qanastek/EMEA-V3 huggingface dataset:
If patients experience visual disorders or loss of consciousness while taking Levviax 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 jew telf mis - sensi waqt li qegħdin jieħdu Levviax, m’ għandhomx isuqu karozza, jħaddmu makkinarju kbir jew ħa 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 ’ g kmieni anke wara l- ewwel doża.
Patients should be cautioned about the potential effects of these events on the ability to
Il- pazjenti għandhom jiġu mwissija dwar dawn l- effetti potenzjali fuq il- ħila li jsuqu u jħaddmu l- makkinarju. im
4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa li l
This is shown below.
F’ 2461 pazjent kurati b ’ Levviax fil- fażi III tal- provi kliniċi, dehru dawn l- effetti mhux mixtieqa, li possibbilment jew probabbilment kienu relatati ma` telithromycin. na
tho Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
au System organ class Blood and the
7 Sistema tal - klassifika ta ’ l - organi Disturbi tad - demm u tas - sistema limfatika
Very common (≥ 1/ 10)
Komuni ħafna (≥1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
Komuni (≥1/ 100 sa < 1/ 10)
Uncommon (≥ 1/ 1,000 to < 1/ 100) Eosinophilia
Mhux komuni (≥1/ 1, 000 sa < 1/ 100) Ejosinofilja Vertigo, ngħas,
Rare (≥ 1/ 10,000 to < 1/ 1,000)
Rari (≥1/ 10, 000 sa < 1/ 1, 000) Telfien mis -
Very rare (< 1/ 10,000)
Rari ħafna (< 1/ 10, 000) Parosmja
r lymphatic system
Disturbi fis -
ge disorders Nervous system disorders
t sensi għal nervi, nuqqas ta ’ sistema nervuża
Dizziness, headache,
uġigħ ta ’ ras,
lon
za żmien qasir, Tibdil tat- togħma rqad, paresteżija
Vertigo somnolence,
riz Disturbi fl - għajnejn
Transient loss of
Vista mċajpra
Parosmia
Diplopja
disturbance of taste
to Disturbi fil- qalb u dawk vaskulari
nervousness, insomnia,
Ħmura tal- wiċċ palpitazzjonijiet
consciousness, paraesthesia
Arritmija ta ’ l - atriji tal- qalb,,
Eye disorders
aw pressjoni baxxa, bradikardija Disturbi gastro -
Blurred vision
Dijarea
Diplopia
Tqalligħ,
Cardiovascular disorders
Infezzjoni tal -
t
Kolite
Flush Palpitations
x intestinali
Atrial arrhythmia, hypotension, bradycardia
rimettar, uġigħ
Gastro-intestinal
ħalq b’ Candida,
Diarrhoea
psewdomembraneja
uc
du
Oral Candida
gastro- intestinali, gass fl- istonku
Pseudomembranous
stomatite, anoressija, stitikezza ħa
disorders
Disturbi fil- fwied
rod
Epatite
vomiting, gastrointestinal pain, flatulence
Suffejra kolestatika
infection, stomatitis anorexia,
u fil- marrara
colitis
tal- fwied (AST, ALT, alkaline ’ g phosphatase)
constipation,, Hepato-biliary disorders
Disturbi fil- ġilda
lP
im
Increase in liver enzymes (AST, ALT, alkaline
Raxx, urtikarja,
Hepatitis
Ekżema
Cholestatic jaundice
Erytema multiforme
phosphatase) Skin and subcutaneous
u fit- tessuti ta ’ taħt il- ġilda
na
ħakk
Rash, urticaria, pruritus
Disturbi muskolu -
Eczema
li l
Erythema multiforme
Bugħawwieġ
tissue disorders Musculoskeletal, connective tissue i dic
skeletrali u tal - connective tissue na
Reproductive system disorders
Disturbi tas - sistema riproduttiva
Vaginal Candida infection
iċi
Visual disturbances (< 1%) associated Me
Infezzjoni tal - vaġina b’ Candida
with the use of Levviax, including blurred vision, difficulty
Id- disturbi fil- vista (< 1%) li kienu assoċjati ma ’ l- użu ta ’ Levviax, u li nkludew vista mċajpra, disturb ed
focusing and diplopia, were mostly mild to moderate.
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 l- avvenimineti ma tm
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
kienux assoċjati ma ’ sinjali t’ abnormalitajiet okulari (ara sezzjonijiet 4. 4 u 4. 7).
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ∆ 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- ∆QTc > 30 msec f’ 7. 6% u 7% tal- każijiet, rispettivament.
No patient in either group developed a ∆ QTc > 60 msec.
Ebda pazjent fiż- żewġ gruppi ma żviluppa ∆QTc > 60 msec.
