FrancophonIA/ELRC3.0 huggingface dataset:
English: 10-15 cm 2.0 - 2.5 bar
Maltese: 10 cm-15 cm 2.0 bar-2.5 bar
English: Omrix Pressure Regulator
Maltese: Regolatur tal-Pressjoni Omrix
English: 6 cm Yellow Flexible Tip
Maltese: Flessibbli Safra 6 cm
English: Recommended distance from target tissue
Maltese: Distanza rrakkomandata mit-tessut fil-mira
English: The text should read as follows: “Store at  -18C.
Maltese: “Aħżen f' -18 C.
English: • „Quixil should not be used in endoscopic surgery or for keyhole surgery.“
Maltese: • “Quixil m'għandux jintuża f'kirurġija endoskopika jew għal keyhole surgery.
English: Surgery
Maltese: Ponta
English: PACKAGE LEAFLET
Maltese: Regolatur tal
English: After thawing, unopened vials can be stored at 2 - 8C and protected from light, for up to 30 days.
Maltese: Wara li jinħallu, kunjetti mhux miftuħin jistgħu jinħażnu f'temperatura ta' 2 C-8C u protetti mid-dawl għal 30 jum.
English: Quixil Applicator Device
Maltese: Tagħmir tal-Applikatur ta' Quixil
English: “Quixil should only be used by experienced surgeons.
Maltese: “Quixil għandu jintuża biss minn kirurgi esperti.
English: In the absence of a specific recommendation avoid using pressure above 2.0-2.5 bars.
Maltese: Fin-nuqqas ta' rakkomandazzjoni speċifika evita li tuża pressjoni ogħla minn 2.0 bar-2.5 bar.
English: Prior to applying Quixil the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Maltese: Qabel ma Quixil jiġi applikat iż-żona tal-wiċċ tal-ferita għandha tiġi xxuttaat b'teknika standard (eż. l-applikazzjoni intermittenti ta' għafsiet, imselħiet, użu ta' tagħmir ta' ġbid tal-arja).
English: In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the tissue surface.
Maltese: Fin-nuqqas ta' rakkomandazzjoni speċifika evita l-isprejjar eqreb minn 10 cm-15 cm mill-wiċċ tat-tessut.
English: • “Spray application of Quixil should not be used in endoscopic procedures.”
Maltese: • “L-applikazzjoni bl-isprej ta' Quixil m'għandhiex tintuża għal proċeduri endoskopiċi.”
English: Open surgery
Maltese: Kirurġija miftuħa
English: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.
Maltese: “L-użu ta' Quixil huwa ristrett għall-kirurgi esperti li ġew imħarrġa fl-użu ta' QUIXIL.
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (See sections 4.2 and 4.4).
Maltese: Meta tisprejja Quixil, bidliet fil-pressjoni tad-demm, il-polz, is-saturazzjoni tal-ossiġenu u l-end tidal CO2 għandhom jiġu mmonitorjati minħabba l-possibilità li jkun hemm emboliżmu tal-arja jew tal-gass (Ara s-sezzjonijiet 4.2 u 4.4).
English: The following changes should be made to the SmPC of Quixil:
Maltese: QUIXIL M'għandekx tingħata Quixil:
English: • Handling
Maltese: a
English: The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Maltese: Imbagħad, il-prodott għandu jkun sprejjat fuq il-wiċċ tat-tessut fi splużjonijiet qosra (0.1 ml0.2 ml) biex ikun ifformat saff konsistenti u rqiq.
English: When applying Quixil using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer (see table in Section 6.6 for pressures and distance).
Maltese: Meta Quixil jiġi applikat permezz ta' tagħmir tal-isprej, kun żgur li tintuża pressjoni u distanza mit-tessut fil-firxa rrakkomandata mill-manifattur tattagħmir tal-isprej (ara t-tabella f'Sezzjoni 6.6 għall-pressjonijiet u ddistanza).
English: In the absence of a specific recommendation Quixil should not be sprayed closer than 10-15 cm from the tissue surface.
