FrancophonIA/ELRC3.0 huggingface dataset:
English: No TdPs were reported in over 15,000 patients in clinical studies and in over 90,000 patients in Post Marketing Studies and the frequency of treatment-emergent serious cardiac events was similar to that of the comparator.
Maltese: Ebda TdPs ma ġie rrappurtat f'aktar minn 15,000 pazjent fi studji kliniċi u f'aktar minn 90,000 pazjent fi Studji ta' Wara it-Tqegħid fis-Suq u l-frekwenza ta' avvenimenti kardijaċi serji li jirriżultaw mit-trattament kienet simili għal dik tal-komparatur.
English: The CHMP adopted a List of Questions, to be addressed by the Applicant.
Maltese: IsCHMP adotta Lista ta' Mistoqsijiet, li għandha tiġi indirizzata mill-Applikant.
English: CARTON FOR UNIT PACK AND LABEL - GLASS BOTTLE
Maltese: KARTUNA GĦALL-PAKKETT WIEĦED U TIKKETTA - FLIXKUN
English: - Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8).
Maltese: - B'moxifloxacin kienu rrapportati każijiet ta' reazzjonijiet bullużi tal-ġilda bħas-sindrome Stevens-Johnson jew nekrolisi epidermika tossika (ara sezzjoni 4.8).
English: General symptomatic therapy should be initiated.
Maltese: Għandha tinbeda terapija sintomatika ġenerali.
English: #ESBL-producing strains are commonly also resistant to fluoroquinolones.
Maltese: #Razez li jipproduċu ESBL b'mod komuni huma reżistenti wkoll għal fluoroquinolones.
English: Greece:
Maltese: L-Olanda:
English: PHARMACEUTICAL FORM AND CONTENTS 5 bottles with 250 ml solution for infusion Multipack
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 5 fliexken b'250 ml ta' soluzzjoni għall-infużjoni Multipack
English: Contains sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections.
Maltese: Fih sodium chloride, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għallaġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Increased blood clotting Allergic Reactions Uncommon: Allergic reaction Rare:
Maltese: Tagħqid tad-demm miżjud Reazzjonijiet allerġiċi Mhux komuni: Reazzjoni allerġika Rari:
English: Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
Maltese: Superinfezzjonijiet ikkawżati minn batterja jew fungi reżistenti eż. kandidajasi orali u vaġinali
English: Octegra contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Maltese: Octegra fih moxifloxacin bħala sustanza attiva li jagħmel parti minn grupp ta' antibijotiċi msejħa fluoroquinolones.
English: The frequencies of cardiac adverse events and adverse events were similar and the postmarketing observational studies and post-marketing surveillance of spontaneous adverse events do not show any evidence that IV/oral moxifloxacin is associated with a significantly higher risk of developing liver or cardiac adverse events than standard therapy.
Maltese: Il-frekwenzi ta' avvenimenti avversi kardijaċi u avvenimenti avversi kienu simili u l-istudji ta' osservazzjoni ta' wara t-tqegħid fis-suq u s-sorveljanza ta' wara t-tqegħid fis-suq ta' avvenimenti avversi spontanji ma juru ebda evidenza li moxifloxacin IV/orali huwa assoċjat ma' riskju ferm ogħla li wieħed jiżviluppa avvenimenti avversi tal-fwied jew tal-qalb milli fit-terapija standard.
English: Octegra is packaged in cartons containing a 250ml glass bottle with a chlorobutyl rubber stopper.
Maltese: Octegra huwa ppakkjat f'kartun li fihom flixkun tal-ħġieġ ta' 250ml b'tapp tal-lasktu chlorobutyl.
English: Uncommon: Itching, rash, skin hives, dry skin Very rare:
Maltese: Mhux komuni: Ħakk, raxx, urtikarja fil-ġilda, ġilda xotta Rari ħafna:
English: Renal impairment (incl.
