FrancophonIA/ELRC3.0 huggingface dataset:
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Maltese: Filwaqt li 96% (93%) tal-pazjenti b'CCyR (PCyR) kienu stmati li kienu ħielsa minn avvanz fit-12-il xahar għall-Fażi aċċelerata/blast crisis fl-84 xahar, 81% biss tal-pazjenti mingħajr MCyR fit-12-il xahar kienu ħielsa minn avvanz għal CML fl-84 xahar (p<0.
English: Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
Maltese: Kienu rrappurtati 17il pazjent b'GIST (b'Kit u mutazzjonijiet PDGFR jew mingħajrhom) f'7 pubblikazzjonijiet.
English: Close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).
Maltese: Huwa rrakkomandat li wieħed josserva mill-qrib ir-rata li biha jkunu qed jikbru t-tfal meta jingħataw trattament b'imatinib (ara sezzjoni 4.8).
English: Posology for DFSP The recommended dose of Glivec is 800 mg/day for adult patients with DFSP.
Maltese: Pożoloġija għal DFSP Id-doża ta' Glivec rakkomandata għal pazjenti adulti b'DFSP hija 800 mg/jum.
English: Each tablet of Glivec contains 100 mg imatinib (as mesilate).
Maltese: Kull pillola ta' Glivec fiha 100 mg imatinib (bħal mesilate).
English: Resume treatment with Glivec at 600 mg. 3.
Maltese: Erġa ibda l-kura b'Glivec b'600 mg.
English: Each tablet of Glivec contains 400 mg imatinib (as mesilate).
Maltese: Kull pillola ta' Glivec fiha 400 mg imatinib (bħal mesilate).
English: Glivec 50 mg hard capsules Packs containing 30 capsules.
Maltese: Folji ta' l-aluminium/PVC Glivec 50 mg kapsuli ibsin Pakketti li fihom 30 kapsula.
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy
Maltese: Dawn jistgħu jkunu sinjali ta' ħsara fil-kanali tad-demm magħrufa bħala mikroanġjopatija trombotika (TMA - thrombotic microangiopathy).
English: Anaphylactic shock* Blood and lymphatic system disorders Very common:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni:
English: MTX 500 mg/m i.v.
Maltese: MTX 500 mg/m i.v. (24 h), jiem 1, 15;
English: The remaining circulating radioactivity consisted of a number of minor metabolites.
Maltese: Ir-radjuattività l-oħra fiċ-ċirkolazzjoni kienet minħabba numru ta'metaboli minuri.
English: In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily.
Maltese: F'dan l-istudju, żiediet tad-doża tħallew minn 400 mg kuljum għal 600 mg kuljum, imbagħad minn 600 mg kuljum għal 800 mg kuljum.
English: Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.
Maltese: Dożi ogħla ta' Glivec u paracetamol ma ġewx studjati.
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Maltese: • pazjenti adulti b'mard majelopisplatiku/majeloproliferattiv (MDS/MPD) assoċjat ma' tibdil filġene tar-riċettur tal-fattur ta' tkabbir li jkun ġej minn plejtlets (PDGFR).
English: Carriers of HBV who require treatment with Glivec should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: Portatuti tal-HBV li jeħtieġu l-kura b'Glivec għandhom jiġu mmonitorjati mill-qrib għal sinjali u għal sintomi tal-infezzjoni attiva tal-HBV waqt ilkura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Maltese: L-età medjana kienet ta' 51 sena (minn 18-70 sena), b' 21.9% tal-pazjenti jkollhom ≥ 60 sena. 59% kienu rġiel filwaqt li 41% kienu nisa; 89.9% kienu kawkasi u 4.7% kienu pazjenti suwed.
English: Glivec was administered intermittently in cohorts 1-5, with increasing duration and earlier start of Glivec from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of Glivec (longest duration in days with continuous daily Glivec dosing during the first chemotherapy treatment courses).
