qanastek/EMEA-V3 huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged bacteria against which Ketek is active can be found in the Summary of Product Characteristics (also part of the EPAR).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged batterji li Ketek huwa attiv kontihom tinstab fis- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How has Ketek been studied?
Kif ġie studjat Ketek?
Ketek has been studied in 10 main studies involving a total of over 4,000 patients.
Ketek ġie studjat f’ 10 studji ewlenin li fihom b’ kollox ħadu sehem iktar minn 4, 000 pazjent.
Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
Erba ’ studji ħarsu lejn l- effetti tiegħu fil- pulmoniti ħfief jew moderati li ttieħdu fil- komunità, tnejn ħarsu lejn is- sinusite akuta, tnejn ħarsu lejn it- taħrix tal- bronkite kronika u tnejn ħarsu lejn it- tonsillite jew il - farinġite.
All but two of the studies compared Ketek’ s effects to those of other antibiotics.
L- istudji kollha ħlief tnejn qabblu l- effetti ta ’ Ketek ma ’ dawk ta ’ antibijotiċi oħra.
The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘ satisfactory’ reductions in the amount of bacteria detected in samples.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien il- proporzjon ta ’ pazjenti li fiequ fi tmiem it- trattament kif determinat minn tnaqqis fis- sintomi, jew li kellhom tnaqqis ‘ sodisfaċenti ’ fl- ammont ta ’ batterji misjuba fil- kampjuni.
What benefit has Ketek shown during the studies?
X’ inhu l- benefiċċju ta ’ Ketek li ntwera f’ dawn l- istudji?
Ketek was as effective as the comparator antibiotics.
Ketek kien effikaċi bħall- antibijotiċi li tqabbel magħhom.
For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/ clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment.
Għall- pulmonite u l- bronkite kronika, Ketek kien effikaċi daqs amoxicillin, clarithromycin, trovafloxacin, amoxicillin/ clavulanic acid u cefuroxime axetil, b’ bejn 82 u 95% tal- pazjenti ma jkollhom l- ebda sintomu fi tmiem it- trattament.
In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/ clavulanic acid.
F’ pazjenti b’ sinusite akuta, korsijiet ta ’ ħames u għaxart ijiem ta ’ Ketek wasslu għal rati ta ’ fejqan simili għal dawk li dehru meta ntuża amoxicillin/ clavulanic acid.
For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels in samples taken from the throat.
Għat- tonsillite jew għall- farinġite, bejn 84 u 92% tal- pazjenti li ngħataw Ketek, il- peniċillina jew clarithromycin kellhom tnaqqis sodisfaċenti fit - tnaqqis tal- livelli batteriċi fil- kampjuni meħuda mill- gerżuma.
What is the risk associated with Ketek?
X’ inhu r- riskju assoċjat ma ’ Ketek?
The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea.
L- iktar effett sekondarju komuni ma ’ Ketek (li deher f’ iktar minn pazjent wieħed minn kull 10) hu d - dijarea.
For the full list of all side effects reported with Ketek, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Ketek, ara l- Fuljett ta ’ Tagħrif.
Ketek should not be used in people who may be hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients.
Ketek m’ għandux jingħata lil persuni li jistgħu jkunu allerġiċi għal telithromycin, kwalunkwe makrolide, jew għal kwalunkwe mill- ingredjenti l- oħra.
It should not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness) or who have had hepatitis (inflammation of the liver) or jaundice when they have taken telithromycin in the past.
M’ għandux jintuża minn pazjenti b’ myasthenia gravis (marda tan- nervituri li tikkawża dgħufija muskolari) jew li jkunu spiċċaw b’ epatite (infjammazzjoni tal- fwied) jew suffejra meta jkunu ħadu telithromycin fl- imgħoddi.
Ketek should also not be used in patients who are taking any of the following medicines: • cisapride (used to relieve certain stomach problems); • ‘ ergot alkaloid derivatives’, such as ergotamine and dihydroergotamine (used to treat migraine headache); • pimozide (used to treat mental illness); • astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription); • simvastatin, atorvastatin or lovastastin (used to lower cholesterol in the blood).
Ketek m’ għandux jintuża f’ pazjenti li jkunu qed jieħdu kwalunkwe minn dawn il- mediċini: • cisapride (użat għas- serħan minn ċerti problemi fl- istonku); • ‘ derivattivi ta ’ ergot alkaloid ’, bħal ergotamine u dihydroergotamine (użat fit- trattament ta ’ l - emikranja); • pimozide (użat fit- trattament tal- mard mentali); • astemizole jew terfenadine (komunement użat fit- trattament ta ’ sintomi ta ’ l- allerġija – dawn il - mediċini jistgħu jinkisbu mingħajr riċetta); • simvastatin, atorvastatin jew lovastastin (użati fit- tnaqqis tal- kolesterol fid- demm).
