FrancophonIA/ELRC3.0 huggingface dataset:
English: The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Maltese: Razza L-inċidenza tal-alleli ta' CYP2C19 li tirriżulta f'metaboliżmu intermedju u dgħajjef ta' CYP2C19
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum, f'persuni b'mard sever tal-kliewi (tneħħija talkreatinina minn 5 sa 15 ml/min), l-inibizzjoni tal-agreggrazzjoni tal-plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f'persuni f'saħħithom, madankollu it-titwil fil-ħin tad-dmija kien simili għal dak osservat f'persuni f'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.Barra minn hekk, it-tolleranza klinika kienet tajba fil-pazjenti kollha.
English: Clopidogrel HCS 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel HCS 75 mg pillola miksija b'rita clopidogrel
English: España sanofi-aventis, S.A. Tel: +34 93 485 94 00
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +(48) 22 345 93 00
English: Elimination Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi flurina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
English: Delpharm Dijon
Maltese: • Popolazzjonii pedjatrika
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Maltese: F'pazjenti b'fibrillazzjoni atrijali, clopidogrel għandu jingħata bħala doża waħda kuljum ta' 75 mg. ASA (75-100 mg) għandu jinbeda u jitkompla jittieħed flimkien ma' clopidogrel (ara sezzjoni 5.1
English: Edgefield Avenue, Fawdon
Maltese: phenobarbital, jew oestrogen.
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' impedituri ta' CYP2C19 qawwija jew moderati għandu jiġi skoraġġut (ara sezzjonijiet 4.4 u 5.2).
English: Clopidogrel HCS 75 mg film-coated tablets
Maltese: Clopidogrel HCS 75 mg pilloli miksija b'rita
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Maltese: Ġiet irrapurtata Purpura Tromboċitopenika Trombotika (TTP) b'mod rari ħafna wara l-użu ta'
English: EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Maltese: EU/1/10/651/008 Kartun ta' 28x1 pillola miksija b'rita f'folji ta' doża waħda tal-aluminjuOPA/Al/PVC EU/1/10/651/009 Kartun ta' 28x1 pillola miksija b'rita f'folji ta' doża waħda tal-aluminjuOPA/Al/PVC (pakkett ta' xahar)
English: BATCH NUMBER Batch:
Maltese: Kodiċi ATC:
English: EU/1/10/651/011 Cartons of 50x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Maltese: EU/1/10/651/012 Kartun ta' 50x1 pillola miksija b'rita ġo folji ta' doża waħda tal-aluminjuOPA/Al/PVC
English: EU/1/10/651/009 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters (calendar pack)
Maltese: EU/1/10/651/007 Kartun ta' 100 pillola miksija b'rita ġo folji tal-aluminju-OPA/Al/PVC
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: Infart mijokardijaku reċenti (MI), puplesija reċenti jew mard periferali stabbilit tal-arterji L-istudju CAPRIE kien jinkludi 19,185 pazjent bi trombożi fil-vini li ntweriet permezz ta' infart mijokardijaku reċenti (<35 jum), puplesija iskemika reċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit tal-arterji periferali (PAD).
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Maltese: Minħabba r-riskju ta' żieda fil-konċentrazzjonijiet fil-plażma, it-teħid fl-istess ħin ta' clopidogrel u prodotti mediċinali li jitneħħew primarjament bil-metaboliżmu ta' CYP2C8 (e.ż., repaglinide, paclitaxel) għandu jsir b'kawtela (ara sezzjoni 4.4).
English: Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Maltese: Is-sigurtà tat-teħid flimkien ta' clopidogrel, sustanzi trombolitiċi speċifiċi għall-fibrina jew li m'humiex u heparins ġiet eżaminata f'pazjenti li kellhom infart mijokardijaku akut.
English: Vertigo
Maltese: Fertilità
English: Intracranial
Maltese: anemija
English: Sun
Maltese: Teva
English: Nervous system
Maltese: konċentrazzjoni.
English: Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Maltese: L-aggregazzjoni tal-plejtlits stimulata minn agonisti oħra barra ADP tiġi impedita wkoll permezz ta' mblukkar tal-amplifikazzjoni tal-attivazzjoni ta' plejtlits minn ADP meħlus.
English: Polska sanofi-aventis Sp. z o.o.
