FrancophonIA/ELRC3.0 huggingface dataset:
English: - skin cancer; - lack of red blood cells so you are pale and feel tired; being more prone to infections because of a lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to bleed; - decreased appetite; - confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and delusional; - movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes unpredictable changes in symptoms, due to the return of Parkinson's disease symptoms; sleepiness; dizziness; worsening of Parkinson's disease; pins and needles; headache; tremors; seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, balance and speech); distorted sense of taste; mental health disorders that affecting learning, memory, perception, and problem solving; Horner's syndrome (an eye disorder); dementia;
Maltese: Kumpless ta' sintomi li jixbah lis-sindrome malinn newrolettiku (kkaratterizzat minn żieda fittemperatura, riġidità muskolari, bidla fil-livell ta' koxjenza, u instabbiltà awtonomika), mingħajr lebda etjoloġija ovvja oħra, ġie rrappurtat f'assoċjazzjoni ma' tnaqqis fid-doża, twaqqif, jew bidliet rapidi fit-terapija dopaminerġika fl-isfond.
English: Sweat discolouration
Maltese: Disturbi vaskulari
English: No notable differences between placebo and Inbrija were observed in forced expiratory volume in 1 second (FEV1) following the first dose.
Maltese: L-ebda differenzi sinifikanti bejn ilplaċebo u Inbrija ma kienu osservati fil-volum espiratorju sfurzat f'sekonda waħda (FEV1) wara lewwel doża.
English: Inbrija is a medicine used by inhalation for treating the worsening of your symptoms during the “off periods” of Parkinson's disease.
Maltese: Inbrija huwa mediċina li tittieħed man-nifs biex tittratta laggravar tas-sintomi tiegħek matul il-“perjodi off” tal-marda ta' Parkinson.
English: Levodopa has caused visceral and skeletal malformations in rabbits.
Maltese: Levodopa kkawża malformazzjonijiet vixxerali u skeletali fil-fniek.
English: The change from baseline for DLCO was compared between the Inbrija treatment group and the observational cohort; at the end of 12 months, there was no significant difference in the change from baseline between Inbrija group and the observational cohort in DLCO.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl u mill-umdità u neħħi immedjatament qabel l-użu.
English: Parkinson's disease affects your movement and it is treated with a medicine that you take regularly.
Maltese: Il-marda ta' Parkinson taffettwa l-moviment tiegħek u hija ttrattata b'mediċina li tieħu b'mod regolari.
English: (See sections 4.3 and 4.5).
Maltese: (ara sezzjoni 4.3).
English: Erythema multiforme
Maltese: Ekżema Erytema multiforme
English: • cisapride (digestive problems)
Maltese: • cisapride (problemi diġestivi)
English: Date of latest renewal: 9 July 2011
Maltese: Data tal-aħħar tiġdid: 9 ta' Lulju 2011
English: • pimozide (psychiatric problems)
Maltese: • pimozide (problemi psikjatriċi)
English: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Maltese: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160
English: - The active substance is telithromycin.
Maltese: - Is-sustanza attiva hi telithromycin.
English: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Maltese: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Ir-Rumanija
English: -Renal impairment
Maltese: -Indeboliment renali
English: • saquinavir (anti-HIV treatment)
Maltese: • saquinavir (kura kontra l-HIV)
English: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Maltese: Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Ir-Rumanija
English: Available as packs of 10, 14, 20 and 100 tablets.
Maltese: Huma disponibbli f'pakketti ta' 10, 14, 20 u 100 pillola.
English: The volume of distribution is 2.9±1.0 l/kg.
Maltese: Il-volum tad-distrubuzzjoni huwa ta' 2.9±1.0 l/kg.
English: More than 80% of MRSA express cMLSB.
Maltese: Aktar minn 80% ta' MRSA juru cMLSB.
