FrancophonIA/ELRC3.0 huggingface dataset:
English: These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Maltese: Dawn it-tumuri jistgħu jkunu marbuta ma' antagoniżmu tad-dopamina D2 fit-tul u iperprolaktinemija.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 50 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 50 mg paliperidone.
English: Musculoskeletal and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, muscular weakness, neck pain rhabdomyolysis, joint swelling posture abnormal
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi uġigħ muskoluskelettriku, uġigħ fid-dahar, artralġja żieda fil-creatine phosphokinase fiddemm, spażmi filmuskoli, ebusija filġogi, dgħufija filmuskoli, uġigħ flgħonq rabdomijolisi, nefħa fil-ġogi qagħda mhux normali
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 150 mg paliperidone.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Maltese: Din il-mediċina tista' tnaqqas l-effett ta' mediċini kontra l-marda ta' Parkinson u s-sindromu ta' nuqqas ta' kwiet fir-riġlejn (eż., levodopa).
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when Xeplion is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
Maltese: Minħabba l-potenzjal li għandu li jinduċi l-ipotensjoni ortostatika (ara sezzjoni 4.4), jista' jiġi osservat effett kumulattiv meta Xeplion jingħata ma' aġenti terapewtiċi oħrajn li għandhom dan il-potenzjal eż. antipsikotiċi oħrajn, triċikliċi.
English: Xeplion should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Maltese: Xeplion m'għandux jintuża sabiex jikkontrolla stati ta' aġitazzjoni akuta jew stati psikotiċi severi meta jkun meħtieġ kontroll immedjat tas-sintomi.
English: Reproductive system and breast disorders amenorrhoea, galactorrhoea erectile dysfunction, ejaculation disorder, menstrual disorder e, gynaecomastia, sexual dysfunction, breast pain breast discomfort, breast engorgement, breast enlargement, vaginal discharge priapism
Maltese: Disturbi fissistema riproduttiva u fissider amenorrea, galaktorrea disfunzjoni erettili, disturb fleġakulazzjoni, disturb fil-menstrwazzjoni e, ġinekomastja, funzjoni sesswali ħażina, uġigħ fis-sider skumdità fis-sider, konġestjoni fissider, tkabbir tassider, tisfija millvaġina prijapiżmu
English: • glaucoma (increased pressure within the eyeball)
Maltese: • glawkoma (żieda fil-pressjoni ġewwa l-boċċa tal-għajn)
English: • experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
Maltese: • ikollok allerġija severa kkaratterizzata minn deni, nefħa fil-ħalq, fil-wiċċ, fix-xufftejn jew flilsien, qtugħ ta' nifs, ħakk, raxx fil-ġilda u xi kultant tnaqqis fil-pressjoni tad-demm (li tammonta għal ‘reazzjoni anafilattika').
English: Blood and lymphatic system disorders white blood cell count decreased, thrombocytopenia, anaemia neutropenia, eosinophil count increased agranulocytosis
Maltese: Jekk tinnota kwalunkwe minn dawn is-sintomi, fittex minnufih l-għajnuna medika
English: Each Xeplion 50 mg pre-filled syringe contains 78 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' Xeplion 50 mg fiha 78 mg ta' paliperidone palmitate.
English: Ear and labyrinth disorders vertigo, tinnitus, ear pain
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: Xeplion 50 mg prolonged release suspension for injection Paliperidone
Maltese: Xeplion 50 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Paliperidone
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg).
Maltese: • ikollok tagħqid tad-demm fil-vini speċjalment fir-riġlejn (sintomi jinkludu nefħa, uġigħ u ħmura fis-sieq).
