FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may prescribe Synjardy together with another diabetes medicine.
Maltese: Synjardy jista' jintuża wkoll ma' mediċini oħra.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Maltese: Fi studji kliniċi kkontrollati, dożi waħdanin ta' sa 800 mg empagliflozin (ekwivalenti għal 32 darba l-ogħla doża rakkomandata ta' kuljum) f'voluntiera b'saħħithom u dożi multipli ta' kuljum ta' sa 100 mg empagliflozin (ekwivalenti għal 4 darbiet l-ogħla doża rakkomandata ta' kuljum) f'pazjenti b'dijabete ta' tip 2 ma wrew l-ebda tossiċità.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Maltese: Is-sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm, livelli ta' lactate tal-plasma ogħla minn 5 mmol/l, u żieda fl-intervall tal-anjoni u l-proporzjon ta' lactate/pyruvate.
English: Table 4: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Maltese: Tabella 4: Riżultati tal-effikaċja f'Ġimgħat 18 u 52 fi studju kkontrollat bi plaċebo ta' empagliflozin bħala terapija aġġuntiva ma' dożi mogħtija diversi drabi kuljum ta' insulina bi jew mingħajr terapija konkomitanti b'metformin
English: Add-on to metformin and a sulphonylurea therapya Placebo
Maltese: Terapija aġġuntiva ma' metformin u sulphonylureaa Plaċebo
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidosi dijabetika jrid jitqies fil-każ ta' sintomi mhux tipiċi bħal nawsja, rimettar, anoressija, uġigħ addominali, għatx kbir, diffikultà fit-teħid tan-nifs, konfużjoni, għeja mhux tas-soltu jew ngħas.
English: The overall frequency of urinary tract infection reported as adverse event was higher in patients treated with empagliflozin 10 mg on a background of metformin compared to patients treated with placebo or empagliflozin 25 mg on a background of metformin (see section 4.8).
Maltese: pazjenti kkurati bi plaċebo jew b'empagliflozin 25 mg fuq terapija fl-sfond ta' metformin (ara sezzjoni 4.8).
English: Symptoms
Maltese: TIKKETTAR
English: • reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
Maltese: • inaqqas il-produzzjoni ta' glukosju tal-fwied billi jimpedixxi l-glukoneoġenesi u l-glikoġenolisi,
English: • if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis.
Maltese: • jekk għandek dijabete mhux ikkontrollata, pereżempju b'ipergliċemija severa (zokkor tad-demm għoli), nawsja, rimettar, deidrazzjoni, telf tal-piż rapidu jew ketoaċidożi.
English: There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance (see section 4.4)).
Maltese: sawm, malnutriment jew indeboliment tal-fwied minħabba s-sustanza attiva metformin (ara sezzjoni 4.4)
English: For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin In patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken.
Maltese: F'pazjenti li d-dijabete tagħhom mhix ikkontrollata b'mod adegwat b'metformin waħdu jew flimkien ma' prodotti mediċinali oħra li jnaqqsu l-glukosju, id-doża rakkomandata tal-bidu ta' Synjardy għandha tkun ta' empagliflozin 5 mg darbtejn kuljum (doża ta' kuljum ta' 10 mg) u d-doża ta' metformin simili għal dik li diġà qed jieħdu.
English: 2 not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value ≤0.0005
Maltese: (5.5 mmol/l), wara l-ikla < 140 mg/dl (7.8 mmol/l) * valur p ≤ 0.0005 ** valur p < 0.005
English: Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component.
Maltese: It-trattament b'aġent tal-kuntrast jodinat jista' jnaqqas il-funzjoni tal-kliewi tiegħek u jżid ir-riskju ta' effetti sekondarji minħabba l-komponent ta' metformin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha 5 mg empagliflozin u 850 mg metformin hydrochloride.
English: 200 mg (1 mg/ml) after reconstitution
Maltese: 200 mg (1 mg/ml) wara rikostituzzjoni
English: 1 Bottle
Maltese: 1 flixkun
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: 200 mg Powder for oral solution Oral use
Maltese: 200 mg Trab li jinħall f'likwidu u jittieħed mill-ħalq
English: 20 mg Gastro-resistant capsule, hard
Maltese: 20 mg Kapsula gastroreżistenti, iebsa flixkun (HPDE)
English: Bottle (HDPE) 14 capsules
Maltese: 14-il kapsula
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu catechol-O-methyl transferase (COMT).
