FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study on pharmacokinetics of fosamprenavir in paediatric patients, eight subjects 12 to 18 years of age received the standard fosamprenavir adult tablet dose of 700 mg twice daily (with ritonavir 100 mg twice daily).
Maltese: Fi studju kliniku fuq il-farmakokinetika ta' fosamprenavir f'pazjenti pedjatriċi, 8 suġġetti minn 12 sa 18 il-sena irċevew id-doża standard għall-kbar ta' 700mg darbtejn kuljum għal pilloli ta '
English: FPV/RTV 700 mg/100 mg
Maltese: fosamprenavir / ritonavir 700 mg /100 mg darbtejn kuljum.
English: Treatment-emergent major or APV-associated protease mutations were observed in virus isolated from 2 patients.
Maltese: Mutazzjonijiet tal-protease maġġuri li rriżultaw wara l-kura jew assoċjati mal-APV ġew osservati fil-virus iżolat minn 2 pazjenti.
English: Susceptiple to FPV/RTV
Maltese: L-ebda studju ta' interazzjoni mediċinali FPV/RTV
English: It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate.
Maltese: phenytoin fil-plażma tkun sorveljata u d-doża ta'
English: (listed in section 6), or to ritonavir.
Maltese: (elenkati fis-sezzjoni 6), jew għal ritonavir.
English: (Mild CYP2D6 inhibition by RTV)
Maltese: (Inibizzjoni ħafifa ta' CYP2D6 minn RTV)
English: Toxicity was not aggravated when juvenile animals were treated as compared with adult animals, but the data did indicate a steeper dose response.
Maltese: It-tossiċità ma aggravatx meta annimali minorenni ingħataw l-istess kura bħal annimali adulti, imma d-data uriet rispons fid-doża aktar wieqfa.
English: In reproductive toxicity studies with fosamprenavir in rats, male fertility was not affected.
Maltese: Fi studji b'fosamprenavir dwar tossicità riproduttiva fil-firien, il-fertilità maskili ma ġietx affettwata.
English: As shown in the above table, there were only 16 patients harbouring baseline virus with resistance to FPV/RTV according to the ANRS score.
Maltese: Kif muri fit-tabella t'hawn fuq, kien hemm biss 16-il pazjent li kellhom virus reżistenti għal FPV/RTV fil-linja bażi skont il-punteġġ ANRS.
English: Body System
Maltese: Reżistenza
English: I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Maltese: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V u L90M u hija assoċċjata ma' żieda fir-reżistenza finotipika għal fosamprenavir ma' ritonavir kif ukoll bħala ċans anqas ta' rispons viroloġiku (reżistenza).
English: Norethisterone: AUC
Maltese: Reazzjoni avversa
English: Fosamprenavir with ritonavir was generally well-tolerated in subjects with mild, moderate, or severe hepatic impairment, and these regimens had similar adverse event and clinical laboratory profiles as previous studies of HIV-1 infected subjects with normal hepatic function.
Maltese: fosamprenavir ma' ritonavir u dawn s-sistemi ta' trattament urew profil ta' effetti avversi u profil kiniku tal-laboratorju simili għal dawk f'studji li saru qabel f'suġġetti bl-infezzjoni HIV-1 b'funzjoni tal-fwied normali.
English: Compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily, 12 to 18 year old subjects had 20 % lower plasma APV AUC(024), 23 % lower Cmax, and 20 % lower Cmin values.
Maltese: 12 u t-18 il-sena kellhom valuri ta' AUC ta' APV aktar baxx fil-plażma b'20% (0-24), Cmax aktar baxxbi 23% u Cmin aktar baxx b'20%.
English: • lopinavir/ritonavir combination (used to treat HIV infection)
Maltese: • teħid flimkien ta' lopinavir/ritonavir (li jintużaw biex jikkuraw infezzjonijiet ta' HIV)
English: Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e.g. desipramine and nortriptyline) when coadministered with Telzir (see section 4.5).
