FrancophonIA/ELRC3.0 huggingface dataset:
English: • has an impact on germinal cells and is reprotoxic in animals and humans, The CHMP is of the view that the overall risk of cancer, early foetal loss and impact on fertility associated with the use of Caustinerf arsenical, Yranicid arsenical and other medicinal products cannot be ruled out and the risk minimisation measures proposed by the MAHs will not allow avoiding the impact on human fertility.
Maltese: • għandu effett fuq ċelloli ġerminali u huwa reprotossiku fl-annimali u fil-bnedmin, Is-CHMP huwa tal-fehma li r-riskju ġenerali ta' kanċer, telf kmieni tal-fetu u l-impatt fuq il-fertilità assoċjat mal-użu ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati ma jistax jiġi eskluż u lmiżuri għat-tnaqqis tar-riskju proposti mill-MAHs ma jippermettux li jiġi evitat l-impatt fuq fertilità umana.
English: • introduce a contraindication in children, pregnant and lactating women;
Maltese: • tiġi introdotta kontraindikazzjoni fit-tfal, nisa tqal u li qed ireddgħu;
English: Finally the CHMP noted that no national, European and international guideline endorse the use of arsenic dental paste in clinical practice.
Maltese: Finalment, is-CHMP innota li ebda linji gwida nazzjonali, Ewropea u internazzjonali ma tappoġġa l-użu ta' pejst dentali arseniku fi prattika klinika.
English: The French National Competent Authority (NCA) considered that the modifications of the SmPC proposed by the MAHs were neither acceptable nor appropriate given the genotoxicity data provided and the recommendation of the expert panel.
Maltese: L-Awtorità Kompetenti Nazzjonali Franċiża (NCA) ikkunsidrat li l-modifikazzjonijiet fl-SmPC proposti millMAH la kienu aċċettabli u lanqas xierqa minħabba d-dejta ta' ġenotossiċità pprovduta u rrakkomandazzjonijiet tal-panil ta' esperti.
English: In its assessment the CHMP considered all available data submitted by the MAHs as well as published literature and data available to the Member States.
Maltese: Dan inkluda t-tweġibiet tal-MAHs, dejta disponibbli għall-Istati Membri u letteratura ppubblikata li saret disponibbli wara l-awtorizzazzjonijiet għat-tqegħid fis-suq oriġinali.
English: • The CHMP took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of Caustinerf arsenical, Yranicid arsenical and associated names for topical use in the painless topical devitalisation of the dental pulp.
Maltese: • Is-CHMP ikkunsidra l-pożizzjoni tal-MAH li kull dejta disponibbli ġiet ipprovduta u li ma kienx possibbli li tiġi pprovduta aktar dejta biex turi l-benefiċċju kliniku ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fid-devitalizzazzjoni bla uġigħ tal-polpa dentali.
English: • The CHMP considered that the available efficacy data, including data which became available since the initial marketing authorisations of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in its approved indication, were limited.
Maltese: • Is-CHMP ikkunsidra li d-dejta disponibbli dwar l-effikaċja, inkluża dejta li saret disponibbli wara lawtorizzazzjonijiet għat-tqegħid fis-suq inizjali ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fl-indikazzjoni approvata, kienet limitata.
English: • The CHMP considered the genotoxicity of arsenic trioxide and that its use is associated with a potential risk of carcinogenicity and serious adverse reactions such as tissue necrosis sometimes leading to sequelae.
Maltese: • Is-CHMP ikkunsidra l-ġenotossiċità ta' arsenic trioxide u li l-użu tiegħu huwa asoċjat ma' riskju potenzjali ta' karċinoġenità u reazzjonijiet avversi serji bħal nekrożi tat-tessut li xi kultant twassal għal sequelae.
English: • the risk of necrosis to periodontal tissues is high in comparison to the other serious adverse events and the necrosis of periodontal tissues together with infectious complications remain a very serious known adverse effect, hard to treat and difficult to control despite the SmPC
Maltese: • ir-riskju ta' nekrożi għal tessuti peridontali huwa ogħli meta mqabbel mal-avvenimenti avversi serji l-oħrajn u n-nekrożi ta' tessuti peridontali flimkien ma' kumplikazzjonijiet infettużi tibqa' effett avvers magħruf serju ħafna, li diffiċli biex jiġi trattat u diffiċli biex jiġi kontrollat minkejja rrakkomandazzjonijiet tas-SmPC.
