FrancophonIA/ELRC3.0 huggingface dataset:
English: Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
Maltese: Telithromycin huwa derivat semi-sintetiku ta' erythromycin A li jappartjeni għall-ketolidi, klassi ta' antibijotiċi relatati mal-makrolidi.
English: Concomitant administration of Ketek and colchicine in patients with renal and/or hepatic impairment (see section 4.5).
Maltese: It-teħid ta' Ketek flimkien ma colchicine f'pazjenti b'indeboliment renali u/jew epatiku (ara sezzjoni 4.5)
English: Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Maltese: Dawn l-effetti deheru meta l-livelli ta' mediċina mhux marbuta fil-plażma kienu 8 sa 13-il darba tal-livell mistenni waqt l-użu kliniku.
English: Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Maltese: Telithromycin, iżda mhux il-prodotti metaboliċi umani ewlenin tiegħu, kellu attività impeditriċi fuq il-kanali HERG u Kv1.5.
English: There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
Maltese: Ma kienx hemm rapporti ta' TdP jew arritmji tal-ventrikoli tal-qalb, jew sinkope relatata, fil-programm kliniku, u ebda subgruppi li kienu f'riskju ma kienu identifikati.
English: The marketing authorisation holder of Ketek is:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur:
English: Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Maltese: Għalhekk, meta jingħata flimkien ma' indutturi ta' CYP3A4 (bħal ir-rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) huwa probabbli li jirriżulta f'livelli ta' telithromycin anqas minn dawk terapewtiċi, b'nuqqas ta' effikaċja. Linduzzjoni tonqos gradwalment f'temp ta' ġimgħatejn mill-waqfien tal-kura b'indutturi ta' CYP3A4.
English: In patients with severely impaired renal and/or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole), is contraindicated.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi u/jew tal-funzjoni epatika, l-użu konkomitanti ta' Ketek ma' impedituri qawwija ta' CYP3A4, bħall-impeditur ta' protease jew l-antifungali tat-tip azole (eż. ketoconazole, fluconazole), huwa kontra-indikat.
English: Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Maltese: Ranitidine (meta jittieħed siegħa qabel Ketek) u sustanzi kontra l-aċidu fl-istonku li għandhom aluminium u magnesium hydroxide, m'għandhomx effetti kliniċi rilevanti fuq il-farmakokinetiċi ta`
English: Although Ketek has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Maltese: Għalkemm ma kienx hemm interazzjoni farmakokinetika u farmakodinamika meta ingħatat doża waħda ta` Ketek ma` warfarin, għandu jkun ikkunsidrat l-immoniterjar aktar spiss talprothrombin time/INR (International Normalised Ratio) waqt il-kura konkomitanti.
English: The usual duration of treatment is 5 days for infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and 7 to 10 days for pneumonia.
Maltese: It-tul ta' żmien tal-kura huwa normalment 5 ijiem għall-infezzjonijiet tal-gerżuma, infezzjonijiet tassinuses ta' l-imnieħer, u infezzjonijiet tal-passaġġi respiratorji f'dawk il-pazjenti li ilhom ibatu minn diffikultajiet fin-nifs, u minn 7 sa 10 ijiem għall-pulmonite.
English: Resistant
Maltese: Disturbi
English: In in vitro studies the activity of telithromycin was reduced against organisms that express the erythromycin erm(B) or mef(A) related resistance mechanisms.
Maltese: Fi studji in vitro, l-attività ta' telithromycin kienet mnaqqsa kontra l-organiżmi li juru il-mekkaniżmi ta' reżistenza li għandhom x'jaqsmu ma' erythromycin erm(B) jew mef(A).
English: • a medicine called protease inhibitor (anti-HIV treatment)
Maltese: • mediċina li tissejaħ inibitur tal-protease (trattament kontra
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: mediated resistance in vitro in Staphylococcus aureus, Streptococcus pneumoniae, or Streptococcus
Maltese: In vitro, fil-batteri Staphylococcus aureus, Streptococcus pneumoniae, jew Streptococcus pyogenes, telithromycin ma jwassalx għat-turija ta' reżistenza kkawżata mill-makrolidi-lincosamide
English: Colchicine intoxication, including fatal cases, has been reported in patients treated with colchicine and strong CYP 3A4 inhibitors.
