FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni rigward il-kura b'Kolbam, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: For small children who cannot swallow capsules, the contents can be mixed in with infant formula, expressed breast milk, mashed potatoes or fruit puree.
Maltese: Għat-tfal żgħar li ma jistgħux jibilgħu l-kapsuli, il-kontenut jista' jitħallat mal-formula tat-trabi, ħalib tas-sider espress, patata maxx jew puree tal-frott.
English: This helps to reduce the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Maltese: Dan jgħin sabiex inaqqas il-produzzjoni tal-aċidi biljari anormali u jikkontribwixxi għall-attività normali tal-bili fis-sistema diġestiva, u b'hekk inaqqas is-sintomi tal-kundizzjoni.
English: What information is still awaited for Kolbam?
Maltese: Liema informazzjoni għadha mistennija għal Kolbam?
English: How is Kolbam used?
Maltese: Kif jaħdem Kolbam?
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Maltese: de la Industria N0 30 28108 Alcobendas Madrid
English: 3 See section 4.4.
Maltese: 3 Ara sezzjoni 4.4.
English: Capsule content Hypromellose
Maltese: Kontenut tal-kapsula Hypromellose
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Maltese: Enzimi tal-fwied għoljin (ALT, AST, alkaline phosphatase)
English: Duloxetine (as hydrochloride)
Maltese: Duloxetine (bħala hydrochloride)
English: България ТП "Ели Лили Недерланд" Б.В.
Maltese: ТП "Ели Лили Недерланд" Б.В. - България тел.
English: Hepatitis3
Maltese: Epatite3
English: Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Maltese: Pakkett multiplu: 500 (25 pakkett ta' 20 ) kapsula gastro-reżistenti iebsa Pakkett multiplu: 100 (5 pakketti ta' 20) kapsula gastro-reżistenti iebsa
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: Iż-żewġ ċitokromi P450-2D6 u 1A2 jikkatalizzaw il-formazzjoni tażżewġ prodotti metaboliċi prinċipali l-glukuronidu kkonjugat ta' 4-hydroxy duloxetine u l-konjugat tas sulfat ta' 5-hydroxy 6-methoxy duloxetine.
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%
English: Xeristar increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: Xeristar jżid il-livelli ta' serotonin u ta' noradrenaline fis sistema nervuża.
English: Xeristar 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
Maltese: Xeristar 30 mg issibu f'pakketti ta' 7 u 28 kapsula Xeristar 60 mg issibu f'pakketti ta' 28, 56, 84, 98, 100 u 500 kapsula.
English: 28 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules 56 hard gastro-resistant capsules
Maltese: 28 kapsula gastro-reżistenti iebsa 84 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa 56 kapsula gastro-reżistenti iebsa
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: fluoxetine 2/225 [0.9%], plaċebo 1/220 [0.5%]).
English: Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
Maltese: Ipertensjoni3,7 Ipotensjoni ortostatika2
English: Xeristar contains the active substance duloxetine.
Maltese: Xeristar fih is-sustanza attiva duloxetine.
English: Other medicines and Xeristar
Maltese: Medicini oħra u Xeristar
English: Xeristar 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: Xeristar 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: 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'
English: Dehydration Hyponatraemia SIADH6
Maltese: Deidrazzjoni Iponatrimja SIADH6
English: EU/1/04/297/005 EU/1/04/297/006 EU/1/04/297/007 EU/1/04/297/008
Maltese: EU/1/04/297/007 EU/1/04/297/008
English: Date of first authorisation: 17 December 2004 Date of latest renewal: 24 June 2009
Maltese: Data tal-aħħar tiġdid: 24 ta' Ġunju 2009
English: Xeristar 30 mg Xeristar 30 mg is available in packs of 7 and 28 hard gastro-resistant capsules.
Maltese: Xeristar 30 mg Xeristar 30 mg issibu f'pakketti ta' 7 u 28 kapsula gastro-reżistenti iebsa.
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Maltese: Emorraġija gastro intestinali7
English: Tolerability of Xeristar 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Maltese: It-tollerabilità ta' Xeristar 60 mg darba kuljum f'pazjenti anzjani kien simili għal dak osservat fl-adulti iżgħar.
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 was -0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Maltese: 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: Capsule shell
Maltese: KARTUN GĦALL-KAPSULI
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, emorraġija gastro-intestinali u emorraġija wara l-ħlas b'inibituri selettivi ta'ġbir mill-ġdid ta' serotonin (SSRIs) u inibituri ta' ġbir mill-ġdid ta' serotonin /noradrenaline (SNRIs), fosthom duloxetine.
English: Concomitant use of Xeristar with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Xeristar ma' inibituri ta' monoamine oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra-indikat (ara sezzjoni 4.5).
English: Česká republika ELI LILLY ČR, s.r.o.
Maltese: Slovenská republika Eli Lilly Slovakia, s.r.o.
