qanastek/EMEA-V3 huggingface dataset:
To cover all etiologic agents of PID a combination with another antibiotic class such as the cephalosporins (e. g. ceftriaxone 250 mg intramuscular (IM) in a single dose) should be given empirically, which would be similar to other recommended treatment regimens given in combination.
Biex ikunu koperti l- aġenti kollha li jistgħu jikkawżaw PID, għandha tingħata empirikament kombinazzjoni ma ’ klassi antibijotika oħra bħal cephalosporins (per eżempju doża waħdanija ta ’ 250 mg ceftriaxone fil- muskolu (IM) f’ doża waħdanija), li tkun simili għal programmi ta ’ trattament rakkomandati oħra mogħtija f’ kombinazzjoni.
Although it is well known that monotherapy increases compliance, this example of combination therapy would not decrease compliance since the proposed cephalosporin would only have to be given once during the physician’ s visit and only moxifloxacin would have to be continued orally.
Għalkemm huwa magħruf sew li l- monoterapija żżid il- konformità, dan l- eżempju ta ’ terapija kombinata ma jnaqqasx il- konformità billi cephalosporin propost ikollu jingħata darba biss waqt iż - żjara tat- tabib u moxifloxacin biss ikollu jitkompla oralment.
Although it is acknowledged that approximately 95% of the women with a PID might be ‘ overtreated’ by this combination therapy this fact outweighs the potential risk of not treating approximately 5% of a mainly very young population which could develop serious long-term sequelae.
Għalkemm huwa magħruf li madwar 95% tan- nisa bil- PID jistgħu jiġu ‘ ttrattati żżejjed ’ permezz ta ’ din it- terapija kombinata, dan il- fatt jegħleb ir- riskju potenzjali tan- nuqqas ta ’ trattament ta ’ madwar 5% tal- popolazzjoni ġeneralment żagħżugħa ħafna li tista ’ twassal għall- iżvilupp ta ’ komplikazzjonijiet serji ħafna maż- żmien.
Safety
Is- Sigurtà
5-10 days), on the risk of coadministration with other QT-affecting substances and on the possible adverse effects on cartilage in the treatment population.
F’ din il- proċedura ta ’ riferiment, is- CHMP iffoka fuq ir- riskju ta ’ titwil aktar frekwenti tat- taqsima QT fin- nisa fid- dawl ta ’ programmi itwal ta ’ trattament fil- PID (14- il jum meta mqabbla ma ’ bejn 5 u għaxart ijiem), fuq ir- riskju ta ’ meta jingħata flimkien ma ’ sustanzi oħra li jaffettwaw il- QT u fuq l - effetti sekondarji possibbli fuq il- qarquċa fil- popolazzjoni ttrattata.
QT-prolongation is a known undesirable effect of moxifloxacin.
It- titwil tat- taqsima QT huwa effett mhux mixtieq magħruf ta ’ moxifloxacin.
Available data demonstrated no evidence for increased cardiac morbidity related to oral moxifloxacin therapy when compared to comparator antibiotic therapy, especially in a younger female population, although in other trials QT interval prolongation and torsades de pointes were more common in women than in men.
Id- dejta disponibbli ma wriet l- ebda evidenza ta ’ żieda fil- morbidità relatata mat- terapija orali b’ moxifloxacin meta mqabbla ma ’ terapija antibijotika, speċjalment f’ popolazzjoni femminili iżgħar, għalkemm fi studji oħra it - titwil tal- QT u t- torsades de pointes kienu iktar komuni fin- nisa milli fl- irġiel.
Women with PID are generally young women with few underlying diseases and concomitant medications.
In- nisa bil- PID huma ġeneralment iżgħar bi ftit mardiet bażi u li ftit ikunu qed jieħdu mediċini oħra.
The analysis of the incidence of cardiac adverse events did not reveal any special subgroups of PID patients for whom moxifloxacin presents a greater risk than comparator treatments.
L- analiżi ta ’ l- inċidenza ta ’ avvenimenti sekondarji relatati mal- qalb ma wrietx xi gruppi speċjali ta ’ pazjenti bil- PID li għalihom moxifloxacin jippreżenta riskju ikbar mit- trattament tat- tqabbil.
The CHMP considered that in general women treated for PID for up to 14 days are not at an increased risk of cardiac adverse events compared to the shorter treatment duration in the other indications.
Is- CHMP ikkunsidra li b’ mod ġenerali n- nisa ttrattati bil- PID għal massimu ta ’ 14- il jum m’ humiex f’ riskju ikbar ta ’ avvenimenti sekondarji tal- qalb meta mqabbla ma ’ trattament iqsar għall - indikazzjonijet l- oħra.
Concerning overall cardiac adverse events, no differences between short (up to 5 days) and longer duration (up to 15 days) of moxifloxacin therapy were observed.
Dwar l- avvenimenti sekondarji tal- qalb, ma dehrux differenzi bejn terapija b’ moxifloxacin qasira (ta ’ mhux iktar minn ħamest ijiem) u itwal (ta ’ mhux iktar minn 15- il jum).
In addition, the risk of QT- prolongation is already sufficiently addressed in the Product Information and will be adequately followed up by the MAH in the post-marketing setting.
Barra minn hekk, ir- riskju ta ’ titwil fit- taqsima QT diġà huwa indirizzat b’ mod suffiċjenti fit- Tagħrif dwar il- prodott u se jiġi segwit adegwatament mill- MAH wara t- tqegħid fis- suq.
The CHMP considered that QT-prolongation in PID should however be carefully addressed by the MAH in future PSURs.
Is- CHMP ikkunsidra madankollu li t- titwil tat- taqsima QT fil- PID għandha tiġi indirizzata b’ attenzjoni mill- MAH f’ PSURs futuri.
The MAH committed to monitor this adverse event in the next PSURS and committed to provide an updated Risk Management Plan taking into account the new indication mild to moderate PID.