There
Ma kienx ot
7 were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
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. od
During post-marketing experience the following reactions have been reported (frequency unknown): -Immune system disorders:
Wara li l- prodott tpoġġa fuq is- suq dawn ir- reazzjonijiet ġew irrapportati (frekwenza mhux magħrufa):
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock
Edema anġjonewrotika, reazzjonijiet anafilattiċi inkluż ix- xokk
ed -Cardiac disorders:
anafilattiku
QT/ QTc interval prolongation -Gastrointestinal disorders:
- Disturbi fil- qalb: intervall imtawwal tal- QT/ QTc
Pancreatitis, -Hepato-biliary disorders:
- Disturbi fil- fwied u fil- marrara:
Severe hepatitis and liver failure (see section 4.4)
Epatite severa u insuffiċjenza tal- fwied (ara sezzjoni 4. 4).
ris -Nervous system disorders:
- Disturbi fis- sistema nervuża:
Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Każijiet ta ’ deterjorament mgħaġġel ta ’ myasthenia gravis kienu
tho 4.9 Overdose
8 4. 9 Doża eċċessiva
au Blood electrolytes (especially potassium) must be controlled.
L - elettroliti (speċjalment potassium) għandhom ikunu kontrollati.
r ge 5.
t za 5.
5.1 Pharmacodynamic properties lon Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code:
riz 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. no
to Telithromycin huwa derivat semi- sintetiku ta ’ erythromycin A li jappartjeni għall- ketolidi, klassi ta ’
Telithromycin inhibits protein synthesis by acting at the ribosome level. t uc
x Telithromycin jinpedixxi l- formazzjoni tal- proteini billi jaħdem fil- livell tar- ribożomi.
Against erythromycin A resistant rod
du 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.
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.
Meta r- razza tkun reżistenti għal ħa erythromycin A, minħabba mekkaniżmu ta ’ reżistenza MLSB, telithromycin juri affinità ta` aktar minn 20 darba meta imqabbel ma` erythromycin A, fis- sottounita 50S tar- ribożomi tal- mikrobi. ’ g Telithromycin jinterferixxi mal- qari tar- ribożomi fil- livell tar- ribożomi 23S tal- RNA, fejn jinteraġixxi mad- dominji V u II.
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it lP
Barra minn hekk, telithromycin iwaqqaf il- formazzjoni tas- sottounitajiet tar - im
Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits. na
ribożomi 50S u 30S.
Breakpoints
Breakpoints li l
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from i
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, na
intermediately susceptible organisms and intermediately susceptible organisms from resistant dic
huma: suxxettibli ≤0. 5 mg/ l, reżistenti > 2 mg/ l.
organisms, are: susceptible ≤ 0.5 mg/ l, resistant > 2mg/ l.
Il- firxa antibatterika iċi
Antibacterial spectrum Me
Il- prevalenza tar- reżistenza tista ’ tvarja minn post ġeografiku għall- ieħor u minn- żmien għal ieħor għal ed
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.
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. tm
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. ot
8 Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus methicillin susceptible (MSSA)* Lancefield group C and G (ß haemolytic) streptococci
Staphylococcus aureus suxxettibbli għall- methicillin (MSSA) * Pr
ed Streptococcus agalactiae Streptococcus pneumoniae * Viridans group streptococci
Streptococci (β emolitiċi) li jappartjenu għall- gruppi C u G ta ’ Lancefield Streptococcus agalactiae Streptococcus pneumoniae Streptococci tal- grupp viridans
ris Aerobic Gram- negative bacteria
9 Batteri erobiċi Gram- negattivi
Legionella pneumophila
Legionella pneumophila Moraxella catarrhalis
tho Moraxella catarrhalis* Other Chlamydophila pneumoniae*
t Chlamydophila pneumoniae *
au Chlamydia psittaci Mycoplasma pneumoniae*
za Chlamydia psittaci Mycoplasma pneumoniae *
r Species for which acquired resistance may be a problem
riz Speċi fejn ir- reżistenza akkwistata tista ’ tkun problema
ge Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes* lon Aerobic Gram- negative bacteria Haemophilus influenzae$* Haemophilus parainfluenzae$ Inherantly resistant organisms no
aw Staphylococcus aureus reżistenti għall- methicillin (MRSA) + Streptococcus pyogenes *
Aerobic Gram- negative bacteria Acinetobacter Enterobacteriaceae Pseudomonas t uc
Enterobacteriaceae Pseudomonas li l
∗ 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 rod
* 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%. na
against MLSBc.