Ketek should not be taken by patients with a history or a family history of ‘ long QT syndrome’ or with ‘ acquired QT interval prolongation’ (disruption of the heartbeat).
Ketek m’ għandux jittieħed minn pazjenti bi storja jew bi storja familjari tas - ‘ sindromu ta ’ QT twil ’ jew ma ’ ‘ titwil akkwiżit ta ’ l- intervall QT ’ (tħarbit tat- taħbit tal- qalb).
In patients with severe kidney or liver problems, Ketek should not be used with some medicines that may affect the way that telithromycin is broken down, including protease inhibitors (used in HIV infection) and ketoconazole (an antifungal medicine).
F’ pazjenti bi problemi severi tal- fwied jew tal- kliewi, Ketek m’ għandux jintuża ma ’ xi mediċini li jistgħu jaffettwaw il- mod li bih jitkisser telithromycin, inkluż inibituri tal- proteażi (użati fl- infezzjoni ta ’ l- HIV) u ketoconazole (mediċina ta ’ kontra l- fungi).
Why has Ketek been approved?
Għaliex ġie approvat?
The Committee for Medicinal products for Human Use (CHMP) concluded that Ketek’ s benefits are greater than its risks.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) ikkonkluda li l- benefiċċji ta ’ Ketek huma ikbar mir- riskji tiegħu.
The Committee recommended that Ketek be given marketing authorisation, but noted that Ketek is associated with a greater risk of certain side effects than other antibiotics.
Il- Kumitat irrakkomanda li Ketek jingħata l- awtorizzazzjoni għat - tqegħid fis- suq, iżda nnota li Ketek huwa assoċjat ma ’ riskju ikbar ta ’ ċerti effetti sekondarji meta mqabbel ma ’ antibijotiċi oħra.
Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision.
Uħud minn dawn l- effetti sekondarji jistgħu jkunu serji, fosthom teħżin tal- myasthenia gravis, telf temporanju tal- konoxxenza u disturbi temporanji fil- vista.
Therefore, the Committee decided that its use should be reserved to the treatment of community-acquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/ pharyngitis when these antibiotics cannot be used.
Għalhekk, il - Kumitat iddeċieda li l- użu tiegħu għandu jkun riservat għat- trattament ta ’ pulmoniti li ttieħdu fil - komunità, għat- trattament tal- bronkite u s- sinusite meta dawn ikunu kkawżati minn batterji reżistenti għal antibijotiċi beta- lactam jew makrolide, u għat- tonsillite/ farinġite meta dawn l- antibijotiċi ma jkunux jistgħu jintużaw.
Other information about Ketek:
Tagħrif ieħor dwar Ketek:
The European Commission granted a marketing authorisation valid throughout the European Union for Ketek to Aventis Pharma S. A. on 9 July 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Ketek lil Aventis Pharma S. A. fid- 9 ta ’ Lulju 2001.
The marketing authorisation was renewed on 9 July 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 9 ta ’ Lulju 2006.
Ketek 400 mg film-coated tablets.
Ketek pilloli ta ’ 400 mg miksija b’ rita.
Each film-coated tablet contains 400 mg of telithromycin.
Kull pillola miksija b’ rita għandha 400 mg ta ’ telithromycin.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanżi mhux attivi, ara sezzjoni 6. 1
Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other.
Ta ’ kulur oranġjo ċar, oblongi, imbuzzati miż- żewġ naħat, b ’ “ H3647 ” imnaqqax fuq naħa waħda u “ 400 ” fuq in- naħa l- oħra.
When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Meta Ketek jinkiteb mit- tabib, wieħed irid iqis il- gwida uffiċjali fuq l- użu xieraq ta ’ l- antibijotiċi u l - prevalenza lokali tar- reżistenza (ara wkoll sezzjoni 4. 4 u 5. 1).
Ketek is indicated for the treatment of the following infections:
Ketek huwa indikat għall- kura ta ’ l- infezzjonijiet imsemmija hawn taħt:
In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4).
F’ pazjenti ta ’ 18- il sena u akbar: • Pulmonite ħafifa jew ta ’ grad moderat li tkun ittieħdet mill- komunità (ara sezzjoni 4. 4)
• When treating infections caused by known or suspected beta-lactam and/ or macrolide resistant strains (according to history of patients or national and/ or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
• Meta jiġu ttrattati infezzjonijiet ikkawżati minn razez magħrufa jew suspettati reżistenti għal beta- lactam u/ jew makrolidi (skond il- passat mediku tal- pazjenti jew data ta ’ reżistenza nazzjonali u / jew reġjonali) li huma koperti mill- ispettru anti- batteriku ta ’ telithromycin (ara sezzjonijiet 4. 4 u 5. 1) − Aggravament akut ta ’ bronkite kronika − Sinużite akuta
In patients of 12 years and older: • 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).
