FrancophonIA/ELRC3.0 huggingface dataset:
English: Clenil (and associated names) monodose was first approved through national procedure in Italy in 1991, then was approved through national procedures in France, while in Ireland, Germany and Greece through Mutual Recognition procedure with Ireland as Reference Member State.
Maltese: Sanasthmax, Becloneb, Beclospin, Clenil. Clenil (u ismijiet assoċjati) ta' doża waħda kien l-ewwel approvat permezz ta' proċedura nazzjonali fl-Italja fl-1991, imbagħad kien approvat permezz ta' proċeduri nazzjonali fi Franza, filwaqt li fl-Irlanda, fil-Ġermanja u fil-Greċja kien approvat permezz ta' proċedura ta' Rikonoxximent Reċiproku bl-Irlanda li kienet l-Istat Membru ta' Referenza.
English: • The committee agreed on a harmonised product information for Clenil and associated names.
Maltese: • Il-kumitat qabel ma' informazzjoni dwar il-prodott armonizzata għal Clenil u ismijiet assoċjati.
English: Other respiratory conditions with the narrowing of the airways in the lungs (bronchostenotic condition)
Maltese: Kundizzjonijiet respiratorji oħrajn bit-tidjiq tal-passaġġi tal-arja fil-pulmun (kundizzjoni brokostenotika)
English: As regards the indication in wheezing, the term “preschool” as proposed by the MAH was not considered as informative by the CHMP and not in line with the SmPC guideline.
Maltese: Fir-rigward tal-indikazzjoni fit-tħarħir, it-terminu "qabel l-età tal-iskola" kif propost mill-MAH ma kienx meqjus bħala informattiv mis-CHMP u mhux skont il-linja gwida tal-SmPC.
English: Once daily vs twice daily administration
Maltese: Għoti ta' darba kuljum vs darbtejn kuljum
English: Ronde Tocht 11, 1507
Maltese: Ronde Tocht 11, 1507 CC
English: {Name and address} {tel} {fax} {e-mail}
Maltese: {Isem u indirizz} {telefon} {fax} {e-mail}
English: The Netherlands ratiopharm Nederland bv
Maltese: L-Olanda ratiopharm Nederland bv
English: CC Zaandam, The
Maltese: Zaandam, LOlanda
English: Fentanyl ratiopharm 100 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 100 microgram/hr Transdermal patch
Maltese: Fentanyl ratiopharm 100 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 100 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 100 microgram/hr Transdermal patch
English: Fentanyl ratiopharm 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 75 microgram/hr Transdermal patch
Maltese: Fentanyl ratiopharm 75 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 75 microgram/hr Transdermal patch
English: Fentanyl ratiopharm 25 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 25 microgram/hr Transdermal patch
Maltese: Fentanyl ratiopharm 25 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 25 microgram/hr Transdermal patch
English: Fentanyl ratiopharm 50 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 50 µg/uur, pleister voor transdermaal gebruik United Kingdom Telfanyl 50 microgram/hr Transdermal patch
Maltese: Fentanyl ratiopharm 50 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 50 µg/uur, pleister voor transdermaal gebruik Ir-Renju Unit Telfanyl 50 microgram/hr Transdermal patch
English: Fentanyl-ratiopharm 100 µg/h Matrixpflaster
Maltese: Il-Ġermanja Fentanyl-ratiopharm 100 µg/h Matrixpflaster Spanja
English: Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)
Maltese: - ażma, dipressjoni respiratorja jew xi mard fil-pulmun - pressjoni baxxa - indeboliment tal-fwied - indeboliment tal-kliewi - jekk kellek xi ferita f'rasek, tumur ġo moħħok, sinjali ta' żieda tal-pressjoni ġol-kranju
English: Fentanyl-ratiopharm 75 µg/h transdermales Matrixpflaster
Maltese: Fentanylratiopharm 75 µg/h transdermales Matrixpflaster
