FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactions occurred rarely (<1 in 1,000 injections) between 1 and 3 hours, and very rarely (<1 in 10,000 injections) after 3 hours.
Maltese: Reazzjonijiet seħħew rari (< 1 f'1,000 injezzjoni) bejn siegħa u 3 sigħat, u rari ħafna (< 1 f'10,000 injezzjoni) wara 3 sigħat.
English: ZYPADHERA has not been studied in the paediatric population.
Maltese: ZYPADHERA ma ġiex studjat f'popolazzjoni pedjatrika.
English: Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Maltese: Fluoxetine (inibitur ta' CYP2D6), dożi b'waħda ta' antaċidi (aluminju, manjesju) jew cimetidine ma nstabux li jaffettwaw b'mod sinifikanti l-farmakokinetika ta' olanzapine.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Maltese: Il-proporzjon ta' pazjenti li kellhom tibdil avvers, klinikament sinifikanti, f'żieda fil-piż, glucose, kolesterol totali/LDL/HDL jew trigliċeridi żdied maż-żmien.
English: In a Positron Emission Tomography (PET) study in patients treated with ZYPADHERA (300 mg/4 weeks), mean D2 receptor occupancy was 60% or higher at the end of a 6 month period, a level consistent with that found during treatment with oral olanzapine.
Maltese: Fi studju ta' Tomografija bl-Emissjoni ta' Pożitroni (PET) f'pazjenti kkurati b'ZYPADHERA (300 mg/4 gimgħat), l-okkupanza medja ta' riċetturi D2 kienet ta' 60% jew ogħla fit-tmiem ta' perijodu ta' 6 xhur, livell konsistenti ma' dak li nstab waqt kura ta' olanzapine mill-ħalq.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fit-taqsima 6.1.
English: Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Maltese: Effetti riversibbli konsistenti ma' prolaktin elevat fil firien inkludew tnaqqis fil-piż ta' l-ovarji u ta' l-utru u tibdiliet morfoloġiċi fl-epitilju tal-vaġina u fil-glandoli tas-sider.
English: The half-life of olanzapine after ZYPADHERA is 30 days compared to 30 hours following oral administration.
Maltese: Il-half-life ta' olanzapine wara ZYPADHERA huwa ta' 30 jum imqabbel ma' 30 siegħa wara t-teħid millħalq.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Maltese: Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b'attività beta-agonista billi l-istimulazzjoni beta tista' taggrava l-pressjoni baxxa.
English: Oestrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Maltese: Iċ-ċikli estruwi kienu affettwati b'dożi ta' 1.1 mg/kg (3 darbiet id-doża massima fil-bniedem) u l-parametri tar-riproduzzjoni kienu influwenzati fil-firien mogħtija 3 mg/kg (9 darbiet id-doża massima fil-bniedem).
English: Other common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Maltese: Effetti sekondarji oħra komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) jinkludu tibdil fillivelli ta' xi ċelluli tad-demm, ta' xaħmijiet fiċ-ċirkolazzjoni u kmieni fil-kura, żidiet temporanji tal-enzimi tal-fwied; żidiet fil-livelli ta' zokkor fid-demm u fl-awrina; żidiet fil-livelli tal-aċidu uriku u tal-creatine phosphokinase fid-demm; tħossok aktar bil-ġuħ; sturdament; irrekwitezza; rogħda;movimenti mhux tas-soltu (diskajnisjas); stitikezza; ħalq xott; raxx; titlef il-forzi;għeja estrema; retenzjoni tal-ilma li twassal għal nefħa fl-idejn, għekiesi jew saqajn; deni; uġigħ fiġġogi u disfunzjonijiet sesswali bħal tnaqqis fil-libido fl-irġiel u fin-nisa jew disfunzjoni erettili fl irġiel.
English: Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Maltese: Ġie muri li fluvoxamine, inibitur speċifiku ta' CYP1A2, jimpedixxi b'mod sinifikanti lmetaboliżmu ta' olanzapine.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Maltese: Iż-żieda medja f'olanzapine Cmax wara t-teħid ta' fluvoxamine kienet ta' 54% fin-nisa li ma jpejpux u ta' 77% fl-irġiel li jpejpu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 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: Distribution Oral olanzapine is rapidly distributed.
