qanastek/EMEA-V3 huggingface dataset:
In the event of acute overdose the stomach should be emptied.
Fil- każ ta ’ doża eċċessiva u akuta, l- istonku jrid jitbattal.
The patients should be carefully observed and given symptomatic and supportive treatment.
Il- pazjenti għandhom ikunu sorveljati bir - reqqa u jingħataw trattament sintomatiku u ta support.
Adequate hydration should be maintained.
L- idratazzjoni adegwata trid tinżamm.
Blood electrolytes (especially potassium) must be controlled.
L - elettroliti (speċjalment potassium) għandhom ikunu kontrollati.
Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place
Għandu jsir ECG minħabba l - possibiltà li l- intervall tal- QT jitwal b’ riskju akbar ta arritmja.
Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code:
Kategorija farmakoterapewtika: makrolidi, linkosamidi u streptogramini, Kodiċi ATC:
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
Telithromycin huwa derivat semi- sintetiku ta ’ erythromycin A li jappartjeni għall- ketolidi, klassi ta ’ antibijotiċi relatati mal- makrolidi.
Mode of action
Kif jaħdem
Telithromycin inhibits protein synthesis by acting at the ribosome level.
Telithromycin jinpedixxi l- formazzjoni tal- proteini billi jaħdem fil- livell tar- ribożomi.
The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of erythromycin A when the strain is susceptible to erythromycin A.
L- affinità ta` telithromycin għas- sottounità 50S tar- ribożomi tal- batteri, hija 10 darbiet ogħla minn dik ta ’ erythromycin A, meta tkun razza sensittiva għal erythromycin A.
Against erythromycin A resistant strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity compared to erythromycin A in the 50S bacterial subunit.
20 darba meta imqabbel ma` erythromycin A, fis- sottounita 50S tar- ribożomi tal- mikrobi.
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it interacts with domain V and II.
Telithromycin jinterferixxi mal- qari tar- ribożomi fil- livell tar- ribożomi 23S tal- RNA, fejn jinteraġixxi mad- dominji V u II.
Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits.
Barra minn hekk, telithromycin iwaqqaf il- formazzjoni tas- sottounitajiet tar - ribożomi 50S u 30S.
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from intermediately susceptible organisms and intermediately susceptible organisms from resistant organisms, are: susceptible ≤ 0.5 mg/ l, resistant > 2 mg/ l.
Il- livelli ta ’ breakpoints ta` MIC rakkomandati għal telithromycin, li jaqsmu l- mikrobi suxxettibli minn dawk b`suxxettibilità intermedja, u mikrobi b`suxxettibiltà intermedja minn dawk reżistenti, huma: suxxettibli ≤0. 5 mg/ l, reżistenti > 2 mg/ l.
Antibacterial spectrum
Il- firxa antibatterika
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Il- prevalenza tar- reżistenza tista ’ tvarja minn post ġeografiku għall- ieħor u minn- żmien għal ieħor għal xi speċi u jkun aħjar jekk ikun hemm tagħrif fuq reżistenza lokali, speċjalment waqt kura ta` infezzjonijiiet severi.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Skond il- bżonn, il- parir ta ’ esperti għandu jittieħed meta l- prevalenza lokali ta ’ reżistenza hija tali li l- utilità tal- prodott f’ ta ’ l- inqas xi tipi ta ’ infezzjoni hija dubjuża.
This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
Din l- informazzjoni tipprovdi gwida approssimattiva biss, fuq il- probabbilitajiet jekk il- mikrobi hux ser ikunu sensittivi għal telithromycin.
9 Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus methicillin susceptible (MSSA)* Lancefield group C and G (ß haemolytic) streptococci Streptococcus agalactiae Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
9 Speci komunement sensittivi
Legionella pneumophila Moraxella catarrhalis* Other Chlamydophila pneumoniae* Chlamydia psittaci Mycoplasma pneumoniae*
Legionella pneumophila Moraxella catarrhalis
Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes* Aerobic Gram- negative bacteria Haemophilus influenzae$* Haemophilus parainfluenzae$ Inherantly resistant organisms Aerobic Gram- negative bacteria Acinetobacter Enterobacteriaceae Pseudomonas
Staphylococcus aureus reżistenti għall- methicillin (MRSA) + Streptococcus pyogenes *
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications. $natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
Telithromycin mhux attiv kontra MLSBc.
Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function.
pneumoniae u Streptococcus pyogenes, minħabba l- funzjoni tat- 3 keto fil- molekola.
Development of in vitro resistance to telithromycin due to spontaneous mutation is rare.
Żvilupp ta ’ reżistenza in vitro għal telithromycin, minħabba mutazzjoni spontanja, hija rari.
The majority of MRSA are resistant to erythromycin A by a constitutive MLSB mechanism.
B
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related resistance mechanisms but to lesser extent than erythromycin.
Fil -
While exposure to telithromycin did select for pneumococcal mutants with increased MICs, the MICs remained within the proposed susceptibility range.