Maltese: Glivec ingħata b'mod intermittenti b'koorti ta' 1-5, b'żieda fid-dewmien u bi tnedija bikrija ta' Glivec minn koorti għal koorti; koorti 1 jingħata lanqas intensità u koorti 5 jingħata l-ogħla intensità ta' Glivec (l-iktar dewmien fi ġranet b'doża ta' Glivec kuljum b'mod kontinwu matul l-ewwel korsijiet ta' trattament b'kemotarapija).
English: SIA „Novartis Baltics“ Lietuvos filialas Tel: +370 5 269 16 50
Maltese: SIA Novartis Baltics Eesti filiaa Tel: +372 66 30 810
English: Caution should be taken when administering Glivec with inhibitors of the CYP3A4 family.
Maltese: Għandha tintuża kawtela meta Glivec jingħata flimkien ma' sustanzi li jinibixxu lillfamilja tas- CYP3A4.
English: Glivec 50 mg hard capsules imatinib
Maltese: Glivec 50 mg kapsuli ibsin imatinib
English: They are supplied in packs containing 10, 30 or 90 tablets, but these may not all be available in your country.
Maltese: Jiġu f'pakketti ta' 10, 30 jew 90 pillola, iżda jista' jkun li mhux il-pakketti kollha jkunu disponibbli f'pajjiżek.
English: VCR (1.5 mg/m 2/day, IV): days 1, 8 and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Maltese: DAUN (45 mg/m 2/bolus kuljum, IV): jiem 1 u 2
English: What Glivec looks like and contents of the pack Glivec 100 mg capsules are orange to greyish-orange and marked “NVR SI”.
Maltese: Kapsuli Glivec tal-100 mg huma oranġjo jagħtu fl-oranġjo-griż u mmarkati “NVR SI”. Fihom trab abjad jagħti fl-isfar.
English: Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Maltese: Fl-unika prova klinika li saret s'issa, il-kura b'Glivec tkompliet sakemm kien hemm avvanz tal-marda (ara sezzjoni 5.1).
English: repeat step 1 and resume Glivec at reduced dose of 400 mg.
Maltese: F'dawk li ħadu Glivec, id-doża kienet ta' 400 mg kuljum.
English: The capsule shell is composed of gelatin, yellow iron oxide (E172) and titanium dioxide (E171).
Maltese: Il-qoxra tal-kapsula hija magħmula minn gelatin, iron oxide isfar (E172) u titanium dioxide (E171).
English: Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Maltese: Glivec jista' jżid il-konċentrazzjoni fil-plażma ta' mediċini oħrajn li jiġu metabolizzati permezz tas-CYP3A4 (ez., triazolo-benzodiazepines, sustanzi bħal dihydropyridine li jibblokkaw ilkanali li minnhom jgħaddi l-kalċju għal ġoċ-ċelluli, xi tipi ta' sustanzi li jinibixxu lill-HMG-CoA reductase, jiġifieri l-istatins, eċċ.).
English: 9/l, then resume treatment at 200 mg/m
Maltese: Jekk iċ-ċitopenja tippersisti għal ġimgħatejn,erġa naqqas għal 200 mg/m
English: (3 h), day 1; Daunorubicin 60 mg/m i.v.
Maltese: CP 1.2 g/m i.v. (3 h), jum 1; Daunorubicin 60 mg/m i.v. (1 h), jiem 1-3;
English: 9/l and platelets
Maltese: 9/l) kienu bejn
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
Maltese: Għal dożi ta' 400 mg u 800 mg (ara d-dożaġġ rakkomandat hawn taħt) teżisti pillola ta' 100 mg li tista' tinqasam.
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn trabi tat-twelid sa 14-il sena u imatinib ingħata f'doża ta'50 mg kuljum jew f'dożi li jvarjaw minn 400 sa 520 mg/m kuljum.
English: Pharmacokinetics in GIST patients
Maltese: GĦAMLA FARMAĊEWTIKA
English: Glivec 100 mg hard capsules
Maltese: Glivec 100 mg kapsuli ibsin
English: Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys.