English: Fentanyl-ratiopharm 50 µg/h Matrixpflaster
Maltese: Il-Ġermanja Fentanyl-ratiopharm 50 µg/h Matrixpflaster Spanja
English: Fentanyl-ratiopharm 75 µg/h Matrixpflaster
Maltese: Il-Ġermanja Fentanyl-ratiopharm 75 µg/h Matrixpflaster Spanja
English: Fentanyl-ratiopharm 25 µg/h Matrixpflaster
Maltese: Il-Ġermanja Fentanyl-ratiopharm 25 µg/h Matrixpflaster Spanja
English: Fentanyl-ratiopharm 100 µg/h Matrixpflaster and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 100 µg/h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fentanyl-ratiopharm 100 µg/h transdermales Matrixpflaster
Maltese: L-Awstrija Fentanyl-ratiopharm 100 µg/h transdermales Matrixpflaster
English: Fentanyl-ratiopharm 25 µg/h Matrixpflaster and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 25 µg/h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fentanyl-ratiopharm 75 µg/h Matrixpflaster and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 75 µg/h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fentanyl-ratiopharm 50 µg/h Matrixpflaster and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 50 µg/h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fentanyl-ratiopharm 50 µg/h transdermales Matrixpflaster
Maltese: L-Awstrija Fentanyl-ratiopharm 50 µg/h transdermales Matrixpflaster
English: Each patch releases 75 micrograms fentanyl per hour.
Maltese: Kull garża terħi 75 mikrogramma fentanyl fis-siegħa.
English: Fentanyl-ratiopharm 25 µg/h transdermales Matrixpflaster
Maltese: L-Awstrija Fentanyl-ratiopharm 25 µg/h transdermales Matrixpflaster
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Garża trasparenti u bla kulur b'sinjal kaħlani fuq il-fojl warrani: “fentanyl 100 µg/h“.
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 75 µg/h“.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Garża trasparenti u bla kulur b'sinjala kaħlani fuq il-fojl warrani: “fentanyl 75 µg/h“.
English: Packaging Package size
Maltese: Ippakkjar Daqs tal-pakkett Perjodu ta' Tiżmim
English: Primary prevention
Maltese: Prevenzjoni primarja
English: [Product name] belongs to a group of medicines commonly known as fibrates.
Maltese: [Isem tal-prodott] jagħmel parti minn grupp ta' mediċini magħrufa aħjar bħala fibrates.
English: Section 4.1 - Therapeutic indications (to replace current text)
Maltese: Sezzjoni 4.1- Indikazzjonijiet terapewtiċi (bħala sostituzzjoni tal-kitba attwali)
English: The VA-HIT study was a double-blind study comparing gemfibrozil (1200 mg per day) with placebo in 2531 men with a history of coronary heart disease, HDL-C levels of < 40 mg/dL (1.0 mmol/L), and normal LDL C levels.
Maltese: L-istudju VA-HIT kien studju double-blind li qabbel gemfibrozil (1200 mg kuljum) ma' plaċebo f'2531 raġel bi storja ta' mard tal-qalb koronarju, livelli ta' HDL-C <40 mg / dL (1.0 mmol / L), u livelli ta' LDL C normali.
English: Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Maltese: Analiżi oħra ta' sottogrupp speċifikat minn qabel identifikat interazzjoni statistikament sinifikanti ta' kura skont is-sess tal-pazjent (p = 0.01) li tindika benefiċċju possibbli tal-kura ta' terapija kombinata fl-irġiel (p=0.037) iżda riskju potenzjalment ogħla għar-riżultat primarju f'nisa kkurati b'terapija kombinata meta mqabbla ma' terapija b'simvastatin mogħti waħdu (p=0.069).
English: - Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.
Maltese: - Iperkolesterolimja primarja meta statin huwa kontraindikat jew mhux tollerat..
English: Section 5.1 - Pharmacodynamic properties (in addition to current text)
Maltese: Sezzjoni 5.1 - Tagħrif farmakodinamiku (bħala sostituzzjoni tal-kitba attwali)
English: For example the fats known as triglycerides.