Telithromycin mhux attiv kontra MLSBc. iċi
Resistance lP
Reżistenza
The majority of MRSA are na
Żvilupp ta ’ reżistenza in vitro għal telithromycin, minħabba mutazzjoni spontanja, hija rari.
resistant to erythromycin A by a constitutive MLSB mechanism.
Il- maġġoranza tal - MRSA huma reżistenti għall- erythromycin A, permezz ta ’ mekkaniżmu MLSB kostitwit. tm
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related i dic
Fil - ot
Me
waqt li esponiment għal telithromycin laqat mutanti ta` pnewmokokki li kellhom MICs aktar għoljin, l- MICs xorta baqgħu fil- firxa ta ’ sensittivita ’ indikata. od
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/ or penicillin resistance.
Pr
9 Effect on oral and faecal flora
10 Effetti fuq il- flora tal- ħalq u ta` l- ippurgar
ed 5.2 Pharmacokinetic properties
t 5. 2 Tagħrif farmakokinetiku
ris Absorption
za Assorbiment
A mean maximum plasma
Il- livell medju- massimu fil - plażma huwa ta ’ madwar 2 mg/ l u jintlaħaq f’ siegħa sa 3 sigħat wara d- doża, meta telithromycin
tho concentration of about 2 mg/ l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
to jittieħed darba kuljum f’ doża ta ’ 800 mg.
The rate and extent of absorption is unaffected by food intake, and thus Levviax tablets can be given without regard to food.
aw għalhekk, il- pilloli Levviax jistgħu jingħataw mingħajr rigward għall- ikel.
au 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
L- AUC fi stat fiss tiżdied b`1. 5- il
r increased compared to the single dose.
x darba meta mqabbla ma ’ dik ta ’ doża waħda.
ge 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 lon regimen.
du 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 ħa terapewtiku ta ’ 800 mg darba kuljum.
The in vitro protein binding is approximately 60% to 70%.
Distribuzzjoni ’ g L- ammont ta ’ antibijotiku marbut mal- proteina in vitro huwa ta ’ madwar 60% sa 70%.
Telithromycin is widely distributed no
Telithromycin im
throughout the body.
hu mifrux sew fil- ġisem.
The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, t
L- ogħla li l
bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/ l, 318.1±231 mg/ l, 3.88±1.87 mg/ kg, uc
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, na
3.95±0.53 mg/ kg and 6.96±1.58 mg/ kg, respectively.
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. rod
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 iċi
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. ed
Metabolism lP
Metaboliżmu tm
Its principal circulating metabolite represents approximately 13% of telithromycin na
Prodotti ot
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma AUC. i dic
metaboliċi oħrajn instabu fil- plażma, l- awrina u l- ippurgar, li jissarfu f`anqas minn jew daqs 3% tal - plażma AUC. od
Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
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.
Pr
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, Me
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.
Telithromycin displays moderate non-linear pharmacokinetics.
11 Telithropmycin juri farmakokinetiċi moderati u mhux linejari.
The total clearance (mean ±SD) is 10 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.
ed -Renal impairment In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in
Fi studju fejn ntużaw dożi multipli 36 individwu li kellhom indeboliment tal- kliewi, ta ’ gradi
ris 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.).
riz 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 ’ Levviax huwa irrakkomandat (ara
Based on observed data, a 600 mg daily dose is
Minn data ibbażata fuq simulazzjoni,
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.
aw 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.
au 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
x du
r In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with
- Indeboliment epatiku
ge 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 - ħa 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.
Due to limited lon experience in patients with decreased metabolic capacity of the liver, Levviax should be used with caution in patients with hepatic impairment (see also section 4.4).
Dovut għal esperjenza ’ g limitata f’ pazjenti b’ kapaċità metabolika mnaqqsa tal- fwied, Levviax għandu jintuża b’ kawtela f’ pazjenti li għandhom indeboliment epatiku (ara wkoll sezzjoni 4. 4). im
-Elderly subjects In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin no
Il- livell massimu fil- plażma u l- AUC ta` telithromycin f’ persuni li għandhom aktar minn 65 sena li l
were increased approximately 2 fold compared with those achieved in young healthy adults.
(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. na
-Paediatric patients t uc
- Pazjenti pedjatriċi
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 iċi
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 rod
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. ed
years of age.
- Sess
-Gender The pharmacokinetics of telithromycin are similar between males and females. lP
Il- farmakokinetiċi ta ’ telithromycin kienu simili bejn dawk ta ’ sess maskil u dawk ta ’ sess femminili. tm
5.3 Preclinical safety data na
5. 3 Tagħrif ta` qabel l- użu kliniku dwar is- sigurtà tal- mediċina
These effects showed a tendency to regress after i
Studji dwar l- effetti tossiċi b`dożi ripetuti ta` telithromycin li damu 1, 3 u 6 xhur fuq il- far, il- kelb u x - ot
Plasma exposures based on free fraction of active substance, at the no observed dic
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.
adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Dawn l- effetti wrew tendenza li jitilqu wara l- waqfien tal - od
Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues Me
Pr
(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
There was evidence of reversibility upon cessation of treatment.
