FrancophonIA/ELRC3.0 huggingface dataset:
English: • Once diluted, the ibalizumab solution should be administered immediately.
Maltese: • Ladarba tiġi dilwita, is-soluzzjoni ta' ibalizumab għandha tingħata immedjatament.
English: In case of rash, it is recommended that the patient be monitored and symptomatic therapy be initiated when appropriate (e.g. cortisteroids and/or anti-histamine medicinal products).
Maltese: F'każ ta' raxx, huwa rakkomandat li l-pazjent jiġi mmonitorjat u li tinbeda terapija sintomatika meta jkun xieraq (eż. kortikosterojdi u/jew prodotti mediċinali antiistamini).
English: Study TNX-355.03 was a multicenter, randomized, double-blinded, placebo-controlled, multi-dose, 3arm safety and efficacy study in 82 subjects with HIV-1 and who were failing or had failed highly active antiretroviral therapy.
Maltese: L-istudju TNX-355.03 kien studju tas-sigurtà u l-effikaċja multiċentriku, randomizzat, double-blinded,
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Decreased susceptibility to ibalizumab does not alter susceptibility to other approved agents and does not result in the selection of CD4-independent viral isolates.
Maltese: Is-suxxettibilità mnaqqsa għal ibalizumab ma tbiddilx is-suxxettibilità għal aġenti approvati oħrajn u ma tirriżultax fl-għażla ta' iżolati virali indipendenti tas-CD4.
English: Ibalizumab contains less than 1 mmol sodium (23 mg) in each loading dose of 2,000 mg or maintenance dose of 800 mg and therefore is essentially sodium-free.
Maltese: Ibalizumab fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża tal-bidu ta' 2,000 mg jew doża ta'
English: Look out for new signs of infection after receiving Trogarzo; these can be different from person to person depending on the type of infection that was hidden and might include fever, headache, difficulty breathing, stomach ache, coughing and swollen glands (lumps and bumps on your body, neck, armpit or groin).
Maltese: Oqgħod attent għal sinjali ġodda ta' infezzjoni wara li tirċievi Trograzo; dawn jistgħu jkunu differenti minn persuna għal oħra skont ittip ta' infezzjoni li kienet moħbija u jistgħu jinkludu deni, uġigħ ta' ras, diffikultà fit-teħid tan-nifs, uġigħ fl-istonku, sogħla u glandoli minfuħin (boċċi u ħotob fuq ġismek, għonqok, f'abtek jew fl irqiq ta' bejn il-koxxa u ż-żaqq).
English: Fertility
Maltese: KUNJETT
English: Ibalizumab pharmacokinetics have not been evaluated in paediatric patients.
Maltese: Il-farmakokinetika ta' ibalizumab ma ġietx evalwata f'pazjenti pedjatriċi.
English: Trogarzo 200 mg concentrate for solution for infusion
Maltese: Trogarzo 200 mg konċentrat għal soluzzjoni għall-infużjoni GĦAMLA KWALITATTIVA
English: It is unknown whether ibalizumab/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk ibalizumab/metaboliti humiex eliminati fil-ħalib tas-sider tal-bniedem.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: - If you get any side effects, talk to your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif huma il-verzjonijiet finali, li saru waqt il-proċedura Coordination grupp.
English: Summary of product characteristics, labelling and package leaflet
Maltese: Sommarju tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif
English: 84 vials + 88 ampoules + 1 Altera Nebuliser Handset
Maltese: 84 kunjett + 88 ampulla + 1 Altera Nebuliser Handset
English: 84 vials + 88 ampoules
Maltese: 84 kunjett + 88 ampulla
English: Route of Administration Packaging
Maltese: Daqs tal-pakkett
English: Invented name Strength Pharmaceutical Form
Maltese: Għamla farmaċewtika
English: St John's wort
Maltese: John's wort
English: Mylan BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Maltese: Mylan BV, Dieselweg 25, 3752 LB Bunschoten, L-Olanda
English: 3752 LB Bunschoten The Netherlands
Maltese: 3752 LB Bunschoten L-Olanda
English: Opening date:…………
Maltese: Data meta nfetaħ:…………
English: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Maltese: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, L-Ungerija
English: Sugar spheres (sucrose, maize starch) Hypromellose
Maltese: Sferi taz-zokkor (sucrose, maize starch) Hypromellose
English: 117 Allée des Parcs 69800 Saint-Priest France
Maltese: 117 Allée des Parcs, 69800
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: Capsule content: Sugar spheres (sucrose, maize starch), hypromellose, Macrogol, Crospovidone, talc, sucrose, hypromellose phthalate, diethyl phthalate
Maltese: Sferi taz-zokkor (sucrose, maize starch), hypromellose, Macrogol, Crospovidone, talc, sucrose, hypromellose phthalate, diethyl phthalate
English: Abrupt discontinuation should be avoided.