English: • Effect of other medicinal products on Ketek
Maltese: • Effetti ta' prodotti mediċinali oħra fuq Ketek
English: • dronedarone (for atrial fibrillation)
Maltese: • dronedarone (għal fibrillazzjoni atrijali)
English: • terfenadine or astemizole (allergic problems)
Maltese: • terfenadine jew astemizole (problemi ta' allerġija)
English: • ketoconazole or fluconazole (anti-fungal treatment)
Maltese: • ketoconazole jew fluconazole (kura kontra l-infezzjonijiet tal-fungu)
English: Eosinophilia
Maltese: Ejosinofilja
English: Staphylococcus aureus methicillin susceptible (MSSA)*
Maltese: Staphylococcus aureus suxxettibbli għall-methicillin (MSSA)*
English: Arthralgia, myalgia
Maltese: Artralġja, majalġja
English: - The other ingredients are microcrystalline cellulose, povidone (K25), croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol (8000 ), hypromellose (6 cp), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) in the film-coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, povidone (K25), croscarmellose sodium, magnesium stearate fil-qalba tal-pillola kif ukoll talc, macrogol (8000), hypromellose (6 cp), titanium dioxide (E171), iron oxide isfar (E172), iron oxide aħmar (E172) fil-kisja tal-pillola.
English: Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Maltese: Żieda fl-attività ta' l-antikoagulanti kienet rapportata f'pazjenti ittrattati simultanjament blantikoagulanti u l-antibijotiċi, inkluż telithromycin.
English: - some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
Maltese: - xi imblokkaturi tal-kanali tal-kalċju (eż. verapamil, nifedipine, felodipine) (għad-disturbi fil
English: In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ΔQTc >30 msec in 7.6% and 7.0% of cases, respectively.
Maltese: F'studji komparattivi, effetti simili għal dawk osservati b`clarithromycin waqt it-terapija, dehru fil-ΔQTc >30 msec f'7.6% u 7% tal-każijiet, rispettivament.
English: Ketek is an antibiotic of the type macrolides.
Maltese: Ketek huwa antibijotiku tat-tip makrolidi.
English: The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
Maltese: Il-livelli l-aktar baxxi fil-plażma, Cmax, AUC u l-clearance renali, żdiedu b'20%, 73%, 37% u 27%, rispettivament, f'persuni b'saħħithom.
English: No patient in either group developed a ΔQTc >60 msec.
Maltese: ΔQTc >60 msec.
English: Ketek contains the active substance telithromycin.
Maltese: Ketek fih is-sustanza attiva telithromycin.
English: Concomitant administration with simvastatin, atorvastatin, and lovastatin.
Maltese: Jingħata flimkien ma' simvastatin, atorvastatin u lovastatin.
English: Ageusia, anosmia, tremors, convulsions
Maltese: Agewsja, anosmija, tregħid, konvulżjonijiet
English: - phenobarbital or St John's wort (herbal medicine used to treat mild depression) - medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation)
Maltese: - phenobarbital jew St John's wort (mediċina tal-ħxejjex tintuża biex tittratta d-dipressjoni - medicini bħal tacrolimus, cyclosporin u sirolimus (għat-trapjanti ta' l-organi)
English: Telithromycin displays moderate non-linear pharmacokinetics.
Maltese: Telithropmycin juri farmakokinetiċi moderati u mhux linejari.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 9 ta' Lulju 2001
English: Species for which acquired resistance may be a problem Staphylococcus aureus methicillin resistant (MRSA)+
Maltese: Speċi fejn ir-reżistenza akkwistata tista' tkun problema Staphylococcus aureus reżistenti għall-methicillin (MRSA)+
English: The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 3.95±0.53 mg/kg and 6.96±1.58 mg/kg, respectively.
Maltese: L-ogħla konċentrazzjoni tat-totali tat-tessuti fil-likwidu li jmiss ma' l-epitilju, fil-makrofaġi alvejolari, filmukoża tal-bronki, fit-tonsilli u fis-sinus kienu ta' 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 3.95±0.53 mg/kg u 6.96±1.58 mg/kg, rispettivament.
English: The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
Maltese: L-enzima prinċipali ta' CYP450 involuta fil-metaboliżmu ta` telithromycin hija CYP3A4.
English: Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9,
Maltese: Telithromycin huwa impeditur ta' CYP3A4 u CYP2D6, iżda jew m'għandux effett jew għandu wieħed limitat fuq CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 u 2E1.
