FrancophonIA/ELRC3.0 huggingface dataset:
English: Colour mixture blue (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171, indigo carmine E132)
Maltese: Kulur ta' taħlita blu (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171, indigo carmine E132)
English: In female versus male subjects the mean elimination half-life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
Maltese: F' pazjenti femminili f'paragun ma' dawk maskili il-medja tal-half-life ta' l-eliminazzjoni ġiet kemmxejn mtawla (36.7 kontra 32.3 sigħat) u t-tneħħija tnaqqset (18.9 kontra 27.3 l/hr).
English: Excipient with known effect Each film-coated tablet contains 68.9 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 68.9 mg lactose.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskdai li tidher fuq il-kartuna wara “EXP”.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT than D activity in vivo models.
Maltese: Olanzapine wera affinità akbar in vitro għal serotonin 5HT2 milli għarriċetturi ta' dopamine D2 u attività in vivo akbar għal 5HT milli għal D.
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: kien komuni ħafna (64.4%, 31.7% u 12.3% rispettivament).
English: Excipient with known effect Each film-coated tablet contains 137.8 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 137.8 mg lactose.
English: In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Maltese: F'pazjenti li ma jpejpux f'paragun ma' dawk li jpejpu (irġiel u nisa) il-medja tal-half-life ta' leliminazzjoni kien imtawwal (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
English: Other medicines and Olanzapine Teva
Maltese: Mediċini oħra u Olanzapine Teva
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glukożju-gallatożju jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza ta' Lapp lactase jew ta' assorbiment ħażin ta' glukożju-gallatożju m'għandhomx jieħdu din il-mediċina.
English: Tardive dyskinesia11 Amnesia9
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Maltese: Effetti sekondarji mhux komuni ( jistgħu jaffettwaw sa 1 minn kull 100 persuna) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx);dijabete jew dijabete li tmur għall-agħar, kultant assoċjata ma' ketoaċidożi (ketoni fid-demm u fl-awrina) jew koma; aċċessjonijiet, normalment assoċjati ma' storja ta' aċċessjonijiet (epilessija); ebusija tal-muskoli jew spażmi (inklużi movimenti fl għajnejn); sindromu ta' saqajn irrikwieti; problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bilmod; sensittività għad-dawl tax-xemx; tinfaraġ; nefħa fl-addome; telf tal-memorja jew tibda tinsa;
English: The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ml.
Maltese: L-irbit ta' proteini fil-plażma ma' olanzapine kien madwar 93% fuq il-firxa ta' konċentrazzjonijiet ta' madwar 7 sa madwar 1000 ng/ml.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Maltese: F'studju komparattiv, double-blind u multinazzjonali ta' skiżofrenija, ta' manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1,481 pazjent li kellhom gravità differenti ta' lassoċjati sintomi dipressivi (medja ta' punteġg ta' 16.6 meħud fil-bidu tal-kura skond l-iskala li tivvaluta d-dipressjoni ta' Montgomery-Asberg), analiżi prospettiva sekondarja tat-tibdil fil-punteġġ ta'
English: 14 Observed for fasting normal levels at baseline (<1.016 mmol/l) which increased to high
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (<1.016 mmol/l) li żdiedu għal għoljin
English: This medicine contains 2.25 mg/4.5 mg/6.75 mg/9 mg aspartame in each 5 mg/10 mg/15 mg/20 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 2.25 mg/4.5 mg/6.75 mg/9 mg aspartame f'kull pillola li tinħall fil-ħalq ta'
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in 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 komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) jinkludu tibdil fil-livelli 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; irrekwjetezza; rogħda; movimenti mhux tas-soltu (diskajnisjas); stitikezza; ħalq xott; raxx; titlef il-forzi; għeja esaġerata; retenzjoni tal-ilma li twassal għal nefħa fl-idejn, għekiesi jew saqajn; deni; uġigħ fiġ-ġogi u problemi sesswali bħal tnaqqis fil-ħajra sesswali fl-irġiel u n-nisa u impotenza fl-irġiel.
English: The daily dose of Olanzapine Teva is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' Olanzapine Teva hija bejn 5 mg u 20 mg.
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 tal-ovarji u tal-utru u tibdiliet morfoloġiċi fl-epitilju tal-vaġina u fis-sider.