Maltese: Eżempju ix-xaħmijiet magħrufa bħala triglycerides.
English: In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%).
Maltese: Fis-sottogrupp speċifikat minn qabel ta' pazjenti dislipidemiċi, definiti bħala dawk fit-tertile l-iktar baxxa ta' HDL-C (≤34 mg/dl jew 0.88 mmol/L) u l-ogħla tertile ta' TG (≥204 mg/dl jew 2.3 mmol/L) fil-linja bażi, fenofibrate flimkien ma' terapija b'simvastatin wera tnaqqis relattiv ta' 31% meta mqabbel ma' terapija b'simvastatin mogħti waħdu għar-riżultat kompost primarju (proporzjon ta' periklu [HR] 0.69, 95% CI 0.49-0.97, p = 0.03; tnaqqis assolut ta' riskju: 4.95%).
English: The primary event of non-fatal myocardial infarction or cardiac death occurred in 17.3% of gemfibrozil-treated and 21.7% of placebotreated patients (reduction in relative risk 22%; 95% CI, 7 to 35 %; P=0.006).
Maltese: L-avveniment ewlieni ta' infart mijokardijaku mhux fatali jew mewt kardijaku seħħ f'17.3% tal-pazjenti kkurati b'gemfibrozil u 21.7% tal-pazjenti kkurati bil-plaċebo (tnaqqis fir-riskju relattiv ta' 22%; 95% CI, 7 sa 35%; P = 0.006).
English: Among secondary outcomes, patients treated with gemfibrozil experienced relative risk reductions of 25% (95% CI -647%, p=0.10) for stroke, 24% (95% CI 11-36%, p< 0.001) for the combined outcome of death from CHD, non-fatal myocardial infarction, or confirmed stroke, 59% (95% CI 33-75%, p< 0.001) for transient ischaemic attack, and 65% (95% CI 37-80%, p< 0.001) for carotid endarterectomy.
Maltese: Fost ir-riżultati sekondarji, pazjenti kkurati b'gemfibrozil kellhom tnaqqis fir-riskju relattiv ta' 25% (95% CI -6-47%, p = 0.10) għal puplesija, 24% (p 95% CI 11-36%, <0.001) għar-riżultat kombinat ta' mewt minn CHD, infart mijokardijaku mhux fatali, jew puplesija ikkonfermata, 59% (p 95% CI
English: Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, nonfatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%).
Maltese: Fenofibrate flimkien ma' terapija b'simvastatin ma wera l-ebda differenzi sinifikanti meta mqabbel ma' terapija b'simvastatin mogħti waħdu fir-riżultat kompost primarju ta' infart mijokardijaku mhux fatali, puplesija mhux fatali, u mewt kardjovaskulari (proporzjon ta' periklu [HR] 0.92, 95% CI 0.79-1.08, p = 0.32; tnaqqis assolut ta' riskju: 0.74%).
English: [Product name] is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
Maltese: [Isem tal-prodott] huwa indikat bħala żieda mad-dieta u trattamenti oħrajn mhux farmakoloġiċi (e. ż. eżerċizzju, tnaqqis fil-piż) għal dawn li ġejjin:
English: Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated (see section 5.1).
Maltese: Tnaqqis ta' morbożità kardjovaskulari fl-irġiel b'żieda fil-HDL kolesterol u f'riskju għoli għall-ewwel avveniment kardjovaskulari meta statin huwa kontraindikat jew mhux tollerat (ara sezzjoni 5.1).
English: Amendments to be included in the relevant sections of the summary of product characteristics for fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) containing medicinal products
Maltese: Emendi li għandhom jiġu miżjuda fis-sezzjonijiet relevanti tas-sommarji tal-karatteristiċi tal-prodott għal prodotti mediċinali li fihom fenofibrate (kapsuli ta' 100, 300, 67, 200, 250 mg u pilloli miksija b'rita ta' 160 u 145 mg)
English: - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Maltese: - Iperlipidemija mħallta f'pazjenti f'riskju għoli kardjovaskulari flimkien ma' statin meta triglycerides u kolesterol HDL ma jkunux ikkontrollati b'mod adegwat.
