FrancophonIA/ELRC3.0 huggingface dataset:
English: For preparation and intravitreal injection the following medical devices for single use are needed: - a 5 µm filter needle (18G) - a 1 ml sterile syringe (including a 0.05 ml mark) and an injection needle (30G x ½″), for adult patients - a low volume high accuracy sterile syringe, provided together with an injection needle
Maltese: Biex wieħed iħejji ruħu u anke għall-injezzjoni fil-vitriju hemm bżonn tat-tagħmir mediku li ġej u li jista' jintuża darba biss: - labra b'filtru ta' 5 µm (18G) - siringa sterili ta' 1 ml (li tinkludi l-marka ta' 0.05 ml) u labra tal-injezzjoni (30G x ½″), għall pazjenti adulti - siringa b'volum baxx mill-aktar preċiża, ipprovduta flimkien mal-labra tal-injezzjoni
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: Reduction in CSFT
Maltese: Tnaqqis fis-CSFT
English: In the posterior segment, there were vitreal cell infiltration and floaters, which also tended to be dose-dependent and generally persisted to the end of the treatment period.
Maltese: Fis-segment posterjuri, kien hemm infiltrazzjoni ta' ċelluli fil-vitriju u ħjut, li wkoll kellhom tendenza li jkunu jiddependu mid-doża u li ġeneralment baqgħu sa' tmiem il-perijodu tal-kura.
English: In patients with CRVO (CRUISE and extension study HORIZON): Subjects treated with sham in the first 6 months who subsequently received ranibizumab did not achieve comparable gains in VA by Month 24 (~6 letters) compared to subjects treated with ranibizumab from study start (~12 letters).
Maltese: Pazjenti ttrattati b'sham matul lewwel 6 xhur li wara ngħataw ranibizumab ma kisbux kisbiet komparabbli fil-VA sa Xahar 24 (~6 ittri) meta mqabbla ma' pazjenti ttrattati b'ranibizumab sa mill-bidu tal-istudju (~12-il ittra).
English: Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper.
Maltese: Pakkett li fih kunjett wieħed tal-ħġieġ b'ranibizumab b'tapp tal-lastku chlorobutyl.
English: The injection needle should be inserted into the eye 1.0 to 2.0 mm posterior to the limbus, with the needle pointing towards the optic nerve.
Maltese: Il-labra tal-injezzjoni għandha tiddaħħal fl-għajn bejn 1.0 sa 2.0 mm wara l-limbus, bil-ponta tal-labra tħares lejn in-nerv ottiku.
English: The efficacy and safety of Lucentis have been assessed in three randomised, controlled studies of at least 12 months duration.
Maltese: L-effikaċja u s-sigurtà ta' Lucentis kienu evalwati fi tliet studji randomizzati u kkontrollati għal millinqas 12-il xahar.
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Maltese: Il-proċedura tal-injezzjoni għandha ssir taħt kundizzjonijiet asettiċi, li tinkludi l-ħasil tal-idejn b'disinfettant għall-kirurġija, ingwanti sterili, kesa sterili u spekulum sterili ta' tebqet il-għajn (jew ekwivalenti) u li jkun hemm disponibbli paraċenteżi sterili (jekk ikun hemm bżonn).
English: For preparation and intravitreal injection the following medical devices for single use are needed: - a 5 µm filter needle (18G) - a 1 ml sterile syringe (including a 0.05 ml mark) - an injection needle (30G x ½″).
Maltese: Biex wieħed iħejji ruħu u anke għall-injezzjoni fil-vitriju hemm bżonn tat-tagħmir mediku li ġej u li jista' jintuża darba biss: - labra b'filtru ta' 5 µm (18G) - siringa sterili ta' 1 ml (li tinkludi l-marka ta' 0.05 ml) - labra għall-injezzjoni (30G x ½″).
English: Lucentis and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of Lucentis and verteporfin.
Maltese: Lucentis m'għandux jingħata fl-istess ħin ma' prodotti mediċinali oħra kontra l-VEGF (sistemiċi jew okulari).