Maltese: Finnuqqas ta' rakkomandazzjoni speċifika evita l-isprejjar eqreb minn 10 cm-15 cm millwiċċ tat-tessut.
English: 6.4 Special precautions for storage
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: In open wound surgery - for spray application of Quixil, a pressure regulator device that delivers a maximum pressure of no more than 2.5 bar and uses carbon dioxide gas only should be used.
Maltese: F'kirurġija b'ferita miftuħa - għall-applikazzjoni bl-isprej ta' Quixil, għandu jintuża tagħmir b'regolatur tal-pressjoni li jwassal pressjoni massima ta' mhux aktar minn 2.5 bar u juża biss gass tad-dijossidu tal-karbonju.
English: The entire section should read as follows, in bold and underlined format where indicated: “To avoid the risk of life threatening gas or air embolism, Quixil should only be sprayed using pressurised CO2
Maltese: Is-sezzjoni sħiħa għandha tinqara hekk kif ġej, fil-format grassett u sottolinejat fejn indikat: “Biex jiġi evitat ir-riskju ta' emboliżmu tal-arja li jista' jkun ta' theddida għall-ħajja, Quixil għandu jiġi sprejjat billi jintuża biss gass CO2 taħt pressjoni.
English: 4.2 Posology and method of administration The following text should be added to this section: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.“ 4.2.2 Method and Route of Administration
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata It-test ta' din is-sezzjoni għandu jinqara hekk kif ġej: “L-użu ta' Quixil huwa ristrett għall-kirurgi b'esperjenza li ġew imħarrġa fl-użu ta' QUIXIL.”
English: When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer (see section 4.4)
Maltese: Meta Quixil jiġi applikat permezz ta' tagħmir tal-isprej, kun żgur li tintuża pressjoni u distanza mit-tessut fil-firxa rrakkomandata mill-manifattur (ara s-sezzjoni 4.4):
English: Should be replaced with the following text, in bold and underlined format where indicated
Maltese: Għandu jiġi sostitwit bit-test li ġej, fil-format grassett u sottolinejat fejn indikat
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue.”
Maltese: Għall-applikazzjoni bl-isprej: ara s-sezzjonijiet 4.4 u 6.6 għal rakkomandazzjonijiet speċifiċi għall-pressjoni meħtieġa u d-distanza mit-tessut.” 4.3 Kontraindikazzjonijiet
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: ANNESS III Emendi li għandhom jiġu inklużi fis-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Recommended spray pressure
Maltese: Applikazzjoni bħala Sprej
English: Connect the female luer lock of the gas tube (with the bacteriostatic filter) to a pressure regulator The pressure regulator should be used in accordance with the manufacturer's instructions.
Maltese: Qabbad il-lokk tal-luwer feminil tat-tubu tal-gass (mal-filtru batterjostatiku) mar-regolatur tal-pressjoni.
English: Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Maltese: Qabbad it-tubu l-qasir fuq l-apparat tal-applikazzjoni mat-tarf tal-lukkett luwer male tat-tubu t-twil tal-gass.
English: Spray Application
Maltese: • Immaniġġjar
English: To avoid the risk of potentially life threatening air embolism your surgeon is recommended to spray Quixil using pressurised CO2 only.
Maltese: Biex jiġi evitat ir-riskju ta' emboliżmu tal-arja li jista' jkun ta' theddida għall-ħajja,il-kirurgu tiegħek huwa rrakkomandat li jisprejja Quixil billi juża biss gass ta' CO2 taħt pressjoni.
English: “Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Maltese: “Kien hemm każijiet ta' emboliżmu tal-arja jew tal-gass b'theddida għall-ħajja bl-użu ta' regolatur tal-pressjoni sabiex jingħata Quixil.
English: In the absence of a specific recommendation the pressure should not exceed 2.0-2.5 bars.
Maltese: Fin-nuqqas ta' rakkomandazzjoni speċifika l-pressjoni m'għandhiex taqbeż 2.0 bar-2.5 bar.
