FrancophonIA/ELRC3.0 huggingface dataset:
English: The mandate has been endorsed by the Heads of Medicines Agencies.
Maltese: Il-mandat ġie approvat mill-Kapijiet talAġenziji tal-Mediċini.
English: Mandate of the Ad Hoc Pharmacovigilance Inspectors Working Group
Maltese: Rapport mill-Kummissjoni Ewropea
English: The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on two pandemic vaccines.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ta opinjoni pożittiva dwar żewġ vaċċini tal-pandemija.
English: [EMEA/MB/575748/2009] The Board noted the mandate and the report on the first year of operation of the Ad Hoc Pharmacovigilance Inspectors Working Group.
Maltese: Mandat tal-Grupp ta' Ħidma Ad Hoc tal-Ispetturi tal-Farmakoviġilanza [EMEA/MB/575748/2009] Il-Bord ħa nota tal-mandat u tar-rapport dwar l-ewwel sena ta' operat talGrupp ta' Ħidma Ad Hoc tal-Ispetturi tal-Farmakoviġilanza.
English: The changes to the procedure will be introduced in the future revision of the EMEA policy on the handling of conflicts of interests.
Maltese: Il-bidliet fil-proċedura sejrin jiġu introdotti fir-reviżjoni futura tal-politika tal-EMEA dwar l-indirizzar ta' kunflitti ta'
English: The proposal should be finalised for the March 2010 Management Board meeting.
Maltese: Il-proposta għandha tiġi iffinalizzata għal-laqgħa ta' Marzu 2010 tal-Bord ta' Tmexxija.
English: Vacancy notice for the Executive Director's function
Maltese: Avviż ta' post battal għall-funzjoni ta' Direttur Eżekuttiv
English: The proposal also links to the ongoing work at HMA-EMEA level, where a joint training team looks into a strategy aimed at further enhancing skills of the regulators.
Maltese: Il-proposta torbot ukoll max-xogħol li għaddej fil-livell tal-HMA-EMEA, fejn tim ta' taħriġ konġunt qed jinvestiga strateġija mmirata sabiex ittejjeb aktar il-ħiliet tar-regolaturi.
English: While recognising that the interests of the healthcare professionals (HCP) organisations are more diverse than those of the patients, the Board asked to continue to explore ways on how to best develop interaction with healthcare professionals.
Maltese: Filwaqt li jirrikonoxxi li l-interessi tal-organizzazzjonijiet tal-professjonisti tal-kura tas-saħħa (HCP) huma aktar diversi minn dawk tal-pazjenti, il-Bord talab li jkomplu jiġu esplorati modi dwar kif linterazzjoni tiġi żviluppata bl-aħjar mod mal-professjonisti tas-saħħa.
English: The Executive Director has recently attended the European Parliament, where he discussed the topic of pandemic-influenza vaccines.
Maltese: Id-Direttur Eżekuttiv reċentement attenda l-Parlament Ewropew, fejn iddiskuta s-suġġett tal-vaċċini tal-pandemija-influwenza.
English: The CHMP has provided an explanatory note about the rationale for benefit-risk assessment of the vaccines, and published the information on the Agency's website.
Maltese: Is-CHMP ipprovda nota ta' spjega dwar ir-raġuni għall-evalwazzjoni talbenefiċċju-riskju tal-vaċċini, u ppubblika l-informazzjoni fuq il-websajt tal-Aġenzija.
English: The Board also endorsed the proposal to establish a procedure for advanced screening of potential conflicts of interests ahead of the nomination.
Maltese: Il-proċedura tippermetti lill-Aġenzija li tinforma lill-awtorità li tinnomina, dwar kunflitt ta' interessi potenzjali ta' persuna nominata fil-bidu tal-proċedura tannomina.
English: The Management Board discussed that currently there is a lot of duplication in the area of health technology assessment (HTA) among Member States.
