FrancophonIA/ELRC3.0 huggingface dataset:
English: I-67019 Scoppito (L'Aquila), Italy
Maltese: Strada Statale No 17, km 22 I-67019 Scoppito (L'Aquila), L-Italja
English: Common (≥1/100 to
Maltese: (≥1/100 sa <1/10
English: The plasma trough levels, Cmax, AUC and renal clearance were increased by 20 %, 73 %, 37 % and 27% respectively, in healthy volunteers.
Maltese: Il-livelli l-aktar baxxi fil-plażma, Cmax, AUC u l-clearance renali, żdiedu b'20%, 73%, 37% u 27%, rispettivament, f'persuni b'saħħithom.
English: - Acute sinusitis
Maltese: − Sinużite akuta
English: Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
Maltese: titanium dioxide E171, iron oxide isfar E172, iron oxide aħmar E172 fil-kisja tal-pillola.
English: 3 years.
Maltese: 17 h.
English: Croscarmellose sodium Magnesium stearate
Maltese: Croscarmellose sodium
English: Aerobic Gram- negative bacteria Haemophilus influenzae$*
Maltese: Haemophilus influenzae$* Haemophilus parainfluenzae$
English: - Acute exacerbation of chronic bronchitis,
Maltese: − Aggravament akut ta' bronkite kronika
English: Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
Maltese: Levviax huwa kontra-indikat f'pazjenti b'myasthenia gravis (ara sezzjoni 4.4)
English: Blurred vision Diplopia
Maltese: Vista mċajpra Diplopja
English: Available as packs of 10, 14, 20 and 100 tablets.
Maltese: Jinsab f'pakketti ta' 10, 14, 20 u 100 pillola.
English: Microcrystalline cellulose Povidone K25
Maltese: Microcrystalline cellulose
English: Do not take Levviax:
Maltese: Tieħux Levviax:
English: This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Maltese: Dan jista' jtawwal l-intervall tal-QT, arritmji kardijaċi, inkluża takikardja tal-ventrikoli, fibrillazzjoni tal-ventrikoli, u torsades de pointes.
English: • Effect of other medicinal products on Levviax
Maltese: • Effetti ta' prodotti mediċinali oħra fuq Levviax
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanżi mhux attivi, ara sezzjoni 6.1
English: Constipation, anorexia (loss of appetite), stomatitis (inflammation in themouth), oral Candida infection (fungal infection), hepatitis, rash, urticaria (hives), pruritus (itching), eczema, somnolence, insomnia, nervousness, vertigo, paraesthesia (tingling of the hands or feet), , visual disturbances (blurred vision, difficulty in focusing, double vision), , flushes, transient loss of consciousness (fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ECG), hypotension (low blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test).
Maltese: − Stitikezza, nuqqas t'aptit, stomatite (infjammazzjoni tal-ħalq), infezzjoni tal-ħalq bil-Candida (infezzjoni tal-fungu), epatite, raxx, urtikarja, ħakk, ekżema, sonnolenza, insomnja, nervożiżmu, vertigo, parasteżja (tnemnim ta' l-idejn u s-saqajn), disturbi fil-vista (vista mċajpra, diffikulta biex wieħed jiffoka, vista doppja), fwawar, telf mis-sensi għal żmien qasir (ħass ħażin), arritmja, bradikardja, jew palpitazzjonijiet (tibdil fir-rata tal-qalb jew fl-ECG), pressjoni baxxa, eżinofilja (żieda ta' tip ta' ċerti ċelluli bojod fid-demm, tinduna biha permezz ta' test tad-demm).
English: España sanofi-aventis, S.A.U.
Maltese: España sanofi-aventis, S.
English: Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function.
Maltese: Telithromycin ma jinduċix ir-reżistenza MLSB in vitro f'Staphylococcus aureus, Streptococcus pneumoniae u Streptococcus pyogenes, minħabba l-funzjoni tat-3 keto fil-molekola.
