FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for M-M-RVaxPro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal M-M-RVaxPro.
English: A second study in 1,997 children looking specifically at mumps showed that M-M-RVaxPro led to sufficient amounts of antibodies against mumps, while a third study in 776 children showed that immune responses triggered by M-M-RVaxPro were the same regardless of whether it was injected into a muscle or under the skin.
Maltese: It-tieni studju fuq 1,997 tifel u tifla li ħares speċifikament lejn il-gattone wera li M-MRVaxPro wassal għal ammonti suffiċjenti ta' antikorpi kontra l-gattone, filwaqt li t-tielet studju fuq 776 tifel u tifla wera li r-risponsi immunitarji attivati b' M-M-RVaxPro kienu l-istess irrispettivament minn jekk ġiex injettat f' muskolu jew taħt il-ġilda.
English: The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVaxPro on 5 May 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal M-M-RVaxPro valida fl-Unjoni Ewropea kollha fil-5 ta' Mejju 2006.
English: M-M-RVaxPro must not be given during pregnancy, any illness with fever (over 38.5°C) or active untreated tuberculosis (TB).
Maltese: M-M-RVaxPro ma għandux jingħata waqt it-tqala, xi marda bid-deni (aktar minn 38.5°C) jew tuberkulożi attiva u mhux ikkurata (TB).
English: A fourth study in 1,620 babies was carried out with ProQuad (a vaccine that contains similar weakened viruses to those of M-M-RVaxPro).
Maltese: Ir-raba' studju fuq 1,620 tarbija sar bi ProQuad (vaċċin li fih virusis mdgħajfa simili għal dawk f'M-MPVaxPro).
English: M-M-RVaxPro is a vaccine.
Maltese: M-M-RVaxPro huwa vaċċin.
English: What are the risks associated with M-M-RVaxPro?
Maltese: X' inhuma r-riskji assoċjati ma' M-M-RVaxPro?
English: M-M-RVaxPro measles, mumps and rubella vaccine (live)
Maltese: M-M-RVaxPro vaċċin (ħaj) kontra l-ħosba, il-gattone u r-rubella (ħosba Ġermaniża)
English: M-M-RVaxPro is a vaccine used to protect adults and children aged 12 months or older against measles, mumps, and rubella (German measles).
Maltese: M-M-RVaxPro huwa vaċċin użat għall-protezzjoni ta' adulti u tfal minn 12-il xahar ' il fuq kontra lħosba, il-gattone u r-rubella (ħosba Ġermaniża).
English: The most common side effects with M-M-RVaxPro (seen in more than 1 patient in 10) are fever (38.5°C or higher), and injection site redness, pain and swelling.
Maltese: L-effetti sekondarji l-aktar komuni b' M-M-RVaxPro (li dehru f' aktar minn pazjent 1 minn kull 10) huma deni (38.5°C jew aktar), u ħmura, uġiegħ u nefħa fis-sit tal-injezzjoni.
English: M-M-RVaxPro has been shown in studies to be effective at triggering the production of a sufficient amount of antibodies to protect against measles, mumps, and rubella.
Maltese: M-M-RVaxPro ntwera fi studji li huwa effettiv fl-attivazzjoni tal-produzzjoni ta' ammont suffiċjenti ta' antikorpi għall-protezzjoni kontra l-ħosba, il-gattone, u r-rubella.
English: How does M-M-RVaxPro work?
Maltese: M-M-RVaxPro?
English: M-M-RVaxPro should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
Maltese: M-M-RVaxPro ma għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għal xi vaċċin talħosba, il-gattone jew ir-rubella, jew għal kwalunkwe ingredjent ieħor, inkluż in-neomiċina (antibijotiku).
English: Why is M-M-RVaxPro approved?
Maltese: Għaliex ġie approvat M-M-RVaxPro?
English: The company that makes M-M-RVaxPro will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVaxPro leads to side effects such as allergic reactions.
Maltese: M-M-RVaxPro ser tkompli tissorvelja l-effetti sekondarji biex tara jekk lużu tal-albumina rikombinanti fil-proċess tal-manifattura ta' M-M-RVaxPro jwassalx għal effetti sekondarji bħal reazzjonijiet allerġiċi.
English: M-M-RVaxPro contains live attenuated (weakened) measles, mumps and rubella viruses.
Maltese: M-M-RVaxPro fih il-virusis ħajjin u attenwati (mdgħajfa) tal-ħosba, il-gattone u r-rubella.
English: This study showed that, after the second dose, the production of antibodies against mumps and rubella in babies who started vaccination as young as nine months was similar to those of babies who started vaccination at 12 months.
Maltese: Dan l-istudju wera li, wara t-tieni doża, il-produzzjoni ta' antikorpi kontra l-gattone u rrubella fi trabi li bdew it-tilqim sa mill-età żgħira ta' disa' xhur kienet simili għal dik fi trabi li bdew it-tilqim ta' 12-il xahar.