English: EU/1/07/427/001 EU/1/07/427/002 EU/1/07/427/003 EU/1/07/427/038 EU/1/07/427/048 EU/1/07/427/058
Maltese: EU/1/07/427/001 EU/1/07/427/002 EU/1/07/427/003 EU/1/07/427/038 EU/1/07/427/048
English: Colour mixture pink (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171, iron oxide red E172)
Maltese: Kulur ta' taħlita roża (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171, iron oxide aħmar E172)
English: Olanzapine Teva 7.5 mg film-coated tablets
Maltese: Olanzapine Teva 7.5 mg pilloli miksija b'rita
English: Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of the active substance.
Maltese: Kull pillola miksija b'rita ta' Olanzapine Teva fiha 7.5 mg tas-sustanza attiva.
English: 5 Observed for fasting normal levels at baseline (<1.69 mmol/l) which increased to high
Maltese: 5 Innotat għal livelli normali waqt is-sawm fil-linja bażi (<1.69 mmol/l) li żdiedu għal għoljin
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 [AUC] hija 12 sa 15-il darba aktar minn dik ta' raġel mogħti doża ta' 12 mg).
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 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 ), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata mad-demenzja u/jew disturbi fil-komportament, kien hemm żieda ta' darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: ≥25% was common (2.5%).
Maltese: (4.2%) u ≥25% kienet mhux komuni (0.8%).
English: Date of latest renewal: 12.
Maltese: Data tal-aħħar tiġdid: 12 ta' Diċembru 2012
English: Each orodispersible tablet contains 95.0 mg lactose, 0.525 mg sucrose and 4.5 mg aspartame (E951).
Maltese: mg lactose, 0.525 mg sucrose u 4.5 mg aspartame (E951).
English: Each orodispersible tablet contains 47.5 mg lactose, 0.2625 mg sucrose and 2.25 mg aspartame (E951).
Maltese: mg lactose, 0.2625 mg sucrose u 2.25 mg aspartame (E951)
English: Excipient with known effect Each film-coated tablet contains 103.3 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 103.3 mg lactose.
English: EU/1/07/427/035 EU/1/07/427/036 EU/1/07/427/037 EU/1/07/427/047 EU/1/07/427/057 EU/1/07/427/067
Maltese: EU/1/07/427/036 EU/1/07/427/037 EU/1/07/427/047 EU/1/07/427/057 EU/1/07/427/067
English: Mutagenicity
Maltese: JIDHITX
English: A small study of the effect of impaired liver function in 6 subjects with clinically significant (Childs Pugh Classification A (n = 5) and B (n = 1)) cirrhosis revealed little effect on the pharmacokinetics of orally administered olanzapine (2.5 - 7.5 mg single dose): Subjects with mild to moderate hepatic dysfunction had slightly increased systemic clearance and faster elimination half-time compared to subjects with no hepatic dysfunction (n = 3).
Maltese: Studju żgħir dwar l-effett ta' indeboliment fil-funzjoni tal-fwied f'6 suġġetti b'ċirrożi klinikament sinifikanti (Klassifikazzjoni Childs Pugh A (n = 5) u B (n = 1)) wera effett minimu fuq il farmakokinetika ta' olanzapine (2.5 - 7.5 mg bħala doża waħda) mogħti b'mod orali: Suġġetti b'disfunzjoni epatika ħafifa sa moderata kellhom żieda żgħira fit-tneħħija sistemika u half-time taleliminazzjoni aktar mgħaġġel meta mqabbla ma' suġġetti li ma kellhom l-ebda disfunzjoni epatika
English: EU/1/07/427/020 EU/1/07/427/021 EU/1/07/427/022 EU/1/07/427/043 EU/1/07/427/053 EU/1/07/427/063
Maltese: EU/1/07/427/021 EU/1/07/427/022 EU/1/07/427/043 EU/1/07/427/053 EU/1/07/427/063
English: In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine.
Maltese: F'rapporti ta' wara t-tqegħid fis-suq b'olanzapine, każijiet ta' mewt kardijaku f'daqqa ġew rapportati f'pazjenti li kienu fuq olanzapine.
English: 4 Observed for fasting normal levels at baseline (<5.56 mmol/l) which increased to high (≥7 mmol/l).