English: The CHMP is of the view that the reported systemic exposure aggravates the earlier concern about the potential genotoxicity of the products.
Maltese: Is-CHMP huwa talfehma li l-espożizzjoni sistemika rrappurtata żżid it-tħassib preċedenti dwar il ġenotossiċità potenzjali ta' dawn il-prodotti.
English: The CHMP took in account the MAH's position.
Maltese: Is-CHMP qies il-pożizzjoni tal-MAH.
English: • The CHMP therefore concluded, in view of the available data, that the genotoxicity, the risk of carcinogenicity and tissue necrosis associated with the use of Caustinerf arsenical, Yranicid arsenical and associated names for topical use in the treatment of painless topical devitalisation of the dental pulp outweigh the limited benefits.
Maltese: • Is-CHMP għalhekk ikkonkluda, fid-dawl tad-dejta disponibbli, li l-ġenotossiċità, ir-riskju ta' karċinoġenità u nekrożi tat-tessuti assoċjati mal-użu ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fit-trattament ta' devitalizzazzjoni topika bla uġigħ tal-polpa dentali jegħlbu l-benefiċċji limitati.
English: • The monitoring and analysis of reported cases including a specific questionnaire to collect evidence of the indication of the product (use in second intention), sealing of the cavity and the duration of the application.
Maltese: • Is-sorveljanza u l-analiżi tal-każijiet irrappurtati inkluż kwestjonarju speċifiku li jiġbor evidenza tal-indikazzjoni tal-prodott (użu fit-tieni intenzjoni), issiġillar tal-kavità u t-tul tal-aplikazzjoni.
English: • Communication to Health Care Professionals concerning the instructions of use (via a dear Health Care Professional Communication and educational materials).
Maltese: • Komunikazzjoni lil Professjonisti tas-Saħħa dwar l-istruzzjonijiet ta' użu (permezz ta' Komunikazzjoni lil Professjonisti tas-Saħħa u materjal edukattiv).
English: The CHMP therefore concluded that the benefit-risk balance of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in the indication of “painless topical devitalisation of the dental pulp” is not favourable.
Maltese: Is-CHMP għalhekk ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fl-indikazzjoni ta' “devitalizzazzjoni topika bla uġigħ tal-polpa dentali” mhuwiex wieħed favorevoli.
English: After considering the data available and the risk minimisation measures proposed by the MAHs, the CHMP is of the view that the risk of osteonecrosis, soft tissue and dental necrosis, bone fistula and gingival discoloration is highly difficult to minimise or avoid.
Maltese: Wara li kkunsidra d-dejta disponibbli u l-miżuri ta' tnaqqis tar-riskju proposti mill-MAHs, is-CHMP huwa tal-fehma li r-riskju ta' osteonekrożi, nekrożi ta' tessut artab u dentali, fistula tal-għadam u telf fil-kulur tal-ħanek huwa diffiċli ħafna biex jiġi minimizzat jew evitat.
English: The MAHs conducted in vitro testing to assess the genotoxicity of the product Caustinerf arsenical and provided the results of an extensive review performed by an expert in toxicology on the impact of arsenic compounds on somatic cells.
Maltese: Il-MAHs wettqu studji in vitro sabiex jevalwaw il-ġenotossiċità tal-prodott Caustinerf arsenical u pprovdew ir-riżultati ta' reviżjoni estensiva mwettqa minn espert fit-tossikoloġija fuq l-effett ta' komposti talarseniku f'ċelloli somatiċi.