Maltese: Il-Bord ta' Tmexxija iddiskuta li fil-preżent hemm bosta duplikazzjoni fil-qasam tal-evalwazzjoni tatteknoloġija tas-saħħa (HTA) fost l-Istati Membri.
English: The revisions concern the fees for consultation on line-extensions for ancillary substances, including blood derivates, incorporated in medical devices; and the implementation of the new regulation on maximum residue limits.
Maltese: Ir-reviżjonijiet jikkonċernaw il-miżati għal konsultazzjoni fuq estensjonijiet tal-linja għal sustanzi anċillari, inklużi derivattivi tad-demm, inkorporati f'apparat mediku; u l-implimentazzjoni tar-regolament il-ġdid dwar il-limiti massimi ta' residwi.
English: − Thomas Lönngren;
Maltese: L-EMEA nnominat lir-rappreżentanti li ġejjin: Thomas Lönngren;
English: [A6-0162_2009_EN] European Parliament decision on discharge to the Executive Director of the EMEA [EMEA/MB/528743/2009] Update report on EMEA implementation of EU telematics strategy.
Maltese: [EMEA/MB/528743/2009] Rapport ta' aġġornament dwar l-implimentazzjoni tal-EMEA talistrateġija tat-Telematika tal-UE.
English: The composition of the new MBTC is as follows:
Maltese: Il-Bord innomina lill-membri li ġejjin:
English: London, 1 October 2009
Maltese: Minuti tal-erbgħa u sittin laqgħa tal-Bord ta' Tmexxija Londra, 1 ta' Ottubru 2009
English: Update on the pilot project on revision of the payment system
Maltese: Aġġornament dwar il-proġett pilota dwar ir-reviżjoni tas-sistema ta' ħlas
English: The members noted the update report from the European Commission on a range of topics, including: the European Commission's work in the field of pandemic influenza, progress on the inter-service consultation on the variations regulation, the entry into force of the new regulation on maximum residue limits, and work in the field of health technology assessment.
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kummissjoni Ewropea dwar firxa ta' suġġetti, inkluż: il-ħidma tal-Kummissjoni Ewropea fil-qasam tal-influwenza pandemika, il-progress dwar ilkonsultazzjoni bejn is-servizzi fuq ir-regolament tal-varjazzjonijiet, id-dħul fis-seħħ tar-regolament ilġdid dwar il-limiti massimi ta' residwi, u l-ħidma fil-qasam tal-evalwazzjoni tat-teknoloġija tas-saħħa.
English: EMEA/MB/569756/2009] Reports on EudraVigilance implementation for human medicines and medicines for veterinary use.
Maltese: [EMEA/MB/517930/2009] Eżitu tal-proċeduri bil-miktub:
English: The proposal aims to simplify the governance structure, rationalise reporting lines and confirm the appropriate representation of the network.
Maltese: Il-proposta għandha lgħan li tissimplifika l-istruttura ta' governanza, tirrazzjonalizza l-linji ta' rapportar u tikkonferma rrappreżentanza xierqa tan-netwerk.
English: While the Management Board is awaiting a reply from the Commission to its latest correspondence, the Board considers that this issue remains open, and expects that the publication of the vacancy notice will not proceed without the outstanding issue being resolved.
Maltese: Il-Bord talab li jitlaqqa' lkumitat u li jiġu ppreżentati t-termini ta' referenza tiegħu fil-laqgħa ta' Diċembru.
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Isem inventat Qawwa Għamla farmaċewtika
English: EU Number
Maltese: Numru- ta' EU
English: --1 Each dose (0.007 ml) of undiluted vaccine contains: - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria maxima, strain 013 - 196 - 265 sporulated oocysts - Eimeria mitis, strain 006 - 293 - 397 sporulated oocysts - Eimeria praecox, strain 007 - 293 - 397 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Maltese: Eimeria acervulina, strejn 003 - 332 - 450 ooċisti sporulati Eimeria maxima, strejn 013 - 196 - 265 ooċisti sporulati Eimeria mitis, strejn 006 - 293 - 397 ooċisti sporulati Eimeria praecox, strejn 007 - 293 - 397 ooċisti sporulati Eimeria tenella, strejn 004 - 276 - 374 ooċisti sporulati
English: The full EPAR for Pioglitazone Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pioglitazone Teva is a ‘generic medicine'.
