FrancophonIA/ELRC3.0 huggingface dataset:
English: The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.
Maltese: Il-kisja tar-rita ta' kull pillola ta' 15 mg fiha 0.15 mg ta' soya lecithin.
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: Newtropenja, tromboċitopenja jew l-anemija riversibbli żviluppaw fi ftit klieb ittrattati b' 8 jew 10 mg/kg/ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il-kurva] hija 12 sa 15-il darba aktar minn dik ta' raġel mogħti doża ta' 12 mg).
English: EXP
Maltese: Tipjip
English: Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Maltese: Sintomi oħra jistgħu jkunu: konfużjoni akuta, aċċessjonijiet (epilessija), koma, taħlita ta' dawn is-sintomi, deni, nifs aktar mgħaġġel, għaraq, ebusija tal-muskoli u ħedla jew ngħas, tnaqqis fil-frekwenza ta' nifsijiet, aspirazzjoni, pressjoni tad-demm għolja jew baxxa, ritmi mhux normali tal-qalb.
English: Olanzapine Mylan 2.5 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 2.5 mg pilloli Olanzapine
English: Other medicines and Olanzapine Mylan
Maltese: Mediċini oħra u OLANZAPINE MYLAN:
English: 7.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “2.5” on one side and “G” on the other side.
Maltese: 7.0 mm, tonda, mżaqqa normali, pilloli bojod miksija b'rita b' “OZ” fuq “2.5” imnaqqax fuq naħa waħda u b'“G” fuq in-naħa l-oħra.
English: 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets 28 x 1 film-coated tablets
Maltese: 10 pilloli miksijin b'rita 28 pilloli miksijin b'rita 30 pilloli miksijin b'rita 35 pilloli miksijin b'rita 56 pilloli miksijin b'rita 70 pilloli miksijin b'rita 28 × 1 pilloli miksijin b'rita
English: Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Maltese: Il-pulmonite, iż-żieda fit-temperatura tal-ġisem, il-letarġija, l-eritema, l-alluċinazzjonijiet viżivi u l-inkontinenza ta' l-awrina kienu komunement osservati.
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Maltese: Fi studji kliniċi f'pazjenti b'psikożi dovuta għal mediċina (agonist ta' dopamine) assoċjata mal-marda ta' Parkinson, id-deterjorament fis-sintomi tal-marda ta' Parkinson u fl-alluċinazzjonijiet, kienu rrapportati b'mod komuni ħafna u aktar ta' spiss milli bil-plaċebo.
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Maltese: Il-metaboliżmu ta' olanzapine jista' jiżdied bit-tipjip.
English: Olanzapine Mylan 20 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 20 mg pilloli Olanzapine
English: How to store Olanzapine Mylan
Maltese: Tiħux OLANZAPINE MYLAN:
English: INFORMATION IN BRAILLE Olanzapine 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE OLANZAPINE 5 mg
English: Each film-coated tablet contains 228 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 228 mg ta' lactose (bħala monohydrate).
English: A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Fl-istudji ta' terminu qasir,ġie rrapportat ammont akbar ta' żieda fil-piż u tibdil fix-xaħmijiet u prolactin f'pazjenti adolexxenti milli fl-istudji ta' pazjenti adulti (ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Maltese: Fi studju ta' 18-il xhar f'pazjenti b'manija jew b'episodji mħallta stabilizzati fuq olanzapine flimkien ma' stabilizzatur tal-burdata (lithium jew valproate), l-użu fit-tul ta' olanzapine flimkien ma'lithium jew l-valproate ma kienx statistikament sinifikanti superjuri għall-lithium jew għall-valproate waħdu biex jittardja r-rikorrenza bipolari, kif definit skond il-kriterji (dijanjostiċi) tas-sindromu.
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: Wara espożizzjoni fit-tul (għallinqas 48 ġimgħa) ilpazjenti 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: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39-< 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Maltese: Tibdil fil-livelli tal-kolesterol totali waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 4.39 - < 5.17 mmol/l) għal għoljin (≥ 5.17 mmol/l) kienu komuni ħafna.
English: In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Maltese: Fi studju b'doża waħda orali (10 mg) fejn intużat it-Tomografija bl-Emissjoni tal-Pożitroni (PET) f'voluntiera b'saħħithom, olanzapine ipproduċa okkupanza ta' 5HT2A ogħla mir-riċettur ta' dopamine
English: Olanzapine Mylan 15 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 15 mg pillola Olanzapine
English: In clinical studies, the average olanzapine exposure was approximately 27 % higher in adolescents.