Maltese: Insuffiċjenza renali (ara sezzjoni
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Maltese: - Dijarea assoċjata ma' antibijotiċi (AAD) u kolite assoċjata ma' antibijotiċi (AAC), inkluż kolite psewdomembrana u dijarea assoċjata ma' Clostridium difficile, kienu rrapportati f'assoċjazzjoni ma' l-użu ta' antibijotiċi b'firxa wiesgħa inkluż moxifloxacin u jistgħu jvarjaw fis-severità minn dijarea ħafifa għall-kolite fatali.
English: The toxicological experiments did not indicate that the liver was a prominent target organ for moxifloxacin and no specific risk factors for severe hepatic events were identified.
Maltese: L-esperimenti tossikoloġiċi ma ndikawx li l-fwied kien organu fil-mira prominenti għal moxifloxacin u ma ġie identifikat ebda fattur ta' riskju speċifiku għal avvenimenti epatiċi severi.
English: - Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones.
Maltese: - Pazjenti b'passat fil-familja ta', jew nuqqas ta' glucose-6-phosphate dehydrogenase attwali huma suxxettibli għal reazzjonijiet emolitiċi meta kkurati b'quinolones.
English: Moxifloxacin is contraindicated in children and growing adolescents.
Maltese: Moxifloxacin huwa kontra-indikat fit-tfal u adoloxxenti li qed jikbru.
English: Following a 400 mg intravenous infusion recovery of unchanged drug from urine was approximately 22% and from faeces approximately 26%.
Maltese: Wara infużjoni fil-vini ta' 400 mg irkupru tal-mediċina mhux mibdula mill-awrina kienet madwar 22% u mill-purgar madwar 26%.
English: In dogs, high oral doses (≥ 60 mg/kg) leading to plasma concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an atrophy of the retina.
Maltese: Fil-klieb, dożi orali għolja (≥ 60 mg/kg) li jwasslu għall-konċentrazzjonijiet fil-plażma ta' ≥ 20 mg/l ikkawżaw bidliet fl-elettroretinogramma u f'każijiet iżolati atrofija tar-retina.
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Maltese: Reazzjonijiet bullużi tal-ġilda bħas-sindrome Stevens-Johnson jew Nekrolisi epidermika tossika (b'potenzjal ta' periklu għall-ħajja, ara sezzjoni 4.4)
English: In vitro, moxifloxacin revealed cardiac electrophysiological properties that can cause prolongation of the QT interval, even though at high concentrations.
Maltese: In vitro, moxifloxacin wera kwalitajiet kardijaċi elettrofiżjoloġiċi li jistgħu jikkawżaw titwil ta' lintervall QT, anki jekk f'konċentrazzjonijiet għolja.
English: Octegra is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Maltese: Octegra huwa ppakkjat f'boroż tal-polyolefine ta' 250ml b'tieqa tal-polypropylene issiġillati f'fojl talaluminium fuq barra.
English: Unspecific abnormal heart rhythms, irregular heart beat (Torsade de Pointes), stopping of heart beat (see section 2.
Maltese: Ritmu tal-qalb mhux normali mhux speċifikat, rata ta' taħbit tal-qalb irregolari (Torsade de Pointes), waqfien tat-taħbit tal-qalb (ara sezzjoni 2.
English: Injection and infusion site reactions
Maltese: Infusionslösung
English: Alterations of the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis)
Maltese: Bidliet fil-ġilda u fil-membrani mukużi (infafet juġgħu fil-ħalq/imnieħer jew filpene/vaġina) b'potenzjal ta' periklu għall-ħajja (Sindrome Stevens-Johnson, nekrolisi epidermika tossika)
English: The CHMP considers that the totality of the safety data relating to use of moxifloxacin (IV and oral and IV/PO) should be taken into account together when assessing the overall benefit-risk and therefore, the safety profile described for oral administration applies to intravenous administration, with the additional expectation that the difference in PK and in patient and infection characteristics for those in need of initial IV treatment is likely to increase any risks associated with systemic administration.