Maltese: 4 Innotat għal livelli normali waqt is-sawm fil-linja bażi (<5.56 mmol/l) li żdiedu għal għoljin
English: Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance.
Maltese: Kull pillola ta' 10 mg ta' Olanzapine Teva li tinħall fil-ħalq fiha 10 mg tas-sustanza attiva.
English: LIST OF EXCIPIENTS Contains, among others, Lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fiha, fost oħrajn, Lactose monohydrate.
English: Each Olanzapine Teva 2.5 mg film-coated tablet contains 2.5 mg of the active substance.
Maltese: Kull pillola miksija b'rita ta' Olanzapine Teva fiha 2.5 mg tas-sustanza attiva.
English: Each Olanzapine Teva 20 mg film-coated tablet contains 20 mg of the active substance.
Maltese: Kull pillola ta' 20 mg ta' Olanzapine Teva li tinħall fil-ħalq fiha 20 mg tas-sustanza attiva
English: Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' >75 sena u d demenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAEf'assoċjazzjoni ma' trattament b'olanzapine.
English: Olanzapine Teva 20 mg film-coated tablets OPA/alu/PVC-alu blisters in cartons of 28, 30, 35, 56, 70 or 98 film-coated tablets per carton.
Maltese: Olanzapine Teva 20 mg pilloli miksija b'rita Folji ta' OPA/alu/PVC-alu f'kartun ta' 28, 30, 35, 56, 70 jew 98 pillola miksija b'rita f'kull kartuna.
English: Excipient with known effect Each film-coated tablet contains 71.3 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 71.3 mg lactose.
English: Olanzapine Teva 10 mg film-coated tablets EU/1/07/427/011 - 7 tablets, per box EU/1/07/427/083 - 7 x 1 tablets, per box EU/1/07/427/012 - 28 tablets, per box EU/1/07/427/084 - 28 x 1 tablets, per box EU/1/07/427/013 - 30 tablets, per box EU/1/07/427/085 - 30 x 1 tablets, per box EU/1/07/427/041 - 35 tablets, per box EU/1/07/427/086 - 35 x 1 tablets, per box EU/1/07/427/014 - 50 tablets, per box EU/1/07/427/087 - 50 x 1 tablets, per box EU/1/07/427/015 - 56 tablets, per box EU/1/07/427/088 - 56 x 1 tablets, per box EU/1/07/427/069 - 60 tablets, per box EU/1/07/427/051 - 70 tablets, per box EU/1/07/427/089 - 70 x 1 tablets, per box EU/1/07/427/061 - 98 tablets, per box EU/1/07/427/090 - 98 x 1 tablets, per box
Maltese: Olanzapine Teva 10 mg pilloli miksija b'rita EU/1/07/427/011 - 7 pilloli, kull kaxxa EU/1/07/427/083 - 7 x 1 pilloli, kull kaxxa EU/1/07/427/012 - 28 pillola, kull kaxxa EU/1/07/427/084 - 28 x 1 pillola, kull kaxxa EU/1/07/427/013 - 30 pillola, kull kaxxa EU/1/07/427/085 - 30 x 1 pillola, kull kaxxa EU/1/07/427/041 - 35 pillola, kull kaxxa EU/1/07/427/086 - 35 x 1 pillola, kull kaxxa EU/1/07/427/014 - 50 pillola, kull kaxxa EU/1/07/427/087 - 50 x 1 pillola, kull kaxxa EU/1/07/427/015 - 56 pillola, kull kaxxa EU/1/07/427/088 - 56 x 1 pillola, kull kaxxa EU/1/07/427/069 - 60 pillola, kull kaxxa EU/1/07/427/051 - 70 pillola, kull kaxxa EU/1/07/427/089 - 70 x 1 pillola, kull kaxxa EU/1/07/427/061 - 98 pillola, kull kaxxa EU/1/07/427/090 - 98 x 1 pillola, kull kaxxa
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Maltese: Fi studji kliniċi, id-deterjorament fis-sintomi tal-marda ta' Parkinson u alluċinazzjonijiet kienu rrappurtati b'mod komuni ħafna u aktar ta' spiss milli bil plaċebo (ara sezzjoni 4.8), u olanzapine ma kienx aktar effettiv mill-plaċebo fit-trattament tas-sintomi psikotiċi.