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Maltese: Il-half life ta' l-eliminazzjoni ta' duloxetine tvarja minn 8 sa 17-il siegħa (medja ta' 12
English: 28 hard gastro-resistant capsules 7 hard gastro-resistant capsules
Maltese: 28 kapsula gastro-reżistenti iebsa 7 kapsuli gastro-reżistenti ibsin
English: Consequently, caution is advised when Xeristar 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 Xeristar 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: Xeristar 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: Xeristar wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it-titjib filpunteġġ totali tal-Hamilton Anxiety Scale (HAM-A) u kemm skond il-punteġġ ta' indeboliment funzjonali globali tas-Sheehan Disability Scale (SDS).
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Fertilità
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Xeristar and 42% for placebo.
Maltese: L-inċidenza ta' rikaduta waqt il-perijodu miżjud ta' 6 xhur li kien double-blind kien ta' 14% b' Xeristar u ta' 42%
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: GAD (differenza medja bejn duloxetine u plaċebo ta' 2.7 punti [95% CI 1.3-4.0]), wara 10 ġimgħat ta'
English: Medicines like Xeristar (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal Xeristar ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
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: Bħal bi prodotti mediċinali oħra li għandhom azzjoni farmakoloġika simili (anti-depressiv), ġew irrappurtati każi iżolati ta' formazzjoni ta' ideat suwiċidali u mġiba suwiċidali waqt terapija ta' duloxetine jew kmieni wara sospensjoni tal-kura.
English: Medicinal products metabolised by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6.
Maltese: Prodotti mediċinali li jiġu metabolizzati minn CYP2D6:
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p<0.001).
Maltese: Matul il-fażi ta' kura double-blind u kkontrollata bil-plaċebo li damet 52 ġimgħa, 14.4% tal-pazjenti kkurati b'duloxetine u 33.1% tal-pazjenti kkurati bil-plaċebo reġgħu ħassew is-sintomi depressivi tagħhom (p<0.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Maltese: Palpitazzjonijiet Takikardija Arritmija supraventrikolari, l-aktar fibrillazzjoni ta' latrija
English: Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Maltese: L-inkjostru aħdar li jittiekel fih: Iron oxide iswed - sintetiku (E172) Iron oxide isfar - sintetiku (E172) Propylene glycol
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/SNRI.
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: 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: Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules
Maltese: Xeristar 30 mg kapsuli gastro-reżistenti ibsin Xeristar 60 mg kapsuli gastro-reżistenti ibsin
English: Xeristar must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: Xeristar ma jistax jintuża f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min; ara sezzjoni 4.3).
English: Throat tightness Epistaxis
Maltese: Rassa fil-gerżuma Epistassi
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Xeristar 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' Xeristar u 23% ta' pazjenti jieħdu l-plaċebo.
English: EU/1/04/297/002 (28 hard gastro-resistant capsules) EU/1/04/297/003 (84 hard gastro-resistant capsules) EU/1/04/297/004 (98 hard gastro-resistant capsules) EU/1/04/297/005 (56 hard gastro-resistant capsules)
Maltese: EU/1/04/297/002 (28 kapsula gastro-reżistenti iebsa) EU/1/04/297/003 (84 kapsula gastro-reżistenti iebsa) EU/1/04/297/004
English: Xeristar 60 mg hard gastro-resistant capsules Duloxetine
Maltese: Xeristar 60 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Xeristar hard gastro-resistant capsules contain sucrose.
Maltese: Sucrose Xeristar kapsuli gastro-reżistenti ibsin fihom sucrose.
English: EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20)
Maltese: EU/1/04/297/008 (100 kapsula gastro-reżistenti iebsa) (5 pakketti ta' 20)
English: Therefore Xeristar should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, Xeristar m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: The efficacy of Xeristar 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Maltese: L-effikaċja ta' Xeristar 30-120 mg (dożaġġ flessibbli) darba kuljum f'pazjenti anzjani (>65 sena) b'disturb ta' ansjetà ġeneralizzata ġiet evalwata fi studju li wera titjib statistikament sinifikanti filpunteġġ totali tal-HAM-A f'pazjenti kkurati b'duloxetine meta mqabbel ma' pazjenti kkurati bil plaċebo.
English: Xeristar 30 mg hard gastro-resistant capsules Duloxetine
Maltese: Xeristar 30 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: How to store Xeristar
Maltese: TIĦUX Xeristar jekk
English: Menopausal symptoms Galactorrhoea Hyperprolactinae mia
Maltese: Is-sinjali u s-sintomi ta' doża eċċessiva
English: Nervousness Disturbance in attention
Maltese: Disturb ta' ansjetà ġeneralizzata
English: Hallucinations Aggression and anger4
Maltese: Aggressjoni u rabja4
English: Xeristar demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Maltese: Xeristar statistikament wera superjorità fuq plaċebo kkalkulat skond it-titjib fil-punteġġ totali talHamilton Depression Rating Scale (HAM-D) bi 17-il kriterju (li jinkludu kemm sintomi ta' depressjoni emozzjonali kif ukoll dawk somatiċi).
