FrancophonIA/ELRC3.0 huggingface dataset:
English: Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection.
Maltese: B'mod komuni tista' sseħħ żieda żgħira fit-temperatura tal-ġisem (massimu ta' 1.7°C) wara l-injezzjoni.
English: Active substances:
Maltese: TAS-SUSTANZA ATTIVA
English: 21 days after vaccination Duration of immunity: 105 days after vaccination
Maltese: Bidu tal-immunità: 21 jum wara l-vaċċin Tul tal-immunità: 105 jum wara l-vaċċin
English: Shelf life after first opening the container: 24 hours (store at 2 °C - 8 °C).
Maltese: Ladarba jinfetaħ uża fi żmien 24 siegħa (aħżen f'temperatura ta' 2°C - 8°C).
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lot:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/002 PET bottle
Maltese: EU/2/13/149/002 flixkun PET li jkun
English: Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).
Maltese: Kaxxa tal-kartun bi flixkun PET li jkun fih 50 doża (50 ml) jew 100 doża (100 ml).
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 24 hours Between the withdrawals, the vaccine should be stored at 2 °C - 8 °C.
Maltese: Bejn il-ġbid talmediċina permezz tas-siringa minn ġol-kunjett, il-vaċċin għandu jinħażen f'temperatura ta' 2°C - 8°C.
English: ADVICE ON CORRECT ADMINISTRATION It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Maltese: Hu rakkomandat li tuża labra li tkun adattata għall-età tal-qżieqeż (daqs ippreferut ta' 21G u tul ta'
English: Duration of immunity: 105 days after vaccination 4.3 Contraindications
Maltese: Bidu tal-immunità: 21 jum wara l-vaċċinazzjoni Tul tal-immunità: 105 jum wara l-vaċċinazzjoni
English: PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
Maltese: Flixkun PET li jkun fih 50 ml jew 100 ml, magħluq b'tapp tal-lastku tal-bromobutyl u ssiġillat b'għatu tal-aluminju li jista' jitqaċċat.
English: max. 3.5 mg
Maltese: 16 mm).
English: Adjuvant: Aluminium (as hydroxide)
Maltese: INDIKAZZJONI(JIET)
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għall-ingredjent attiv, għas-sustanza mhux attiva jew kwalunkwe ingredjent ieħor.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (with PET bottle of 50 ml or 100 ml)
Maltese: Kaxxa tal-kartun (bi flixkun PET li jkun fih 50 ml jew 100 ml)
English: Only vaccinate healthy animals.
Maltese: kwalunkwe prodott mediċinali veterinarju ieħor.
English: Between the withdrawals the vaccine should be stored at 2 °C - 8 °C.
Maltese: Bejn il-ġbid tal-mediċina permezz tas-siringa minn ġol-kunjett, il-vaċċin għandu jinħażen f'temperatura ta' 2°C - 8°C.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħrajn u forom oħra ta' interazzjoni:
English: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf substance between the two medicinal products may differ.
Maltese: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf
English: • The CHMP reviewed available data and information provided by the MAHs/applicants, as well as information provided by Semler Research Centre Private Ltd;
Maltese: • Is-CHMP irrieżamina d-data u l-informazzjoni disponibbli pprovduta mill-MAHs/mill-applikanti, kif ukoll l-informazzjoni pprovduta minn Semler Research Centre Private Ltd;
English: Between 29 September 2015 and 9 October 2015, the United States Food and Drug Administration (FDA) performed a Good Clinical Practice (GCP) inspection at the bioanalytical facility Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore - 560 078 India.
Maltese: Bejn id-29 ta' Settembru 2015 u d-9 ta' Ottubru 2015, l-Amministrazzjoni tal-ikel u l-Pilloli (Food and Drug Administration (FDA)) tal-Istati Uniti għamlet spezzjoni tal-Prattika Klinika Tajba (PKT) fil-faċilità bijoanalitika Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore560 078 India.