English: To further address the risks of carcinogenicity and tissue necrosis and in response to the outstanding issues expressed by the CHMP, the MAHs propose the following additional risk minimisation measures:
Maltese: Sabiex ikomplu jindirizzaw ir-riskju ta' karċinoġenità u nekrożi tat-tessut u bi tweġiba għall-kwistjonijiet pendenti espressi mis-CHMP, il-MAHs ipproponew il-miżuri ta' minimizzazzjoni tar-riskju li ġejjin:
English: • amendments in the product information in sections 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 and 5.3 of the
Maltese: • emendi fl-informazzjoni dwar il-prodott fis-sezzjonijiet 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 u 5.3 tasSmPC: o li l-indikazzjoni tiġi limitata għall-użu tal-aħħar linja, jiġifieri fis-sitwazzjonijiet meta tekniki ta' anestesija m'humiex disponibbli jew mhumiex possibbli f'pazjenti tal-UE; o li jiġi kontro-indikat l-użu tal-prodotti fit-tfal, f'nisa tqal u f'nisa li qed ireddgħu; o li tissaħħaħ l-indikazzjoni riveduta u kundizzjonijiet lokali, l-issiġillar tal-kavità li tkun qiegħda tiġi trattata sabiex tiġi minimizzata t-tnixxija diretta tal-materjal u d-diffużjoni tal-arseniku, it-tnaqqis tal-espożizzjoni (3 ijiem flok 7 ijiem) b'monitoraġġ mill-qrib u twissija tal-okkorrenza ta' uġigħ;
English: The CHMP considered the proposed changes by the MAHs in the Summary of Product Characteristics and Patient Leaflet to mitigate these risks and concluded that these risk minimisation measures would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level.
Maltese: Is-CHMP ikkunsidra t-tibdiliet proposti mill-MAHs fis-Sommarju tal-Karatteristiċi tal-Prodott u Fuljett talPazjent biex jitnaqqsu dawn ir-riskju u kkonkluda li dawn il-miżuri għat-tnaqqis tar-riskju m'humiex kapaċi jnaqqsu b'mod adegwat ir-riskji ta' reazzjonijiet avversi serji għal livelli klinikament aċċettabli.
English: The provided study demonstrated low but measurable systemic level of arsenic after dental use.
Maltese: L-istudju pprovdut juri livelli sistemiċi baxxi iżda li jistgħu jitkejlu ta' arseniku wara użu dentali.
English: The MAHs confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical benefit of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use containing products in local anaesthesia.
Maltese: Il-MAHs ikkonfermaw li ġiet ipprovduta kull dejta disponibbli u mhux ħa jkunu jistgħu jipprovdu aktar dejta biex jintwerew il-benefiċċji kliniċi ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati ta' prodotti li fihom arseniku għal użu topiku f'anesteżija lokali.
English: With regards to the proposed DUS, the CHMP is of the opinion that it would not be ethically acceptable to expose patients to arsenic trioxide for which an expert panel concluded that a genotoxic, reprotoxic and carcinogenic risks have been demonstrated.
Maltese: Fir-rigward tad-DUS proposti, is-CHMP huwa tal-opinjoni li m'huwiex etikament aċċettabli li l-pazjenti jiġu esposti għal arsenic trioxide li għalih, panil ta' esperti kkonkluda li ntwera riskju ġenotossiku, reprotossiku u karċinoġeniku għalih.
English: The clinical experience in patients ≥75 years is limited.
Maltese: ≥75 sena hija limitata.
English: MSD Α.Φ.Β.Ε.Ε.
Maltese: Ελλάδα MSD Α.Φ.Β.Ε.Ε.
English: • Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)
Maltese: • Grupp Streptococcus anginosus (fosthom S. anginosus, S. intermedius u S. constellatus)
English: mannitol, sodium hydroxide, hydrochloric acid
Maltese: TA' EĊĊIPJENTI mannitol, sodium hydroxide, hydrochloric acid
English: Yellow iron oxide (E172)
Maltese: Yellow iron oxide (E172) 6.2 Inkompatibbiltajiet
English: imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and sertraline (used to treat depression)
Maltese: imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline u sertraline (użati għat-trattament tad-depressjoni)
English: Serotonin syndrome
Maltese: Sindrome ta' serotonin
English: Susceptible (≤S) Resistant (R>)
Maltese: Suxxettibbli (≤S) Reżistenti (R>)
English: Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see section 4.5).