Maltese: Monitoraġġ ta' konċentrazzjonijiet terapewtiċi hu rakkomandat għal meta antidepressanti triċikliki (e.g desipramine u nortriptyline) jittieħdu flimkien ma' Telzir (ara sezzjoni 4.5).
English: After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation.
Maltese: Wara li jingħata mill-ħalq, fosamprenavir jiġi idrolizzat malajr u kważi kompletament f'amprenavir u fosfat inorganiku qabel ma jasal fiċ-ċirkolazzjoni sistemika.
English: Week 96 Week 144
Maltese: Ġimgħa 96 Ġimgħa 144
English: (CYP3A4 induction by FPV/RTV)
Maltese: (Inibizzjoni CYP3A4 minn FPV/RTV)
English: Patients on stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response.
Maltese: Parametri tal-piż u metaboliċi Żieda fil-piż u fil-livelli ta' lipidi u glucose fid-demm tista' sseħħ matul terapija antiretrovirali.
English: The most frequently (> 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Maltese: Ir-reazzjonijiet avversi li ġew irrappurtati bl-akbar frekwenza (> 5% ta' suġġetti adulti li ħadu t trattament) bit-taħlita ta' fosamprenavir/ritonavir kienu reazzjonijiet gastro-intestinali (dardir, dijarea,
English: Rat pups exposed pre and post-natally to amprenavir and fosamprenavir showed developmental toxicity (see section 5.3).
Maltese: Firien tat-twelid li kienu esposti għal amprenavir u fosamprenavir qabel u wara t-twelid urew tossiċità ta' l-iżvilupp (ara sezzjoni 5.3).
English: Cisapride: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Cisapride: ↑ mistennija (Inibizzjoni ta' CYP3A4 minn FPV/RTV)
English: Children and adolescents: The adverse reaction profile in children and adolescents is based on integrated safety data from two studies (APV29005 Week 24 data and APV20003 Week 168 data [final data]) in which 158 HIV-1 infected subjects 2 to 18 years of age received fosamprenavir with ritonavir with background nucleoside reverse transcriptase inhibitor therapy (see section 5.1 for information on dosing regimens applied for each age group).
Maltese: 168 [dejta finali]) fejn 158 individwu mill-età ta' sentejn sa 18 il-sena infettati bl-HIV-1 irċivew fosamprenavir ma' ritonavir bi sfond ta' terapija ta' inibitur nuklejosida ta' reverse tanscriptase (ara sezzjoni 5.1 għal tagħrif dwar l-iskedi tad-doża applikati għal kull età). 79 % tal-individwi rċivew aktar minn 48 ġimgħa ta' esponiment.
English: The principal route of amprenavir and ritonavir elimination is hepatic metabolism.
Maltese: Ir-rotta ewlenija tat-tneħħija ta' amprenavir u ritonavir hi l-metaboliżmu tal-fwied.
English: Amprenavir: Cmax ↔ Amprenavir: AUC ↔
Maltese: Amprenavir: Cmax ↔ Amprenavir:
English: Significant reductions in amprenavir Cmin observed may result in virological failure in patients.
Maltese: għal falliment viroloġiku fil pazjenti.
English: • If you have a known allergy to medicines containing sulphonamide.
Maltese: - Jekk taf li għandek allerġija għal mediċini li fihom sulphonamide.