12 fil- bniedem wara sitt xhur, rispettivament.
The significance of these findings for humans is unknown.
Kien hemm evidenza ta ’ rivversibiltà wara l- waqfien tal - kura.
11 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.
Hypokalaemia and quinidine had additive/ supra-additive effects in vitro while potentiation was evident with sotalol.
Telithromycin, iżda
Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
t mhux il- prodotti metaboliċi umani ewlenin tiegħu, kellu attività impeditriċi fuq il- kanali HERG u
ed 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
Studies in rats and rabbits were inconclusive with respect to potential
Studji fuq il- firien u l- fniek ma kienux
ris for teratogenicity, there was equivocal evidence of adverse effects on foetal development at high doses.
to 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.
tho Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
aw Telithromycin u l- prodotti metaboliċi ewlenin fil- bniedem ma wrewx potenzjal ġenotossiku f’ testijiet in vitro u in vivo.
au 6.
x 6.
6.1 List of excipients
du 6. 1 Il- qalba
r ge Tablet core:
Lista ta ’ sustanzi mhux attivi tal- pillola:
Microcrystalline cellulose lon Povidone K25 Croscarmellose sodium Magnesium stearate no
Microcrystalline cellulose Povidone K25 im
Talc Macrogol 8000 t
Talc na
Hypromellose 6 cp uc
Macrogol 8000 Hypromellose 6 cp Titanium dioxide E171 iċi
Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172 rod
Yellow iron oxide E172 Red iron oxide E172 ed
6.2 Incompatibilities
6. 2 Inkompatibiltajiet tm
Not applicable. lP
Ma jgħoddx f’ dan il- każ.
6.3 Shelf life na
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali ot
3 years.
3 snin od
6.4 Special precautions for storage i dic
6. 4 Prekawzjonijiet speċjali għall- ħażna Pr
6.5 Nature and contents of container Me
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Available as pack of 5 x 2 tablets.
13 PVC opak/ fojl ta ’ l- aluminju
12 Opaque PVC/ Aluminium perforated unit dose blisters.
Jinsab f’ pakketti ta 5 x 2 pilloli PVC opak/ fojl ta ’ l- aluminju imtaqqab doża doża
6.6 Special precautions for disposal
t 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
ed No special requirements.
za L- ebda ħtigijiet speċjali.
ris 7.
riz 7.
Aventis Pharma S. A.
to Aventis Pharma S. A.
tho 20, Avenue Raymond Aron F-92160 ANTONY France
aw 20, Avenue Raymond Aron F- 92160 ANTONY Franza
au 8.
x du 8.
9. ge DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION lon Date of first authorisation:
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L- AWTORIZZAZZJONI ’ g Data ta ’ l- ewwel awtorizzazzjoni:
9 July 2001 Date of first renewal:
9 ta ’ Lulju 2001 im
9 July 2006 no
9 ta ’ Lulju 2006 li l
DATE OF REVISION OF THE TEXT t uc rod lP i na dic Me
DATA TA ’ META ĠIET RIVEDUTA L- KITBA na iċi ed tm ot od Pr
13 ed ris tho r au ge lon ANNEX II
14 t za riz to aw x du ħa ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE no
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - ’ g MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT im
B.
B. ed tm
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lP nai dic Me
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ li l na iċi
14 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
ed Strada Statale No 17, km22 67019 Scoppito (L’ Aquila) Italy
t 67019 Scoppito (L’ Aquila)
ris B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
tho • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
to • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS -
au Medicinal product subject to medical prescription
aw SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Prodott mediċinali jingħata bir- riċetta tat- tabib.
r EFFECTIVE USE OF THE MEDICINAL PRODUCT
x • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU
ge Not applicable lon • OTHER CONDITIONS
du MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The holder of this marketing Authorisation will have to submit PSURs every 6 months.