Maltese: Tedizolid huwa inibitur reversibbli, mhux selettiv ta' monoamine oxidase (MAO) in vitro (ara sezzjoni 4.5).
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Maltese: Titanium dioxide (E171)
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Maltese: European Committee on Antimicrobial Susceptibility Testing) huma.
English: The film coat of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Maltese: Il-kisja tar-rita tal-pillola fiha polyvinyl alcohol, titanium dioxide (E171), macrogol, talc u iron isfar (E172).
English: • The active substance is tedizolid phosphate.
Maltese: • Is-sustanza attiva hija tedizolid phosphate.
English: Organisms
Maltese: Organiżmi
English: Elderly (≥65 years)
Maltese: Anzjani (≥65 sena)
English: Beta haemolytic Streptococci of Groups A,B,C,G Viridans group streptococci (Streptococcus anginosus group only)
Maltese: Streptokokki beta emolitiċi tal-Gruppi A,B,C,G Streptokokki tal-grupp viridans (grupp Streptococcus anginosus biss)
English: Vulvovaginal pruritus
Maltese: Ħakk vulvovaġinali
English: Potential serotonergic interactions
Maltese: Interazzjonijiet serotonerġiċi potenzjali
English: Membrane transporters
Maltese: Trasportaturi tal-membrana
English: Laboratoires Merck Sharp & Dohme-Chibret Route de Marsat, Riom 63963, Clermont-Ferrand Cedex 9 France
Maltese: Route de Marsat, Riom 63963, Clermont-Ferrand Cedex 9 Franza
English: Tedizolid phosphate is an oxazolidinone phosphate prodrug.
Maltese: Tedizolid phosphate huwa promediċina tal-fosfat ta' oxazolidinone.
English: In vitro drug combination studies with tedizolid and amphotericin B, aztreonam, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazole, minocycline, piperacillin, rifampicin, terbinafine, trimethoprim/sulfamethoxazole, and vancomycin indicate that neither synergy nor antagonism have been demonstrated.
Maltese: Studji in vitro ta' taħlita mediċinali b'tedizolid u amphotericin B, aztreonam, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazole, minocycline, piperacillin, rifampicin, terbinafine, trimethoprim/sulfamethoxazole, u vancomycin, jindikaw li la ntweriet sinerġija u lanqas intwera antagoniżmu.
English: In vitro studies in human liver microsomes indicate that tedizolid phosphate and tedizolid do not significantly inhibit metabolism mediated by any of the following CYP isoenzymes (CYP1A2, CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6, and CYP3A4).
Maltese: Studju in vitro f'mikrosomi tal-fwied tal-bniedem jindikaw li tedizolid phosphate u tedizolid mhumiex inibituri sostanzjali tal-metaboliżmu medjat minn xi waħda mill-isoenzimi ta' CYP li ġejjin (CYP1A2, CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6, u CYP3A4).
English: The absolute bioavailability of tedizolid is above 90%.
Maltese: Il-bijodisponibbiltà assoluta ta' tedizolid hija aktar minn 90%.
English: Tedizolid inhibits mitochondrial protein synthesis.
Maltese: Tedizolid jinibixxi s-sinteżi tal-proteini mitokondrijali.
English: • sumatriptan, zolmitriptan (used to treat migraine)
Maltese: • sumatriptan, zolmitriptan (użati għat-trattament tal-emigranja) Tqala u treddigħ
English: 6 × 1 tablets in aluminum/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.
Maltese: 6 × 1 pilloli f'fojl tal-aluminju/Polyethylene Terephthalate (PET)/Karta u f'folji ta' doża waħda li ma jistgħux jiftħuhom it-tfal perforati trasparenti tal-polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC).
English: Clostridioides difficile associated diarrhoea (CDAD) has been reported for tedizolid phosphate (see section 4.8).
Maltese: Dijarea assoċjata ma' Clostridioides difficile Dijarea assoċjata ma' Clostridioides difficile (CDAD - Clostridium difficile associated diarrhoea) ġiet irrapportata għal tedizolid phosphate (ara sezzjoni 4.8).