English: When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes antibodies against them.
Maltese: Fil-futur, issistema immunitarja tkun tista' tipproduċi antikorpi iktar malajr meta tkun esposta għal kwalunkwe minn dawn il-virusis.
English: For the full list of all side effects reported with M-M-RVaxPro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b' M-M-RVaxPro, ara l-fuljett ta' tagħrif.
English: It is given as one dose injected into a muscle or under the skin, preferably in the thighs of younger children and the shoulder in older children and adults.
Maltese: Jingħata bħala doża waħda injettata f' muskolu jew taħt il-ġilda, preferibbilment fil-koxox ta' tfal iżgħar u fl-ispalla fi tfal akbar u fl-adulti.
English: (See sections 4.5 and 5.2)
Maltese: (Ara taqsimiet 4.5 u 5.2)
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 ( > 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: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: .IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 1996 Date of latest renewal: 12 September 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Settembru 1996 Data tal-aħħar tiġdid: 12 ta' Settembru 2006
English: (tablet coating) macrogol and synthetic red iron oxide (E172)
Maltese: (kisja tal-pillola) macrogol u iron oxide aħmar sintetiku (E172)
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA 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' ZYPREXA.
English: Parkinsonism6
Maltese: Parkinsoniżmu6 Diskineżja6
English: Discontinuation symptoms7,12
Maltese: Sintomi ta' twaqqif tal-kura7,12
English: ZYPREXA is available in packs containing 28, 35, 56, 70 or 98 tablets.
Maltese: ZYPREXA hu disponibbli f'pakketti li fihom 28, 35, 56, 70 jew 98 pillola.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; 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) 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: (tablet coating) shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour (E132), ethanol anhydrous, isopropyl alcohol, butyl alcohol, ammonium hydroxide
Maltese: (kisja tal-pillola) shellac, macrogol, propylene glycol, polysorbate 80 u bħala sustanza li tagħti kulur indigo carmine (E132) ethanol anidriku, isopropyl alcohol, butyl alcohol, ammonium hydroxide
English: • The active substance is olanzapine.
Maltese: • Is-sustanza attiva hi olanzapine.
English: ZYPREXA contains the active substance olanzapine.
Maltese: ZYPREXA fih is-sustanza attiva olanzapine.
English: LIST OF EXCIPIENTS Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide
Maltese: Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide
English: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall għarrieda (ara taqsima 4.4)11
English: Cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.
Maltese: Strixxi ta' folji ta' l-aluminju cold-formed f'kartuni ta' 28, 35, 56, 70 jew 98 pillola kull kartuna.
English: 28 coated tablets 35 coated tablets 56 coated tablets 70 coated tablets 98 coated tablets
Maltese: 28 pillola miksija 35 pillola miksija 56 pillola miksija 70 pillola miksija 98 pillola miksija
English: Edible blue ink (shellac, ethanol anhydrous, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium hydroxide, indigo carmine E132)
Maltese: Inka blu li tittiekel (shellac, ethanol anidriku, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium hydroxide, indigo carmine E132)
English: Up to 20 mg in 24 hours may be given.
Maltese: Sa 20 mg f'24 siegħa tista' tingħata.
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 tal-piż tal-ġisem tagħhom.
English: The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml.
Maltese: Il-fjala għandha 11.0 mg olanzapine bħala soluzzjoni ta' 5 mg/ml.
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 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: Colour mixture pink (titanium dioxide E171, macrogol, lactose monohydrate, hypromellose, synthetic red iron oxide)
Maltese: Kulur tat-taħlita roża (titanium dioxide E171, macrogol, lactose monohydrate, hypromellose, iron oxide aħmar sintetiku)
English: Volume of injection (ml)
Maltese: Volum ta' injezzjoni (ml)
English: Decreased bioavailability
Maltese: Biodisponibilità mnaqqsa
English: • The other ingredients are - (tablet core) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate and - (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.
Maltese: • Is-sustanzi l-oħra huma - (qalba tal-pillola) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate u - (kisja tal-pillola) hypromellose, titanium dioxide (E171), carnauba wax.
English: Colour mixture light blue (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, indigo carmine colour (E132))
Maltese: Kulur tat-taħlita blu ċar (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, kulur indigo carmine (E132))
English: Hydrochloric acid.
Maltese: Hydrochloric acid Sodium hydroxide
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u ∝1-aċidglycoprotein.
English: The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml (1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10 mg olanzapine).
Maltese: Il-fjala għandha 11.0 mg olanzapine bħala soluzzjoni ta' 5 mg/ml (1 mg olanzapine tibqa fil-fjala u fis siringa, b'hekk tkun tista tinjetta 10 mg ta' olanzapine).