10 waqt li esponiment għal telithromycin laqat mutanti ta` pnewmokokki li kellhom MICs aktar għoljin, l- MICs xorta baqgħu fil- firxa ta ’ sensittivita ’ indikata.
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/ or penicillin resistance.
Għal Streptococcus pneuomniae m’ hemmx cross - jew ko- reżistenza bejn telithromycin u klassijiet oħra ta` antibatteriċi inklużi erythromycin A u/ jew reżistenza għall- penicillin..
For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Għal Streptococcus pyogenes isseħħ cross- resistance għall- razzez li jkunu reżistenti għal erythromycin A ta` livell għoli.
10 Effect on oral and faecal flora
Effetti fuq il- flora tal- ħalq u ta` l- ippurgar
In a comparative study in healthy human volunteers, telithromycin 800 mg daily and clarithromycin 500 mg twice daily for 10 days showed a similar and reversible reduction of oral and faecal flora.
Fi studju komparattiv, f’ persuni volontiera b’ saħħithom, telithromycin 800 mg kuljum u clarithromycin 500 mg darbtejn kuljum għal 10 ijiem, wera tnaqqis simili u riversibbli tal- flora tal - ħalq u ta ’ l- ippurgar.
However, in contrast to clarithromycin, no resistant strains of alpha streptococci emerged in saliva on treatment with telithromycin.
Madankollu, kuntrarju għall - clarithromycin, waqt kura b` telithromycin ma tfaċcawx alfa streprokokki reżistenti għal telithromycin fis- saliva.
Following oral administration, telithromycin is fairly rapidly absorbed.
Telithromycin huwa assorbit pjuttost malajr meta jittieħed oralment.
A mean maximum plasma concentration of about 2 mg/ l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
Il- livell medju- massimu fil - plażma huwa ta ’ madwar 2 mg/ l u jintlaħaq f’ siegħa sa 3 sigħat wara d- doża, meta telithromycin jittieħed darba kuljum f’ doża ta ’ 800 mg.
The absolute bioavailability is about 57% after a single dose of 800 mg.
L- ammont ta ’ kemm jinfirex mal- gisem huwa ta ’ madwar 57% wara doża waħda ta ’ 800 mg.
The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Ir- rata u l- grad ta ’ l- assorbiment mhux effettwat bl- ikel, u għalhekk, il- pilloli Ketek jistgħu jingħataw mingħajr rigward għall- ikel.
Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/ l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg.
Il- livelli medji, fissi u l- aktar baxxi fil- plażma huma ta ’ bejn 0. 04 u 0. 07 mg/ l, u jintlaħqu fi 3 jew 4 ijiem, meta telithromycin jittieħed darba kuljum f’ doża ta ’ 800 mg.
At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
L- AUC fi stat fiss tiżdied b`1. 5- il darba meta mqabbla ma ’ dik ta ’ doża waħda.
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.
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. 2±0. 2 mg/ l (firxa ta ’ 0. 010 sa 1. 29 mg/ l), waqt reġimen terapewtiku ta ’ 800 mg darba kuljum.
The in vitro protein binding is approximately 60% to 70%.
L- ammont ta ’ antibijotiku marbut mal- proteina in vitro huwa ta ’ madwar 60% sa 70%.
Telithromycin is widely distributed throughout the body.
Telithromycin hu mifrux sew fil- ġisem.
The volume of distribution is 2.9±1.0 l/ kg.
Il- volum tad- distrubuzzjoni huwa ta ’ 2. 9±1. 0 l/ kg.
Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Ikun hemm distribuzzjoni mgħaġġla ta` telithromycin fit- tessuti li twassal għal livelli ta ’ telithromycin ogħla b`ammont sostanzjali fil- maġġoranza tat- tessuti li jiġu milquta milli fil- plażma.
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.
L- ogħla konċentrazzjoni tat- totali tat- tessuti fil- likwidu li jmiss ma ’ l- epitilju, fil- makrofaġi alvejolari, fil - mukoża 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.
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.
Il- konċentrazzjoni totali fit- tessuti, 24 siegħa wara doża waħda, fil- likwidu li jmiss ma ’ l- epitilju, fil- makrofaġi alvejolari, fil- mukoża tal- bronki, fit - tonsilli 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.
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/ l.
Il- medja tal- konċentrazzjoni massima ta` telithromycin fiċ- ċelluli bojod tad- demm kienet ta ’ 83±25 mg/ l.
Telithromycin is metabolized primarily by the liver.
Telithromycin huwa fil- parti l- kbira metabolizzat mill- fwied.
After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Wara li jittieħed mill- ħalq, id- doża titneħħa f`żewġ terzi bħala metaboli u terz mhux mibdul.
The main circulating compound in plasma is telithromycin.
Is- sustanza prinċipali li tiċċirkola fil- plażma hija telithromycin.
Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Il- prodott metaboliku ewlieni fiċ- ċirkolazzjoni jirrappreżenta madwar 13% ta` telithromycin AUC, u hu inqas qawwi kontra l- mikrobi minn telithromycin innifsu.
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma AUC.
