FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Maltese: Effetti sekondarji rrapportati b'mod mhux komuni (jistgħu jaffetwaw sa 1 minn kull 100 pazjent) inkludew, tnaqqis fl-akutezza fil-vista, vista' doppja, sensazzjoni mhux normali ta' l-għajn, fsada mill-pene, preżenza ta' demm fis-semen u/jew fl-awrina u tkabbir tas-sider fl-irġiel.
English: How to store Mysildecard
Maltese: Kif gћandek tieћu Mysildecard
English: Estimates based on ANCOVA with adjustments for the covariates baseline peak VO2, etiology and weight group
Maltese: Stimi bbażati fuq ANCOVA b'aġġustamenti għal covariates tal-punt l-aktar għoli ta' VO2 mil-linja bażi, etjoloġija u l-piż tal-grupp
English: A total of 134 patients were treated with sildenafil in the initial study, and their long term survival status was assessed for a minimum of 3 years.
Maltese: Total ta' 134 pazjent kienu trattati b'sildenafil fl-istudju tal-bidu, u l-istat ta' sopravvivenza fit-tul tagħhom kien assessjat mill-inqas għal 3 snin.
English: By sildenafil treatment group, median duration of sildenafil treatment was 1696 days (excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study).
Maltese: Skont il-grupp ta' trattament b'sildenafil, it-tul medjan tat-trattament b'sildenafil kien 1,696 jum (li jeskludi l-5 individwi li rċivew plaċebo fl-istudju double-blind u li ma ġewx ikkurati fl-istudju ta' estensjoni fit-tul).
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'saħħithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li jirriżulta f'bejn wieħed u ieħor 90% tal-konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u l-metabolu attiv N-desmethly mqabbel ma' dawk li nstabu f'voluntiera żagħżagħ b'saħħithom (18-45 sena).
English: Suddenly stopping your treatment with Mysildecard may lead to your symptoms getting worse.
Maltese: Jekk twaqqaf it-trattament tiegħek b'Mysildecard f'daqqa, dan jista' jirriżulta f'aggravar tas-sintomi.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE03
Maltese: L-KITBA Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomised to placebo.
Maltese: Fl-istudju ewlieni ikkontrollat bi plaċebo ta' kif jaħdem sildenafil fuq pressjoni għolja arterjali tal-pulmun, total ta' 207 pazjent ġew trattati b'mod każwali b'dożi ta' 20 mg, 40 mg, jew 80 mg TID ta' sildenafil u 70 pazjent ingħataw il-plaċebo b'mod każwali.
English: Musculoskeletal and connective tissue disorders Very common pain in extremity
Maltese: Disturbi muskolu-skeltrali u tat-tessuti konnettivi Komuni ħafna uġigħ fl-estremitajiet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' sildenafil (bħala citrate).
English: Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
Maltese: Tabella 2: Il-perċentwali tal-bidla ikkoreġuta tal-plaċebo fil-punt l-aktar għoli ta' VO2 mil-linja bażi tal-grupp li qed jirċievi t-trattament
English: The duration of treatment was 16 weeks.
Maltese: It-tul tat-trattament kien ta' 16-il ġimgħa.
English: 23 subjects experienced clinical worsening events in the placebo group (17.6%) compared with 8 subjects in the sildenafil group (6.0%).
Maltese: Tlieta u għoxrin suġġett fil-grupp tal-plaċebo (17.6%) esperjenzaw avvenimenti kliniċi li marru għall-agħar meta mqabbla mat-tmien suġġetti fil-grupp ta' sildenafil
English: CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
Maltese: Indutturi ta' CYP3A4 dehru li għandhom impatt sostanzjali fuq il-farmakokinetiċi ta' sildenafil f'pazjenti bi pressjoni arterjali għolja fil-pulmun, u dan ġie kkonfermat fi studju in vivo ta' l-interazzjoni ma' l-induttur ta' CYP3A4 bosentan.
English: Protein binding is independent of total drug concentrations.
Maltese: L-irbit mal-proteini huwa indipendenti mill-konċentrazzjoni totali tal-mediċina.
