FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Quinsair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Quinsair contains the active substance levofloxacin.
Maltese: Quinsair fih is-sustanza attiva levofloxacin.
English: Other information about Quinsair
Maltese: Informazzjoni oħra dwar Quinsair
English: The most common side effects with Quinsair are cough (seen in 54% of patients), dysgeusia (taste disturbances, 30%) and tiredness/weakness (25%).
Maltese: L-effetti sekondarji l-aktar komuni bi Quinsair huma sogħla (osservata f'54% tal-pazjenti), disgewżja (disturbi fit-togħma, 30%) u għeja/dgħjufija (25%).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Quinsair on 26 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Quinsair fis-26 ta' Marzu 2015.
English: Why is Quinsair approved?
Maltese: Għaliex ġie approvat Quinsair?
English: This is a summary of the European public assessment report (EPAR) for Quinsair.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Quinsair.
English: The active substance in Quinsair, levofloxacin, belongs to the group of antibiotics known as ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Quinsair, levofloxacin, tagħmel parti mill-grupp ta' antibijotiċi magħrufin bħala “fluoroquinolones”.
English: The first study, which involved 330 patients, compared Quinsair with placebo (a dummy treatment), while the second, involving 282 patients, compared it with another inhaled antibiotic (tobramycin).
Maltese: 330 pazjent, qabbel Quinsair ma' plaċebo (kura finta), filwaqt li t-tieni wieħed, li involva 282 pazjent, qabblu ma' antibjotiku ieħor li jittieħed man-nifs (tobramycin).
English: What are the risks associated with Quinsair?
Maltese: X'inhuma r-riskji assoċjati ma' Quinsair?
English: Regarding safety, Quinsair was well tolerated with side effects similar to those of levofloxacin given systemically (throughout the body).
Maltese: Fir-rigward tas-sigurtà, Quinsair kien ittollerat sew b'effetti sekondarji simili għal dawk ta' levofloxacin mogħti b'mod sistemiku (fil-ġisem kollu).
English: Following 28 days of treatment, the patients taking Quinsair had an improvement in FEV1 of 1.73%, while for patients taking placebo the improvement in FEV1 was of around 0.43%.
Maltese: Wara 28 jum ta' kura, il-pazjenti li kienu qegħdin jieħdu Quinsair kellhom titjib f'FEV1 ta' 1.73%, filwaqt li għall-pazjenti li kienu qegħdin jieħdu plaċebo, it-titjib f'FEV1 kien ta' madwar 0.
English: Quinsair is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in adults who have cystic fibrosis.
Maltese: Quinsair huwa antibjotiku użat għall-kura ta' infezzjoni tal-pulmun fit-tul ikkawżata mill-batterja Pseudomonas aeruginosa f'adulti li għandhom fibrożi ċistika.
English: Quinsair has been investigated in two main studies in patients who had cystic fibrosis with P. aeruginosa lung infection.
Maltese: Quinsair ġie studjat f'żewġ provi ewlenin fuq pazjenti li kellhom fibrożi ċistika b'infezzjoni pulmonari P. aeruginosa.
English: Quinsair is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Maltese: Quinsair jiġi bħala soluzzjoni għan-nebulizzatur f'kontenituri b'doża waħda li jissejħu “ampulli”.
English: In the first study, Quinsair was shown to be better than placebo at improving the patients' forced expiratory volume in one second (FEV1), adjusted for the patient's age, height and sex. FEV1 is the most air a person can breathe out in one second.
Maltese: Fl-ewwel studju, Quinsair intwera li huwa aħjar minn plaċebo biex itejjeb il-volum espiratorju sfurzat f'sekonda (FEV1), aġġustat skont l-età, it-tul u s-sess tal-pazjent.
English: In both studies, the majority of patients were adults.
Maltese: Fiż-żewġ studji, il-maġġoranza tal-pazjenti kienu adulti.
English: Quinsair must not be used in patients with epilepsy and those with a history of tendon disorders related to the use of fluoroquinolone antibiotics.
