FrancophonIA/ELRC3.0 huggingface dataset:
English: Tedizolid phosphate was negative for genotoxicity in all in vitro assays (bacterial reverse mutation [Ames], Chinese hamster lung [CHL] cell chromosomal aberration) and in all in vivo tests (mouse bone marrow micronucleus, rat liver unscheduled DNA synthesis).
Maltese: Tedizolid phosphate kien negattiv għal ġenotossiċità fl-assaġġi in vitro kollha (mutazzjoni batterjali maqluba [Ames], aberrazzjoni kromosomali taċ-ċelluli tal-pulmun tal-ħamster Ċiniż [CHL - Chinese hamster lung]) u fit-testijiet in vivo kollha (mikronukleu tal-mudullun tal-għadam tal-ġurdien, sintesi tad-DNA mhux skedata tal-fwied tal-firien).
English: It is available in 6 × 1 tablets in perforated unit-dose blisters.
Maltese: Huwa disponibbli bħala 6 pilloli× 1 f'folji mtaqqbin b'dożi waħdiet.
English: - are taking certain medicines to treat migraine known as “triptans”.
Maltese: - qed tieħu ċerti mediċini użati għat-trattament tal-emigranja magħrufin bħala “triptans”.
English: It is available in packs containing 1 or 6 vials.
Maltese: Disponibbli f'pakketti ta' kunjett 1 u 6 kunjetti.
English: • sulfasalazine (used to treat inflammatory bowel diseases)
Maltese: • sulfasalazine (jintuża għat-trattament ta' mard infjammatorju fil-musrana)
English: The pharmacokinetics of tedizolid in elderly healthy volunteers (age 65 years and older, with at least 5 subjects at least 75 years old; n=14) was comparable to younger control subjects (25 to 45 years old; n=14) following administration of a single oral dose of tedizolid phosphate 200 mg.
Maltese: Il-farmakokinetika ta' tedizolid f'voluntiera anzjani f'saħħithom (li għandhom 65 sena u aktar, b'talinqas 5 individwi li għandhom tal-inqas 75 sena; n=14) kienet paragunabbli ma' individwi iżgħar bħala kontroll (25 sa 45 sena; n=14) wara għoti ta' doża orali waħda ta' tedizolid phosphate 200 mg.
English: Appropriate supportive measures, antibiotic treatment of C. difficile, and surgical evaluation should be considered.
Maltese: Miżuri ta' appoġġ xierqa, trattament antibijotiku ta' C. difficile, u evalwazzjoni kirurġika għandhom jiġu kkunsidrati.
English: Multiple sulfotransferase (SULT) isoforms (SULT1A1, SULT1A2, and SULT2A1) were identified in vitro that are capable of conjugating tedizolid which suggests that no single isozyme is critical to the clearance of tedizolid.
Maltese: Ġew identifikati isoformi multipli (SULT1A1, SULT1A2, u SULT2A1) ta' sulfotransferase (SULT) in vitro li huma kapaċi jikkonjugaw tedizolid li jissuġġerixxi li l-ebda isoenzima waħedha ma hija kruċjali għat-tneħħija ta' tedizolid.
English: Česká republika Merck Sharp & Dohme s.r.o.
Maltese: Slovenská republika Merck Sharp & Dohme, s. r. o.
English: The most commonly observed mutations in staphylococci and enterococci that result in oxazolidinone resistance are in one or more copies of the 23S rRNA genes (G2576U and T2500A).
Maltese: Il-mutazzjonijiet osservati l-aktar komuni fi staphylokokki u enterokokki li jirriżultaw f'reżistenza għal oxazolidinone huma f'kopja waħda jew aktar tal-ġeni 23S rRNA (G2576U u T2500A).
English: Tedizolid, generated from tedizolid phosphate after metabolic activation (in vitro and in vivo), was also tested for genotoxicity.
Maltese: Tedizolid, iġġenerat minn tedizolid phosphate wara attivazzjoni metabolika (in vitro u in vivo), kien ittestjat ukoll għal ġenotossiċità.
English: In a clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), midazolam AUC and Cmax when co-administered with tedizolid phosphate were 81% and 83% of midazolam AUC and Cmax when administered alone, respectively.
