FrancophonIA/ELRC3.0 huggingface dataset:
English: Embryo/fetal developmental and perinatal studies have shown indications of developmental delay (reduced weights, delayed ossification, hydronephrosis, hydrourether, and/or distended renal pelvis with reduced or absent papillae) as well as increased numbers of perinatal and neonatal deaths in offspring of rats treated from mid-pregnancy with oral doses below the maximum recommended human dose for ADASUVE on a mg/m basis (see section 4.6).
Maltese: Studji dwar liżvilupp tal-embriju/fetu u perinatali wrew indikazzjonijiet ta' dewmien fl-iżvilupp (piżijiet imnaqqsa, ossifikazzjoni mdewwma, idronefrożi, idrouretru, u/jew pelvis renali mwessa' b'papillae mnaqqsa jew nieqsa) kif ukoll għadd ta' mwiet perinatali u neonatali ikbar fil-frieħ ta' firien ikkurati minn nofs ittqala b'dożi orali taħt id-doża umana massima rakkomandata għal ADASUVE fuq bażi ta' mg/m
English: Each inhaler delivers 9.1 mg loxapine.
Maltese: Kull inalatur jagħti 9.1 mg loxapine.
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: Il-manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija fil-muskoli, bidla fl-istat mentali u evidenza ta' instabilità awtonomika (polz jew pressjoni tad-demm irregolari, takikardija, dijaforesi u disritmija tal-qalb).
English: Seizures / convulsions
Maltese: Aċċessjonijiet / konvulżjonijiet
English: Pull tab
Maltese: Iġbed it-tab
English: Inhalation powder
Maltese: Mhux applikabbli
English: In vitro studies indicate that loxapine and 8-OH-loxapine are not inducers of CYP1A2, 2B6 or 3A4 enzymes at clinically relevant concentrations.
Maltese: Studji in vitro jindikaw li loxapine u 8-OH-loxapine mhumiex indutturi ta' enzimi CYP1A2, 2B6 jew 3A4 f'konċentrazzjonijiet klinikament rilevanti.
English: You will use ADASUVE under the supervision of a doctor or nurse.
Maltese: Trid tuża ADASUVE taħt is-superviżjoni ta' tabib jew infermier.
English: The pharmacokinetic parameters of loxapine were determined in subjects on chronic, stable antipsychotic regimens following repeat administration of ADASUVE every 4 hours for a total of 3 doses (either 4.5 mg or 9.1 mg).
Maltese: Il-parametri farmakokinetiċi ta' loxapine ġew stabbiliti f'individwi b'korsijiet antipsikotiċi stabbli wara li ADASUVE ingħata b'mod ripetut kull 4 sigħat għal total ta' 3 dożi (jew 4.5 mg jew 9.1 mg).
English: A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm.
Maltese: Bronkodilatur beta-agonista li jaġixxi malajr għandu jkun disponibbli għal kura ta' bronkospażmu possibbli.
English: Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease [COPD] (see section 4.4).
Maltese: Pazjenti b'sinjali/sintomi respiratorji akuti (eż. tħarħir) jew b'mard attiv tal-passaġġi tal-arja (bħal pazjenti bl-ażżma jew mard kroniku ostruttiv tal-pulmun [COPD] (ara sezzjoni 4.4).
English: ADASUVE with alcohol Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.
Maltese: ADASUVE mal-alkoħol Peress li ADASUVE jaffettwa s-sistema nervuża, l-alkoħol għandu jiġi evitat meta jintuża ADASUVE.
English: Each inhaler delivers 4.5 mg loxapine.
Maltese: Kull inalatur jagħti 4.5 mg loxapine.
English: In vitro studies indicated that loxapine was not a substrate for P-glycoprotein (P-gp), but does inhibit P-gp.
Maltese: Studji in vitro indikaw li loxapine ma kienx substrat għall-glikoproteina-P (P-gp), iżda fil-fatt jinibixxi l-P-gp.
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Maltese: ADASUVE 4.5 mg jiġi f'kartuna ta' 1 jew 5 unitajiet.