Ma jgħoddx f’ dan il- każ. • KUNDIZZJONIJIET OĦRA
rod
’ g
dic
ħa
LABELLING AND PACKAGE LEAFLET t no uc rod lP nai dic Me
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jissottometti PSURs kull 6 xhur. im li l na iċi ed tm ot od Pr
16 Me dic ina lP rod uc t
16 t za riz to aw x du ħa ANNESS III
LABELLING lon ge PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
17 Pr od ot tm ed iċi na li l
tho
18 im A.
ed Levviax 400 mg film-coated tablets Telithromycin
Levviax 400 mg pilloli miksija b’ rita
ris 2.
riz 2.
tho Each film-coated tablet contains 400 mg of telithromycin
to Kull pillola miksija b’ rita għandha 400 mg telithromycin
au 3.
aw 3.
r 4.
x 4.
ge 10 film-coated tablets 14 film-coated tablets lon 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets no
du 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
Read the package leaflet before use t uc
Aqra l- fuljett ta ’ tagħrif qabel l- użu. li l
Oral use rod
Użu orali na
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA iċi
Keep out of the reach and sight of children lP
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. tm
OTHER SPECIAL WARNING(S), IF NECESSARY i na
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA ot
EXPIRY DATE dic
DATA TA ’ META JISKADI od
EXP {month/ year} Me
EXP {XX/ SSSS} Pr
ed F-92160 ANTONY France
t Franza
ris 12.
za riz 12.
tho EU/ 1/ 01/ 192/ 001 10 tablets EU/ 1/ 01/ 192/ 002 14 tablets EU/ 1/ 01/ 192/ 003 20 tablets
to EU/ 1/ 01/ 192/ 002 14- il pillola EU/ 1/ 01/ 192/ 003 20 pillola
au EU/ 1/ 01/ 192/ 004 100 tablets EU/ 1/ 01/ 192/ 005 5x2 tablets
aw EU/ 1/ 01/ 192/ 004 100 pillola EU/ 1/ 01/ 192/ 005 5 x 2 pilloli
r 13.
x 13.
Batch {number} ge lon 14.
du Lot {numru} ħa 14.
Medicinal product subject to medical prescription no
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA ’ g Prodott mediċinali jingħata bir- riċetta tat- tabib. im
INSTRUCTIONS ON USE t uc
STRUZZJONIJIET DWAR L- UŻU li l na
INFORMATION IN BRAILLE rod
INFORMAZZJONI BIL- BRAILLE
Levviax lP i na dic Me
Levviax iċi ed tm ot od Pr
19 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
ed Levviax 400 mg film-coated tablets Telithromycin
Levviax 400 mg pilloli miksija b’ rita Telithromycin
ris 2.
t za 2.
tho Aventis Pharma S. A.
riz to 3.
au EXP {month/ year}
aw EXP{ XX/ SSSS}
r ge 4.
x 4.
Batch {number} lon t no uc rod lP i na dic Me
du Lot {numru} ħa ’ g im li l na iċi ed tm ot od Pr
PACKAGE LEAFLET lon ge
21 Pr od ot tm ed iċi na li l
PACKAGE LEAFLET:
22 im ’ g B.
Levviax 400 mg film-coated tablets Telithromycin
Levviax 400 mg pilloli miksija b’ rita Telithromycin
You may need to read it again.
Jista ’ jkollok bżonn terġa ’ taqrah
- If you have further questions, ask your doctor or your pharmacist.
t − Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This medicine has been prescribed for you.
za − Din il- mediċina ġiet mogħtija lilek.
ris if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
riz − 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.
tho In this leaflet:
to F’ dan il- fuljett:
What Levviax is and what it is used for
X’ inhu Levviax u għalxiex jintuża
au 2.
aw 2.
Before you take Levviax.
Qabel ma tieħu Levviax 3.
How to take Levviax.
Kif għandek tieħu Levviax 4.
How to store Levviax
Kif taħżen Levviax
r 6.
x 6.
1.
du 1.
WHAT LEVVIAX IS AND WHAT IT IS USED FOR ge lon Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides.
Levviaxjappartjeni għall- klassi ta ’ mediċini msejjħa ketolidi, klassi ġdida t’ antibijotiċi relatata mal - makrolidi.
Antibiotics stop the growth of bacteria which cause infections.
L- antibijotiċi jwaqqfu l- mikrobi, li qegħdin jikkaġunaw l- infezzjonijiet, milli jikbru. ’ g
Levviax is used in adults and adolescents of 12 years and older to treat infections due to bacteria no
Levviaxjintuża fl- adulti u l- adolexxenti minn 12- il sena ’ l fuq biex ikunu kurati infezzjonijiet im
against which the medicine is active.
ikkawżati mill- batteri, li l- mediċina hija attiva kontrihom.
In adolescents of 12 years and older, Levviax can be used to treat: infections of the throat.
Fl- adoloxxenti ta ’ 12- il sena u akbar, Levviaxjista ’ jintuża biex ikunu ittrattati l- infezzjonijiet tal- gerżuma.