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu© European Medicines Agency, 2008.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Maltese: • phaeochromocytoma (tumur tal-glandola adrenali);
English: It is available as brown-orange tablets (200 mg).
Maltese: Jiġi bħala pilloli kannella fl-oranġjo (200 mg).
English: The marketing authorisation was renewed on 16 September 2003 and on 16 September 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fis-16 ta' Settembru 2003 u fis-16 ta' Settembru 2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTESS EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) COMTESS Sommarju ta' l-EPAR għall-pubbliku
English: The marketing authorisation holder is Orion Corporation.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Orion Corporation.
English: Comtess is a medicine that contains the active substance entacapone.
Maltese: Comtess hu mediċina li fiha s-sustanza attiva entacapone.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Maltese: • każijiet preċedenti tas-sindromu newrolettiku malinn (disturb perikoluż tas-sistema nervuża ikkawżata minn mediċini antipsikotiċi) jew rabdomjolożi (rhabdomyolysis - tkissir tal-fibri tal muskoli).
English: In the second study, the ‘on' time was increased by 35 minutes compared with placebo.
Maltese: Fit-tieni studju, il-ħin ‘on' żdied b'35 minuta meta mqabbel mal-plaċebo.
English: • liver disease;
Maltese: • mard tal-fwied;
English: Comtess can only be used with conventional combinations of levodopa.
Maltese: Comtess jista' jintuża biss ma' kombinazzjonjiet konvenzjonali ta' levodopa.
English: The most common side effects with Comtess (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Maltese: L-iktar effetti sekondarji komuni ma' Comtess (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma d-diskinesja (movimenti inkontrollabbli), id-dardir u tibdil fil-kulur ta' l-awrina li ma jagħmilx ħsara.
English: The patients then lose their ability to control their movements reliably.
Maltese: Il-pazjenti mbagħad jitilfu labilità li jikkontrollaw il-moviment b'mod affidabbli.
English: Comtess has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Maltese: Comtess ġie studjat fi 376 pazjent bil-marda tal-Parkinson, f'żewġ studji li damu sitt xhur li kejlu leffetti taż-żieda ta' Comtess jew plaċebo (mediċina finta) mal-kombinazzjoni ta' levodopa u carbidopa jew levodopa u benserazide.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Comtess should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Maltese: Comtess m'għandux jintuża flimkien ma' mediċini oħra li jagħmlu parti mill-grupp ta' ‘inibituri talmonoamino ossidażi' (monoamine oxidase - tip ta' mediċina kontra d-dipressjoni).
English: What is the risk associated with Comtess?
Maltese: X'inhu r-riskju assoċjat ma' Comtess?
English: Why has Comtess been approved?
Maltese: Għaliex ġie approvat Comtess?
English: Comtess is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Maltese: Comtess jintuża biss f'kombinazzjoni jew ma' levodopa u benserazide jew ma' levodopa u carbidopa.
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Maltese: Jittieħed bħala pillola waħda ma' kull doża tal-mediċina l-oħra, sa mhux iktar minn 10 pilloli kuljum.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Comtess huma ikbar mir-riskji tiegħu meta użat bħala żieda mal-preparazzjonijiet standard ta' levodopa/benserazide jew levodopa/carbidopa għall-użu f'pazjenti bil-marda tal-Parkinson u għal tibdiliet f'daqqa fil-moviment fi tmiem id-doża, li ma jkunux jistgħu jiġu stabbiliti f'dawn ilkombinazzjonijiet.
English: How does Comtess work?
Maltese: Għal xiex jintuża Comtess?
English: Comtess is used to treat patients with Parkinson's disease.
Maltese: Comtess jintuża fit-trattament ta' pazjenti bil-marda tal-Parkinson.
English: The active substance in Comtess, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Maltese: Is-sustanza attiva f'Comtess, entacapone, taħdem billi treġġa' għan-normal il-livelli ta' dopamina fil-partijiet tal-moħħ li jikkontrollaw ilmoviment u l-ko-ordinazzjoni.
English: How has Comtess been studied?