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Maltese: Kategorija farmakoterapewtika: antibijotiċi għal użu sistemiku, makrolidi, linkosamidi u streptogramini, Kodiċi ATC:
English: • Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
Maltese: • Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes bħala alternattiva meta lantibijotiċi beta-lactam ma jkunux adatti f'pajjiżi/reġuni bi prevalenza sinifikanti ta' S. pyogenes reżistenti għall-makrolidi, meta medjati b'ermTR jew mefA (ara sezzjonijiet 4.4 u 5.1).
English: • Effect of Ketek on other medicinal products
Maltese: • Effetti ta Ketek fuq prodotti mediċinali oħra
English: Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
Maltese: Studji ta interazzjoni ma` itraconazole u ketoconazole, żewġ impedituri ta' CYP3A4, urew li l-livelli massimi ta` telithromycin fil-plażma żdiedu, rispettivament, b' 1.22 u 1.51-il darba, u l-AUC b'1.54 u 2.0-il darba, rispettivament.
English: The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22% of this.
Maltese: Il-clearance totali (medja ± SD) hija ta' madwar 58±5 l/h wara li jingħata fil-vina, waqt li madwar 22% ta' dan iseħħ permezz tal-clearance renali .
English: Ketek has been shown to increase the plasma concentrations of digoxin, a P-glycoprotein substrate.
Maltese: Ketek intwera li jżid il-livelli fil-plażma ta' digoxin, substrat ta' P-glycoprotein.
English: L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
Maltese: L. pneumophila huwa sensittiv ħafna għal telithromycin in vitro, madankollu, l-esperjenza klinika filkura tal-pulmonite ikkaġunata minn Legionella hija limitata.
English: The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg and 1.58±1.68 mg/kg, respectively.
Maltese: Il-konċentrazzjoni totali fit-tessuti, 24 siegħa wara doża waħda, fil-likwidu li jmiss ma' l-epitilju, fil-makrofaġi alvejolari, fil-mukoża tal-bronki, fittonsilli u fis-sinus kienu ta' 0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg u 1.58±1.68 mg/kg, rispettivament.
English: The in vitro protein binding is approximately 60% to 70%.
Maltese: L-ammont ta' antibijotiku marbut mal-proteina in vitro huwa ta' madwar 60% sa 70%.
English: This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Maltese: Dan jista' jtawwal l-intervall tal-QT, arritmji kardijaċi, inkluża takikardja talventrikoli, fibrillazzjoni tal-ventrikoli, u torsades de pointes.
English: QT/QTc interval prolongation, ventricular arrhythmia (including ventricular tachycardia, torsade de pointes) with potential fatal outcome (see section 4.4)
Maltese: Intervall imtawwal talQT/QTc, arritmja ventrikulari (fosthom takikardija ventrikulari, torsade de pointes) li jista' jkollhom eżitu fatali (ara sezzjoni 4.4)
English: Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Maltese: Telithromycin jinpedixxi l-formazzjoni tal-proteini billi jinteraġixxi maż-żoni II u V tal-RNA ribosomali 23S tas-sottounità tar-ribosoma 50S.
English: When simvastatin was coadministered with Ketek, there was a 5.3-fold increase in simvastatin Cmax, an 8.9-fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatin acid AUC.
Maltese: Meta simvastatin ingħata flimkien ma` Ketek kien hemm żieda ta' 5.3 darbiet fil-livell ta` simvastatin Cmax, u żieda ta' 8.9 darbiet fil-livell ta' simvastatin AUC, u 15-il darba aktar fil-livell ta' simvastatin acid Cmax, u żieda ta' 11-il darba l-AUC ta` simvastatin acid.
English: Concomitant administration of Ketek with drugs that are substrates of P-glycoprotein might result in increased exposure to the P-glycoprotein substrates such as digoxin and dabigatran etexilate.
Maltese: It-teħid ta' Ketek flimkien ma' mediċini li huma substrati ta' P-glycoprotein jista' jirriżulta f'żieda fl-espożizzjoni għas-substrati ta' P-glycoprotein bħal digoxin u dabigatran etexilate.