English: • newborn babies born to mothers who have taken Xeplion during pregnancy may experience side effects of the drug and/or withdrawal symptoms, such as irritability, slow, or sustained muscle contractions, shaking, sleepiness, breathing, or feeding problems
Maltese: • trabi tat-twelid imwielda minn ommijiet li jkunu ħadu Xeplion matul it-tqala jista' jkollhom effetti sekondarji tal-mediċina u/jew sintomi ta' twaqqif tal-mediċina, bħal irritabbiltà,
English: body temperature increased, gait abnormal, chest pain, chest discomfort, malaise, induration hypothermia, chills, thirst, drug withdrawal syndrome, injection site abscess, injection site cellulitis, injection site cyst, injection site haematoma body temperature decreased, injection site necrosis, injection site ulcer
Maltese: żieda fit-temperatura tal-ġisem, mixi mhux normali, uġigħ fissider, skumdità fissider, telqa tal-ġisem mingħajr sinjali ta' mard, ebusija ipotermja, tkexkix ta' bard, għatx, sindrome ta' waqfien ta' mediċina li tivvizzjak, axxess fis-sit talinjezzjoni, ċellulite fis-sit talinjezzjoni, ċesta fis-sit talinjezzjoni, ematoma fis-sit tal-injezzjoni tnaqqis fittemperatura tal-ġisem, nekrożi fis-sit tal-injezzjoni, ulċera fis-sit tal-injezzjoni
English: Based on a limited number of observations with Xeplion in subjects with mild renal impairment and pharmacokinetic simulations, a reduced dose is recommended (see section 4.2).
Maltese: Skont għadd żgħir ta' osservazzjonijiet b'Xeplion f'individwi b'indeboliment renali ħafif u simulazzjonijiet farmakokinetiċi, hija rrakkomandata doża mnaqqsa (ara sezzjoni 4.2).
English: Safety data involving concomitant use of Xeplion with other antipsychotics is limited.
Maltese: Id-dejta dwar is-sigurtà li tinvolvi l-użu ta' Xeplion flimkien ma' mediċini antipsikotiċi oħra hja limitata.
English: Metabolism and nutrition disorders hyperglycaemia, weight increased, weight decreased, decreased appetite diabetes mellitus d, hyperinsulinaemia, increased appetite, anorexia, blood triglycerides increased, blood cholesterol increased diabetic ketoacidosis, hypoglycaemia, polydipsia water intoxication
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni ipergliċemija, żieda fil-piż, tnaqqis fil-piż, nuqqas ta' aptit dijabete mellitus d, iperinsulinemija, żieda fl-aptit, anoreksja, żieda fit-trigliċeridi tad-demm żieda filkolesterol tad-demm ketoaċidożi taddijabete, ipogliċemija, polidipsja intossikazzjon i ta' ilma
English: Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Janssen-Cilag International NV Turnhoutseweg 30
English: In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Maltese: Pożittivi tfisser sintomi żejda li normalment ma jkunux preżenti.
English: Grasp the needle sheath using the plastic peel pouch.
Maltese: Dawn jistgħu jkunu senjali ta' puplesija.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Maltese: Il-parti l-kbira ta' dawn ir-reazzjonijiet ġew irrapportati li kienu ta' severità ħafifa għal moderata.
English: • excessive passing of gas or wind
Maltese: • xorb eċċessiv ta' ilma
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Maltese: Prodotti mediċinali b'karatteristiċi antagonistiċi għar-riċettur ta' dopamine ġew assoċjati malinduzzjoni ta' diskajneżja tardiva kkaratterizzata minn ċaqliq ritmiku involontarju, l-iktar tal-ilsien u/jew tal-wiċċ.
English: Vascular disorders hypertension hypotension, orthostatic hypotension venous thrombosis, flushing pulmonary embolism, ischaemia
Maltese: • skumdità fl-addome, infezzjoni fl-istonku jew fil-musrana, diffikultà biex tibla', ħalq xott
English: 75 mg monthly
Maltese: 75 mg kull xahar
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Lista ta` l-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, id detenturi ta` l-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Strengths Phramaceutical form
Maltese: LEFLUNOMID ACTAVIS 100
English: (Invented) name
Maltese: Anness I
English: Member State EU/EEA
Maltese: Il-Pajjiżi l-Baxxi
English: Strength Pharmaceutical form
Maltese: Pharma
English: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Maltese: Ελλάδα ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: De la Industria, 30, 28108 Alcobendas, Madrid, Spain.