F’ pazjenti bejn it- 12 - il sena u akbar: • Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes bħala alternattiva meta l - antibijotiċi 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).
The recommended dose is 800 mg once a day i. e. two 400 mg tablets once a day.
Id- doża rakkomandata hija ta ’ 800 mg darba kuljum, jiġifieri żewġ pilloli ta ’ 400 mg il- waħda darba kuljum.
The tablets should be swallowed whole with a sufficient amount of water.
Il- pilloli għandhom jittieħdu sħaħ b’ ammont xieraq ta ’ ilma.
The tablets may be taken with or without food.
Il- pilloli jistgħu jittieħdu fuq l - ikel jew fuq stonku vojt.
Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Jista ’ jiġi kkunsidrat li Ketek jiġi mogħti f’ ħin l- irqad, sabiex jitnaqqas l - impatt potenzjali ta ’ disturbi fil- vista u telf tas- sensi (ara sezzjoni 4. 4).
In patients of 18 years and older, according to the indication, the treatment regimen will be:
F’ pazjenti ta ’ 18- il sena u akbar, ir- reġimen ta ’ trattament, skond l- indikazzjoni, għandha tkun: − Pulmonite li tkun ittieħdet mill- komunità:
800 mg once a day for 7 to 10 days,
800 mg darba kuljum, għall- perijodu bejn 7 u 10 ijiem. − Aggravament akut ta ’ bronkite kronika:
800 mg once a day for 5 days,
800 mg darba kuljum għal 5 ijiem. − Sinużite akuta:
800 mg once a day for 5 days,
800 mg darba kuljum għal 5 ijiem. − Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes:
800 mg once a day for 5 days.
800 mg darba kuljum għal 5 ijiem
- Tonsillitis/ pharyngitis caused by Streptococcus pyogenes:
2 F’ pazjenti ta ’ bejn it- 12 u t- 18- il sena, ir- reġimen ta ’ trattament għandha tkun: − Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes:
2 In the elderly:
Fl- anzjani:
No dosage adjustment is required in elderly patients based on age alone.
M’ hemmx bżonn tibdil fid- doża f’ pazjenti anzjani minħabba biss l- età tagħhom.
In children:
Fit- tfal:
Ketek is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
Ketek mhux irrakkomandat għall- użu fit- tfal ta taħt it- 12- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Impaired renal function:
Indeboliment fil- funzjoni renali:
No dosage adjustment is necessary in patients with mild or moderate renal impairment.
M’ hemmx bżonn ta` tibdil fid- doża f’ pazjenti li għandhom indeboliment renali ħafif jew moderat.
Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance < 30ml/ min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Ketek mhux irrakkomandat bħala l- ewwel għażla f’ pazjenti b’ indeboliment renali sever (meta r- rata li biha titneħħa l- krejatinina tkun < 30 ml/ min) jew pazjenti b’ indeboliment sever renali u dak epatiku ko- eżistenti, għax il- forma tad- doża ottima (600 mg) mhix disponibbli.
If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg dose.
Jekk ikun meqjus li t- trattament b’ telithromycin huwa neċessarju dawn il- pazjenti jistgħu jkunu ittrattati b’ doża li talterna bejn ta ’ 800 mg kuljum u 400 mg kuljum, u li tibda b’ doża ta 800 mg.
In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
F’ pazjenti fuq dijaliżi tad- demm, il- pożoloġija għandha tkun aġġustata sabiex Ketek 800 mg jingħata wara s- sessjoni tad- dijaliżi (ara wkoll sezzjoni 5. 2).
Impaired hepatic function:
Indeboliment fil- funzjoni epatika:
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, unless renal function is severely impaired, however the experience in patients with impaired hepatic function is limited.
M’ hemmx bżonn ta tibdil fid- doża f’ pazjenti li għandhom indeboliment ħafif, moderat jew sever tal - fwied, sakemm ma jkunx hemm indeboliment renali sever, madankollu, l- esperjenza f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied hija limitata.
Hence, Ketek should be used with caution (see also section 4.4 and 5.2).
Għalhekk, Ketek għandu jintuża b’ kawtela (ara wkoll sezzjoni 4. 4 u 5. 2).
Ketek is contraindicated in patients with myasthenia gravis (see section 4.4).
Ketek huwa kontra- indikat f’ pazjenti b’ myasthenia gravis (ara sezzjoni 4. 4)
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients.
F’ każ ta ’ allerġija għas- sustanza attiva, għal kwalunkwe antibijotiku li jappartjeni għall- klassi tal - makrolidi, jew għal xi wieħed mill- ingredjenti mhux attivi.
Ketek must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
Ketek m’ għandux jintuża f’ pazjenti bi storja preċedenti ta ’ epatite u/ jew is- suffejra assoċjata ma ’ l- użu ta ’ telithromycin.
