FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience with Vyxeos liposomal in patients with baseline serum bilirubin greater than 50 µmol/L, severe renal impairment (creatinine clearance less than 30 mL/min), or end stage renal disease.
Maltese: M'hemm l-ebda esperjenza b'Vyxeos liposomali f'pazjenti b'bilirubina fis-seru fil-linja bażi akbar minn 50 µmol/L, indeboliment tal-kliewi sever (tneħħija tal-kreatinina inqas minn 30 mL/min), jew marda tal-kliewi fl-aħħar stadju.
English: The delivery of daunorubicin and cytarabine in the Vyxeos liposomal formulation is anticipated to reduce the possibility of interactions, because systemic free-drug concentrations of daunorubicin and cytarabine are much lower than when administered as the non-liposomal formulation.
Maltese: It-twassil ta' daunorubicin u cytarabine fil-formulazzjoni lipożomali ta' Vyxeos liposomali huwa antiċipat li jnaqqas il-possibbiltà ta' interazzjonijiet, minħabba li l-konċentrazzjonijiet sistemiċi mingħajr mediċina ta' daunorubicin u cytarabine huma ħafna aktar baxxi milli meta jingħataw bħala l-formulazzjoni mhux lipożomali.
English: For severe/life-threatening hypersensitivity symptoms (e.g., hypotension requiring vasopressor therapy, angioedema, respiratory distress requiring bronchodilation therapy, generalised urticaria), the treatment should be stopped.
Maltese: Għal sintomi ta' sensittività eċċessiva severi/ta' periklu għall-ħajja (eż., pressjoni baxxa li teħtieġ terapija b'vażopressur, anġjoedima, tbatija respiratorja li teħtieġ terapija ta' bronkodilazzjoni, urtikarja ġeneralizzata), il-kura għandha titwaqqaf.
English: Although central nervous system (CNS) and cardiovascular system parameters were included in these studies, given the observed morbidity and mortality, there was insufficient information to arrive at an integrated assessment of safety pharmacology of Vyxeos liposomal.
Maltese: Għalkemm il-parametri tas-sistema nervuża ċentrali (CNS) u tas-sistema kardjovaskulari ġew inklużi f'dawn l-istudji, minħabba l-morbidità u l-mortalità osservati, ma kienx hemm biżżejjed informazzjoni sabiex wieħed jasal għal valutazzjoni integrata tal-farmakoloġija tas-sigurtà ta' Vyxeos liposomali.
English: Hypersensitivity reactions were very common ADRs in Vyxeos liposomal clinical studies.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva kienu ADRs komuni ħafna fl-istudji kliniċi b'Vyxeos liposomali.
English: The most common haemorrhagic event was epistaxis, and the majority of these were considered not serious (29.1%).
Maltese: L-avveniment emorraġiku l-aktar komuni kien epistassi, u l-maġġoranza ta' dawn tqiesu bħala mhux serji (29.1%).
English: • Gently invert each vial 5 times prior to withdrawing the concentrate for dilution.
Maltese: • Bil-mod eqleb kull kunjett 5 darbiet qabel tiġbed il-konċentrat għad-dilwizzjoni.
English: There was no evidence of time-dependent kinetics or major departures from dose proportionality over the range of 1.3 mg/3 mg per m to 59 mg/134 mg per m
Maltese: Ma kien hemm l-ebda evidenza ta' kinetika dipendenti fuq iż-żmien jew tluq maġġuri mill-propozjonalità tad-doża fuq il-medda ta' 1.3 mg/3 mg għal kull m² sa 59 mg/134 mg għal kull m² (0.03 sa 1.3 drabi d-dożaġġ rakkomandat approvat).
English: Headache (1.1)
Maltese: Komuni Uġigħ ta' ras (1.1)
English: Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Maltese: Kull kunjett fih 44 mg ta' daunorubicin u 100 mg ta' cytarabine.
English: Vyxeos liposomal delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time.