Maltese: (2 mg) ta' midazolam (sustrat ta' CYP3A4) waħdu jew f'kombinazzjoni ma' tedizolid phosphate (doża orali ta' 200 mg darba kuljum għal 10 ijiem), l-AUC u s-Cmax ta' midazolam meta ingħata flimkien ma' tedizolid phosphate kienu 81% u 83% l-AUC u s-Cmax ta' midazolam meta ingħata waħdu, rispettivament.
English: Film-coated tablet 6 x 1 film-coated tablets
Maltese: Pillola miksija b'rita 6 x 1 pilloli miksijin b'rita
English: 3) or severely immunocompromised patients.
Maltese: <1,000 ċellula/mm3) jew pazjenti immunokompromessi severament.
English: Oval (13.8 mm long by 7.4 mm wide) yellow film-coated tablet debossed with “TZD” on the obverse side and “200” on the reverse side.
Maltese: Pillola ovali (twila 13.8 mm u wiesgħa 7.4 mm) safra miksija b'rita mnaqqxa b'“TZD” fuq in-naħa ta' quddiem u b‘200' fuq in-naħa ta' wara.
English: Medicinal products inhibiting peristalsis are contraindicated in this situation.
Maltese: Prodotti mediċinali li jinibixxu l-peristalsi huma kontraindikati f'din is-sitwazzjoni.
English: • statins such as pitavastatin, rosuvastatin (used to lower blood cholesterol)
Maltese: • statins bħal pitavastatin, rosuvastatin (jintużaw biex ibaxxu l-kolesterol fid-demm)
English: Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.
Maltese: It-trattament b'sustanzi antibatteriċi jbiddel il-flora normali tal-kolon u jista' jippermetti tkabbir żejjed ta' C. difficile.
English: A second resistance mechanism is encoded by a plasmid-borne and transposon associated chloramphenicol-florfenicol resistance (cfr) gene, conferring resistance in staphylococci and enterococci to oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramin A and 16-membered macrolides.
Maltese: Mekkaniżmu ta' reżistenza ieħor huwa kowd speċifikat minn ġene ta' reżistenza għal chloramphenicol-florfenicol (cfr - chloramphenicol-florfenicol resistance) li jinġarr mill-plasmid u huwa assoċjat ma' transposon, li jikkonferixxi reżistenza fi staphylokokki u enterokokki għal oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramini A u makrolidi b'16-il membru.
English: Infusion related reaction Peripheral oedema
Maltese: Reazzjoni marbuta mal-infużjoni Edema periferali
English: Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11
Maltese: Antibatteriċi għal użu sistemiku, antibatteriċi oħra, Kodiċi ATC:
English: Table 1 Frequency of adverse reactions by System Organ Class in pooled Phase 3 comparative clinical studies
Maltese: Tabella 1 Frekwenza tar-reazzjonijiet avversi skont il-Klassi tas-Sistemi u tal-Organi f'ġabra ta' studji kliniċi komparattivi ta' Fażi 3 Klassi tas-Sistemi u tal-Organi
English: Organisms resistant to oxazolidinones via mutations in chromosomal genes encoding 23S rRNA or ribosomal proteins (L3 and L4) are generally cross-resistant to tedizolid.
Maltese: Lorganiżmi reżistenti għal oxazolidinones permezz ta' mutazzjonijiet fil-ġeni kromosomali li jispeċifikaw il-kowd ta' 23S rRNA jew il-proteini tar-ribosoma (L3 u L4) ġeneralment għandhom reżistentza inkroċjata għal tedizolid.
English: The median tyramine dose required to cause an increase in systolic blood pressure of ≥30 mmHg from pre-dose baseline was 325 mg with tedizolid phosphate compared to 425 mg with placebo.
Maltese: Id-doża medjana ta' tyramine meħtieġa li tikkawża żieda fil-pressjoni tad-demm sistolika ta' ≥30 mmHg mil linja bażi qabel id-doża kienet 325 mg b'tedizolid phosphate meta mqabbla ma' 425 mg bi plaċebo.
English: Lactic acidosis has been reported with the use of another member of the oxazolidinone class.
Maltese: Aċidożi lattika Aċidożi lattika ġiet irrapportata bl-użu ta' membru ieħor tal-klassi ta' oxazolidinone.
English: The pharmacokinetics of tedizolid were evaluated in adolescent subjects (12 to 17 years; n=20) following administration of a single oral or IV dose of tedizolid phosphate 200 mg.