English: There are no data available on fertility.
Maltese: Ma hemm l-ebda dejta disponibbli dwar il-fertilità.
English: For the primary endpoint the pre-specified significance level for the one-sided p-value was 0.025.
Maltese: Għall-endpoint primarju l-livell ta' sinjifikat prespeċifikat għall-valur-p minn naħa waħda kien ta' 0.025.
English: For preparation and intravitreal injection the following medical devices for single use are needed: - a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided) - a low volume high accuracy sterile syringe (supplied separately inside the VISISURE kit) - an injection needle (30G x ½″) (supplied separately inside the VISISURE kit)
Maltese: Biex wieħed iħejji ruħu u anke għall-injezzjoni fil-vitriju hemm bżonn tat-tagħmir mediku li ġej u li jista' jintuża darba biss: - labra b'filtru ta' 5 µm (18G x 1½″, 1.2 mm x 40 mm, ipprovduta) - siringa b'volum baxx mill-aktar preċiża (ipprovduta separatament fuq ġewwa tal-kit
English: The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Maltese: Id-doża ta' Lucentis rrakkomandata hija ta' 0.5 mg mogħtija bħala injezzjoni singola ġol-vitriju.
English: (letters)
Maltese: (ANCHOR)
English: For preterm infants the recommended dose for Lucentis is 0.2 mg given as a single intravitreal injection.
Maltese: Fil-każ ta' trabi mwielda qabel iż-żmien id-doża rrakkommandata ta' Lucentis hi ta' 0.2 mg bħala injezzjoni intravitreali singola.
English: DRSS = diabetic retinopathy severity score, n = number of patients who satisfied the condition at the visit, N = total number of study eyes.
Maltese: DRSS = punteġġ fil-gravità tar-retinopatija dijabetika, n = għadd ta' pazjenti li ssodisfaw il-kundizzjoni dakinhar tal-vista, N = l-għadd totali ta' għajnejn fl-istudju.
English: VIAL + FILTER NEEDLE
Maltese: Pakkett b'kunjett +labra b'filtru
English: Hepatic impairment
Maltese: Nażofarinġite
English: Following intravitreal administration of Lucentis to preterm infants with ROP at a dose of 0.2 mg (per eye), serum ranibizumab concentrations were higher than those observed in neovascular AMD adult patients receiving 0.5 mg in one eye. Based on a population pharmacokinetic analysis, the differences in Cmax and AUCinf were approximately 16-fold and 12-fold higher, respectively.
Maltese: Skont analiżi talfarmakokinetiċi tal-popolazzjoni, id-differenzi fis-Cmax u l-AUCinf kienu ta' madwar 16-il darba u 12-il darba ogħla, rispettivament.
English: Figure 6 Mean change from baseline BCVA over time to Month 6 and Month 12 (CRUISE)
Maltese: Il-bidla medja minn BCVA tal-linja bażi maż-żmien sa Xahar 6 u Xahar 12 (CRUISE)
English: Prepare
Maltese: Introduzzjoni
English: For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
Maltese: Fil-każ ta' CNV sekondarja għal mijopija patoloġika (PM), ħafna pazjenti jaf ikollhom bżonn ta' injezzjoni waħda jew tnejn biss matul l-ewwel sena (ara sezzjoni 5.1).
English: Note: The dose must be set to 0.05 ml.
Maltese: Nota: Issettja d-doża għal 0.05 ml.
English: Figure 4 Mean change in visual acuity from baseline over time in study D2301 (RESTORE)
Maltese: Kejl tar-riżultat f'Xahar 12 meta mqabbel mal-linja bażi fl-istudju D2301 (RESTORE)
English: BRIGHTER was a 3-arm randomised active-controlled study that compared 0.5 mg ranibizumab given as monotherapy or in combination with adjunctive laser photocoagulation to laser photocoagulation alone.