Maltese: Il-metaboliżmu ta' Glivec issir l-aktar permezz tal-fwied, u 13% biss ta'l-eskrezzjoni hija minn ġolkliewi.
English: CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1 Remission induction DEX 10 mg/m oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m i.v.
Maltese: CP 1.2 g/m i.v. (3 h), jum 1; Daunorubicin 60 mg/m i.v. (1 h), jiem 1-3; Vincristine 1.3 mg/m2 i.v., jiem 1, 8, 15, 21; Prednisolone 60 mg/m 2/jum orali
English: • Use about 200 ml for each 400 mg tablet.
Maltese: • Uża madwar 200 ml għal kull pillola ta' 400 mg.
English: Length of treatment in the clinical trial supporting this indication was 36 months (see section 5.1).
Maltese: It-tul ta' żmien ta' kura fil-provi kliniċi għal din l-indikazzjoni kien ta' 36-il xahar (ara sezzjoni 5.1).
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5).
Maltese: Każijiet kliniċi ta' ipertajrojdiżmu kienu rapurtati f'pazjenti li tneħħietilhom it-tajrojd li jkunu qed jirċievu terapija b'levothyroxine waqt il-kura b'Glivec (ara sezzjoni 4.5).
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia (NEL)
Maltese: Rispons ematoloġiku Rispons ematoloġiku komplet (CHR)
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Maltese: • Nawsja, qtugħ ta' nifs, taħbit tal-qalb irregolari, awrina mċajpra, għeja u/jew skumdità fil-ġogi b'rabta ma' riżultati tal-laboratorju mhux normali (eż. potassju għoli, aċidu uriku u livelli ta'
English: (1 h), days 28-31, 35-38, 42-45;
Maltese: CP 1 g/m i.v. (1 h), jiem 26, 46; Ara-C 75 mg/m i.v. (1 h), jiem 28-31, 35-38, 42-45;
English: The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn 8 snin sa 18-il sena u imatinib ingħata kemm f'kundizzjonijiet adjuvanti kif ukoll metastatiċi f'dożi li jvarjaw minn 300 sa 800 mg kuljum.
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Maltese: Id-doża tal-bidu hija 600 mg li għandha tittieħed bħala pillola waħda ta' 400 mg flimkien ma' żewġ pilloli ta' 100 mg darba kuljum.
English: Glivec 400 mg film-coated tablets imatinib
Maltese: Glivec 400 mg pilloli miksija b'rita imatinib
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with Glivec.
Maltese: Inħoloq reġistru ta' osservazzjoni (studju L2401) sabiex tinġabar data dwar is-sigurtà u l-effikaċja fuq medda ta' żmien fost pazjenti li jbatu minn neoplażmi majeloproliferattivi b'arranġament PGDFR- β u li kienu ttrattati bi Glivec.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Glivec.
Maltese: Kien hemm rapporti li saru wara li lprodott tqiegħed fis-suq dwar abborti spontanji u anomaliji konġenitali fi trabi minn nisa li ħadu Glivec.
English: DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
Maltese: Vindesine 3 mg/m i.v., jum 1;
English: Do not take Glivec: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Glivec: - jekk inti allerġiku għal imatinib jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: listed in Appendix V.
Maltese: Ċiklu 5
English: repeat step 1 and resume Glivec at reduced dose of 300 mg.
Maltese: 9/l, erġa irrepeti Nru. 1 u erġa ibda Glivec b'doża mnaqqsa ta' 300 mg.
English: Study AJP01 Induction therapy CP 1.2 g/m i.v.
Maltese: 9/l, imbagħad erġa ibda l-kura b'200 mg/m
English: If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.
Maltese: Jekk id-doża ta' kuljum tkun 800 mg, (8 kapsuli), għandek tieħu 4 kapsuli filgħodu u 4 kapsuli filgħaxija.
English: Patients had received a median of 14 months of prior IFN therapy at doses  25 x 10
Maltese: Il-tul medjan tat-terapija tal-publikazzjoni kien ivarja bejn 4 ġimgħat u aktar minn 20 xahar.