Maltese: Is-CHMP jikkunsidra li t-totalità tad-dejta tas-sigurtà relatata mal-użu ta' moxifloxacin (IV u orali u IV/PO) għandha tiġi kkunsidrata flimkien meta ssir valutazzjoni talbenefiċċji-riskji ġenerali u għalhekk, il-profil tas-sigurtà deskritt għall-amministrazzjoni orali japplika għall-amministrazzjoni ġol-vini, bl-istennija addizzjonali li d-differenza fil-PK u fil-karatteristiċi talpazjent u tal-infezzjoni għal dawk li jeħtieġu trattament IV inizjali wisq probabbli tkabbar kwalunkwe riskju assoċjat mal-amministrazzjoni sistemika.
English: Luxembourg Bayer HealthCare AG 51368 Leverkusen Germany
Maltese: Il-Lussemburgu Bayer HealthCare AG 51368 Leverkusen
English: Quinolones, including moxifloxacin, are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals.
Maltese: Quinolones, inkluż moxifloxacin, huma magħrufa li jikkawżaw leżjonijiet fil-kartilaġini tal-ġogi dijartrojdi maġġuri f'bhejjem mhux maturi.
English: Fluoroquinolones exhibit a concentration dependent killing of bacteria.
Maltese: Fluoroquinolones juru qtil ta' batterja dipendenti mill-konċentrazzjoni.
English: The CHMP considered that the effects of moxifloxacin on QTc indicate a correlation between plasma concentration and QTc.
Maltese: Is-CHMP ikkunsidra li l-effetti ta' moxifloxacin fuq QTc jindikaw korrelazzjoni bejn il-konċentrazzjoni tal-plażma u QTc.
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Maltese: - B'moxifloxacin kienu irrapportati każijiet ta' epatite fulminanti (inkluż każijiet fatali) li potenzjalment iwasslu għall-insuffiċjenza tal-fwied (ara sezzjoni 4.8).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Borża ta' 250 ml fiha 400 mg moxifloxacin (bħala hydrochloride).
English: NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally] Moxifloxacin
Maltese: Octegra u ismijiet assoċjati miegħu (ara Anness I) 400 mg/250 ml soluzzjoni għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] Moxifloxacin
English: Anorexia Constipation Dyspepsia Flatulence Gastritis
Maltese: Anoressija Stitikezza Dispepsja Gass fl-istonku Gastrite
English: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).
Maltese: Fin-nuqqas ta' tagħrif dwar il-bnedmin u minħabba r-riskju sperimentali ta' ħsara kkawżata minn fluoroquinolones lill-kartilaġini li jġorru l-piż ta' bhejjem mhux maturi, t-treddigħ huwa kontra-indikat waqt terapija b'moxifloxacin (ara sezzjoni 4.3).
English: Important information about some of the ingredients of Octegra This medicinal product contains 787mg (approximately 34mmol) sodium per dose.
Maltese: Dan il-prodott mediċinali fih 787mg (madwar 34mmol) ta' sodium f'kull doża..
English: and monkeys (p.o.) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin.
Maltese: Studji fil-firien (p.o. u i.v.) u xadini (p.o.) ma wrewx evidenza ta' teratoġeniċità jew indeboliment tal-fertilità wara għoti ta' moxifloxacin.
English: After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval.
Maltese: Wara għoti fil-vini ta' moxifloxacin lill-klieb (30 mg/kg infuż fuq medda ta' 15, 30 jew 60 minuta) ilgrad ta' titwil ta' QT kien dipendenti b'mod ċar fuq ir-rata ta' l-infużjoni, i.e. iktar ma jkun qasir ilħin ta' l-infużjoni iktar jispikka t-titwil ta' l-intervall QT. Ma deher l-ebda titwil ta' l-intervall QT meta doża ta' 30 mg/kg kienet infuża fuq medda ta' 60 minuta.
English: [Moxifloxacin] 400 mg solution for infusion is indicated for the treatment of: - Community acquired pneumonia - Complicated skin and structure infections
Maltese: [Moxifloxacin] soluzzjoni ta' 400 mg għall-infużjoni hija indikata għat-trattament ta':
English: The 250 ml bottle is available in packs of 1 and 5 bottles.