English: • “Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Maltese: • “Kien hemm każijiet ta' emboliżmu tal-arja jew tal-gass li bl-użu ta' tagħmir talisprej li fihom regolatur tal-pressjoni sabiex jingħata Quixil.
English: To avoid the risk of potentially life threatening air embolism Quixil should be sprayed using pressurised CO2 gas only.
Maltese: Biex jiġi evitat ir-riskju ta' emboliżmu tal-arja li jista' jkun ta' theddida għall-ħajja, Quixil għandu jiġi sprejjat billi jintuża biss gass ta' CO2 taħt pressjoni.
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Maltese: Meta tisprejja Quixil, bidliet fil-pressjoni tad-demm, il-polz, issaturazzjoni tal-ossiġenu u l-end tidal CO2 għandhom jiġu mmonitorjati minħabba lpossibilità li jkun hemm emboliżmu tal-arja jew tal-gass.
English: When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:
Maltese: Meta Quixil jiġi applikat permezz ta' tagħmir tal-isprej, kun żgur li tintuża pressjoni u distanza mit-tessut fil-firxa rrakkomandata mill-manifattur kif ġej:
English: Quixil forms a clear film over the area of application.
Maltese: Quixil jifforma rita ċara fuq l-erja talapplikazzjoni.
English: HOW QUIXIL IS USED
Maltese: KIF JINTUŻA L-QUIXIL
English: Whereas
Maltese: il
English: in FeSSIF and FeSSGF
Maltese: fil-FeSSIF u l-FeSSGF
English: Pharmaceutical data
Maltese: Dejta farmaċewtika
English: Pharmacokinetic data
Maltese: Dejta farmakokinetika
English: • The Committed considered the notification of the referral triggered by Denmark under Article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdi mid-Danimarka skont l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: Lee et al. 2003 investigated the pharmacokinetics of Ritalin LA 40 mg capsule (Methylphenidate hydrochloride also consisting of an IR and ER component) under fasted conditions and after administration of a high fat breakfast.
Maltese: Lee et al. 2003 investigaw il-farmakokinetika ta' Ritalin LA 40 mg kapsula (Methylphenidate hydrochloride li jikkonsisti wkoll minn komponent IR u ER) f'kundizzjonijiet ta' stonku vojt u wara l għoti ta' kolazzjon b'kontenut għoli ta' xaħam.
English: Two types of profiles were seen.
Maltese: Kienu osservati żewġ tipi ta' profili.
English: Grounds for positive opinion
Maltese: Raġunijiet għall-opinjoni pożittiva
English: • methylphenidate exhibits linear kinetics among all strengths
Maltese: • methylphenidate juri kinetika lineari bejn il-qawwiet kollha
English: Methylphenidate Sandoz (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Maltese: Methylphenidate Sandoz (18 mg, 36 mg u 54 mg) huwa indikat fil-kura tad-disturb ta' Nuqqas ta' Attenzjoni/Attività Eċċessiva (ADHD) fi tfal ta' bejn 6 u 18-il sena, darba kuljum filgħodu u jista' jittieħed mal-ikel jew fuq stonku vojt.
English: • all strengths shows comparable dissolution profiles in various media in the pH range 1 to 6.8,
Maltese: • il-qawwiet kollha juru profili ta' tidwib komparabbli f'diversi mezzi fil-medda ta' pH ta' 1 sa 6.8,
English: The PK parameters for the fed study for the immediate release phase were the following: Cmax(0-2h) = 74.8 -142.7 and AUC (0-2h) = 60.0 - 155.6 (90% CI).
Maltese: Il-parametri PK tal-istudju li fih il-mediċina ngħatat wara l-ikel, għall-fażi li terħi l-mediċina b'mod immedjat, kienu dawn li ġejjin: Cmax(0-2h) = 74.8 -142.7 u AUC (0-2h) = 60.0 - 155.6
English: The studies demonstrated bioequivalence between test and reference product according to the guideline requirements for a modified release dosage form (Guideline on the investigation of bioequivalence, 2010 CPMP/EWP/QWP/1401/98 Rev. 1 and Note for Guidance on Modified Release Oral and Transdermal Dosage Forms, 1999 EMA/CPMP/EWP/280/96 Corr*) in force at time of study conduct (2009 - 2010).