Maltese: Pioglitazone Teva huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva on 26 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pioglitazone Teva fil-26 ta' Marzu 2012.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pioglitazone Teva.
English: The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day.
Maltese: Id-doża inizjali rakkomandata ta' Pioglitazone Teva hi 15 jew 30 mg darba kuljum.
English: This means that Pioglitazone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Pioglitazone Teva għandu kwalità komparabbli u li huwa bijoekwivalenti għal Actos.
English: The active substance in Pioglitazone Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone Teva, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: What is Pioglitazone Teva?
Maltese: Kif jintuża Pioglitazone Teva?
English: Pioglitazone Teva can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Pioglitazone Teva jista' jintuża' wkoll kemm mal-metaformina kif ukoll mas-sulfonilurea f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti minkejja terapija doppja mill-ħalq (‘terapija trippla').
English: Pioglitazone Teva can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Pioglitazone Teva jista' jintuża wkoll flimkien mal-metformina f'pazjenti li ma jkunux jistgħu jiġu kkontrollati b'mod sodisfaċenti bil-metformina biss, jew bis-sulfonilurea (tip ieħor ta' mediċina antidiabetika) meta tkunx tista' tintuża l-metformina (‘terapija doppja').
English: Because Pioglitazone Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone Teva huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: Why has Pioglitazone Teva been approved?
Maltese: Għaliex ġie approvat Pioglitazone Teva?
English: Pioglitazone Teva is a medicine that contains the active substance pioglitazone.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Because Pioglitazone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pioglitazone Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Pioglitazone Teva should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: Pioglitazone Teva is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Pioglitazone Teva jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikulari f'dawk li jkollhom piż eċċessiv.
English: How does Pioglitazone Teva work?
Maltese: Għal xiex jintuża Pioglitazone Teva?
English: 1 tablet
Maltese: Pillola li tintmagħad Qtates
English: Via Morolense, 5 03013 Ferentino (FR) Italy
Maltese: SX. Via Morolense, 5 03013 Ferentino (FR) L-Italja
English: PK parameters arithmetic mean (%CV)
Maltese: Parametri PK medja aritmetika (%CV)
English: Thrombophlebitis a
Maltese: Tromboflebite a
English: - The active substance is eravacycline.
Maltese: - Is-sustanza attiva hi eravacycline.
English: Dublin 2, D02 T380, Ireland
Maltese: Dublin 2, D02 T380, L-Irlanda
English: Total Dose (mg)
Maltese: Doża Totali (mg)
English: mannitol (E421), sodium hydroxide, hydrochloric acid
Maltese: TA' EĊĊIPJENTI mannitol (E421), sodium hydroxide, hydrochloric acid
English: Tetraphase Pharmaceuticals Ireland Limited 10 Earlsfort Terrace
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Tetraphase Pharmaceuticals Ireland Limited 10 Earlsfort Terrace
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA13.
Maltese: Antibatteriċi għal użu sistemiku, itetracyclines, Kodiċi ATC: J01AA13.
English: Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia
Maltese: Żieda fl-aspartate aminotransferase (AST) Żieda fl-alanine aminotransferase (ALT) Iperbilirubinemija
English: See example calculations in Table 3.
Maltese: Ara eżempji ta' kalkoli fit-Tabella 3.
English: Xerava is an antibiotic medicine that contains the active substance eravacycline.
Maltese: Xerava huwa mediċina antibijotika li fiha s-sustanza attiva eravacycline.
English: A course of treatment usually lasts for 4 to 14 days.
Maltese: Kors ta' kura normalment jieħu bejn 4 u 14-il jum.