Maltese: Quinsair ma għandux jintuża f'pazjenti b'epilessija u dawk bi storja ta' mard fit-tendini relatat mal-użu ta' antibijotiċi flouroquinolone.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections.
Maltese: Fibrożi ċistika hija marda li tintiret fejn ikun hemm akkumulazzjoni ta' mukus oħxon fil-pulmun li tippermetti lill-batterji jikbru aktar faċilment, u dan jikkawża infezzjonijiet.
English: Because levofloxacin has a potential risk on cartilage, the use of the product was not considered justified in adolescents.
Maltese: Peress li levofloxacin għandu riskju potenzjali fuq il-qarquċa, l-użu tal-prodott ma kienx ikkunsidrat ġustifikat fl-adolexxenti.
English: A risk management plan has been developed to ensure that Quinsair is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Quinsair jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Quinsair?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Quinsair?
English: For the full list of all side effects reported with Quinsair, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Quinsair, ara l-fuljett ta' tagħrif.
English: Quinsair is inhaled using a device called Zirela nebuliser system, which converts the solution in the ampoule into a fine mist.
Maltese: Quinsair jittieħed man-nifs permezz ta' apparat imsejjaħ nebulizzatur ta' Zirela, li jibdel is-soluzzjoni tal-ampulla f'raxx ħafif.
English: In addition, the company that markets Quinsair will carry out a study to investigate the long-term safety of Quinsair when used in clinical practice in the European Union.
Maltese: Barra minn hekk, il-kumpanija li tikkummerċjalizza Quinsair ser twettaq studju biex tinvestiga s-sigurtà fit-tul ta' Quinsair meta jintuża fi prattika klinika fl-Unjoni Ewropea.
English: London, 19 November 2009 Doc.
Maltese: Londra, 19 ta' Novembru 2009 Dok. ta' ref.:
English: Ref.: EMEA/CHMP/730064/2009
Maltese: EMA/730064/2009 EMEA/H/C/997
English: What is Gemesis?
Maltese: X'inhu Gemesis?
English: The active substance in Gemesis, becaplermin, is a recombinant human platelet-derived growth factor (PDGF).
Maltese: Is-sustanza attiva f'Gemesis, becaplermin, hija fattur rikombinanti uman derivat mit-tkabbir talplatelet (recombinant human platelet-derived growth factor (PDGF)).
English: The company that applied for authorisation is BioMimetic Therapeutics Ltd.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija BioMimetic Therapeutics Ltd.
English: Becaplermin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human platelet-derived growth factor.
Maltese: Becaplermin huwa prodott b'metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': jiġifieri prodott minn-ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi li tipproduċi l-fattur tat-tkabbir BB derivat mill-plattelet uman.
English: How was Gemesis expected to work?
Maltese: Għal xiex kien mistenni li jintuża Gemesis?
English: The kit consists of a prefilled syringe containing the active substance becaplermin and a cup containing granules of β-tricalcium phosphate to be used as a matrix.
Maltese: Gemesis huwa kitt għal impjant Il-kitt jikkonsisti f'siringa mimlija minn qabel li jkun fiha s-sustanza attiva becaplermin u tazza mimlija granuli ta' fosfat β-tricalcium sabiex jintuża bħala matriċi.
English: The main measure of effectiveness was the change in ‘clinical attachment level' (CAL) after 24 weeks.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-varjazzjoni fil-'livell ta' kisba klinika' (‘clinical attachment level' (CAL)) wara 24 ġimgħa.
English: In one main study involving 180 adults with advanced periodontal disease, Gemesis was compared with the matrix alone.
Maltese: Fi studju ewlieni li involva 180 adult b'mard peridentali avvanzat, Gemesis tqabbel malmatriċi waħedha.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Gemesis, intended for bone and periodontal (around the teeth) regeneration in adults.
Maltese: Fit-23 ta' Lulju 2009, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq tal-prodott mediċinali Gemesis maħsub għal riġenerazzjoni tal-għadam u paradentali (madwar is-snien) fl-adulti.