Maltese: Avvelenament b'colchicine, li inkludew każijiet fatali, ġew irrapportati f'pazjenti kkurati b'colchicine u inibituri qawwijin ta' CYP3A4.
English: The affinity of telithromycin for the 50S ribosomal subunits of organisms susceptible to erythromycin A is 10-fold higher than that of erythromycin A.
Maltese: L-affinità ta` telithromycin għas-sottounitajiet tar-ribosomi 50S tal-organiżmi li huma sensittivi għal erythromycin A hija 10 darbiet ogħla minn dik ta' erythromycin A.
English: This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Maltese: Din liskema tikkorrispondi għall-espożizzjoni sistemika ta' livelli ta' sustanza attiva u libera ta' mhux anqas minn 9 darbiet il-livelli mistennija fil-bniedem wara xahar, u anqas minn darba il-livell mistenni fil-bniedem wara sitt xhur, rispettivament.
English: Telithromycin has been shown to decrease the Cmax by 34 % and AUC of sotalol by 20 % due to
Maltese: Ġie muri li telithromycin inaqqas is-Cmax b'34 % u l-AUC ta' sotalol b'20 % minħabba tnaqqis fl
English: Blood electrolytes (especially potassium) must be controlled.
Maltese: Lelettroliti (speċjalment potassium) għandhom ikunu kontrollati.
English: Concomitant administration with ergot alkaloid derivatives (such as ergotamine and
Maltese: L-użu flimkien ma' derivattivi alkalojdi tal-ergot (bħal ergotamine u dihydroergotamine) (ara sezzjoni
English: Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
Maltese: (bħal irrifampiċin, phenytoin, carbamazepine, phenobarbital u St John's wort).
English: Streptococcus pyogenes that show high-level resistance to erythromycin A are cross-resistant to
Maltese: Streptococcus pyogenes li juru reżistenza qawwija għal erythromycin A huma wkoll reżistenti għal
English: Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Maltese: Minn data ibbażata fuq simulazzjoni, sistema ta' dożaġġ li talterna bejn 800 mg kuljum u 400 mg kuljum f'pazjenti b'indeboliment sever renali tapprossima l-AUC (0-48 sigħat) f'individwi b'saħħithom li jirċievu 800 mg darba kuljum.
English: • ergotamine or dihydroergotamine (tablets or inhaler for migraine)
Maltese: • ergotamine jew dihydroergotamine (pilloli jew sustanza li tittieħed man-nifs (inħejler) għall-emikranja)
English: If you have kidney problems (severe renal insufficiency) you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Maltese: Jekk għandek problemi tal-kliewi (indeboliment sever tal-kliewi) għandek tieħu 800 mg kuljum (żewġ pilloli ta' 400 mg) li talterna ma 400 mg kuljum (pillola waħda ta' 400 mg), u tibda bid-doża
English: Pregnancy, breast-feeding and fertility
Maltese: Cyclosporin, tacrolimus, sirolimus
English: During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Maltese: Meta jingħata f'dożi repetuti ma` rifampicin u telithromycin, is-Cmax u l-AUC ta` telithromycin kienu mnaqqsin b'medja ta' 79% u 86%, rispettivament.
English: Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Maltese: Id-derivattivi alkalojdi ta' ergot (bħal ergotamine u dihydroergotamine) Permezz t'estrapolazzjoni mill-erythromycin A u l-josamycin, l-użu ta' Ketek u d-derivattivi alkalojdi flimkien jistgħu jwasslu għal spażmu sever ta' l-arterji (ergotiżmu), li jista' jwassal għall-nekrożi ta' lestremitajiet.
English: The majority of methicillin-resistant S. aureus (MRSA) express cMLSB.
Maltese: Il-biċċa l-kbira ta' S.aureus reżistenti għall-metiċillina (MRSA) juru
English: This should be taken into account when treating infections caused by H. influenzae.
Maltese: Dan għandu jitqies waqt kura għal infezzjoniet ikkaġunati minn H.
English: Atrial arrhythmia, hypotension, bradycardia
Maltese: Arritmija ta' l-atriji tal-qalb, pressjoni baxxa, bradikardja
English: Concomitant administration of strong CYP3A4 inhibitors (such as telithromycin) and calcium channel blockers that are metabolized by CYP3A4 (e.g. verapamil, nifedipine, felodipine) may result in hypotension, bradycardia or loss of consciousness, and should therefore be avoided.