Maltese: Vyxeos liposomali jagħti kombinazzjoni sinerġistika ta' daunorubicin u cytarabine liċ-ċelluli tal-lewkimja għal perjodu ta' żmien imtawwal.
English: Dizziness (23.2)
Maltese: Komuni Ħafna Uġigħ ta' ras (32.3) Sturdament (23.2)
English: For classification of ADRs which occur at Grades 3-5, a comprehensive listing is available from the NCI at NCI CTCAE.
Maltese: Għall-klassifikazzjoni ta' ADRs li jseħħu fi Gradi 3-5, hemm elenkar komprensiv disponibbli mill-NCI f'CTCAE tal-NCI.
English: For mild hypersensitivity symptoms (e.g., mild flushing, rash, pruritus), the treatment should be stopped, and the patient should be supervised, including monitoring of vital signs.
Maltese: Għal sintomi ta' sensittività eċċessiva ħfief (eż., vampati ħfief, raxx ħfief, prurite ħfief), il-kura għandha titwaqqaf, u l-pazjent għandu jiġi sorveljat, inkluż monitoraġġ ta' sinjali ewlenin.
English: Unlike non-liposomal daunorubicin and cytarabine, which are quickly metabolised to the respective metabolites, daunorubicin and cytarabine after Vyxeos liposomal administration are free bases encapsulated in liposomes.
Maltese: Għall-kuntrarju ta' daunorubicin u cytarabine mhux lipożomali, li malajr jiġu mmetabolizzati għall-metaboliti rispettivi, daunorubicin u cytarabine wara l-għoti ta' Vyxeos liposomali huma bażijiet liberi inkapsulati fil-lipożomi.
English: Dyspepsia (0.5) Vomiting (0.3)
Maltese: Mhux komuni Vista batuta (0.3)
English: The pharmacokinetics in patients with bilirubin greater than 50 µmol/L is unknown.
Maltese: Il-farmakokinetika f'pazjenti b'bilirubina iktar minn 50 µmol/L mhijiex magħrufa.
English: No dose adjustment is required in elderly patients (≥65 years) (see section 5.2).
Maltese: Popolazzjoni anzjana Mhu meħtieġ l-ebda aġġustament fid-doża f'pazjenti anzjani (≥65 sena) (ara sezzjoni 5.2).
English: Age, sex, race, body weight, body mass index, and white blood cell count do not have a clinically important effect on the exposure of total daunorubicin or cytarabine after adjusting dose by body surface area.
Maltese: L-età, is-sess, ir-razza, il-piż tal-ġisem, l-indiċi tal-massa tal-ġisem u l-għadd taċ-ċelluli bojod tad-demm m'għandhomx effett klinikament importanti fuq l-esponiment tat-total ta' daunorubicin jew cytarabine wara l-aġġustament tad-doża mill-erja tas-superfiċje tal-ġisem.
English: Discontinue Vyxeos liposomal in patients with signs or symptoms of acute copper toxicity.
Maltese: Waqqaf Vyxeos liposomali f'pazjenti b'sinjali jew b'sintomi ta' tossiċità akuta għar-ram.
English: Vyxeos liposomal should only be used in patients with severe hepatic impairment if the benefits outweigh the risks (see section 4.4).
Maltese: Il-kura b'Vyxeos liposomali għandha titwaqqaf f'pazjenti li jiżviluppaw sinjali jew sintomi ta' kardjomijopatija, sakemm il-benefiċċji ma jkunux akbar mir-riskji (ara sezzjoni 4.4).
English: • redness of skin, rashes, muscle aches, headache, bone pain, joint pain, tiredness, generalised swelling including swelling of your arms and legs
Maltese: • ħmura tal-ġilda, raxx, uġigħ fil-muskoli, uġigħ ta' ras, uġigħ fl-għadam, uġigħ fil-ġogi, għeja,
English: Pneumonia, sepsis and bacteriaemia were the most frequently seen serious infection ADRs in the clinical studies population.