English: They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Maltese: Jiġu f'pakketti ta' 24, 48, 96, 120 jew 180 kapsula, iżda jista' jkun li mhux il-pakketti kollha jkunu disponibbli f'pajjiżek.
English: Chronic phase, newly diagnosed: This phase III study in adult patients compared treatment with either single-agent Glivec or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Maltese: III qabbel il-kura b'Glivec waħdu mal-kura b'taħlita ta' interferon-alpha (IFN) u cytarabine (Ara-C) flimkien.
English: 9/l,
Maltese: 9/l) f'
English: Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Maltese: Żieda qawwija fil-livelli tat-transaminases (<5%) jew tal-bilirubin (<1%) kienet evidenti f'pazjenti b'CML u s-soltu kienet kontrollata bi tnaqqis fid-doża jew inkella billi kien imwaqqaf għal ftit żmien it-trattament (it-tul medjan ta' dawn l-episodji kien ta' bejn wieħed u ieħor, ġimgħa).
English: Glivec 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 400 mg ta' imatinib (bħala mesilate).
English: In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
Maltese: F'pazjenti b'GIST l-esponiment f'livelli fissi, kien 1.5-il darba ogħla minn dak li ġie osservat f' pazjenti b' CML li kienu fuq l-istess doża (400 mg kuljum).
English: How to store Glivec
Maltese: Kif gћandek tieћu Glivec
English: The application was submitted to the Concerned Member States (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden) under the mutual recognition procedure.
Maltese: L-applikazzjoni ġiet sottomessa lill-Istati Membri Kkonċernati (L-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, ilLussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Repubblika Slovakka, Spanja u lIsvezja) skont il-proċedura ta' rikonoxximent reċiproku.
English: Clavudale 50 mg was authorised in the United Kingdom on 08/01/2010 under Article 13(1) of Directive 2001/82/EC.
Maltese: Clavudale 50 mg ġie awtorizzat fir-Renju Unit fi 08/01/2010 skont l-Artikolu 13(1) tadDirettiva 2001/82/KE.
English: • the similarity of the generic and reference product formulations;
Maltese: • is-similarità tal-formulazzjonijiet tal-prodott ġeneriku u ta' referenza;
English: The proposed standard dose rate is 12.5 mg/kg twice daily for 5-7 days.
Maltese: Ir-rata ta' doża standard proposta hija ta' 12.5 mg/kg darbtejn kuljum għal 5-7 ijiem.
English: Clavudale 50 mg tablets contain amoxicillin and clavulanic acid in a ratio of 4:1, thus the 50 mg tablet contains 40 mg amoxicillin/10 mg clavulanic acid.
Maltese: Clavudale 50 mg pilloli fih amoxicillin u aċidu klavulaniku fi proporzjon ta' 4:1, għalhekk il-pillola ta' 50 mg fiha 40 mg amoxicillin/10 mg aċidu klavulaniku.
English: For a minority of cases (refractory cases), a dose rate of 25 mg/kg twice daily for up to 28 days is proposed.
Maltese: F'minorità ta' każijiet (każijiet refrattorji), hija proposta rata ta' doża ta' 25 mg/kg darbtejn kuljum sa 28 ġurnata.
English: Applicant/Marketing Authorisation Holder
Maltese: Applikant/Iddetentur talawtorizzazzjoni għattqegħid fis-suq
English: The proposed indications are a range of diseases including deep and superficial pyoderma, soft tissue infections, dental infections, urinary tract infections, respiratory disease and enteritis in dogs and cats.
Maltese: L-indikazzjonijiet proposti huma firxa ta' mard li jinkludu pijoderma profonda u superfiċjali, infezzjonijiet tat-tessut artab, infezzjonijiet tas-snien, infezzjonijiet tal-apparat urinarju, mard respiratorju u enterite fil-klieb u l-qtates.