English: Amendments to be included in the relevant sections of the summary of product characteristics for bezafibrate, ciprofibrate and fenofibrate (267 mg capsules and 215 mg film coated tablets) containing medicinal products
Maltese: Emendi li għandhom jiġu miżjuda fis-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi tal-prodott għal prodotti mediċinali li fihom bezafibrate, ciprofibrate u fenofibrate (kapsuli ta' 267 mg u pilloli miksija b'rita ta' 215 mg)
English: There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.
Maltese: Hemm evidenza li t-trattament bil-fibrates jista' jnaqqas xi episodji ta' mard tal-qalb koronarju imma ma wriex li jnaqqas l-mortalità mill-kawżi kollha fil-prevenzjoni primarja jew sekondarja ta' mard kardjovaskulari.
English: Amendments to be included in the relevant sections of the package leaflet for fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) containing medicinal products
Maltese: Emendi li għandhom jiġu miżjuda fis-sezzjonijiet relevanti tal-fuljett ta' tagħrif tal-prodotti medicinali li fihom fenofibrate (kapsuli ta' 100, 300, 67, 200, 250 mg u pilloli miksija b'rita ta' 160 u 145 mg)
English: Amendments to be included in the relevant sections of the summary of product characteristics for gemfibrozil containing medicinal products
Maltese: Emendi li għandhom jiġu miżjuda fis-sezzjonijiet relevanti tas-sommarji tal-karatteristiċi tal-prodott għal prodotti mediċinali li fihom gemfibrozil
English: After one year, the mean HDL-C level was 6% higher and the mean triglyceride level was 31% lower in the gemfibrozil group than in the placebo group.
Maltese: Wara sena, il-medja tal-livell ta' HDL-C kien ta' 6% ogħla u l-medja tal-livell tat-trigliċeridi kien ta' 31% inqas fil-grupp ta' gemfibrozil meta mqabbla mal-grupp tal-plaċebo.
English: Amendments to be included in the relevant sections of the package leaflet bezafibrate, ciprofibrate and fenofibrate (267 mg capsules and 215 mg film coated tablets) containing medicinal products
Maltese: Emendi li għandhom jiġu miżjuda fis-sezzjonijiet relevanti tal-fuljett ta' tagħrif tal-prodotti medicinali li fihom bezafibrate, ciprofibrate u fenofibrate (kapsuli ta' 267 mg u pilloli miksija b'rita ta' 215 mg)
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebocontrolled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Maltese: Il-prova ta' Azzjoni biex Jiġi Kkontrollat Riskju Kardjovaskulari f'Pazjenti bid-Dijabete (ACCORD) dwar il-lipidi, kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo li sar fuq 5,518il pazjent b'dijabete mellitus ta' tip 2 ikkurati b'fenofibrate flimkien ma' simvastatin.
English: [Product name] can be used when other medicines [statins] are unsuitable, to reduce the occurrence of heart problems in men who are at high risk and who have increased ‘bad cholesterol'
Maltese: [Isem tal-prodott] jista' jiġi użat meta mediċini oħra [statins] ma jistgħux jiġu użati, sabiex titnaqqas il-frekwenza fil-problemi fil-qalb fi rġiel li qiegħdin f'riskju għoli u li għadhom livelli għoljin ta ‘kolesterol ħazin'
English: This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Maltese: Dan ma kienx osservat fis-sottogrupp ta' pazjenti dislipidemiċi msemmi qabel, iżda lanqas ma kien hemm l-ebda evidenza ċara ta' benefiċċju f'nisa dislipidemiċi kkurati b'fenofibrate flimkien ma' simvastatin, u effett possibbli ta' ħsara f'dan is-sottogrupp ma setax jiġi eskluż.