Maltese: CPMP/EWP/QWP/1401/98 Rev. 1 u Nota għal Gwida dwar Forom ta' Dożaġġ Orali u Minn Ġol-Ġilda li Jerħu l-Mediċina b'Mod Modifikat, 1999 EMA/CPMP/EWP/280/96 Corr*) fisseħħ fiż-żmien li twettaq l-istudju (2009 - 2010).
English: The 90% CI for these measures were within the acceptance interval of 80%-125%.
Maltese: L-intervall ta' kunfidenza ta' 90% għal dawn il-kejlijiet kien fi ħdan l-intervall ta' aċċettazzjoni ta' 80%-125%.
English: The current repeat use procedure started in April 2012, two months after the EMA Question & Answer Position Paper (EMA/618604/2008 Rev. 4) concerning biphasic formulations was published.
Maltese: Il-proċedura preżenti għallużu ripetut bdiet f'April 2012, xahrejn wara li kien ippubblikat id-Dokument ta' Pożizzjoni ‘Mistoqsijiet u Tweġibiet' tal-EMA (EMA/618604/2008 Rev. 4) dwar formulazzjonijiet b'żewġ fażijiet.
English: Methylphenidate Sandoz which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Maltese: Methylphenidate Sandoz, li fih is-sustanza attiva methylphenidate hydrochloride, huwa pillola miksija b'rita, b'qalba b'żewġ saffi, li terħi l-mediċina bil-mod, ikkontrollata b'mod osmotiku.
English: The dissolution is rapid for the outer coating and similar between the test and reference product in various media in the pH range 1 to 6.8 as well as in FeSSIF (Fed state simulated intestinal fluid) and FeSSGF (Fed state simulated gastric fluid).
Maltese: It-tidwib huwa rapidu għall-kisja ta' barra u simili bejn il-prodott tat-test u l prodott ta' referenza f'diversi mezzi fil-medda ta' pH ta' 1 sa 6.8 kif ukoll fil-FeSSIF (Fed statesimulated intestinal fluid) u l-FeSSGF (Fed state simulated gastric fluid).
English: The first pharmacokinetic studies were performed by the applicant/MAH in 2009-2010 and submitted in the first DCP starting in January 2011.
Maltese: L-ewwel studji farmakokinetiċi twettqu mill-applikant/detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fis-snin 2009-2010 u kienu ppreżentati fl-ewwel DCP minn Jannar 2011.
English: In addition, the draft guideline on pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) states that the regulatory criteria applied for biphasic modified release products should follow the criteria applied for the prolonged release phase with additional pharmacokinetic parameters (partial AUC and Cmax).
Maltese: Barra minn hekk, l-abbozz ta' linja gwida dwar l-evalwazzjoni farmakokinetika u klinika ta' forom ta' dożaġġ li jerħu l-mediċina b'mod modifikat (EMA/CPMP/EWP/280/96 Corr1) isostni li l-kriterji regolatorji applikati għall-prodotti b'żewġ fażijiet li jerħu l-mediċina b'mod modifikat għandhom isegwu l-kriterji applikati għall-fażi li terħi l-mediċina bil-mod b'parametri farmakokinetiċi addizzjonali (AUC u Cmax parzjali).
English: The first profile was a biphasic profile (“target profile” of the reference product Concerta) with an early maximum followed by a decrease or an approximated plateau in the plasma concentrations.
Maltese: L-ewwel profil kien profil b'żewġ fażijiet (il-“profil fil-mira” tal-prodott ta' referenza Concerta) b'konċentrazzjoni massima bikrija segwita minn tnaqqis jew livell stabbli approssimat fil-konċentrazzjonijiet fil-plażma.
English: • The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Sandoz 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
Maltese: • Il-Kumitat ivvaluta d-dejta kollha ppreżentata mill-applikant sabiex jappoġġa l-bijoekwivalenza bejn Methylphenidate Sandoz 18 mg, 36 mg, 54 mg pilloli li jerħu l-mediċina bil-mod u l-prodott ta' referenza.