Il- MAH intrabat li jissorvelja dan l- episodju avvers fil- PSURS li kien imiss u li jipprovdi Pjan ta ’ Ġestjoni tar- Riskji li jqis l- indikazzjoni l- ġdida ta ’ PID ħafifa jew moderata.
Due to the potential risk of adverse effects on the cartilage in patients under the age of 18 years, and the fact that PID mostly affects young women, the existing wording of the contraindication in children and adolescents was further specified namely that it is contraindicated in patients below 18 years of age.
Minħabba r- riskju potenzjali ta ’ effetti sekondarji fuq il- qarquċa f’ pazjenti ta ’ iktar minn 18- il sena, u l- fatt li l- PID taffettwa l- ikar lin- nisa żgħażagħ, il- formolazzjoni tal- kliem eżistenti tal - kontraindikazzjoni fit- tfal u l- adolexxenti kienet speċifikata iktar, jiġifieri li huwa kontraindikat f’ pazjenti li jkollhom inqas minn 18- il sena.
Overall, the CHMP agreed that the benefit/ risk balance of moxifloxacin in the PID indication over 14 days is positive.
Kollox ma ’ kollox, is- CHMP qabel li l- bilanċ bejn il- benefiċċju u r- riskju ta ’ moxifloxacin fl - indikazzjoni tal- PID matul l- 14- il jum huwa wieħed pożittiv.
Information and recommendations regarding taking measures before prescribing moxifloxacin are adequately addressed in the ‘ contraindications’ and ‘ warnings-precaution of use’ sections of the SPC and PL.
Tagħrif u rakkomandazzjonijiet dwar it - teħid ta ’ miżuri qabel il- preskrizzjoni ta ’ moxifloxacin huma indirizzati b’ mod xieraq fis- sezzjonijiet tal - ‘ kontraindikazzjonijiet ’ u ‘ twissijiet- prekawzjonijiet għall- użu ’ ta ’ l- SPC u l- PL.
6 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT U L- FULJETT TA ’ TAGĦRIF
- The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC)
- Il- Kumitat ikkunsidra r- Riferiment magħmul skond l- Artikolu 6( 12) tar- Regolament tal -
No 1084/ 2003, for Actira and associated names (See Annex 1).
Kummissjoni (KE) Nru 1084/ 2003, għal Actira u ismijiet assoċjati (ara l- Anness 1).
- The Committee considered that robust data is available showing the efficacy of Actira in the
- Il- Kumitat ikkunsidra li hemm dejta robusta li turi l- effikaċja ta ’ Actira fl- indikazzjoni “ Trattament
indication “ Treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis”, however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacin- resistant N. gonorrhoeae can be excluded.
ta ’ mard infjammatorju tal- pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal- passaġġ ġenitali ta ’ fuq, inklużi s- salpinġite u l- endometrite ”, madankollu minħabba r- reżistenza li qed tiżviluppa minn N. gonorrhoeae, moxifloxacin m’ għandux jintuża fil- monoterapija empirika, sakemm ma tkunx tista ’ tiġi eskluża razza ta ’ N. gonorrhoeae reżistenti għal moxifloxacin.
- The Committee considered that no additional safety concerns were expected with the claimed
- Il- Kumitat ikkunsidra li ma kienx mistenni iktar tħassib ma ’ l- indikazzjoni kklejmjata meta mqabbla
indication in comparison to the previously approved indications.
ma ’ l- indikazzjonijiet approvati qabel.
- The Committee, in view of the presented data on efficacy and safety, considered that the Benefit /
- Il- Kumitat, fid- dawl tad- dejta ppreżentata fuq l- effikaċja u s- sigurtà, ikkunsidra li l- bilanċ bejn il -
Risk balance for Actira and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable;
Benefiċċju u r- Riskju għal Actira u ismijiet assoċjati fit - “ Trattament ta ’ mard infjammatorju tal- pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal- passaġġ ġenitali ta ’ fuq, inklużi s- salpinġite u l - endometrite ” bir- restrizzjonijiet relatati mal- monoterapija empirika kien wieħed favorevoli;
- The CHMP, as a consequence, recommended the amendment of the Summary of Product
- Minħabba f’ hekk, is- CHMP irrakkomanda l- emenda ta ’ sezzjonijiet 4. 1, 4. 2, 4. 3, 4. 4, 5. 1 u 5. 2 tas -
Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Actira and associated names (see Annex I).
Sommarju tal- Karatteristiċi tal- Prodott u s- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif stabbiliti fl - Anness III għal Actira u ismijiet assoċjati (ara l- Anness I).
7 ANNEX III
ANNESS III
AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET (RELEVANT SECTIONS ONLY)
EMENDI LIS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U FULJETT TA ’ TAGĦRIF (SEZZJONIJIET RILEVANTI BISS)
9 4.
9 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
[Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections:
[Isem Ivvintat] 400 mg, pilloli miksija b’ rita huma ndikati għall- kura tal- infezzjonijiet mill- batterji li ġejjin:
- Acute exacerbation of chronic bronchitis
- Irkadar akut ta ’ bronkite kronika
- Community acquired pneumonia, except severe cases
- Pnewmonja miksuba mill- komunità, minbarra każijiet severi
- Acute bacterial sinusitis (adequately diagnosed)
- Sinożite akuta mill- batterji (iddijanjostikata b’ mod adegwat)
- Mild to moderate pelvic inflammatory disease (i. e. infections of female upper genital tract,
- Marda infjammatorja ħafifa sa moderata tal- pelvi (i. e. infezzjonijiet ta ’ l- apparat ġenitali ta ’ fuq
including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
tal- mara, inkluż salfinġite u endometrite), mingħajr axxess tubo- ovarjan jew pelviku assoċjat.