Maltese: Tibdiliet fit-togħma, agewsja
English: EU/1/10/651/012 Cartons of 56x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Maltese: EU/1/10/651/013 Kartun ta' 56x1 pillola miksija b'rita ġo folji ta' doża waħda tal-aluminju
English: Sanofi Synthelabo Limited Edgefield Avenue
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: F'pazjenti li għandhom metabolizzaturi dgħajfin ta' CYP2C19, clopidogrel f'dożi rakkomandati jifformaw inqas mis-sustanza attiva ta' clopidogrel u għandhom inqas effett fuq ilfunzjoni tal-plejtlits.
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti impedituri qawwija jew moderati ta' CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Plavix 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Maltese: Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrochloride).
English: Pregnancy and breast-feeding It is preferable not to take this product during pregnancy.
Maltese: Huwa preferibbli li ma tużax dan il-prodott waqt it-tqala u t-treddigħ.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Maltese: Frekwenzi ppubblikati għall- batut CYP2C19 huma madwar 2% għal
English: EU/1/10/651/010 Cartons of 30x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Maltese: EU/1/10/651/011 Kartun ta' 30x1 pillola miksija b'rita ġo folji ta' doża waħda tal-aluminju
English: Recent ischaemic stroke
Maltese: .8 Effetti mhux mixtieqa
English: Hrvatska sanofi-aventis Croatia d.o.o.
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW L-ISTRIXXI
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: dijarea, uġigħ addominali, dispepsja
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Maltese: F'COMMIT, ir-rata totali ta' fsada maġġuri mhux ċerebrali jew ta' fsada ċerebrali kienet baxxa u simili fiż-zewġ gruppi (0.6% kontra 0.5% fil-gruppi clopidogrel + ASA u l-plaċebo + ASA,
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Maltese: Tagħrif mill-istudju CAPRIE jindika li phenytoin u tolbutamide li huma metabolizzati b'CYP2C9 jistgħu jiġu amministrat b'sigurtà flimkien ma' clopidogrel.
English: Acquired haemophilia has been reported following use of clopidogrel.
Maltese: COMMIT u ACTIVE-A huma diskussi hawn taħt.
English: 08028- Barcelona España
Maltese: 08028- Barcelona
English: • recreational (illegal) drugs
Maltese: • drogi (illegali) rikreattivi
English: Rescue medication was administered in respectively 32.6%, 11.1 % and 14.6 % of patients.
Maltese: Medikazzjoni ta' salvataġġ ġiet amministrata fi 32.6%, 11.1 % u 14.6 % tal-pazjenti rispettivament.
English: • adrenaline
Maltese: • adrenalina
English: SN: {number} NN: {number}
Maltese: {numru} NN: {numru}
English: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona España
Maltese: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona Spanja
English: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Spain
Maltese: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Spanja
English: The terminal elimination half-life (T½) ranged from 6 to 8 hours.
Maltese: Il-half-life tal-eliminazzjoni terminali (T ½) kienet tvarja minn 6 sa 8 sigħat.
English: PC: {number}
Maltese: PC:
English: EU/1/13/823/001 (5 single-dose inhalers) EU/1/13/823/003 (1 single-dose inhaler)
Maltese: EU/1/13/823/001 (5 inalaturi ta' doża waħda) EU/1/13/823/003 (Inalatur 1 ta' doża waħda)
English: EU/1/13/823/002 (5 single-dose inhalers) EU/1/13/823/004 (1 single-dose inhaler)
Maltese: EU/1/13/823/002 (5 inalaturi ta' doża waħda) EU/1/13/823/004 (Inalatur 1 ta' doża waħda)
English: The active substance is loxapine.
Maltese: Is-sustanza attiva hija loxapine.
English: Uncommon: bronchospasm (including shortness of breath) Gastrointestinal disorders
Maltese: Mhux komuni: bronkospażmu (inkluż qtugħ ta' nifs) Disturbi gastrointestinali
English: Pharmacotherapeutic group: psycholeptics, antipsychotics; ATC code: N05AH01
Maltese: Grupp farmakoterapewtiku: psikolettiċi, antipsikotiċi; Kodiċi ATC:
English: MedDRA system organ classification Nervous system disorders
Maltese: Sistema tal-klassifika tal-organi skont MedDRA Disturbi fis-sistema nervuża
English: Adrenaline
Maltese: Adrenalina
English: Neuroleptic malignant syndrome (NMS)
Maltese: Sindromu newrolettiku malinn (NMS)
English: Date of first authorisation: 20 February 2013 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Frar 2013 Data tal-aħħar tiġdid:
English: • medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
Maltese: • mediċini li jistgħu jpoġġuk f'riskju ta' aċċessjonijiet (pereżempju, clozapine, tricyclics jew SSRIs,
English: Latvija AOP Orphan Pharmaceuticals AG LT
Maltese: AOP Orphan Pharmaceuticals AG
English: Loxapine is 96.6% bound to human plasma proteins.