English: 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: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara taqsima 6.3.
English: Withdraw 2.1 ml of water for injection into a sterile syringe.
Maltese: Iġbed 2.1 ml ta' ilma għall-injezzjonijiet f'siringa sterilizzata.
English: Single use vial.
Maltese: Ghal uzu intramuskolari.
English: ZYPREXA with alcohol
Maltese: ZYPREXA mal-alkoħol
English: TABLET STRENGTH
Maltese: TAL-PILLOLA
English: Administer the solution intramuscularly.
Maltese: Agħti is-soluzzjoni intramuskolari.
English: In
Maltese: L
English: • The other ingredients are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, tartaric acid, hydrochloric acid u sodium hydroxide.
English: ZYPREXA 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg coated tablets 3 years.
Maltese: ZYPREXA 5 mg, 7.5 mg, 10 mg, 15 mg u 20 mg pilloli miksija 3 snin.
English: (tablet coating) triacetin and indigo carmine colour (E132)
Maltese: (kisja tal-pillola) triacetin u bħala sustanza li tagħti kulur indigo carmine (E132)
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists (see section 6.2).
Maltese: Olanzapine jista' jantagonizza l-effetti ta' agonisti ta' dopamine diretti jew indiretti (ara taqsima 6.2).
English: The recommended starting dose in elderly patients (> 60 years) is 2.5 - 5 mg.
Maltese: Id-doża rakkomandata tal-bidu f'pazjenti anzjani (> 60 sena) hija 2.5 - 5 mg.
English: 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95 % confidence interval utilising the Olanzapine Integrated Database.
Maltese: 12 Avveniment avvers identifikat minn rappurtaġġ spontanju wara li l-prodott tqiegħed fis-suq bil frekwenza stmata fl-ogħla limitu tan-95% intervall ta' kunfidenza bl-użu tad-Database Integrat ta' Olanzapine.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during oral clinical trials revealed a low incidence of related events.
Maltese: Waqt li olanzapine wera attività antikolinerġika in vitro, ersperjenza waqt il-provi kliniċi uriet inċidenza baxxa ta' ġrajjiet relatati.
English: ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets
Maltese: Pilloli ZYPREXA 2.5 mg, 5 mg, 7.5 mg u 10 mg
English: Colour mixture white (hypromellose, titanium dioxide E171, macrogol, polysorbate 80) Carnauba wax
Maltese: Kulur tat-taħlita abjad (hypromellose, titanium dioxide E171, macrogol, polysorbate 80)
English: Cytochromes P450CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Maltese: enżimi ċitokromju P450-CYP1A2 u P450-CYP2D6 jikkontrbwixxu għall-formazzjoni ta' prodotti metaboliċi tat-tip N-desmethyl u 2-hydroxymethyl.
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' l assoċjati 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' l-atteġġament bejn il-bidu u fl-aħħar tal-kura wriet titjib statistikament sinifikanti (p= 0.001) favur olanzapine (-6.0) kontra haloperidol (-3.1).
English: ZYPREXA 2.5 mg coated tablets ZYPREXA 5 mg coated tablets ZYPREXA 7.5 mg coated tablets ZYPREXA 10 mg coated tablets ZYPREXA 15 mg coated tablets ZYPREXA 20 mg coated tablets
Maltese: ZYPREXA 2.5 mg pilloli miksija ZYPREXA 5 mg pilloli miksija ZYPREXA 7.5 mg pilloli miksija ZYPREXA 10 mg pilloli miksija ZYPREXA 15 mg pilloli miksija ZYPREXA 20 mg pilloli miksija
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu ta' rtirar mill mediċina neonatali (ara taqsima 4.6)
English: ZYPREXA 2.5 mg , 5 mg, 7.5 mg and 10 mg coated tablets Hypromellose
Maltese: ZYPREXA 2.5 mg , 5 mg, 7.5 mg u 10 mg pilloli miksija Hypromellose
English: INFORMATION IN BRAILLE ZYPREXA 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA 20 mg
English: 2 years.
Maltese: D2.
English: ZYPREXA Injection is available in a pack containing 1 or 10 vial(s).
Maltese: L-injezzjoni ta' ZYPREXA hija disponibbli f'pakkett ta' 1 jew 10 kunjetti.
English: Uncommon (≥ 1/1,000 to < 1/100): Hypoventilation.
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100):
English: ZYPREXA tablets contain lactose.
Maltese: Il-pilloli ZYPREXA fihom l-lactose.
English: • Mania, a condition with symptoms of excitement or euphoria.
Maltese: • Manija, kondizzjoni b'sintomi ta' eċitament jew ewforija.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models.