English: Loxapine may cause severe respiratory depression if combined with other CNS-depressants (see section 4.4).
Maltese: Loxapine jista' jikkawża depressjoni respiratorja severa jekk jitħallat ma' depressanti oħra tas-CNS (ara sezzjoni 4.4).
English: Higher doses of lorazepam have not been studied.
Maltese: Dożi ogħla ta' lorazepam ma ġewx studjati.
English: Treatment N
Maltese: Kura N
English: Elderly patients with dementia-related psychosis
Maltese: Pazjenti anzjani bi psikożi relatata mad-dimenzja
English: ADASUVE has not been studied in elderly patients, including those with dementia-related psychosis.
Maltese: ADASUVE ma ġiex studjat f'pazjenti anzjani, inklużi dawk bi psikożi relatata mad-dimenzja.
English: Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
Maltese: Kull inalatur ta' doża waħda fih 5 mg loxapine u jagħti 4.5 mg loxapine.
English: Main results of the pivotal efficacy studies: comparisons between ADASUVE 4.5 mg, 9.1 mg, and placebo
Maltese: Ir-riżultati ewlenin tal-istudji tal-effikaċja pivotali: tqabbil bejn ADASUVE 4.5 mg, 9.1 mg, u plaċebo
English: Loxapine exposure in the first 2 hours after administration (AUC0-2h, a measure of early exposure that is relevant to the onset of therapeutic effect) was 25.6 ng*h/mL for the 4.5 mg dose and 66.7 ng*h/mL for the 9.1 mg dose in healthy subjects.
Maltese: L-espożizzjoni għal loxapine fl-ewwel sagħtejn wara l-għoti (AUC0-2h, miżura ta' espożizzjoni bikjira li hija rilevanti għall-bidu tal-effett terapewtiku) kienet ta' 25.6 ng*h/mL għad-doża ta' 4.5 mg u 66.7 ng*h/mL għad-doża ta' 9.1 mg f'individwi b'saħħithom.
English: Female rats did not mate due to persistent diestrus after oral treatment with loxapine.
Maltese: Firien nisa ma tgħammrux minħabba diestru persistenti wara kura orali b'loxapine.
English: Potential for ADASUVE to affect other medicinal products
Maltese: Potenzjal li ADASUVE jaffettwa prodotti mediċinali oħra
English: Seizures have been reported in patients receiving oral loxapine at antipsychotic dose levels, and may occur in epileptic patients even with maintenance of routine anticonvulsant drug therapy (see section 4.5).
Maltese: F'pazjenti li kienu qegħdin jirċievu loxapine orali f'dożi antipsikotiċi, kien hemm rapporti ta' aċċessjonijiet li jistgħu jseħħu f'pazjenti epilettiċi anki b' terapija ta' rutina b'mediċini antikonvulżivi (ara sezzjoni 4.5).
English: The main metabolic pathways include hydroxylation to form 8-OH-loxapine and 7-OH-loxapine, N-oxidation to form loxapine N-oxide, and de-methylation to form amoxapine.
Maltese: Ir-rotot metaboliċi ewlenin jinkludu l-idrossilazzjoni biex jiġu ffurmati 8-OH-loxapine u 7-OH-loxapine, Noxidation biex jiffurmaw loxapine N-oxide, u de-methylation biex jiffurmaw amoxapine.
English: For ADASUVE, the order of metabolites observed in humans (based on systemic exposure) was 8-OH-loxapine >> loxapine N oxide > 7-OH-loxapine > amoxapine, with plasma levels of 8-OH-loxapine similar to the parent compound.
Maltese: Għal ADASUVE, l-ordni tal-metaboliti osservati fil-bnedmin (abbażi ta' espożizzjoni sistemika) kien 8OH-loxapine >> loxapine N oxide> 7-OH-loxapine> amoxapine, b'livelli fil-plażma ta' 8-OHloxapine simili għall-kompost prinċipali. 8-OH-loxapine mhuwiex attiv farmakoloġikament fir-riċettur D2 filwaqt li l-metabolit minuri, 7-OH-loxapine, għandu affinità għolja ta' rbit mar-riċetturi D2.