Maltese: Il-pulmonite, is-sepsis u l-batteremija kienu l-ADRs ta' infezzjoni serja li dehru bl-aktar mod frekwenti fil-popolazzjoni tal-istudji kliniċi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vyxeos liposomal in one or more subsets of the paediatric population in AML (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Vyxeos liposomali f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika f'AML (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The treatment should be restarted slowly once the symptoms have resolved, by halving the rate of infusion and intravenous diphenhydramine (20-25 mg) and intravenous dexamethasone (10 mg) should be given.
Maltese: Il-kura għandha terġa' tinbeda bil-mod ladarba jkun fiequ s-sintomi, billi r-rata tal-infużjoni tingħata bin-nofs u jingħata diphenhydramine ġol-vini (20-25 mg) u dexamethasone ġol-vini (10 mg).
English: Carcinogenicity, mutagenicity, and reproductive toxicity studies have not been conducted with Vyxeos liposomal.
Maltese: Ma twettqux studji dwar il-karċinoġeniċità, il-mutaġeniċità u l-effett tossiku fuq is-sistema riproduttiva b'Vyxeos liposomali.
English: Based on findings in animals, male fertility may be compromised by treatment with Vyxeos liposomal (see section 5.3).
Maltese: Abbażi ta' sejbiet f'annimali, il-fertilità fl-irġiel tista' tiġi kompromessa permezz ta' trattament b'Vyxeos liposomali (ara 5.3).
English: Strength Pharmaceutical Form
Maltese: Isem Qawwa Għamla farmaċewtika
English: Difference in the incidence of adverse events
Maltese: Differenza fl-inċidenza ta' avvenimenti avversi
English: Tobramycin is an aminoglycoside antibiotic.
Maltese: Tobramycin huwa antibijotiku aminoglikoside.
English: Konstan MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, Zhang J, Angyalosi G, He E, Geller DE (2011).
Maltese: MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, Zhang J, Angyalosi G, He E, Geller DE (2011).
English: The CMDh 60 day procedure was initiated on 03 August 2015.
Maltese: Il-proċedura ta' 60 jum tas-CMDh inbdiet fit3 ta' Awwissu 2015.
English: The Decentralised procedure LT/H/0112/001/DC started on 24 September 2014.
Maltese: Il-proċedura Deċentralizzata LT/H/0112/001/DC bdiet fl-24 ta' Settembru 2014.
English: The application was submitted to the reference Member State (RMS): Lithuania, and the concerned Member States (CMS): Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Maltese: L-applikazzjoni ġiet ippreżentata lill-Istat Membru ta' referenza (RMS): il-Litwanja, u l-Istati Membri kkonċernati (CMS): il-Bulgarija, l-Estonja, l-Ungerija, il-Latvja, il-Polonja u r-Rumanija.
English: These observations were replicated in post-hoc analyses of different age groups.
Maltese: Dawn l-osservazzjonijiet ġew replikati f'analiżi post hoc ta' gruppi tal-età differenti.
English: The EAGER study
Maltese: L-istudju EAGER
English: The smallest difference was observed in the adult population (45% powder inhalation vs 34% nebuliser solution).
Maltese: L-iżgħar differenza kienet osservata fil-popolazzjoni adulta (45% inalazzjoni tat-trab kontra 34% soluzzjoni għannebulizzatur).
English: Results of audiology performed in a subpopulation of patients (TIP: 78 [25.3%]; TIS: 45 [21.5%]) revealed that a higher proportion of TIP-treated patients (25.6%; 20/78) than TIS-treated patients (15.6%; 7/45) experienced a decrease from baseline in any audiology test frequency at any visit.
Maltese: 3%]; TIS: 45 [21.5%]) żvelaw li proporzjon ogħla ta' pazjenti kkurati bit-TIP (25.6%; 20/78) minn pazjenti kkurati bit-TIS (15.
English: 2 Geller DE, Nasr SZ, Piggott S, He E, Angyalosi G, Higgins M (2014).