Maltese: Loxapine huwa 96.6 % marbut mal-proteini tal-plażma tal-bniedem.
English: Uncommon: dystonia, dyskinesia, oculogyration, tremor, akathisia/restlessness
Maltese: Mhux komuni: distonija, diskajneżja, okuloġirazzjoni, tregħid, akatisja/irrekwitezza Disturbi vaskulari
English: • are an older person with dementia (loss of memory and other mental abilities).
Maltese: • inti persuna anzjana bid-demenzja (telf ta' memorja u ta' kapaċitajiet mentali oħra).
English: Hypersensitivity to the active substance, or to amoxapine.
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal amoxapine.
English: Loxapine is a substrate for flavin-containing mono-oxygenases (FMOs), and for several CYP450 isozymes (see section 5.2).
Maltese: Loxapine huwa substrat għal mono-oxygenases li fihom flavin (FMOs), u għal diversi isoenzimi ta' CYP450 (ara sezzjoni 5.2).
English: Concomitant use of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin, enoxacin, propranolol and refecoxib) should be avoided, if possible.
Maltese: inibituri ta' CYP1A2 (eż. fluvoxamine, ciprofloxacin, enoxacin, propranolol u refecoxib) għandu jiġi evitat.
English: General:
Maltese: Ġenerali:
English: FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spain
Maltese: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spanja
English: The potential for loxapine and its metabolites (amoxapine, 7-OH-loxapine, 8-OH-loxapine, and loxapine-N-oxide) to inhibit CYP450 - mediated drug metabolism has been examined in vitro for CYPs 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Maltese: Il-potenzjal li loxapine u l-metaboliti tiegħu (amoxapine, 7-OH-loxapine, 8-OH-loxapine, u loxapineN-oxide) jimpedixxu l-metaboliżmu tal-mediċina medjat minn CYP450 ġie eżaminat in vitro għasCYPs 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: Common: dizziness
Maltese: Komuni ħafna: disgewżja
English: Intoxication or physical disease (delirium)
Maltese: Intossikazzjoni u mard fiżiku (delirju)
English: If vasopressor therapy is required, noradrenaline or phenylephrine is preferred.
Maltese: Jekk tkun meħtieġa terapija b'vasopressur, huwa preferut noradrenaline jew phenylephrine.
English: Respiratory, thoracic and mediastinal disorders Common: throat irritation
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni: irritazzjoni fil-gerżuma
English: • medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”
Maltese: • mediċini bħal fluvoxamine, propranolol, u enoxacin u mediċini oħra li jinibixxu enzima tal-fwied partikolari msejħa “CYP450 1A2.
English: Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
Maltese: Għandu jkun hemm disponibbli trattament bi bronkodilatur beta-agonist li jaħdem malajr għat-trattament ta' effetti sekondarji respiratorji serji (bronkospażmu) possibbli.
English: Loxapine is a substrate for several CYP450 isozymes; in vitro studies demonstrated that 7-OHloxapine is formed mainly by CYPs 3A4 and 2D6, 8-OH-loxapine is formed mainly by CYP1A2, amoxapine is formed mainly by CYP3A4, 2C19, and 2C8, and loxapine N-oxide is formed by FMOs.
Maltese: Loxapine huwa substrat ta' diversi isożimi CYP450; studji in vitro wrew li 7-OH-loxapine huwa ffurmat primarjament minn CYPs 3A4 u 2D6, 8-OH-loxapine huwa ffurmat primarjament minn CYP1A2, amoxapine huwa ffurmat primarjament minn CYP3A4, 2C19, u 2C8 , u loxapine N-oxide huwa ffurmat minn FMOs.