Maltese: Għandha tiġi evitata sospensjoni f'daqqa waħda.
English: See section 4.4.
Maltese: Ara sezzjoni 4.4
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Maltese: Duloxetine huwa bejn wieħed u ieħor 96% marbut mal-proteini tal-plażma umana.
English: Marketing Authorisation Holder Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Maltese: Mylan S.A.S., 117 Allée des Parcs, 69800
English: 2D barcode carrying the unique identifier included
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
Maltese: Linka bajda li tista' tittiekol: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Maltese: L-ammonti li jikkorispondu għal tnaqqis ta' mill-inqas ta' 50% fl-uġigħ kienu 50% u 26% rispettivament.
English: Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172).
Maltese: Linka tad-deheb li tista' tittiekol: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172).
English: 60 mg capsules
Maltese: 60 mg kapsuli
English: Serotonin syndrome Convulsion Psychomotor restlessness Extra-pyramidal symptoms
Maltese: Sindrome ta' serotonin Konvulżjoni Irrekwitezza psikomotorja Sintomi ekstrapiramidali
English: 30 mg capsules
Maltese: 30 mg kapsuli
English: Hepatic impairment: 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: Hepatitis Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Maltese: Enzimi talfwied għoljin (ALT, AST, alkaline phosphatase)
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 iċ-ċitokrom P450-2D6 kif ukoll 1A2 jikkatalizzaw ilformazzjoni taż-żewġ prodotti metaboliċi prinċipali l-glukuronidu kkonjugat ta' 4-hydroxy duloxetine u l-konjugat tas-sulfat ta' 5-hydroxy 6-methoxy duloxetine.
English: Not statistically significantly different from placebo.
Maltese: Statistikament mhuwiex differenti b'mod sinifikanti minn plaċebo.
English: Capsule shell: Brilliant blue (E133), yellow iron oxide (E172) (60 mg only), titanium dioxide (E171), gelatin and edible gold ink (30 mg only) or edible white ink (60 mg only).
Maltese: Brilliant blue (E133), yellow iron oxide (172) (60 mg biss), titanium dioxide (E171), gelatin u linka tad-deheb li tista' tittiekol (30 mg biss) jew linka bajda li tista' tittiekol (60 mg biss).
English: Duloxetine Mylan is indicated in adults.
Maltese: Duloxetine Mylan huwa indikat għall-adulti.
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Maltese: Disturbi muskolu-skeletriki u tat-tessuti konnetivi Uġigħ muskoluskeletali
English: 7 hard gastro-resistant capsules 14 hard gastro-resistant capsules 28 hard gastro-resistant capsules 49 hard gastro-resistant capsules 98 hard gastro-resistant capsules 7 x 1 hard gastro-resistant capsules 28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules
Maltese: 7 kapsuli gastro-reżistenti ibsin 14 kapsuli gastro-reżistenti ibsin 28 kapsula gastro-reżistenti iebsa 49 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa 7 x 1 kapsula gastro-reżistenti iebsa 28 x 1 kapsula gastro-reżistenti iebsa 30 x 1 kapsula gastro-reżistenti iebsa
English: 30 hard gastro-resistant capsules 100 hard gastro-resistant capsules 250 hard gastro-resistant capsules 500 hard gastro-resistant capsules
Maltese: 30 kapsula gastro-reżistenti iebsa 100 kapsula gastro-reżistenti iebsa 250 kapsula gastro-reżistenti iebsa 500 kapsula gastro-reżistenti iebsa
English: Suicidal behaviour Mania
Maltese: Imġiba suwiċidali Manija
English: The incidence of relapse during the 6-months double-blind follow-up period was 14% for duloxetine and 42% for placebo.
Maltese: L-inċidenza ta' rikaduta waqt il-perijodu miżjud ta' 6 xhur li kien double-blind kien ta' 14 % b'Duloxetine u ta' 42 % bi plaċebo.
English: Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Maltese: Duloxetine ma weriex effikaċja fit-tnaqqis ta' uġigħ kif imkejjel mill-miżura tal-effett primarju tal-punt finali ta' punteġġ medju ta' uġigħ tal-Brief Pain Inventory (BPI): l-inqas bidla medja fil-kwadranti (least squares -LS) mil-linja bażi fil-punteġġ medju ta' uġigħ BPI wara 13-il ġimgħa kien ta' -0.97 fil-grupp ta' plaċebo, mqabbel ma' -1.62 fil-grupp ta' duloxetine 30/60 mg (p = 0.052).
English: Stevens-Johnson Syndrome Angio-neurotic oedema
Maltese: Sindromu ta' Stevens-Johnson Edima anġjonewrotika
English: Duloxetine Mylan contains sucrose and sodium
Maltese: Duloxetine Mylan fih s-sucrose u sodium
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 inngħas,ir-rispons kliniku kien osservat f'47% tal-pazjenti li rċevew duloxetine u f'27% tal-pazjenti li kienu fuq plaċebo.