English: • if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).
Maltese: • jekk għandek problemi fil-pulmun bħal ażma jew mard kroniku ostruttiv fil-pulmun (li t-tabib tiegħek seta' rrefera għalih bħala “COPD”).
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg loxapine.
Maltese: Kull inalatur ta' doża waħda fih 10 mg loxapine u jagħti 9.1 mg loxapine.
English: Other medicines and ADASUVE
Maltese: Mediċini oħra u ADASUVE
English: Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (Tmax) by 2 minutes.
Maltese: L-għoti ta' ADASUVE rriżultat f'assorbiment rapidu ta' loxapine f'medja ta' żmien ta' konċentrazzjoni massima fil-plażma (Tmax) ta' 2 minuti.
English: 2 hr post dose
Maltese: Sagħtejn wara d-doża
English: Adrenaline should not be used, since beta-adrenoceptor stimulation may worsen hypotension in the setting of loxapine-induced partial alpha-adrenoceptor blockade (see section 4.5).
Maltese: M'għandhiex tintuża l-adrenalina, billi l-istimulazzjoni talbeta-adrenoceptor tista' tiggrava l-pressjoni baxxa fl-ambitu ta' imblokk parzjali tal-alphaadrenoceptor indott minn loxapine (ara sezzjoni 4.5).
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonija, ipotonija, tregħid, ħedla ta' ngħas, problemi respiratorji, jew disturb fit-treddigħ.
English: • medicines to treat a breathing problem
Maltese: • mediċini biex tikkura problema fin-nifs
English: In a supportive Phase 2 single dose study enrolling a total of 129 patients with schizophrenia and schizoaffective disorder the decrease in PEC change after 2 hours was -5.0 for placebo, -6.7 for ADASUVE 4.5 mg, and -8.6 (p<0.001) for ADASUVE 9.1 mg.
Maltese: għal plaċebo, -6.7 għal ADASUVE 4.5 mg, u -8.6 (p<0.001) għal ADASUVE 9.1 mg.
English: The product is packaged in a sealed pouch.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: There were no important differences in the exposure or disposition of loxapine following administration of ADASUVE due to age, gender, race, weight, or body mass index (BMI).
Maltese: Ma kienx hemm differenzi importanti fl-espożizzjoni jew id-dispożizzjoni ta' loxapine wara l-għoti ta' ADASUVE minħabba l-età, is-sess, ir-razza, il-piż, jew l-indiċi tal-massa tal-ġisem (BMI).
English: • Statement on acute setting of indication
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà
English: At therapeutic concentrations, however, it is not expected to inhibit P-gp-mediated transport of other medicinal products in a clinically significant manner.
Maltese: F'konċentrazzjonijiet terapewtiċi, madankollu, mhuwiex mistenni li jinibixxi t-trasport medjat mill-P-gp ta' prodotti mediċinali oħra b'mod klinikament sinifikanti.
English: A majority of the patients in both Phase 3 studies were smokers with about 82% of the patients with schizophrenia and 74% of the patients with bipolar disorder currently smoking.
Maltese: Il-maġġoranza tal-pazjenti fiż-żewġ studji ta' Fażi 3 kienu jpejpu, b'madwar 82% tal-pazjenti bi skiżofrenija u 74% tal-pazjenti b'disturb bipolari kienu jpejpu.
English: Children and adolescents ADASUVE is not for use in children and adolescents under 18 years.
Maltese: Tfal u adolexxenti ADASUVE ma għandux jintuża minn tfal u adolexxenti li għandhom anqas minn 18-il sena.
English: ADASUVE 4.5 mg inhalation powder loxapine
Maltese: ADASUVE 4.5 mg trab li jittieħed man-nifs loxapine
English: ADASUVE contains the active substance loxapine, which belongs to a group of medicines called antipsychotics.
Maltese: ADASUVE fih is-sustanza attiva loxapine, li tagħmel parti minn grupp ta' mediċini msejħa antipsikotiċi.