Maltese: BRIGHTER kien studju kkontrollat blattiv randomizzat mifrux fuq 3 gruppi li qabbel 0.5 mg ranibizumab mogħtija bħala monoterapija jew flimkien ma' fotokoagulazzjoni bil-lejżer ma' fotokoagulazzjoni bil-lejżer waħidha.
English: Urinary tract infection*
Maltese: Infezzjoni fl-apparat tal-awrina*
English: Most patients (78%) in the clinical study received one injection per eye.
Maltese: Bosta pazjenti (78%) fl-istudju kliniku mwettaq ngħataw injezzjoni waħda f'kull għajn.
English: B. PACKAGE LEAFLET
Maltese: Trattament b'suċċess
English: This corresponds to an injection volume of 0.05 ml.
Maltese: Dan jikkorrispondi għal volum ta' injezzjoni ta' 0.05 ml.
English: In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV.
Maltese: Meta jkun hemm iż-żejjed, VEGF-A jikkawża tkabbir mhux normali tal-arterji tad-demm u nefħa fl-għan li tista' twassal għal indeboliment tal-vista f'mard bħal AMD, DME, PDR, RVO, PM u CNV.
English: In BRIGHTER, ranibizumab 0.5 mg with adjunctive laser therapy demonstrated non-inferiority versus ranibizumab monotherapy from baseline to Month 24 (95% CI -2.8, 1.4).
Maltese: Il-biċċa l-kbira tal-pazjenti ttrattati b'ranibizumab 0.2 mg (78.1%) ingħataw injezzjoni waħda f'kull għajn.
English: What Lucentis looks like and contents of the pack Lucentis is a solution for injection in a vial (0.23 ml).
Maltese: Lucentis huwa soluzzjoni għall-injezzjoni f'kunjett (0.23 ml).
English: This summary was last updated in 08-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2010.
English: B.V. can be started between a few days and 35 days after the attack;
Maltese: B.V jista' jinbeda bejn ftit jiem sa 35 jum wara l-attakk;
English: The full EPAR for Clopidogrel Teva Generics B.V. can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Clopidogrel Teva Generics B.V. jista' jinstab fis-sit elettroniku tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Clopidogrel Teva Generics B.V. is a ‘generic medicine'.
Maltese: Clopidogrel Teva Generics B.V. huwa ‘mediċina ġenerika'.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Maltese: Imbagħad, ilkura tkompli bid-doża standard ta' 75 mg darba kuljum għal mill-inqas erba' ġimgħat (f'infart mijokardijaku b'elevazzjoni tas-segment ST) jew għal sa 12-il xahar (fis-sindromu mingħajr elevazzjoni tas-segment ST).
English: This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva Generics B.V.
Maltese: Dan id-dokument huwa sommarju tar-rapport ta' valutazzjoni pubblika Ewropew (EPAR) għal Clopidogrel Teva Generics B.V.
English: The active substance in Clopidogrel Teva Generics B.V., clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Teva Generics B.V., clopidogrel, hija inibitur tal-għaqid tal-plejtlits.
English: This means that Clopidogrel Teva Generics B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel Teva Generics B.V. huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) u msejħa Plavix.
English: Clopidogrel Teva Generics B.V. is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Teva Generics B.V. huwa prodott mediċinali li fih is-sustanza attiva clopidogrel.
English: Clopidogrel Teva Generics B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Teva Generics B.V. jintuża fl-adulti għall-prevenzjoni ta' avvenimenti aterotrombotiċi (problemi kkawżati minn emboli tad-demm u twebbis tal-arterji). Clopidogrel Teva Generics B.V. jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: • pazjenti li għandhom kundizzjoni magħrufa bħala ‘sindromu koronarju akut', meta għandu jingħata mal-aspirina (mediċina oħra li tipprevjeni l-emboli), inklużi pazjenti li kellhom stent imdaħħal (tubu qasir imqiegħed f'arterja biex ma jħallihiex tingħalaq).
English: In acute coronary syndrome, Clopidogrel Teva Generics B.V. is used together with aspirin and treatment generally starts with a loading dose of four tablets.