English: •Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
Maltese: • Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes bħala alternattiva meta lantibijotiċi beta-lactam ma jkunux adatti f'pajjiżi/reġuni bi prevalenza sinifikanti ta' S. pyogenes reżistenti għall-makrolidi, meta medjati b'ermTR jew mefA (ara sezzjonijiet 4.4 u 5.1).
English: Aerobic Gram-positive bacteria
Maltese: Batteri erobici Gram-negattivi
English: MARKETING AUTHORISATION NUMBERS EU/1/01/192/001-005
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/192/001-005
English: The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22 % of this.
Maltese: Il-clearance totali (medja ± SD) hija ta' madwar 58±5 l/h wara li jingħata fil-vina, waqt li madwar 22% ta' dan iseħħ permezz tal-clearance renali .
English: Rare (≥1/10,000 to
Maltese: (≥1/10,000 sa
English: The in vitro protein binding is approximately 60 % to 70 %.
Maltese: L-ammont ta' antibijotiku marbut mal-proteina in vitro huwa ta' madwar 60% sa 70%.
English: Opaque PVC/Aluminium blisters
Maltese: PVC opak/fojl ta' l-aluminju
English: • Effect of Levviax on other medicinal product
Maltese: • Effetti ta Levviax fuq prodotti mediċinali oħra
English: -Hepatic impairment
Maltese: - Indeboliment epatiku
English: Date of first renewal: 9 July 2006
Maltese: Data ta' l-ewwel tiġdid: 9 ta' Lulju 2006
English: It is particularly important for your doctor to know if you are taking medicines containing phenytoin, and carbamazepine (for epilepsy), rifampicin (antibiotic), phenobarbital or St John's wort, medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart disorder) or the anti HIV medicine ritonavir.
Maltese: Huwa partikolarment importanti li t-tabib tiegħek ikun jaf jekk qed tieħu xi mediċini li fihom phenytoin u carbamazepine (għall-epilessija), rifampicin (antibijotiku), phenobarbital jew St John's wort, medicini bħal tacrolimus, cyclosporin u sirolimus (għat-trapjanti ta' l-organi), jew metoprolol (għad-disturbi fil-qalb) jew ritonavir, mediċina kontra l-HIV.
English: Oral Candida infection, stomatitis anorexia, constipation, ,
Maltese: Infezzjoni talħalq b'Candida, stomatite, anoressija, stitikezza
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets Telithromycin
Maltese: TAL-PRODOTT MEDIĊINALI Levviax 400 mg pilloli miksija b'rita Telithromycin
English: The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Maltese: Il-medja tal-konċentrazzjoni massima ta` telithromycin fiċ-ċelluli bojod tad-demm kienet ta' 83±25 mg/l.
English: Concomitant administration of Levviax 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).
Maltese: L-użu ta' Levviax 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).
English: Medicinal products with a potential to prolong QT interval Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Maltese: Prodotti mediċinali bil-potenzjal li jtawwlu l-intervall tal-QT Levviax huwa mistenni li jżid il-livelli fil-plażma ta' cisapride, pimozide, astemizole u terfenadine.
English: 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets
Maltese: 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
English: Available as pack of 5 x 2 tablets.
Maltese: Jinsab f'pakketti ta 5 x 2 pilloli
English: Levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “H3647” on one side and “400” on the other.
Maltese: Il-pilloli ta' Levviax400 mg huma ta' kulur oranġjo ċar, oblongi, imbuzzati miż-żewġ naħat, miksija b'rita, b' “H3647” imnaqqax fuq naħa waħda u “400” fuq in-naħa l-oħra.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes*
Maltese: Staphylococcus aureus reżistenti għall-methicillin (MRSA)+ Streptococcus pyogenes*
English: Uncommon (≥1/1,000 to
Maltese: (≥1/1,000 sa
English: • ergotamine or dihydroergotamine (tablets or inhaler for migraine)
Maltese: • ergotamine jew dihydroergotamine (pilloli jew sustanza li tittieħed man-nifs (inħejler)
English: In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 mL/min) compared to healthy volunteers were observed and a reduced dosage of Levviax is recommended (See Section 4.2.).