Maltese: Distribuzzjoni Olanzapine mill-ħalq jiġi distribwit b'mod rapidu.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Maltese: Il-manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali mibdul, u evidenza ta' instabbilità awtonomika (polz jew pressjoni tad-demm irregolari,
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Maltese: 10 mg/kg/jum (espożizzjoni totali ta' olanzapine [AUC] hija 12 sa 15-il darba aktar minn dik ta'
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Maltese: Olanzapine ma kienx mutaġeniku jew klastoġeniku f'firxa sħiħa ta' testijiet standard, li inkludew testijiet ta' mutazzjoni tal-batteri kif ukoll testijiet fuq il-mammiferi kemm in vitro kif ukoll in vivo mill-ħalq.
English: General disorders and administration site conditions Asthenia
Maltese: ISTRUZZJONIJIET GĦAR-RIKOSTITUZZJONI U AMMINISTRAZZJONI
English: The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Maltese: Parkinson f'pazjenti bil-marda ta' Parkinson u d-demenzja (ara taqsima 4.4).
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in oral olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5%, respectively).
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo (li damu minn 6 sa 12-il ġimgħa) f'pazjenti anzjani (età medja ta' 78 sena) li kellhom psikożi relatata mad-demenzja u/jew disturbi fl-imġiba, kien hemm żieda doppja fl-inċidenza ta' mwiet fil-pazjenti kkurati b'olanzapine mill-ħalq meta mqabbla ma' pazjenti kkurati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Adverse reactions seen with olanzapine The undesirable effects listed below have been observed following administration of olanzapine.
Maltese: L-effetti mhux mixtieqa ta' hawn taħt ġew osservati wara li ngħata olanzapine.
English: ZYPADHERA 405 mg powder: Type I glass vial.
Maltese: Trab ta'Zypadhera 405 mg: Kunjett tal-ħġieġ Tip I.
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hours) and the clearance was reduced (17.5 versus 18.2 l/hr).
Maltese: mhux irrakkomandat għall-kura fil-popolazzjoni anzjana (65 u fuqhom) sakemm ma tiġix stabbilita rutina ta' dożaġġ ittollerata tajjeb u effettiva b'olanzapine mill-ħalq, f'anzjani b'saħħithom (65 u fuqhom) kontra persuni mhux anzjani, il-medja tal-half-life ta' l-eliminazzjoni kien imtawwal (51.8 kontra 33.8 siegħa) u t-tneħħija kienet imnaqqsa (17.5 kontra 18.2 l/siegħa).
English: Neutropenia
Maltese: Sonnolenza
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Ġustifikazzjoni biex ma jkunx inkluż il-Braille aċċettata
English: Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Maltese: (għallinqas 48 ġimgħa), il-pazjenti li żiedu ≥ 7 %, ≥ 15 % u ≥ 25 % mil-linja bażi tal-piż tal ġisem tagħhom kienu komuni ħafna (64.4 %, 31.7 % u 12.3 % rispettivament).
English: Mutagenicity
Maltese: Mannitol
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 web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini. D.
English: One carton contains one vial of powder for prolonged release suspension for injection, one vial of 3 ml solvent, one syringe with safety needle, 19 gauge, 38mm, attached and three separate safety needles; one 19 gauge, 38mm needle and two 19 gauge 50mm needles.
Maltese: ZYPADHERA huwa trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod. Kartuna waħda fiha kunjett wieħed ta' trab għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod , kunjett wieħed ta' 3 ml ta' solvent, siringa waħda b'labra tas-sigurtà 19 gejġ, 38 mm mwaħħla u tliet labar tas-sigurtà separati, labra waħda ta' 19 gejġ, 38 mm u żewġ labar ta'
English: Only remove the device with the engaged needle from the syringe when required by a specific medical procedure.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni talprodott mediċinali.
English: Amenorrhea Breast enlargement Galactorrhea in females
Maltese: Olanzapine wera affinità akbar in vitro għar-riċetturi ta' serotonin
English: • rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: • tħabbit mgħaġġel tal-qalb, aġitazzjoni/aggressività, problemi biex jitkellmu, movimenti mhux tas-soltu (speċjalment tal-ħalq jew ta' l-ilsien) u tnaqqis fil-livell ta' koxjenza.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Maltese: Fi studji li damu sejrin mhux aktar minn 3 xhur fil-ġrieden u mhux aktar minn sena fil-firien u fil klieb, l-effetti predominanti kienu d-depressjoni ta' CNS, effetti antikolinerġiċi, u disturbi ematoloġiċi periferali.
English: ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Maltese: ZYPADHERA 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 300 mg olanzapine.