Maltese: Fis-sindromu koronarju akut, Clopidogrel Teva Generics B.V. jintuża flimkien mal-aspirina u l-kura ġeneralment tinbeda b'doża ta' inizjazzjoni ta' erba' pilloli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Generics B.V. to Teva Generics B.V. on 28 October 2010.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Clopidogrel Teva Generics B.V. lil Teva Generics B.V. fl-28 ta' Ottubru 2010.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Generics B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP ikkonkluda li, skont il-ħtiġijiet tal-UE, Clopidogrel Teva Generics B.V. intwera li għandu kwalità komparabbli u huwa bijoekwlvalenti għal Plavix.
English: What are the benefit and risk of Clopidogrel Teva Generics B.V.?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Clopidogrel Teva Generics B.V.?
English: Clopidogrel Teva Generics B.V. can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Maltese: Clopidogrel Teva Generics B.V. jista' jintuża f'pazjenti li kellhom attakk tal-qalb b'‘elevazzjoni tas-segment ST' (qari mhux normali fuq ECG jew elettrokardjogramma) meta t-tabib jaħseb li jibbenefikaw mit-trattament.
English: Because Clopidogrel Teva Generics B.V. is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Minħabba li Clopidogrel Teva Generics B.V. hija mediċina ġenerika, studji f'pazjenti ġew limitati għal li jiddeterminaw li hija bijoekwovalenti għall-mediċina ta' referenza, Plavix.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Maltese: Dan iwaqqaf lill-plejtlits milli jsiru ‘jwaħħlu', inaqqas ir-riskju ta' formazzjoni ta' emboli fiddemm u jgħin fil-prevenzjoni ta' attakk tal-qalb jew puplesija oħra.
English: Because Clopidogrel Teva Generics B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Clopidogrel Teva Generics B.V. hija mediċina ġenerika u hija bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tagħha jitqiesu bħala l-istess bħal dawk tal-mediċina ta' referenza.
English: • patients who have recently had a myocardial infarction (heart attack).
Maltese: • pazjenti li riċentament kellhom infart mijokardijaku (attakk tal-qalb). Clopidogrel Teva Generics
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Maltese: Jista' jintuża wkoll f'pazjenti li ma għandhomx dan il-qari mhux normali fuq l-ECG, jekk ikollhom anġina instabbli (tip serju ta' uġigħ fis-sider) jew kellhom infart mijokardijaku ‘non-Q-wave'.
English: Other information about Clopidogrel Teva Generics B.V.:
Maltese: Tagħrif ieħor dwar Clopidogrel Teva Generics B.V.:
English: Clopidogrel Teva Generics B.V. is converted into its active form in the body.
Maltese: Clopdogrel Teva Generics B.V. jinqeleb għall-forma attiva tiegħu fil-ġisem.
English: Ref. EMEA/CHMP/335293/2009 EMEA/H/A-30/1000
Maltese: EMEA/CHMP/356536/2009 EMEA/H/A-30/1000
English: Dr Alar Irs (Estonia)
Maltese: Alar Irs (Estonja)
English: Dr Liv Mathiesen (Norway)
Maltese: Dott. Liv Mathiesen (Norveġja)
English: London, 28 May 2009 Doc.
Maltese: Londra, 28 ta' Mejju 2009 Dok. ta' ref.
English: June 2008
Maltese: Ġunju 2008
English: Second and third trimester of pregnancy (section 4.4 and 4.6).
Maltese: It-tieni u t-tielet trimestru ta' tqala (sezzjoni 4.4 u 4.6).
English: Diovan Comp is used to treat patients with hypertension (high blood pressure), and is also available in the EU under other trade names: Co-Angiosan, Co-Angiosane, Co-Dalzad, Co-Diovan, Co-Diovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus, and Valsartan/Hydroklortiazide.