Maltese: ss, u żieda ta' darbtejn aktar fl-AUC (0-24)ss b'dożi multipli ta' 800 mg fil-grupp ta' pazjenti li kellhom indeboliment sever renali (CLCR <30 ml/min), meta mqabblin ma' voluntiera b'saħħithom; dożaġġ imnaqqas ta' Levviax huwa irrakkomandat (ara sezzjoni 4.2).
English: Additional side effects which may occur with Levviax are: abnormality of electrocardiogram (ECG) called prolongation of QT interval and inflamed pancreas (pancreatitis).
Maltese: Abnormalità fl-elettrokardjogramma (ECG) li tissejjaħ intervall tal-QT imtawwal u infjammazzjoni tal-frixa (pankreatite).
English: System organ class
Maltese: Sistema talklassifika ta' lorgani ħafna
English: Approximately one-third of telithromycin was eliminated unchanged; 20 % in faeces and 12 % in urine.
Maltese: Madwar terz ta` telithromycin tneħħa kif inhu, 20% fl-ippurgar u 12% fl-awrina.
English: The manufacturer of Levviax is: Aventis Pharma S.p.A.
Maltese: Aventis Pharma S.p.A.
English: Hypokalaemia and quinidine had additive/supra-additive effects in vitro while potentiation was evident with sotalol.
Maltese: Ipokalimja u quinidine kellhom effetti addittivi/supra-addittivi in vitro, waqt li b`sotalol l-effett kien rafforzat.
English: Vertigo somnolence, nervousness, insomnia,
Maltese: Vertigo, ngħas, nervi,nuqqas ta' rqad,
English: Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Maltese: Ranitidine (meta jittieħed siegħa qabel Levviax) u sustanzi kontra l-aċidu fl-istonku li għandhom aluminium u magnesium hydroxide, m'għandhomx effetti kliniċi rilevanti fuq il-farmakokinetiċi ta` telithromycin.
English: When simvastatin was coadministered with Levviax, 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.
Maltese: Meta simvastatin ingħata flimkien ma` Levviax 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.
English: In this leaflet:
Maltese: Sími:
English: • a medicine called protease inhibitor (HIV treatment) Refer also to section “Taking other medicines”.
Maltese: • mediċina li tissejaħ inibitur tal-protease (trattament tal-HIV) Ara wkoll it-sezzjoni “Użu ta' mediċini oħra”
English: 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.
Maltese: 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 talħalq u ta' l-ippurgar.
English: After oral administration of radiolabelled telithromycin, 76 % of the radioactivity was recovered from faeces, and 17 % from the urine.
Maltese: Wara li telithromycin radjutikkettat jingħata mill-ħalq, 76% tar-radjuattività instabet fl-ippurgar u 17% fl-awrina.
English: Enterobacteriaceae
Maltese: Enterobacteriaceae Pseudomonas
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of telithromycin
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita għandha 400 mg telithromycin
English: When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Maltese: Meta metoprolol (substrat ta' CYP2D6) kien ingħata flimkien ma' Levviax, metoprolol Cmax u l-AUC żdiedu b'madwar 38%; madankollu, ma kienx hemm effett fuq il-half life ta` l-eliminazzjoni ta` metoprolol.
English: Development of in vitro resistance to telithromycin due to spontaneous mutation is rare.
Maltese: Żvilupp ta' reżistenza in vitro għal telithromycin, minħabba mutazzjoni spontanja, hija rari.
English: BATCH NUMBER Batch {number}
Maltese: NUMRU TAL-LOTT Lot {numru}
English: Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides.
Maltese: Levviaxjappartjeni għall-klassi ta' mediċini msejjħa ketolidi, klassi ġdida t'antibijotiċi relatata malmakrolidi.
