u 98 kapsula.
English: DO NOT take ARICLAIM if you:
Maltese: X'fih ARICLAIM:
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati minn rapporti spontanji u f'provi kliniċi kkontrollati bil plaċebo.
English: INFORMATION IN BRAILLE ARICLAIM 60 mg
Maltese: ARICLAIM 60 mg
English: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Maltese: Kontenut tal-kapsula: hypromellose, hypromellose acetate succinate, sucrose, sferi taz-zokkor, talkum,titanium dioxide (E171), triethyl citrate.
English: Hard gastro-resistant capsule.
Maltese: Kapsula gastro-reżistenti iebsa.
English: 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Maltese: 28 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: ID-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 August 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Awissu 2004
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with ARICLAIM and 23% of patients taking placebo.
Maltese: F'provi kliniċi avvenimenti mhux mixtieqa b'sospensjoni tal-kura f'daqqa seħħew f'madwar 45% ta' pazjenti b'kura ta' ARICLAIM u 23% ta' pazjenti jieħdu l-plaċebo.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Maltese: Kontraċettivi orali u sustanzi sterojdi oħra: Riżultati ta' studji in vitro juru li duloxetine ma jistimulax l-attività katalitika ta' CYP3A.
English: ARICLAIM contains sucrose
Maltese: ARICLAIM fih s-sucrose
English: ARICLAIM contains sucrose.
Maltese: ARICLAIM fih s-sucrose.
English: ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
Maltese: ARICLAIM 30 mg issibu f'pakketti ta' 7, 28 u 98 kapsula ARICLAIM 60 mg issibu f'pakketti ta' 28 u 98 kapsula.
English: The plasma concentration of duloxetine displays large inter-individual variability (see section 5.2).
Maltese: Il konċentrazzjoni fil-plażma ta' duloxetine turi varjabbilità kbira bejn individwu u ieħor (ara sezzjoni 5.2).
English: EU/1/04/283/012
Maltese: EU/1/04/283/011 EU/1/04/283/012
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Maltese: Ma ġiet osservata l-ebda differenza klinikament sinifikanti meta ġie kkalkulat il-QT, il-PR, il-QRS, jew il-QTcB bejn pazjenti fuq kura ta' duloxetine u pazjenti fuq plaċebo.
English: Menopausal symptoms Galactorrhoea
Maltese: Sintomi tal menopawża
English: Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, ARICLAIM m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Maltese: Il-kapsuli ta' 30 mg huma blu u bojod u huma stampati b''30 mg' u l-kodiċi ‘9543'.
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Maltese: Il-kapsuli ta' 60 mg huma blu u bojod u huma stampati b''60 mg' u l-kodiċi ‘9542'.
English: Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Maltese: Konsegwentement, huwa rrakkomandat li ARICLAIM jingħata b'attenzjoni meta jittieħed flimkien ma' prodotti mediċinali jew sustanzi li jaħdmu b'mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti-psikotiċi, phenobarbital,
English: ARICLAIM must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: ARICLAIM ma jistax jiġi użat f'pazjenti b'indeboliment renali gravi (tneħħija tal-krejatinina <30 ml/min; ara sezzjoni 4.3).
English: The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Maltese: L-effikaċja ta' duloxetine bħala kura għall-uġigħ newropatiku tad-dijabete kien stabbilit f'żewġ studji ta' 12-il ġimgħa, b'dożi fissi, ikkontrollati bi plaċebo,randomised u double-blind f'adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad-dijabete għallinqas għal 6 xhur.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Maltese: Analiżi ta' numru ta' studji kliniċi kkontrollati bi plaċebo ta' prodotti mediċinali antidipressivi li ntużaw f'disturbi psikjatriċi wrew riskju ogħla ta' mġiba suwiċidali bl-antidipressivi meta mqabbla ma' plaċebo f'pazjenti iżgħar minn 25 sena.
English: Concomitant use of ARICLAIM with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' ARICLAIM ma' inibituri ta' monoamine oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra-indikat (ara sezzjoni 4.5).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Maltese: intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucroseisomaltase m'għandhomx jieħdu din il-mediċina.
English: How to take ARICLAIM
Maltese: TIĦUX ARICLAIM jekk
English: Infections and infestations Immune system disorders
Maltese: Infezzjonijiet u infestazzjonijiet Disturbi fis-sistema immuni
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
Maltese: ARICLAIM 30 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
Maltese: ARICLAIM 60 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: When stopping treatment with ARICLAIM 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'ARICLAIM 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: Stomatitis Haematochezia Breath odour Microscopic colitis
Maltese: Disturbi muskolu-skeletriki u tat-tessuti konnetivi Uġigħ muskoluskeletali
English: ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Maltese: ARICLAIM m'għandux jiġi użat flimkien ma' fluvoxamine, ciprofloxacin jew enoxacin (jiġifieri inibituri qawwija ta' CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine filplażma (ara sezzjoni 4.5).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Hyponatraemia may be due to a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Maltese: L-iponatrimja tista' sseħħ minħabba sindromu ta' sekrezzjoni mhux f'loka tal-ormon anti-dijuretiku (SIADH).