English: Erythromycin: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Maltese: Erythromycin: ↑ mistennija (Inibizzjoni ta' CYP3A4 minn FPV/RTV)
English: Despite reducing the dosing frequency of ritonavir, subjects with severe hepatic impairment had 64% higher ritonavir Cmax, 40% higher ritonavir AUC(0-24), and 38% higher ritonavir C12 than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Maltese: Minkejja li kien tnaqqis fil-frekwenza tad-doża ta' ritonavir, suġġetti b'indebboliment sever tal-fwied kellhom 64% ta' Cmax ta' ritonavir aktar għoli, 40% AUC(0-24) aktar għoli, u 38% ta' C12 ta' ritonavir aktar għoli minn dak li ntlaħaq f'suġġetti b'funzjoni normali tal-fwied li kienu fuq sistema ta' kura standard ta' fosamprenavir ma' ritonavir ta' 700mg / 100mg darbtejn kuljum.,
English: Baseline Characteristics ART/PI status, n (%) ART-naïve ART-experienced, PI-naïve PI-experienced Median duration of prior ART exposure, weeks NRTI PI Median plasma HIV-1 RNA log10 copies/mL
Maltese: Wara li temmew il-perjodu ta' 48 ġimgħa ta' kura, l-individwi fil-postijiet Ewropej u Kanadiżi kienu eliġibbli biex jipparteċipaw fi studju ta' estensjoni sal-Ġimgħa 144 billi żammew l-istess kura li kellhom fir-randomisation oriġinali. 22% biss mill-popolazzjoni oriġinali tal-istudju KLEAN
English: It is bound to the alpha-1acid glycoprotein (AAG) and albumin,but has a higher affinity for AAG.
Maltese: Din tkun imwaħħla l-biċċa l-kbira ma' l-alpha-1-acid glycoprotein (AAG) u ma' l-albumina, iżda għandha iżjed affinità għal AAG.
English: NAME OF THE MEDICINAL PRODUCT Telzir 50 mg/ml oral suspension
Maltese: Suspensjoni orali ta' 50 mg/ml Telzir
English: ADRENORECEPTOR ANTAGONIST Alfuzosin,
Maltese: Ma sarux studji komparattivi fi tfal jew adolexxenti.
English: Tel: + 385 1 6051 999
Maltese: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy') to treat adults, adolescents and children aged over 6 years infected with HIV.
Maltese: (‘terapija kombinata') fil-kura ta' adulti, adolexxenti u tfal ta' 6 snin u aktar, infettati bl'HIV.
English: Amprenavir: AUC ↓ 82% Contraindicated (see section
Maltese: AUC ↓ 82%
English: Most adverse reactions associated with fosamprenavir/ritonavir combination therapies were mild to moderate in severity, early in onset and rarely treatment limiting.
Maltese: Ħafna mir-reazzjonijiet avversi assoċjati ma' terapija kombinata ta' fosamprenavir/ritonavir kienu ta' serjetà ħafifa għal moderata, seħħew fil-bidu tat trattament u rarament kellhom effett fuq it-tkomplija tat-trattament.
English: In the studies of PI-experienced adult patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V, and L90M.
Maltese: Fl-istudji ta' pazjenti adulti b'esperjenza PI, APV30003 u l-estensjoni tiegħu, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg darbtejn kuljum: n=107), ħarġu dawn il-mutazzjonijiet li ġejjin f'pazjenti li esperjenzaw falliment viroloġiku matul 96 ġimgħa:
English: Fosamprenavir with ritonavir therapy should be definitively stopped in case of severe rash or in case of rash of mild or moderate intensity associated with systemic or mucosal signs (see section 4.4).
Maltese: Telzir għandu jitwaqqaf għal kollox f'każ ta' raxx severi, jew f'każ ta' raxx b'intensità moderata b'sintomi sistemiċi jew mukużi (ara sezzjoni 4.8).
English: The population enrolled mainly consisted of moderately antiretroviral experienced patients.
Maltese: Il-grupp ta' pazjenti li ħadu sehem kien jikkonsisti primarjament minn pazjenti b'esperjenza antiretrovirali moderata.
English: Median Change from baseline in CD4 cells (cells/µl)
Maltese: Tibdil mill-linja bażi fiċ-ċelluli CD4 (ċelluli/µl)
English: Immune Reactivation Syndrome: in HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: Sindromu tar-Riattivazzjoni Immunitarja: f'pazjenti infettati bl-HIV b'defiċjenza severa fl-immunità fiż-żmien tal-bidu tat-terapija antiretrovirali kombinata (TARK), reazzjoni nfjammatorja tista'
English: Adverse reaction
Maltese: ANTI-RETROVIRALI
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Maltese: Xorta tista' titrasmetti l-HIV waqt li tkun qed tieħu din il-mediċina, għalkemm ir riskju jitbaxxa b'terapija antiretrovirali effettiva.