English: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Maltese: − Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes: 800 mg darba kuljum għal 5
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship: The AUC/MIC ratio has been shown to be the PK/PD parameter that correlates best with the efficacy
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (FK/FD): Ġie muri li l-proporzjon AUC/MIC huwa l-parametru FK/FD li jorbot l-aktar mal-effikaċja ta'
English: Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir.
Maltese: Prodotti mediċinali bil-potenzjal li jtawlu l-intervall tal-QT Ketek huwa mistenni li jżid il-livelli fil-plażma ta' cisapride, pimozide, astemizole, terfenadine dronedarone, saquinavir.
English: Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Maltese: Telithromycin huwa impeditur ta` CYP3A4 u impeditur dgħajjef ta' CYP2D6.
English: Hypokalaemia and quinidine had additive/supraadditive effects in vitro while potentiation was evident with sotalol.
Maltese: Ipokalimja u quinidine kellhom effetti addittivi/supra-addittivi in vitro, waqt li b`sotalol l-effett kien rafforzat.
English: In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
Maltese: Minn studju ibbażat fuq doża waħda (ta' 800 mg) fi 12-il pazjent u studju ibbażat fuq dożi multipli (ta' 800 mg) fi 13-il pazjent b`indeboliment epatiku minn ħafif sa sever (Klassi Child Pugh A, B u Ċ), iċĊmax, AUC u t1/2 ta' telithromycin kienu simili meta mqabblin ma' dawk li nstabu f'individwi b'saħħithom, ta' l-istess età u s-sess maskil jew dak femminil.
English: Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with “H3647” on one side and “400” on the other.
Maltese: Il-pilloli ta' Ketek 400 mg huma ta' kulur oranġjo ċar, oblongi, imbuzzati miż-żewġ naħat, miksija b'rita, b' “H3647” imnaqqax fuq naħa waħda u “400” fuq in-naħa l-oħra.
English: These include Class IA (e.g.quinidine, procainamide, disopyramide) and Class III (e.g. dofetilide, amiodarone) antiarrhythmic agents, citalopram, tricyclic antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungals (e.g. fluconazole, pentamidine), and some
Maltese: III (eż. dofetilide, amiodarone) , citalopram, antidippressivi triċikliċi, methadone, xi antipsikotiċi (eż. phenothiazines), fluoroquinolones (eż. moxifloxacin), xi antifungali (eż. fluconazole, pentamidine), u xi mediċini antivirali (eż. telaprevir).
English: Ketek 400 mg film-coated tablets Telithromycin
Maltese: Ketek 400 mg pilloli miksija b'rita Telithromycin
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 ml/min) compared to healthy volunteers were observed and a reduced dosage of Ketek is recommended (see section 4.2).
Maltese: ss, u żieda ta' darbtejn aktar fl-AUC (0-24)ss b'dożi multipli ta' 800 mg fil-grupp ta' pazjenti li kellhom indeboliment sever renali (CLCR <30 ml/min), meta mqabblin ma' voluntiera b'saħħithom; dożaġġ imnaqqas ta' Ketek huwa irrakkomandat (ara sezzjoni 4.2).
English: Concomitant administration with medicinal products that prolong the QT interval and are CYP3A4 substrates, such as cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir (see section
Maltese: L-użu flimkien ma' prodotti mediċinali li jtawlu l-intervall QT u huma substrati ta' CYP3A4 bħal: cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir (ara sezzjoni 4.5).
English: Calcium channel blockers that are metabolized by CYP3A4
Maltese: Imblokkaturi tal-kanali tal-kalċju li huma mmetabolizzati minn CYP3A4
English: In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Maltese: Studji in vivo bissimvastatin, midazolam u cisapride urew inibizzjoni qawwija ta' CYP3A4 intestinali, u inibizzjoni moderata ta' CYP3A4 tal-fwied.
English: Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Maltese: Telithromycin u l-prodotti metaboliċi ewlenin fil-bniedem ma wrewx potenzjal ġenotossiku f'testijiet in vitro u in vivo.
English: Pathogen
Maltese: Digoxin
English: Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Maltese: Madwar terz ta` telithromycin tneħħa kif inhu, 20% fl-ippurgar u 12% fl-awrina.