Maltese: Kif ġie studjat Comtess?
English: In the first study, adding Comtess increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Maltese: Fl-ewwel studju, iż-żieda ta' Comtess żiedet il-ħin li jkunu ‘on' b' siegħa u 18-il minuta iktar miż-żieda tal-plaċebo.
English: For the full list of all side effects reported with Comtess, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrappurtati b'Comtess, ara l-Fuljett ta' Tagħrif.
English: What is Comtess?
Maltese: X'inhu Comtess?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtess on 16 September 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Comtess fis-16 ta' Settembru 1998.
English: of Council Directive 2001/83/EC.
Maltese: Direttiva tal-Kunsill 2001/83/KE.
English: Finland Vitabalans Oy Varastokatu 8
Maltese: Il-Finlandja Vitabalans Oy Varastokatu 8
English: The results show that the 90% confidence interval of the AUCt (0.727-0.967) and Cmax (0.727-0.945) of the test product (Loraxin) to the product Clarityn did not conform to the acceptance interval of 0.81.25.
Maltese: Ir-riżultati juru li l-intervall ta' kunfidenza ta' 90% tal-AUCt (0.727-0.967) u tas-Cmax (0.727-0.945) tal-prodott li qed jiġi ttestjat (Loraxin) mal-prodott Clarityn ma kienx konformi mal-intervall ta' aċċettazzjoni ta' 0.8-1.25.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, kompożizzjoni farmaċewtika, qawwa tal-prodott mediċinali, metodu ta' amministrazzjoni, applikant, detentur talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: • the provided data does not show that Loraxin is similar to the product used in the pivotal clinical studies described in the submitted bibliography.
Maltese: • id-dejta pprovduta ma turix li Loraxin huwa simili għall-prodott użat fl-istudji kliniċi pivotali deskritti fil-bibljografija sottomessa.
English: Loratadine was first authorised as Claritine 10mg tablet in Belgium, since 1987.
Maltese: Loratadine kien l-ewwel awtorizzat bħala Claritine 10mg pillola fil-Belġju, u ilu sa mill-1987.
English: The MAH also presented their grounds at an oral explanation on 16 October 2012.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ippreżenta wkoll ir-raġunijiet tagħhom waqt spjegazzjoni orali fis-16 ta' Ottubru 2012.
English: Loraxin 10 mg is a conventional compressed immediate release tablet with loratadine as the active substance.
Maltese: Loraxin 10 mg huwa pillola konvenzjonali kkompressata b'rilaxx immedjat b'loratadine bħala s-sustanza attiva.
English: Although the 90% confidence interval of the AUCt (0.884-1.035) and Cmax (0.822-0.989) of the metabolite desloratadine were within the acceptance interval, the CHMP considered that the pharmacokinetic data did not support the submitted bibliographic data since the evaluation of bioequivalence should in principle be based upon measured concentrations of the parent compound (in this case loratadine and not desloratadine).
Maltese: Għalkemm l-intervall ta' kunfidenza ta' 90% tal-AUCt (0.884-1.035) u tasCmax (0.822-0.989) tal-metabolit desloratadine kien fl-intervall ta' aċċettazzjoni, is-CHMP ikkunsidra li d-dejta farmakokinetika ma kinitx tappoġġa d-dejta biblijografika sottomessa peress li l-evalwazzjoni ta' bijoekwivalenza għandha fil-prinċipju tkun ibbażata fuq il-konċentrazzjonijiet imkejla tas-sustanza oriġinali (f'dan il-każ loratadine u mhux desloratadine).
English: The lower limit of detection in the analytical method used was 0.2 ng/ml, and due to this, over 50% of the plasma samples loratadine/desloratadine concentrations were below the lower limit of quantification and could not be determined.
Maltese: Il-limitu l-aktar baxx ta' skoperta fil-metodu analitiku użat kien ta' 0.2 ng/ml, u minħabba dan, aktar minn 50% tal-konċentrazzjonijiet ta' loratadine/desloratadine filkampjuni tal-plasma kienu taħt il-limitu l-aktar baxx ta' kwantifikazzjoni u ma setgħux jiġu stabbiliti.