[Invented name] 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e. g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
[Isem Ivvintat] 400 mg, pilloli miksija b’ rita mhux irrakkomandati għall- użu bħala monoterapija tal- marda infjammatorja ħafifa sa moderata tal- pelvi, iżda għandu jingħata flimkien ma ’ sustanza anti- batterika xierqa oħra (e. ż. cephalosporin) minħabba żjieda fir- reżistenza għal moxifloxacin ta ’ Neisseria gonorrhoeae sakemm ma tiġix eskluża Neisseria gonorrhoeae reżistenti għal moxifloxacin (ara sezzjonijiet 4. 4 u 5. 1).
[Invented name] 400 mg film-coated tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
[Isem Ivvintat] 400 mg, pilloli miksija b’ rita huma ndikati għall- kura ta ’ l- infezzjonijiet imsemmija fuq jekk dawn huma kkawżati minn batterja suxxettibli għal moxifloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata kunsiderazzjoni lill- gwida uffiċjali dwar l- użu xieraq ta ’ sustanzi anti- batteriċi.
Dosage (adults) One 400 mg film-coated tablet once daily.
Dożaġġ (adulti) Pillola waħda miksija b’ rita ta ’ 400 mg darba kuljum.
Renal/ hepatic impairment No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i. e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Indeboliment renali/ tal- fwied L- ebda aġġustament fid- doża ma ’ huwa meħtieġ f’ pazjenti b’ indeboliment tal- funzjoni renali ħafif sa sever jew f’ pazjenti fuq dijalisi kronika i. e. emodijalisi u dijalisi peritoneali ambulatorja kontinwa (ara sezzjoni 5. 2 għal aktar dettalji).
There is insufficient data in patients with impaired liver function (see section 4.3).
M’ hemmx tagħrif biżżejjed dwar pazjenti b’ indeboliment tal- funzjoni tal- fwied (ara sezzjoni 4. 3).
Other special populations No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Popolazzjonijiet speċjali oħra L- ebda aġgustament fid- dożaġġ ma ’ huwa meħtieġ fl- anzjani u f’ pazjenti b’ piż tal- ġisem baxx.
Children and adolescents Moxifloxacin is contraindicated in children and adolescents (< 18 years).
Tfal u adoloxxenti Moxifloxacin huwa kontra- indikat fit- tfal u l- adoloxxenti (< 18- il sena).
Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
L- effikaċja u s- sigurtà ta ’ moxifloxacin fit- tfal u l- adoloxxenti ma ġewx stabbiliti (ara sezzjoni 4. 3).
Method of administration The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Metodu ta ’ l- għoti Il- pilloli miksija b’ rita għandhom jinbelgħu sħaħ ma ’ likwidu suffiċjenti u jistgħu jittieħdu indipendentament mill- ikliet.
Duration of administration [Invented name] 400 mg film-coated tablets should be used for the following treatment durations:
Tul ta ’ l- għoti [Isem Ivvintat] 400 mg, pilloli miksija b’ rita għandhom jiġu wżati għat- tul ta ’ kura li ġejjin:
5 - 10 days - days
5 - 10 ġranet
Community acquired pneumonia
- Pnewmonja miksuba mill- komunità
10
10 ġranet -
-
Sinożite akuta
Acute sinusitis 7 days
7 ġranet
Mild to moderate pelvic inflammatory disease
Marda infjammatorja tal- pelvi ħafifa sa moderata
14 days
14- il ġurnata
10 [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
[Isem Ivvintat] 400 mg, pilloli miksija b’ rita ġew studjati fi provi kliniċi sa 14- il ġurnata ta ’ kura.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
11 Id- doża rrakkomandata (400 mg darba kuljum) u t- tul tat- terapija għall- indikazzjoni li qed tiġi kkurata m’ għandhomx jinqabżu.
- Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
- Sensittività eċċessiva għal moxifloxacin, quinolones oħra jew għal xi sustanzi mhux attivi.
- Pregnancy and lactation (see section 4.6).
- Tqala u treddigħ (ara sezzjoni 4. 6).
- Patients below 18 years of age.
- Pazjenti b’ età taħt 18- il sena.
- Patients with a history of tendon disease/ disorder related to quinolone treatment.
- Pazjenti b’ passat ta ’ marda/ disturb fit- tendon relata ma ’ kura b’ quinolone.
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.
Kemm f’ investigazzjonijiet prekliniċi kif ukoll fil- bnedmin, wara esponiment għal moxifloxacin, kienu osservati tibdiliet fl- elettrofiżjoloġija kardijaka fil- forma ta ’ titwil ta ’ QT.
For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with:
Għalhekk, għar - raġunijiet ta ’ sigurtà tal- mediċina, moxifloxacin huwa kontra- indikat f’ pazjenti b ’:
- Congenital or documented acquired QT prolongation
- Titwil ta ’ QT miksub b’ mod konġenitali jew dokumentat
- Electrolyte disturbances, particularly in uncorrected hypokalaemia
- Disturbi fl- elektroliti, partikolarment f’ każ ta ’ ipokalimja mhux ikkoreġuta
- Clinically relevant bradycardia
- Bradikardija ta ’ rilevanza klinika
- Clinically relevant heart failure with reduced left-ventricular ejection fraction
- Insuffiċjenza tal- qalb ta ’ rilevanza klinika bi frazzjoni ta ’ tneħħija ventrikolari tax- xellug
- Previous history of symptomatic arrhythmias
- Passat ta ’ arritmija sintomatika
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Moxifloxacin m’ għandux jintuża fl- istess waqt ma ’ mediċini oħra li jtawwlu l- intervall ta ’ QT (ara wkoll sezzjoni 4. 5).
Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Minħabba tagħrif kliniku limitat, moxifloxacin huwa kontra- indikat ukoll f’ pazjenti b’ indeboliment tal- funzjoni tal- fwied (Child Pugh C) u f’ pazjenti b’ żjieda fit- transaminases ta ’ > 5 darbiet tal- ULN.