Maltese: Il-flixkun ta' 250 ml huwa disponibbli f'pakketti ta' 1 u 5 fliexken.
English: HOW TO STORE OCTEGRA
Maltese: QABEL MA TUŻA OCTEGRA
English: At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.
Maltese: F'temperaturi ta' ħażna friski jista' jkun hemm preċipitazzjoni li terġa' tinħall f'temperatura talkamra.
English: Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Maltese: Moxifloxacin m'għandux jintuża fl-istess waqt ma' mediċini oħra li jtawwlu l-intervall ta' QT (ara wkoll sezzjoni 4.5).
English: Moxifloxacin IV for cSSSI was approved in 2005 in all countries that had already approved the intravenous formulation for use in CAP. No consensus was reached on Day 60 of the CMD(h) referral and the procedure was therefore referred to the CHMP.
Maltese: Moxifloxacin IV għal cSSSI ġie approvat fl-2005 fil-pajjiżi kollha li kienu diġà approvaw il-formolazzjoni ta' ġol-vini għallużu fil-CAP.
English: LDH increase) Increased bilirubin Increased gammaglutamyltransferase Increase in blood alkaline phosphatase
Maltese: Indeboliment talfwied (inkluż żjieda fl-LDH) Żjieda fil-bilirubin Żjieda ta' gammaglutamyltransferase Żjieda ta' alkaline phosphatase fiddemm
English: Dyspnea (including asthmatic conditions)
Maltese: Qtugħ ta' nifs (inkluż kondizzjonijiet ażmatiċi)
English: Leucopenia(s) Neutropenia Thrombocytopenia Thrombocythemia Blood eosinophilia Prothrombin time prolonged / INR increased
Maltese: Lewkopenija(i) Newtropenija Tromboċitopenija Tromboċitemija Esinofilja taddemm
English: Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Maltese: It-tneħħija renali tammonta għal madwar 2453 ml/min u b'hekk tissuġġerixxi assorbiment tubulari parzjali mill-ġdid tal-mediċina mill-kliewi.
English: In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide.
Maltese: Fi studji li twettqu f'voluntiera dijabetiċi, l-għoti ta' moxifloxacin orali flimkien ma' glibenclamide wassal għall-tnaqqis ta' madwar 21% fil-konċentrazzjonijiet massima fil-plażma ta' glibenclamide.
English: Tendonitis (see section 4.4) Muscle cramp Muscle twitching
Maltese: Tendonite (ara sezzjoni 4.4) Bugħawwieġ filmuskoli
English: In particular there is no clinical evidence to support an assertion that moxifloxacin might remain clinically active against organisms that have acquired reduced susceptibility to other fluoroquinolones.
Maltese: B'mod partikolari m'hemm ebda evidenza klinika li tappoġġja affermazzjoni li moxifloxacin jista' jibqa' attiv klinikament kontra organiżmi li akkwistaw suxxettibbiltà mnaqqsa għal fluoroquinolones oħra.
English: Treatment of cSSI
Maltese: Trattament ta' cSSI
English: Changes in INR
Maltese: Bidliet fl-INR
English: - Octegra may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4.
Maltese: - Octegra jista' jikkawża infjammazzjoni rapida u severa tal-fwied li tista' twassal għallinsuffiċjenza tal-fwied li hija ta' periklu għall-ħajja (inkluż każijiet fatali, ara sezzjoni 4.
English: An analysis of cardiac safety in sequential IV/oral clinical studies (overall and cSSSIs) was presented, along with an overview of the incidence of treatmentemergent adverse events relevant as surrogates for arrhythmia.
Maltese: Analiżi tas-sigurtà kardijaka fi studji kliniċi IV/orali sekwenzjali (ġenerali u cSSSIs) ġiet ippreżentata, flimkien ma' ħarsa ġenerali tal-inċidenza tal-avvenimenti avversi li jirriżultaw mit-trattamenti rilevanti bħala sostituti għallarritmija.