English: Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues (e.g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been observed in rats and dogs administered telithromycin at repeated doses of 150 mg/kg/day or more for 1 month and 20 mg/kg/day or more for 3-6 months.
Maltese: Il-fosfolipidożi (stat ta' meta jiżdiedu l-ammonti ta' fosfolipidi fiċ-ċelluli), li effettwat numru ta'organi u tessuti (per eżempju, il-fwied, il-kliewi, il-pulmun, it-timu, il-milsa, il-marrara, in-nodi limfatiċi meżenteriċi, u l-passaġġ gastro-intestinali), tfaċċat fil-fariet u l-klieb, li ngħataw telithromycin f'dożi repetuti ta' 150 mg/kg/jum jew aktar, għal xahar, u 20 mg/kg/jum jew aktar, għal 3 sa 6 xhur.
English: Due to a potential to increase the QT interval, Ketek should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, or bradycardia (<50 bpm), during concomitant administration of Ketek with QT interval prolonging agents, or in patients concomitantly treated with potent CYP 3A4 inhibitors such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole) (see sections 4.3 and 4.5).
Maltese: Minħabba l-possibbiltà li jista jtawwal l-intervall tal-QT, Ketek għandu jintuża b'kawtela f'pazjenti li jbatu b'mard koronarju tal-qalb, li għandhom passat ta' taħbit irregolari tal-ventrikoli tal-qalb, livell baxx u mhux korrett tal-potassium u / jew tal-magnesium fid-demm, jew bradikardja (<50 bpm), waqt l-użu ta' Ketek flimkien ma' sustanzi li jtawwlu l-intervall tal-QT, jew f'pazjenti li qed jiġu kkurati flistess ħin b'impedituri qawwija ta' CYP3A4, bħall-impedituri tal-protease jew l-antifungali tat-tip azole (eż. ketoconazole, fluconazole) (ara sezzjonijiet 4.3 u 4.5).
English: Telithromycin is also a P-glycoprotein inhibitor.
Maltese: Telithromycin huwa wkoll inibitur ta' P-glycoprotein.
English: After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Maltese: Wara li telithromycin radjutikkettat jingħata mill-ħalq, 76% tar-radjuattività instabet fl-ippurgar u 17% fl-awrina.
English: Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h. The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
Maltese: Il-half-life ta` l-eliminazzjoni ta' telithromycin hija bejn 2 - 3 sigħat, u l-half-life terminali, inqas importanti, hija madwar 10 sigħat wara doża ta' 800 mg darba kuljum.
English: Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Maltese: Esponimenti fil-plażma ibbażata fuq il-parti tas-sustanza attiva u mhux marbuta, f'livelli meta ma jkunux osservati effetti avversi, kienu minn 1.6 sa 13-il darba l-esponiment kliniku mistenni.
English: The exposure of pravastatin, rosuvastatin and to a lesser extent fluvastatin, may be increased due to possible involvement of transporters proteins, but this increase is expected to be lesser than interactions involving CYP3A4 inhibition.
Maltese: L-esponiment ta' pravastatin, rosuvastatin, u f'dimensjoni anqas fluvastatin, jista' jiżdied minħabba l-possibbilta' ta' involviment tat-trasportaturi tal-proteini, imma din iż-żieda hija mistennija li tkun inqas mill-interazzjonijiet li jinvolvu l- inibizzjoni ta' CYP3A4.
English: When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Maltese: Meta metoprolol (substrat ta' CYP2D6) kien ingħata flimkien ma' Ketek, metoprolol Cmax u l-AUC żdiedu b'madwar 38%; madankollu, ma kienx hemm effett fuq il-half life ta` l-eliminazzjoni ta` metoprolol.
English: Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Maltese: Il-prodott metaboliku ewlieni fiċ-ċirkolazzjoni jirrappreżenta madwar 13% ta` telithromycin AUC, u hu inqas qawwi kontra l-mikrobi minn telithromycin innifsu.
English: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Maltese: • Pulmonite ħafifa jew ta' grad moderat li tkun ittieħdet mill-komunità (ara sezzjoni 4.4)