English: Because the pharmacokinetic studies were performed in 20092010 the Q&A Position Paper was not taken into consideration by the applicant/MAH.
Maltese: Peress li l-istudji farmakokinetiċi twettqu fis-snin 2009-2010, id-Dokument ta' Pożizzjoni ‘Mistoqsijiet u Tweġibiet' ma ġiex ikkunsidrat mill-applikant/detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Overall summary of the scientific evaluation of Methylphenidate Sandoz and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Methylphenidate Sandoz u ismijiet assoċjati (ara Anness I)
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Sandoz 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Maltese: L-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura ta' rikonoxximent reċiproku (MRP) għall-użu ripetut ippreżentata għall-prodott mediċinali Methylphenidate Sandoz 18mg, 36mg, 54mg pilloli hija applikazzjoni ġenerika skont l-Artikolu 10.
English: This is also due to the fact that the intra-individual variability decreased (19% instead of 110% for AUC, and 12% instead of 67% for Cmax) by taking into account only those subjects who exhibit a distinct peak for the initial phase under high fat fed conditions.
Maltese: Dan huwa dovut ukoll għall-fatt li l-varjabbiltà intra-individwu naqset (19% minflok 110% għall-AUC, u 12% minflok 67% għas-Cmax) billi jitqiesu biss dawk l-individwi li juru konċentrazzjoni massima distinta għall-fażi inizjali f'kundizzjonijiet fejn il-mediċina ngħatat wara tteħid ta' ikel b'ħafna xaħam.
English: The study evaluated the subjects which showed the characteristic biphasic profile of methylphenidate osmotic release formulation during the initial phase for both test and reference (n=8), and excluded subjects showing a continuous profile for at least one of the treatments.
Maltese: L-istudju evalwa l-individwi li wrew il-profil bifażiku karatteristiku talformulazzjoni ta' methylphenidate b'rilaxx osmotiku matul il-fażi inizjali kemm għat-test kif ukoll għarreferenza (n=8), u eskluda individwi li wrew profil kontinwu għal mill-anqas wieħed mit-trattamenti.
English: Methylphenidate Sandoz's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Maltese: Il-formulazzjoni ta' Methylphenidate Sandoz hija ddisinjata b'kisja fuq barra li fiha l-parti li terħi lmediċina mill-ewwel madwar il-qalba li terħi l-mediċina bil-mod (ikkontrollata b'mod osmotiku).
English: The applicant/MAH claimed that this is primarily attributed to the high intra-subject variability (66.5% for Cmax(0-2h), 110.1% for AUC (0-2h)) observed in this early phase as the point estimators Cmax(0-2h) and AUC (0-2h) are very close to 100% indicating that with an adequate sample size bioequivalence could have been shown also for these two parameters.
Maltese: 1% għall-AUC (0-2h)) li kienet osservata f'din il-fażi bikrija billi l-istimaturi tal-punti Cmax(0-2h) u AUC (0-2h) huma qrib ħafna ta' 100% li jindika li b'daqs ta' kampjun adegwat setgħet tintwera bijoekwivalenza wkoll għal dawn iż-żewġ parametri.
English: Based on the discussion above, the CHMP accepted the arguments provided by the applicant/MAH and agreed that the waiver of the studies under fed conditions for the lower strengths (18 mg and 36 mg) is justified.
Maltese: Abbażi tad-diskussjoni ta' hawn fuq, is-CHMP aċċetta l-argumenti pprovduti mill-applikant/detentur talawtorizzazzjoni għat-tqegħid fis-suq u qabel li r-rinunzja għall-istudji f'kundizzjonijiet ta' wara l-ikel għall-qawwiet aktar baxxi (18 mg u 36 mg) hija ġustifikata.
English: In support of the application, the applicant/MAH performed three single dose studies under fasting conditions with the 18, 36 and 54 mg tablets and one single dose study under fed conditions with the 54 mg tablet.