English: Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials
Maltese: Tabella 1 Tabella b'lista ta' reazzjonijiet avversi għal eravacycline fi provi kliniċi
English: Hypersensitivity to tetracycline class antibiotics.
Maltese: Sensittività eċċessiva għal antibijotiċi tal-klassi ta' tetracyclines.
English: Eravacycline and its metabolites are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 in vitro.
Maltese: Eravacycline u l-metaboliti tiegħu mhumiex inibituri ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew ta' CYP3A4 in vitro.
English: Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1).
Maltese: Xerava huwa indikat għall-kura ta' infezzjonijiet intra-addominali komplikati (cIAI) fl-adulti (ara sezzjonijiet 4.4 u 5.1).
English: Eravacycline, TP-498 and TP-6208 are not inhibitors of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 or MATE2-K transporters.
Maltese: Eravacycline, TP-498 u TP-6208 mhumiex inibituri tat-trasportaturi ta' BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 jew ta' MATE2-K.
English: TP-6208 and TP-498 are not considered to be pharmacologically active.
Maltese: TP-6208 u TP-498 mhumiex meqjusa li huma farmakoloġikament attivi.
English: Powder for concentrate for solution for infusion Multipack: 12 (12x1) vials
Maltese: U KONTENUT Trab għal konċentrat għal soluzzjoni għall-infużjoni Pakkett multiplu: 12-il (12x1) kunjett
English: MIC Breakpoints (µg/mL) Susceptible (S ≤)
Maltese: Valuri Kritiċi tal-MIC (µg/mL) Suxxettibbli (S ≤)
English: Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline.
Maltese: Kien hemm rapporti ta' effetti sekondarji oħra b'antibijotiċi itetracyclines oħra inklużi minocycline u doxycycline.
English: a Mean (range) represented b AUC of Day 1 = AUC 0-12 after the first dose and AUC for Day 10 = steady state AUC0- 12
Maltese: a Medja (medda) rappreżentata L-AUC tal-Jum 1 = AUC 0-12 wara l-ewwel doża u l-AUC għall-Jum 10 = l-AUC0- 12 fi stat fiss
English: Potential for drug-drug interactions
Maltese: Potenzjal għal interazzjonijiet mediċinali
English: 1.0 mg/kg IV every 12 hours (n=6) Day 1 2125 (15) Day 10 1825 (16)
Maltese: Jum 1 2125 (15) Jum 10 1825 (16)
English: Additional minor metabolites are formed by glucuronidation, oxidation and hydrolysis.
Maltese: Metaboliti minuri addizzjonali jiġu ffurmati minn glukuronidazzjoni, ossidazzjoni u idroliżi.
English: The metabolites TP-498 and TP-6208 are not inhibitors of P-gp in vitro.
Maltese: Il-metaboliti TP-498 u TP-6208 mhumiex inibituri ta' P-gp in vitro.
English: The in vitro binding of eravacycline to human plasma proteins increases with increasing concentrations, with 79%, 86% and 90% (bound) at 0.1, 1 and10 µg/mL, respectively.
Maltese: L-irbit in vitro ta' eravacycline mal-proteini tal-plażma tal-bniedem jiżdied b'żieda filkonċentrazzjonijiet, b'79%, 86% u 90% (marbut) f'doża ta' 0.1, 1 u ta' 10 µg/mL, rispettivament.
English: See example calculations in Table 1.
Maltese: Ara eżempji ta' kalkoli fit-Tabella 1.
English: For patients weighing ≥ 40 kg - 49 kg:
Maltese: Għal pazjenti li jiżnu bejn ≥ 40 kg - 49 kg:
English: In clinical trials, the most common adverse reactions in patients with cIAI treated with eravacycline (n=576) were nausea (3.0%), vomiting, infusion site phlebitis (each 1.9%), phlebitis (1.4%), infusion site thrombosis (0.9%), diarrhoea (0.7%), vessel puncture site erythema (0.5%), hyperhidrosis, thrombophlebitis, infusion site hypoaesthesia, and headache (each 0.3%), which were generally mild or moderate in severity.