- Hypersensitivity and allergic reactions have been reported for fluoroquinolones including
- Reazzjonijiet ta ’ sensittività eċċessiva u allerġiċi ġew irrapportati għal fluoroquinolones inkluż
moxifloxacin after first administration.
moxifloxacin wara l- ewwel għoti.
Anaphylactic reactions can progress to a life-threatening shock, even after the first administration.
Reazzjonijiet anafilattiċi jistgħu jipprogredixxu għal xokk ta ’ periklu għal- ħajja.
In these cases moxifloxacin should be discontinued and suitable treatment (e. g. treatment for shock) initiated.
F’ dawn il- każijiet moxifloxacin għandu jitwaqqaf u għandha tinbeda kura xierqa (e. ż. kura għal xokk).
- Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some
Fl -
In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.
analiżi ta ’ l- ECGs miksuba fil- programm ta ’ prova klinika, it- titwil ta ’ QTc b’ moxifloxacin kien ta ’ 6 msec ± 26 msec, 1. 4% meta mqabbel mal- linja bażi.
Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin.
Medikazzjoni li tista ’ tnaqqas il - livelli ta ’ potassju għandha tiġi wżata b’ kawtela f’ pazjenti li qed jirċievu moxifloxacin.
Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest (see also section 4.3).
Moxifloxacin għandu jiġi wżat b’ kawtela f’ pazjenti b’ kundizzjonijiet proarritmiċi li ma jgħaddux, bħal iskemija mijokardijaka akuta jew titwil ta ’ QT għax dawn jistgħu jwasslu għal żjieda fir- riskju ta ’ arritmija ventrikulari (inkluż torsade de pointes) u arrest kardijaku (ara wkoll sezzjoni 4. 3).
The magnitude of QT prolongation may increase with increasing concentrations of the drug.
Id- daqs tat- titwil ta ’ QT jista ’ jiżdied b’ żjieda fil- konċentrazzjonijiet tal- mediċina.
Therefore, the recommended dose should not be exceeded.
Għalhekk, id- doża rrakkomandata m’ għandiex tinqabeż.
The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
Il- benefiċċju ta ’ kura b’ moxifloxacin, speċjalment f’ infezzjonijiet bi grad baxx ta ’ severità, għandu jiġi bbilanċjat bl- informazzjoni li hemm fis- sezzjoni ta ’ twissijiet u prekawzjonijiet.
If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Jekk is- sinjali ta ’ arritmija kardijaka seħħew waqt kura b’ moxifloxacin, il- kura għandha titwaqqaf u għandha ssir ECG.
- Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been
- B’ moxifloxacin ġew irrapportati każijiet ta ’ epatite fulminanti li potenzjalment iwasslu għall -
reported with moxifloxacin (see section 4.8).
insuffiċjenza tal- fwied ta ’ periklu għall- ħajja (ara sezzjoni 4. 8).
Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Pazjenti għandhom jiġu avżati biex jikkuntattjaw lit- tabib tagħhom qabel ikomplu l- kura jekk jiżviluppaw sinjali u sintomi ta ’ marda fulminanti tal- fwied, bħal astenja assoċjata ma ’ suffejra li tiżviluppa malajr, awrina skura, tendenza ta ’ fsada jew enċefalopatija tal- fwied.
Liver function tests/ investigations should be performed in cases where indications of liver dysfunction occur.
F’ każijiet fejn iseħħu ndikazzjonijiet ta ’ disfunzjoni tal- fwied, għandhom jitwettqu testijiet/ investigazzjonijiet tal- funzjoni ta- fwied.
- Quinolones are known to trigger seizures.
- Quinolones huma magħrufa li jikkawżaw eċċessjonijiet.
Use should be with caution in patients with CNS
L- użu għandu jsir b’ kawtela f’ pazjenti
disorders which may predispose to seizures or lower the seizure threshold.
b’ disturbi tas- CNS li jistgħu jippredisponu għall- eċċessjonijiet jew inaqqsu r- reżistenza għall - eċċessjonijiet.
- Antibiotic associated colitis (incl. pseudomembranous colitis) has been reported in association
- Kolite assoċjata ma ’ anti- bijotiċi (inkluż kolite psewdomembranuża) kienet irrapportata
with the use of broad spectrum antibiotics including moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
f’ assoċjazzjoni ma ’ l- użu ta ’ anti- bijotiċi bi spettru wiesgħa inkluż moxifloxacin; għalhekk huwa importanti li tiġi kkunsidrata din id- dijanjosi f’ pazjenti li jiżviluppaw dijarea serja waqt jew wara l- użu ta ’ moxifloxacin.
In this situation adequate therapeutic measures should be initiated immediately.
F’ din is- sitwazzjoni miżuri terapewtiċi adegwati għandhom jinbdew minnufih.
Drugs inhibiting peristalsis are contraindicated in this situation.
Mediċini li jinibixxu l- peristalsi huma kontra- indikati f’ din is- sitwazzjoni.
- Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin,
- Infjammazzjoni jew tiċrit tat- tendon jistgħu jseħħu b’ terapija b’ quinolone inkluż moxifloxacin,
particularly in elderly patients and in those treated concurrently with corticosteroids.
speċjalment f’ pazjenti anzjani u f’ dawk ikkurati fl- istess waqt b’ kortikosterojdi.
At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin and rest the affected limb(s).
Ma ’ l- ewwel sinjal ta ’ uġigħ jew infjammazjoni, l- pazjenti għandhom iwaqqfu t- terapija b’ moxifloxacin u jserrħu d- driegħ jew riġel affettwat/ i.
- Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to
- Pazjent anzjani b’ disturbi renali għandhom jużaw moxifloxacin b’ kawtela jekk huma mhux
maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
kapaċi jżommu teħid adegwat ta ’ fluwidi, minħabba li deidratazzjoni tista ’ żżid ir- riskju ta ’ insuffiċjenza renali.