Concomitant administration of Ketek and any of the following substances is contraindicated: cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5).
L- użu ta ’ Ketek flimkien ma ’ wieħed mis- sustanzi msemmija hawn taħt huwa kontra- indikat: cisapride, derivattivi ta ’ l- alkalojdi ta ’ l- ergot (bħall- ergotamine u dihydroergotamine), pimożide, astemizole u terfenadine (ara sezzjoni 4. 5).
Ketek should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
Ketek m’ għandux jingħata flimkien ma ’ simvastatin, atorvastatin u lovastatin.
Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Il- kura b’ dawn il - mediċini trid titwaqqaf waqt il- kura b’ Ketek (ara sezzjoni 4. 5).
Ketek is contraindicated in patients with a 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.
Ketek huwa kontra- indikat f’ pazjenti li għandhom sindromu ta ’ l- intervall QT twil, kemm jekk konġenitu, kif ukoll jekk jeżisti fil- passat mediku tal- familja (jekk mhux eskluż permezz ta ’ ECG) u f’ dawk il- pazjenti li magħrufa li għandhom intervall QT twil.
In patients with severely impaired renal and/ or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated.
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 ketoconazole, huwa kontra - indikat.
As with macrolides, due to a potential to increase QT interval, Ketek should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (< 50 bpm), or during concomitant administration of Ketek with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
Minħabba li, bħall- makrolidi jista jtawwal l- intervall tal- QT, Ketek għandu jintuża bir- reqqa 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, bradikardja (< 50 bpm), jew waqt
As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and / or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis.
Bħal kważi l- antibijotiċi kollha, id- dijarrea, speċjalment meta tkun qawwija, persistenti u / jew bid - demm, waqt jew wara l- kura b`Ketek, tista ’ tkun ikkawżata minn kolite psewdomembranea.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/ or specific therapy.
Jekk ikun hemm il- ħsieb li jista jkun hemm kolite psewdomembranja, il- kura trid titwaqqaf minnufih u l- pazjenti jridu jingħataw kura b’ miżuri ta support u / jew terapija speċifika.
3 Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.
Deterjorament ta ’ myasthenia gravis kienu rrappurtati f’ pazjenti ikkurati b’ telithromycin u kultant ġraw fi ftit sigħat wara l- ewwel doża.
Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Ir- rapporti inkludew imwiet u indeboliment akut fil- funzjoni respiratorja, li tista ’ tkun fatali, ikkaratterizzata b’ bidu mgħaġġel (ara sezzjoni 4. 8).
Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
Tibdil fl- enżimi tal- fwied kienu komunement innotati fi studji kliniċi b’ telithromycin.
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
Epatite severa u indeboliment sever tal- fwied, inklużi każijiet fatali (li ġeneralment kienu assoċjati ma ’ mard serju li kien qed ibati minnu l- pazjent jew medikazzjoni konkomitanti) kienu rapportati wara li l- prodott tpoġġa fuq is suq (ara sezzjoni 4. 8).
These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.
Dawn ir reazzjonijiet epatiċi kienu innotati waqt jew immedjatament wara t- trattament, u fil- biċċa kbira tal- każijiet kienu riversibbli wara l- waqfien ta ’ telithromycin.
Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Il- pazjenti għandhom ikunu mwissija biex iwaqqfu t- trattament u jkellmu lit- tabib tagħhom jekk jiżvilluppaw sintomi jew sinjali ta ’ mard tal- fwied bħal anoressja, suffejra, awrina skura, ħakk jew uġigħ addominali mat- tagħfis.
Due to limited experience, Ketek should be used with caution in patients with liver impairment (see section 5.2).
Minħabba esperjenza limitata, Ketek għandu jintuża b’ kawtela f’ pazjenti li għandhom indeboliment tal- fwied (ara sezzjoni 5. 2).
Ketek may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
Ketek jista ’ jikkawża disturbi fil- vista partikularment fit- tnaqqis fl- abilita ’ biex jaddatta u l- abilita ’ ta ’ ħelsien ta ’ l- addattament tal- vista.
Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Disturbi fil- vista kienu jinkludu vista mċajpra, diffikulta biex wieħed jiffoka u diplopja.
Most events were mild to moderate; however, severe cases have been reported.
Il- biċċa l- kbira tal- każijiet kienu minn ħfief sa moderati; madankollu, każijiet ta ’ grad sever ġew irraportati.
(see sections 4.7 and 4.8).
(ara sezzjonijiet 4. 7 u 4. 8).
There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8).
Wara li l- prodott tpoġġa fuq is- suq, kien hemm rapporti ta ’ reazzjonijiet avversi ta ’ telf ħafif mis- sensi u kienu jinkludu xi każijiet assoċjati mas- sindromu vagal (ara sezzjonijiet 4. 7 u 4. 8).
Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Jista ’ jiġi kkunsidrat li Ketek jiġi mogħti f’ ħin l- irqad, sabiex jitnaqqas l- impatt potenzjali ta ’ disturbi fil- vista u telf tas- sensi.
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort).
Ketek m’ għandux jintuża waqt u għal ġimgħatejn wara kura b`sustanzi li jinduċu CYP3A4 (bħal ir - rifampiċin, phenytoin, carbamazepine, phenobarbital u St John’ s wort).
Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Kura konkomitanti b’ dawn il - prodotti mediċinali tista ’ tirriżulta f’ livelli ta telithromycin taħt dawk terapewtiċi u għalhekk, dawn jistgħu jwasslu ghall- falliment fil- kura (ara sezzjoni 4. 5.).
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 (see section 4.5).
Ketek huwa impeditur ta ’ CYP3A4 u għandu jintuża taħt ċirkostanzi speċifiċi biss waqt il- kura bi prodotti mediċinali oħra li jkunu metabolizzati minn CYP3A4 (ara sezzjoni 4. 5).
In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
F’ żoni ġeografiċi b’ inċidenza għolja ta ’ reżistenza għall- erythromycin A, huwa importanti bmod partikolari li jitqies l- isvilupp tal- mekkaniżmu ta suxxettibilità lejn telithromycin u antibijotiċi oħra.
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Fil- pulmonite li tittieħed mill- komunità, l- effikaċja ntweriet f’ numru limitat ta ’ pazjenti li kellhom fatturi ta` riskju, bħal dawk bil- preżenza tal- pnewmokokki fiċ- ċirkolazzjoni tad- demm, jew dawk li kellhom ’ l fuq minn 65 sena.
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.
Esperjenza tal- kura ta ’ infezzjonijiet kawżati minn S. pneumoniae reżistenti għall- penicillin / jew l - erythromycin 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 għall - antibijotiċi.
Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.
Trid tittieħed kawtela meta S. aureus huwa suspettat li qed jikkaġuna l- infezzjoni u hemm probabiltà li jkun reżistenti għall- erythromycin skond l- epidemjoloġija tal- post.
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
4 L. pneumophila huwa sensittiv ħafna għal telithromycin in vitro, madankollu, l- esperjenza klinika fil - kura tal- pulmonite ikkaġunata minn Legionella hija limitata.
As for macrolides, H. influenzae is classified as intermediately susceptible.
Bħal fil- każ tal- makrolidi, H. influenzae huwa ikklassifikat bħala mikrobu ta ’ sensittività medja.
This should be taken into account when treating infections caused by H. influenzae.
Influenzae.
4 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interaction studies have only been performed in adults.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmċewtiku tal- prodott fl - adulti.
• Effect of Ketek on other medicinal product
• Effetti ta Ketek fuq prodotti mediċinali oħra
Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Telithromycin huwa impeditur ta` CYP3A4 u impeditur dgħajjef ta ’ CYP2D6.
In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Studji in vivo bis - simvastatin, midazolam u cisapride urew inibizzjoni qawwija ta ’ CYP3A4 intestinali, u inibizzjoni moderata ta ’ CYP3A4 tal- fwied.
The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Il- grad t’ inibizzjoni b’ substrati diversi ta ’ CYP3A4 huwa diffiċili li jkun antiċipat.
Hence, Ketek should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
Għalhekk, Ketek m’ għandux jintuża waqt il- kura bi prodotti mediċinali li huma substrati ta ’ CYP3A4, sakemm il- livelli fil- plażma tas- substrat ta ’ CYP3A4, l- effikaċja u l- okkorrenzi avversi jistgħu jkunu osservati mill- qrib.
Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Alternattivament, il- kura bis- substrati ta ’ CYP3A4 trid titwaqqaf waqt il- kura b’ Ketek.
Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Prodotti mediċinali bil- potenzjal li jtawwlu l- intervall tal- QT Ketek huwa mistenni li jżid il- livelli fil- plażma ta ’ cisapride, pimozide, astemizole u terfenadine.
This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Dan jista ’ jtawwal l- intervall tal- QT, arritmji kardijaċi, inkluża takikardja tal- ventrikoli, fibrillazzjoni tal - ventrikoli, u torsades de pointes.
Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3).
(ara sezzjoni 4. 3).
Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
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).
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.
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 ’ l - estremitajiet.
The combination is contraindicated (see section 4.3).
L- użu flimkien huwa għalhekk kontra- indikat (ara sezzjoni 4. 3).
Statins 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 simvastatine acid AUC.
Statins Meta simvastatin ingħata flimkien ma` Ketek kien hemm żieda ta ’ 5. 3- il draba fil- livell ta` simvastatin Cmax, u żieda ta ’ 8. 9- il draba fil- livell ta ’ simvastatin AUC, u 15- il darba aktar fil- livell ta ’ simvastatine acid Cmax, u żieda ta ’ 11- il darba l- AUC ta` simvastatin acid.