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Maltese: Wara doża orali, it-tneħħija apparenti ta' duloxetine mill-plażma tvarja minn 33 sa 261 l/hr (medja 101 l/hr).
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 listat ta' metaboliżmu minn CYP2D6.
English: Hallucinations Aggression and anger
Maltese: Alluċinazzjonijiet Aggressjoni u rabja
English: The randomised, double-blind, placebo-controlled, parallel study of duloxetine was conducted in 184 adolescents aged 13 to 18 years (mean age 15.53 years) with JPFS.
Maltese: L-istudju paralleli, ikkontrollat bil-plaċebo, double-blind u magħmul b'mod arbitrarju ta' duloxetine sar f'184 adolexxent b'etajiet minn 13 sa 18-il sena (età medja ta' 15.
English: Syncope Hypertension Orthostatic hypotension Peripheral coldness
Maltese: Sinkope Ipertensjoni Ipotensjoni ortostatika
English: Multipack: 98 (2 packs of 49) hard gastro-resistant capsules
Maltese: Kapsuli gastroreżistenti ibsin Pakkett multiplu: 98 (2 pakketti ta' 49) kapsuli gastroreżistenti ibsin
English: • feeling of dizziness or “spinning” (vertigo), ear pain
Maltese: • sensazzjoni ta' surdament jew ‘spinning'(vertiġini), uġigħ fil-widnejn
English: Major Depressive Disorder: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Maltese: Disturb Depressiv Maġġuri; Duloxetine ġie studjat f'programm kliniku li kien jinvolvi 3,158 pazjent (1,285 pazjenti-snin ta' espożizzjoni) li laħaq il-kriterji DSM-IV għal depressjoni maġġuri.
English: The safety results from this study were consistent with the known safety profile of duloxetine.
Maltese: Ir-riżultati ta' sigurtà minn dan l-istudju kienu konsistenti mal-profil ta' sigurtà magħruf ta' duloxetine.
English: In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetinetreated paediatric patients (see section 4.4).
Maltese: F'studji li damu sa disa' xhur, ġie osservat li f'pazjenti pedjatriċi kkurati b'duloxetine kien hemm medja ta' tnaqqis ġenerali ta' 1% fil-perċentili ta' tul (tnaqqis ta' 2% fit-tfal (7-11-il sena) u żieda ta' 0.3% fl-adolexxenti (12-17-il sena)) (ara sezzjoni 4.4).
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Maltese: Ġew irrappurtati fsada mhux normali, bħal ekimosi, purpura u emorraġija gastro-intestinali b'inibituri selettivi ta'ġbir mill-ġdid ta' serotonin (SSRIs) u inibituri ta' ġbir mill-ġdid ta' serotonin/noradrenaline (SNRIs), fosthom duloxetine.
English: Duloxetine Mylan 30 mg is available in blister packs of 7, 14, 28, 49, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 7 x1, 28 x 1, 30 x 1 capsules and in bottles containing 30, 100, 250, 500 capsules and a desiccant.
Maltese: Duloxetine Mylan 30 mg hu disponibbli f'pakketti bil-folji li jkun fihom 7, 14, 28, 49, 98 u f'pakkett multiplu ta' 98 li jkun fih 2 kartuniet, li kull waħda jkun fiha 49 kapsula, f'pakketti ta' folji perforati li jkun fihom 7 x 1, 28 x 1, 30 x 1 kapsula u fi fliexken li jkun fihom 30, 100, 250, 500 kapsula u dessikant.
English: • muscle pain, muscle spasm
Maltese: • uġigħ fil-muskoli, spażmu fil-muskolu
English: Duloxetine Mylan contains the active substance duloxetine.
Maltese: Duloxetine Mylan fih is-sustanza attiva duloxetine.
English: Consequently, caution is advised when Duloxetine Mylan 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 Duloxetine Mylan 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, anti-istamini sedattivi).
English: Duloxetine Mylan increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: Duloxetine Mylan jżid il-livelli ta' serotonin u ta' noradrenaline fis-sistema nervuża.
English: 60 mg capsules EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015
Maltese: 60 mg kapsuli EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014
English: Duloxetine Mylan 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 28 x 1, 30 x 1, and 100 x 1capsules and bottles containing 30, 100, 250 and 500 capsules and a desiccant.
Maltese: Duloxetine Mylan 60 mg hu disponibbli f'pakketti bil-folji li jkun fihom 14, 28, 49, 84, 98 u f'pakkett multiplu ta' 98 li jkun fih 2 kartuniet, li kull waħda jkun fiha 49 kapsula, f'pakketti ta' folji perforati li jkun fihom 28 x 1, 30 x 1, u 100 x 1 kapsula u fi fliexken li jkun fihom 30, 100, 250 u 500 kapsula u dessikant.