Maltese: 2 Geller DE, Nasr SZ, Piggott S, He E, Angyalosi G, Higgins M (2014). Tobramycin trab għall-inalazzjoni f'pazjenti bil-fibrożi ċistika:
English: The overall discontinuation rates for TIP were 3.6% in the children (≥6 to <13 years), 18.2% in the adolescents (≥13 to <20 years), and 32.7% in the adults (≥ 20 years), while the discontinuation rates with TIS were 16.7% in the children and adolescents, and 18.9% in the adults.
Maltese: Ir-rati ġenerali ta' twaqqif ta' TIP kienu 3.6% fit-tfal (≥6 sa <13-il sena), 18.2% fl-adolexxenti (≥13 sa <20 sena), u 32.7% fl-adulti (≥ 20 sena), waqt li r-rati ta' twaqqif ta' TIS kienu 16.7% fit-tfal u l-adolexxenti, u 18.9% fl-adulti.
English: The most common reasons for discontinuation were adverse events (AEs) - 40 (13.0%) of TIP as compared to 17 (8.1%) TIS-treated patients.
Maltese: Irraġunijiet l-aktar komuni għat-twaqqif kienu avvenimenti avversi (AEs) - 40 (13.0%) ta' TIP meta mqabbla ma' 17-il pazjent (8.1%) kkurati b'TIS.
English: The medicinal product TOBI Podhaler 28 mg inhalation powder is covered by an orphan designation in the condition treatment of P. aeruginosa lung infection in cystic fibrosis (orphan designation EU/3/03/140).
Maltese: Il-prodott mediċinali TOBI Podhaler 28 mg trab għall-inalazzjoni huwa kopert minn deżinjazzjoni ta' orfni fil-kura tal-kundizzjoni P. aeruginosa infezzjoni tal-pulmun fil-fibrożi ċistika (deżinjazzjoni ta' orfni UE/3/03/140).
English: Other treatment-related AEs more commonly reported in the TIP group were dysphonia (13.6% vs 3.8%) and dysgeusia (3.9% vs 0.5%).
Maltese: AEs oħrajn relatati mal-kura irrapportati b'mod aktar komuni fil-grupp tat-TIP kienu disfonija (13.6% kontra 3.8%) u disgewsja (3.9% kontra 0.5%).
English: UAB “VVB” submitted on 2 May 2014 a marketing authorisation application for Tobramycin VVB 300 mg/5 ml nebuliser solution (hereinafter “Tobramycin VVB”) as an abridged application in accordance with Article 10(3) of Directive 2001/83/EC, referring to Nebcin solution for injection (PL 13621/0059) for the purpose of the data exclusivity, and to TOBI 300 mg/5 ml nebuliser solution (hereinafter “TOBI”; PL 00101/0935) for the purpose of the SmPC/clinical comparator.
Maltese: "VVB" ippreżentat applikazzjoni ta' awtorizzazzjoni għat-tqegħid fis-suq fit-2 ta' Mejju 2014 għal Tobramycin VVB 300 mg/5 ml soluzzjoni għan-nebulizzatur (minn hawn 'il quddiem "Tobramycin VVB”) bħala applikazzjoni mqassra skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE, li tirreferi għal soluzzjoni Nebcin għall-injezzjoni (PL 13621/0059) għall-finijiet ta' esklussività tad-data, u għal TOBI 300 mg/5 ml soluzzjoni għan-nebulizzatur (minn hawn 'il quddiem “TOBI”; PL 00101/0935) għall-finijiet ta' SmPC/komparatur kliniku.
English: Cough events were suspected by the investigator as being related to study drug in 25.3% and 4.3% of patients in the TIP and TIS group, respectively.
Maltese: Avvenimenti ta' sogħla kienu suspettati mill-investigatur bħala relatati mal-mediċina tal-istudju f'25.3% u f'4.3% tal-pazjenti fil-grupp tat-TIP u tat-TIS, rispettivament.
English: The proposed therapeutic indication for Tobramycin VVB 300 mg/5 ml nebuliser solution is the same as for TOBI Podhaler (EU/1/10/652, Tobramycin, inhalation powder) and identical to that of TOBI 300 mg/5ml nebuliser solution: “suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.”