Maltese: Il-farmakokinetika ta' tedizolid ġiet evalwata f'individwi adolexxenti (12 sa 17 il sena; n=20) wara lgħoti ta' doża orali jew ġol-vina waħda ta' tedizolid phosphate 200 mg.
English: Foetal developmental effects occurring in mice in the absence of maternal toxicity included reduced foetal weights and an increased incidence of costal cartilage fusion (an exacerbation of the normal genetic predisposition to sternal variations in the CD-1 strain of mice) at the high dose of 25 mg/kg/day (4-fold the estimated human exposure level based on AUCs).
Maltese: Effetti fl-iżvilupp tal-fetu li jseħħu fil-ġrieden fin-nuqqas ta' tossiċità tal-omm inkluż tnaqqis fil-piżijiet tal-fetu u żieda fl-inċidenza ta' fużjoni talqarquċa kostali (taħrix tal-predisposizzjoni ġenetika normali għal varjazzjonijiet sternali fir-razza CD-1 tal-ġrieden) bid-doża għolja ta' 25 mg/kg/jum (4-darbiet il-livell ta' espożizzjoni tal-bniedem ibbażat fuq l-AUCs).
English: In vitro studies have shown that drug interactions between tedizolid and inhibitors or inducers of cytochrome P450 (CYP) isoenzymes are unanticipated.
Maltese: Studji in vitro urew li mhumiex antiċipati interazzjonijiet bejn il-mediċini bejn tedizolid u inibituri jew indutturi tal-isoenzimi taċ-ċitokrom P450 (CYP).
English: Spontaneous reports of serotonin syndrome associated with the co-administration of another member of the oxazolidinone class together with serotonergic agents have been reported (see section 4.5).
Maltese: Ġew irrapportati rapporti spontanji ta' sindrome ta' serotonin assoċjati mal-għoti flimkien ta' membru ieħor tal-klassi ta' oxazolidinone flimkien mas-sustanzi serotonerġiċi (ara sezzjoni 4.5).
English: • Anxiety, irritability, shaking or trembling
Maltese: • Ansjetà, irritabbiltà, tregħid jew tertir
English: It belongs to a group of medicines called “oxazolidinones.”
Maltese: Huwa jifforma parti minn grupp ta' mediċini msejħa “oxazolidinones”.
English: The average binding of tedizolid to human plasma proteins is approximately 70-90%.
Maltese: It-twaħħil medju ta' tedizolid mal-proteini tal-plażma tal-bniedem huwa madwar 70-90%.
English: Vulvovaginal mycotic infection Fungal infection Vulvovaginal candidiasis Abscess
Maltese: Infezzjoni mikotika vulvo vaġinali
English: At steady state, tedizolid mean (SD) Cmax values of 2.2 (0.6) and 3.0 (0.7) mcg/mL and AUC values of 25.6 (8.5) and 29.2 (6.2) mcg·h/mL were similar with oral and IV administration of tedizolid phosphate, respectively.
Maltese: Fi stat fiss, il-medja tal-valuri tas-Cmax (SD) ta' tedizolid ta' 2.2 (0.6) u 3.0 (0.7) mkg/mL u l-valuri talAUC ta' 25.6
English: Sivextro is an antibiotic that contains the active substance tedizolid phosphate.
Maltese: Sivextro huwa antibijotiku li fih is-sustanza attiva tedizolid phosphate.
English: The following adverse reactions have been identified in two comparative pivotal Phase 3 studies with Sivextro (Table 1).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati f'żewġ studji komparattivi pivitali ta' Fażi 3 u studju wieħed wara l-awtorizzazzjoni b'Sivextro (Tabella 1).
English: There is no Phase 3 clinical experience in patients with co-administration of tedizolid phosphate with serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medicines with potential adrenergic or serotonergic activity.
Maltese: [SSRI], inibituri tat-teħid millġdid ta' norepinephrine u serotonin (SNRI), antidipressanti triċikliċi, inibituri MAO, triptani, u mediċini oħrajn bil-possibbiltà ta' attività adrenerġika jew serotonerġika.
English: Pharmacokinetic studies were conducted in healthy volunteers and population pharmacokinetic analyses were conducted in patients from Phase 3 studies.