In vivo interaction studies with other statins have not been performed, but Ketek may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Studji in vivo ta ’ interazzjoni ma ’ statins oħra ma sarux, iżda Ketek jista ’ jikkawża interazzjoni simili ma` lovastatin u atorvastatin, interazzjoni anqas qawwija ma ’ cerivastatin u ftit jew xejn ma ’ provastatin u fluvastatin.
Ketek should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Ketek m’ għandux jintuża flimkien ma ’ simvastatin, atorvastatin u lovastatin.
Treatment with these agents should be interrupted during Ketek treatment.
Il- kura b’ dawn is- sustanzi għandha titwaqqaf waqt il- kura b`Ketek.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
Serivastatin għandu jintuża b’ kawtela, u l- pazjenti għandhom ikunu osservati mill - qrib għal sinjali u sintomi ta` mijopatija u rabdomajoliżi.
Benzodiazepins 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.
Benzodajażepini 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.
The midazolam half- life was increased about 2.5-fold.
Il- half life ta ’ midazolam żdiedet b’ madwar 2. 5- il darba.
Oral administration of midazolam concomitantly with Ketek should be avoided.
Il- forma orali ta` midazolam flimkien ma` Ketek għandu jkun evitat.
Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient be undertaken.
Id- doża intravenuża ta ’ midazolam għandha tkun aġġustata skond il- ħtieġa u l- pazjent irid ijun immoniterjat.
The same precautions should also apply to the other benzodiazepins which are metabolized by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
L- istess kawtela tapplika għall- benżodijażepini oħra li huma metaboliżzati minn CYP3A4 (partikolarment triazolam, iżda anke f’ dimensjoni anqas l- alprazolam).
For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Għal dawk il- benżodijażepini li mhux metaboliżzati minn CYP3A4 (temazepam, nitrażepam, lorazepam) interazzjoni ma` Ketek mhux probabbli.
Cyclosporin, tacrolimus, sirolimus Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
5 Cyclosporin, tacrolimus, sirolimus Minħabba li telithromycin jista jinpedixxi CYP3A4, dan jista ’ jżid il- livelli fid- demm tas- substrati ta ’ CYP34A4.
Thus, when initiating telithromycin in patients already receiving any of theses immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored and their doses decreased as necessary.
Għalhekk, meta jibda jingħata telithromycin f’ pazjenti li diġa qed jieħdu kwalunkwe wieħed minn dawn il- prodotti li jissoprimu l- immunità, il- livelli ta ’ cyclosporin, tacrolimus u sirolimus għandhom ikunu segwiti b’ kawtela, u d- dożi tagħhom jitnaqqsu skond il- ħtieġa.
When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
Meta telithromycin jitwaqqaf, il- livelli ta ’ cyclosporin, tacrolimus jew sirolimus iridu jerġgħu jkunu segwiti b’ kawtela, u d- dożi tagħhom miżjuda skond il- ħtieġa.
5 Metoprolol 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.
Metoprolol 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.
The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Iż- zieda fl- esponiment ta ’ metoprolol jista ’ jkun ta ’ importanza klinika f’ pazjenti b’ indeboliment tal- qalb kurati b`metoprolol.
In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Metoprolol, li hu substrat ta ’ CYP2D6, meta jintuża ma` Ketek għandu jingħata b`kawtela f`dawn il - pazjenti.
Digoxin Ketek has been shown to increase the plasma concentrations of digoxin.
Digoxin Ketek intwera li jżid il- livelli ta ’ digoxin fil- plażma.
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
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.
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Ma kienx hemm tibdil sinifikanti fil- parametri ta ’ l- ECG u l- anqas dehru sinjali ta ’ tossiċità b`digoxin.
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Ketek.
Mandankollu, il- livelli ta` digoxin fis- serum jridu jkun mkejla meta digoxin jingħata ma` Ketek.
Theophylline There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Theophylline Ma kienx hemm interazzjoni famakokinetika rilevanti ta ’ Ketek meta ingħata ma` theophylline fil - forma li tinħall bil- mod.
However, the co-administration of both medicinal products should be separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
Madankollu, meta jingħataw flimkien dawn iż- żewġ prodotti mediċinali għandu jkun distanzjat b’ siegħa biex ikunu evitati effetti kollaterali diġestivi mhux mixtieqa, bħad - dardir u r- rimettar.
Oral anticoagulants Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Antikoagulanti Orali Żieda fl- attività ta ’ l- antikoagulanti kienet rapportata f’ pazjenti ittrattati simultanjament bl - antikoagulanti u l- antibijotiċi, inkluż telithromycin.
The mechanisms are incompletely known.
Il- mekkaniżmi m’ humiex magħrufa għal kollox.
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.