English: The World Health Organisation (WHO) also inspected the same bioanalytical facility and the Semler clinical facility located at PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India between 27 and 31 January 2015, and performed a follow-up inspection between 2 and 5 December 2015 to verify compliance with GLP and GCP.
Maltese: Bejn is-27 u l-31 ta' Jannar 2015, l-Organizzazzjoni Dinjija tas-Saħħa (WHO) spezzjonat l-istess faċilità bijoanalitika kif ukoll il-faċilità klinika ta' Semler li tinsab PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India, u bejn it-2 u l-5 ta' Diċembru 2015 għamlet spezzjoni ta' segwitu sabiex tivverifika l-konformità mal-GLP u l-GCP.
English: Alternative data were submitted to demonstrate the bioequivalence of abacavir/lamivudine-containing medicinal products to an EU reference medicinal product.
Maltese: Ġiet ippreżentata data alternattiva sabiex turi l-bijoekwivalenza ta' prodotti mediċinali li fihom labakavir/il-lamivudina għal prodott mediċinali ta' referenza tal-UE.
English: The inspection found significant instances of misconduct, including the substitution and manipulation of study subject samples.
Maltese: L-ispezzjoni sabet każijiet serji ta' kondotta ħażina, inklużi s-sostituzzjoni u l-manipulazzjoni talkampjuni soġġetti tal-istudji.
English: A number of corrective and preventive actions (CAPA) are proposed or have already been already implemented to address the findings of the FDA and WHO inspections.
Maltese: Huma proposti jew diġà ġew implimentati diversi azzjonijiet korrettivi u preventivi (CAPA) sabiex jiġu indirizzati s-sejbiet talispezzjonijiet tal-FDA u d-WHO.
English: The findings of the FDA and WHO inspections raise serious concerns relating to the suitability of the quality management system in place at the Semler JP Nagar and Sakar Nagar sites.
Maltese: Is-sejbiet tal-ispezzjonijiet tal-FDA u d-WHO jqajmu tħassib serju dwar l-idoneità tas-sistema ta' ġestjoni tal-kwalità stabbilita fis-siti ta' Semler JP Nagar u Sakar Nagar.
English: Data from all bioequivalence studies performed at Semler Research Private Limited in Bangalore India and submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Maltese: Id-data mill-istudji kollha talbijoekwivalenza mwettqin f'Semler Research Private Limited f'Bangalore, l-Indja, u sottomessa lillAwtoritajiet Kompetenti sabiex tintwera l-bijoekwivalenza tal-prodotti mediċinali mal-oriġinatur hija meqjusa bħala mhux affidabbli.
English: • The CHMP concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
Maltese: • Għal ċerti prodotti, jista' jkun hemm disponibbli riżultati mid-data dwar il-bijoekwivalenza blużu ta' Prodotti Mediċinali ta' Referenza mhux tal-UE.
English: • Pharmacovigilance data on specific products included in this procedure have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Maltese: • Id-data dwar il-farmakoviġilanza rigward prodotti speċifiċi inklużi f'din il-proċedura ma indikat l-ebda problema li setgħet tiġi attribwita għan-nuqqas ta' bijoekwivalenza, bħat-tnaqqis fleffikaċja jew it-taħżin fis-sigurtà u t-tollerabbiltà.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Semler, Bangalore, India;
Maltese: • Is-CHMP ikkunsidra l-proċedura taħt l-Artikolu 31 tad-Direttiva 2001/83/KE għallawtorizzazzjonijiet għat-tqegħid fis-suq u għall-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali li għalihom il-partijiet kliniċi u/jew bijoanalitiċi tal-istudji twettqu f'Semler, Balgalore, l-Indja;
English: In view of the findings described above and the necessity to protect public health in the EU, the United Kingdom, Germany, Spain, the Netherlands and Denmark considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites and also that of pending marketing authorisation applications (MAA).