Maltese: Studji farmakokinetiċi twettqu f'voluntiera f'saħħithom u analiżijiet farmakokinetiċi tal-popolazzjoni twettqu f'pazjenti minn studji ta' Fażi 3.
English: - are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors).
Maltese: (inibituri selettivi tat-teħid mill-ġdid ta' serotonin) jew MAOIs (inibituri ta' monoamine oxidase).
English: Tedizolid was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow micronucleus assay.
Maltese: Tedizolid kien pożittiv f'assaġġ tal-aberrazzjoni kromosomali taċ-ċellula ta' CHL in vitro, iżda negattiv għal ġenotossiċità f'assaġġi oħrajn in vitro (Ames, mutaġeniċità tal-limfoma tal-ġrieden) u in vivo f'assaġġ tal-mikronukleu tal-mudullun tal-għadam tal-ġurdien.
English: • Allergic reaction
Maltese: • Reazzjoni allerġika
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: In cases where tedizolid phosphate was discontinued, the affected haematological parameters have returned back to pre-treatment levels.
Maltese: Fil-każijiet fejn tedizolid phosphate twaqqaf, il-parametri ematoloġiċi affettwati rritornaw lura għal-livelli ta' qabel it-trattament.
English: Lymphadenopathy
Maltese: FARMAĊEWTIKU
English: Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com
Maltese: Tel: +34 91 321 06 00 msd_info@merck.com
English: Irritability Pyrexia
Maltese: Tkexkix Irritabbiltà Deni
English: The elimination half-life of tedizolid is approximately 12 hours and the intravenous clearance is 6-7 L/h.
Maltese: Il-half life tal-eliminazzjoni ta' tedizolid hija madwar 12-il siegħa u l-eliminazzjoni mill-vina hija 6-7 L/siegħa.
English: Nasal dryness Pulmonary congestion
Maltese: Imnieħer xott Konġestjoni pulmonari
English: • The other ingredients are mannitol, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
Maltese: • Is-sustanzi mhux attivi l-oħra huma mannitol, sodium hydroxide (għall-aġġustament tal-pH) u hydrochloric acid (għall-aġġustament tal-pH).
English: Urticaria
Maltese: Infużjoni
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30%
Maltese: Is-Cmax u l-AUC ta' tedizolid żdiedu bejn wieħed u ieħor proporzjonalment għad-doża f'medda ta' doża orali unika ta' 200 mg sa 1,200 mg u fil-medda kollha tad-doża ġol-vina ta' 100 mg sa 400 mg.
English: Effects of other medicines on Sivextro
Maltese: L-Effetti ta' mediċini oħra fuq Sivextro
English: • Respiratory tract (sinuses, throat and chest) infection
Maltese: • Infezzjoni fil-passaġġ respiratorju (sinus, griżmejn u sider)
English: Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been reported in patients treated with another member of the oxazolidinone class and the risk of these effects appeared to be related to the duration of treatment.
Maltese: Majelosoppressjoni (fosthom anemija, lewkopenja, panċitopenja u tromboċitopenja) ġiet irrapportata f'pazjenti ittrattati b'membru ieħor tal-klassi ta' oxazolidinone u r-riskju ta' dawn l-effetti deher li kien relatat mat-tul tat-trattament.
English: The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal products is unlikely.
Maltese: Il-mekkaniżmu ta' azzjoni huwa differenti minn dak ta' prodotti mediċinali antibatteriċi tal-klassi nonoxazolidinone; għalhekk, reżistenza inkroċjata bejn tedizolid u klassijiet oħra ta' prodotti mediċinali antibatteriċi hija improbabbli.
English: Pruritus allergic Rash maculo-papular Rash papular Rash pruritic
Maltese: Ħakk allerġiku Raxx, makulo-papulari
English: These dose levels equate to exposure margins of ≥ 5.3-fold for males and ≥ 4.2-fold for females relative to tedizolid plasma AUC0-24 levels at the human oral therapeutic dose.
Maltese: Dawn il-livelli ta' dożi huma ekwivalenti għal marġini ta' espożizzjoni ta' ≥5.3 darbiet għall-irġiel u ≥4.2 darbiet għan-nisa meta mqabbla mal-livelli tal-AUC0-24 ta' tedizolid fil-plażma bid-doża terapewtika orali tal-bniedem.