English: The effects of Gemesis were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Gemesis ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati filbniedem.
English: What was Gemesis expected to be used for?
Maltese: Kif kien mistenni li jaħdem Gemesis?
English: Becaplermin was expected to work in the same way as human platelet-derived growth factor, stimulating cell growth in the bone and gums around the teeth and helping tissue to heal.
Maltese: Becaplermin kin mistenni li jaħdem bl-istess mod kif il-fattur uman derivat mit-tkabbir tal-platelet,bl-istitmulazzjoni tat-tkabbir taċ-ċelloli fl-għadam u lħniek madwar is-snien u jgħin lit-tessut sabiex ifieq.
English: The CHMP noted that the company did not at this time have sufficient information on how strongly becaplermin binds to PDGF receptors and did not sufficiently demonstrate that Gemesis used in clinical studies was comparable to the product intended to be placed on the market.
Maltese: Gemesis kien mistenni li jintuża sabiex jiġġenera mill-ġdid tessuti fl-adulti b'difetti madwar snienhom, fosthom difetti madwar l-għadma u ħniek li dejjem qegħdin jittieklu.
English: 300 mg Powder for concentrate for solution for infusion
Maltese: 300 mg Trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Strength Pharmaceutical form
Maltese: Forma Farmaċewtika
English: Route of administration
Maltese: Rotta ta' administrazzjoni
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants/ marketing authorisation holders in the Member States
Maltese: rottot ta' administrazjoni, applikanti/detenturi ta' l- awtorizzazzjoni għat-tqegħid fis-suq f'stati membri
English: Danmark SanoSwiss UAB Litauen
Maltese: SanoSwiss UAB Litauen
English: ATC code: N05A H03.
Maltese: N05A H03.
English: Crospovidone type B
Maltese: Crospovidone tip B
English: Teva Pharmaceutical Works Co. Ltd Pallagi út 13, 4042 Debrecen Hungary
Maltese: Teva Pharmaceutical Works Co. Ltd Pallagi út 13, 4042 Debrecen L-Ungerija
English: Teva Ελλάς Α.Ε.
Maltese: Teva Ελλάς Α.Ε. Ελλάδα
English: Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Maltese: Il-qalba tal-pillola Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Maltese: Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
English: Merckle GmbH Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3, 89143 Blaubeuren,
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurtà Adulti
English: Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), silica colloidal anhydrous, microcrystalline cellulose, magnesium stearate.
Maltese: Qalba tal-pillola: lactose monohydrate, hydroxypropylcellulose, crospovidone (tip A), silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate.
English: The mean increase in olanzapine AUC was 52% and 108% respectively.
Maltese: Iż-żjieda medja fl-AUC ta' olanzapine kienet 52% u 108% rispettivament.
English: The frequency terms listed are defined as follows: Very common (≥1/10), 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 (>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 magħrufa (ma jistgħux jiġu stmati mill-informazzjoni li hemm disponibbli).
English: Olanzapine Teva contains the active substance olanzapine.
Maltese: Olanzapine Teva fih is-sustanza attiva olanzapine.
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines.
Maltese: Kategorija farmakoterapewtika: psikolettiċi, diazepines, oxazepines, thiazepins u oxepines, Kodiċi ATC:
English: Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Eastbourne, East Sussex, BN22 9AG Renju Unit
English: Swensweg 5, 2031 GA Haarlem, The Netherlands
Maltese: Swensweg 5, 2031 GA Haarlem, Il-Pajjiżi l-Baxxi
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Renju Unit
English: - carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Teva 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: Lemon flavour [flavouring preparation(s), maltodextrin, sucrose, gum arabic (E414), glyceryl triacetate (E1518) and alpha-Tocopherol (E307)]
Maltese: Togħma ta' lumi [preparazzjoni(jiet) li jagħtu togħma, maltodextrin, sucrose, gomma arabika (E414), glyceryl triacetate (E1518) u alpha-Tocopherol (E307)]
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: Brampton Road, Hampden Park Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park Eastbourne, East Sussex, BN22 9AG Renju Unit
English: Olanzapine Teva contains lactose, sucrose and aspartame This medicine contains lactose and sucrose.