Maltese: L-indikazzjoni terapewtika proposta għal Tobramycin VVB 300mg/5 ml soluzzjoni għan-nebulizzatur hija l-istess bħal TOBI Podhaler (UE/1/10/652, Tobramycin, trab għall-inalazzjoni) u identika għal dik ta' TOBI 300 mg/5ml soluzzjoni għannebulizzatur: “terapija ta' trażżin għal infezzjoni pulmonarja kronika minħabba Pseudomonas aeruginosa fl-adulti u fit-tfal fl-età ta' 6 snin u aktar bil-fibrożi ċistika.
English: This is particularly illustrated by the differences in the discontinuation rates due to AEs (13% for the inhalation powder vs. 8% for the nebuliser solution), development of cough as an adverse drug related event (25% for the inhalation powder vs. 4% for the nebuliser solution) and dysphonia rates (13% for the inhalation powder vs. 4% for the nebuliser solution).
Maltese: Dan huwa muri b'mod partikolari mid-differenzi fir-rati ta' twaqqif minħabba l-AEs (13% għat-trab għall-inalazzjoni kontra 8% għassoluzzjoni għan-nebulizzatur), l-iżvilupp tas-sogħla bħala avveniment avvers relatat mal-mediċina (25% għat-trab għall-inalazzjoni kontra 4% għas-soluzzjoni għan-nebulizzatur) u rati tad-disfonija (13% għat-trab għall-inalazzjoni kontra 4% għas-soluzzjoni għan-nebulizzatur).
English: Post hoc subgroup analyses of EAGER data compared the safety profiles of TIP and TIS in children, adolescents, and adults.
Maltese: Analiżi post hoc tas-sottogrupp tad-data EAGER qabblet l-profili tas-sigurtà ta' TIP u TIS fit-tfal, fladolexxenti, u fl-adulti.
English: The difference is even more pronounced in the adult cystic fibrosis patient population (14% difference in overall discontinuations and 8% - in discontinuations due to AEs).
Maltese: Id-differenza hija aktar qawwija fil-popolazzjoni tal-pazjenti adulti bilfibrożi ċistika (14% differenza fi twaqqif ġenerali u 8% - fi twaqqif minħabba AEs).
English: The proposed medicinal product contains the same qualitative and quantitative composition and the same pharmaceutical form as TOBI 300mg/5 ml nebuliser solution, therefore clinical studies for demonstrating therapeutic equivalence can be waived in accordance with the scientific guidelines (EMEA/CHMP/QWP/49313/2005 Corr. and CPMP/EWP/4151/00 Rev.1).
Maltese: Il-prodott mediċinali propost fih l-istess kompożizzjoni kwalitattiva u kwantitattiva u l-istess għamla farmaċewtika bħal TOBI 300mg/5 ml soluzzjoni għan-nebulizzatur, għaldaqstant studji kliniċi sabiex juru l-ekwivalenza terapewtika jistgħu jiġu rinunzjati skont il-linji gwida xjentifiċi (EMEA/CHMP/QWP/49313/2005 Corr. u CPMP/EWP/4151/00
English: In addition, 3.9% (12/308) of TIP-treated patients discontinued due to cough vs 1% (2/209) of TIS-treated patients.
Maltese: Barra minn hekk, 3.9% (12/308) talpazjenti kkurati bit-TIP waqfu minħabba s-sogħla kontra 1% (2/209) ta' pazjenti kkurati bit-TIS.
English: 3 European Cystic Fibrosis Society (ECFS) Patient registry annual data report 2008-2009 v. 03.2012.
Maltese: 3 Ir-rapport annwali 2008-2009 v. 03.2012 tar-Reġistru tal-Pazjenti tas-Soċjetà Ewropea dwar il-Fibrożi Ċistika (ECFS).
English: The frequency of severe cough events was also higher in TIP group (2.6% versus 1.9%).