English: The manufacturer was Altana for studies Pan 2006/006 and Pan 2006/007, and Nycomed for study 2009-2106.
Maltese: Il-manifattur għall-istudji Pan 2006/006 u Pan 2006/007 kien Altana, u għall istudju 2009-2106 kien Nycomed.
English: Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE
Maltese: Olinka (UK) Limited 38/40 Chamberlayne Road London, Ir-Renju Unit NW10 3JE
English: Furthermore, an increase in T-max from 1-4 hours under fasting conditions to between 5 and 12 hours (attributed to delayed absorption with food) was published by the FDA in their Summary of Approval of the originator, Protonix 20 mg and Protonix 40 mg. [US FDA Summary of Approval Protonix 20 mg and Protonix 40 mg].
Maltese: Barra minn hekk, żieda fit-T-max minn 1-4 sigħat taħt kundizzjonijiet ta' sawm għal bejn 5 u 12-il siegħa (attribwita għal assorbiment imdewwem malikel) ġiet ippubblikata mill-FDA fis-Sommarju ta' Approvazzjoni tal-oriġinatur tagħhom, Protonix 20 mg u Protonix 40 mg. [US FDA Sommarju ta' Approvazzjoni Protonix 20 mg u Protonix 40 mg].
English: For Cmax the confidence interval is 77.6-95.6% which is slightly below the acceptance interval (80-125) but the intraindividual variability (2 period 2 sequence design) is higher than 30% (36%), similar to the data reported in the literature for pantoprazole.
Maltese: Fil-każ tas-Cmax, l-intervall ta' fiduċja huwa ta' 77.6-95.6% li huwa xi ftit taħt l-intervall ta' aċċettazzjoni (80-125) iżda l-varjabbiltà individwali (disinn ta' 2 perijodi 2 sekwenzi) huwa ogħla minn 30% (36%), simili għaddejta rrappurtata fil-letteratura għal pantoprazole.
English: It included the requested data about long-term stability of human plasma samples along with long-term stability data of stock solutions (749 days at -25°C) and auto-sampler stability (122.5 hours at 5°C).
Maltese: Dan kien jinkludi d-dejta mitluba dwar listabbiltà fit-tul ta' kampjuni ta' plażma umana flimkien ma' dejta dwar l-istabbiltà fit-tul ta' soluzzjonijiet tal-istokk (749 jum f'temperatura ta' -25°C) u l-istabbiltà ta' auto-sampler (122.5 sigħat f'temperatura ta' 5°C).
English: Gastro-resistant tablet
Maltese: Pillola gastro-reżistenti
English: The basis of Pantoprazole Olinka application is the establishment of bioequivalence between the proposed generic formulation and the originator (Pantecta 40 mg by Altana Pharma AG, Spain).
Maltese: Il-bażi tal-applikazzjoni ta' Pantoprazole Olinka hija l-istabbiliment ta' bijoekwivalenza bejn ilformolazzjoni ġenerika proposta u l-oriġinatur (Pantecta 40 mg minn Altana Pharma AG, Spanja).
English: There were laboratory abnormalities in the post-study laboratory evaluations for altogether 11 subjects.
Maltese: Kien hemm anormalitajiet tal-laboratorju fl-evalwazzjonijiet tal-laboratorju ta' wara l-istudju għall-11-il suġġett kollha.
English: United Kingdom Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE
Maltese: Ir-Repubblika Slovakka Olinka (UK) Limited 38/40 Chamberlayne Road London, Ir-Renju Unit
English: The documentation of the analytical methods comprised an Analytical Report and a Re-validation report.
Maltese: Id-dokumentazzjoni tal-metodi analitiċi kienet tinkludi Rapport Analitiku u rapport ta' Validazzjoni millĠdid.
English: Standard criteria for bioequivalence were used i.e. the 90 % CI for the AUC and Cmax ratios must lie within the accepted range of 0.80-1.25.