English: Should bronchospasm occur after treatment with ADASUVE, it can be treated with a short-acting beta-agonist bronchodilator, e.g., salbutamol (see sections 4.2 and 4.8).
Maltese: Jekk ilbronkospażmu jseħħ wara t-trattament b'ADASUVE, huwa jista' jiġi ttrattat bi bronkodilatur betaagonist li jaħdem malajr, eż. salbutamol (ara sezzjonijiet 4.2 u 4.8).
English: Loxapine is metabolised extensively in the liver, with multiple metabolites formed.
Maltese: Loxapine huwa metabolizzat b'mod estensiv fil-fwied, bid-diversi metaboliti ffurmati.
English: • Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE.
Maltese: • Sindromu Newrolettiku Malinn (NMS) huwa sett ta' sintomi li jistgħu jseħħu jekk tkun qed tieħu mediċini antipsikotiċi, inkluż ADASUVE.
English: Pull tab.
Maltese: Iġbed it-tab.
English: The mean age of randomized patients was 43.1 years in Study 004-301 and 40.8 years in Study 004-302: young adults (18-25 years old) were scarcely (7.3%) represented in either trial.
Maltese: L-età medja tal-pazjenti magħżula b'mod każwali kienet ta' 43.1 sena fl-Istudju 004-301 u ta' 40.8 sena fl-Istudju 004-302: iż-żgħażagħ (ta' bejn 18-25 sena) ftit (7.3%) kienu rappreżentati fl-istudji.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali addizzjonali jistgħu jinkludu żieda fil-creatine phosphokinase, mijoglobinurja (rabdomijolisi), u insuffiċjenza renali akuta.
English: In female rats, reproductive effects have been observed (see section 5.3).
Maltese: Fil-firien nisa, kienu osservati effetti fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: • Addtional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: AUC0-2h, AUCinf, and Cmax increased in a dose-dependent manner.
Maltese: AUC0-2h, AUCinf, Cmax żdiedu b'mod li jiddependi mid-doża.
English: In the two Phase 3 studies patients were enrolled who had acute agitation of at least moderate level (14 or higher on Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) scale (poor impulse control, tension, hostility, uncooperativeness, and excitement).
Maltese: Fiż-żewġ studji ta' Fażi 3 kienu rreġistrati pazjenti li kellhom aġitazzjoni akuta mill-anqas ta' livell moderat (14 jew ogħla fuq l-iskala tal-Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) (kontroll fqir tal-impulsi, tensjoni, ostilità, nuqqas ta' kooperazzjoni, u eċitament).
English: With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention).
Maltese: B'għoti orali kroniku ta' loxapine, ir-reazzjonijiet avversi li ġew irrappurtati kienu jinkludu sedazzjoni u ħedla ta' ngħas; sintomi ekstrapiramidali (eż. tregħid, akatisja, riġidità, u distonija); effetti kardjovaskulari (eż. takikardija, pressjoni baxxa, pressjoni għolja, pressjoni baxxa ortostatika, sturdament, u sinkope); u effetti antikolinerġiċi (eż. għajnejn xotti, vista mċajpra, u żamma tal-awrina).
English: Patients should receive regular treatment immediately after control of acute agitation symptoms.
Maltese: Il-pazjenti għandhom jirċievu trattament regolari immedjatament wara l-kontroll tas-sintomi ta' aġitazzjoni akuta.
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Maltese: Is-sintomi ekstrapiramidali (inkluża distonja akuta) huma effetti ta' klassi magħrufa għall-antipsikotiċi.
English: The adverse reactions listed below are categorized using the following convention: 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).
Maltese: Rari (≥ 1/10,000 sa < 1/1,000);
English: Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs) .
Maltese: Loxapine mhuwiex mistenni li jikkawża interazzjonijiet farmakokinetiċi klinikament importanti ma' prodotti mediċinali li huma jew metabolizzati minn isoenzimi taċ-ċitokromu P450 (CYP450) jew glucuronidated minn human uridine 5'-diphosphoglucuronosyl transferases (UGTs).
English: • Administration of a maximum of 2 doses
Maltese: • Għoti ta' massimu ta' 2 dożi
English: In addition, in vitro studies indicate that loxapine and 8-OH loxapine are not inhibitors of UGT1A1, 1A3, 1A4, 2B7 and 2B15.
Maltese: Ukoll, studji in vitro jindikaw li loxapine u 8-OH loxapine mhumiex impedituri ta' UGT1A1, 1A3, 1A4, 2B7 u 2B15.