Maltese: Fi studji kliniċi, il-medja ta' espożizzjoni għal olanzapine kienet bejn wieħed u ieħor ta' 27% ogħla fl-adolexxenti.
English: Each film-coated tablet contains 152 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 152 mg ta' lactose (bħala monohydrate).
English: In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
Maltese: F'pazjenti li l-episodju ta' manija tagħhom irreaġixxa għat-trattament ta' olanzapine, olanzapine hija indikata għall-prevenzjoni ta' rikorrenza f'pazjenti b'diżordni bipolari (ara sezzjoni 5.1).
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Maltese: Disturbi fil-fwied u fil-marrara Żieda ta' aminotransferases talfwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet filbidu tal-kura (ara sezzjoni 4.4)
English: 10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and “G” on the other side.
Maltese: 2 mm, tondi, mżaqqa normali, imnaqqxa b' “OZ 10” fuq naħa waħda u b' “G” fuq in-naħa l-oħra.
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: P6 PFi studji kliniċi, l-inċidenza tal-marda ta' Parkinson u distonja f'pazjenti kkurati b' olanzapine kienet numerikament ogħla, imma statistikament mhux differenti b'mod sinifikattiv mill-plaċebo.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Maltese: L-espożizzjoni (mg/kg) medja fit-trabi fl-istat fiss kienet stimata li kienet 1.8% tad-doża ta' olanzapine fl-omm.
English: Tardive Dyskinesia
Maltese: Diskajneżja Tardiva
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: Wara kura għal żmien qasir (medjan ta' tul ta' żmien ta' 47 ġurnata), zieda fil-piż ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem kienet komuni ħafna (22 %) ≥ 15% kienet komuni (4.2 %) u ≥ 25 % ma kinitx komuni (0.8 %).
English: Olanzapine Mylan 10 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 10 mg pillola Olanzapine
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 trattament b'olanzapine flimkien ma' lithium jew divalproex, żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem seħħet f' 17.4% tal-pazjenti waqt it-trattament akut (sa 6 ġimgħat).
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: Trattament b'olanzapine għal żmien twil (sa 12-il xahar) bl-għan ta' prevenzjoni ta' episodju ieħor f'pazjenti b'mard bipolari kien assoċjat ma' żieda ta' ≥ 7% mil-linja bażi tal-piż talġisem f' 39.9% tal-pazjenti.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Maltese: Psikożi relatata mad-demenzja u/jew disturbi fil-komportament Olanzapine mhux irrakkomandat għall-użu f'pazjenti b'psikożi relatata mad-demenzja u/jew disturbi fil-komportament, dovut għal żieda fil-mortalità u r-riskju ta' inċident ċerebro-vaskulari.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Maltese: Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma' haloperidol fit-termini tal-proporzjon ta' pazjenti f'remissjoni sintomatika minn manija u depressjoni f' 6 u 12-il ġimgħa.
English: Parkinson's disease
Maltese: Marda ta' Parkinson
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, ta' nuqqas tal-Lapp lactase jew ta' nuqqas fl-assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Maltese: Trattament sintomatiku u l-monitoraġġ tal-funzjoni ta' l-organi vitali għandhom isiru skond il-qagħda klinika, inkluż it-trattament għall-pressjoni baxxa u kolass taċ-ċirkolazzjoni u sosteniment pulmonari.
English: Olanzapine Mylan 5 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 5 mg pilloli Olanzapine
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Maltese: Fi studju ta' terapija ta' pazjenti trattati flimkien b'lithium jew b'valproate għal minimu ta' ġimgħatejn, iż-żjieda ta' olanzapine 10 mg (terapija flimkien ma' lithium jew valproate) wara 6 ġimgħat irriżultat f'tnaqqis akbar tas-sintomi tal-manija milli b'monoterapija b'lithium jew b'valproate.
English: Patients treated with any antipsychotic medicines, including olanzapine, 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 OLANZAPINE MYLAN, 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: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Maltese: Olanzapine naqset ir-rispons kundizzjonat u ta' skansar, test indikattiv ta' l-attività antipsikotika, f'dożi anqas minn dawk li jwasslu għall-katalepsi, riżultat indikattiv ta' l-effett mhux mixtieq tassistema (motorjali).