English: HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro resistant capsules
Maltese: Pakkett bil-fliexken tal-HDPE, b'dessikant, li jkun fih 30, 100, 250 u 500 kapsula gastro-reżistenti iebsa.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8).
Maltese: Inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina (SSRIs)/inibituri tal-assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4.8).
English: • blurred eyesight
Maltese: • vista mċajpra
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta ' eċċipjenti, ara sezzjoni 6.1.
English: Capsule content
Maltese: TAL-KAPSULI
English: Tolerability of duloxetine 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Maltese: It-tollerabilità ta' Duloxetine 60 mg darba kuljum f'pazjenti anzjani kien simili għal dak osservat fl-adulti iżgħar.
English: Excipient(s) with known effect Each capsule contains 124.2 mg sucrose.
Maltese: Kull kapsula fiha 124.2 mg ta' sucrose.
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: Other medicines and Duloxetine Mylan
Maltese: Mediċini oħra u Duloxetine Mylan
English: Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Maltese: Il-farmakokinetika ta' theophylline, sustrat ta' CYP1A2, ma ġietx affettwata b'mod sinifikanti meta ngħata flimkien ma' duloxetine (60 mg darbtejn kuljum).
English: Medicinal products containing duloxetine
Maltese: Effetti ta'prodotti mediċinali oħra fuq duloxetine
English: Serotonin syndrome symptoms may include mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Maltese: Is-sintomi tas-sindromu ta' serotonin jistgħu jinkludu tibdil fl-istat mentali (eż. aġitazzjoni, alluċinazzjonijiet, koma), instabilità sutonomis (eż. takikardija, pressjoni tad-demm li mhijiex stabbli, ipertermija), aberrazzjonijiet newromuskulari (eż. iperriflessi, problemi ta' koordinazzjoni) u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: Diabetic Peripheral Neuropathic Pain: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Maltese: Uġigħ Newropatiku Periferiku Tad-dijabete:Bħal bi prodotti mediċinali oħra li għandhom azzjoni farmakoloġika simili (anti-depressivi), ġew irrappurtati każi iżolati ta' formazzjoni ta' ideat suwiċidali u mġiba suwiċidali waqt terapija ta' duloxetine jew kmieni wara sospensjoni tal-kura.
English: Psychiatric disorders Insomnia
Maltese: Disturbi psikjatriċi Insomnja
English: Treatment with duloxetine showed a statistically significantly greater improvement in GAD symptoms, as measured by PARS severity score for GAD (mean difference between duloxetine and placebo of 2.7 points [95% CI 1.3-4.0]), after 10 weeks of treatment.
Maltese: Il-kura b'duloxetine wriet titjib akbar li kien statistikament sinifikanti fis-sintomi tal-GAD, skont il-punteġġ ta' severità PARS għal GAD (differenza medja bejn duloxetine u plaċebo ta' 2.7 punti [95% CI 1.3-4.0]), wara 10 ġimgħat ta' kura.
English: There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs.
Maltese: Kien hemm rapporti ta' disfunzjoni sesswali fit-tul fejn is-sintomi komplew minkejja l-waqfien ta' SSRIs/SNRIs.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Maltese: Brilliant blue (E133) Yellow iron oxide (E172) Titanium dioxide (E171) Ġelatina
English: Duloxetine demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Maltese: Duloxetine wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it-titjib fil-punteġġ totali tal-Hamilton Anxiety Scale (HAM-A) u kemm skond il-punteġġ ta' indeboliment funzjonali globali tas-Sheehan Disability Scale (SDS).
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: Duloxetine Mylan must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: Duloxetine Mylan ma jistax jintuża f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min; ara sezzjoni 4.3).
English: Duloxetine may increase the risk of postpartum haemorrhage (see section 4.6).
Maltese: Duloxetine jista 'jżid ir-riskju ta' emorraġija wara l-ħlas (ara sezzjoni 4.6).
English: Medicines like Duloxetine Mylan (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal Duloxetine Mylan ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
English: Throat tightness Epistaxis
Maltese: Rassa filgerżuma Epistassi
English: Date of first authorisation: 19 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 Ġunju, 2015
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Maltese: Sommarju f'forma tabulari tar-reazzjonijiet avversi Tabella 1 turi r-reazzjonijiet avversi osservati minn rapporti spontanji u f'provi kliniċi kkontrollati bilplaċebo.
English: As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
Maltese: Bħala rakkomandazzjoni ġenerali, il-kura ta' lanzjani għandha tiġi segwita b'attenzjoni (ara sezzjonijiet 4.2 u 4.4).