- If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should
- Jekk il- vista tiddgħajjef jew ikun hemm xi effett fuq l- għajnejn, speċjalista ta ’ l- għajnejn
be consulted immediately.
għandu jiġi kkonsultat immedjatament.
- Quinolones have been shown to cause photosensitivity reactions in patients.
- Quinolones intwerew li jikkawżaw reazzjonijiet ta ’ fotosensittività f’ pazjenti.
However, studies
Iżda, studji wrew
have shown that moxifloxacin has a lower risk to induce photosensitivity.
li moxifloxacin għandu riskju aktar baxx li jinduċi fotosensittività.
Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/ or strong sunlight during treatment with moxifloxacin.
Madankollu l- pazjenti għandhom jiġu avżati biex jevitaw esponiment għall- irradjazzjoni UV jew għal dawl tax- xemx estensiv u/ jew qawwi waqt kura b’ moxifloxacin.
- Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are
- Pazjenti b’ passat fil- familja ta ’ nuqqas ta ’ glucose- 6- phosphate dehydrogenase attwali huma
prone to haemolytic reactions when treated with quinolones.
suxxettibli għal reazzjonijiet emolitiċi meta kkurati b’ quinolones.
Therefore, moxifloxacin should be used with caution in these patients.
Għalhekk, moxifloxacin għandu jiġi wżat b’ kawtela f’ dawn il- pazjenti.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
- Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, nuqqas ta ’ Lapp lactase, jew
glucose-galactose malabsorption should not take this medicine.
assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
- For patients with complicated pelvic inflammatory disease (e. g. associated with a tubo-ovarian
- Għall- pazjenti b’ marda infjammatorja tal- pelvi kumplikata (e. ż. assoċjata ma ’ axxess tubo -
or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with [Invented name] 400 mg film-coated tablets is not recommended.
ovarju jew tal- pelvi), li għalihom kura ġol- vini hija kkunsidrata bħala neċessarja, kura b ’ [Isem Ivvintat] 400 mg pilloli miksija b’ rita mhux irrakkomandata.
- Pelvic inflammatory disease may be caused by fluoroquinolone resistant Neisseria
- Marda infjammatorja tal- pelvi tista ’ tkun ikkawżata minn Neisseria gonorrhoeae reżistenti għal
gonorrhoeae.
fluoroquinolone.
Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e. g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Għalhekk f’ każijiet bħal dawn moxifloxacin empiriku għandu jingħata flimkien ma ’ anti- bijotiku xieraq ieħor (e. ż. cephalosporin) sakemm Neisseria gonorrhoeae reżistenti għal moxifloxacin tista ’ tiġi eskluża.
If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Jekk titjib kliniku ma jintlaħaqx wara 3 ġranet ta ’ kura, it- terapija għandha tiġi kkunsidrata mill- ġdid.
- Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of
- Minħabba effetti avversi fuq il- kartilaġini ta ’ annimali frieħ (ara sezzjoni 5. 3) l- użu ta ’
moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).
moxifloxacin fit- tfal u l- adoloxxenti < 18- il sena huwa kontra- indikat (ara sezzjoni 4. 3).
J01 MA 14
Anti- batteriċi quinolone, fluoroquinolones, Kodiċi ATC: J01 MA 14
Mechanism of action Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.
Mekkaniżmu ta ’ azzjoni Moxifloxacin għandu attività in vitro kontra firxa wiesgħa ta ’ patoġeni pożittivi għal Gram u negattivi għal Gram.
The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.
L- azzjoni batteriċida ta ’ moxifloxacin tirriżulta mill- inibizzjoni taż- żewġ topoisomerases tat- tip II (DNA gyrase u topoisomerase IV) meħtieġa għar- replikazzjoni, transkrizzjoni u tiswija tad- DNA tal - betterji.
It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant
Jidher li l- parti ta ’ C8- methoxy tikkontribwixxi attività msaħħa u selezzjoni aktar baxxa għall - mutanti reżistenti ta ’ batterja pożittiva għal Gram meta mqabbel mal- parti C8- H.
The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Il- preżenza tas - sostitwent voluminuż bicycloamine fil- pożizzjoni C- 7 tipprevjeni effluss attiv, assoċjat mal l- ġeni norA jew pmrA li jidrhu f’ ċerti batterja pożittivi għal Gram.
Pharmacodynamic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate.
Investigazzjonijiet farakodinamiċi wrew li moxifloxacin juri rata ta ’ qtil dipendenti mid- doża.
Minimum bactericidal concentrations (MBC) were found to be in the range of the minimum inhibitory concentrations (MIC).
Konċentrazzjonijiet batteriċida minimi (MBC) instabu li kienu fil- firxa tal- konċentrazzjonijiet inibitorji minimi (MIC).
Interference with culture test Moxifloxacin therapy may give false negative culture results for Mycobacterium spp. by suppression of mycobacterial growth.
13 Interferenza b’ test ta ’ kultura Terapija b’ moxifloxacin tista ’ tagħti riżultati tal- kultura negattivi foloz għal Mycobacterium spp. permeżż ta ’ sopressjoni tat- tkabbir tal- Mycobacteria.
Effect on the intestinal flora in humans The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin:
Effett fuq il- flora intestinali fil- bnedmin Il- bidliet fil- flora intestinali li ġejjin dehru f’ voluntiera wara l- għoti orali ta ’ moxifloxacin:
Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp. were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp..
Escherichia coli, Bacillus spp., Enterococcus spp., u Klebsiella spp. kienu mnaqqsa, kif kienu wkoll anerobi Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., u Peptostreptococcus spp.
For Bacteroides fragilis there was an increase.
Kien hemm żjieda ta ’ Bacteroides fragilis.
These changes returned to normal within two weeks.
Dawn il- bidliet reġgħu lura għan- normal fi żmien ġimagħtejn.