Maltese: Fid-dawl tas-sejbiet deskritti hawn fuq u l-ħtieġa li tkun protetta s-saħħa pubblika fl-UE, ir-Renju Unit, il-Ġermanja, Spanja, in-Netherlands u d-Danimarka qiesu li huwa fl-interess tal-Unjoni li l-kwistjoni tiġi riferuta lis-CHMP, u li dan jintalab jivvaluta l-impatt tas-sejbiet imsemmijin hawn fuq, fuq il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li ġew awtorizzati mill-Istati Membri fuq il-bażi tal-provi kliniċi rilevanti mwettqin f'dawn is-siti kif ukoll dak tal-applikazzjonijiet pendenti għall-awtorizzazzjoni għat-tqegħid fis-suq (MAA).
English: If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects.
Maltese: Jekk il-bijodisponibilità tal-prodott hija ogħla mill-bijodisponibilità tal-prodott mediċinali ta' referenza, din tista' tirriżulta għal esponiment ogħla milli intiż tal-pazjenti għas-sustanza attiva, li potenzjalment iwassal għal żieda fl-inċidenza jew fis-severità tal-effetti avversi.
English: − Authorised medicinal products and marketing authorisation applications for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
Maltese: − Prodotti mediċinali awtorizzati u applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq li għalihom ġiet ippreżentata data ta' bijoekwivalenza alternattiva jew ġustifikazzjoni iżda din tqieset bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward talprodott mediċinali ta' referenza tal-UE (anness IB);
English: b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
Maltese: L-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq li għalihom id-data ta' bijoekwivalenza jew il-ġustifikazzjoni ma kinux ippreżentati jew tqiesu bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE (anness IB) ma jissodisfawx il-kriterji għall-awtorizzazzjoni, billi d-dettalji li jappoġġjaw lawtorizzazzjonijiet għat-tqegħid fis-suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u r riskju ta' dawn l-awtorizzazzjonijiet għat-tqegħid fis-suq mhuwiex favorevoli skont l-Artikolu 26tad-Direttiva 2001/83/KE.
English: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisations is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li għalihom id-data ta' bijoekwivalenza jew il-ġustifikazzjoni ma kinux ippreżentati jew tqiesu bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE (anness IB) għandhom jiġu sospiżi, billi d-dettalji li jappoġġjaw l-awtorizzazzjonijiet għat-tqegħid fis-suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u r-riskju ta' dawn lawtorizzazzjonijiet għat-tqegħid fis-suq mhuwiex meqjus favorevoli skont l-Artikolu 116 tadDirettiva 2001/83/KE.
English: In their own investigation and analysis of the studies concerned by the FDA inspection, and also in their investigation for similar anomalies or patterns in other studies, Semler found no conclusive evidence of inappropriate data manipulation, substitution or dilution.
Maltese: Fl-investigazzjoni u fl-analiżi tagħha stess tal-istudji kkonċernati mill-ispezzjoni tal-FDA, u anki flinvestigazzjoni tagħha għal anomaliji jew xejriet simili fi studji oħrajn, Semler ma sabet ebda evidenza konklużiva ta' manipulazzjoni, sostituzzjoni jew dilwizzjoni skorretta tad-data.
English: However, pharmacovigilance activities may lack the ability to detect a signal with regard to efficacy or safety and tolerability, therefore CHMP is of the opinion that the absence of any pharmacovigilance signal does not offer sufficient reassurance to conclude on a positive benefit-risk balance in the absence of the demonstration of bioequivalence with the EU reference medicinal product.
Maltese: Madankollu, l-attivitajiet tal-farmakoviġilanza jistgħu jkunu neqsin mill-ħila li jidentifikaw sinjal fir-rigward tal-effikaċja jew is-sigurtà u ttollerabbiltà, u għalhekk is-CHMP huwa tal-fehma li n-nuqqas ta' kwalunkwe sinjal talfarmakoviġilanza ma joffrix garanzija biżżejjed sabiex tinħareġ konklużjoni dwar il-bilanċ bejn il-benefiċċju u r-riskju fin-nuqqas ta' wiri ta' bijoekwivalenza mal-prodott mediċinali ta' referenza tal-UE.