English: Tardive dyskinesia
Maltese: Diskajneżja tardiva
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Maltese: Fi studji kliniċi, l-inċidenza ta' Parkinsoniżmu u distonja f'pazjenti kkurati b'olanzapine kienet numerikament ogħla, iżda mhux differenti mill-plaċebo b'mod statistikament sinifikanti.
English: Post-injection syndrome reactions have occurred with ZYPADHERA leading to symptoms consistent with olanzapine overdose (see sections 4.2 and 4.4).
Maltese: Reazzjonijiet avversi li dehru b'olanzapine pamoate Reazzjonijiet ta' sindromu ta' wara l-injezzjoni li jwasslu għal sintomi konsistenti ma' doża eċċessiva ta' olanzapine (ara taqsimiet 4.2 u 4.4) seħħew b'ZYPADHERA.
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Maltese: Fl-assenza ta' tagħrif dettaljat dwar passat diġà eżistenti ta' disturbi individwali akuti u tardivi ta' moviment ekstrapiramidali, fil-preżent ma jistax jiġi konkluż li olanzapine jipproduċi anqas diskineżja tardiva u/jew sindromi ekstrapiramidali tardivi oħra.
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
Maltese: F'każi ta' insuffiċjenza epatika moderata (ċirrożi, Child-Pugh Klassi A jew B), id-doża tal-bidu għandha tkun ta' 150 mg kull 4 ġimgħat u tiżdied biss b'kawtela.
English: anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Maltese: Livelli għolja ta' aminotransferases tal-fwied, ALT, AST, temporanji u mingħajr sintomi kienu komuni, speċjalment fil-bidu tal-kura.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin (≥
English: In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF<500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Maltese: Fi studji kliniċi b'olanzapine mill-ħalq, żidiet fil-QTc li kienu klinikament sinifikanti (korrezzjoni fil-QT skont Fridericia [QTcF] > 500 millisekondi [msek] f'kwalunkwe ħin wara l-kejl tal-valur bażilari f'pazjenti b'valur bażilari ta' QTcF < 500 msek) ma kienux komuni (0.1% sa 1%)
English: ZYPADHERA 405 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Maltese: ZYPADHERA 405 mg: Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Pazjenti kkurati b'mediċini antipsikotiċi, inkluż ZYPADHERA, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, polijurja, polifaġja u debbulizza) u pazjenti bid-dijabete mellitus jew li għandhom fatturi ta' riskju għad-dijabete mellitus għandhom jiġu segwiti b'mod regolari f'każ li l-kontroll tal-glukosju jmur għall-agħar.
English: In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Maltese: F'44 pazjenti b'skiżofrenja > 65 sena, doża ta' 5 sa 20 mg/jum ma ġietx assoċjata ma' l-ebda profil ta' ġrajjiet avversi li jintgħaraf.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term oral olanzapine studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Maltese: dejta kkontrollata ta' effikaċja hija limitata għal studji ta' terminu qasir b'olanzapine li jittieħed mill-ħalq fl-iskiżofrenja (6 ġimgħat) u manija assoċjata ma' mard bipolari ta' tip I (3 ġimgħat), li involviet anqas minn 200 adolexxent.
English: Among all ZYPADHERA treated patients, sedation was reported by 4.7% of patients.
Maltese: Fil-pazjenti kollha kkurati b'ZYPADHERA, is-sedazzjoni ġiet irrapportata minn 4.7% tal-pazjenti.
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Tagħrif disponibbli s'issa huwa deskritt f'taqsimiet 4.8 u 5.1 iżda ma tista' ssir ebda rakkomandazzjoni dwar pożoloġija.
English: The second, a long term study in clinically stable patients (n=1065) (baseline mean Total PANSS Score 54.33 to 57.75) who were initially treated with oral olanzapine for 4 to 8 weeks and then switched to continue on oral olanzapine or to ZYPADHERA for 24 weeks.
Maltese: It-tieni, studju fit-tul f'pazjenti klinikament stabbli (n=1065) (Punteġġ PANSS Totali medju millinja bażi 54.33 sa 57.75) li għall-ewwel kienu kkurati b'olanzapine mill-ħalq għal 4 sa 8 ġimgħat u mbagħad inqalbu biex ikomplu jieħdu olanzapine mill-ħalq jew ZYPADHERA għal 24 gimgħa.
English: Clinical signs and symptoms included symptoms of sedation (ranging from mild in severity up to coma) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Maltese: Fost is-sinjali u s sintomi kliniċi nsibu sintomi ta' sedazzjoni (li jvarjaw minn ħfief fis-severità sa koma) u/jew delirju (inklużi konfużjoni, diżorjentament, aġitazzjoni, ansjetà u indeboliment konoxxittiv ieħor).