Maltese: Il-frekwenza ta' avvenimenti ta' sogħla severa kienet ukoll ogħla fil-grupp tat-TIP (2.6% kontra 1.9%).
English: The differences in terms of safety (in terms of tolerability) observed in the EAGER trial between the nebuliser solution and the inhalation powder, favouring the nebuliser solution regarding the occurrence of cough and discontinuation of treatment, are relevant and support the claim of greater safety (in terms of tolerability), as per article Article 8(3)(c) of Regulation (EC) No 141/2000, of Tobramycin VVB in those patients who develop intolerance to TOBI Podhaler.
Maltese: Id-differenzi f'termini ta' sigurtà (f'termini ta' tollerabbiltà) osservati fil-prova EAGER bejn is-soluzzjoni għan-nebulizzatur u t-trab għall-inalazzjoni, li jiffavorixxu s-soluzzjoni għan-nebulizzatur rigward lokkorrenza ta' sogħla u twaqqif tal-kura, huma relevanti u jappoġġjaw l-istqarrija ta' sigurtà akbar (f'termini ta' tollerabbiltà) skont l-Artikolu 8(3)(c) tar-Regolament (KE) Nru 141/2000, ta' Tobramycin VVB f'dawk il-pazjenti li jizviluppaw intolleranza għal TOBI Podhaler.
English: The Applicant's claim for clinical superiority based on greater safety (tolerability) of tobramycin nebulizer solution (TIS) over tobramycin inhalation powder (TIP) in a substantial portion of the target population relies on clinical data generated by the open-label EAGER study1 and its post hoc analyses2.
Maltese: L-istqarrija tal-Applikant ta' superjorità klinika abbażi ta' sigurtà akbar (tollerabbiltà) ta' tobramycin soluzzjoni għan-nebulizzatur (TIS) fuq tobramycin trab għall-inalazzjoni (TIP) f'parti sostanzjali talpopolazzjoni fil-mira tiddependi minn data klinika ġġenerata mill-istudju open-label EAGER1 u l-analiżi post hoc tagħha2.
English: Fewer adolescents and adults on TIS discontinued study medication as a result of AEs, compared with those on TIP (9.1% on TIS discontinued vs 17.3% on TIP).
Maltese: Inqas adolexxenti u adulti fuq TIS waqqfu l-mediċina ta' studju bħala riżultat ta' AEs, meta mqabbla ma' dawk fuq TIP (9.1% fuq TIS waqfu kontra 17.3% fuq TIP).
English: Considering the data from EAGER study and its post-hoc analyses, the difference in overall discontinuations is nearly 9% and difference in discontinuations due AEs is ~5% in favour of Tobramycin nebuliser solution.
Maltese: Wara li kkunsidra d-data mill-istudju EAGER u l-analiżi post hoc tiegħu, id-differenza fit-twaqqif ġenerali hija ta' kważi 9% u d-differenza fit-twaqqif minħabba AEs hija ~5% favur Tobramycin soluzzjoni għan-nebulizzatur.
English: The applicant of Tobramycin VVB has applied for a derogation from the market exclusivity of TOBI Podhaler 28 mg inhalation powder claiming that Tobramycin VVB 300 mg/5 ml nebuliser solution is clinically superior to the authorised orphan medicinal product (TOBI Podhaler 28 mg inhalation powder) in terms of providing greater safety in a substantial portion of the target population.
Maltese: L-applikant ta' Tobramycin VVB applika għal deroga mill-esklussività tas-suq ta' TOBI Podhaler 28 mg trab għall-inalazzjoni fejn saħaq li Tobramycin VVB 300mg/5 ml soluzzjoni għan-nebulizzatur huwa klinikament superjuri għall-prodott mediċinali orfni awtorizzat (TOBI Podhaler 28 mg trab għallinalazzjoni) billi jipprovdi sigurtà akbar f'parti sostanzjali tal-popolazzjoni fil-mira.
English: During the discussion, CHMP also noted the differences in terms of inhalation time between Tobramycin VVB and Tobi Podhaler.