Mechanism of resistance Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Mekkaniżmu ta ’ reżistenza Mekkaniżmi ta ’ reżistenza li jinattivaw penicillins, cephalosporins, aminoglycosides, macrolides u tetracyclines ma jinterferixxux ma ’ l- attività anti- batterika ta ’ moxifloxacin.
Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
Mekkaniżmi ta ’ reżistenza oħra bħall- barrieri għall- permeabilità (komuni f’ Pseudomonas aeruginosa) u mekkaniżmi ta ’ effluss jistgħu wkoll jaffettwaw is- suxxettibilità għal moxifloxacin.
In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV.
Reżistenza in vitro għal moxifloxacin tinkiseb permezz ta ’ proċess ta ’ passi wara xulxin permezz ta ’ mutazzjonijiet fis- sit immirat fiż- żewġ topoisomerases tat- tip II, DNA gyrase u topoisomerase IV.
Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
Moxifloxacin huwa substrat fqir għall- mekkaniżmi ta’ effluss attiv f’ organiżmi pożittivi għal Gram.
Cross-resistance is observed with other fluoroquinolones.
Cross- resistance hija osservata b’ fluoroquinolones oħra.
However, as moxifloxacin inhibits both topoisomerase II and IV with similar activity in some Gram-positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to moxifloxacin.
Iżda, peress li moxifloxacin jinibixxi kemm topoisomerase II kif ukoll IV b’ attività simili f’ xi batterja pożittiva għal Gram, batterja bħal din tista ’ tkun reżistenti għal quinolones oħra, iżda suxxettibli għal moxifloxacin.
In vitro Susceptibility Data
Tagħrif ta ’ Suxxettibilitài in vitro
EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006):
Punti kritiċi ta ’ MIC kliniċi EUCAST għal moxifloxacin (31. 01. 2006):
Organism Staphylococcus spp.
Organiżmu Staphylococcus spp.
Susceptible ≤ 0.5 mg/ l
Suxxettibilità ≤ 0. 5 mg/ l ≤ 0. 5 mg/ l
Resistant > 1 mg/ l
Reżistenza > 1 mg/ l > 0. 5 mg/ l
S. pneumoniae Streptococcus Groups A, B, C, G H. influenzae and M. catarrhalis Enterobacteriaceae Non-species related breakpoints* * Non-species related breakpoints have been determined
Catarrhalis Enterobacteriaceae
≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l mainly on the basis of
≤ 0. 5 mg/ l ≤ 0. 5 mg/ l ≤ 0. 5 mg/ l
> 0.5 mg/ l > 1 mg/ l > 0.5 mg/ l > 1 mg/ l > 1 mg/ l
> 1 mg/ l > 0. 5 mg/ l > 1 mg/ l
pharmacokinetic/ pharmacodynamic data and are independent of MIC distributions of specific species.
* Punti kritiċi mhux relatati ma ’ speċi ġew determinati primarjament fuq il- bażi ta ’ tagħrif farmakokinetiku/ farmakodinamiku u huma indipendenti mid- distribuzzjonijiet ta ’ MIC għall - ispeċi speċifiċi.
They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).
Huma għall- użu biss għall- ispeċi li ma ngħatawx punt kritiku speċifiku għall - ispeċi u mhux għall- użu fi speċi fejn kriterji ta ’ interpretazzjoni għadhom ma ġewx iddeterminati (anerobi negattivi għal Gram).
Clinical and Laboratory Standards Institute™ (CLSI), formerly NCCLS breakpoints are presented in the below table for MIC testing (mg/ l) or disc diffusion testing (zone diameter [mm]) using a 5-µg moxifloxacin disc.
Istitut ta ’ Kriterji Kliniċi u tal- Laboratorju™ (CLSI), punti kritċi NCCLS ta ’ qabel, huma ppreżentati fit- tabella taħt għall- ittestjar ta ’ MIC (mg/ l) jew ittestjar tad- diffużjoni tad- disk (dijametru taż- żona [mm]) bl- użu ta ’ disk ta ’ 5- µg moxifloxacin.
13 Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
Punti kritiċi ta ’ MIC u tad- diffużjoni tad- disk ta ’ l- Istitut ta ’ Kriterji Kliniċi u tal- Laboratorju™ (CLSI) għal Staphylococcus spp. u organiżmi fastidjużi (M100- S17, 2007) u punti kritiċi ta ’ MIC għal anerobi (M11- A7, 2007):
Organism S. pneumoniae
Organiżmu S. pneumoniae
Susceptible ≤ 1 mg/ l ≥ 18 mm
Suxxettibli ≤ 1 mg/ l
Intermediate 2 mg/ l 15 - 17 mm
Intermedju 2 mg/ l
Resistant ≥ 4 mg/ l ≤ 14 mm
Reżistenti ≥ 4 mg/ l
1 mg/ l 21 - 23 mm
1 mg/ l 21 - 23 mm
Anaerobes
Anerobi
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
14 Il- prevalenza ta ’ reżistenza miksuba tista ’ tvarja ġeografikament u maż- żmien għal speċi magħżula u nformazzjoni lokali tar- reżistenza hija mixtieqa, b’ mod partikolari meta qed jiġu kkurati infezzjonijiet severi.
As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable.
Għandu jinkiseb parir ta ’ espert skond il- bżonn meta l- prevalenza lokali ta ’ reżistenza hija tali li l- utilità tas- sustanza hija dubjuża ta ’ l- inqas f’ xi tipi ta ’ infezzjonijiet.
14 Commonly susceptible species Aerobic Gram-positive micro-organisms Gardnerella vaginalis Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B) Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae* Streptococcus pyogenes* (Group A) Aerobic Gram-negative micro-organisms Haemophilus influenzae* Haemophilus parainfluenzae* Klebsiella pneumoniae*# Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms Fusobacterium spp.