English: gait disturbances, esp. due to dizziness or vertigo)
Maltese: Disturbi filkoordinazzjoni (inkluż disturbi filmixja, speċjalment ikkawżati minn sturdament jew vertigo)
English: Ear Rare:
Maltese: Rari ħafna:
English: - The active substance is moxifloxacin.
Maltese: X'fih Octegra - Is-sustanza attiva hi moxifloxacin.
English: An additive effect on QT interval between moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded.
Maltese: Interazzjonijiet ma' prodotti mediċinali Ma jistax jiġi eskluż effett addittiv fuq l-intervall QT bejn moxifloxacin u prodotti mediċinali oħra li jistgħu jtawwlu l-intervall QTc.
English: Kidney
Maltese: Kliewi
English: There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section
Maltese: Kien hemm każijiet rari ħafna ta' l-effetti sekondarji li ġejjin irrapportati wara kura b'fluoroquinolones oħrajn, li possibilment jistgħu jseħħu wkoll waqt kura b' moxifloxacin: telf temporanju tal-vista, ipernatrimija, iperkalċimija, emolisi, rabdomijolisi, reazzjonijiet ta' fotosensittività (ara sezzjoni 4.4).
English: Jaundice Hepatitis (predominantly cholestatic)
Maltese: Suffejra Epatite (l-aktar kolestatika)
English: The Applicant discussed the many factors that affect the QT interval and stated that while prolongation of the QTc interval is commonly used as a surrogate marker for the risk of developing ventricular arrhythmias such as Torsade de Pointes (TdP), there is no consensus on the degree of QT prolongation that is considered clinically significant.
Maltese: L-Applikant iddiskuta l-bosta fatturi li jaffettwaw l-intervall QT u ddikjara li filwaqt li lprolongazzjoni tal-intervall QTc tintuża b'mod komuni bħala punt finali konvenzjonali għar-riskju taliżvilupp ta' arritmiji ventrikolari bħal pereżempju Torsade de Pointes (TdP), m'hemm ebda kunsens fuq il-grad ta' prolongazzjoni tal-QT li huwa kkunsidrat klinikament sinifikanti.
English: The Applicant concluded that moxifloxacin has enhanced activity against penicillin/macrolide-susceptible and -resistant strains of S. pneumoniae, is active against pathogens associated with atypical pneumonia and is consistently effective in hospitalised patients requiring initial IV therapy.
Maltese: L-Applikant ikkonkluda li moxifloxacin saħħaħ l-attività kontra l-ispeċi ta' S. pneumoniae li huma suxxettibbli u reżistenti għall-peniċillin/makrolid, huwa attiv kontra patoġeni assoċjati ma' pnewmonija atipika u huwa effettiv b'mod kostanti f'pazjenti li qegħdin jinżammu l-isptar li jeħtieġu terapija inizjali IV.
English: 6.3 Shelf life Polyolefine bag: 3 years Glass bottle:
Maltese: Borża tal-polyolefine: 3 snin Flixkun tal-ħġieġ:
English: Intravenous use 400 mg / 250 ml
Maltese: Użu għal ġol-vini 400 mg / 250 ml
English: The CHMP acknowledges that a drug prolonging the QTc does not necessarily translate into a higher risk of cardiac ADRs, including arrhythmias.
Maltese: IsCHMP jirrikonoxxi li mediċina li ttawwal il-QTc mhux neċessarjament tfisser li sejjer ikun hemm riskju ogħla ta' ADRs kardijaċi, inklużi l-arritmiji.
English: The Applicant accepted the restriction of cSSSI to a secondline treatment together with a warning towards MRSA in section 4.4.
Maltese: L-Applikant aċċetta r-restrizzjoni ta' cSSSI għal trattament tat-tieni linja flimkien ma' twissija lejn l-MRSA fissezzjoni 4.4.
English: Infusion site (thrombo-) phlebitis
Maltese: Indeboliment renali / tal-fwied
English: Spontaneous reporting rates are higher for IV/sequential treatment than for oral treatment and the Applicant's argument that this is accounted for by the greater background morbidity in the population treated with IV/PO compared to those treated only with PO moxifloxacin can be partly accepted.