English: Monoamine oxidase inhibition
Maltese: Inibituri ta' monoamine oxidase
English: The eGFR was calculated using the MDRD4 equation.
Maltese: L-eGFR kien ikkalkolat permezz talekwazzjoni MDRD4.
English: Multiple sulfotransferase (SULT) enzymes (SULT1A1, SULT1A2, and SULT2A1) are involved in the biotransformation of tedizolid, to form an inactive and non-circulating sulphate conjugate found in the excreta.
Maltese: Diversi enzimi ta' sulfotransferase (SULT) (SULT1A1, SULT1A2, u SULT2A1) huma involuti fil-bijotrasformazzjoni ta' tedizolid, biex jiffurmaw konjugat ta' sulphate inattiv u li ma jiċċirkolax misjub fl-eskreta.
English: Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Maltese: Sivextro huwa indikat għat-trattament ta' infezzjonijiet batterjali akuti tal-ġilda u fl-istruttura tal-ġilda (ABSSSI - acute bacterial skin and skin structure infections) fl-adulti (ara sezzjonijiet 4.4 u 5.1).
English: Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the microbiologically active moiety, tedizolid.
Maltese: Tedizolid phosphate huwa kkonvertit minn plażma endoġena u phosphatases tat-tessuti għall-parti mikrobijoloġikament attiva, tedizolid.
English: Peripheral neuropathy and optic nerve disorders
Maltese: Newropatija periferali u disturbi fin-nervituri ottiċi
English: Safety was additionally evaluated in a randomized, double-blind, multicenter study conducted in China, the Philippines, Taiwan, and the US, which included a total 292 adult patients treated with tedizolid phosphate 200 mg administered IV and/or oral once daily for 6 days, and 297 patients treated with linezolid 600 mg administered IV and/or oral every 12 hours for 10 days for ABSSSI.
Maltese: Is-sigurtà kienet evalwata b'mod addizzjonali fi studju arbitrarju, b'ħafna ċentri fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża li sar fiċ-Ċina, fil-Filippini, fit-Tajwan, u fl-Istati Uniti, li kien jinkludi totali ta' 292 pazjent adult ittrattati b'tedizolid phosphate 200 mg mogħti IV u/jew mill-ħalq darba kuljum għal 6 ijiem, u 297 pazjent ittrattati b'linezolid 600 mg mogħti IV u/jew mill-ħalq kull 12-il siegħa għal 10 ijiem għal ABSSSI.
English: Table 1 Frequency of adverse reactions by System Organ Class in comparative clinical studies
Maltese: Tabella 1 Frekwenza tar-reazzjonijiet avversi skont il-Klassi tas-Sistemi u tal-Organi fi studji kliniċi komparattivi
English: In Phase 3 studies, subjects taking serotonergic agents including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine (5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded.
Maltese: Fi studji ta' Fażi 3, l-individwi li jieħdu sustanzi serotonerġiċi inkluż antidipressanti bħal inibituri selettivi tat-teħid mill-ġdid ta' serotonin (SSRIs), antidepressanti triċikliċi, u agonisti tar-riċettur ta' 5-hydroxytryptamine (5-HT1) ta' serotonin (triptani), meperidine, jew buspirone ġew esklużi.
English: Sivextro 200 mg tablets tedizolid phosphate
Maltese: Sivextro 200 mg pilloli tedizolid phosphate
English: The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at least 16 times that in immunocompetent animals (see section 4.4).
Maltese: Il-proporzjon tal-AUC/MIC biex tinkiseb batterjostasi fil-ġrieden newtropeniċi kien mill-inqas 16-il darba dak f'annimali immunokompetenti (ara sezzjoni 4.4).
English: Tedizolid is generally not active against Gram-negative bacteria.
Maltese: Tedizolid ġeneralment mhuwiex attiv kontra batterji tat-tip Gram-negattivi.
English: Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.
Maltese: Tedizolid huwa batterjostatiku kontra enterokokki, staphylokokki, u streptokokki in vitro.