Maltese: B'appoġġ għall-applikazzjoni, l-applikant/detentur tal-awtorizzazzjoni għat-tqegħid fis-suq wettaq tliet studji b'doża unika f'kundizzjonijiet ta' stonku vojt bil-pilloli ta' 18, 36 u 54 mg u studju wieħed b'doża unika f'kundizzjonijiet ta' wara l-ikel bil-pillola ta' 54 mg.
English: However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Sandoz and the reference formulations.
Maltese: Madankollu, il-Kumitat huwa tal-opinjoni li d-devjazzjoni osservata hija attribwita għall-varjabbiltà bejn l-individwi u għal kundizzjonijiet fiżjoloġiċi wara t-teħid ta' ikla b'kontenut għoli ta' xaħam u ma tfissirx differenzi filkwalità bejn Methylphenidate Sandoz u l-formulazzjonijiet ta' referenza.
English: The second profile was a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Maltese: It-tieni profil kien profil kontinwu mingħajr konċentrazzjoni massima bikrija, fejn il-konċentrazzjonijiet ta' methylphenidate jiżdiedu bil-mod wara intervall erratiku.
English: Concentration maximal (0-2h) (Cmax(0-2h)), Area Under the Curve(0-2h) (AUC(0-2h)), Cmax(2-24h), AUC (2-24h)) had not been shown between the applied and the reference product.
Maltese: Matul il-proċedura ta' rikonoxximent reċiproku għall-użu ripetut, il-Ġermanja u l-Pajjiżi l-Baxxi esprimew l-opinjoni li ma kinitx intweriet bijoekwivalenza f'kundizzjonijiet ta' wara l-ikel bejn il-prodott li qed issir l-applikazzjoni għalih u l-prodott ta' referenza, meta ntużaw il-kejlijiet parzjali (jiġifieri lKonċentrazzjoni massima (0-2h) (Cmax(0-2h)), l-Erja taħt il-Kurva(0-2h) (AUC(0-2h)), is-Cmax(2-24h), u lAUC (2-24h)).
English: Regarding the results obtained in the fed study (2009-18-PRT-2), it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Maltese: Rigward ir-riżultati miksuba fl-istudju li fih il-mediċina ngħatat wara l-ikel (2009-18-PRT-2), intwera li meta pparagunat mal-istudju li fih il-mediċina ngħatat fuq stonku vojt, diversi individwi ma kellhomx profil b'żewġ fażijiet iżda profil kontinwu mingħajr konċentrazzjoni massima bikrija, fejn ilkonċentrazzjonijiet ta' methylphenidate jiżdiedu bil-mod wara intervall (lag time) erratiku.
English: The studies under fed and fasting conditions demonstrated bioequivalence between test and reference product using the entire dose interval (AUC(0-24h) and Cmax(0-24h)).
Maltese: L-istudju li fih il-mediċina ngħatat wara l-ikel naqas milli jissodisfa l-kriterji standard ta' aċċettazzjoni għall-bijoekwivalenza għall-fażi li terħi l-mediċina mill-ewwel (AUC(0-2h) u Cmax(0-2h)).
English: The additional in vitro dissolution profiles of test and reference product without the immediate release coating demonstrate that a lag time is seen for the prolonged release part and that the active substance in the immediate layer is released fast and independent from the prolonged release part. All in vivo and in vitro results indicate that the prolonged release phase (osmotic controlled) is unaffected by food intake.
Maltese: B'appoġġ għall-affermazzjoni li l-varjabbiltà għolja li dehret fl-istudju li fih il-mediċina ngħatat wara likel hija attribwita għal kundizzjonijiet fiżjoloġiċi wara t-teħid ta' ikla b'kontenut għoli ta' xaħam u mhux għal differenzi bejn il-formulazzjoni tat-test u l-formulazzjoni ta' referenza, hija pprovduta diskussjoni dwar id-dejta mil-letteratura u r-riżultati miksuba fl-istudju li fih il-mediċina ngħatat wara likel.