English: NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Mysildecard 20 mg pilloli miksija b'rita
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-pakkett wara EXP.
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving sildenafil than those receiving placebo leading to the premature termination of this study.
Maltese: Fi studju kliniku, rapporti ta' avvenimenti ta' kriżijiet vaso-okklusivi fejn kien meħtieġ dħul fl-isptar kienu aktar komuni f'pazjenti li qed jirċievu sildenafil meta mqabbla ma' dawk li qed jirċievu l-plaċebo.
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Maltese: Instabu differenzi ħfief u temporanji ta' diskriminazzjoni tal-kulur (blu/aħdar) f'xi pazjenti li wżaw il-Farnsworth-Munsell 100
English: During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part of the survival follow-up.
Maltese: Waqt li kien għaddej l-istudju, kien hemm total ta' 42 mewta rrapurtata, kemm jekk waqt it-trattament kif ukoll irrappurtar bħala parti mill-monitoraġġ ta' wara t-trattament.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Maltese: Barra minn hekk, il-valuri ta' AUC u Cmax għall-metabolu N-desmethyl, żdiedu b'mod sinifikanti b'154% u 87% rispettivament f'suġġetti b'ċirrożi meta mqabbla ma' pazjenti b'funzjoni renali normali.
English: Between 20% and 31% of the women became pregnant.
Maltese: Bejn 20% u 31% tan-nisa ħarġu tqal.
English: The full EPAR for Orgalutran can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Orgalutran jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: After treatment with Orgalutran, the average number of eggs that could be harvested was between 7.9 and 11.6 per woman.
Maltese: Wara kura b'Orgalutran, l-għadd medju ta' bajd li seta' jinħażen kien bejn 7.9 u 11.6 kull mara.
English: The active substance in Orgalutran, ganirelix, blocks the receptors for a natural hormone called gonadotrophin-releasing hormone (GnRH).
Maltese: Is-sustanza attiva f'Orgalutran, il-ganirelix, timblokka l-effetti ta' ormon naturali msejjaħ ormon li jerħi l-gonadotrofina (GnRH).
English: Each syringe contains 0.25 mg of the active substance, ganirelix.
Maltese: Kull siringa fiha 0.25 mg tassustanza attiva ganirelix.
English: This is called ‘ovarian hyperstimulation syndrome'.
Maltese: Dan jissejjaħ is-‘sindromu ta' stimulazzjoni eċċessiva tal-ovarji'.
English: Treatment should start on day 5 or 6 after the start of ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin alfa (a modified FSH).
Maltese: It-trattament għandu jinbeda f'jum 5 sa 6 wara l-bidu ta' stimulazzjoni tal-ovarji b'ormon li jistimula l-follikuli (FSH) jew korifollitropina alfa (FSH modifikat).
English: This document is a summary of the European Public Assessment Report (EPAR) for Orgalutran.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Orgalutran.
English: Why has Orgalutran been approved?
Maltese: Għaliex ġie approvat Orgalutran?
English: Doctors and patients must be aware of this possibility.
Maltese: Tobba u pazjenti għandhom ikunu konxji ta' din il-possibilità.
English: What is Orgalutran?
Maltese: X'inhu Orgalutran?
English: Orgalutran should not be used in people who may be hypersensitive (allergic) to ganirelix, to any of the other ingredients, to GnRH or to other GnRH analogues (medicines that have a similar structure to GnRH and modify the activity of GnRH in the body).
Maltese: Orgalutran ma għandux jintuża f'nies li jista' jkollhom sensittività eċċessiva (allerġiċi) għal ganirelix, għal xi sustanza oħra tiegħu, għal GnRH jew għal analogi oħrajn tal-GnRH (mediċini li għandhom struttura simili għal GnRH u li jimmodifikaw ir-rilaxx ta' GnRH fil-ġisem).
English: The ability of Orgalutran to prevent premature ovulation has been studied in three main studies involving 1,335 women.
Maltese: L-effikaċja ta' Orgalutran fil-prevenzjoni tal-ovulazzjoni prematura ġiet studjata fi tliet studji ewlenin li kienu jinvolvu 1 335 mara.