Maltese: Diovan Comp jintuża fit-trattament ta' pazjenti b'ipertensjoni (pressjoni għolja tad-demm), u huwa wkoll disponibbli fl-UE taħt ismijiet kummerċjali oħra: Co-Angiosan, Co-Angiosane, Co-Dalzad, CoDiovan, Co-Diovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus, u Valsartan/Hydroklortiazide.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: 1 Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza fuq il-bażi ta' deċiżjonijiet differenti adottati mill-Istati membri
English: Severe renal impairment (creatinine clearance <30 ml/min), anuria.
Maltese: Indeboliment renali gravi (tneħħija tal-kreatinina <30 ml/min), anurja.
English: Diovan Comp contains two active substances, valsartan and hydrochlorothiazide.
Maltese: Diovan Comp fih żewġ sustanzi attivi, valsartan u hydrochlorothiazide.
English: What is Diovan Comp?
Maltese: X'inhu Diovan Comp?
English: Questions and answers on the referral for Diovan Comp and associated names tablets containing valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg)
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għall-pilloli Diovan Comp u ismijiet assoċjati li fihom valsartan (80, 160 jew 320 mg) u hydrochlorothiazide (12.5 jew 25 mg)
English: Company responses provided on: 27 October 2008, 16 February 2009 Opinion date:
Maltese: 27 ta' Ottubru 2008, 16 ta' Frar 2009
English: The CHMP harmonised the SPC section on special warnings and included warnings about photosensitivity and problems with the function of the parathyroid glands in patients taking ‘thiazide' diuretics such as hydrochlorothiazide.
Maltese: Is-CHMP armonizza s-sezzjoni tal-SPC dwar it-twissijiet speċjali u inkluda twissijiet dwar ilfotosensittività u problemi li jirrigwardaw il-funzjoni tal-glandoli paratirojdali f'pazjenti li jieħdu dijuretiċi ‘thiazide' bħal hydrochlorothiazide.
English: Why was Diovan Comp reviewed?
Maltese: Għaliex ġie rivedut Diovan Comp?
English: Severe hepatic impairment, biliary cirrhosis and cholestasis.
Maltese: Indeboliment epatiku gravi, ċirrożi biljari u kolestażi.
English: The CHMP agreed on a harmonised indication (the disease for which the medicine may be used): “Treatment of essential hypertension in adults.
Maltese: Is-CHMP qabel fuq indikazzjoni armonizzata (il-marda li għaliha tista' tintuża l-mediċina): “Trattament ipertensjoni essenzjali fl-adulti.
English: Diovan Comp was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Il-Grupp ta' Koordinament dwar il-Proċeduri Reċiproċi u Deċentralizzati - Bniedem (CMD(h)) identifika lħtieġa ta' armonizzazzjoni ta' Diovan Comp.
English: The European Medicines Agency (EMEA) has completed a review of Diovan Comp and associated names.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) lestiet ir-reviżjoni ta' Diovan Comp u ismijiet assoċjati.
English: Valsartan works by blocking the effect of angiotensin II.
Maltese: Valsartan jaħdem billi jimblokka l-effett talanġjotensina II.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan Comp in the European Union (EU) and the European Economic Area (EEA).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li jeħtieġ li l-informazzjoni tal-preskrizzjoni għal Diovan Comp tkun armonizzata fl-Unjoni Ewropea (UE) u fiż-Żona Ekonomika Ewropea (ŻEE).
English: The CHMP discussed the use of Diovan Comp in patients previously treated with other angiotensin II receptor antagonists and agreed that the switch to Diovan Comp should only be for patients previously treated with valsartan.
Maltese: Is-CHMP ddiskuta kif Diovan Comp, li huwa kombinazzjoni ta' dożi fissi ta' żewġ sustanzi attivi, għandu jiġi introdott fit-trattament ta' pazjenti li l-ipertensjoni tagħhom mhijiex ikkontrollata b'xi waħda mis-sustanzi attivi użati f'monoterapija.
English: Diovan Comp fixed-dose combination is indicated in
Maltese: Diovan Comp u ismijiet assoċjati huma awtorizzati fl-UE permezz ta' proċeduri nazzjonali.