Speċi suxxettibli b’ mod komuni Mikro- organiżmi aerobiċi pożittivi għal Gram Gardnerella vaginalis Staphylococcus aureus * (suxxettibli għal methicillin) Streptococcus agalactiae (Grupp B) Grupp ta ’ Streptococcus milleri * (S. anginosus, S. constellatus u S. intermedius) Streptococcus pneumoniae * Streptococcus pyogenes * (Grupp A) Mikro- organiżmi aerobiċi negattiv għal Gram Haemophilus influenzae * Haemophilus parainfluenzae * Klebsiella pneumoniae * # Moraxella (Branhamella) catarrhalis * Mikro- organiżmi anaerobiċi Fusobacterium spp.
Prevotella spp. “ Other” micro-organisms Chlamydophila (Chlamydia) pneumoniae* Chlamydia trachomatis* Coxiella burnetii Legionella pneumophila Mycoplasma genitalium Mycoplasma hominis Mycoplasma pneumoniae* Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-resistant)+ Aerobic Gram-negative micro-organisms Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca Neisseria gonorrhoeae*+ Inherently resistant organisms Aerobic Gram-negative micro-organisms Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications. # ESBL-producing strains are commonly resistant to fluoroquinolones + Resistance rate > 50% in one or more countries
Mikro- organiżmi “ oħra ” Chlamydophila (Chlamydia) pneumoniae * Chlamydia trachomatis * Coxiella burnetii Legionella pneumophila Mycoplasma genitalium Mycoplasma hominis Mycoplasma pneumoniae * Speċi li għalihom reżistenza miksuba tista ’ tkun probema Mikro- organiżmi aerobiċi pożittivi għal Gram Staphylococcus aureus (reżistenti għal methicillin) + Mikro- organiżmi aerobiċi negattivi għal Gram Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Neisseria gonorrhoeae * + Organiżmi reżistenti b’ mod inerenti Mikro- organiżmi aerobiċi negattivi għal Gram Pseudomonas aeruginosa * Attività kienet murija b’ mod sodisfaċenti f’ razez suxxettibli fi studji kliniċi fl- indikazzjonijiet kliniċi approvati. # Razez li jipproduċu ESBL huma reżistenti b’ mod komuni għal fluoroquinolones + Rata ta ’ reżistenza > 50% f’ pajjiż wieħed jew aktar
5.2 Pharmacokinetic properties
15 5. 2 Tagħrif farmakokinetiku
Absorption and Bioavailability Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Assorbiment u bijodisponibiltà Wara għoti orali moxifloxacin huwa assorbit malajr u kważi kompletament.
The absolute bioavailability amounts to approximately 91%.
Il- bijodisponibiltà assoluta hija ta ’ madwar 91%.
Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Il- farmakokinetika hija lineari fil- firxa ta ’ doża waħda ta ’ 50 - 800 mg u sa dożaġġ ta ’ 600 mg darba kuljum fuq medda ta ’ 10 ġranet.
Following a 400 mg oral dose peak concentrations of 3.1 mg/ l are reached within 0.5 - 4 h post administration.
Wara doża orali ta ’ 400 mg konċentrazzjonijiet massimi ta ’ 3. 1 mg/ l jintlaħqu fi żmien 0. 5 - 4 h wara l- għoti.
Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/ l, respectively.
Konċentrazzjonijiet massimi u minimi fil- plażma fi stat fiss (400 mg darba kuljum) kienu 3. 2 u 0. 6 mg/ l, rispettivament.
At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose.
Fi stat fiss l- esponiment fl- intervall ta ’ dożaġġ huwa madwar 30% ogħla milli wara l- ewwel doża.
15 Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/ l is observed.
Distribuzzjoni Moxifloxacin huwa distribwit malajr fl- ispazji ekstravaskulari; wara doża ta ’ 400 mg hija osservata AUC ta ’ 35 m· gh/ l.
The steady-state volume of distribution (Vss) is approximately 2 l/ kg.
Il- volum ta ’ distribuzzjoni fi stat fiss (Vss) huwa madwar 2 l/ kg.
In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
Esperimenti in vitro u ex vivo wrew twaħħil mal- proteini ta ’ madwar 40 - 42% independenti mill- konċentrazzjoni tal - mediċina.
Moxifloxacin is mainly bound to serum albumin.
Fil- biċċa l- kbira, Moxifloxacin huwa mwaħħal ma ’ l- albumina fis- serum.
The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin:
Il- konċentrazzjonijiet massimi li ġejjin (medja ġeometrika) kienu osservati wara għoti ta ’ doża orali waħda ta ’ 400 mg moxifloxacin:
Tissue Plasma Saliva Blister fluid Bronchial mucosa Alveolar macrophages Epithelial lining fluid Maxillary sinus Ethmoid sinus Nasal polyps Interstitial fluid Female genital tract* * intravenous administration of a 1 10 h after administration 2 unbound concentration 3 from 3 h up to 36 h post dose 4 at the end of infusion
Tessut Plażma Saliva Fluwidu fin- nuffata
Concentration 3.1 mg/ l 3.6 mg/ l 1.61 mg/ l 5.4 mg/ kg 56.7 mg/ kg 20.7 mg/ l 7.5 mg/ kg 8.2 mg/ kg 9.1 mg/ kg 1.02 mg/ l 10.24 mg/ kg single 400 mg dose
Konċentrazzjoni 3. 1 mg/ l 3. 6 mg/ l 1. 61 mg/ l
Site:
Proporzjoni Sit:
Plasma ratio - 0.75 - 1.3 1.71 1.7 - 2.1 18.6 - 70.0 5-7 2.0 2.1 2.6 0.8 - 1.42,3 1.724
Mukuża tal- bronki Makrofaġi alveolari Fluwidu tal- kisja tal - epitilju
Metabolism
10. 24 mg/ kg
Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/ faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Metaboliżmu Moxifloxacin jgħaddi minn bijotrasformazzjoni ta ’ Fażi II u jitneħħa mir- rotot renali u biljari/ tal - purgar bħala mediċina mhux mibdula kif ukoll f’ forma ta ’ sustanza sulfo (M1) u glucuronide (M2).