English: See the SmPC for more information.
Maltese: Ara l-SmPC għal aktar informazzjoni.
English: Caution is advised if loxapine is combined with other medicinal products known to lower the seizure threshold, e.g. phenothiazines or butyrophenones, clozapine, tricyclics or selective serotonine reuptake inhibitors (SSRIs), tramadol, mefloquine (see section 4.4).
Maltese: Hija rakkomandata kawtela jekk loxapine jiġi kombinat ma' prodotti mediċinali oħra li huma magħrufa li jbaxxu l-limitu għall-aċċessjonijiet, eż. phenothiazines jew butyrophenones, clozapine, tricyclics jew inibituri selettivi tat-teħid mill-ġdid tas-serotonin (SSRIs), tramadol, mefloquine (ara sezzjoni 4.4).
English: PEC Responders = > 40% change from PEC Baseline; CGI-I Responders = Score of 1 (Very Much Improved) or 2 (Much Improved) PBO = placebo SD=Standard Deviation
Maltese: Dawk li wieġbu CGI-I = Punteġġ ta' 1 (Titjib Qawwi Ħafna) jew 2 (Titjib Qawwi) PBO = plaċebo SD=Devjazzjoni Standard
English: Angelini S.p.A. Tel: +39 06 780531
Maltese: Tel: +39 06 780531
English: Women in the schizophrenia trial were scarcely represented (26.5%), and about half of the patients were male (49.7%) in Study 004-302.
Maltese: 5%), u madwar nofs il-pazjenti kienu rġiel (49.7%) fl-Istudju 004-302.
English: Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson medicinal products or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
Maltese: Ir-reazzjonijiet ekstrapiramidali severi għandhom jiġu trattati bi prodotti mediċinali antikolinerġiċi kontra l-parkinson jew diphenhydramine hydrochloride, u għandha tinbeda terapija antikonvulżiva kif indikat.
English: Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorder) or bipolar disorder, treated with ADASUVE 4.5 mg (265 patients) or ADASUVE 9.1 mg (259 patients).
Maltese: Il-valutazzjoni tar-reazzjonijiet avversi minn dejta tal-istudji kliniċi hija bbażata fuq żewġ provi kliniċi qosra ta' Fażi 3 u prova klinika waħda qasira ta' Fażi 2A (24 siegħa) ikkontrollati bil-plaċebo li rreġistraw 524 pazjent adult b'aġitazzjoni assoċjata ma' skiżofrenija (fosthom 27 pazjent b'disturb skiżoaffettiv) jew disturb bipolari, mogħtija ADASUVE 4.5 mg (265 pazjent) jew ADASUVE 9.1 mg (259 pazjent).
English: How to use ADASUVE
Maltese: Tużax ADASUVE
English: Adverse reactions seen with chronic oral loxapine use
Maltese: Reazzjonijiet avversi li dehru b'użu orali kroniku ta' loxapine
English: Patients were randomised to placebo, ADASUVE 4.5 mg and ADASUVE 9.1 mg.
Maltese: Ilpazjenti kienu ntgħażlu b'mod każwali għall-plaċebo, ADASUVE 4.5 mg u ADASUVE 9.1 mg.
English: • Availabilty of rescue medications (short acting beta agonist bronchodilator) during treatment
Maltese: • Disponibilità ta' medikazzjonijiet ta' salvataġġ (bronkodilatur beta agonista li jaġixxi malajr) matul il-kura
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Maltese: ADASUVE 9.1 mg jiġi f'kartuna ta' 1 jew 5 unitajiet.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 LISTA
English: In female smokers exposure (AUCinf) to ADASUVE and its active metabolite 7-OH-loxapine is lower than in female non-smokers (84% vs 109% 7-OH-loxapine/Loxapine Ratio), which is probably due to an increase in loxapine clearance in smokers.
Maltese: Fin-nisa li jpejpu, l-espożizzjoni (AUCinf) għal ADASUVE u l-metabolit attiv tiegħu 7-OH-loxapine hija anqas milli fin-nisa li ma jpejpux (Proporzjon ta' 84 % kontra 109 % 7-OH-loxapine/Loxapine), li probabbilment hija dovuta għal żieda fit-tneħħija ta' loxapine f'min ipejjep.