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Maltese: Tibdil fil-livelli tal-kolesterol totali waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 5.17 - < 6.2 mmol/l) għal għoljin (≥ 6.2 mmol/l) kienu komuni ħafna.
English: • Parkinson's disease
Maltese: • Mard ta' Parkinson
English: Absolute oral bioavailability relative to intravenous administration has not been determined.
Maltese: Il-biodisponibilità' assoluta orali relattiva għal amministrazzjoni fil-vina ma' kienitx determinata.
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 fis-sider.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja, ipotonja, rogħda, ħedla, skumdità respiratorja, jew disturb fit-tmigħ.
English: Sedation affected mating performance of male rats.
Maltese: Remettar sfurzat mhux rakkomandat.
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: Każijiet rari li ġew rappurtati bħala NMS kienu rrappurtati f'assoċjazzjoni ma' olanzapine ukoll. Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad-demm jew tal-polz irregolari, takikardija, dijaforeżi, u taħbit tal-qalb irregolari).
English: The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Maltese: Il-prodott metaboliku li l-aktar jiċċirkola huwa 10-N- glukoronide, li ma jaqsamx il-barriera bejn id-demm u l-moħħ.
English: In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Maltese: F'pazjenti b'diżordni ta' manija jew diżordni bipolari b'episodju mħallat, olanzapine wera effikaċja superjuri għall-plaċebo u għal valproate semisodium (divaproex) fit-tnaqqis ta' sintomi manijaċi f'aktar minn 3 ġimgħat.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia.
Maltese: Sinjali kliniċi inkludew sedazzjoni, atassja, rogħda, żjieda fir-rata tal-qalb, diffikultà fir-respirazzjoni, tidjiq tal-pupilla ta' l-għajn, u l-anoreksja.
English: Olanzapine Mylan 7.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 7.5” on one side and “G” on the other side.
Maltese: L-Olanzapine Mylan 7.5 mg huma 9.0 mm, tonda, mżaqqa normali, pilloli bojod miksija b'rita b' “OZ 7.5” imnaqqax fuq naħa waħda u b'“G” fuq in-naħa l-oħra.
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1).
Maltese: Studji f'pazjenti bejn it-13 u s-17-il sena wrew reazzjonijiet avversi varji, fosthom żieda fil-piż, tibdil fil-parametri metaboliċi u żieda fillivelli ta' prolactin (ara sezzjonijiet 4.8 u 5.1).
English: Perforated unit dose blisters:
Maltese: Il-prevenzjoni tar-rikorrenza fid-diżordni bipolari:
English: Olanzapine Mylan 7.5 mg, 15 mg and 20 mg is available in packs containing 100 film-coated tablets.
Maltese: L-OlanzapineMylan tal-7.5 mg, tal-15 mg u tal-20 mg jinbiegħu f'pakketti ta' 100 pilloa miksija b'rita.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Maltese: Iż-żjieda medja f' olanzapine Cmax wara t-teħid ta' fluvoxamine kienet 54% fin-nisa li ma jpejpux u 77% fl-irġiel li jpejpu.
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Maltese: Ġew rappurtati każijiet fatali b' dożi akuti u eċċessivi baxxi daqs 450 mg iżda kien hemm ukoll każ fejn pazjent baqa ħaj wara doża eċċessiva akuta ta' madwar 2 g ta' olanzapine meħud b'mod orali.
English: Olanzapine Mylan 2.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 2.5” on one side and “G” on the other side.
Maltese: L-Olanzapine Mylan 2.5 mg huma 7.0 mm, tonda, mżaqqa normali, pilloli bojod miksija b'rita b' “OZ 2.5” imnaqqax fuq naħa waħda u b'“G” fuq in-naħa l-oħra.
English: Excipients with known effect
Maltese: Effetti sekondarji possibbli
English: EU/1/08/475/030 EU/1/08/475/031 EU/1/08/475/032 EU/1/08/475/033 EU/1/08/475/045 EU/1/08/475/046 EU/1/08/475/060
Maltese: EU/1/08/475/031 EU/1/08/475/032 EU/1/08/475/033 EU/1/08/475/045
English: Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Maltese: Olanzapine hija metabolizzata fil-fwied minn metodi konjugattivi u ossidattivi.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Maltese: Aċċessjonijiet li filmaġġoranza tagħhom kien rrappurtat passat mediku ta' aċċessjonijiet jew fatturi tar-riskju għallaċċessjonijiet11
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Maltese: Fl-istudju, ir-riskju ta' olanzapine kien simili għar-riskju minn antipsikotiċi atipiċi li kienu inklużi f'analiżi minn numru ta' studji.