English: Vascular disorders
Maltese: QOXRA TAL-APPARAT
English: • Caution to be exercised when ADASUVE is administered in patients with known cardiovascular disease or a family history of QT prolongation, and in cases of concomitant use with other medicial products known to prolong the QT interval
Maltese: • Għandha tiġi eżerċitata l-kawtela meta ADASUVE jingħata f'pazjenti b'mard kardjovaskulari magħruf jew bi storja familjari ta' prolongament tal-QT, u f'każijiet ta' użu konkomitanti ma' prodotti mediċinali oħra magħrufa li jtawwlu l-intervall QT
English: Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited.
Maltese: Għalhekk, ir-riskju ta' interazzjonijiet metaboliċi kkawżati minn effett fuq isoforma individwali huwa limitat.
English: ADASUVE 9.1 mg inhalation powder loxapine
Maltese: ADASUVE 9.1 mg trab li jittieħed man-nifs loxapine
English: ADASUVE should not be re-administered in patients who develop any respiratory signs/symptoms (see section 4.3).
Maltese: ADASUVE m'għandux jerġa' jingħata lil pazjenti li jiżviluppaw sinjali/sintomi respiratorji (ara sezzjoni 4.3).
English: • have or had seizures (convulsions)
Maltese: • ikollok jew kellek aċċessjonijiet (konvulżjonijiet)
English: • lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness
Maltese: • lorazepam jew mediċini oħra li jaġixxu ċentralment (għall-kura tal-ansjetà, id-depressjoni, l-uġigħ,
English: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
Maltese: ADASUVE huwa indikat għall-kontroll rapidu ta' aġitazzjoni ħafifa għal moderata f'pazjenti adulti bi skiżofrenija jew disturb bipolari.
English: Decreased agitation was evident 10 minutes after Dose 1, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, for both 4.5 mg and 9.1 mg doses in both schizophrenia and bipolar disorder patients.
Maltese: It-tnaqqis fl-aġitazzjoni kien evidenti 10 minuti wara l-ewwel doża, l-ewwel ħin ta' valutazzjoni, u filvalutazzjonijiet suċċessivi kollha matul il-perjodu ta' evalwazzjoni ta' 24 siegħa, għad-dożi kemm ta' 4.5 mg kif ukoll ta' 9.1 mg kemm fil-pazjenti bi skiżofrenija kif ukoll fil-pazjenti b'disturb bipolari.
English: AOP Orphan Pharmaceuticals AG HU Tel.: +36 1 3192633
Maltese: HU Tel.: +36 1 3192633
English: As would be expected from the pharmacologic actions of loxapine, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness (see section 4.4).
Maltese: Kif jista' jkun mistenni mill-azzjonijiet farmakoloġiċi ta' loxapine, is-sejbiet kliniċi jistgħu jvarjaw minn depressjoni ħafifa tas-CNS u s-sistemi kardjovaskulari għal pressjoni baxxa profonda, depressjoni respiratorja, u telfien mis-sensi (ara sezzjoni 4.4).
English: General disorders and administration site conditions Common: fatigue
Maltese: Komuni ħafna: sedazzjoni/ħedla ta' ngħas Komuni: sturdament
English: • ever had muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still
Maltese: • qatt kellek movimenti tal-muskoli jew fl-għajnejn li ma stajtx tikkontrolla, nuqqas ta'
English: Inclusion in Study 004-301 required a diagnosis of schizophrenia.
Maltese: L-inklużjoni fl-Istudju 004-301 kienet teħtieġ dijanjosi ta' skiżofrenija.
English: Tardive dyskinesia
Maltese: Tqala u treddigħ
English: Risk of QT prolongation:
Maltese: • Osservazzjoni ta' pazjenti għal siegħa wara kull doża ta' ADASUVE Riskju ta' prolongament tal-QT:
English: The white inhaler (housing) is molded from a medical-grade polycarbonate.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih L-inalatur l-abjad (qoxra) huwa ffurmat minn polycarbonate ta' grad mediku.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:
Maltese: L-MAH għandu jiżgura li, wara diskussjonijiet u ftehim mal-Awtoritajiet Nazzjonali Kompetenti f'kull Stat Membru fejn ADASUVE jitqiegħed fis-suq, mat-tnedija u wara t-tnedija, ilprofessjonisti kollha tal-kura tas-saħħa li huma mistennija li jużaw ADASUVE jiġu pprovduti b'pakkett ta' informazzjoni li jkun fih il-punti li ġejjin:
English: Among the other endpoints were PEC and Clinical Global ImpressionImprovement (CGI-I) responders at 2 hours after dose 1, and total number of patients per group who received 1, 2, or 3 doses of study medication with and without rescue medication.