Maltese: Waqt id-diskussjoni, is-CHMP innota wkoll id-differenzi f'termini ta' ħin tal-inalazzjoni bejn Tobramycin VVB u Tobi Podhaler.
English: In the EAGER study, cough described as an adverse drug related event was observed in 25% of patients on the inhalation powder vs. 4% of patients on the nebuliser solution.
Maltese: Fl-istudju EAGER, is-sogħla deskritta bħala avveniment avvers relatat mal-mediċina kienet osservata f'25% tal-pazjenti fuq it-trab tal-inalazzjoni kontra 4% talpazjenti fuq is-soluzzjoni għan-nebulizzatur.
English: Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC, to the CHMP was made by the Reference Member State Lithuania on 14 October 2015 based on concerns raised by the Concerned Member State Poland.
Maltese: Saret notifika tar-riferiment għal arbitraġġ, taħt l-Artikolu 29(4) tad-Direttiva 2001/83/KE, lis-CHMP mill-Istat Membru ta' Referenza, il-Litwanja, fl-14 ta' Ottubru 2015 abbażi ta' tħassib imqajjem millIstat Membru Kkonċernat, il-Polonja.
English: • The Committee was of the view that the data support the claim for clinical superiority of Tobramycin VVB versus TOBI Podhaler based on greater safety in a substantial portion of the target population, as per Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000;
Maltese: • Il-Kumitat kien tal-fehma li d-data tappoġġja l-istqarrija ta' superjorità klinika ta' Tobramycin VVB kontra TOBI Podhaler abbażi ta' sigurtà akbar f'parti sostanzjali tal-popolazzjoni fil-mira, skont lArtikolu 8(3)(c) tar-Regolament (KE) Nru 141/2000 li jinqara flimkien mal-Artikolu 3(3)(d)(2) tarRegolament (KE) Nru 847/2000;
English: differences in the rates of incidence of cough in all age groups.
Maltese: rispons permezz tal-grupp tal-età.
English: In the EAGER trial, the overall discontinuation rate was higher with TIP (26.9%) than TIS (18.2%).
Maltese: Fil-prova EAGER, ir-rata ġenerali ta' twaqqif kienet ogħla bit-TIP (26.9%) milli bit-TIS (18.2%).
English: This study evaluated the safety, efficacy and convenience of TIP vs TIS in CF patients aged 6 years and above with chronic P. aeruginosa infection.
Maltese: TIS f'pazjenti bis-CF fl-età ta' 6 snin u aktar bl-infezzjoni kronika P. aeruginosa.
English: RMS and CMSs agreed that Tobramycin VVB is comparable to TOBI 300 mg/5 ml nebuliser solution and therefore available efficacy and safety data for TOBI can be extrapolated to Tobramycin VVB.
Maltese: Ir-RMS u s-CMS qablu li Tobramycin VVB huwa komparabbli ma' TOBI 300mg/5 ml soluzzjoni għan-nebulizzatur u għaldaqstant data dwar l-effikaċja u sigurtà disponibbli għal TOBI tista' tkun estrapolata għal Tobramycin VVB.
English: Overall, in the context of the claim of clinical superiority based on a greater safety according to Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000, CHMP considered that a substantial portion of the target population experiences greater safety (in terms of tolerability) with Tobramycin VVB in terms of the incidence of cough and treatment discontinuation, as compared to TOBI Podhaler.
Maltese: B'mod ġenerali, fil-kuntest tal-istqarrija ta' superjorità klinika abbażi ta' sigurtà akbar skont lArtikolu 8(3)(c) tar-Regolament (KE) Nru 141/2000 li jinqara flimkien mal-Artikolu 3(3)(d)(2) tarRegolament (KE) Nru 847/2000, is-CHMP ikkunsidra li parti sostanzjali tal-popolazzjoni fil-mira tesperjenza sigurtà akbar (f'termini ta' tollerabbiltà) b'Tobramycin VVB f'termini tal-inċidenza tas-sogħla u t-twaqqif tal-kura, meta mqabbel ma' TOBI Podhaler.