English: Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Maltese: Xeristar 30 mg Il-parti prinċipali abjad opak, stampat b' ‘30 mg' u għatu blu opak, stampat b' ‘9543'.
English: Xeristar 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: Xeristar m'għandux jiġi użat flimkien ma' fluvoxamine, ciprofloxacin jew enoxacin (jiġifieri inibituri qawwija ta' CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine fil-plażma (ara sezzjoni 4.5).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucraseisomaltase m'għandhomx jieħdu din il-mediċina.
English: Xeristar contains sucrose.
Maltese: Xeristar fih s-sucrose.
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Xeristar 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' Xeristar bħala kura għall-uġigħ newropatiku tad-dijabete kien stabbilit f'żewġ studji ta' 12-il ġimgħa, b'dożi fissi, ikkontrollati bil 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 bil-plaċebo ta' prodotti mediċinali antidepressiv li ntużaw f'disturbi psikjatriċi wrew riskju ogħla ta' mġiba suwiċidali bl-antidepressiv meta mqabbla ma' plaċebo f'pazjenti iżgħar minn 25 sena.
English: Talk to your doctor before you take Xeristar if you: - are taking other medicines to treat depression (see ‘Other medicines and Xeristar') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar')
Maltese: għandek problemi f'għajnejk bħal xi tip ta' glawkoma (pressjoni għolja fl-għajn). għandek passat ta' emorraġija (tendenza li tiżviluppa tbenġil), speċjalment jekk inti tqila (ara ‘Tqala u treddigħ'). qiegħed/qiegħda f'riskju li jitbaxxielek il-livell ta' sodium (per eżempju jekk qiegħed/qiegħda tieħu d-dijuretiċi, speċjalment jekk inti anzjan/anzjana) qiegħed/qiegħda tirċievi fl-istess waqt kura b'mediċina oħra li tista' tikkawżalek ħsara fil fwied.
English: Effect of duloxetine on other medicinal products
Maltese: Effetti ta'prodotti mediċinali oħra fuq duloxetine
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba assoċjata mas suwiċidju (attentati ta' suwiċidju u ħsibijiet suwiċidali) u ostilità (l-aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f'provi kliniċi fuq tfal u adolexxenti kkurati b'anti depressiv meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: Caution is advised if Xeristar is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Maltese: prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti-depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Maltese: Xeristar 60 mg Il-parti prinċipali aħdar opak, stampat b' ‘60 mg' u għatu blu opak, stampat b' ‘9543'.
English: Urinary retention Urinary hesitation Nocturia
Maltese: Tegħreq matul il-lejl Urtikarja
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
English: Interstitial lung disease10
Maltese: Mard tal-interstizju tal-pulmun10
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Maltese: 261 l/hr (medja 101 l/hr).
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Xeristar 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Maltese: Madankollu, bħal b'mediċina oħra, il-kura ta' l-anzjani għandha tiġi segwita b'attenzjoni, speċjalment b'Xeristar 120 mg kuljum għal disturb depressiv maġġuri jew disturb ta' ansjetà ġeneralizzata, fejn l informazzjoni hija limitata (ara sezzjonijiet 4.4 u 5.2).
English: Data on the use of Xeristar 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Maltese: Anzjani L-informazzjoni dwar l-użu ta' Xeristar 120 mg f'pazjenti anzjani b'disturb depressiv maġġuri u b'disturb ta' ansjetà ġeneralizzata hija limitata.
English: Xeristar is indicated in adults.
Maltese: Kura ta' disturb ta' ansjetà ġeneralizzata Xeristar huwa indikat għall-adulti.
English: Xeristar 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Maltese: Xeristar 60 mg sa 120 mg kuljum wera superjorità statistikament sinifikanti meta mqabbel ma'
English: Postpartum haemorrhage6
Maltese: Insuffiċjenza epatika6
English: Ejaculation disorder
Maltese: Indeboliment filvista
English: Pharmacodynamic effects
Maltese: Il-farmakokinetika ta'
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
Maltese: Tagħrif minn studji kliniċi wera li hemm żieda fir-riskju ta' mġiba suwiċidali f'adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b'antidepressiv.
English: Duloxetine may increase the risk of postpartum haemorrhage (see section 4.6).
Maltese: duloxetine jew kmieni wara sospensjoni tal-kura (ara sezzjoni 4.8).
English: When stopping treatment with Xeristar 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'Xeristar 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: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: (45 mg/kg/ġurnata) , qabel u waqt li kienu qed jagħmlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis fil konsum ta' l-ikel matern u fil-piż, diżordni fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ hajjin u fis-sopravivenza tal-ferħ ta' l-annimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: Hard gastro-resistant capsule.
Maltese: Il-Qoxra tal-kapsula