English: Ελλάδα
Maltese: Uġigħ ta' ras
English: For administration, the reconstituted solution must be further diluted in 250 mL 0.9% sodium chloride.
Maltese: Għall-għoti, is-soluzzjoni rikostitwita għandha titħallat aktar b'250 mL ta' 0.9% sodium chloride.
English: The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts <1,000 cells/mm
Maltese: Is-sigurtà u l-effikaċja ta' tedizolid phosphate f'pazjenti b'newtropenja (għadd ta' newtrofili < 1,000 ċelluli/mm3) ma ġewx investigati.
English: The AUC/MIC ratio was the pharmacodynamic parameter shown to best correlate with efficacy in mouse thigh and lung S. aureus infection models.
Maltese: Il-proporzjon ta' AUC/MIC kien il-parametru farmakondinamiku muri li jikkorrelata l-aħjar maleffikaċja fil-mudelli ta' infezzjoni S. aureus tal-koxxa u l-pulmun tal-ġrieden.
English: Serotonergic agents
Maltese: Sustanzi serotonerġiċi
English: Due to a hydroxymethyl group in the C5 position, tedizolid retains activity against strains of Staphylococcus aureus that express the cfr gene in the absence of chromosomal mutations.
Maltese: Minħabba grupp ta' hydroxymethyl fil-pożizzjoni C5, tedizolid iżomm attività kontra razez ta' Staphylococcus aureus li jesprimu l-ġene cfr fin-nuqqas ta' mutazzjonijiet kromosomali.
English: Other medicines and Sivextro
Maltese: Mediċini oħra u Sivextro
English: Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets.
Maltese: Dożaġġ ripetut orali u ġol-vina ta' tedizolid phosphate fi studji tossikoloġiċi ta' xahar u 3-xhur filfirien ipproduċew ipoċellularità tal-mudullun tal-għadam (ċelluli mijelojdi, eritrojdi, u megakarjoċiti) li kienet tiddependi fuq id-doża u ż-żmien, bi tnaqqis assoċjat fl-RBCs, WBCs u plejtlits li jiċċirkolaw.
English: Alternative therapies should be considered when treating patients with neutropenia and ABSSSI (see section 5.1).
Maltese: Għandhom jiġu kkunsidrati terapiji alternattivi waqt it-trattament ta' pazjenti b'newtropenja u b'ABSSSI (ara sezzjoni 5.1).
English: Adrenergic agents
Maltese: Sustanzi adrenerġiċi
English: Vascular disorders
Maltese: Paraestesija Ipoestesija
English: Tedizolid is primarily active against Gram-positive bacteria.
Maltese: Tedizolid huwa primarjament attiv kontra batterji Gram pożittivi.
English: There are limited data in patients on the interaction between serotonergic agents and tedizolid phosphate.
Maltese: Hemm data limitata f'pazjenti dwar l-interazzjoni bejn is-sustanzi serotonerġiċi u tedizolid phosphate.
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with tedizolid phosphate.
Maltese: Fi studju kliniku li qabbel il-farmakokinetika ta' doża waħda (10 mg) ta' rosuvastatin (sustrat talProteina ta' Reżistenza tal-Kanċer tas-Sider [BCRP - Breast Cancer Resistant Protein]) waħdu jew f'kombinazzjoni ma' tedizolid phosphate (doża orali ta' 200 mg darba kuljum), l-AUC u s-Cmax ta'
English: Danmark MSD Danmark ApS Tlf: +45 4482 4000 dkmail@merck.com
Maltese: Tlf: +45 4482 4000
English: This study used sensitive morphologic evaluation of perfusion-fixed peripheral and central nervous system tissue.
Maltese: Dan l-istudju uża evalwazzjoni morfoloġika sensittiva ta' tessut periferali u tas-sistema nervuża ċentrali ppreservat permezz ta' perfużjoni.
English: No evidence of neurotoxicity, including neurobehavioral changes or optic or peripheral neuropathy, was associated with tedizolid after 1, 3, 6 or 9 months of oral administration up to doses with plasma exposure levels (AUC) up to 8-fold greater than the expected human plasma exposure at the oral therapeutic dose.