English: • accepted demonstration of bioequivalence within the 0.8-1.25 acceptance limits in dogs with a different tablet strength;
Maltese: • it-turija aċċettata ta' bijoekwivalenza ta' bejn il-limiti ta' aċċettazzjoni ta' 0.8-1.25 fil-klieb permezz ta' pillola b'qawwa differenti;
English: In the in vivo bioequivalence study conducted in cats, the 90% confidence interval for the ratio of geometric means of the pivotal pharmacokinetic parameters for demonstrating bioequivalence fell within pre-defined acceptance limits of 0.8 to 1.25 for clavulanic acid.
Maltese: Flistudju ta' bijoekwivalenza in vivo li sar fuq il-qtates, l-intervall ta' fiduċja ta' 90% għall-proporzjon talmezzi ġeometriċi tal-parametri farmakokinetiċi pivotali biex juri l-bijoekwivalenza kien jaqa' fil-limiti pre-definiti ta' aċċettazzjoni ta' 0.8 sa 1.25 għall-aċidu klavulaniku.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the member states
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi ta' annimal, mnejn jingħata, lapplikant/id-detentur tal-awtorizzazzjoni għat-tqegħid fissuq fl-Istati Membri
English: The reason for the anomalous pharmacokinetic profile in this cat is not known.
Maltese: Irraġuni għall-profil farmakokinetiku anomalu f'dan il-qattus mhijiex magħrufa.
English: This referral under Article 33(4) of Directive 2001/82/EC was made on the basis that the applicant had not satisfactorily demonstrated bioequivalence between the generic product, Clavudale 50 mg tablet for cats and dogs, and the reference product, Synulox Palatable Tablets 50 mg, in the cat target species.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE sar fuq bażi li l-applikant ma kienx wera b'mod suffiċjenti l-bijoekwivalenza bejn il-prodott ġeneriku, Clavudale 50 mg pillola għall-qtates u l-klieb, u l-prodott ta' referenza, Synulox Palatable Tablets 50 mg, fil-qtates bħala l-ispeċi fil-mira.
English: The dissolution studies presented by the applicant demonstrated similar dissolution profiles when different strengths of the generic and reference products were compared, which provides further reassurance on the pharmaceutical quality of the tablets.
Maltese: L-istudji ta' dissoluzzjoni ppreżentati mill-applikant urew profili simili ta' dissoluzzjoni meta tqabblu qawwiet differenti tal-prodotti ġeneriċi u ta' referenza, li jipprovdu riassigurazzjoni ulterjuri dwar ilkwalità farmaċewtika tal-pilloli.
English: In addition, a comparative in vitro dissolution study was conducted between the generic and reference products.
Maltese: Barra minn hekk, sar studju komparattiv ta' dissoluzzjoni in vitro bejn il-prodotti ġeneriċi u ta' referenza.
English: When data from one particular cat, considered an outlier by the applicant, were excluded from the analysis, the 90% confidence internal fell within the acceptance limits.
Maltese: Meta dejta minn qattus partikulari, ikkunsidrata bħala varjabbli ħafna mill-applikant, kienet eskluża mill-analiżi, l-intervall ta' fiduċja ta' 90% waqa' bejn illimiti ta' aċċettazzjoni.
English: Overall summary of the scientific evaluation of Clavudale 50 mg tablet for cats and dogs and associated names (see Annex I), hereinafter referred to as Clavudale 50 mg
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Clavudale 50 mg pilloli għall-qtates u l-klieb u l-ismijiet assoċjati (ara anness I), minn hawn il-quddiem issir referenza għalih bħala Clavudale 50 mg
English: The applicant had conducted a two-period crossover in vivo bioequivalence study in cats.
Maltese: L-applikant kien wettaq studju ta' bijoekwivalenza in vivo crossover fuq żewġ perjodi fil-qtates.
English: However, in the case of the amoxicillin, the lower limit of the 90% confidence interval for the ratio of geometric means for maximum plasma concentration (Cmax) and area under the plasma concentration/time curve (AUC) fell just below the acceptance limit.