Maltese: De la Industria, 30, 28108 Alcobendas, Madrid, Spanja.
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Maltese: de la Industria N° 30 28108 Alcobendas Madrid
English: • depression
Maltese: • depressjoni
English: Each capsule may contain up to 111 mg sucrose.
Maltese: Kull kapsula jista' jkollha sa 111 mg sucrose.
English: Manufacturer: Lilly S.A., Avda.
Maltese: Lilly S.A., Avda.
English: The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Maltese: Il-biodisponibiltà orali assoluta ta' duloxetine kienet mifruxa bejn 32% sa 80% (medja ta' 50%).
English: Hypertension3,7 Orthostatic hypotension2
Maltese: Ipertensjoni3,7 Ipotensjoni ortostatika2
English: Duloxetine is approximately 96% bound to human plasma proteins.
Maltese: Duloxetine huwa bejn wieħed u ieħor 96% marbut mal-proteini tal-plażma umana.
English: ATC code: N06AX21.
Maltese: N06AX21
English: Syncope2
Maltese: Sinkope2
English: Pharmacotherapeutic group: psychoanaleptics, antidepressants, other antidepressants.
Maltese: Kategorija farmakoterapewtika: psikoanalettiċi, antidepressivi, antidepressivi oħra.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: 3 See section 4.4.
Maltese: 3 Ara sezzjoni 4.4
English: The active substance is duloxetine.
Maltese: Is-sustanza attiva hi duloxetine.
English: Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Each capsule may contain up to 56 mg sucrose.
Maltese: Kull kapsula jista' jkollha sa 56 mg sucrose.
English: During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Maltese: Matul il-perijodu ta' kura akuta ta' 10 ġimgħat, ġiet irrapportata mġiba suwiċidali (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], plaċebo 1/220 [0.5%]).
English: 7 Not statistically significantly different from placebo.
Maltese: 7 Statistikament mhuwiex differenti b'mod sinifikanti minn plaċebo.
English: Current available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Id-dejta li hemm disponibbli bħalissa hija deskritta f'sezzjonijiet 4.8, 5.1 u 5
English: Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Maltese: Polyvinylchloride (PVC), polyethylene (PE), u folja tal-polychlorotrifluoroethylene (PCTFE)
English: Convulsion1
Maltese: Konvulżjoni1
English: Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic).
Maltese: Eżempji ta' MAOIs jinkludu moclobemide (antidipressiv) u linezolid (antibijotiku).
English: Suicidal behaviour5,7
Maltese: Imġiba suwiċidali5,7
English: Duloxetine Lilly is indicated in adults.
Maltese: Duloxetine Lilly huwa indikat għall-adulti.
English: Table 1: Adverse reactions
Maltese: Tabella 1: Reazzjonijiet avversi
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Maltese: 50% fl-uġigħ kienu 50% u 26% rispettivament.
English: Abrupt discontinuation should be avoided.
Maltese: Sospensjoni tal-kura Għandha tiġi evitata sospensjoni f'daqqa waħda.
English: Trismus
Maltese: Trismu
English: Ελλάδα
Maltese: OĦRA TAL
English: Akathisia/psychomotor restlessness
Maltese: Akatiżja/irrekwitezza psikomotorja
English: Mania
Maltese: Manija
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni fuq lużu pedjatriku.
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 (Ara fl-aħħar ta' sezzjoni 2 għal aktar informazzjoni dwar sucrose).
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 bilplaċebo.
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: EU/1/14/972/001 EU/1/14/972/002 EU/1/14/972/003 EU/1/14/972/004 EU/1/14/972/005 EU/1/14/972/006 EU/1/14/972/007 EU/1/14/972/008 EU/1/14/972/009
Maltese: EU/1/14/972/006 EU/1/14/972/007 EU/1/14/972/008 EU/1/14/972/009
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).
Maltese: Wara doża minn ġol-vini t-tneħħija mill-plażma ta' duloxetine tvarja minn 22 l/hr sa 46 l/hr (medja ta' 36 l/hr).