English: The contraindications removed were: hepatic encephalopathy, biliary obstruction, gout and Addison's disease.
Maltese: Ilkontraindikazzjonijiet li tneħħew kienu: enċefalopatija epatika, ostruzzjoni biljari, gotta u marda ta' Addison.
English: Hydrochlorothiazide is a diuretic.
Maltese: L-anġjotensina
English: Local irritation potential
Maltese: Potenzjal ta' irritazzjoni lokali
English: Following the approach of Kuss (Kuss O: How to use SAS for logistic regression with correlated data.
Maltese: Billi segwa l-approċċ ta' Kuss (Kuss O: How to use SAS for logistic regression with correlated data.
English: The reference medicinal product is Dorogesic 25 - 100 µg/h, (MAH Janssen-Cilag, Neuss, Germany).
Maltese: Il-prodott mediċinali ta' referenza huwa Dorogesic 25 - 100 µg/siegħa, (MAH JanssenCilag, Neuss, il-Ġermanja).
English: Single dose: OR estimate: 5.67, 95 % CI [1.12; 28.78] p = 0.0371 Multiple dose: OR estimate: 1.41, 95 % CI [0.97; 2.05] p = 0.0716
Maltese: 0371 Doża multipla: stima OR: 1.41, 95 % CI [0.97; 2.05] p = 0.0716
English: The legal basis for this application refers to: Article 10(1) of Directive 2001/83/EC, as amended.
Maltese: Il-bażi ġuridika għal din l-applikazzjoni tirreferi għal: l-Artikolu 10(1) tad-Direttiva 2001/83/KE, kif emendata.
English: It is an accepted clinical reality that for transdermal therapy a skin irritation score of 1 is common and without further clinical relevance.
Maltese: Hija realtà klinika aċċettata li għat-terapija transdermika, punteġġ ta' irritazzjoni tal-ġilda ta' 1 huwa komuni u mingħajr rilevanza klinika oħra.
English: Fentanyl is 75-100 times more potent than parenteral morphine.
Maltese: Fentanyl huwa 75-100 darba aktar qawwi minn morfina parenterali.
English: SAS User Group International (SUGI) Conference Proceedings 27, Paper 261-27 (2002)), the Applicant recalculated the logistic mixed model using the SAS Procedure NLMIXED (SAS Version 9.1.3).
Maltese: SAS User Group International (SUGI) Conference Proceedings 27, Paper 261-27 (2002)), l-Applikant reġa' kkalkula l-mudell loġistiku mħallat bl-użu tal-Proċedura tal-SAS NLMIXED (Verżjoni SAS 9.1.3). L-għażla tal-punt finali binarju (“reazzjoni tal-ġilda > 1”) kienet tinkludi trattament (test vs. referenza) u osservazzjoni (f'sigħat mill-ewwel amministrazzjoni) bħala varjabbli ta' spjegazzjoni fissi u effett random fuq il-pazjent.
English: In the statistical analysis performed by the objecting CMS, only a small percentage of incidences of skin irritations, calculated as 3.28 % (SD)/8.46%(MD) for the Fentrix patch and 0.64 % (SD)/5.93%(MD) for the reference patch, have been included to evaluate the comparability of the safety profile.
Maltese: 46%(MD) għall-istikk ta' Fentrix u 0.64% (SD)/5.93%(MD) għall-istikk ta' referenza, ġew inklużi biex tiġi evalwata lkomparabbiltà tal-profil ta' sigurtà.
English: However, the predominant constituents of the patch - mainly two of the adhesives, were not found to be sensitive to the skin of guinea pigs when tested alone according to guidelines CPMP/SWP/2145/00 and OECD 406 (Buehler method).
Maltese: Madankollu, il-kostitwenti predominanti tal-istikk - prinċipalment tnejn mill-adeżivi, ma nstabux li kienu sensittivi għall-ġilda tal-fniek tal-Indi meta ġew ittestjati waħedhom skont il-linji gwida CPMP/SWP/2145/00 u OECD 406 (metodu Buehler).