In adults, Levviax can be used to treat infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia. t uc
Fl- adulti, l- infezzjonijiet li Levviaxjista ’ jintuża kontrihom huma: infezzjonijiet tal- gerżuma, infezzjonijiet tas- sinus, li l
BEFORE YOU TAKE LEVVIAX rod
QABEL MA TIEĦU LEVVIAX iċi
Do not take Levviax:
Tieħux Levviax: ed
- if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any of
− 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 - tm
the other ingredients of Levviax.
ingredjenti l- oħrajn ta ’ Levviax.
If in doubt, talk to your doctor or pharmacist. if you have had a hepatitis and/ or jaundice while taking Levviax in the past.
Jekk tiġi fid- dubju kellem lit- tabib jew l- ispiżjar tiegħek.
- if you are taking certain medicinal products to control the blood level of cholesterol or other lipids.
− jekk kellek epatite u/ jew is- suffejra waqt li kont qed tieħu Levviax fil- passat ot
- if you or someone in your family are known to have an abnormality of electrocardiogram (ECG)
− jekk qed tieħu xi prodotti mediċinali biex jikkontrollawlek il- livell tal- kolesterol jew xaħmijiet oħra fid- demm od
- while taking other medicines containing any of the following active substances:
− 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:
i
Pr
• ergotamine or dihydroergotamine (tablets or inhaler for migraine) dic
ergotamine jew dihydroergotamine (pilloli jew sustanza li tittieħed man- nifs (inħejler) għall- migranja)
• terfenadine or astemizole (allergic problems) • cisapride (digestive problems) • pimozide (psychiatric problems) Me
terfenadine jew astemizole (problemi ta ’ allerġija) cisapride (problemi diġestivi) pimozide (problemi psikjatriċi)
- if you have severely impaired renal function and/ or severely impaired hepatic function, do not take
23 − Jekk qed tbati minn indeboliment sever renali u/ jew indeboliment sever tal- fwied, tieħux Levviax waqt li qed tieħu mediċini oħra li fihom kwalunkwe waħda minn dawn is- sustanzi attivi:
Levviax while taking other medicines containing any of the following active substances: • ketoconazole (anti fungal treatment) • a medicine called protease inhibitor (HIV treatment) Refer also to section “ Taking other medicines”.
ketoconazole (kura kontra l- infezzjonijiet tal- fungu) mediċina li tissejaħ inibitur tal- protease (trattament tal- HIV)
Take special care with Levviax:
Ara wkoll it- sezzjoni “ Użu ta ’ mediċini oħra ”
22
Oqgħod attent ħafna b’ Levviax:
- if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias,
t − jekk għandek xi mard tal- qalb bħal mard koronarju tal- qalb, arritmjii tal- ventrikoli,
bradycardia or if you have had certain abnormal blood tests due to medical conditions such as hypokalaemia, hypomagnesaemia.
za bradikardja, jew jekk għamilt xi testijiet li żvelaw kundizzjonijiet mediċi bħall- potassium jew magnesium baxx fid- demm
- if you develop severe or prolonged or bloody diarrhoea during or after taking Levviax tablets,
riz − jekk tiżviluppa dijarrea severa jew fit- tul, jew bid- demm, waqt jew wara li tkun ħadt il- pilloli Levviax.
consult your doctor immediately since it may be necessary to interrupt the treatment.
Kellem lit- tabib tiegħek immedjatament għax jista ’ jagħti l- każ li jkollok twaqqaf il - kura.
This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment
Dan jista ’ jkun sinjal ta ’ infjammazzjoni tal- musrana (kolite psewdomembranja) li tista ’
- if you have liver disease.
to isseħħ wara l- kura bl- antibijotiċi. − jekk għandek mard tal- fwied
- if you experience visual disturbances (blurred vision, difficulty in focusing, double vision)
aw − jekk ikollok disturbi fil- vista (vista mċajpra, diffikulta biex wieħed jiffoka, vista doppja) − jekk ikollok telf mis- sensi għal żmien qasir (ħass ħażin) − Il- pilloli ta ’ Levviaxmhux irrakkomandati għall- użu fit- tfal u adoloxxenti taħt it- 12- il sena.
tho Refer also to sections “ Do not take Levviax”, “ Taking other medicines” and “ Driving and using machines”.
x Ara wkoll Is- sezzjoni “ Tieħux Levviax ” u “ Użu ta ’ mediċini oħra ” u “ Sewqan u tħaddim ta ’ magni ”.
au Please tell your doctor if you are taking or have recently taken any other medecines, including medicines obtained without a prescription, as some of them could have an interaction with Levviax.
du Meta tieħu mediċini oħra Jekk jogħgbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki ħa dawk mingħajr riċetta tat - tabib, għax xi wħud minnhom jistgħu ma jaqblux ma` Levviax.
r You should not use Levviax with medicines containing ergotamine or dihydroergotamine tablets or
M’ għandekx tuża Levviax ma ’ mediċini li fihom ergotamine jew dihydroergotamine taħt għamla ta ’ ’ g pilloli jew inħejlers għall- migranja, terfenadine jew astemizole għal problemi allerġiċi, cisapride għal im
ge ergotamine inhalers for migraine, terfenadine or astemizole for allergic problems, cisapride for digestive problems and pimozide for psychiatric problems.
problemi diġestivi u pimozide għal problemi psikjatriċi.