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: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Maltese: It-teħid flimkien mal-faħam attivat wera li jnaqqas il-Bijodisponibilità orali ta' olanzapine b' 50% sa 60%.
English: 8 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 Fi provi kliniċi li damu sejrin sa 12-il ġimgħa, il-konċentrazzjonijiet ta' prolactin fil-plażma kienu jaqbżu l-livell normali fil-medda ta' ta' fuq f'madwar 30% ta' pazjenti kkurati b'olanzapine b'valur ta' prolactin fiq il-livell ta' riferiment bażi normali.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 7.5 mg film-coated tablets Olanzapine
Maltese: Olanzapine Teva 7.5 mg pilloli miksija b'rita Olanzapine
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: 15 Tibdil fil-livelli tal-kolesterol totali waqt is-sawm minn normal fil-linja bażi (<4.39 mmol/l) għal għoljin (≥5.17 mmol/l) kienu komuni.
English: Olanzapine Teva 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine.
Maltese: Kull pillola li tinħall fil-ħalq fiha 20 mg olanzapine.
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: (Body Mass Index - BMI), fil-kategoriji kollha.
English: Olanzapine Teva 20 mg orodispersible tablets
Maltese: Olanzapine Teva 20 mg pilloli miksija b'rita
English: Oedema
Maltese: FOLJA
English: Olanzapine Teva 7.5 mg film-coated tablets EU/1/07/427/008 - 28 tablets, per box EU/1/07/427/077 - 28 x 1 tablets, per box EU/1/07/427/009 - 30 tablets, per box EU/1/07/427/078 - 30 x 1 tablets, per box EU/1/07/427/040 - 35 tablets, per box EU/1/07/427/079 - 35 x 1 tablets, per box EU/1/07/427/010 - 56 tablets, per box EU/1/07/427/080 - 56 x 1 tablets, per box EU/1/07/427/068 - 60 tablets, per box EU/1/07/427/050 - 70 tablets, per box EU/1/07/427/081 - 70 x 1 tablets, per box EU/1/07/427/060 - 98 tablets, per box EU/1/07/427/082 - 98 x 1 tablets, per box
Maltese: Olanzapine Teva 7.5 mg pilloli miksija b'rita EU/1/07/427/008 - 28 pillola, kull kaxxa EU/1/07/427/077 - 28 x 1 pillola, kull kaxxa EU/1/07/427/009 - 30 pillola, kull kaxxa EU/1/07/427/078 - 30 x 1 pillola, kull kaxxa EU/1/07/427/040 - 35 pillola, kull kaxxa EU/1/07/427/079 - 35 x 1 pillola, kull kaxxa EU/1/07/427/010 - 56 pillola, kull kaxxa EU/1/07/427/080 - 56 x 1 pillola, kull kaxxa EU/1/07/427/068 - 60 pillola, kull kaxxa EU/1/07/427/050 - 70 pillola, kull kaxxa EU/1/07/427/081 - 70 x 1 pillola, kull kaxxa EU/1/07/427/060 - 98 pillola, kull kaxxa EU/1/07/427/082 - 98 x 1 pillola, kull kaxxa
English: Biotransformation
Maltese: Tromboemboliżmu
English: Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance.
Maltese: Kull pillola ta' 15 mg ta' Olanzapine Teva li tinħall fil-ħalq fiha 15 mg tas-sustanza attiva.