Maltese: IV/sekwenzjali milli għat-trattament orali u l-argument tal-Applikant li dan iseħħ minħabba l-morbidità tal-isfond akbar filpopulazzjoni li ġiet trattata b'IV/PO meta mqabbla ma' dawk li ġew trattati b'moxifloxacin PO biss jista' jiġi aċċettat parzjalment.
English: loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory
Maltese: Indeboliment fis-sensazzjoni tal-ġilda, bidliet fix-xamm (inkluż telf tas-sens taxxamm), ħolm mhux normali, disturb fil-bilanċ u koordinazzjoni batuta (kkawżata minn sturdament), konvulżjonijiet, konċentrazzjoni disturbata, indeboliment fil-kliem, telf parzjali jew totali tal-memorja
English: Neither the CAPNETZ data nor the meta-analysis support the conclusion that moxifloxacin is better than alternatives.
Maltese: La d-dejta ta' CAPNETZ u lanqas il-meta-analiżi ma jappoġġaw il-konklużjoni li moxifloxacin huwa aħjar mill-alternattivi.
English: The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:
Maltese: L-effetti mhux mixiteqa li ġejjin għandhom kategorija ta' frekwenza ogħla fis-sottogrupp ta' pazjenti kkurati fil-vini bi jew bla terapija orali sussegwenti:
English: Read the package leaflet before use.
Maltese: PAKKETT TA' BARRA U BORŻA
English: Each bottle bag contains 400mg moxifloxacin (as hydrochloride).
Maltese: Kull flixkun fih borża fiha 400mg moxifloxacin (bħala hydrochloride).
English: In conclusion, the efficacy data for IV/PO moxifloxacin in treatment of CAP and cSSSI are considered to be sufficient but not overwhelmingly convincing and suggest that IV/PO moxifloxacin is not among the optimal treatments for either of these indications.
Maltese: Bħala konklużjoni, id-dejta tal-effikaċja għal moxifloxacin IV/PO fit-trattament ta' CAP u cSSSI hija kkunsidrata suffiċjenti iżda mhux konvinċenti ħafna u tissuġġerixxi li moxifloxacin IV/PO mhuwiex fost ittrattamenti ottimali għal dawn iż-żewġ indikazzjonijiet.
English: The Applicant concluded that there are no differences between moxifloxacin and the comparator when comparing the total numbers and frequencies of reports on possible drug-related hepatic disorders.
Maltese: LApplikant ikkonkluda li m'hemm ebda differenza bejn moxifloxacin u l-komparatur meta jiġu mqabbla l-għadd totali u l-frekwenzi ta' rapporti fuq disturbi epatiċi possibbli relatati mal-mediċini.
English: The data revealed no new decrease in moxifloxacin susceptibility and the Applicant concluded that the susceptibilities for relevant species were correctly reflected in section 5.1 of the SPC with no significant trends or changes.
Maltese: Id-dejta ma wriet ebda tnaqqis ġdid fissuxxettibbiltà għal moxifloxacin u l-Applikant ikkonkluda li s-suxxettibbiltajiet għal speċi rilevanti ġew riflessi b'mod korrett fis-sezzjoni 5.1 tal-SPC b'ebda tendenza jew bidla sinifikanti.
English: - Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Maltese: - Sensittività eċċessiva għal moxifloxacin, quinolones oħra jew għal xi sustanzi mhux attivi.
English: After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/l).
Maltese: Wara infużjoni waħda ta' 400 mg fil-vini fuq medda ta' siegħa kienu osservati konċentrazzjonijiet massimi fil-plażma ta' madwar 4.1 mg/l fl-aħħar ta' l-infużjoni li jikkorrispondu għal żjieda medja ta' madwar 26% relattiv għal dawk li kienu osservati wara għoti orali (3.1 mg/l).
English: Moxifloxacinwas genotoxic in in vitro tests using bacteria or mammalian cells.
Maltese: Moxifloxacin kien ġenotossiku f'testijiet in vitro bl-użu ta' batterja jew ċelluli mammiferi.