FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine had no teratogenic effects.
Maltese: Olanzapine ma kellu l-ebda effetti teratoġeniċi.
English: (See Figure B)
Maltese: (Ara Figura B)
English: Neuroleptic Malignant Syndrome (NMS)
Maltese: Sindromu Newrolettiku Malinn (NMS)
English: General CNS activity
Maltese: Attività ġenerali ta' CNS
English: The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Maltese: Iż-żieda medja fl-AUC ta' olanzapine kienet ta' 52% u 108% rispettivament.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Maltese: Olanzapine ma jimpedixxix l-isoenzimi CYP450 prinċipali in vitro (eż. 1A2, 2D6, 2C9, 2C19,
English: (See Figure A)
Maltese: (Ara Figura A)
English: ZYPADHERA contains the active substance olanzapine.
Maltese: ZYPADHERA fiha s-sustanza attiva olanzapine.
English: Dose (mg)
Maltese: (mg)
English: High uric acid 10
Maltese: Uric acid għoli10
English: Dystonia (including oculogyration)11 Tardive dyskinesia11
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11
English: For instructions for use, see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara taqsima 6.1.
English: There have been reports of agitation, hypertonia,
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja,
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
Maltese: • carbamazepine (anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant), jew ciprofloxacin (antibijotiku), għax jista' jkun hemm bżonn li tbiddel id-doża tiegħek ta'
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α-1 adrenergic; and histamine H1 receptors.
Maltese: għal riċetturi ta' serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; riċetturi muskariniċi kolinerġiċi M1-M5; α-1 adrenerġiċi; riċetturi histamine H1.
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Maltese: Id-dożi medjani letali kienu ta' madwar 210 mg/kg (ġrieden) u 175 mg/kg (firien).
English: • Prostate problems
Maltese: • Problemi fil-prostata
English: The predominant pharmacologic activity is from the parent, olanzapine.
Maltese: L-attività farmakoloġika predominanti tiġi mis-sustanza oriġinali, olanzapine.
English: Induction of CYP1A2
Maltese: Inibizzjoni ta' CYP1A2
English: ZYPADHERA with alcohol
Maltese: ZYPADHERA mal-alkoħol
English: Thromboembolis m (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Maltese: Tromboemboliżmu (inkluż l-emboliżmu pulmonari u ttrombożi tal-vini filfond) (ara taqsima 4.4)
English: 15 mg/day
Maltese: 15 mg/jum
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Maltese: Komuni ħafna ( > 1/10), komuni ( > 1/100 sa < 1/10), mhux komuni ( > 1/1,000 sa < 1/100), rari ( > 1/10,000 sa < 1/1,000), rari ħafna ( < 1/10,000), mhux magħruf (ma jistgħux jiġu stmati millinformazzjoni li hemm disponibbli).
English: ZYPADHERA vial strength (mg)
Maltese: ZYPADHERA qawwa tal-kunjett (mg)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: 20 mg/day
Maltese: 20 mg/jum
English: STEP 3: Reconstituting ZYPADHERA 1.
Maltese: Ir-rikostituzzjoni ta' ZYPADHERA 1.
English: NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Maltese: NMS huwa kundizzjoni potenzjalment fatali assoċjat ma' prodotti mediċinali antipsikotiċi.
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Maltese: B'espożizzjoni fit-tul (għallinqas 24 ġimgħa), 89.4 % żiedu ≥ 7 %, 55.3 % żiedu ≥ 15 % u 29.1 % żiedu ≥ 25 % mil-linja bażi talpiż tal-ġisem tagħhom.
English: • One Hypodermic syringe and safety needle (Hypodermic Device)
Maltese: • Siringa u labra tas-sigurtà Hypodermic waħda (L-Apparat Hypodermic )
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10).
English: Amnesia 9
Maltese: Amnesija9
English: ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Maltese: ZYPADHERA ma ġiex studjat b'mod sistematiku f'pazjenti anzjani (> 65 sena).
English: ZYPADHERA is not recommended to be started in patients >75 years (see section 4.4).
Maltese: ZYPADHERA mhux irrakkomandat li jinbeda f'pazjenti ta' > 75 sena (ara taqsima 4.4).
English: Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Maltese: Komuni ħafna: Żieda fil-piż13, livelli elevati ta' trigliċeridi14, żieda fl-aptit.
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Maltese: (≥ 1.467 mmol/l) u tibdil fit-trigliċeridi waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 1.016 mmol/l - < 1.467 mmol/l) għal għoljin (≥ 1.467 mmol/l).
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Maltese: 16 F'47.4% tal-pazjenti adolexxenti ġew irrapportati livelli għoljin ta' prolactin fil-plażma.