Maltese: Fost l-endpoints l-oħra kien hemm il-PEC u dawk li wieġbu għall-Impressjoni Klinika Globali - Titjib (CGI-I) sagħtejn wara lewwel doża, u n-numru totali ta' pazjenti f'kull grupp li rċevew 1, 2, jew 3 dożi tal-medikazzjoni talistudju b'medikazzjoni ta' salvataġġ u mingħajrha.
English: Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment.
Maltese: Indeboliment renali u/jew epatiku ADASUVE ma ġiex studjat f'pazjenti b'indeboliment renali jew epatiku.
English: The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ADASUVE f'pazjenti ta' 'l fuq minn 65 sena ma ġewx determinati s'issa.
English: • if you are allergic to loxapine or amoxapine;
Maltese: • jekk inti allerġiku għal loxapine jew amoxapine;
English: Renal failure following oral loxapine overdosage has also been reported.
Maltese: Kien hemm rapporti wkoll ta' insuffiċjenza renali wara doża eċċessiva ta' loxapine orali.
English: PEC Change
Maltese: Bidla PEC
English: Κύπρος Τhespis Pharmaceutical Ltd Tηλ:
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Potential for other medicinal products to affect ADASUVE
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw ADASUVE
English: ADASUVE is used to treat acute symptoms of mild-to-moderate agitation that may occur in adult patients who have schizophrenia or bipolar disorder.
Maltese: ADASUVE jintuża biex jikkura s-sintomi akuti ta' aġitazzjoni ħafifa sa moderata li jistgħu jseħħu f'pazjenti adulti li għandhom skizofrenija jew disturbi bipolari.
English: What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Maltese: Billi din id-doża ma tistax tintlaħaq b'din il-preżentazzjoni (ADASUVE 4.5 mg), il-preżentazzjoni ADASUVE 9.1 mg għandha tintuża inizjalment.
English: Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine.
Maltese: Pressjoni baxxa severa tista' tkun mistennija biex tirrispondi għall-għoti ta' noradrenaline jew phenylephrine.
English: The potential risk of QTc prolongation due to interaction with medicinal products known to prolong QTc interval is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali ta' titwil fil-QTc minħabba interazzjoni ma' prodotti mediċinali li huma magħrufa li jtawlu l-intervall QTc.
English: CGI-I Responder
Maltese: Sorsi oħra ta' informazzjoni
English: Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE.
Maltese: Kien hemm rapporti ta' pressjoni baxxa ħafifa fi provi kliniċi qosra (24 siegħa) ikkontrollati bilplaċebo fuq pazjenti aġitati li ngħataw ADASUVE.
English: 5 single-dose inhalers
Maltese: 5 inalaturi ta' doża waħda
English: PC: {number} SN: {number} NN: {number}
Maltese: • jekk għandek sintomi ta' tħarħir jew qtugħ ta' nifs;
English: Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE.
Maltese: Titwil klinikament rilevanti fil-QT ma jidhirx li huwa assoċjat ma' doża waħda u dożi ripetuti ta' ADASUVE.
English: Rescue medication (intramuscular lorazepam) was given if medically required.
Maltese: Ingħatat medikazzjoni ta' salvataġġ (lorazepam ġol-muskoli) jekk din kienet medikament meħtieġa.
English: Hypotension
Maltese: Ipoventilazzjoni
English: Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.
Maltese: L-eżami tas-subsettijiet tal-popolazzjoni (età, razza, u sess) ma wera l-ebda rispons differenzjali fuq ilbażi ta' dawn is-sottogruppi.