M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
M1 u M2 huma l- uniċi metaboliti rilevanti fil- bnedmin, it- tnejn huma mikrobijoloġikament inattivi.
In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed.
Fi studji kliniċi ta ’ Fażi I u in vitro ma kienu osservati l- ebda interazzjonijiet farmakokiniċi metaboliċi ma ’ mediċini oħra li jgħaddu minn bijotrasformazzjoni ta ’ Fażi I li tinvolvi enżimi taċ- ċitokromju P450.
There is no indication of oxidative metabolism.
M’ hemmx indikazzjoni ta ’ metaboliżmu ossidattiv.
Elimination Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Eliminazzjoni Moxifloxacin huwa eliminat mill- plażma b’ medja tal- half- life terminali ta ’ madwar 12- il siegħa.
The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/ min.
Il - medja tat- tneħħija mill- ġisem apparenti totali wara doża ta ’ 400 mg tvarja minn 179 sa 246 ml/ min.
Renal clearance amounted to about 24 - 53 ml/ min suggesting partial tubular reabsorption of the drug from the kidneys.
It - tneħħija renali tammonta għal madwar 24 - 53 ml/ min u b’ hekk tissuġġerixxi assorbiment tubulari parzjali mill- ġdid tal- mediċina mill- kliewi.
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
16 Wara doża ta ’ 400 mg, l- irkupru mill- awrina (madwar 19% għall- mediċina mhux mibdula, madwar 2. 5% għal M1, u madwar 14% għal M2) u mill- purgar (madwar 25% għall- mediċina mhux mibdula, madwar 36% għal M1, u l- ebda rkupru għal M2) ammonta għal madwar 96%.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
L- għoti ta ’ moxifloxacin flimkien ma ’ ranitidine jew probenecid ma biddlux it- tneħħija renali tal - mediċina oriġinali.
Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
Konċentrazzjonijiet ogħla fil- plażma huma osservati f’ voluntiera b’ saħħithom b’ piż tal- ġisem baxx (bħal nisa) u f’ voluntiera anzjani.
As renal function decreases,
Il- kwalitajiet farmakokinetiċi ta ’ moxifloxacin mhumiex differenti b’ mod sinifikanti f’ pazjenti b’ indeboliment renali (inkluż tneħħija tal- krejatinina > 20 ml/ min/ 1. 73 m2).
16 concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/ min/ 1.73 m2).
Kif il- funzjoni renali tonqos, il- konċentrazzjonijiet tal- metabolit M2 (glucuronide) tiżdied b’ fattur sa 2. 5 (bi tneħħija tal - krejatinina ta ’ < 30 ml/ min/ 1. 73 m2).
On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Fuq bażi ta ’ studji farmakokinetiċi li twettqu s’ issa f’ pazjenti b’ insuffiċjenza tal- fwied (Child Pugh A, B), mhux possibli li jiġi determinat jekk hemmx xi differenzi meta mqabbel ma ’ voluntiera b’ saħħithom.
Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
Indeboliment tal- funzjoni tal- fwied kienet assoċjata ma ’ esponiment ogħla għal M1 fil - plażma, filwaqt li esponiment għall- mediċina oriġinali kien komparabbli għall- esponiment f’ voluntiera b’ saħħithom.
There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.
M’ hemm biżżejjed esperjenza fl- użu kliniku ta ’ moxifloxacin f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied.
17 PACKAGE LEAFLET
17 FULJETT TA ’ TAGĦRIF
WHAT [INVENTED NAME] 400 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
X’ INHU [ISEM IVVINTAT] 400MG PILLOLI MIKSIJA B’ RITA U GĦALXIEX JINTUŻA
[Invented name] is an antibiotic belonging to the quinolone family.
[Isem Ivvintat] huwa anti- bijotiku li jagħmel parti mill- familja ta ’ quinolones.
[Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
[Isem Ivvintat] fih moxifloxacin bħala sustanza attiva li tagħmel parti minn grupp ta ’ anti- bijotiċi msejħa fluoroquinolones.
[Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
[Isem Ivvintat] jaħdem billi joqtol il- batterja li tikkawża infezzjonijiet, jekk dawn huma kkawżati minn batterja li hija suxxettibli għas- sustanza attiva moxifloxacin.
[Invented name] is used in adults for treating the following bacterial infections:
[Isem Ivvintat] jintuża fl- adulti għall- kura ta ’ l- infezzjonijiet mill- batterja li ġejjin:
- Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis)
- Irkadar f’ daqqa ta ’ bronkite kronika (irkadar akut ta ’ bronkite kronika)
- Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases
- Infezzjoni tal- pulmun (pnewmonja) miksuba minn barra l- isptar, minbarra każijiet severi.
- Acute infection of the sinuses (acute bacterial sinusitis)
- Infezzjoni akuta tas- sinusis (sinożite akuta mill- batterja)
- Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease),
- Infezzjonijiet ħfief sa moderati ta ’ l- apparat ġenitali ta ’ fuq tal- mara (marda infjammatorja tal -
including infections of the fallopian tubes and infections of the uterus mucous membrane.
pelvi), inkluż infezzjonijiet tat- tubi fallopjani u infezzjonijiet tal- membrana mukuża ta ’ l- utru.
[Invented name] tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to [Invented name] tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section 2.
It- tabib tiegħek jista ’ wkoll jippreskrivi anti- bijotiku ieħor flimkien mal- pilloli [Isem Ivvintat] għall- kura ta ’ l- infezzjonijiet ta ’ l- apparat ġenitali ta ’ fuq tal- mara (ara sezzjoni 2.
Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
Qabel ma tieħu [Isem Ivvintat] …, Oqgħod attent ħafna …, Qabel tieħu [Isem Ivvintat] 400mg pilloli miksija b’ rita).