English: Solvent for ZYPADHERA
Maltese: Solvent għal ZYPADHERA
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Maltese: M'hemmx dejta kkontrollata dwar il-manteniment tal-effett jew dwaris-sigurtà fit-tul (ara taqsimiet 4.4 u 4.8).
English: Acute (single-dose) toxicity
Maltese: Tossiċità akuta (b'doża waħda)
English: Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Maltese: Olanzapine pamoate monohydrate ekwivalenti għal 405 mg olanzapine .
English: • Two 19-gauge, 50 mm Hypodermic safety needles
Maltese: • Żewġ labar tas-sigurtà Hypodermic 19-gejġ, 50 mm
English: High creatine phosphokinase11 High Gamma Glutamyltransfera se 10
Maltese: Creatine phosphokinase għoli11 Gamma
English: The major circulating metabolite is the 10-N-glucuronide.
Maltese: Il metabolit prinċipali li jiċċirkola huwa 10-N-glucuronide.
English: Date of latest renewal: 26/08/2013
Maltese: Data tal-ewwel awtorizzazzjoni: 19/11/2008 Data tal-aħħar tiġdid: 26/08/2013
English: The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension,
Maltese: Fi studji kliniċi, l-aktar reazzjonijiet avversi li ġew irrapportati b'mod frekwenti (jidhru f'> 1% talpazjenti) u li huma assoċjati ma' l-użu ta' l-olanzapine kienu sonnolenza, żieda fil-piż, eosinofilja, livelli għolja ta' prolactin, kolesterol, glucose u trigliċeridi (ara taqsima 4.4), glukosurja, żieda fl aptit, sturdament, akatiżja, parkinsoniżmu, lewkopenija, newtropenija (ara taqsima 4.4),
English: Three Hypodermic safety needles.
Maltese: Tliet labar tas-sigurtà Hypodermic.
English: In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was sedation (ZYPADHERA 8.2%, placebo 2.0%).
Maltese: ZYPADHERA milli fil-grupp tal-plaċebo (ZYPADHERA 8.2%, plaċebo 2.0%).
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 medja tat-tarbija (mg/kg) f'steady-state ġie stmat li kienet 1.8% tad-doża ta' olanzapine fl-omm (mg/kg).
English: Urinary incontinence
Maltese: Inkontinenza urinarja, żamma talurina
English: Glucosuria
Maltese: Glikosurja
English: • One 19-gauge, 38 mm Hypodermic safety needle
Maltese: • Labra tas-sigurtà waħda Hypodermic 19-gejġ, 38 mm
English: After reconstitution: 150 mg/ml olanzapine.
Maltese: 150 mg/ml olanzapine
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Maltese: Olanzapine huwa sustanza antipsikotika, kontra l-manija u stabilizzatur tal-burdata li juri profil farmakoloġiku wiesa' f'numru ta' sistemi ta' riċetturi.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Maltese: Il-grad ta' tibdil fil-kolesterol totali waqt issawm, kolesterol tat-tip LDL, trigliċeridi, u prolactin (ara taqsimiet 4.4 u 4.8) kien akbar fl adolexxenti milli fl-adulti.
English: Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Maltese: Olanzapine pamoate monohydrate ekwivalenti għal 300 mg olanzapine.
English: One Hypodermic syringe and safety needle.
Maltese: Siringa waħda Hypodermic u labra tas-sigurtà.
English: After clinical reassessment dose may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Maltese: Wara rivalutazzjoni klinika d-doża tista' tiġi aġġustata f'skala ta' bejn 150 mg sa 300 mg kull ġimagħtejn jew 300 sa 405 mg kull 4 ġimgħat.
English: Tolerance developed to the CNS depression.
Maltese: Kien hemm żviluppi fit-tolleranza għad-depressjoni ta' CNS.
English: After repeated IM injections with 150 to 300 mg ZYPADHERA every two weeks, the 10th to 90th percentile of steady-state plasma concentrations of olanzapine were between 4.2 and 73.2 ng/ml.
Maltese: Wara injezzjonijiet repetuti ġol-muskoli b'150 sa 300 mg ZYPADHERA kull ġimagħtejn, l-10 sa d-90 perċentil ta' konċentrazzjonijiet ta' olanzapine fil-plażma f'steady-state kienu bejn 4.2 u 73.2 ng/ml.
English: A total of 1469 patients with schizophrenia were included in 2 pivotal trials:
Maltese: Total ta' 1469 pazjent b'skiżofrenja ġew inklużi f'2 studji kruċjali:
English: One carton contains one vial of powder and one vial of solvent, one Hypodermic 3ml syringe with preattached 19-gauge, 38 mm safety needle, one 19-gauge, 38 mm Hypodermic safety needle and two 19gauge, 50 mm Hypodermic safety needles.