English: Other information about Orgalutran:
Maltese: Tagħrif ieħor dwar Orgalutran:
English: Orgalutran is given as a single 0.25-mg injection under the skin once a day.
Maltese: Orgalutran jingħata b'injezzjoni waħda ta' 0.25 mg taħt il-ġilda darba kuljum.
English: Orgalutran was compared with buserelin, leuprorelin, and triptorelin (GnRH agonists: another group of medicines used to prevent premature ovulation, which work by stimulating the receptor for GnRH to such an extent that the body stops making LH).
Maltese: GnRH: grupp ieħor ta' mediċini użat biex jimpedixxi ovulazzjoni prematura, li jaħdem billi jistimula lproduzzjoni ta' GnRH sa tali punt li l-ġisem jieqaf jagħmel LH).
English: In premature ovulation, the ovaries release eggs that may be immature and not suitable for use in techniques such as in-vitro fertilisation.
Maltese: F'ovulazzjoni prematura, l-ovarji jerħu l-bajd li jistgħu jkunu immaturi u mhux xierqa sabiex jintużaw f'tekniki bħal fertilizzazzjoni in-vitro.
English: Orgalutran is used to prevent premature ovulation (early release of eggs from the ovary) in women having fertility treatment and who are having ovarian stimulation (stimulation of the ovaries so that they produce more eggs).
Maltese: Orgalutran jintuża biex jimpedixxi ovulazzjoni prematura (rilaxx bikri tal-bajd mill-ovarji) f'nisa li jkunu qegħdin jagħmlu trattament tal-fertilità u li jkunu qegħdin jagħmlu stimulazzjoni tal-ovarji (stimulazzjoni tal-ovarji sabiex jipproduċu aktar bajd).
English: By blocking the effect of GnRH, Orgalutran stops the production of LH, and therefore prevents premature ovulation.
Maltese: Billi jimblokka l-effett ta' GnRH, Orgalutran iwaqqaf il-produzzjoni ta' LH, u għaldaqstant jimpedixxi ovulazzjoni prematura.
English: What is the risk associated with Orgalutran?
Maltese: X'inhu r-riskju assoċjat ma' Orgalutran?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orgalutran to N.V. Organon on 17 May 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Orgalutran lil N.V.
English: The CHMP decided that Orgalutran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Orgalutran huma akbar mir-riskji tiegħu u rrakomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: A few days later, a hormone called human chorionic gonadotrophin (hCG) is given to trigger ovulation, and the eggs are then harvested.
Maltese: Ftit jiem iktar tard, jingħata ormon imsejjaħ gonadotrofina korjoniku uman (hCG) biex jagħti bidu għall-ovulazzjoni, u mbagħad, il-bajd jinħażen.
English: 3641 RT Mijdrecht Netherlands
Maltese: 3641 RT Mijdrecht L-Olanda
English: B-1050 Brussel Belgium
Maltese: B-1050 Brussel
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Maltese: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Il-Portugall
English: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex
Maltese: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex Franza
English: Berkshire RG14 1JA United Kingdom
Maltese: Berkshire RG14 1JA Ir-Renju Unit
English: 151 25 Marousi - Athens Greece
Maltese: 151 25 MarousiAthens
English: Luxembourg Bayer SA-NV Avenue Louise 143
Maltese: Il-Lussemburgu Bayer SA-NV Avenue Louise 143
English: Slovenia BAYER d.o.o.
Maltese: Is-Slovenja BAYER d.o.o. Bravničarjeva 13
English: Blackthorn Road Dublin 18
Maltese: Bayer Limited The Atrium Blackthorn Road, Dublin 18
English: The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI.
Maltese: It-tul totali rrakkomandat ta' kura fil-vini u orali huwa 7 - 14-il ġurnata għal CAP u 721 ġurnata għal cSSSI.
English: Belgium Bayer SA-NV Avenue Louise 143
Maltese: Bayer SA-NV Avenue Louise 143 Louizalaan
English: Nervous System Common:
Maltese: Sistema Nervuża Komuni:
English: Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, Compound Sodium Lactate Solution (Hartmann's Solution, Ringer-Lactate Solution).