You should not use Levviax if you are taking certain medicinal products to control the blood level of cholesterol or other lipids, like lon simvastatin.
M’ għandekx tuża Levviax jekk qed tieħu ċerti prodotti mediċinali bħal simvastatin, biex jikkontrollawlek il- livell tal- kolesterol fid- demm few xaħmijiet oħrajn.
Refer also to section “ Do not take Levviax”.
Ara wkoll it- sezzjoni “ Tieħux Levviax ” li l
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 no
Huwa partikolarment importanti li t- tabib tiegħek ikun jaf jekk qed tieħu xi mediċini li fihom na
like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart disorder) or the anti HIV medicine ritonavir. t
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. iċi
Taking Levviax with food and drink uc
Meta tieħu Levviax ma ’ l- ikel u max- xorb ed
Levviax may be taken with or without food.
Levviax jista ’ jittieħed qabel jew wara l- ikel.
Pregnancy and Breast-feeding rod
Tqala u Treddigħ tm
If you are pregnant do not take Levviax tablets as the safety of Levviax in pregnancy is insufficiently established.
Jekk inti tqila b’ tarbija tieħux pilloli ta ’ Levviax għax is- sigurtà ta ’ Levviax fit- tqala mhix suffiċjentement stabbilita.
If you are breast-feeding do not take Levviax tablets.
Jekk qed tredda ’ tieħux pilloli ta ’ Levviax.
Driving and using machines lP
Sewqan u tħaddim ta ’ magni ot
Limit driving or other hazardous activities while taking Levviax.
Waqt li qiegħed tieħu Levviax, illimita s- sewqan u attivitajiet oħra ta ’ periklu.
If you have vision problems or faint while taking Levviax do not drive, operate heavy machinery, or engage in dangerous activities.
Jekk ikollok problemi fil- vista jew ħass ħażin waqt li qiegħed tieħu Levviax, issuqx, tħaddimx makkinarju kbir, jew od
Taking Levviax tablets may cause side effects such as visual disturbances, which may reduce the na
Meta tieħu pilloli ta ’ Levviax jistgħu jitfaċċaw xi effetti sekondarji bħal disturbi fil- vista li jistgħu Pr
capacity to carry out certain tasks.
jnaqqsu l- abbiltà biex tagħmel ċertu xogħol.
Rare cases of transient loss of consciousness (fainting), which may be preceded by vagal symptoms (malaise, gastrointestinal distress), have been reported.
Każijiet rari transitorji ta ’ telf mis- sensi (ħass ħażin), li jistgħu jkunu preċeduti minn sintomi tan- nervaturi tal- vagus (telqa, disturbi gastro- intestinali), kienu irrapportati.
These symptoms may appear as early as after the first dose of Levviax. i dic
Dawn is- sintomi jistgħu jitfaċċaw anki wara l- ewwel doża ta ’ Levviax.
HOW TO TAKE LEVVIAX Me
KIF GĦANDEK TIEĦU LEVVIAX
Your doctor will tell you how many Levviax tablets to take, at what time and for how long.
It- tabib tiegħek jgħidlek kemm għandek tieħu pilloli Levviax, 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.
24 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 Levviax 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 ’ 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).
23 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.
t za 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.
Swallow the tablets whole with a glass of water.
riz Ibla ’ l- pilloli sħaħ b’ tazza ilma.
It is best to take tablets at the same time each day.
to l- aħjar li tieħu l- pilloli kuljum fl- istess ħin.
ed If you take more Levviax than you should If you accidentally take one tablet too many, nothing is likely to happen.
aw Jekk tieħu Levviax aktar milli suppost Jekk aċċidentalment tieħu pillola waħda żejda, x’ aktarx m’ hu ser jiġri xejn.
If you accidentally take
Jekk tieħu aktar pilloli bi żball, ħu parir tat- tabib jew ta` l- ispiżjar tiegħek.
tho If you forget to take Levviax If you forget to take a dose, take it as soon as possible.
x Jekk tinsa tieħu Levviax
au If you stop taking Levviax Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
du Jekk insejt tieħu doża, ħudha kemm jista ’ jkun malajr.