Maltese: Kaxxa fiha kunjett wieħed bit-trab u kunjett wieħed bis-solvent, siringa ta' 3 ml Hyopdermic waħda b'labra tas-sigurtà 19-gejġ, 38 mm mwaħħla magħha, labra tas-sigurtà Hypodermic waħda ta' 19-gejġ, 38 mm u żewġ labar tas-sigurtà Hypodermic ta' 19-gejġ, 50 mm.
English: Vial of suspension after reconstitution: 24 hours.
Maltese: Kunjett ta' suspensjoni wara r-rikostituzzjoni: 24 siegħa
English: Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Maltese: Għandha tingħata attenzjoni speċjali meta tiġi applikata t-teknika adattata ta' l-injezzjoni sabiex tiġi evitata injezzjoni involontarja intravaskulari jew taħt il-ġilda (ara taqsima 6.6).
English: Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Maltese: Sinjali ta' tossiċità orali fl-annimali gerriema kienu karatteristiċi tas-sustanzi antipsikotiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż-żieda tal-piż.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Ilma għall-injezzjonijiet Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Maltese: L-eċċipjenti tas-solvent huma carmellose sodium, mannitol, polysorbate 80, ilma għallinjezzjonijiet, hydrochloric acid, sodium hydroxide.
English: Use in elderly (>75 years)
Maltese: Użu f'pazjenti anzjani (> 75sena)
English: Bromobutyl stopper with steel blue colour seal.
Maltese: Tapp ta' bromobutyl b'siġill kulur blu filgriż.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Maltese: Studju ta' bilanċ tal-massa wera li madwar 57% ta' olanzapine radjuattiv deher fl-urina, prinċipalment bħala metaboliti.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Maltese: Waqt li olanzapine wera attività antikolinerġika in vitro, esperjenza waqt l-istudji kliniċi wriet inċidenza baxxa ta' ġrajjiet relatati.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Maltese: aminotransferases talfwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet fil bidu tal-kura (ara taqsima 4.4)
English: Visitwise mean change from baseline to endpoint in PANSS Total score indicated that by Day 3, patients in the 300 mg/2 weeks and 405 mg/4 weeks treatment groups had statistically significantly greater reductions in PANSS Total score compared to placebo (-8.6, -8.2, and -5.2, respectively).
Maltese: 300 mg/ġimagħtejn u 405 mg/4 ġimgħat kellhom tnaqqis akbar b'mod statistikament sinifikanti fil-punteġġ Totali PANSS imqabbel ma' plaċebo (-8.6, -8.2, u -5.2, rispettivament).
English: Figure A: Tap firmly to mix 10.
Maltese: Taptap b'mod sod sabiex tħallat 10.
English: 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: Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Maltese: Studji fuq l-imġiba ta' lannimali b'olanzapine indikaw antagoniżmu għal 5HT, dopamine, u dak kolinerġiku, konsistenti mal-profil ta' rbit mar-riċettur.
English: In plasma, olanzapine is bound to albumin and α1-acid glycoprotein.
Maltese: olanzapine jkun marbut ma' l-albumina u ma' α1-glikoproteina aċida.
English: In the same clinical trials, cerebrovascular adverse reactions (CVAEvents e.g., stroke, transient ischemic attack), including fatalities, were reported.
Maltese: Fl-istess studji kliniċi, ġew irrapportati reazzjonijiet avversi ċerebrovaskulari (CVAE eż. puplesija, attakki iskemiċi temporanji) inkluż l-imwiet.
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Effetti sekondarji rari ħafna jinkludu reazzjonijiet allerġiċi serji bħal Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS).
English: • dizziness
Maltese: • Dijabete
English: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32 (0)
English: 210 mg/2 weeks or 405 mg/4 weeks
Maltese: 10 mg/jum210 mg/ġimagħtejn jew 405 mg/4
English: ZYPADHERA is given in doses of 150 mg to 300 mg every 2 weeks or 300 mg to 405 mg every 4 weeks.
Maltese: ZYPADHERA jingħata f'dożi ta' 150 mg għal 300 mg kull ġimgħatejn jew 300 mg għal 405 mg kull 4 ġimgħat.
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Maltese: Minħabba li in vitro jikkaġuna antagoniżmu ma' dopamine, olanzapine jista' jantagonizza l-effetti diretti u indiretti ta' l-agonisti ta' dopamine.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Maltese: In-newtropenja kienet irrappurtata b'mod komuni meta olanzapine u valproate intużaw flimkien (ara taqsima 4.8).
English: The first, an 8-week, placebo controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.
Maltese: L-ewwel, studju kkontrollat mill-plaċebo, li dam 8 gimgħat, f'pazjenti adulti (n=404) li esperjenzaw sintomi psikotiċi akuti.