English: Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for abacavir/lamivudinecontaining medicinal products (annex IA) and concludes that, with regards to marketing authorisation applications for abacavir/lamivudine-containing medicinal products, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data.
Maltese: Xi wħud minn dawn il-prodotti mediċinali awtorizzati jistgħu jkunu kkunsidrati bħala kritiċi millIstati Membri individwali tal-UE dwar l-evalwazzjoni tal-ħtieġa medika potenzjali mhux issodisfata, meta jitqiesu d-disponibbiltà ta' prodotti mediċinali alternattivi xierqa fl-Istat(i) Membru/i rispettiv(i) tal-UE u, kif ikun xieraq, in-natura tal-marda li trid tiġi kkurata.
English: Under Article 10(1) of Directive 2001/83/EC, these data are not acceptable to support a positive benefit-risk balance for the concerned products and cannot substitute the requirement to demonstrate bioequivalence between test product and a suitable EU reference product.
Maltese: Skont l-Artikolu 10(1) tad-Direttiva 2001/83/KE, din id-data mhijiex aċċettabbli sabiex issostni bilanċ pożittiv bejn il-benefiċċju u rriskju għall-prodotti kkonċernati u ma tistax tieħu post ir-rekwiżit li tintwera bijoekwivalenza bejn il-prodott tat-test u prodott ta' referenza xieraq tal-UE.
English: • Reanalysis and audits of data for specific studies did not point to any irregularity.
Maltese: • Analiżi mill-ġdid u awditi tad-data għal studji speċifiċi ma indikaw ebda irregolarità.
English: For a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC as amended, bioequivalence is crucial for the conclusion that efficacy and safety are similar to that of the reference product.
Maltese: Għal prodott mediċinali b'awtorizzazzjoni għat-tqegħid fis-suq jew applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq skont l-Artikolu 10(1) tad-Direttiva 2001/83/KE kif emendata, il-bijoekwivalenza hija kruċjali għall-konklużjoni li l-effikaċja u s-sigurtà huma simili għal dawk tal-prodott ta' referenza.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Ir-rati ta' twaqqif f'din il-popolazzjoni kienu simili għal dawk irrappurtati filpopolazzjoni ġenerali.
English: Località Marino del Tronto, 63100 Ascoli Piceno (AP) Italy
Maltese: Località Marino del Tronto, 63100 Ascoli Piceno (AP) L-Italja
English: Study 2 (n=1023) 4W CQR CA Wk 9-52 4W CQR CA Wk 9-52
Maltese: Studju 2 (n=1023) 4W CQR CA Wk 9-52 4W CQR CA Wk 9-52
English: Paranoiab
Maltese: Paranojja
English: The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.
Maltese: L-enzimi P450 ittestjati għall-inibizzjoni kienu: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, u 3A4/5.
English: System Organ Class
Maltese: Sistema talKlassifika ta' lOrgani
English: Ísland Icepharma hf.
Maltese: Icepharma hf.
English: Difference (95% CI)
Maltese: Differenza (95% CI)
English: Study 1 (n=1022)
Maltese: Studju 1 (n=1022)
English: Store below 30°C
Maltese: Aħżen f'temperatura taħt 30°C
English: Days 4 - 7:
Maltese: Jum 4 - 7:
English: Linearity/Non linearity
Maltese: Lineari/Mhux lineari
English: Glycosuria, polyuria
Maltese: Glikosurja, polijurja
English: UNIQUE IDENTIFIER - 2D BARCODE Not Applicable
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Analyses of Clinical Trials:
Maltese: Analiżijiet tal-Provi Kliniċi:
English: Erythema Multiforme, angioedema Musculoskeletal and connective tissue disorders Common
Maltese: Erythema Multiforme, anġjoedema Disturbi muskolu-skeltrali u tal-connective tissue Komuni
English: Placebo (N=3449)
Maltese: Plaċebo (N=3449)
English: Placebo N=2014
Maltese: Plaċebo N=2014
English: Blisters: 3 years
Maltese: Folji: 3 snin
English: Non-psychiatric Cohort N=3984 Varenicline Bupropion
Maltese: Koorti Mhux Psikjatriku N=3984 Varenicline Bupropion
English: In circulation, varenicline comprises 91% of drug-related material.