English: Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Maltese: Għalkemm ma ġewx imwettqa studji kliniċi magħmulin biex iqabblu l-adolexxenti ma' l-adulti, informazzjoni millistudji ta' l-adolexxenti ġiet imqabbla ma' dik ta' l-istudji ta' l-adulti.
English: However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Maltese: l-impatt ta' l-età, is-sess, jew tat-tipjip fuq il-clearance ta' olanzapine u fuq il-half life huwa żgħir f'paragun mal-varjabilità totali ta' bejn individwi.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Mylan.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu OLANZAPINE MYLAN.
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu li titbaxxa t-temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija tal-ġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30 % of olanzapine treated patients with normal baseline prolactin value.
Maltese: 8 F'studji kliniċi li damu sa 12-il ġimgħa, il-konċentrazzjonijiet fil-plażma ta' prolactin qabżu l-ogħla limitu tal-marġni normali f'madwar 30 % tal-pazjenti kkurati b'olanzapine u li bħala linja bażi kellhom valuri normali ta' prolactin.
English: Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Maltese: Studji fuq l-imġieba ta' l-annimali li ingħataw olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti malprofil tar-riċettur li jorbot.
English: Bottles:
Maltese: Fliexken:
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Maltese: Olanzapine uriet ukoll vantaġġ statistiku u sinifikanti fuq il-plaċebo filprevenzjoni, kemm f'attakki ġodda ta' manija kif ukoll f'attakki ġodda ta' depressjoni.
English: Glucosuria
Maltese: Newtropenja
English: Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Maltese: Olanzapine inbeda b' 2.5 mg/ġurnata u żdied bil-mod għall-massimu ta' 15 mg/ġurnata ibbażat fuq il-ġudizzju tar-riċerkatur.
English: 56 film-coated tablets
Maltese: 56 pilloli miksijin b'rita
English: Olanzapine Mylan 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine.
Maltese: OLANZAPINE MYLAN 2.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 2.5 mg olanzapine.
English: Olanzapine is indicated for the treatment of schizophrenia.
Maltese: Olanzapine hija indikata għat-trattament tal-iskiżofrenja.
English: Children and adolescents Olanzapine Mylan is not for patients who are under 18 years.
Maltese: Tfal u adolexxenti OLANZAPINE MYLAN mhux għal pazjenti li għandhom anqas minn 18-il sena.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: P1 PĠiet osservata żieda fil-piż, klinikament sinifikanti, fil-linja bażi ta' l-Indiċi tal-Massa tal-Ġisem (Body Mass Index - BMI).
English: Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Maltese: Ibbażat fuq riżultati ta' studji fuq il-ġrieden u l-firien, kien konkluż li olanzapine mhuwiex kanċeroġeniku.
English: EU/1/08/475/007 EU/1/08/475/008 EU/1/08/475/009 EU/1/08/475/010 EU/1/08/475/037 EU/1/08/475/038 EU/1/08/475/053 EU/1/08/475/061
Maltese: EU/1/08/475/007 EU/1/08/475/008 EU/1/08/475/009 EU/1/08/475/010
English: Urinary incontinence, urinary retention Urinary hesitation11
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Inkontinenza urinarja, żamma tal-urina
English: 8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” on the other side.
Maltese: Pilloli miksija b'rita ta' 8.0 mm, tondi, konvessi normali, ta' kulur abjad, imnaqqxin b'“OZ” fuq “5” fuq naħa waħda u “G” fuq in-naħa l-oħra.
English: EU/1/08/475/001 EU/1/08/475/002 EU/1/08/475/003 EU/1/08/475/004 EU/1/08/475/035 EU/1/08/475/036 EU/1/08/475/056
Maltese: EU/1/08/475/002 EU/1/08/475/003 EU/1/08/475/004
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Maltese: FIS-SUQ Mylan S.A.S.
English: 28 film-coated tablets
Maltese: 28 pilloli miksijin b'rita