English: Other 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 oħra 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); sindrome ta' saqajn irrekwieti; problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bil-mod; sensittività għad-dawl tax-xemx; tinfaraġ; l-addome jintefaħ; titlef il-memorja jew tibda tinsa; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l urina; jaqa' x-xagħar; nuqqas ta' jew tnaqqis fil-mestrwazzjoni u tibdil fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
English: The solvent ingredients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid and sodium hydroxide.
Maltese: TA' EĊĊIPJENTI L-eċċipjenti tas-solvent huma carmellose sodium, mannitol, polysorbate 80, ilma għall injezzjonijiet, hydrochloric acid, sodium hydroxide.
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Maltese: Għalhekk, mhux mistenni li jseħħ xi effett partikolari ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku ta' olanzapine kif ivverifikat minn studji in vivo fejn ma nstabet ebda inibizzjoni tal-metaboliżmu tas-sustanzi attivi li ġejjin: antidepressiv triċikliku (li jirrapreżenta l aktar is-sensiela ta' reazzjonijiet ta' CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jewdiazepam (CYP3A4 u 2C19).
English: Musculoskeletal and connective tissue disorders Arthralgia9
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue
English: In clinical trials with ZYPADHERA the incidence of injection site related adverse reactions was approximately 8%.
Maltese: Fi studji kliniċi b'ZYPADHERA l-inċidenza ta' reazzjonijiet avversi relatati mas-sit ta' linjezzjoni kien madwar 8%.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and <0.1%) when oral olanzapine is stopped abruptly.
Maltese: Sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, dardir, jew rimettar ġew irrappurtati b'mod rari ( ≥ 0.01% u < 0.1%) meta olanzapine mill-ħalq twaqqaf f'daqqa.
English: • Vial of solvent for ZYPADHERA
Maltese: • Kunjett ta' solvent għal ZYPADHERA
English: After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
Maltese: Wara r-rikostituzzjoni: 1 ml ta' suspensjoni fih 150 mg/ml olanzapine.
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: 17-il sena wrew reazzjonijiet avversi varji, fosthom żieda fil-piż, tibdil fil-parametri metaboliċi u żieda fil-livelli ta' prolactin (ara taqsimiet 4.8 u 5.1).
English: The plasma protein binding of olanzapine is about 93% over the concentration range of 7 to about 1000 ng/mL.
Maltese: L-irbit ta' olanzapine mal-proteini tal-plażma huwa madwar 93% fuq l-iskala tal-konċentrazzjoni ta' 7 sa madwar 1000 ng/mL.
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Maltese: 1.69 mmol/l - < 2.26 mmol/l) għal għoljin (≥ 2.26 mmol/l) kienu komuni ħafna.
English: Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Maltese: Sintomi oħra li ġew innutati jinkludu sintomi ekstrapiramidali, disartrija, atassja, aggressjoni,
English: Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 2025 °C.
Maltese: L-istabilità kimika u fiżika tas-suspensjoni fil-kunjetti ġiet ipprovata għal 24 siegħa f'20-25 °C.
English: Neuroleptic malignant syndrome (see section 4.4)12
Maltese: Sindromu ta' rtirar mill mediċina neonatali (ara taqsima 4.6)
English: The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ZYPADHERA fit-tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Table 1 Recommended dose scheme between oral olanzapine and ZYPADHERA Target oral olanzapine dose Recommended starting dose of ZYPADHERA
Maltese: Tabella 1 Skema ta' doża rrakkomandata bejn olanzapine mill-ħalq u ZYPADHERA
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 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: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15% of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Maltese: 13 Wara kura għal żmien qasir (medjan ta' tul ta' żmien ta' 22 ġurnata), żieda fil-piż ta' > 7% millinja bażi tal-piż tal-ġisem (kg) kienet komuni ħafna (40.6 %), ≥ 15% mil-linja bażi tal-piż talġisem kienet komuni (7.1 %) u ≥ 25 % kienet komuni (2.5 %).
English: (≥ 6.2 mmol/l) were very common.
Maltese: 6.2 mmol/l).
English: Adverse reactions seen with olanzapine pamoate
Maltese: Reazzjonijiet avversi li dehru b'olanzapine
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 vaskulari/imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' kura b'olanzapine.
English: ZYPADHERA 210 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Maltese: ZYPADHERA 210 mg: Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Maltese: 5-HT2 milli ta' dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/hr) versus males (27.3 l/hr), and in non-smokers (18.6 l/hr) versus smokers (27.7 l/hr).
Maltese: It-tneħħija ta' olanzapine mill-plażma wara li olanzapine ttieħed mill-ħalq hija aktar baxxa fin nisa (18.9 l/siegħa) kontra l-irġiel (27.3 l/siegħa), u f'minn ma jpejjipx (18.6 l/siegħa) kontra minn ipejjep (27.7 l/siegħa).