Prodotti metaboliċi oħrajn instabu fil- plażma, l- awrina u l- ippurgar, li jissarfu f`anqas minn jew daqs 3% tal - plażma AUC.
Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
11 Telithromycin huwa metabolizzat minn iżoenżimi ta ’ CYP450, kif ukoll minn enżimi li mhumiex tat - tip CYP.
The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
L- enzima prinċipali ta ’ CYP450 involuta fil- metaboliżmu ta` telithromycin hija CYP3A4.
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 and 2E1.
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.
After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Wara li telithromycin radjutikkettat jingħata mill- ħalq, 76% tar- radjuattività instabet fl- ippurgar u 17% fl- awrina.
Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Madwar terz ta` telithromycin tneħħa kif inhu, 20% fl- ippurgar u 12% fl- awrina.
Telithromycin displays moderate non-linear pharmacokinetics.
Telithropmycin juri farmakokinetiċi moderati u mhux linejari.
The total clearance (mean ±SD) is 11 approximately 58±5 l/ h after an intravenous administration with renal clearance accounting for about 22% of this.
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.
Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h.
Telithromycin juri nżul tri- esponenzjali mill- plażma, b’ half- life ta` distribuzzjoni mgħaġġla ta ’ 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.
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.
Special populations
- Indeboliment renali
-Renal impairment 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.).
Fi studju fejn ntużaw dożi multipli 36 individwu li kellhom indeboliment tal- kliewi, ta ’ gradi differenti, kien hemm żieda ta ’ 1. 4 drabi fiċ- Cmax. 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).
Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Minn data innotata, doża ta ’ 600 mg kuljum, bejn wieħed u ieħor hija ekwivalenti għad - doża li għandhom jiġu esposti għaliha individwi b’ saħħithom.
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.
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.
The effect of dialysis on the elimination of telithromycin has not been assessed.
L- effett tad- dijaliżi, fit- tneħħija ta` telithromycin, ma kienx studjat.
-Hepatic impairment 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.
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), iċ - Ċmax, 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.
In both studies, higher renal elimination was observed in the hepatically impaired patients.
Fiż- żewġ studji, tneħħija ogħla mill - kliewi kienet osservata f’ dawk il- pazjenti li kellhom indeboloiment epatiku.
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).
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).
-Elderly subjects In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin were increased approximately 2 fold compared with those achieved in young healthy adults.
Il- livell massimu fil- plażma u l- AUC ta` telithromycin f’ persuni li għandhom aktar minn 65 sena (medja ta ’ 75 sena) żdied madwar darbtejn, meta mqabbel ma ’ dak milħuq f’ adulti b’ saħħithom u t’ età żgħira.
These changes in pharmacokinetics do not necessitate dosage adjustment.
Dawn it- tibdiliet farmakokinetiċi m`għandhomx bżonn tibdil fid- dosa.
-Paediatric patients The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
Il- farmakokinetiċi ta ’ telithtromycin f’ popolazzjoni pedjatrika, iżgħar minn 12- il sena ma kienux studjati.
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.
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.
-Gender The pharmacokinetics of telithromycin are similar between males and females.
Il- farmakokinetiċi ta ’ telithromycin kienu simili bejn dawk ta ’ sess maskil u dawk ta ’ sess femminili.
5.3 Preclinical safety data
12 5. 3 Tagħrif ta` qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Repeated dose toxicity studies of 1, 3 and 6 months 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.
Studji dwar l- effetti tossiċi b`dożi ripetuti ta` telithromycin li damu 1, 3 u 6 xhur fuq il- far, il- kelb u x - xadina, 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.
These effects showed a tendency to regress after cessation of treatment.
Dawn l- effetti wrew tendenza li jitilqu wara l- waqfien tal - kura.
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.
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.
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.
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.
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.
Din l - iskema 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.
There was evidence of reversibility upon cessation of treatment.
Kien hemm evidenza ta ’ rivversibiltà wara l- waqfien tal - kura.
The significance of these findings for humans is unknown.
It- tifsira ta ’ dawn is- sejbiet fir- rigward tal- bniedem mhux magħrufa.
12 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.
Bħall- makrolidi, telithromycin tawwal l- intervall tal- Tc fil- klieb, kif ukoll tawwal l- action potential fil- fibri ta ’ Purkinje fil- fenek in vitro.
Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
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.
Hypokalaemia and quinidine had additive/ supra-additive effects in vitro while potentiation was evident with sotalol.
Ipokalimja u quinidine kellhom effetti addittivi/ supra- addittivi in vitro, waqt li b`sotalol l- effett kien rafforzat.
Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Telithromycin, iżda mhux il- prodotti metaboliċi umani ewlenin tiegħu, kellu attività impeditriċi fuq il- kanali HERG u Kv1. 5.
Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
Studji tossiċi fuq ir- riproduttività wrew maturazzjoni mnaqqsa fuq il- gameti tal- far, u effetti avversi fuq il- fertilazzjoni.
At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
F’ dożi għoljin kien hemm effetti tossiċi fuq l- embriju u żieda fin- numru ta każijiet ta` ossifikazzjoni mhux kompleta, u anomaliji ta ’ l- għadam.