Maltese: (bħal telithromycin) flimkien ma' imblokkaturi tal-kanali tal-kalċju li huma mmetabolizzati minn CYP3A4 (eż. verapamil, nifedipine, felodipine) jista' jirriżulta f'ipotensjoni, bradikardija jew telf mis-sensi u għalhekk għandhom jiġu evitati.
English: pain, flatulence constipation
Maltese: Konfużjoni, alluċinazzjoni
English: Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Maltese: Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
English: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity Confusion, hallucination
Maltese: − ħedla, diffikultajiet biex torqod (insomnja), nervożiżmu, vertigo
English: The patients should be carefully observed and given symptomatic and supportive treatment.
Maltese: Il-pazjenti għandhom ikunu sorveljati birreqqa u jingħataw trattament sintomatiku u ta support.
English: The recommended dose of Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Maltese: Id-doża rakkomandata ta' Ketek għall-adulti u t-tfal ta' 12-il sena jew akbar hija ta' żewġ pilloli ta' 400 mg darba kuljum (800 mg darba kuljum).
English: Telithromycin is known to be a strong CYP3A4 inhibitor and is also a P-glycoprotein inhibitor.
Maltese: Huwa magħruf li telithromycin huwa inibitur qawwi ta' CYP3A4 u huwa wkoll inibitur ta' P-glycoprotein.
English: Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Maltese: Tagħrif limitat, miġbur minn pazjenti pedjatriċi bejn it-13 u 17-il sena, wera li l-livelli ta' telithromycin f'dan il-grupp kienu simili għal dawk f'pazjenti bejn 18 u 40 sena.
English: Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Maltese: Minn data innotata, doża ta' 600 mg kuljum, bejn wieħed u ieħor hija ekwivalenti għaddoża li għandhom jiġu esposti għaliha individwi b'saħħithom.
English: Exposure to telithromycin in vitro did select for pneumococcal mutants with increased MICs of telithromycin, generally resulting in MIC values of ≤1 mg/l.
Maltese: In vitro, l-espożizzjoni ta' telithromycin ġabet selezzjoni ta' mutanti ta' pnewmokokki b'żieda flMIC's ta' telithromycin, li ħafna drabi rriżulta f'valuri ta' MIC ≤1 mg/l.
English: There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Maltese: Ma kienx hemm tibdil sinifikanti fil-parametri ta' l-ECG u l-anqas dehru sinjali ta' tossiċità b`digoxin.
English: These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
Maltese: Dawn l-avvenimineti ma kienux assoċjati ma' sinjali t'abnormalitajiet okulari (ara sezzjonijiet 4.4 u 4.7).
English: Ketek is indicated for the treatment of the following infections:
Maltese: Ketek huwa indikat għall-kura ta' l-infezzjonijiet imsemmija hawn taħt :
English: When midazolam was coadministered with Ketek, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Maltese: Meta midazolam ingħata flimkien ma` Ketek, l-AUC ta` midazolam żdiedet 2.2-il darba wara li ngħata fil-vina u 6.1-il darba meta ngħata mill-ħalq.
English: Slovenija sanofi-aventis d.o.o.
Maltese: sanofi-aventis S.p.A.
English: The correlation between macrolide MICs and clinical outcome is weak for H. influenzae.
Maltese: Bħal fil-każ tal-makrolidi, H. influenzae huwa ikklassifikat bħala mikrobu ta' sensittività medja.
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Maltese: − jekk tbati minn myasthenia gravis, marda rari li tikkawża dgħjufija muskolari.
English: The midazolam halflife was increased about 2.5-fold.
Maltese: Il-half life ta' midazolam żdiedet b'madwar 2.5-il darba.
English: - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Maltese: − Aggravament akut ta' bronkite kronika: 800 mg darba kuljum għal 5 ijiem.
English: • ergotamine or dihydroergotamine (tablets or inhaler for migraine) - if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), other medicines containing any of the following active substances:
Maltese: − jekk qed tbati minn problemi tal-kliewi (indeboliment sever renali) u/jew problemi tal-fwied (indeboliment sever tal-fwied), tieħux Ketek waqt li qed tieħu mediċini oħra li fihom kwalunkwe
English: Telithromycin does not induce expression of macrolide-lincosamide-streptogramin B (MLSB)
Maltese: − mediċini oħra li jistgħu jtawlu l-intervall QT tal-elettrokardjogramma (ECG) bħal:
English: There have been post-marketing adverse reaction reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8).