English: Suicidal ideation5,7
Maltese: Formazzjoni ta' ideat suwiċidali5,7
English: Stevens-Johnson Syndrome6
Maltese: Sindromu ta' Stevens-Johnson6
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Maltese: (ALT, AST, alkaline phosphatase)
English: Aggression and anger4
Maltese: Aggressjoni u rabja4
English: Hypertensive crisis3,6
Maltese: Kriżi ipertensiva3,6
English: 28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Maltese: 28 kapsula gastro-reżistenti iebsa 56 kapsula gastro-reżistenti iebsa 84 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa
English: Duloxetine Lilly 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.
Maltese: Duloxetine Lilly 60 mg issibu f'pakketti ta' 28, 56, 84 u 98 kapsula gastro-reżistenti iebsa u f'pakketti multipli li fihom 100 (5 pakketti ta' 20) u 500 (25 pakkett ta' 20) kapsula gastro-reżistenti iebsa.
English: • generalised anxiety disorder (chronic feeling of anxiety or nervousness)
Maltese: • disturb ta' l-ansjetà ġeneralizzata (sensazzjoni kronika ta' ansjetà jew nervożità)
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy duloxetine.
Maltese: Kemm P450-2D6 kif ukoll 1A2 jikkatalizzaw il-formazzjoni taż-żewġ prodotti metaboliċi prinċipali l-glukuronidu kkonjugat ta' 4-hydroxy duloxetine u l-konjugat tas-sulfat ta' 5-hydroxy 6
English: For further information see section 5.1.
Maltese: Għal aktar informazzjoni ara sezzjoni 5.1.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Maltese: Il-farmakokinetika ta' duloxetine turu varjabiltà kbira bejn persuna u oħra (ġeneralment 50-60%), in parti dovuta għas-sess, l-età, is-sitwazzjoni tat-tipjip u l istat ta' metaboliżmu minn CYP2D6.
English: Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
Maltese: Indeboliment gravi tal-kliewi (tneħħija tal-kreatinina <30 ml/min) (ara sezzjoni 4.4).
English: For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% of patients on placebo.
Maltese: F'pazjenti li ma qabadhomx in-ngħas,ir-rispons kliniku kien osservat f'47% tal-pazjenti li rċevew duloxetine u f'27% tal-pazjenti li kienu fuq plaċebo.
English: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Maltese: Duloxetine huwa inibitur ta' ġbir mill-ġdid (reuptake inhibitor) kemm tas-serotonin (5-HT) u kemm tan-noradrenaline (NA).
English: Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Maltese: Inkjostru abjad li jittiekel: titanium dioxide (E171), propylene glycol, shellac, povidone.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Maltese: Palpitazzjonijiet Takikardija Arritmija supraventrikolari, laktar fibrillazzjoni ta' l-atrija
English: The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Maltese: Huwa kkalkulat li d-doża ta' kuljum fit-trabi fuq bażi ta' mg/kg hija bejn wieħed u ieħor 0.14% tad-doża materna (ara sezzjoni 5.2).
English: Eli Lilly Slovakia, s.r.o.
Maltese: Slovenská republika Eli Lilly Slovakia, s.r.o.
English: Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Maltese: Mediċini li jżidu l-livell ta' serotonin: Triptans, tramadol, tryptophan, SSRIs (bħal paroxetine u fluoxetine), SNRIs (bħal venlafaxine), antidipressivi triċikliċi (bħal clomipramine,amitriptyline), pethidine, St.John's Wort u MAOIs (bħal moclobemide u linezolid).
English: Major depressive disorder
Maltese: Disturb depressiv maġġuri
English: The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Maltese: L-inċidenza ta' rikaduta matul il-perijodu ta' 6 xhur ta' follow-up, li kien double-blind, kienet ta' 17% u 29% għal duloxetine u plaċebo, rispettivament.
English: Duloxetine Lilly contains the active substance duloxetine.
Maltese: Duloxetine Lilly fih is-sustanza attiva duloxetine.
English: Serotonin syndrome6
Maltese: Sindrome ta' serotonin6
English: b. Tabulated list of adverse reactions
Maltese: b. Lista f'forma tabulari tar-reazzjonijiet avversi
English: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Maltese: Indeboliment tal-fwied Mard moderat fil-fwied (Child Pugh Klassi B) affettwa l-farmakokinetika ta' duloxetine.