Maltese: Olanzapine wera affinità akbar in vitro għar-riċetturi ta' serotonin 5-HT2 milli ta' dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: ZYPREXA 2.5 mg coated tablets ZYPREXA 5 mg coated tablets ZYPREXA 7.5 mg coated tablets ZYPREXA 10 mg coated tablets ZYPREXA 15 mg coated tablets ZYPREXA 20 mg coated tablets Olanzapine
Maltese: ZYPREXA 2.5 mg, pilloli miksija ZYPREXA 5 mg, pilloli miksija ZYPREXA 7.5 mg, pilloli miksija ZYPREXA 10 mg, pilloli miksija ZYPREXA 15 mg, pilloli miksija ZYPREXA 20 mg, pilloli miksija Olanzapine
English: INFORMATION IN BRAILLE ZYPREXA 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA 7.5 mg
English: There is a risk of feeling drowsy when you are given ZYPREXA.
Maltese: Hemm ir-riskju li tħossok imħeddel meta tingħata ZYPREXA.
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: 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,
English: Depending on the patient's clinical status (see section 4.4), a second injection, 2.5 - 5 mg, may be administered 2 hours after the first injection.
Maltese: Skond l-istat kliniku talpazjent (ara taqsima 4.4), it-tieni injezzjoni, 2.5 -5 mg tista' tingħata sagħtejn wara l-ewwel injezzjoni.
English: Photosensitivity reaction Alopecia
Maltese: Reazzjoni ta' fotosensittività
English: 1 vial EU/1/96/022/017 Powder for solution for injection.
Maltese: Kunjett 1 EU/1/96/022/017 Trab għal soluzzjoni għall-injezzjoni.
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, ma hemm ebda reazzjoni partikolari mistennija kif verifikat minn studji in vivo fejn ma nstabet ebda inibizzjoni tal-metaboliżmu tas-sustanzi attivi li ġejjin: anti-dipressant triċikliku (jirrapreżenta l-aktar il-passaġġ permezz ta' CYP2D6), warfarina (CYP2C9), theophylline (CYP1A2)
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Maltese: 2.26 mmol/l) għal għoljin (≥ 2.26 mmol/l) kienu komuni ħafna.
English: ZYPREXA 20 mg tablets
Maltese: ZYPREXA 20 mg pilloli miksija
English: ZYPREXA contains lactose
Maltese: ZYPREXA fih lactose:
English: IM olanzapine has not been studied in patients with alcohol or drug intoxication (see section 4.4).
Maltese: IM olanzapine ma kienetx studjata f'pazjenti b'intossikazzjoni b'alkoħol jew drogi (ara taqsima 4.4).
English: How to take ZYPREXA
Maltese: Tieħux ZYPREXA
English: In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
Maltese: Fit-tieni studju ta' 12-il xhar dwar ir-rikorrenza preventiva f'pazjenti b'episodju ta' manija li kienu ikkontrollati b'olanzapine u l-lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija olanzapine jew il-lithium waħdu.Olanzapine kien statistikament mhux inferjuri għall-lithium fuq lgħan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
English: Inject into a vial of ZYPREXA
Maltese: Mediċini oħra u ZYPREXA
English: INFORMATION IN BRAILLE ZYPREXA 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA 2.5 mg
English: ZYPREXA 15 mg coated tablets Elliptical, blue, coated tablets debossed with “LILLY” and a numeric identicode “4415”.
Maltese: Pilloli, elliptiċi, blu u miksijin, imnaqqxa b' "LILLY" u b'kodiċi tal-identità numeriku "4415".
English: Uncommon (≥ 1/1,000 to < 1/100): Sinus pause.
Maltese: Komuni ( ≥ 1/100 sa < 1/10):
English: ZYPREXA 7.5 mg coated tablets
Maltese: ZYPREXA 7.5 mg pilloli miksija
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Maltese: Fl-assenza ta' tagħrif dettaljat dwar passat pri ezistenti ta' disturbi akuti u movimenti tardivi ekstrapiramidali, fil-preżent ma jistax jiġi konkluż li olanzapine jipproduċi anqas diskineżja tardiva u/jew sindromi ekstrapiramidali tardivi oħra.
English: ZYPREXA 15 mg tablets
Maltese: Pilloli ZYPREXA 15 mg
English: Each vial contains 10 mg of the active substance.
Maltese: Kull kunjett fih10 mg tas-sustanza attiva.
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: 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), żieda fil-piż ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem kienet komuni ħafna (22.2 %), ≥ 15% kienet komuni (4.2 %) u ≥ 25 % ma kinitx komuni (0.8 %).
English: Smoking
Maltese: (DRESS)
English: Each coated tablet contains 2.5 mg olanzapine.
Maltese: Kull pillola miksija għandha 2.5 mg olanzapine.
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 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: 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: Each coated tablet contains 7.5 mg olanzapine.
Maltese: Kull pillola miksija għandha 7.5 mg olanzapine.