Studies in rats and rabbits were inconclusive with respect to potential for teratogenicity, there was equivocal evidence of adverse effects on foetal development at high doses.
Studji fuq il- firien u l- fniek ma kienux konklużivi dwar il- possibiltà ta ’ effett teratoġeniku, kien hemm evidenża mhux ċara ta ’ effetti mhux mixtieqa fuq l- izvilupp tal- fetu meta ingħataw dożi għoljin.
Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Telithromycin u l- prodotti metaboliċi ewlenin fil- bniedem ma wrewx potenzjal ġenotossiku f’ testijiet in vitro u in vivo.
No carcinogenicity studies have been conducted with telithromycin.
Ma sarux studji fuq telithromycin rigward kanċeroġenitiċità.
Microcrystalline cellulose Povidone K25 Croscarmellose sodium Magnesium stearate
Microcrystalline cellulose Povidone K25 Croscarmellose sodium Magnesium stearate
Tablet coating:
Il- kisja tal- pillola:
Talc Macrogol 8000 Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
Talc Macrogol 8000 Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
No special precautions for storage.
M’ hemm l’ ebda struzzjonijiet għal ħazna speċjali.
Two tablets are contained in each blister cavity.
Żewġ pilloli jinsabu f’ kull kavita mżaqqa fl- istrixxa.
Available as packs of 10, 14, 20 and 100 tablets.
Jinsab f’ pakketti ta ’ 10, 14, 20 u 100 pillola.
Opaque PVC/ Aluminium blisters
PVC opak/ fojl ta ’ l- aluminju
Opaque PVC/ Aluminium perforated unit dose blisters.
Jinsab f’ pakketti ta 5 x 2 pilloli PVC opak/ fojl ta ’ l- aluminju imtaqqab doża doża
No special requirements.
L- ebda ħtigijiet speċjali.
20, Avenue Raymond Aron F-92160 ANTONY France
20, Avenue Raymond Aron F- 92160 ANTONY Franza
9 July 2001 Date of first renewal:
9 ta ’ Lulju 2001 Data ta ’ l- ewwel tiġdid:
9 July 2006
9 ta ’ Lulju 2006
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott:
Strada Statale No 17, km22 67019 Scoppito (L’ Aquila) Italy
Strada Statale No 17, km22 67019 Scoppito (L’ Aquila) L- Italja
The holder of this marketing Authorisation will have to submit yearly PSURs.
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jissottometti PSURs darba fis- sena.
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Kartuna
Ketek 400 mg film-coated tablets Telithromycin
Ketek 400 mg pilloli miksija b’ rita Telithromycin
Each film-coated tablet contains 400 mg of telithromycin
Kull pillola miksija b’ rita għandha 400 mg telithromycin
10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets
10 pilloli miksija b’ rita 14- il pillola miksija b’ rita 20 pillola miksija b’ rita 100 pillola miksija b’ rita 5 x 2 pilloli miksija b’ rita
METHOD AND, ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
EXP {month/ year}
EXP {XX/ SSSS}
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA KIF JINĦAŻEN
MARKETING AUTORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 01/ 191/ 001 10 tablets EU/ 1/ 01/ 191/ 002 14 tablets EU/ 1/ 01/ 191/ 003 20 tablets EU/ 1/ 01/ 191/ 004 100 tablets EU/ 1/ 01/ 191/ 005 5x2 tablets
EU/ 1/ 01/ 191/ 001 10 pilloli EU/ 1/ 01/ 191/ 002 14- il pillola EU/ 1/ 01/ 191/ 003 20 pillola EU/ 1/ 01/ 191/ 004 100 pillola EU/ 1/ 01/ 191/ 005 5 x 2 pilloli
Batch {number}
Lot {numru}
EXP {month/ year}
EXP{ XX/ SSSS}
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGHMEL UŻU MINNU
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina. − Żomm dan il- fuljett.
It may harm them, even
Jista ’ jkollok bżonn terġa ’ taqrah − Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. − Din il- mediċina ġiet mogħtija lilek.
if their symptoms are the same as yours.
M’ għandekx tgħaddiha lil persuni oħra.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Ketek is and what it is used for 2.
X’ inhu Ketek u għalxiex jintuża 2.
Before you take Ketek.
Qabel ma tieħu Ketek 3.
How to take Ketek.
Kif għandek tieħu Ketek 4.
Possible side effects 5.
Effeti sekondarji li jista ’ jkollu 5.
How to store Ketek 6.
Kif taħżen Ketek 6.
WHAT KETEK IS AND WHAT IT IS USED FOR
X’ INHU KETEK U GĦALXIEX JINTUŻA
Ketek is an antibiotic of the type macrolides.
Ketek huwa antibijotiku tat- tip makrolidi.
Antibiotics stop the growth of bacteria which cause infections.
L- antibijotiċi jwaqqfu l- mikrobi, li qegħdin jikkaġunaw l- infezzjonijiet, milli jikbru.
Ketek is used to treat infections due to bacteria against which the medicine is active.