English: Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature noninfectious viral particles.
Maltese: Amprenavir jeħel mas-sit attiv tal-protease HIV-1 li ma jħallix il-proċessar ta' prekursuri virali ta' gag u gag-pol polyprotein u b'hekk jiġu ffurmati partiċelli virali mhux maturi li ma jinfettawx.
English: Tadalafil
Maltese: TAFFETTWA
English: If you have moderate liver disease the dose is 9 ml Telzir oral suspension (450 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Maltese: Jekk tbati minn mard moderat tal-fwied id-doża rakkomandata ta' 9ml ta' suspensjoni orali ta' Telzir (450mg ta' fosamprenavir) darbtejn kuljum ma' 100mg ta' ritonavir darba kuljum biss.
English: In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Maltese: F'adulti li diġà ngħataw ammonti moderati ta' antiretrovirali, Telzir flimkien ma' doża żgħira ta'
English: The apparent volume of distribution of amprenavir following administration of Telzir is approximately 430 l (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
Maltese: Jidher li l-volum tad-distribuzzjoni ta' amprenavir wara li jittieħed Telzir, huwa ta' madwar 430 1(6 1/kg jekk tieħu piż ta' ġisem ta' 70 kg), li jissuġġerixxi li l-volum tad-distribuzzjoni huwa kbir,
English: Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir.
Maltese: Barra minn hekk amprenavir huwa wkoll impeditur għall-enzima CYP3A4, għalkemm inqas minn ritonavir.
English: Metabolites account for approximately 14 % of the administered amprenavir dose in the urine, and approximately 75 % in the faeces.
Maltese: Il-metaboliti fl-awrina jagħmlu tajjeb għal madwar 14% tad-doża ta' amprenavir li tkun ingħatat, u għal madwar 75% fil purgar.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors with Telzir/ritonavir (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mwissija dwar dawn l-effetti sekondarji li jista' jkun hemm meta jużaw impedituri ta' PDE5 flimkien ma' Telzir/ritonavir (ara sezzjoni 4.4).
English: For adults with severe hepatic impairment (Child-Pugh score: 10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Maltese: Għal adulti b'indeboliment sever tal-fwied (Child-Pugh score: 10-15): fosamprenavir għandu jintuża b 'kawtela u f'dożi mnaqqsa ta' 300mg fosamprenavir darbtejn kuljum ma' 100mg ritonavir darba kuljum.
English: If you have mild liver disease, the dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Maltese: Jekk tbati minn mard mhux serju tal-fwied, id-doża hija ta' 14ml ta' suspensjoni orali ta' Telzir (700mg fosamprenavir) darbtejn kuljum b'100mg ritonavir darba kuljum biss.
English: (CYP3A4 inhibition)
Maltese: (Inibizzjoni ta' CYP3A4)
English: Abacavir
Maltese: Maraviroc
English: In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
Maltese: Fi studji pivotali dwar Telzir, f'pazjenti li qed jieħdu fosamprenavir ma' ritonavir ma kien hemm l-ebda evidenza ta' riskju akbar ta' raxx f'pazjenti b'passat ta' allergiji għas-sulfonamidi meta mqabbla ma' dawk li ma kellhomx allerġiji għas-sulphonamides.
English: Increased plasma concentrations of quetiapine may lead to coma.
Maltese: quetiapine fil-plasma tista' twassal għal koma.
English: Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products.
Maltese: Telzir għandu jittieħed flimkien ma' dożi baxxi ta' ritonavir u mediċini antiretrovirali oħra.
English: Halofantrine No drug interaction studies.