Maltese: Fi provi kliniċi, ir-reazzjonijiet avversi l-aktar komuni f'pazjenti b'cIAI li kienu qed jingħataw kura b'eravacycline (n=576) kienu dardir (3.0%), rimettar, flebite fis-sit tal-infużjoni (1.9% kull waħda), flebite (1.4%), trombożi fis-sit tal-infużjoni (0.9%), dijarea (0.7%), eritema fis-sit tat-titqib talvina (0.5%), iperidrożi, tromboflebite, ipoestesija fis-sit tal-infużjoni, u uġigħ ta' ras (0.3% kull waħda), li ġeneralment kienu ta' severità ħafifa jew moderata.
English: After further dilution 1 mL contains 0.3 mg eravacycline.
Maltese: Wara dilwizzjoni ulterjuri kull 1 mL fih 0.3 mg ta' eravacycline.
English: The C-7 and C-9 substitutions in eravacycline are not present in any naturally occurring or semisynthetic tetracyclines and the substitution pattern imparts microbiological activities including retention of in vitro potency against Gram-positive and Gram-negative strains expressing tetracycline-specific resistance mechanism(s) (i.e., efflux mediated by tet(A), tet(B), and tet(K); ribosomal protection as encoded by tet(M) and tet(Q)).
Maltese: Is-sostituzzjonijiet C-7 u C-9 f'eravacycline mhuma preżenti f'ebda tetraċiklin li jseħħ b'mod naturali jew semisintetiku u l-mudell ta' sostituzzjoni juri l-attivitajiet mikrobijoloġiċi inkluż iż-żamma ta' potenza in vitro kontra razez Gram-pożittivi u Gram-negattivi li jesprimu mekkaniżmu(i) ta' reżistenza speċifika għat-itetracyclines (jiġifieri, effluss medjat minn tet(A), tet(B), u tet(K); protezzjoni ribosomali kif ikkodifikat minn tet(M) u tet(Q)).
English: Eravacycline is metabolised primarily by CYP3A4- and FMO-mediated oxidation of the pyrrolidine ring to TP-6208, and by chemical epimerisation at C-4 to TP-498.
Maltese: Eravacycline huwa metabolizzat primarjament minn ossidazzjoni medjata minn CYP3A4 u minn FMO taċ-ċirku pirrolidin għal TP-6208, u minn epimerizzazzjoni kimika fis-C-4 għal TP-498.
English: The geometric mean AUC0-inf for eravacycline was increased by 22.9%, 37.9%, and 110.3% for subjects with mild, moderate, and severe hepatic impairment versus healthy subjects, respectively.
Maltese: Il-medja ġeometrika tal-AUC0-inf għal eravacycline żdiedet bi 22.9%, 37.9%, u 110.3% għal individwi b'indeboliment tal-fwied ħafif, moderat, u sever meta mqabbla ma' individwi b'saħħithom, rispettivament.
English: The geometric mean Cmax for eravacycline was increased by 13.9%, 16.3%, and 19.7% for subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), and severe (Child-Pugh Class C) hepatic impairment versus healthy subjects, respectively.
Maltese: Il-medja ġeometrika tas-Cmax għal eravacycline żdiedet bi 13.9%, 16.3%, u 19.7% għal individwi b'indeboliment tal-fwied ħafif (Child-Pugh tal-Klassi A), moderat (Child-Pugh tal-Klassi B), u sever (Child-Pugh tal-Klassi Ċ) meta mqabbla ma' individwi b'saħħithom, rispettivament.
English: Table 2 Mean (%CV) plasma pharmacokinetic parameters of eravacycline after single and multiple intravenous and in healthy adults
Maltese: Tabella 2 Proprjetajiet farmakokinetiċi medji (%CV) ta' eravacycline fil-plażma wara infużjoni unika u wara diversi infużjonijiet fil-vina u f'adulti b'saħħithom
English: In vitro, eravacycline was shown to be a substrate for the transporters P-gp, OATP1B1 and OATP1B3.