Maltese: newrotossiċità, inkluż il-bidliet fl-imġiba newroloġika jew in-newropatija ottika jew periferali, assoċjata ma' tedizolid wara l-1, 3, 6 jew 9 xhur ta' għoti orali sa dożi b'livelli ta' espożizzjoni filplażma (AUC) sa 8-darbiet akbar mill-espożizzjoni mistennija fil-plażma tal-bniedem fid-doża terapewtika orali.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Sivextro
English: C-labeled tedizolid phosphate under fasted conditions, the majority of elimination occurred via the liver with 81.5% of the radioactive dose recovered in faeces and 18% in urine, with most of the elimination (>85%) occurring within 96 hours.
Maltese: Wara għoti orali wieħed ta' tedizolid phosphate ttikkettat b'14C f'kundizzjonijiet ta' sawm, il-maġġoranza tal-eliminazzjoni seħħet fil-fwied b'81.5% tad-doża radjoattiva rkuprata fl-ippurgar u bi 18% flawrina, bil-biċċa l-kbira tal-eliminazzjoni (>85%) sseħħ fi żmien 96 siegħa.
English: Tedizolid phosphate had no adverse effects on the fertility or reproductive performance of male rats, including spermatogenesis, at oral doses up to the maximum tested dose of 50 mg/kg/day, or adult female rats at oral doses up to the maximum tested dose of 15 mg/kg/day.
Maltese: firien irġiel, inkluż l-ispermatoġenesi, f'dożi orali sal-akbar doża ttestjata ta' 50 mg/kg/jum, jew firien nisa adulti f'dożi orali sal-akbar doża ttestjata ta' 15 mg/kg/jum.
English: The potential for serotonergic interactions has not been studied in either patients or healthy volunteers (see section 5.2).
Maltese: Il-potenzjal għal interazzjonijiet serotonerġiċi ma ġiex studjat la fuq pazjenti u lanqas fuq voluntiera f'saħħithom (ara sezzjoni 5.2).
English: Tedizolid is a reversible inhibitor of monoamine oxidase (MAO) in vitro; however, no interaction is anticipated when comparing the IC50 for MAO-A inhibition and the anticipated plasma exposures in man. Drug interaction studies to determine effects of 200 mg oral tedizolid phosphate at steady state on pseudoephedrine and tyramine pressor effects were conducted in healthy volunteers.
Maltese: Tedizolid huwa inibitur riversibbli ta' monoamine oxidase (MAO) in vitro; madankollu, ma hija mistennija l-ebda interazzjoni meta wieħed iqabbel l-IC50 għall-inibizzjoni ta' MAO-A u l espożizzjonijiet fil-plażma mistennija fil-bniedem.
English: Hyperhidrosis Pruritus
Maltese: Ħakk ġeneralizzat Iperidrożi
English: Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe renal impairment defined as eGFR <30 mL/min, the Cmax was basically unchanged and AUC0-∞ was changed by less than 10% compared to 8 matched healthy subject controls.
Maltese: Wara għoti ta' doża waħda ġol-vina ta' 200 mg ta' tedizolid phosphate lil 8 individwi b'indeboliment renali sever iddefinit bħala eGFR <30 mL/min, is-Cmax baqa' bażikament mhux mibdul u l-AUC0-∞ inbidel b'inqas minn 10% meta mqabbel ma' 8 kontrolli ta' individwi f''saħħithom korrispondenti.
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u fis sider
English: The pharmacokinetics of tedizolid were similar in males and females.
Maltese: Il-farmakokinetika ta' tedizolid kienet simili bejn l-irġiel u n-nisa.
English: The safety profile in this study was similar to the Phase 3 clinical trials; however, infusion site reactions (phlebitis) were reported more frequently (2.7%) in tedizolid phosphate treated subjects than in the linezolid control group (0%), particularly among Asian patients.
Maltese: Il-profil ta' sigurtà f'dan l-istudju kien jixbah lill-provi kliniċi ta' Fażi 3; madankollu, reazzjonijiet fil-post tal-infużjoni (flebite) ġew irrappurtati b'mod aktar frekwenti (2.7%) f'individwi trattati b'tedizolid phosphate milli fil-grupp ta' kontroll ta' linezolid (0%), b'mod partikolari fost pazjenti Asjatiċi.
English: Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate.
Maltese: Kull kunjett fih disodium tedizolid phosphate li jikkorrispondi għal 200 mg tedizolid phosphate.