English: Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Maltese: Studji fl-annimali juru tossiċità fis-sistema riproduttiva f'livelli ta' esponiment sistemiku (AUC) ta' duloxetine anqas millesponiment kliniku massimu (ara sezzjoni 5.3).
English: Clinical efficacy and safety
Maltese: Sigurtà u effikaċja klinika
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Maltese: S.A Pārstāvniecība Latvijā Tel:
English: Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.
Maltese: Inkjostru aħdar li jittiekel: iron oxide iswed sintetiku (E172), iron oxide isfar sintetiku (E172), propylene glycol, shellac.
English: Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) statistically separated from placebo on change from baseline to endpoint in the Children´s Depression Rating Scale-Revised (CDRS-R) total score.
Maltese: Bħala bidla mil-linja bażi sar-riżultat finali, la duloxetine (30-120 mg) u lanqas il-fergħa ta' kontroll attiv (fluoxetine 20-40 mg) ma sseparaw b'mod statistiku mill-plaċebo fil-valur totali taċ-Children´s Depression Rating Scale-Revised (CDRS-R).
English: Laryngitis
Maltese: Larinġite
English: Multipack: 100 (5 packs of 20) hard gastro-resistant capsules Multipack: 500 (25 packs of 20) hard gastro-resistant capsules
Maltese: Pakkett multiplu: 500 (25 pakkett of 20) kapsula gastro-reżistenti iebsa.
English: For generalised anxiety disorder:
Maltese: Disturb Depressiv Maġġuri:
English: Duloxetine Lilly increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: Duloxetine Lilly jżid il-livelli ta' serotonin u ta' noradrenaline fis-sistema nervuża.
English: Eosinophilic pneumonia6
Maltese: Pulmonite eosinofilika6
English: Duloxetine Lilly contains sucrose
Maltese: Duloxetine Lilly fih s-sucrose
English: Medicinal products containing duloxetine
Maltese: Prodotti mediċinali li fihom duloxetine
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Maltese: Kolite mikroskopika9
English: Peripheral coldness
Maltese: Ksieħ periferiku
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Maltese: L-AUC fiss ta' tolterodine (2 mg darbtejn kuljum) tiżdied b'71% meta jingħata flimkien ma' duloxetine (40 mg darbtejn kuljum), iżda ma jaffettwax il-farmakokinetika tal-metabolat attiv tiegħu 5-hydroxyl u mhux irrakkomandat li jsir aġġustament ta' doża.
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Maltese: Imqabbla ma' pazjenti b'saħħithom, it-tneħħija apparenti mill-plażma ta' duloxetine kienet 79% anqas, il-half life terminali apparenti kien 2.3 darbiet itwal u l-AUC kien 3.7 darbiet ogħla f'pazjenti li kellhom mard moderat fil-fwied.
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Maltese: Disturbi muskolu-skeletriki u tat-tessuti konnetivi
English: Duloxetine Lilly contains sucrose.
Maltese: Duloxetine Lilly fih s-sucrose.
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebo-treated patients.
Maltese: F'provi kliniċi, total ta' 467 pazjent pedjatriku, li għall-ewwel ġew mogħtija b'mod arbitrarju duloxetine, kellhom medja ta' tnaqqis fil-piż ta' 0.1 kg fl-10 ġimgħa meta mqabbel ma' żieda medja ta' 0.9 kg f'353 pazjent ikkurat bil-plaċebo.
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Maltese: Emorraġija gastrointestinali7
English: Tolerability of Duloxetine Lilly 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Maltese: It-tollerabilità ta' Duloxetine Lilly 60 mg darba kuljum f'pazjenti anzjani kien simili għal dak osservat fl-adulti iżgħar.
English: Date of first authorisation: 08 December 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 08 Diċembru 2014
English: Duloxetine Lilly must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: Duloxetine Lilly ma jistax jintuża f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min; ara sezzjoni 4.3).