English: Olanzapine Teva 5 mg film-coated tablets EU/1/07/427/004 - 28 tablets, per box EU/1/07/427/070 - 28 x 1 tablets, per box EU/1/07/427/005 - 30 tablets, per box EU/1/07/427/071 - 30 x 1 tablets, per box EU/1/07/427/039 - 35 tablets, per box EU/1/07/427/072 - 35 x 1 tablets, per box EU/1/07/427/006 - 50 tablets, per box EU/1/07/427/073 - 50 x 1 tablets, per box EU/1/07/427/007 - 56 tablets, per box EU/1/07/427/074 - 56 x 1 tablets, per box EU/1/07/427/049 - 70 tablets, per box EU/1/07/427/075 - 70 x 1 tablets, per box EU/1/07/427/059 - 98 tablets, per box EU/1/07/427/076 - 98 x 1 tablets, per box
Maltese: Olanzapine Teva 5 mg pilloli miksija b'rita EU/1/07/427/004 - 28 pillola, kull kaxxa EU/1/07/427/070 - 28 x 1 pillola, kull kaxxa EU/1/07/427/005 - 30 pillola, kull kaxxa EU/1/07/427/071 - 30 x 1 pillola, kull kaxxa EU/1/07/427/039 - 35 pillola, kull kaxxa EU/1/07/427/072 - 35 x 1 pillola, kull kaxxa EU/1/07/427/006 - 50 pillola, kull kaxxa EU/1/07/427/073 - 50 x 1 pillola, kull kaxxa EU/1/07/427/007 - 56 pillola, kull kaxxa EU/1/07/427/074 - 56 x 1 pillola, kull kaxxa EU/1/07/427/049 - 70 pillola, kull kaxxa EU/1/07/427/075 - 70 x 1 pillola, kull kaxxa EU/1/07/427/059 - 98 pillola, kull kaxxa
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 fil livelli ta' prolactin (ara sezzjonijiet 4.8 u 5.1).
English: EU/1/07/427/017 - 30 tablets, per box
Maltese: EU/1/07/427/017 - 30 pillola, kull kaxxa
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg orodispersible tablets Olanzapine
Maltese: Olanzapine Teva 20 mg pilloli miksija b'rita Olanzapine
English: EU/1/07/427/019 - 56 tablets, per box
Maltese: EU/1/07/427/019 - 56 pillola, kull kaxxa
English: Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance.
Maltese: Kull pillola ta' 5 mg ta' Olanzapine Teva li tinħall fil-ħalq fiha 5 mg tas-sustanza attiva.
English: EU/1/07/427/042 - 35 tablets, per box
Maltese: EU/1/07/427/042 - 35 pillola, kull kaxxa
English: Olanzapine Teva 5 mg orodispersible tablets
Maltese: Olanzapine Teva 5 mg pilloli miksija b'rita
English: Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets
Maltese: 2.5 mg pilloli miksija b'rita Olanzapine Teva 5 mg pilloli miksija b'rita Olanzapine Teva 7.5 mg pilloli miksija b'rita Olanzapine Teva 10 mg pilloli miksija b'rita Olanzapine Teva 15 mg pilloli miksija b'rita Olanzapine Teva 20 mg pilloli miksija b'rita
English: Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets Olanzapine
Maltese: 2.5 mg pilloli miksija b'rita Olanzapine Teva 5 mg pilloli miksija b'rita Olanzapine Teva 7.5 mg pilloli miksija b'rita Olanzapine Teva 10 mg pilloli miksija b'rita Olanzapine Teva 15-il mg pilloli miksija b'rita Olanzapine Teva 20 mg pilloli miksija b'rita
English: 3 Observed for fasting normal levels at baseline (<5.17 mmol/l) which increased to high
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (<5.17 mmol/l) li żdiedu għal għoljin
English: EU/1/07/427/018 - 50 tablets, per box
Maltese: EU/1/07/427/018 - 50 pillola, kull kaxxa
English: Olanzapine Teva 15 mg orodispersible tablets
Maltese: Olanzapine Teva 15 mg pilloli miksija b'rita
English: 28 film-coated tablets 28 x 1 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 35 film-coated tablets 35 x 1 film-coated tablets 50 film-coated tablets 50 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 70 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets
Maltese: 28 pillola miksija b'rita 28 x 1 pillola miksija b'rita 30 pillola miksija b'rita 30 x 1 pillola miksija b'rita 35 pillola miksija b'rita 35 x 1 pillola miksija b'rita 50 pillola miksija b'rita 50 x 1 pillola miksija b'rita 56 pillola miksija b'rita 56 x 1 pillola miksija b'rita 70 pillola miksija b'rita 70 x 1 pillola miksija b'rita 98 pillola miksija b'rita 98 x 1 pillola miksija b'rita
English: Olanzapine Teva 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine.
Maltese: Kull pillola li tinħall fil-ħalq fiha 5 mg olanzapine.
English: 6 weeks).
Maltese: (n = 3).