Għalkemm ma kienx hemm interazzjoni farmakokinetika u farmakodinamika meta ingħatat doża waħda ta` Ketek ma` warfarin, għandu jkun ikkunsidrat l- immoniterjar aktar spiss tal - prothrombin time/ INR (International Normalised Ratio) waqt il- kura konkomitanti.
Oral contraceptives There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Kontraċettivi orali M’ hemx interazzjoni farmakodinamika jew farmakokinetika klinikament relevanti b’ dożi baxxi tal - kontraċettivi orali tat- tip tliet fażijiet f’ suġgetti f’ saħħithom.
• Effect of other medicinal products on Ketek
• Effetti ta ’ prodotti mediċinali oħra fuq Ketek
During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
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.
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.
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.
The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
L - induzzjoni tonqos gradwalment f’ temp ta ’ ġimgħatejn mill- waqfien tal- kura b’ indutturi ta ’ CYP3A4.
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Ketek m’ għandux jintuża waqt u ġimgħatejn wara t- trattament bl- indutturi ta ’ CYP3A4.
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.
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.
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Dawn it- tibdiliet fl- effetti farmakokinetiċi ta` telithromycin ma jwasslux biex id- doża jkollha tkun mibdula, għax l- esponiment għal telithromycin tibqa ’ sew fil- limiti tat - tolleranza.
The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
L- effett ta ’ ritonavir fuq telithromycin ma kienx studjat u jista ’ jwassal għal esponiment akbar għal telithromycin.
The combination should be used with caution.
Għandha tittieħed kawtela meta jingħataw flimkien.
Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
6 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` telithromycin.
There are no adequate data from the use of Ketek in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Ketek waqt it- tqala.
Ketek should not be used during pregnancy unless clearly necessary.
Ketek m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
6 Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Telithromycin jinsab fil- ħalib ta ’ l- annimali li qegħdin ireddgħu, f’ livelli ta ’ 5 darbiet aktar minn dawk tal- livelli fil- plażma ta ’ l- omm.
Corresponding data for humans is not available.
M’ hemmx tagħrif korrispondenti għall- bniedem.
Ketek should not be used by breast- feeding women.
Ketek m’ għandux jintuża f’ nisa li qed ireddgħu.
Ketek may cause undesirable effects such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks.
Ketek jista ’ jikkawża effetti mhux mixtieqa bħal disturbi fil- vista, konfużjoni jew alluċinazzjoni li jistgħu itelfu biex jintemmu ċerti attivitajiet.
In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8).
Addizzjonalment, każijiet rari ta ’ telf mis- sensi għal żmien qasir, li jistgħu jkunu preċeduti minn sintomi ikkaġunati minn nervaturi tal- vagus, ġew irrapportati (ara sezzjoni 4. 8).
Because of potential visual difficulties, loss of consciousness, confusion or hallucination, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Ketek.
Minħabba problemi potenzjali fil- vista, telf mis- sensi, konfużjoni jew alluċinazzjoni, il- pazjenti għandhom jippruvaw inaqqsu mill- attivitajiet bħal sewqan ta ’ karozza, tħaddim ta ’ makkinarju kbir jew jagħmlu attivatijiet oħra ta ’ periklu waqt li qegħdin jiġu ttrattati bil - ketek.
If patients experience visual disorders, loss of consciousness, confusion or hallucination while taking Ketek, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Jekk pazjenti jkollhom disturbi fil- vista, telf mis- sensi, konfużjoni jew alluċinazzjoni waqt li qegħdin jieħdu Ketek, m’ għandhomx isuqu karozza, jħaddmu makkinarju kbir jew jagħmlu attivitajiet oħra ta ’ periklu (ara sezzjonijiet 4. 4 u 4. 8)
Patients should be informed that these undesirable effects may occur as early as after the first dose of medication.
Il- pazjenti għandhom ikunu informati bir- riskju ta ’ dawn l- effetti mhux mixtieqa, li jiġru daqshekk kmieni anke wara l- ewwel doża.
Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Il- pazjenti għandhom jiġu mwissija dwar dawn l- effetti potenzjali fuq il- ħila li jsuqu u jħaddmu l- makkinarju.
This is shown below.
F’ 2461 pazjent kurati b’ Ketek fil- fażi III tal- provi kliniċi, u wara li l- prodott tpoġġa fuq is- suq dehru dawn l- effetti mhux mixtieqa, li possibbilment jew probabbilment kienu relatati ma` telithromycin.