Maltese: Olanzapine Teva fih lactose, sucrose and aspartame
English: - The other ingredients are mannitol, aspartame (E951), magnesium stearate, crospovidone type B, lactose monohydrate, hydroxypropylcellulose and lemon flavour [flavouring preparation(s), maltodextrin, sucrose, gum arabic (E414), glyceryl triacetate (E1518) and alphatocopherol (E307)].
Maltese: - Is-sustanzi l-oħra huma mannitol, aspartame (E951), magnesium stearate, crospovidone tip B, lactose monohydrate, hydroxypropylcellulose u togħma ta' lumi [preparazzjoni(jiet) li jagħtu togħma, maltodextrin, sucrose, gomma arabika (E414), glyceryl triacetate (E1518) u alphatocopherol (E307)].
English: 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1 M5; α1 adrenergic; and histamine H1 receptors.
Maltese: Fi studji ta' qabel l-użu kliniku, olanzapine wera firxa ta' affinitajiet għar-riċetturi (Ki; <100 nM) serotoniċi 5HT2A/2C, 5HT3, 5HT6; dopamine D1,D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi M1 M5; α1 adrenerġiċi; u riċetturi ta' l-istamina H1.
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Maltese: Olanzapine jintrabat prinċipalment mal-albumina u α1-acid glycoprotein
English: Glutamyltransfera se10
Maltese: Gamma Glutamyltransferase għoli10
English: (≥1.69 mmol/l-<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: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Maltese: olanzapine (5-20 mg) wera profil ta' sigurtà kumparabbli f'pazjenti nisa (n=467) u f'pazjenti rġiel
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 skiżofreniċi li għandhom >65 sena, id-dosaġġ minn 5 sa 20 mg/ġurnata ma kienx assoċjat ma' xi profil distint ta' avvenimenti avversi.
English: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Maltese: Olanzapine huwa indikat għat-trattament ta' episodju ta' manija moderat jew serju.
English: Olanzapine Teva with alcohol
Maltese: Olanzapine Teva mal-alkoħol
English: Urinary incontinence Urinary retention Urinary hesitation11
Maltese: Inkontinenza urinarja Żamma tal-urina
English: (≥ 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: High uric acid10
Maltese: Uric Acid għoli10
English: Thromboembolis m (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Maltese: Tromboemboliżmu (inkluż l-emboliżmu pulmonari u t-trombożi tal-vini fil-fond) (ara sezzjoni 4.4)
English: There were more smokers among subjects with cirrhosis (4/6; 67%) than among subjects with no hepatic dysfunction (0/3; 0%).
Maltese: Kien hemm aktar nies li jpejpu fost is-suġġetti b'ċirrożi (4/6; 67 %) milli fost is-suġġetti li ma kellhom l-ebda disfunzjoni epatika (0/3; 0 %).
English: Neuroleptic malignant syndrome (see section 4.4)12
Maltese: Malinn (ara sezzjoni 4.4)12
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 għal perijodu twil ta' żmien (għallinqas 24 ġ2B24al, 89.4% żiedu ≥7%, 55.3% żiedu ≥15% u 29.1% żiedu ≥25% mill-piż bażilari tagħhom.
English: Olanzapine Teva contains lactose
Maltese: Olanzapine Teva fih lactose:
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 il-provi kliniċi uriet inċidenza baxxa ta' ġrajjiet relatati.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Maltese: In-newtropenja kienet rappurtata spiss meta olanzapine u l-valproate intużaw flimkien (ara sezzjoni 4.8).
English: Each orodispersible tablet contains 190.0 mg lactose, 1.05 mg sucrose and 9.0 mg aspartame (E951).
Maltese: 0 mg lactose, 1.05 mg sucrose u 9.0 mg aspartame (E951).