English: • Pharmacokinetic data
Maltese: • Dejta farmakokinetika
English: The mutual recognition marketing authorisation application presented for the medicinal product Loraxin 10 mg tablets is a well-established use (WEU) application according to Article 10a of Directive 2001/83/EC.
Maltese: L-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal rikonoxximent reċiproku ppreżentata għall-prodott mediċinali Loraxin 10 mg pilloli hija applikazzjoni għall-użu stabbilit sew (WEU) skont lArtikolu 10a tad-Direttiva 2001/83/KE.
English: Following the adoption of the CHMP opinion and recommendations during the June 2012 CHMP meeting, a request for re-examination was received from the MAH Vitabalans Oy on 6 July 2012 and the detailed grounds were submitted on 31 August 2012.
Maltese: Wara l-adozzjoni tal-opinjoni tas-CHMP u r-rakkomandazzjonijiet waqt il-laqgħa tas-CHMP ta' Ġunju 2012, fis-6 ta' Lulju 2012 ġiet riċevuta talba għal eżami mill-ġdid mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq Oy Vitabalans u r-raġunijiet dettaljati ġew sottomessi fil31 ta' Awissu 2012.
English: As discussed previously a pharmacokinetic study was provided to bridge Loraxin to the published literature and the AUCt and Cmax of Loraxin to the product Clarityn did not conform to the acceptance interval of 0.8-1.25 for the parent compound, loratadine.
Maltese: Kif diskuss qabel kien ġie pprovdut studju farmakokinetiku biex jorbot lil Loraxin mar-reċensjoni ppubblikata u l-AUCt u s-Cmax ta' Loraxin mal-prodott Clarityn ma kinux konformi mal-intervall ta' aċċettazzjoni ta' 0.8-1.25 għas-sustanza oriġinali, loratadine.
English: • The Committee considered the notification of the referral triggered by Finland under Article 29(4)
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdija mill-Finlandja skont l-Artikolu 29(4) tad
English: why the applied loratadine 10 mg product would cause a potential serious risk to public health how the applied loratadine 10 mg product would cause a potential serious risk to public health
Maltese: għaliex il-prodott applikat ta' loratadine 10 mg sejjer joħloq riskju potenzjali għas-saħħa pubblika kif il-prodott applikat ta' loratadine 10 mg sejjer joħloq riskju serju potenzjali għas-saħħa pubblika
English: In these studies pharmacokinetic parameters have been studied after single dose as well as after 10 days (40 mg/day) administration of loratadine.
Maltese: F'dawn listudji, il-parametri farmakokinetiċi ġew studjati wara l-għoti ta' doża unika ta' loratadine kif ukoll wara 10 ijiem (40 mg/kuljum).
English: Loratadine is not a BCS class I (high solubility-high permeability) or III ((high solubility-low permeability) substance, which might otherwise have supported an extrapolation based on the pharmaceutical data.
Maltese: Loratadine mhuwiex sustanza tal-klassi I tal-BCS (solubbilità għolja-permeabiltà għolja) jew tal-klassi III (solubbilità għolja-permeabiltà baxxa), li kieku kien jappoġġja estrapolazzjoni bbażata fuq id-dejta farmaċewtika.
English: The MAH expressed its disagreement on some procedural aspects of the mutual recognition procedure, the CMDh procedure and the referral procedure under Article 29(4) of Directive 2001/83/EC.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq esprima n-nuqqas ta' qbil tiegħu dwar xi aspetti proċedurali tal-proċedura ta' rikonoxximent reċiproku, il-proċedura tas-CMDh u l-proċedura ta' riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE.
English: The populations studied have been healthy adult volunteers as well as children and renal impairment patients.
Maltese: Il-popolazzjonijiet studjati kienu voluntiera adulti b'saħħithom kif ukoll tfal u pazjenti b'indeboliment renali.
English: Instead, as it is a BCS class II (low solubility-high permeability) or IV (low solubility-low permeability) substance additional data would be needed to support the relevance of the bibliographic data to demonstrate efficacy and safety of Loraxin.
Maltese: Minflok, peress li huwa sustanza talklassi II tal-BCS (solubbilità baxxa-permeabiltà għolja) jew tal-klassi IV (solubbilità baxxa-permeabiltà baxxa) sejjer ikun hemm il-ħtieġa ta' dejta addizzjonali dwar is-sustanza biex tappoġġa r-rilevanza tad-dejta biblijografika li turi l-effikaċja u s-sigurtà ta' Loraxin.
