FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs, tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Maltese: Bħal kull sustanza serotonerġika oħra, il-kura b'duloxetine tista' tikkawża s-sindromu ta' serotonin, kundizzjoni li tista' tkun ta' periklu għall-ħajja, speċjalment jekk fl-istess ħin ikun qed jintużaw sustanzi serotonerġiċi oħra (li jinkludu SSRIs, SNRIs, antidipressivi triċikliċi jew triptans), sustanzi li jnaqqsu l-metaboliżmu ta' serotonin bħal MAOIs jew antipsikotiċi jew antagonisti oħra ta' dopamine li jistgħu jaffettwaw is-sistemi ta' newrotrasmissjoni seotonerġiċi (ara sezzjonijiet 4.3 u 4.5).
English: Glaucoma
Maltese: Shellac
English: PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Maltese: Pakkett bil-folji tal-PVC/PE/PVdC/Aluminju li jkun fih 7, 14, 28, 49, 98 u pakketti multipli li jkun fihom 98 (2 pakketti ta' 49) kapsula gastro-reżistenti iebsa.
English: Caution is advised if Duloxetine Mylan is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Maltese: Hu rrakkomandat li Duloxetine Mylan jingħata b'attenzjoni jekk jittieħed flimkien ma' prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti-depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: 30 mg capsules Each capsule contains 30 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 30 mg jew 60 mg ta' duloxetine (bħala hydrochloride).
English: Dizziness Lethargy Tremor Paraesthesia
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Paediatric population: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Maltese: Il-farmakokinetika ta' duloxetine, wara l-għoti mill-ħalq b'skeda ta' dożaġġ ta' 20 sa 120 mg darba kuljum f'pazjenti pedjiatriċi b'etajiet minn 7 sa 17-il sena b'disturb depressiv maġġuri, ġiet ikkaratterizzata bl-użu ta' analiżi ta' mudelli ta' popolazzjoni bbażati fuq tagħrif minn 3 studji.
English: PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Maltese: Pakkett bil-folji tal-PVC/PE/PVdC/Aluminju li jkun fih 14, 28, 49, 98 u pakketti multipli li jkun fihom 98 (2 pakketti ta' 49) kapsula gastro-reżistenti iebsa.
English: The concomitant use of Duloxetine Mylan with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' Duloxetine Mylan ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: Night sweats Urticaria
Maltese: Insuffiċjenza epatika Suffejra
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Maltese: Emorraġija ginekoloġika Disturbi filmestrwazzjoni Disfunzjoni sesswali Uġigħ testikulari
English: Somnolence
Maltese: Suwiċidju
English: The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
Maltese: Prodotti mediċinali li jiġu metabolizzati minn CYP2D6:
English: Eosinophilic pneumonia9
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali 3 snin
English: How to store Duloxetine Mylan
Maltese: Kif gћandek tieћu Duloxetine Mylan
English: For generalised anxiety disorder:
Maltese: Distrub ta' Ansjetà Ġeneralizzata:
English: Duloxetine 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Maltese: Duloxetine 60mg darba kuljum wera superjorità statistikament sinifikanti meta mqabbel ma' plaċebo (p=0.004) f'daq li għandu x'jaqsam ir-riżultat primarju, ilprevenzjoni ta' rikaduta depressiva, ikkalkulata permezz taż-żmien li għadda sar-rikaduta.
English: 49 hard gastro-resistant capsules Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Bottle packs only: Once opened, use within 180 days.
Maltese: Pakketti tal-fliexken biss: La darba jinfetaħ, uża fi żmien 180 jum.
English: The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo treated patients.
Maltese: Każi ta' kriżi ipertensiva b'duloxetine ġew irrapurtati, speċjalment f'pazjenti li diġà kellhom l-ipertensjoni.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Mania and seizures
Maltese: Manija u aċċessjonijiet
English: Generalised Anxiety Disorder: Duloxetine demonstrated statistically significant superiority over placebo in five out of five studies including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Maltese: Duloxetine wera superjorità statistikament sinifikanti fuq plaċebo f'kull wieħed minn ħames studji li jinkludu erba' studji magħmula f'sitwazzjonijiet akuti, ikontrollati bi plaċebo, double-blind u randomised u studju ta' prevenzjoni ta' rikaduta f'pazjenti adulti b'disturb ta' ansjetà ġeneralizzata.
English: - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Mylan') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Maltese: - qiegħed/qiegħda tieħu jew ħadt reċentement f'dawn l-aħħar erbatax-il ġurnata, xi mediċina oħra magħrufa bħala inibitur ta' monoamine oxidase (MAOI) (ara ‘Medicini oħra u Duloxetine Mylan') - qiegħed/qiegħda tieħu fluvoxamine li normalment jintuża għall-kura tad-depressjoni, ciprofloxacine jew enoxacin li jintużaw għall-kura ta' xi infezzjonijiet.