Maltese: In vitro, eravacycline ntwera li huwa substrat għat-trasportaturi P-gp, OATP1B1 u OATP1B3.
English: Date of first authorisation: 20 September 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2018
English: Pack sizes: 1 vial and multipacks containing 12 (12 packs of 1) vials.
Maltese: Daqsijiet tal-pakketti: kunjett wieħed u pakketti multipli li fihom 12-il (12-il pakkett ta' 1) kunjett.
English: Xerava 50 mg powder for concentrate eravacycline
Maltese: Xerava 50 mg trab għal konċentrat eravacycline
English: Tetracycline class effects
Maltese: Effetti tal-klassi ta' itetracyclines
English: For patients weighing >100 kg:
Maltese: Għal pazjenti li jiżnu >100 kg:
English: Eravacycline is a substrate for the transporters P-gp, OATP1B1 and OATP1B3 but not for BCRP.
Maltese: Eravacycline huwa substrat għat-trasportaturi ta' P-gp, OATP1B1 u OATP1B3 iżda mhux għal BCRP.
English: Eravacycline, TP-498 and TP-6208 are not inducers of CYP1A2, CYP2B6 or CYP3A4.
Maltese: Eravacycline, TP-498 u TP-6208 mhumiex indutturi ta' CYP1A2, CYP2B6 jew ta' CYP3A4.
English: Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline.
Maltese: Mediċini li jinduċu s-CYP3A4 huma mistennija li jżidu r-rata u l-firxa tal-metaboliżmu ta' eravacycline.
English: Potential for other medicinal products to affect the pharmacokinetics of eravacycline
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw il-farmakokinetika ta' eravacycline
English: There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems.
Maltese: Ma hemm lebda reżistenza inkroċjata bbażata fuq il-mira bejn eravacycline u klassijiet oħrajn ta' antibijotiċi bħal quinolones, penicillins, cephalosporins, u carbapenems.
English: The geometric least square mean Cmax for eravacycline was increased by 8.8% for subjects with end stage renal disease (ESRD) versus healthy subjects with 90% CI -19.4, 45.2.
Maltese: Il-medja tal-inqas kwadru ġeometriku tas-Cmax għal eravacycline żdiedet bi 8.8% għal individwi b'mard renali fl-aħħar stadju (ESRD) meta mqabbla ma' individwi b'saħħithom b'CI ta' 90% ta'19.4, 45.2.
English: A drug-drug interaction in vivo cannot be excluded and co-administration of eravacycline and other medicinal products that inhibit these transporters (examples of OATP1B1/3 inhibitors; atazanavir, cyclosporine, lopinavir, and saquinavir) may increase the eravacycline plasma concentration.
Maltese: Ma tistax tiġi eskluża interazzjoni mediċinali in vivo u l-għoti flimkien ta' eravacycline u prodotti mediċinali oħra li jinibixxu dawn it-trasportaturi (eżempji ta' inibituri ta' OATP1B1/3; atazanavir, cyclosporine, lopinavir, u saquinavir) jista' jżid il-konċentrazzjoni ta' eravacycline fil-plażma.
English: Table 3 Example calculations for weights ranging from 40 kg to 200 kg
Maltese: Tabella 3 Eżempji ta' kalkoli għal piżijiet li jvarjaw bejn 40 kg sa 200 kg
English: Renal clearance and biliary and direct intestinal excretion account for approximately 35% and 48% of total body clearance after administration of a single IV dose of 60 mg 14C-eravacycline, respectively.
Maltese: L-eliminazzjoni mill-kliewi u biljari u eskrezzjoni intestinali diretta jirrappreżentaw madwar 35% u 48% tal-eliminazzjoni totali mill-ġisem wara l-għoti ta' doża unika ġol-vina ta' 60 mg ta'