English: These studies include loratadine products in several strengths from 5 mg up to 40 mg.
Maltese: Dawn l-istudji jinkludu prodotti ta' loratadine f'bosta qawwiet minn 5 mg sa 40 mg.
English: The marketing authorisation for Loraxin and associated names will have to be suspended in the reference Member State, where the product is currently authorised, until such time as adequate data is presented, which will allow a judgment to be made that in spite of the existing formulation differences, Loraxin and the products included in the literature references are considered similar, such that the data generated with these products may be considered relevant to Loraxin, and therefore address the potential serious risk to public health identified by Sweden and Poland.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq huwa mitlub jippreżenta dejta adegwata, li tippermetti li jsir ġudizzju li minkejja d-differenzi eżistenti fil-formulazzjoni, Loraxin u l-prodotti inklużi fir-referenzi tar-reċensjoni huma kkunsidrati simili, tant li d-dejta ġġenerata b'dawn il-prodotti tista' tiġi kkunsidrata rilevanti għal Loraxin.
English: More importantly, the sensitivity of the assay was considered to be insufficient to detect low concentrations of the parent compound (and the main metabolite desloratadine).
Maltese: Aktar importanti minn hekk, is-sensittività talanaliżi kienet meqjusa bħala insuffiċjenti biex tiskopri konċentrazzjonijiet baxxi tas-sustanza oriġinali (u l-metabolit prinċipali desloratadine).
English: This study was a two period cross-over bioequivalence study with only 40 subjects (in total 80 separate drug intake events).
Maltese: Dan l-istudju kien studju cross-over ta' bijoekwivalenza fuq żewġ perjodi b'40 suġġett biss (total ta' 80 avveniment separat tat-teħid talmediċina).
English: The use of loratidine is wide in clinical practice and a number of published papers have been submitted in support of efficacy and safety.
Maltese: L-użu ta' loratidine fil-prattika klinika huwa wiesgħa u għadd ta' dokumenti ppubblikati ġew sottomessi b'sostenn tal-effikaċja u s-sigurtà.
English: Furthermore, there were extensive inter-subject variabilities in the absorption parameters of loratadine.
Maltese: Barra minn hekk, kien hemm varjabilitajiet estensivi bejn is-suġġetti fil-parametri ta' assorbiment ta' loratadine.
English: The report of a pharmacokinetic study (Report V-808) submitted by the MAH in support of the marketing authorisation application was considered by the CHMP, since the inclusion of pharmacokinetic data in support of a well-established use application could be considered, if it is intended to show the relevance of the literature used to demonstrate safety and efficacy as regards the product concerned.
Maltese: Ir-rapport ta' studju farmakokinetiku (Rapport V-808) sottomess mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq b'appoġġ għall-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq ġie kkunsidrat mis-CHMP, peress li l-inklużjoni ta' dejta farmakokinetika b'appoġġ għal applikazzjoni għall użu stabbilit sew tista' tiġi kkunsidrata, jekk hija maħsuba biex turi r-rilevanza tar-reċensjoni użatabiex turi s-sigurtà u l-effikaċja fir-rigward tal-prodott ikkonċernat.
English: On the basis of the bibliographic data submitted, taken together with the pharmaceutical, pharmacokinetic and clinical documentation, the MAH failed to establish the relevance of these data to demonstrate safety and efficacy of Loraxin.
Maltese: Abbażi tad-dejta biblijografika sottomessa, meħuda flimkien mad-dokumentazzjoni farmaċewtika, farmakokinetika u klinika, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq naqas milli jistabbilixxi r-rilevanza ta' din id-dejta biex juri s-sigurtà u l-effikaċja ta' Loraxin.
English: In order to show the relevance of the bibliographic data used in support of the application for Loraxin, the MAH referred to pharmaceutical, pharmacokinetic and clinical data.
Maltese: Biex juri r-rilevanza tad-dejta biblijografika użata b'appoġġ għall-applikazzjoni għal Loraxin, iddetentur tal-awtorizzazzjoni għat-tqegħid fis-suq irrefera għad-dejta farmaċewtika, farmakokinetika u klinika.