Ketek jintuża biex ikunu kurati infezzjonijiet ikkawżati mill- batteri, li l- mediċina hija attiva kontrihom.
- In adults, Ketek is used to treat infections of the throat, infections of the sinuses (hollow cavities in
- Fl- adulti, Ketek jintuża biex jittratta l- infezzjonijiet tal- gerżuma, infezzjonijiet tas- sinus
the bones around the nose) and chest infections in patients with long standing breathing difficulties and lung infection (pneumonia).
(kavitajiet fl- għadam, mimlija bl- arja li huma konnessi ma ’ l- imnifsejn) u infezzjonijiet tal - bronki f’ pazjenti li ilhom ibatu minn problemi tan- nifs għal żmien twil, u infezzjoni fil- pulmun (pnewmonja).
- In adolescents of 12 years and older, Ketek is used to treat infections of the throat.
- Fl- adoloxxenti ta ’ 12- il sena u akbar, Ketek jintuża biex ikunu ittrattati l- infezzjonijiet tal -
BEFORE YOU TAKE KETEK
gerżuma.
Do not take Ketek:
QABEL MA TIEĦU KETEK
- if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Tieħux Ketek: − jekk tbati minn myasthenia gravis, marda rari li tikkawża dgħjufija muskolari. − jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telithromycin, għal kwalunkwe mill- antibijotiċi li jappartjenu għall- klassi tal- makrolidi, jew għal kwalunkwe wieħed mill - ingredjenti l- oħrajn ta ’ Ketek.
- if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any
Jekk tiġi fid- dubju kellem lit- tabib jew l- ispiżjar tiegħek. − jekk kellek mard tal- fwied (epatite u/ jew is- suffejra) waqt li kont qed tieħu Ketek fil- passat − jekk qed tieħu xi prodotti mediċinali biex jikkontrollawlek il- livell tal- kolesterol jew xaħmijiet oħra fid- demm bħal simvastatin, minħabba li l- effetti mhux mixtieqa tal- prodotti mediċinali jistgħu jiżdiedu. − jekk taf li inti jew xi ħadd fil- familja tiegħek għandkom abnormalità fl- elettro - kardjogramma (ECG), hekk imsejjħa “ sindromu tal- QT twil ” − waqt li qed tieħu xi mediċini oħra li fihom waħda minn dawn is- sustanzi attivi:
of the other ingredients of Ketek.
•
- if you have had a liver disease (hepatitis and/ or jaundice) while taking Ketek in the past.
ergotamine jew dihydroergotamine (pilloli jew sustanza li tittieħed man- nifs (inħejler) għall- migranja)
- if you are taking certain medicinal products to control the blood level of cholesterol or other lipids
• •
• ergotamine or dihydroergotamine (tablets or inhaler for migraine) • terfenadine or astemizole (allergic problems) • cisapride (digestive problems) • pimozide (psychiatric problems)
terfenadine jew astemizole (problemi ta ’ allerġija) cisapride (problemi diġestivi)
- if you have kidney problems (severely impaired renal function) and/ or liver problems (severely
pimozide (problemi psikjatriċi)
impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances: • ketoconazole (anti fungal treatment) • a medicine called protease inhibitor (anti HIV treatment)
− 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 waħda minn dawn is- sustanzi attivi:
Take special care with Ketek:
• •
- if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias,
ketoconazole (kura kontra l- infezzjonijiet tal- fungu) mediċina li tissejaħ inibitur tal- protease (trattament kontra HIV)
bradycardia (changes in heart rate or electrocardiogram) or if you have had certain abnormal blood tests due to medical conditions such as low levels of potassium (hypokalaemia), low levels of magnesium (hypomagnesaemia).
Oqgħod attent ħafna b’ Ketek: − jekk għandek xi mard tal- qalb bħal mard koronarju tal- qalb, arritmjii tal- ventrikoli, bradikardja (tibdil fir- rata tat- taħbit tal- qalb jew à fl- elettrokardjogramma), jew jekk għamilt xi testijiet li żvelaw kundizzjonijiet mediċi bħall- livelli baxxi fid- demm tal- potassium (ipokalimja), livelli baxxi fid- demm tal- magnesium (ipomanjesimja). − jekk tiżviluppa dijarrea severa jew fit- tul, jew bid- demm, waqt jew wara li tkun ħadt il- pilloli Ketek.
- if you develop severe or prolonged or bloody diarrhoea during or after taking Ketek tablets,
Kellem lit- tabib tiegħek immedjatament għax jista ’ jagħti l- każ li jkollok twaqqaf il - kura.
This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Dan jista ’ jkun sinjal ta ’ infjammazzjoni tal- musrana li tista ’ isseħħ wara l- kura bl - antibijotiċi. − jekk għandek mard tal- fwied − jekk ikollok disturbi fil- vista (vista mċajpra, diffikulta biex wieħed jiffoka, vista doppja) − jekk ikollok ħass ħażin (telf mis- sensi għal żmien qasir)
- if you have liver disease.
Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu Ketek
- if you experience visual disturbances (blurred vision, difficulty in focusing, double vision)
Il- pilloli ta ’ Ketek mhux irrakkomandati għall- użu fit- tfal u adoloxxenti taħt it- 12- il sena.
- if you experience fainting (transient loss of consciousness).
Ara wkoll Is- sezzjoni “ Tieħux Ketek ” u “ Użu ta ’ mediċini oħra ” u “ Sewqan u tħaddim ta ’ magni ”.
If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Meta tieħu mediċini oħra Jekk jogħgbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta tat - tabib, għax xi wħud minnhom jistgħu jaffettwaw jew jiġu affettwati b’ Ketek.
Ketek tablets are not recommended for use in children and adolescents less than 12 years old.
Dawn il- mediċini li m’ għandhomx jittieħdu ma ’ Ketek:
Refer also to sections “ Do not take Ketek”, “ Taking other medicines” and “ Driving and using machines”.
- prodotti mediċinali, biex jikkontrollawlek il- livell tal- kolesterol fid- demm jew xaħmijiet
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as some of them could affect or be affected by Ketek.
oħrajn bħal simvastatin, minħabba li l- effetti mhux mixtieqa tal- prodotti mediċinali jistgħu jiżdiedu.
These medicines must not be taken with Ketek:
- xi mediċini oħra li fihom waħda minn dawn is- sustanzi attivi li ġejjin
- medicinal products to control the blood level of cholesterol or other lipids like simvastatin, as the
•
side effects of the medicinal products could be increased.
ergotamine jew dihydroergotamine (pilloli jew sustanza li tittieħed man- nifs (inħejler) għall- migranja)
- other medicines containing any of the following active substances:
• • •
• ergotamine or dihydroergotamine (tablets or inhaler for migraine) • terfenadine or astemizole (allergic problems) • cisapride (digestive problems) • pimozide (psychiatric problems)
terfenadine jew astemizole (problemi ta ’ allerġija) cisapride (problemi diġestivi) pimozide (problemi psikjatriċi)
- if you have kidney problems (severely impaired renal function) and/ or liver problems (severely
− Jekk qed tbati minn problemi tal- kliewi (indeboliment renali sever) u/ jew problemi tal- fwied (indeboliment tal- fwied sever), tieħux Ketek waqt li qed tieħu mediċini oħra li fihom kwalunkwe waħda minn dawn is- sustanzi attivi li ġejjin:
impaired hepatic function), other medicines containing any of the following active substances: • ketoconazole (anti fungal treatment) • a medicine called protease inhibitor (anti HIV treatment)
ketoconazole (kura kontra l- infezzjonijiet tal- fungu) mediċina li tissejaħ inibitur tal- protease (trattament kontra HIV)
It is important to tell your doctor if you are taking:
Huwa importanti li tgħid lit- tabib tiegħek jekk qed tieħu:
- medicines containing phenytoin, and carbamazepine (for epilepsy)
- xi mediċini li fihom phenytoin u carbamazepine (għall- epilessija)
- rifampicin (antibiotic)
- rifampicin (antibijotiku)
- phenobarbital or St John’ s wort, (herbal medicine used to treat mild depressions)
- phenobarbital jew St John’ s wort (mediċina tal- ħxejjex tintuża biex tittratta d- dipressjoni
- medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation)
- medicini bħal tacrolimus, cyclosporin u sirolimus (għat- trapjanti ta ’ l- organi)
- metoprolol (for heart disorders)
- metoprolol (għad- disturbi fil- qalb)
- ritonavir (anti HIV medicine).
- ritonavir (mediċina kontra l- HIV).
Taking Ketek with food and drink Ketek may be taken with or without food.
24 Meta tieħu Ketek ma ’ l- ikel u max- xorb Ketek jista ’ jittieħed qabel jew wara l- ikel.
Pregnancy and Breast-feeding If you are pregnant do not take Ketek tablets as the safety of Ketek in pregnancy is insufficiently established.
Tqala u Treddigħ Jekk inti tqila b’ tarbija tieħux pilloli ta ’ Ketek għax is- sigurtà ta ’ Ketek fit- tqala mhix suffiċjentement stabbilita.
If you are breast-feeding do not take Ketek tablets.
Jekk qed tredda ’ tieħux pilloli ta ’ Ketek.
24 Driving and using machines Limit driving or other hazardous activities while taking Ketek.
Sewqan u tħaddim ta ’ magni Waqt li qiegħed tieħu Ketek, illimita s- sewqan u attivitajiet oħra ta ’ periklu.
If you have vision problems, faint or experience confusion or hallucination while taking Ketek, do not drive, operate heavy machinery, or engage in dangerous activities.
Jekk ikollok problemi fil- vista, ħass ħażin jew tesperjenza konfużjoni jew alluċinazzjoni waqt li qiegħed tieħu Ketek, issuqx, tħaddimx makkinarju kbir, jew tagħmel attivitajiet oħra ta ’ periklu.
Taking Ketek tablets may cause side effects such as visual disturbances, confusion or hallucination, which may reduce the capacity to carry out certain tasks.