Maltese: Huwa importanti li l-pazjenti li ngħatalhom telithromycin jiġu mgħarrfa li waqt il-kura jistgħu jseħħu reazzjonijiet avversi viżwali (ara sezzjonijiet 4.7 u 4.8).
English: Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.02-7.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose regimen.
Maltese: L-ogħla u l-iżgħar livelli medji fil-plażma, meta ntlaħaq stat fiss u miżmum fil-pazjenti, kienu 2.9±1.6 mg/l (firxa ta' 0.02-7.6 mg/l), u 0.
English: Pseudomembranou s colitis (see section 4.4)
Maltese: Epatite severa u insuffiċjenza tal-fwied (ara sezzjoni 4.4)
English: Concomitant administration of Ketek and colchicine is contraindicated in patients with renal and/or hepatic
Maltese: It-teħid ta' Ketek flimkien ma' colchicine huwa kontra-indikat f'pazjenti b'indeboliment renali u/jew epatiku
English: Cholestatic jaundice
Maltese: Suffejra kolestatika
English: Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Maltese: Minħabba li telithromycin jista jinpedixxi CYP3A4, dan jista' jżid il-livelli fid-demm tas-substrati ta' CYP34A4.
English: Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Maltese: Ir-rapporti inkludew imwiet u indeboliment akut fil-funzjoni respiratorja, li tista' tkun fatali, ikkaratterizzata b'bidu mgħaġġel (ara sezzjoni 4.8).
English: Immune system disorders
Maltese: Rappurtar tal-effetti sekondarji
English: Limit driving or other hazardous activities while taking Ketek.
Maltese: Waqt li qiegħed tieħu Ketek, illimita s-sewqan u attivitajiet oħra ta' periklu.
English: Exposure to colchicine, a CYP3A4 and P-glycoprotein substrate, may therefore be expected to increase if Ketek and colchicine are co-administered.
Maltese: Għalhekk, huwa mistenni li l-espożizzjoni għal colchicine, substrat ta' CYP3A4
English: Microcrystalline cellulose Povidone K25
Maltese: Dawn jinkludu s-sustanzi antiarritmiċi Klassi
English: Each film-coated tablet contains 400 mg of telithromycin.
Maltese: Kull pillola fiha 400mg ta' telithromycin.
English: Streptococcus pneumoniae does not demonstrate cross-resistance between erythromycin A and
Maltese: Għal Streptococcus pneumoniae, reżistenza għal erythromycin A ma jfissirx reżistenza għal
English: In similarity to some macrolides, telithromycin caused a prolongation of QTc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Maltese: Bħall-makrolidi, telithromycin tawwal l-intervall tal-QTc fil-klieb, kif ukoll tawwal l-action potential fil-fibri ta' Purkinje fil-fenek in vitro.
English: Light orange, oblong, biconvex tablet, imprinted with ‘H3647' on one side and ‘400' on the other.
Maltese: Ta' kulur oranġjo ċar, oblongi, imbuzzati miż-żewġ naħat, b' 'H3647‘ imnaqqax fuq naħa waħda u
English: Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB).
Maltese: Telithromycin mhuwiex attiv kontra l-organiżmi li juru b'mod kostituttiv il-fattur deteminanti ta' reżistenza MLSB (cMLSB).
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Maltese: Prodotti metaboliċi oħrajn instabu fil-plażma, l-awrina u l-ippurgar, li jissarfu f`anqas minn jew daqs 3% tal
English: The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Maltese: Il-grad t'inibizzjoni b'substrati diversi ta' CYP3A4 huwa diffiċili li jkun antiċipat.
English: Ketek may produce a similar interaction with lovastatin and atorvastatin which are also mainly metabolised by CYP3A4.
Maltese: Ketek jista' jikkawża interazzjoni simili ma` lovastatin u atorvastatin, li huma fil-biċċa l-kbira metabolizzati wkoll bil-CYP3A4..
English: Therefore the MIC breakpoint for telithromycin was set to categorise wild-type H. influenzae as having intermediate susceptibility.
Maltese: Għalhekk il-breakpoint tal-MIC għal telithromycin ġie magħmul biex jikkunsidra s-suxxettibilità ta' H.influenzae wild-type bħala tat-tip intermedjarja.