Maltese: Fiċ-ċirkolazzjoni, varenicline jiġbor 91% tal-materjal relatat mal-mediċina.
English: Severe cutaneous reactions, including Stevens Johnson Syndrome and
Maltese: Reazzjonijiet severi fil-ġilda, li jinkludu sindrome Stevens Johnson u
English: Comparative clinical studies
Maltese: Studji kliniċi komparattivi
English: Bupropion vs Placebo
Maltese: Bupropion vs Plaċebo
English: CHAMPIX vs. placebo p < 0.0001
Maltese: CHAMPIX vs plaċebo p < 0.0001
English: CHAMPIX, (n = 248) Placebo, (n = 251) Odds ratio (CHAMPIX vs.
Maltese: CHAMPIX, (n = 248) Plaċebo, (n = 251)
English: Placebo n=604
Maltese: Plaċebo n=604
English: *CA: Continuous Abstinence
Maltese: Rata ta' Astinenza Kontinwa
English: Placebo n=245
Maltese: Plaċebo n=245
English: The elimination half-life of varenicline is approximately 24 hours.
Maltese: Il-half life ta' l-eliminazzjoni ta' varenicline hi bejn wieħed u ieħor 24 siegħa.
English: Additionally, a small number of MACE occurred up to 30 days after treatment (CHAMPIX 13 [0.31%]; placebo 6 [0.21%]).
Maltese: Kien hemm ukoll numru żgħir ta' MACE sa 30 ġurnata wara t-trattament (CHAMPIX 13 [0.31%]; plaċebo 6 [0.21%]).
English: Psychiatric Cohort N=4074
Maltese: Koorti Psikjatriku N=4074
English: Non-psychiatric Cohort N=3984
Maltese: Koorti mhux psikjatriku N=3984
English: Maintenance pack
Maltese: Pakketti ta' manteniment
English: NRT vs Placebo
Maltese: NRT vs Plaċebo
English: The pharmacokinetics of varenicline in elderly patients with normal renal function (aged 65-75 years) is similar to that of younger adult subjects (see section 4.2).
Maltese: Il-farmakokinetika ta' varenicline f'pazjenti anzjani b'funzjoni tal-kliewi normali (eta' 65-75 sena) hi simili għal dik ta' pazjenti adulti iżgħar (ara sezzjoni 4.2).
English: Nicotine replacement therapy (NRT)
Maltese: Terapija ta' sostituzzjoni tan-nikotina (NRT)
English: Psychiatric Adverse Events Occurring in ≥ 1% of Patients from Pooled Data from 18 Clinical Trials:
Maltese: Avvenimenti Psikjatriċi Avversi li Seħħew f'≥ 1% tal-Pazjenti minn Dejta Miġbura minn 18il Prova Klinika:
English: Do not take CHAMPIX:
Maltese: Tiħux CHAMPIX:
English: Hypromellose Titanium Dioxide (E171) Macrogol 400
Maltese: Titanium Dioxide (E171) Macrogol 400
English: Placebo (N=777)
Maltese: Plaċebo (N=777)
English: CHAMPIX is indicated for smoking cessation in adults.
Maltese: CHAMPIX huwa indikat għat-twaqqif tat-tipjip f'persuni adulti.
English: NRT Placebo
Maltese: NRT Plaċebo
English: Patients were stratified by age (12-16 years of age and 17-19 years of age) and by body weight (≤55 kg and >55 kg).