English: Caution is advisable if Duloxetine Mylan is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Maltese: Barra dan, hemm nuqqas ta' informazzjoni f'tfal u f'adolexxenti dwar is-sigurtà fit-tul li jirrigwarda l-iżvilupp tal-ġisem, il-maturazzjoni u l-iżvilupp konjittiv u ta' l-imġiba (ara sezzjoni 4.8).
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 30 mg ta ' duloxetine (bħala hydrochloride).
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
Maltese: Peress li CYP1A2 huwa involut fil-metaboliżmu ta' duloxetine, bl-użu fl-istess ħin ta' duloxetine ma' inibituri qawwija ta' CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta' duloxetine. Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta' CYP1A2, naqqas it-tneħħija tal-plażma apparenti ta' duloxetine b'madwar 77% u żied b'6 darbiet lAUCo-t .
English: BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula gastro-reżistenti iebsa. 30 mg kapsuli
English: Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Maltese: Duloxetine ġie assoċjat ma' żieda fil-pressjoni tad-demm u ipertensjoni klinikament sinifikanti f'xi pazjenti.
English: Renal impairment
Maltese: Vaskulite kutanea
English: For further information see section 5.1.
Maltese: Għal aktar informazzjoni ara sezzjoni 5
English: Hard gastro-resistant capsule
Maltese: Kapsuli gastro-reżistenti ibsin
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Maltese: Id-depressjoni hija assoċjata ma' riskju akbar ta' ħsibijiet suwiċidali, ħsara lill-persuna nnifisha, u suwiċidju (avvenimenti marbuta ma' suwiċidju).
English: Estimated frequency based on all clinical trial data.
Maltese: Stima tal-frekwenza bbażata fuq tagħrif mill-provi kliniċi kollha.
English: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Maltese: Ittagħrif farmakokinetiku fuq duloxetine huwa limitat f'pazjenti b'indeboliment tal-kliewi ta' grad ħafif jew wieħed moderat.
English: Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Maltese: L-informazzjoni dwar l-użu ta' Duloxetine Mylan 120 mg f'pazjenti anzjani b'disturb depressiv maġġuri u b'disturb ta' ansjetà ġeneralizzata hija limitata.
English: In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Maltese: Fi studju ta' tossiċità ta' qabel u wara t-twelid, fil-far, duloxetine ikkaġuna effetti avversi ta' komportament fil-frieħ, f'livelli ta' espożiżżjoni sistemika anqas mill-esponiment massimu kliniku (AUC).
English: Arcana Arzneimittel GmbH Tel.: +43 1 416 2418
Maltese: Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00
English: • dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin
Maltese: • ħsibijiet ta' suwiċidju, diffikultà biex torqod, tgħażiż tas-snien, tħossok diżorjentat, nuqqas ta' motivazzjoni
English: 28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules 100 x 1 hard gastro-resistant capsules
Maltese: 14 kapsula gastro-reżistenti iebsa 28 kapsula gastro-reżistenti iebsa 49 kapsula gastro-reżistenti iebsa 84 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa 28 x 1 kapsula gastro-reżistenti iebsa 30 x 1 kapsula gastro-reżistenti iebsa 100 x 1 kapsula gastro-reżistenti iebsa
English: Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Maltese: Każi ta' formazzjoni ta' ħsibijiet suwiċidali u mġiba suwiċidali ġew irrappurtati waqt terapija ta' duloxetine jew kmieni wara sospensjoni tal-kura (ara sezzjoni 4.8).
English: When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Maltese: Meta jittieħdu waqt ittqala, mediċini simili (SSRIs) jistgħu jżidu r-riskju ta' kundizzjoni serja fit-trabi li tissejjaħ ipertensjoni pulmonarja persistenti fit-tarbija tat-twelid (PPHN), li ġġiegħel it-tarbija tieħu n-nifs aktar malajr u jkollha kulur blu.
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Maltese: • sogħla, tħarħir u qtugħ ta' nifs li jistgħu jkunu akkumpanjati minn temperatura għolja
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Mylan.
Maltese: Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b'liema mod jaffettwak Duloxetine Mylan.
English: Do not use this medicine after the expiry date which is stated on the carton.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna.
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Maltese: Riġidità talmuskoli Kontrazzjoni involontarja tal-muskolu
English: Ear and labyrinth disorders Tinnitus
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Tinnitus
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Duloxetine Mylan (see section 4.4).
Maltese: L-antibijotiku linezolid huwa MAOI riversibbli u mhux selettiv u m'għandux jingħata lill-pazjenti kkurati b'Duloxetine Mylan (ara sezzjoni 4.4).