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Maltese: Kull inalatur ta' doża waħda fih 10 mg ta' loxapine u jipprovdi 9.1 mg ta' loxapine.
English: New-born infants exposed repeatedly to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Maltese: Trabi tat-twelid esposti ripetutament għal antipsikotiċi matul it-tielet trimestru tat-tqala huma f'riskju ta' reazzjonijiet avversi fosthom sintomi ekstrapiramidali u/jew sintomi tal-irtirar li jistgħu jvarjaw fisseverità u d-dewmien tagħhom wara l-ħlas.
English: Inclusion in Study 004-302 required a diagnosis of bipolar disorder (current episode manic or mixed).
Maltese: L-inklużjoni fl-Istudju 004302 kienet teħtieġ dijanjosi ta' disturb bipolari (episodju kurrenti ta' manija jew imħallat).
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
Maltese: ADASUVE 9.1 mg trab li jittieħed man-nifs, lest minn qabel loxapine
English: Open pouch
Maltese: U L-UŻU
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Maltese: ADASUVE 4.5 mg trab li jittieħed man-nifs, lest minn qabel loxapine
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADASUVE in the subset of the paediatric population from 12 to less than 18 years of age for the treatment of schizophrenia and in the subset from 10 years to less than 18 years of age in bipolar disorder (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'ADASUVE fis-subsett tal-popolazzjoni pedjatrika ta' bejn it-12-il sena sa anqas minn 18-il sena għall-kura tal-iskizofrenija u fis-subsett ta' bejn l-10 snin sa anqas minn 18-il sena fil-mard bipolari (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Maltese: Qabel it-tnedija f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel dwar programm edukattiv mal-Awtorità Nazzjonali Kompetenti.
English: Typically, this will occur within 25 minutes of use.
Maltese: Ġeneralment, dan iseħħ fi żmien 25 minuta minn meta jkun intuża.
English: A population pharmacokinetic analysis that compared exposures in smokers versus non-smokers indicated that smoking, which induces CYP1A2, had a minimal effect on the exposure to ADASUVE.
Maltese: Analiżi farmakokinetika tal-popolazzjoni li qabblet l-espożizzjonijiet f'min ipejjep kontra min ma jpejjipx indikat li t-tipjip, li jinduċi CYP1A2, kellu effett minimu fuq l-espożizzjoni għal ADASUVE.
English: None
Maltese: Tqala
English: Caution should be exercised when ADASUVE is administered in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products known to prolong the QT interval.
Maltese: Għandha ssir attenzjoni meta ADASUVE jingħata lil pazjenti b'mard kardjovaskulari magħruf jew storja familjari ta' titwil fil-QT, u fl-użu konkomitanti ta' prodotti mediċinali oħra magħrufa li jtawlu l-intervall QT.
English: How to use ADASUVE 4.
Maltese: Kif għandek tuża ADASUVE 4.
English: ADASUVE is not indicated for the treatment of patients with dementia-related psychosis.
Maltese: ADASUVE mhuwiex indikat għat-trattament ta' pazjenti bi psikożi relatata mad-dimenzja.
English: Uncommon (may affect up to 1 in 100 people): muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still.
Maltese: Mhux komuni (tista' taffettwa sa persuna waħda minn kull 100 persuna): movimenti tal-muskoli jew tal-għajnejn li ma tistax tikkontrollahom, nuqqas ta' koordinazzjoni, kontrazzjoni muskolari sostnuta, jew sensazzjoni ta' aġitazzjoni jew li ma jistax jirnexxielek toqgħod bilqiegħda għal tul ta' ħin twil.
English: Concomitant administration of benzodiazepines or other hypnosedatives or respiratory depressants may be associated with excessive sedation and respiratory depression or respiratory failure.
Maltese: L-għoti konkomitanti ta' benzodiazepines jew ipnosedattivi jew depressanti respiratorji oħra jista' jkun assoċjat ma' sedazzjoni eċċessiva u depressjoni respiratorja jew insuffiċjenza respiratorja.
English: OTHER
Maltese: Tnejn