Meta tieħu pilloli ta ’ Ketek jistgħu jitfaċċaw xi effetti sekondarji bħal disturbi fil- vista, konfużjoni jew alluċinazzjoni li jistgħu jnaqqsu l- abbiltà biex tagħmel ċertu xogħol.
Rare cases of fainting (transient loss of consciousness), which may be preceded by a general feeling of being sick (e. g. nausea, stomach upsets) have been reported.
Każijiet rari ta ’ ħass ħażin (telf mis- sensi għal żmien qasir), li jistgħu jkunu preċeduti minn sensazzjoni ġenerali ta ’ dardir (e. ż. dardir, tqalligħ ta ’ l- istonku) kienu irrapportati.
These symptoms may appear as early as after the first dose of Ketek.
Dawn is- sintomi jistgħu jitfaċċaw anki wara l- ewwel doża ta ’ Ketek.
HOW TO TAKE KETEK
KIF GĦANDEK TIEĦU KETEK
Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
It- tabib tiegħek jgħidlek kemm għandek tieħu pilloli Ketek, x’ ħin u għal kemm żmien.
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.
It- tul ta ’ żmien tal- kura huwa normalment 5 ijiem għall- infezzjonijiet tal- gerżuma, infezzjonijiet tas - sinuses 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.
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).
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).
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.
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 ta ’ 800 mg.
Swallow the tablets whole with a glass of water.
Ibla ’ l- pilloli sħaħ b’ tazza ilma.
It is best to take tablets at the same time each day.
l- aħjar li tieħu l- pilloli kuljum fl- istess ħin.
If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness.
Jekk hu possibli ħu l- pilloli qabel tidħol torqod, biex tnaqqas l- impatt potenzjali ta’ disturbi fil- vista u telf mis- sensi
If you take more Ketek than you should If you accidentally take one tablet too many, nothing is likely to happen.
Jekk tieħu Ketek aktar milli suppost Jekk aċċidentalment tieħu pillola waħda żejda, x’ aktarx m’ hu ser jiġri xejn.
If you accidentally take several tablets too many, contact your doctor or pharmacist.
Jekk tieħu aktar pilloli bi żball, ħu parir tat- tabib jew ta` l- ispiżjar tiegħek.
If possible, take your tablets or the box with you to show the doctor or pharmacist.
Jekk huwa possibli ħu l- pilloli jew il- kaxxa miegħek biex turihom / turiha lit- tabib jew lill- ispiżjar.
If you forget to take Ketek If you forget to take a dose, take it as soon as possible.
Jekk tinsa tieħu Ketek Jekk insejt tieħu doża, ħudha kemm jista ’ jkun malajr.
However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Madankollu, jekk ikun wasal il- ħin għad- doża li tmiss, aqbeż id- doża li tlift u ħu l- pillola li jmiss fil- ħin tas- soltu.
If you stop taking Ketek Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Jekk tieqaf tieħu Ketek Ħu l- kors sħiħ ta ’ pilloli li ordnalek it- tabib.
If you stop taking the tablets too soon, the infection may return, or your condition may get worse.
Anki jekk tibda tħossok aħjar qabel ma tkun spiċċajthom kollha.
If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Jekk twaqqaf il- pilloli qabel iż- żmien, l- infezzjoni tista ’ terġa ’ tiġi lura, jew il- kundizzjoni tiegħek tista ’ taqleb għall- agħar Jekk twaqqaf il- pilloli malajr wisq tista ’ toħloq reżistenza tal- mikrobi għall- mediċina.
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking the next dose.
Jekk tħoss li qed tbati minn xi effett sekondarju, għid lit- tabib immedjatament biex tieħu parir qabel ma jmissek tieħu d- doża li tmiss.
Like all medicines Ketek can cause side effects, although not everybody gets them.
Bħall- kull medicina oħra, Ketek jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Ħafna minnhom huma rari u jgħaddu, iżda każijiet rari ħafna ta ’ reazzjonijiet avversi u serji li jinvolvu l- fwied u jikkaġunaw indeboliment epatiku, inklużi każijiet fatali kienu rapportati.
The side effects are described into the following frequencies very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000
L- effetti mhux mixtieqa huma deskritti fil- frekwenzi li ġejjin komuni ħafna: jaffettwa 1 minn kull 10 pazjenti li jagħmel użu minnu komuni: jaffettwa 1 sa 10 minn kull 100 pazjent li jagħmel użu minnu mhux komuni: jaffettwa 1 sa 10 minn kull 1000 pazjent li jagħmel użu minnu rari: jaffettwa 1 sa 10 minn kull 10, 000 pazjent li jagħmel użu minnu rari ħafna: jaffettwa anqas minn 1 f’ kull 10, 000 pazjent li jagħmel użu minnu
If you notice any of the following, stop taking Ketek and tell your doctor immediately:
Jekk tinnota xi waħda minn dawn l- effetti msemmija hawn taħt, waqqaf Ketek u għid lit- tabib tiegħek immedjatament: − Reazzjonijiet tal- ġilda jew dawk allerġiċi bħall- nefħa tal- wiċċ jew kondizzjonijiet serji tal - ġilda ikkaratterizzati minn tbajja ’ ħomor jew infafet (frekwenza mhux magħrufa). − Dijarrea severa, persistenti jew bid- demm, flimkien ma` wġigħ ta ’ żaqq jew deni, jistgħu jkunu sinjali ta ’ infjammazzjoni serja tal- musrana, li tista ’ isseħħ rari ħafna wara kura bl- antibijotiċi (rari ħafna). − Sinjali u sintomi ta ’ mard tal- fwied (epatite) bħal sfurija tal- ġilda u ta ’ l- għajnejn, awrina skura, ħakk, nuqqas ta ’ aptit jew uġigħ addominali (mhux komuni). − Deterjorament ta ’ marda msejħa myasthenia gravis, marda rari li tikkawża dgħjufija tal - muskoli (frekwenza mhux magħrufa).
sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics (very rare).
Dawn l- effetti serji msemmija hawn fuq jistgħu jinħtieġu attenzjoni medika urġenti.
The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:
L- effetti l- oħra mhux mixtieqa u imniżżla hawn taħt qed jingħataw b’ estimu tal- frekwenza li bihom jistgħu iseħħu b’ Ketek:
Very common side effects diarrhoea, usually mild and temporary.
Effetti komuni ħafna dijarrea, normalment ħafifa u temporanja.
- inflammation in the mouth, fungal infection in the mouth (Candida infection)
Effetti komuni − dardir, rimettar, uġigħ ta ’ żaqq, gass − sturdament, uġigħ ta ’ ras, tibdil fit- togħma − infezzjoni bil- Candida tal- vaġina (infezzjoni b’ fungus karatterizzat b’ ħakk lokali, ħruq u tisfija bajda) − żieda fil- livell ta ’ l- enżimi tal- fwied (tinduna biha permezz ta ’ test tad- demm).
- liver problem (hepatitis)
Effetti oħra mhux komuni, jew rari - stitikezza, nuqqas t’ aptit (anoressija) − infjammazzjoni tal- ħalq, infezzjoni tal- fungu tal- ħalq (infezzjoni bil- Candida) () − Problemi tal- fwied( epatite) − raxx, urtikarja, ħakk, ekżema − ħedla, diffikultajiet biex torqod (insomnja), nervożiżmu, vertigo − tnemnim ta ’ l- idejn u s- saqajn (parasteżja) − disturbi fil- vista (vista mċajpra, diffikulta biex wieħed jiffoka, vista doppja) − fwawar, ħass ħażin (telf mis- sensi għal żmien qasir) − tibdil fir- rata tat- taħbit tal- qalb (taħbit bil- mod tal- qalb) jew abnormalità fl - elettrokardjogramma (ECG), − pressjoni baxxa (ipotensjoni) − żieda ta ’ tip ta ’ ċerti ċelluli bojod fid- demm, tinduna biha permezz ta ’ test tad- demm (eżinofilja).
26
26 Effetti sekondarji rari ħafna
- inflamed pancreas
- infjammazzjoni tal- frixa
- joint and muscle pain
- uġigħ fil- muskoli u fil- ġogi
- confusion
- konfużjoni
- hallucination (seeing or hearing things that are not there)
- alluċinazzjoni (taqriq l- għajnejn jew il- widnejn meta wieħed jidhirlu li qed jara jew jisma ’ xi
- loss of taste and smell
ħaġa li ma teżistix)
- liver failure has been reported.
- indeboliment tal- fwied kien rapportat.
If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on, tell your doctor.
Jekk waħda minn dawn l- effetti mhux mixtieqa qiegħda tagħtik fastidju, hija severa, jew ma tmurx waħidha meta tkompli tieħu l- kura, għid lit- tabib tiegħek.
HOW TO STORE KETEK
KIF TAĦŻEN KETEK
Do not use Ketek after the expiry date which is stated on the pack.
Tużax Ketek wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
What Ketek contains
X’ fih Ketek
- The active substance is telithromycin
- Is- sustanza attiva hi telithromycin.
- The other ingredients are microcrystalline cellulose, povidone K25, croscarmellose sodium,
- Is- sustanzi l- oħra huma 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.
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.
What Ketek looks like and contents of the pack
Id- Dehra tal Ketek u l- kontenuti tal- pakkett
Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “ H3647 ” on one side and “ 400” on the other.
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.
Ketek tablets are presented in blister packs.
Il- pilloli ta ’ Ketek jiġu ġo folji.
Two tablets are contained in each blister cavity.
Hemm żewġ pilloli f’ kull kavità tal- folja.
They are available in packs of 10, 5x2, 14, 20 and 100 tablets.
Huma disponibbli f’ pakketti ta ’ 10, 5x2, 14, 20 u 100 pillola.
The marketing authorisation holder of Ketek is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ta ’ Ketek huwa:
20 Avenue Raymond Aron F-92160 ANTONY France
20 Avenue Raymond Aron F- 92160 ANTONY Franza