English: Biotransformation: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Maltese: Duloxetine huwa metaboliżżat b'mod estensiv u l-eskrezzjoni tal-prodotti metaboliċi jsir l-aktar fl-urina.
English: Contains sucrose See leaflet for further information
Maltese: Fih is-sucrose Ara l-fuljett għal aktar informazzjoni
English: • Duloxetine Mylan may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Maltese: • Duloxetine Mylan jista' jkollu effetti li ma tkunx taf dwarhom bħal żidiet fl-enzimi tal-fwied jew fil-livelli tal-potassju, tal-creatine phosphokinase, taz-zokkor jew tal-kolesterol fid-demm
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Maltese: Differenzi farmakokinetiċi kienu identifikati bejn l-irġiel u n-nisa ( it-tneħħija apparenti millplażma huwa bejn wieħed u ieħor 50% inqas fin-nisa).
English: Urine odour abnormal
Maltese: Orgażmu mhux normali
English: Astellas Pharma BV, Erasmus Park, Square Marie Curie 50, Building 5, 1st floor
Maltese: BV, Erasmus Park, Square Marie Curie 50, Building 5, 1st floor
English: Belgium Magenta Pharma Consulting
Maltese: Il-Belġju Magenta Pharma Consulting
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, l-applikanti u d-detenturi ta` l-awtorizzazzjoni għat tqegħid fis-suq fl-Istati Membri
English: 1 mg/ml (5ml)
Maltese: 1 mg/ml (5 ml) Soluzzjoni għallinjezzjoni
English: Pharmaceuticals Limited
Maltese: Ir-Renju Unit Mercury Pharmaceuticals Limited
English: Solution for infusion Intravenous use
Maltese: Soluzzjoni għallinfużjoni
English: United Kingdom
Maltese: The Netherlands
English: Co-rapporteur(s):
Maltese: Ko-rapporteur(i):
English: Jens Ersbøll (Denmark)
Maltese: Jens Ersbøll (Danimarka)
English: 4.3 Contra-indications
Maltese: 4.3 Kontra indikazzjonijiet
English: EMA/CHMP/466386/2010 rev. EMEA/H/A-30/001266
Maltese: EMA/CHMP/466386/2010 rev.
English: 20 April 2010
Maltese: 20 ta' April 2010
English: What is Daivobet?
Maltese: X'inhu Daivobet?
English: Further treatment can be given under medical supervision.
Maltese: Aktar kura tista' tingħata taħt superviżjoni medika.
English: What are the conclusions of the CHMP?
Maltese: X'inhuma l-konklużjonijiet tal-CHMP?
English: Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) EMA/CHMP/466386/2010
Maltese: Mistoqsijiet u tweġibiet dwar Daivobet u l-ismijiet assoċjati (calcipotriol/betamethasone ġel u ingwent, 50 mikrogramma/0.5 mg per g) EMA/CHMP/466386/2010
English: 30 September 2010
Maltese: 30 ta' Settembru 2010
English: Daivobet contains two active substances: calcipotriol and betamethasone.
Maltese: Daivobet fih żewġ sustanzi attivi: calcipotriol u betamethasone.
English: On 10 March 2010, Leo Pharmaceutical Products referred Daivobet to the CHMP in order to harmonise the marketing authorisations for the product in the EU.
Maltese: Fl-10 ta' Marzu 2010, Leo Pharmaceutical Products irreferiet Daivobet lis-CHMP sabiex tarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodott fl-UE.
English: The company that markets these medicines is Leo Pharmaceutical Products.
Maltese: Il-kumpanija li tikkummerċjalizza dawn il-mediċini hija Leo Pharmaceutical Products.
English: Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g)
Maltese: Mistoqsijiet u tweġibiet dwar Daivobet u l-ismijiet assoċjati (calcipotriol/betamethasone ġel u ingwent, 50 mikrogramma/0.5 mg per g)
English: The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis.
Maltese: Il-Kumitat armonizza wkoll lista ta' kontraindikazzjonijiet relatati ma' kundizzjonijiet tal-ġilda, inkluż leżjonijiet virali tal-ġilda, infezzjonijiet tal-ġilda fungali jew batterjali, infezzjonijiet parasitiċi u problemi tal-ġilda kkawżati minn tuberkolożi jew sifilli.
English: The European Medicines Agency has completed a review of Daivobet.
Maltese: L-Aġenzija Ewropea tal-Mediċina temmet reviżjoni ta' Daivobet.
English: For the full list, see the harmonised SmPC.
Maltese: Għal-lista sħiħa, ara l-SmPC armonizzata.
English: Calcipotriol, a substance derived from vitamin D, acts through receptors in the skin to prevent the multiplication of cells that cause the scaly patches in psoriasis.