English: The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in the pooled controlled Phase 3 clinical studies (tedizolid phosphate 200 mg once daily for 6 days) were nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), and were generally mild to moderate in severity.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi rrapportati l-aktar ta' spiss li jseħħu f'pazjenti li jingħataw tedizolid phosphate f'ġabra ta' studji kliniċi kkontrollati ta' Fażi 3 (tedizolid phosphate 200 mg darba kuljum għal 6 ijiem) kienu nawsja (6.9%), uġigħ ta' ras (3.5%), dijarea (3.2%) u rimettar (2.3%), u ġeneralment kienu ħfief sa moderati fis-severità tagħhom.
English: Merck Sharp & Dohme, Lda Tel: +351 21 4465700 inform_pt@merck.com
Maltese: Merck Sharp & Dohme, Lda Tel: +351 21 4465700
English: , Mg including Lactated Ringer's Injection and Hartmann's Solution.
Maltese: Ca2+, Mg2+), inkluż l-Injezzjoni ta' Lactated Ringer u s-Soluzzjoni ta' Hartmann.
English: • Decrease or loss of skin sensitivity, tingling/prickling skin sensation
Maltese: • Tnaqqis jew telf ta' sensittività tal-ġilda, sensazzjoni ta' tnemnim/tingiż fil-ġilda
English: EU/1/15/991/002 1 vial EU/1/15/991/003 6 vials
Maltese: EU/1/15/991/003 6 kunjetti
English: A special neuropathology study was conducted in pigmented Long Evans rats administered tedizolid phosphate daily for up to 9 months.
Maltese: Studju newropatoloġiku speċjali twettaq f'firien Long Evans ippigmentati mogħtija tedizolid phosphate kuljum sa 9 xhur.
English: • Blurred vision, ‘floaters' (small shapes seen floating in the field of vision)
Maltese: • Vista mċajpra, "floaters" (forom żgħar għaddejjin fil-kamp viżiv)
English: The potential for tedizolid or tedizolid phosphate to inhibit transport of probe substrates of important drug uptake (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2) and efflux transporters (P-gp and BCRP) was tested in vitro.
Maltese: Il-potenzjal għal tedizolid jew tedizolid phosphate li jinibixxu t-trasport ta' substrati użati biex jidentifikaw teħid mill-ġdid importanti tal-mediċina (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, u
English: Following administration of a single 200 mg oral dose of tedizolid phosphate, the pharmacokinetics of tedizolid are not altered in patients with moderate (n=8) or severe (n=8) hepatic impairment (Child-Pugh Class B and C).
Maltese: Wara għoti ta' doża orali waħda ta' 200 mg ta' tedizolid phosphate, il-farmakokinetika ta' tedizolid ma tinbidilx f'pazjenti b'indeboliment moderat (n=8) jew sever (n=8) tal-fwied (Child-Pugh Klassi B u Ċ).
English: Antibacterial activity against other relevant pathogens
Maltese: Attività antibatterjali kontra patoġeni rilevanti oħrajn
English: • methotrexate (used to treat cancer, rheumatoid arthritis or psoriasis)
Maltese: • methotrexate (jintuża għat-trattament tal-kanċer, artrite rewmatojde jew psorjasi)
English: • topotecan (used to treat cancer)
Maltese: • topotecan (jintuża għat-trattament tal-kanċer)
English: Type I (10 ml) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper.
Maltese: Kunjett tal-ħġieġ tat-Tip I (10 ml) ċar tal-borosilicate forma ta' tubu b'tapp tal-gomma chlorobutyl griż silikonizzat.
English: Clostridioides difficile associated diarrhoea
Maltese: Axxessi Kolite bi Clostridioides difficile
English: Tedizolid did not alter activity of selected CYP isoenzymes, but induction of CYP3A4 mRNA was observed in vitro in hepatocytes.
Maltese: isoenzimi magħżula ta' CYP, iżda kienet osservata induzzjoni tal-mRNA ta' CYP3A4 in vitro f'epatoċiti.
English: MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@ msd.no
Maltese: Tlf: +47 32 20 73 00