English: Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %).
Maltese: ≥ 15% kienet komuni (4.2 %) u ≥ 25 % ma kinitx komuni (0.8 %).
English: • excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness.
Maltese: • ngħas eċċessiv, sturdament, konfużjoni, diżorjentament, problemi biex titkellem, problemi biex timxi, ebusija fil-muskoli jew tregħid, debbulizza, irritabbilità, aggressjoni, ansjetà, żieda fil-pressjoni tad-demm, jew aċċessjonijiet u jistgħu jwasslu biex tintilef minn sensik.
English: ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Maltese: ZYPADHERA 405 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.
English: Final volume to inject (ml)
Maltese: Volum finali li għandu jiġi injettat (ml)
English: ZYPADHERA olanzapine powder and solvent for prolonged release suspension for injection
Maltese: ZYPADHERA olanzapine trab u solvent għal suspensjoni għall-injezzjoni li terħi lmediċina bil-mod
English: Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Maltese: Pazjenti kkurati b'olanzapine kellhom inċidenza ta' Parkinsoniżmu, akatiżja u distonja aktar baxxa meta mqabbel ma' dożi aġġustati bil-mod ta' haloperidol.
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Maltese: ZYPADHERA 210 mg, 300mg jew 405 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod m'għandux jitfixkel ma' olanzapine 10 mg trab għal soluzzjoni għall injezzjoni.
English: Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Maltese: Assorbiment Olanzapine jiġi metabolizzat fil-fwied minn sensieli ta' reazzjonijiet konjugattivi u ossidattivi.
English: ZYPADHERA 300 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Maltese: ZYPADHERA 300 mg: Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal
English: Dysarthria Stuttering11
Maltese: Sturdament Akatizja6
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of patients.
Maltese: Kura b'olanzapine għal żmien twil (sa 12-il xahar) bl-għan ta' prevenzjoni ta' episodji oħra f'pazjenti b'mard bipolari kien assoċjat ma' żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem f'39.9% tal-pazjenti.
English: In most cases, initial signs and symptoms related to this reaction have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 - 72 hours after injection.
Maltese: F'ħafna każijiet, sinjali u sintomi inizjali relatati ma' din ir-reazzjoni dehru fi żmien siegħa wara l-injezzjoni, u fil-każijiet kollha ġie rrapportat li f'24 - 72 siegħa wara l-injezzjoni kien hemm irkuprar komplet.
English: ZYPADHERA 300 mg powder: Type I glass vial.
Maltese: Trab ta' Zypadhera 300 mg: Kunjett tal-ħġieġ Tip I.
English: All 3 ZYPADHERA treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.
Maltese: It-3 gruppi ta' kura b'ZYPADHERA wrew titjib akbar b'mod statistikament sinifikanti mill-plaċebo li beda sa l-aħħar ta' Ġimgħa 1.
English: In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Maltese: Fi klieb b'ċitopenja, ma kien hemm ebda effetti avversi fuq ċelloli proġenituri u ċelloli proliferanti tal-mudullun.
English: After reconstitution each ml of suspension contains 150 mg olanzapine.
Maltese: Wara r rikostituzzjoni kull millilitru ta' suspensjoni fih 150 mg olanzapine.
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hours) or clearance (21.2 versus 25.0 l/hr).
Maltese: F'pazjenti b'indeboliment tal-kliewi (tneħħija tal-krejatinina < 10 ml/min) kontra pazjenti b'saħħithom, ma kienx hemm differenza sinifikanti fil-medja tal-half-life ta' l-eliminazzjoni (37.7 kontra
English: Fatal outcomes have been reported for acute oral overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Maltese: Ġew irrappurtati każijiet fatali b'dożi eċċessivi akuti baxxi daqs 450 mg iżda ġew irrapportati wkoll każijiet ta' sopravivenza wara doża eċċessiva akuta ta' madwar 2 g ta'
English: During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Maltese: Waqt kura b'olanzapine flimkien ma' lithium jew divalproex, żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem seħħet f'17.4% tal-pazjenti waqt il-kura akuta (sa 6 ġimgħat).
English: hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: koma, possibiltà ta' sindromu newrolettiku malinn, depressjoni respiratorja, aspirazzjoni,
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Maltese: 7 Sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, tqalligħ u rimettar ġew irrapportati meta olanzapine jitwaqqaf f'daqqa.
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Maltese: U KWANTITATTIVA ZYPADHERA 210 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.