If you stop taking the tablets too soon, the infection may return, or your
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. ħa Jekk tieqaf tieħu Levviax Ħu l- kors sħiħ ta ’ pilloli li ordnalek it- tabib.
ge If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Anki jekk tibda tħossok aħjar qabel ma tkun spiċċajthom ’ g kollha.
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking the next dose. lon If you have any further questions on the use of this product, ask your doctor or pharmacist. no
Jekk twaqqaf il- pilloli qabel iż- żmien, l- infezzjoni tista ’ terġa ’ tiġi lura, jew il- kundizzjoni tiegħek tista ’ taqleb għall- agħar im
Like all medicines Levviax can cause side effects, although not everybody gets them.
Jekk twaqqaf il- pilloli malajr wisq tista ’ toħloq reżistenza tal- mikrobi għall- mediċina.
Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including t
Jekk tħoss li qed tbati minn xi effett sekondarju, għid lit- tabib immedjatament biex tieħu parir qabel ma jmissek tieħu d- doża li tmiss. li l
So, if any of the following happens, stop taking Levviax and tell your uc
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek. na
doctor immediately:
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU iċi
- Allergic or skin reactions such as face swelling, general allergic reactions including allergic
Ħafna minnhom huma rari u jgħaddu, iżda każijiet rari ħafna ta ’ reazzjonijiet avversi u serji li ed
shock, or serious skin conditions associated with red spots, blisters. rod
jinvolvu l- fwied u jikkaġunaw indeboliment epatiku, inklużi każijiet fatali kienu rapportati.
- Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a
Għalhekk, jekk tħoss xi waħda minn dawn l- effetti msemmija hawn taħt, waqqaf Levviax u għid lit - tabib tiegħek immedjatament: tm
sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics.
− Reazzjonijiet tal- ġilda jew dawk allerġiċi bħall- nefħa tal- wiċċ jew kondizzjonijiet serji tal - ġilda ikkaratterizzati minn tbajja ’ ħomor jew infafet. − Dijarrea severa, persistenti jew bid- demm, flimkien ma` wġigħ ta ’ żaqq jew deni, jistgħu jkunu ot
- Signs and symptoms of hepatitis (liver disease) such as yellowing of skin and eyes, dark urine,
sinjali ta ’ infjammazzjoni serja tal- musrana, li tista ’ isseħħ rari ħafna wara kura bl- antibijotiċi. − Sinjali u sintomi ta ’ epatite (mard tal- fwied) bħal sfurija tal- ġilda u ta ’ l- għajnejn, awrina skura, od
- Worsening of a condition called myasthenia gravis, a rare disease which causes muscle
Pr
The above serious side effects are uncommon (1 out of 1000 to less than 1 out of 100), rare (1 out of 10,000 to less than 1 out of 1000 patients) or very rare (less than 1/ 10,000 patients including isolated i dic
Dawn l- effetti serji msemmija hawn fuq m’ humiex komuni (minn 1 f’ kull 1000 sa anqas minn 1 f’ kull 100), rari (1 f’ kull 10, 000 sa anqas minn 1 f’ kull 1000) jew rari ħafna (anqas minn 1/ 10, 000 pazjent inklużi rapporti iżolati), izda jistgħu jinħtieġu attenzjoni medika urġenti.
Me
L- effetti l- oħra mhux mixtieqa u imniżżla hawn taħt qed jingħataw b’ estimu tal- frekwenza li bihom jistgħu iseħħu.
The most common side effect (10 or more out of 100 patients) which may occur with Levviax is diarrhoea, usually mild and temporary.
25 L- aktar effett komuni (10 jew aktar minn kull 100 pazjent) li jista ’ jseħħ b` huwa id- dijarrea, normalment ħafifa u temporanja.
Other side effects which may commonly (1 to 10 out of 100 patients) occur with Levviax are:
Effetti oħra li jseħħu ta ’ spiss (1 sa 10 minn kull 100 pazjent) b`Levviax huma: − 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),
24 Nausea, vomiting, abdominal pain, flatulence (excess wind), dizziness, headaches, disturbance of taste, vaginal Candida infection (fungal infection associated with local itching, burning and white discharge), increase in liver enzymes (detected by blood test).
t żieda fil- livell ta ’ l- enżimi tal- fwied (tinduna biha permezz ta ’ test tad- demm).
Uncommon or rare side effects (1 out of 10,000 to less than 1 out of 100 patients) which may occur with Levviax are:
za Effetti oħra mhux komuni, jew rari (1 minn kull 10, 000 pazjent sa anqas minn 1 kull 100 pazjent) li jistgħu iseħħu b`Levviax huma:
ed 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
to 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