Maltese: L-ebda studi ta' interazzjoni ta' mediċina.
English: CSF penetration of amprenavir is negligible in humans.
Maltese: amprenavir jista' jirriżulta f'falliment viroloġiku u liżvilupp ta' reżistenza.
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Astemizole Terfenadine
Maltese: Astemizole Terfenadine
English: Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom
Maltese: Durham DL12 8DT, ir-Renju Unit. jew
English: A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir.
Maltese: Tnaqqis ta' mill-anqas 75% tad-doża ta' rifabutin huwa rakkomandat meta jittieħed ma' Telzir flimkien ma' ritonavir.
English: Resistance patterns were similar to those observed in adults.
Maltese: Mudelli ta' reżistenza kienu simili għal dawk osservati fl-adulti.
English: The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
Maltese: Id-doża tal-pilloli ta' Telzir għall-kbar (700mg darbtejn kuljum ma' ritonavir 100mg darbtejn kuljum) tista' tintuża fit-tfal li jiżnu 39 kilo jew aktar u jibilgħu il-pilloli sħaħ.
English: and 6 patients from APV20003.
Maltese: APV29005
English: 400 mg twice daily
Maltese: 400 mg darbtejn kuljum
English: Genotypic interpretation systems may be used to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in subjects with PI-resistant isolates.
Maltese: Jistgħu jintużaw sistemi ta' interpretazzjonijiet ġenotipiċi biex tagħmel estimi ta' l-attivita' ta' amprenavir/ritonavir jew fosamprenavir/ritonavir f'suġġetti b'iżolati reżistenti għal PI.
English: The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Maltese: L-użu ta' Telzir fl-istess ħin ma' halofantrine jew lidocaine (sistemiku) mhux rakkomandat (ara sezzjoni 4.5).
English: Elderly
Maltese: Orali
English: How to store Telzir
Maltese: X'fih Telzir
English: Repeat dose studies with fosamprenavir in rats produced effects consistent with hepatic enzyme induction, which predisposes rats to thyroid neoplasms.
Maltese: Studji b'dożi ripetuti ta' fosamprenavir fil-firien ipproduċew effetti konsistenti ma' induzzjoni ta' enżima tal-fwied, li jippridisponi l-firien għal neoplażmi tat-tirojde.
English: If a patient is already taking St John's wort, check amprenavir, ritonavir and HIV RNA and stop St John's wort.
Maltese: Jekk pazjent ikun diġa qed jieħu St John's wort, iċċekkja amprenavir,
English: There is limited clinical experience (less than 300 pregnancy outcomes) from the use of fosamprenavir in pregnant women.
Maltese: Hemm esperjenza klinika limitata (inqas minn 300 riżultat tat-tqala) mill-użu ta' fosamprenavir f'nisa tqal.
English: GSS was derived using ANRS 2007 guidelines.
Maltese: GSS inkiseb bl-użu tal-linji gwida ANRS 2007. 2RD=F:
English: - lopinavir/ritonavir combination (used to treat HIV infection) - raltegravir (used to treat HIV infection) - , , simeprevir, daclatasvir (used to treat hepatitis C virus infection) - maraviroc (used to treat HIV infection)
Maltese: • carbamezapine, phenobarbital, phenytoin (użati għal kura ta' l-epilessija) • cyclosporin, rapamycin, tacrolimus (użati biex irażżnu is-sistema immunitarja)
English: Haemophiliac patients
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Midazolam: ↑ expected (3-4 fold for parenteral midazolam)
Maltese: • midazolam u triazolam (użati għal kura ta' l-ansjeta')
English: ombitasvir +/- dasabuvir suggest that coadministration of fosamprenavir/ritonavir with paritaprevir/ritonavir/ ombitasvir +/- dasabuvir is likely to lead to increased plasma exposures of paritaprevir due to CYP3A4 enzyme inhibition and higher ritonavir dose.