Maltese: Intużaw kriterji standard għall-bijoekwivalenza, jiġifieri 90% CI għall-AUC u proporzjonijiet Cmax għandhom ikunu fi ħdan il-medda aċċettata ta' 0.80-1.25.
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Czech Republic, Germany, Poland and Slovak Republic.
Maltese: L-Istat Membru ta' Referenza (RMS) għall-proċedura deċentralizzata għal applikazzjoni ta' Pantoprazole Olinka kien ir-Renju Unit u l-Istati Membri Kkonċernati (CMS) kienu: ir-Repubblika Ċeka, il-Ġermanja, ilPolonja u r-Repubblika Slovakka.
English: Olinka submitted two bioequivalence studies which compared the proposed 40 mg formulation to the reference product, Pantecta 40 mg gastro-resistant tablets; one study was conducted under fasting conditions [PAN-2006/007] and the other study under the fed condition [PAN-2006/006].
Maltese: Olinka ssottomettiet żewġ studji ta' bijoekwivalenza li qabblu l-formolazzjoni proposta ta' 40 mg mal-prodott ta' referenza, Pantecta 40 mg pilloli gastro-reżistenti; studju wieħed twettaq taħt kundizzjonijiet ta' sawm [PAN-2006/007] u l-istudju l-ieħor twettaq taħt kundizzjoni wara ikla [PAN-2006/006].
English: The Applicant justified the highly variable pharmacokinetics of pantoprazole, after food administration, referring to the biopharmaceutical classification system (BCS).
Maltese: L-Applikant iġġustifika l-farmakokinetiċi varjabbli ħafna ta' pantoprazole, wara l-amministrazzjoni talikel, billi rrefera għas-sistema ta' klassifikazzjoni bijofarmaċewtika (biopharmaceutical classification system - BCS).
English: The wider acceptance interval (75-133 %) for bioequivalence is considered justified, since pantoprazole is found to be highly variable under fed conditions.
Maltese: L-intervall ta' aċċettazzjoni usa' (75-133 %) għall-bijoekwivalenza huwa kkunsidrat iġġustifikat, minħabba li pantoprazole jinstab li huwa varjabbli ħafna taħt kundizzjonijiet wara ikla.
English: (iii) The results of additional dissolution testing, designed to mimic the gastric environment under fed conditions, and the further support provided by these data together with the discussion of the possible clinical relevance/applicability.
Maltese: (iii) Ir-riżultati ta' provi ta' dissoluzzjoni addizzjonali, imfasslin sabiex jimmimetizzaw l-ambjent gastriku taħt kundizzjonijiet ta' tmigħ, u l-appoġġ ulterjuri pprovdut minn din id-dejta flimkien mad-diskussjoni tarrelevanza klinika possibbli/applikabbiltà.
English: The CHMP, in the adopted List of Questions, requested the Applicant to discuss the design and results of the fed bioequivalence study, in the following key aspects: (i) The justification for the design of the study, particularly the 15 h sampling schedule and the rationale for pre-defining outliers based on the well-characterised and anticipated delayed absorption of pantoprazole with food in a small proportion of subjects - this should be discussed with reference to the current guidelines and in terms of the ability of the evaluable data to exclude a formulation difference under fed conditions.
Maltese: Il-ġustifikazzjoni għad-disinn tal-istudju, b'mod partikolari l-iskeda ta' teħid ta' kampjuni ta' 15-il siegħa u l-iskeda għal dawk li ma jikkonformawx pre-definiti, ibbażata fuq l-assorbiment imdewwem ikkaratterizzat sewwa u mistenni ta' pantoprazole mal-ikel fi proporzjon żgħir ta' suġġetti - dan għandu jiġi diskuss b'referenza għal-linji gwida attwali u fit-termini tal-abbiltà tad-dejta evalwabbli sabiex tiġi eskluża differenza fil-formolazzjoni taħt kundizzjonijiet wara ikla.