System organ class
Sistema tal - klassifika ta ’ l - organi
Very common (≥ 1/ 10)
Komuni Komuni ħafna (≥1/ 100 sa (≥1/ 10) < 1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
Mhux komuni Rari (≥1/ 1, 000 sa (≥1/ 10, 000 < 1/ 100) sa < 1/ 1, 000)
Uncommon Rare (≥ 1/ 1,000 (≥ 1/ 10,000 to to < 1/ 100) < 1/ 1,000)
Rari ħafna (< 1/ 10, 000)
Very rare (< 1/ 10,000)
Frekwenza mhux magħrufa (ma tistax tittieħed stima mid - data disponibbli) *
Frequency unknown (cannot be estimated from available data)*
Disturbi fil- qalb
Cardiac disorders
Fwawar palpitazzjonijiet
Flush Atrial Palpitations arrhythmia, hypotension, bradycardia
Arritmija ta ’ l- atriji tal- qalb, pressjoni baxxa, bradikardja
QT/ QTc interval prolongation
Intervall imtawwal tal - QT/ QTc
Blood and the lymphatic system disorders
Disturbi tad- demm u tas - sistema limfatika
Eosinophilia
Ejosinofilja
Nervous system disorders
7 Sistema tal - klassifika ta ’ l - organi
Dizziness, headache, disturbance of taste
Komuni Komuni ħafna (≥1/ 100 sa (≥1/ 10) < 1/ 10)
Vertigo somnolence, nervousness, insomnia,
Mhux komuni Rari (≥1/ 1, 000 sa (≥1/ 10, 000 < 1/ 100) sa < 1/ 1, 000)
Transient loss Parosmia of consciousness, paraesthesia
Rari ħafna (< 1/ 10, 000)
Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Frekwenza mhux magħrufa (ma tistax tittieħed stima mid - data disponibbli) *
Ageusia, anosmia,
Disturbi fis- sistema nervuża
Eye disorders
Sturdament, uġigħ ta ’ ras, Tibdil tat- togħma
Blurred vision
Vertigo, ngħas, nervi, nuqqas ta ’ rqad,
Diplopia
Parosmja
7 System organ class
Agewsja, anosmija,
Very common (≥ 1/ 10)
Disturbi fl - għajnejn
Common (≥ 1/ 100 to < 1/ 10)
Vista mċajpra
Uncommon Rare (≥ 1/ 1,000 (≥ 1/ 10,000 to to < 1/ 100) < 1/ 1,000)
Diplopja
Very rare (< 1/ 10,000)
Disturbi gastro - intestinali
Frequency unknown (cannot be estimated from available data)*
Dijarea
Gastro-intestinal Diarrhoea Nausea, disorders vomiting, gastrointestin al pain, flatulence
Tqalligħ, rimettar, uġigħ gastro - intestinali, gass fl - istonku
Oral Candida infection, stomatitis anorexia, constipation
Infezzjoni tal - ħalq b’ Candida, stomatite, anoressija, stitikezza
Pseudo- membranous colitis
Kolite psewdomembraneja
Rash, urticaria, pruritus
Raxx, urtikarja, Ekżema ħakk
Muscle cramps
Bugħawwieġ
Arthralgia, myalgia
Artralġja, majalġja
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity
Edema anġjonewrotika, reazzjonijiet anafilattiċi inkluż ix - xokk anafilattiku, sensittivita ’ eċċessiva
Hepato-biliary Increase in disorders liver enzymes (AST, ALT, alkaline phosphatase) Reproductive Vaginal system disorders Candida infection
Żidiet fl - enżimi tal - fwied (AST, ALT, alkaline phosphatase)
Cholestatic jaundice
Suffejra kolestatika
Severe hepatitis and liver failure (see section 4.4)
Epatite severa u insuffiċjenza tal- fwied (ara sezzjoni 4. 4)
Psychiatric disorders * postmarketing experience.
Disturbi psikjatriċi * wara li l- prodott tpoġġa fuq is- suq
Confusion, hallucination
Konfużjoni, alluċinazzjoni
Visual disturbances (< 1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate.
Id- disturbi fil- vista (< 1%) li kienu assoċjati ma ’ l- użu ta ’ Ketek, u li nkludew vista mċajpra, disturb fl - iffukar u diplopja, kienu fil- maġġor parti ħfief jew ta ’ grad moderat.
They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
Dawn ġraw tipikament fi żmien ftit siegħat wara l- ewwel jew it- tieni doża, u reġgħu tfaċċaw wara dożaġġi sussegwenti, damu diversi
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
Dawn l- avvenimineti ma kienux assoċjati ma ’ sinjali t’ abnormalitajiet okulari (ara sezzjonijiet 4. 4 u 4. 7).
In clinical trials the effect on QTc was small (mean of approximately 1 msec).
Fi provi kliniċi, l- effett fuq il- QTc kien żgħir (medja ta ’ madwar 1 msec).
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy Δ QTc > 30 msec in 7.6% and 7.0% of cases, respectively.
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.
No patient in either group developed a Δ QTc > 60 msec.
Ebda pazjent fiż- żewġ gruppi ma żviluppa ΔQTc > 60 msec.
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.
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.