Maltese: Il-pazjenti ġew stratifikati skont l-età (età ta' 12-16il sena u età ta' 17-19-il sena) u skont il-piż tal-ġisem (≤55 kg u >55 kg).
English: RD (95% CI) vs Placebo
Maltese: RD (95% CI) vs Plaċebo
English: Odds ratio in CAR 9-12 (95% CI) [p-value]
Maltese: Proporzjon ta' probabbiltà f'CAR 9-12 (95% CI) [valur p]
English: Minor metabolites in urine include varenicline N-carbamoylglucuronide and hydroxyvarenicline.
Maltese: Il-metaboliti minuri fl-awrina jinkludu varenicline N-carbamoylglucuronide u hydroxyvarenicline.
English: Neuropsychiatric Safety Meta-analyses and Observational Studies:
Maltese: Meta-analiżi tas-Sigurtà Newropsikjatrika u Studji ta' Osservazzjoni:
English: The day you stop smoking should usually be between day 8 and day 14.
Maltese: Il-ġurnata meta tieqaf tpejjep normalment għandha tkun bejn jum 8 u jum 14.
English: Day 1 - 3
Maltese: Jum 1 - 3:
English: Overall n/N (%)
Maltese: Globali n/N (%)
English: Varenicline vs Bupropion 1.77 (1.46, 2.14), P<0.0001
Maltese: Varenicline vs Bupropion 1.77 (1.46, 2.14), P<0.0001 1.74 (1.41, 2.14), P<0.0001 Varenicline vs NRT
English: Minor circulating metabolites include varenicline N-carbamoylglucuronide and N-glucosylvarenicline.
Maltese: Il-metaboliti minuri fiċ-ċirkolazzjoni jinkludu varenicline Ncarbamoylglucuronide u N-glucosylvarenicline.
English: A meta-analysis of 18 double-blind, randomised, placebo-controlled clinical trials was conducted to assess the neuropsychiatric safety of varenicline.
Maltese: Twettqet meta-analiżi ta' 18-il prova klinika, randomizzata, double-blind, ikkontrollata bi plaċebo biex tiġi evalwata s-sigurtà newropsikjatrika ta' varenicline.
English: In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ml).
Maltese: L-istudji in vitro juru li varenicline ma jinibixxix l-enzimi taċ-ċitokromu P450 (IC50> 6,400 ng/ml).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Maltese: Pfizer Europe MA EEIG (bħala MA Holder Logo)
English: Anxiety a
Maltese: ANNESS I
English: Hallucinationsb Homicidal ideationb Maniab
Maltese: Alluċinazzjonijiet Ideat ta' omiċidju Manija
English: During treatment MACE, n (%)
Maltese: MACE, n (%)
English: Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Maltese: Burdati dipressivi, li rarament jinkludu ideat ta' suwiċidju u attentati ta' suwiċidju, jistgħu jkunu sintomu ta' twaqqif tan-nikotina.
English: A meta-analysis of 15 clinical trials of ≥ 12 weeks treatment duration, including 7002 patients (4190 CHAMPIX, 2812 placebo), was conducted to systematically assess the cardiovascular safety of CHAMPIX.
Maltese: Meta-analiżi ta' 15-il prova klinika fejn it-trattament dam ≥ 12-il ġimgħa, li kienet tinkludi 7002 pazjenti (4190 CHAMPIX, 2812 plaċebo), saret sabiex is-sigurtà kardjovaskulari ta' CHAMPIX tkun eżaminata sistematikament.
English: These are equivalent to an estimated increase of 6.5 MACE events and 6.3 MACE events per 1,000 patient-years, respectively of exposure.
Maltese: Dawn huma ekwivalenti għal żieda stimata ta' 6.5 avvenimenti MACE u 6.3 avvenimenti MACE f'kull 1,000 sena ta' esponiment ta' pazjenti, rispettivament għall-esponiment.