English: Atrial arrhythmia, hypotension, bradycardia
Maltese: Arritmija ta' latriji tal-qalb,, pressjoni baxxa, bradikardija
English: Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.027.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose regimen.
Maltese: 2±0.2 mg/l (firxa ta' 0.010 sa 1.29 mg/l), waqt reġimen terapewtiku ta' 800 mg darba kuljum.
English: Lancefield group C and G ( ß haemolytic ) streptococci Streptococcus agalactiae
Maltese: Streptococci (β emolitiċi) li jappartjenu għall-gruppi C u G ta' Lancefield
English: Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
Maltese: (bħal irrifampiċin, phenytoin, carbamazepine, phenobarbital u St John's wort).
English: For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/or penicillin resistance.
Maltese: Għal Streptococcus pneuomniae m'hemmx cross- jew ko-reżistenza bejn telithromycin u klassijiet oħra ta` antibatteriċi inklużi erythromycin A u/jew reżistenza għall-penicillin..
English: Pseudomembranous colitis
Maltese: Suffejra kolestatika
English: The most common side effect (10 or more out of 100 patients) which may occur with Levviax is diarrhoea, usually mild and temporary.
Maltese: L-aktar effett komuni (10 jew aktar minn kull 100 pazjent) li jista' jseħħ b` huwa id-dijarrea, normalment ħafifa u temporanja.
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Maltese: − Deterjorament ta' marda msejħa myasthenia gravis, marda rari li tikkawża dgħjufija tal muskoli.
English: For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Levviax is unlikely.
Maltese: Għal dawk il-benżodijażepini li mhux metaboliżzati minn CYP3A4 (temazepam, nitrażepam, lorazepam) interazzjoni ma` Levviax mhux probabbli.
English: The majority of MRSA are resistant to erythromycin A by a constitutive MLSB mechanism.
Maltese: Il-maġġoranza talMRSA huma reżistenti għall-erythromycin A, permezz ta' mekkaniżmu MLSB kostitwit.
English: If you have severe renal insufficiency you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Maltese: Jekk għandek 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.
English: Although Levviax has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Maltese: Għalkemm ma kienx hemm interazzjoni farmakokinetika u farmakodinamika meta ingħatat doża waħda ta` Levviax ma` warfarin, għandu jkun ikkunsidrat l-immoniterjar aktar spiss talprothrombin time/INR (International Normalised Ratio) waqt il-kura konkomitanti.
English: Its principal circulating metabolite represents approximately 13 % of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Maltese: Il-prodott metaboliku ewlieni fiċ-ċirkolazzjoni jirrappreżenta madwar 13% ta` telithromycin AUC, u hu inqas qawwi kontra l-mikrobi minn telithromycin innifsu.
English: Vaginal Candida infection
Maltese: Infezzjoni talvaġina b'Candida
English: 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. 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.
Maltese: 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.
English: Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
Maltese: Streptococcus pneumoniae
English: If you are breast-feeding do not take Levviax tablets.
Maltese: Jekk qed tredda' tieħux pilloli ta' Levviax.
English: Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Maltese: Id-derivattivi alkalojdi ta' ergot (bħal ergotamine u dihydroergotamine) Permezz t'estrapolazzjoni mill-erythromycin A u l-josamycin, l-użu ta' Levviax u d-derivattivi alkalojdi flimkien jistgħu jwasslu għal spażmu sever ta' l-arterji (ergotiżmu), li jista' jwassal għallnekrożi ta' l-estremitajiet.
English: 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 >2mg/l.
Maltese: 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.
English: When midazolam was coadministered with Levviax, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Maltese: Meta midazolam ingħata flimkien ma` Levviax, l-AUC ta` midazolam żdiedet 2.2-il darba wara li ngħata fil-vina u 6.1-il darba meta ngħata mill-ħalq.
English: $ natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
Maltese: * L-effikaċja klinika ntweriet għal iżolati suxxettibli fl-indikazzjonijiet kliniċi approvati $ sensittività naturali intermedja +** Fost il-MRSA, ir-rata ta' mikrobi MLSBC rezistenti li kienu iżolati hija aktar minn 80%.