Maltese: Hekk ukoll meta fosamprenavir jingħata ma' ritonavir dan jista' jġib tibdil fil-farmakokinetika ta' sustanzi attivi oħra li jużaw dan il-passaġġ metaboliku.
English: Rapamycin
Maltese: Rifampicin
English: Telzir/ritonavir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Telzir/ritonavir and parenteral midazolam.
Maltese: Telzir/ritonavir m'għandhomx jingħataw flimkien ma' midazolam mill-ħalq (ara sezzjoni 4.3), filwaqt li għandha tintuża kawtela mat-tehid flimkien ta' Telzir/ritonavir u midazolam fil-vina.
English: Phenotypic resistance testing
Maltese: Analiżi snapshot
English: ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A Examples of antineoplastic dasatinib: ↑ expected nilotinib: ↑ expected ibrutinib: ↑ expected vinblastine: ↑ expected
Maltese: ART ingħataw kura b'dożi approvati bħalissa ta' fosamprenavir/ritonavir, bħal sistemi oħra ta' kura PI imsaħħin b'ritonavir, il-mutazzjonijiet deskritti ma kienux osservati spiss.
English: 32.27 g
Maltese: Trab: 32.27 g
English: 90 x 1 tablets (unit dose)
Maltese: 90 x 1 pillola (doża waħda)
English: Powder for oral suspension bottle (glass)
Maltese: Trab għal susupensjoni orali
English: 1 bottle
Maltese: 1 Flixkun
English: l t o r
Maltese: Daqs talpakkett t x
English: The full EPAR for Adasuve can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Adasuve, loxapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Adasuve, il-loxapine, hija mediċina antipsikotika.
English: Both studies compared 4.5 mg and 9.1 mg of Adasuve with placebo (a dummy treatment).
Maltese: Iż-żewġ studji qabblu 4.5 mg u 9.1 mg ta' Adasuve ma' plaċebo (kura finta).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adasuve on 20 February 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Adasuve fl-20 ta' Frar 2013.
English: This is a summary of the European public assessment report (EPAR) for Adasuve.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Adasuve.
English: Adasuve is a medicine that contains the active substance loxapine.
Maltese: Adasuve huwa mediċina li fiha s-sustanza attiva loxapine.
English: One study involved 344 patients with schizophrenia and the second study involved 314 patients with bipolar disorder.
Maltese: Fi studju wieħed ħadu sehem 344 pazjent bi skizofrenija u fit-tieni studju ħadu sehem 314-il pazjent b'disturb bipolari.
English: In the study in patients with schizophrenia, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.0 points and patients taking 9.1 mg had an average fall of 8.7 points.
Maltese: Fl-istudju fuq pazjenti bi skizofrenija, pazjenti li kienu qed jieħdu 4.5 mg ta' Adasuve kellhom tnaqqis medju fil-punteġġ PEC ta' 8.0 punti u pazjenti li kienu qed jieħdu 9.1 mg kellhom tnaqqis medju ta' 8.7 punti.
English: The PEC score at the beginning of the study for these groups of patients was between 17 and 18.
Maltese: Il-punteġġ PEC fil-bidu talistudju għal dawn il-gruppi ta' pazjenti kien bejn 17 u 18.
English: The main measure of effectiveness was the change in the patients' symptoms two hours after giving a dose of loxapine, assessed using a standard scale of agitation in patients with schizophrenia and bipolar disorder (positive and negative symptom scale, excited component: PEC score).
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tibdil fis-sintomi tal-pazjenti sagħtejn wara l-għoti ta' doża ta' loxapine, evalwata permezz ta' skala standard ta' aġitazzjoni f'pazjenti bi skiżofrenija u b'disturb bipolari (positive and negative symptom scale, excited komponent: punteġġ PEC).
English: Loxapine works mainly by blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Maltese: Loxapine jaħdem prinċipalment billi jimblokka riċetturi għan-newrotrasmettituri 5hydroxytryptamine (magħruf ukoll bħala serotonin) u dopamine.