Maltese: Calcipotriol, sustanza derivata millvitamina D, jaġixxi mir-riċettaturi fil-ġilda biex jimpedixxi l-multiplikazzjoni ta' ċelloli li jikkawżaw lirqajja' bil-qoxra fi psorjażi.
English: 4.2 Posology and method of administration
Maltese: 4.2 Pożoloġija u metodu ta' kif jingħata
English: Daivobet gel was authorised via a decentralised procedure.
Maltese: Il-ġel Daivobet ġie awtorizzat permezz ta' proċedura deċentralizzata.
English: Why was Daivobet reviewed?
Maltese: Għaliex ġie rivedut Daivobet?
English: Betamethasone is an anti-inflammatory medicine that helps to reduce the inflammation and itching that occur with psoriasis.
Maltese: Betamethasone huwa mediċina anti-infjammatorja li tgħin biex tnaqqas linfjammazzjoni u l-ħakk li jseħħu bi psorjażi.
English: Daivobet is also available in the EU under the trade name Dovobet.
Maltese: Daivobet huwa disponibbli wkoll fl-UE taħt l-isem kummerċjali ta' Dovobet.
English: 22 July 2010
Maltese: 22 ta' Lulju 2010
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li hemm il-ħtieġa li l-informazzjoni ta' preskrizzjoni għal Daivobet tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The CHMP agreed that Daivobet ointment is to be used for the treatment of adults with plaque psoriasis where it is possible to use a topical medicine.
Maltese: Is-CHMP qabel li l-ingwent Daivobet għandu jintuża għall-kura ta' adulti bi psorjażi tal-plakka fejn ikun possibbli li tintuża mediċina għal fuq il-ġilda.
English: Daivobet is used to treat adults with psoriasis (a disease causing red, scaly patches on the skin).
Maltese: Daivobet jintuża biex jittratta adulti b'psorjażi (marda li tikkawża ħmura, irqajja' bil-qoxra fuq il-ġilda).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-SmPCs, it-tikketta u l-fuljetti ta' tagħrif għandhom jiġu armonizzati madwar l-UE kollha.
English: Daivobet gel is for the treatment of psoriasis on the scalp or mild to moderate plaque psoriasis on other parts of the body.
Maltese: Jiġi bħala ġel u ingwent u jintuża fuq il-ġilda (applikat fuq il-ġilda).
English: No more than 15 g of the gel or ointment should be used in one day.
Maltese: Ma għandux jintuża aktar minn 15 g tal-ġel jew ingwent f'ġurnata waħda.
English: Manic episode:
Maltese: Episodju ta' manija:
English: • A blocked intestine (Paralytic ileus)
Maltese: • Intestin imblokkat (Ileus paralitiku)
English: (See sections 4.5 and 5.2)
Maltese: (Ara sezzjonijiet 4.5 u 5.2)
English: Olanzapine had no teratogenic effects.
Maltese: Olanzapine ma kellu ebda effetti teratoġeniċi.
English: Repeated dose toxicity
Maltese: Tossiċità ta' dożi ripetuti
English: Hypromellose Hydroxypropylcellulose Macrogol 8000
Maltese: Il-kisja tal-pillola Hypromellose Hydroxypropylcellulose Macrogol 8000
English: Lactose monohydrate Microcrystalline cellulose Maize starch
Maltese: Il-qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Maize starch
English: The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Maltese: Iż-żieda medja fl-AUC ta' olanzapine kienet 52% u 108% rispettivament.
English: Schizophrenia:
Maltese: Skiżofrenja:
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Maltese: In vitro, olanzapine ma jinibixxix l-iżoenzimi prinċipali CYP450 (eż. 1A2, 2D6, 2C19, 3A4).
English: The other ingredients are mannitol (E421), microcrystalline cellulose, carmellose calcium, sucralose, magnesium stearate and colloidal anhydrous silica.
Maltese: Is-sustanzi l-oħra huma mannitol (E421), microcrystalline cellulose, carmellose calcium, sucralose, magnesium stearate and colloidal anhydrous silica.
English: Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, The Netherlands
Maltese: Apotex Europe B.V. Archimedesweg 2 2333 CN Leiden L-Olanda
English: Photosensitivity reaction Alopecia
Maltese: Reazzjoni ta' fotosensittività Alopeċja
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Maltese: Kategorija farmakoterapewtika: psikolettiċi, diazepines, oxazepines, thiazepins u oxepines, Kodiċi ATC:
English: The other ingredients are (tablet core) lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, (tablet coat) hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide (E171).
Maltese: Is-sustanzi l-oħra huma (qalba tal-pillola) lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, (kisja tal-pillola) hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide (E171).
English: (≥ 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: 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; -1 adrenerġiċi; riċetturi histamine H1.
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: The active substance is olanzapine.
Maltese: Is-sustanza attiva hi olanzapine.
English: Renal Impairment
Maltese: Indeboliment renali