English: Contains among others: lactose, sucrose and aspartame (E951).
Maltese: TA' EĊĊIPJENTI Fiha, fost oħrajn: lactose, sucrose and aspartame (E951).
English: Each orodispersible tablet contains 142.5 mg lactose, 0.7875 mg sucrose and 6.75 mg aspartame (E951).
Maltese: Kull pillola li tinħall fil-ħalq fiha 142.5 mg lactose, 0.7875 mg sucrose u 6.75 mg aspartame (E951).
English: Olanzapine Teva 15 mg film-coated tablets EU/1/07/427/016 - 28 tablets, per box
Maltese: Olanzapine Teva 15-il mg pilloli miksija b'rita EU/1/07/427/016 - 28 pillola, kull kaxxa
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, 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' prolactin, kolesterol, glucose u trigliċeridi, lewkopenija, newtropenija (ara sezzjoni 4.4), glikosurja, żieda fl-aptit, sturdament, akatiżja, parkinsoniżmu (ara sezzjoni 4.4), diskineżja, pressjoni baxxa mal-waqfien, effetti antikolinerġiċi, żieda fil-livelli tal-aminotransferases tal-fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4.4), raxx, astenja, għeja, deni,
English: QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
Maltese: L-Intervall QT Fi studji kliniċi, żidiet fil-QTc li kienu klinikament sinifikanti( korrezzjoni fil-QT skond Fridericia
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Maltese: Studju ta' tqabbil tal-piżijiet wera bejn wieħed u ieħor 57% ta' olanzapine radjuattiv fl-urina, prinċipalment bħala prodotti metaboliċi.
English: Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Maltese: Sintomi komuni ħafna meta ittieħdet doża eċċessiva (>10% inċidenza) jinkludu takikardija, aġitazzjoni/aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas-sensi li tvarja minn sedazzjoni sa koma.
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 hr) or clearance (21.2 versus 25.0 l/hr).
Maltese: ma kienx hemm differenza sinifikanti fil-medja tal-half-life ta' l-eliminazzjoni (37.7 kontra 32.4 siegħa) jew il-clearance (21.2 kontra 25.
English: In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172).
Maltese: Barra minhekk il-qawwa ta' 15 mg fiha wkoll indigo carmine (E132) u l-qawwa ta' 20 mg fiha iron oxide red (E172)
English: Film-coated tablet
Maltese: Żieda fil-piż klinikament sinifikanti
English: - Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Maltese: • Episodji ta' manija moderati għal severi, kondizzjoni b'sintomi ta' eċitament jew ewforija eċitament jew ewforija
English: Tablet coating: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171).
Maltese: Kisi tal-pillola: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171).
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Maltese: F'anzjani b'saħħithom (65 u fuqhom) f'paragun ma' pazjenti mhux anzjani, il-half-life ta' l eliminazzjoni medja twalet (51.8 paragun ma' 33.8 siegħa) u t-tneħħija tnaqqset (17.5 paragun ma' 18.21 l/hr).
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 trattament fuq perijodu ta' żmien qasir (tul medjan ta' 22 jum) żieda fil-piż tal-ġisem ta' ≥7% mil-linja bażi kienet komuni ħafna (40.6%), ≥15% mil-linja bażi tal-piż tal-ġisem kienet komuni (7.1%) u ≥25% kienet komuni (2.5%).
English: December 2007
Maltese: 12 ta' Diċembru 2007
English: How to store Olanzapine Teva
Maltese: Tiħux Olanzapine Teva:
English: Investigations Elevated plasma prolactin levels8
Maltese: Livelli elevati ta' prolactin fil-plażma 8
English: ≥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: QTcF <500 msek) ma kienux komuni (0.1% sa 1%) f'pazjenti kkurati b'olanzapine, b'ebda differenza sinifikattiva fl-avvenimenti assoċjati kardijaċi meta mqabbla ma' plaċebo.
English: Excipient with known effect Each film-coated tablet contains 206.7 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 206.7 mg lactose.