English: For those benzodiazepines which are not metabolised by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Maltese: Għal dawk il-benżodijażepini li mhux metaboliżzati minn CYP3A4 (temazepam, nitrażepam, lorazepam) interazzjoni ma` Ketek mhux probabbli.
English: Ketek should therefore not be used concomitantly with simvastatin, atorvastatin, or lovastatin (see section 4.3).
Maltese: Ketek, għalhekk m'għandux jintuża flimkien ma' simvastatin, atorvastatin jew lovastatin (ara sezzjoni 4.3).
English: In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Maltese: Disturbi fil-vista kienu jinkludu vista mċajpra, diffikulta biex wieħed jiffoka u diplopja.
English: Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Maltese: Id-dijarrea, speċjalment meta tkun qawwija, persistenti u / jew bid-demm, waqt jew wara l-kura b`Ketek, tista' tkun ikkawżata minn kolite psewdomembranea (ara sezzjoni 4.8).
English: Strong CYP3A4 inhibitors must not be co-administered with Ketek in patients with severe renal/or hepatic dysfunction (see section 4.3).
Maltese: Impedituri qawwija ta' CYP3A4 m'għandhomx jingħataw flimkien ma' Ketek f'pazjenti b'disfunzjoni severa fil-kliewi jew tal-fwied (ara sezzjoni 4.3)
English: Slight reductions in fertility indices were seen in rats at parentally toxic doses higher than 150 mg/kg.
Maltese: Tnaqqis żgħir fl-indiċi tal-fertilita' dehru fil-firien b'dożi tossiċi injettati ta' aktar minn 150mg/kg.
English: The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Maltese: Il-breakpoints kliniċi ta` MIC rakkomandati mill-Kumitat Ewropew għall-itestjar ta' Suxxettibilità kontra l-Mikrobu (EUCAST) huma murija hawn taħt:
English: Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Maltese: Ara wkoll is-sezzjonijiet “Tieħux Ketek” u “Mediċini oħra u Ketek” u “Sewqan u tħaddim ta'
English: Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek should be used with caution in patients with hepatic impairment (see also section 4.4).
Maltese: Dovut għal esperjenza limitata f'pazjenti b'kapaċità metabolika mnaqqsa tal-fwied, Ketek għandu jintuża b'kawtela f'pazjenti li għandhom indeboliment epatiku (ara wkoll sezzjoni 4.4).
English: Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
Maltese: Ketek huwa impeditur ta' CYP3A4 u għandu jintuża taħt ċirkostanzi speċifiċi biss waqt il-kura bi prodotti mediċinali oħra li jkunu metabolizzati minn CYP3A4.
English: Repeated dose toxicity studies of 1, 3 and 6 month duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes, and histological evidence of damage.
Maltese: Studji dwar l-effetti tossiċi b`dożi ripetuti ta` telithromycin li damu 1, 3 u 6 xhur fuq il-far, il-kelb u xxadina, urew li l-fwied kien l-organu prinċipali li ntlaqat minn effetti tossiċi, b'livelli għolja t'enżimi tal-fwied, u evidenza ħistoloġika ta' dannu.
English: History of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Maltese: Sindromu ta' l-intervall QT twil, kemm jekk konġenitu, kif ukoll jekk jeżisti fil-passat mediku talfamilja (jekk mhux eskluż permezz ta' ECG) u f'dawk il-pazjenti li magħrufa li għandhom intervall QT twil.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4).
Maltese: Il-kawtela hija neċessarja meta l-Ketek jingħata lill-pazjenti li qed jieħdu prodotti mediċinali oħra li jistgħu jtawwlu l-intervall tal-QT (ara sezzjoni 4.4).
English: Transient loss of consciousness, paraesthesia
Maltese: Telfien mis-sensi għal żmien qasir, paresteżija
English: Experience of treatment of infections caused by penicillin/or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the treatment of susceptible S. pneumoniae.
Maltese: Esperjenza tal-kura ta' infezzjonijiet kawżati minn S. pneumoniae reżistenti għall-penicillin /jew lerythromycin hija limitata, iżda s'issa, l-effikaċja klinika u r-rati ta' eradikazzjoni tal-mikrobu kienu simili meta mqabbla ma` dawk fejn il-kura ta infezzjonijiet b S. pneumoniae sensittivi għallantibijotiċi.