English: Impaired hepatic function:
Maltese: Indeboliment fil-funzjoni epatika:
English: In vivo interaction studies with other statins have not been performed, but Levviax may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Maltese: Studji in vivo ta' interazzjoni ma' statins oħra ma sarux, iżda Levviax jista' jikkawża interazzjoni simili ma` lovastatin u atorvastatin, interazzjoni anqas qawwija ma' cerivastatin u ftit jew xejn ma' provastatin u fluvastatin.
English: The recommended dose of Levviax for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Maltese: Id-doża rakkomandata ta' Levviax għall-adulti u t-tfal ta' 12-il sena jew akbar hija ta' żewġ pilloli ta' 400 mg darba kuljum (800 mg darba kuljum).
English: Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other.
Maltese: Ta' kulur oranġjo ċar, oblongi, imbuzzati miż-żewġ naħat, b' “H3647” imnaqqax fuq naħa waħda u “400” fuq in-naħa l-oħra.
English: In patients of 12 to 18 years old, the treatment regimen will be: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Maltese: − Tonsillite jew farinġite ikkawżata minn Streptococcus pyogenes: 800 mg darba kuljum għal 5
English: This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
Maltese: Din l-informazzjoni tipprovdi gwida approssimattiva biss, fuq il-probabbilitajiet jekk il-mikrobi hux ser ikunu sensittivi għal telithromycin.
English: Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Maltese: Jista' jiġi kkunsidrat li Levviax jiġi mogħti f'ħin l-irqad, sabiex jitnaqqas limpatt potenzjali ta' disturbi fil-vista u telf tas-sensi (ara sezzjoni 4.4).
English: In patients with severely impaired renal and/or hepatic function, concomitant administration of Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi u/jew tal-funzjoni epatika, l-użu konkomitanti ta' Levviax ma' impedituri qawwija ta' CYP3A4, bħall-impeditur ta' protease jew ketoconazole, huwa kontraindikat.
English: During post-marketing experience the following reactions have been reported (frequency unknown): -Immune system disorders: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock -Cardiac disorders: QT/QTc interval prolongation -Gastrointestinal disorders: Pancreatitis, -Hepato-biliary disorders: Severe hepatitis and liver failure (see section 4.4) -Nervous system disorders: Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Maltese: - Disturbi tas-sistema immuni: Edema anġjonewrotika, reazzjonijiet anafilattiċi inkluż ix-xokk anafilattiku - Disturbi fil-qalb: intervall imtawwal tal-QT/QTc - Disturbi gastro-intestinali:
English: Other side effects which may commonly (1 to 10 out of 100 patients) occur with Levviax are:
Maltese: Effetti oħra li jseħħu ta' spiss (1 sa 10 minn kull 100 pazjent) b`Levviax huma:
English: - The active substance is telithromycin - The other ingredients are microcrystalline cellulose, povidone K25, croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol 8000 , hypromellose 6 cp, titanium dioxide E171, yellow iron oxide E172, red iron oxide E172 in the film-coating.
Maltese: magnesium stearate fil-qalba tal-pillola kif ukoll talc, macrogol 8000, hypromellose 6 cp,
English: For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Maltese: Għal Streptococcus pyogenes isseħħ cross-resistance għall-razzez li jkunu reżistenti għal erythromycin A ta` livell għoli.
English: Diarrhoea Nausea, vomiting, gastrointestinal pain, flatulence
Maltese: Tqalligħ, rimettar, uġigħ gastro-intestinali, gass fl-istonku
English: In 2461 patients treated by Levviax in phase III clinical trials, the following undesirable effects possibly or probably related to telithromycin have been reported.
Maltese: III tal-provi kliniċi, dehru dawn l-effetti mhux mixtieqa, li possibbilment jew probabbilment kienu relatati ma` telithromycin.
English: sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
Maltese: sanofi-aventis d.o.o. Tel: +386 1 560