Maltese: Madankollu, fil-każ tal-amoxicillin, il-limitu l-aktar baxx tal-intervall ta' fiduċja ta' 90% għall-proporzjon tal-mezzi ġeometriċi għallkonċentrazzjoni massima tal-plasma (Cmax) u l-erja taħt il-konċentrazzjoni tal-plasma /kurva tal-ħin (AUC) waqa' eżatt taħt il-limitu ta' aċċettazzjoni.
English: Having considered all of the data submitted in writing, the CVMP concludes that there is no rigorous scientific basis for a conclusion of serious risk in the cat target species based on a lower confidence limit for the AUC of amoxicillin which fell only narrowly below the pre-specified lower limit.
Maltese: Wara li kkunsidra d-dejta kollha sottomessa bil-miktub, is-CVMP jikkonkludi li ma hemmx bażi xjentifika rigoruża għal konklużjoni ta' riskju serju fil-qtates bħala l-ispeċi fil-mira fuq bażi ta' limitu aktar baxx ta' fiduċja għall-AUC ta' amoxicillin li waqa' ftit taħt il-limitu l-aktar baxx speċifikat minn qabel.
English: It was considered that, given the similar variability that was seen between the cat study and the larger dog bioequivalence study, the smaller size of the cat study may have made it more vulnerable to the effects of one cat with an anomalous pharmacokinetic profile.
Maltese: Kien ikkunsidrat li, minħabba l-varjabilità simili li kienet dehret bejn l-istudju fuq il-qtates u l-istudju akbar ta' bijoekwivalenza fuq il-klieb, id-daqs iżgħar tal-istudju fuq il-qtates jista' jkun li għamlu aktar vulnerabbli għall-effetti ta' qattus wieħed bi profil farmakokinetiku anomalu.
English: Bioequivalence is claimed with the reference product, Synulox Palatable Tablets 50 mg, marketed by Pfizer Ltd and authorised in the United Kingdom since 20/08/1990.
Maltese: bijoekwivalenza jiġu esklużi jekk ma kinitx saret dispożizzjoni għal dan fil-protokoll tal-istudju.
English: Luxembourg Dechra Limited, Sansaw Business
Maltese: Il-Lussemburgu Dechra Limited, Sansaw Business
English: Norway
Maltese: Qawwiet
English: • the similar and very rapid dissolution profiles of the generic and reference products at three pHs; the weight of evidence is considered to support that the benefits of this product when used in the cat outweigh the potential risks.
Maltese: • il-profili simili u rapidi ħafna ta' dissoluzzjoni tal-prodotti ġeneriċi u ta' referenza fit-tliet pHs;
English: Notwithstanding, the bioequivalence study in dogs provides reassurance that the formulation of the product is unlikely to be a contributing factor impacting on bioavailability in cats given that the 50 mg and 250 mg tablets are directly proportional and bioequivalence was satisfactorily demonstrated in dogs for both active substances.
Maltese: Minkejja dan, l-istudju ta' bijoekwivalenza fil-klieb jipprovdi assigurazzjoni li l-formulazzjoni tal-prodott mhijiex probabbli li tkun fattur li jikkontribwixxi għallimpatt fuq il-bijodisponibilità fil-qtates minħabba li l-pilloli ta' 50 mg u ta' 250 mg huma direttament proporzjonali u l-bijoekwivalenza fil-klieb kienet intweriet b'mod suffiċjenti għaż-żewġ sustanzi attivi.
English: Belgium Dechra Limited, Sansaw Business
Maltese: Id-Danimarka Dechra Limited, Sansaw Business
English: United Kingdom Dechra Limited, Sansaw Business
Maltese: In-Norveġja Dechra Limited, Sansaw Business
English: Consequently the matter was referred to the CVMP.
Maltese: Bħala konsegwenza l-kwistjoni ġiet riferuta lis-CVMP.
English: The active substance in TESLASCAN, mangafodipir, contains manganese, a metal element.
Maltese: Is-sustanza attiva f'TESLASCAN, mangafodipir, fiha l-manganiż, element metalliku.
English: This summary was last updated in 04-2007.©EMEA 2007
Maltese: ©EMEA 2007