Maltese: Ilma għall-injezzjonijiet, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, soluzzjoni ta' Ringer, Soluzzjoni ta' Compound Sodium Lactate (Soluzzjoni ta' Hartmann, Soluzzjoni ta' Ringer-Lactate).
English: Latvia:
Maltese: Il-Latvija:
English: The following solutions were incompatible with Avalox: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Maltese: Soluzzjonijiet ta' 10% u 20% sodium chloride, Soluzzjonijiet ta' 4.2% u 8.4% sodium bicarbonate
English: Bayer Hellas S.A.
Maltese: Bayer Hellas S.A. Sorou 18-20
English: Before you use Avalox..., Take special care ...).
Maltese: Qabel ma tuża Avalox ..., Oqgħod attent ħafna ...).
English: - Patients with a history of tendon disease/disorder related to quinolone treatment.
Maltese: - Pazjenti b'passat ta' mard/disturbi fit-tendon relatati ma' kura b'quinolone.
English: Therefore, do not take the following medicines during treatment with Avalox: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
Maltese: Għalhekk, tieħux il-mediċini li ġejjin flimkien ma' Avalox: Mediċini li jagħmlu parti mill-grupp ta' anti-arritmijaċi (eż. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), newrolettiċi (eż. phenothiazines, pimozide, sertindole, haloperidol, sultopride), antidepressanti triċikliċi, ċertu sustanzi kontra l-mikrobi (eż. sparfloxacin, erythromycin ġol-vini, pentamidine, mediċini kontra l-malarja speċjalment halofantrine), ċertu antistamini (eż. terfenadine, astemizole, mizolastine), u mediċini oħra (eż. cisapride, vincamine ġol-vini, bepridil u diphemanil).
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including Avalox.
Maltese: - Inti tista' tiżviluppa dijarea waqt li qed tieħu jew wara li ħadt, antibijotiċi inkluż Avalox.
English: Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair.
Maltese: Moxifloxacin jinibixxi topoisomerases tat-tip II (DNA gyrase u topoisomerase IV) li huma meħtieġa għar-replikazzjoni, transkrizzjoni u tiswija tad-DNA tal- batterji.
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal (approximately 40%) and biliary/faecal (approximately 60%) pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Maltese: II u jitneħħa mir-rotot renali (madwar 40%) u biljari/tal-purgar (madwar 60%) bħala mediċina mhux mibdula kif ukoll f'forma ta' sustanza sulfo (M1) u glucuronide (M2).
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section 4.4)”
Maltese: “Infezzjonijiet ikkumplikati tal-ġilda u tal-istruttura tal-ġilda biss meta l-użu ta' aġenti antibatterjali, li normalment huma rakkomandati għat-trattament inizjali ta' din l-infezzjoni, jiġi kkunsidrat bħala mhux xieraq (ara s-sezzjoni 4.4)”
English: Contains sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pHadjustment) and water for injections.
Maltese: Fih sodium chloride, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għallaġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Avalox contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Maltese: Avalox 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 post-marketing 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: Avalox is packaged in cartons containing a 250ml glass bottle with a chlorobutyl rubber stopper.
Maltese: Avalox huwa ppakkjat f'kartun li fihom flixkun tal-ħġieġ ta' 250ml b'tapp tal-lasktu chlorobutyl.
English: Important information about some of the ingredients of Avalox 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: Látvia
Maltese: ISEM
English: Avalox is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Maltese: Avalox huwa ppakkjat f'boroż tal-polyolefine ta' 250ml b'tieqa tal-polypropylene issiġillati f'fojl talaluminium fuq barra.
English: Germany Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen Germany
Maltese: Il-Ġermanja Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen
English: - The active substance is moxifloxacin.
Maltese: X'fih Avalox - Is-sustanza attiva hi moxifloxacin.
English: NAME OF THE MEDICINAL PRODUCT Avalox and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally] Moxifloxacin
Maltese: Avalox u ismijiet assoċjati miegħu (ara Anness I) 400 mg/250 ml soluzzjoni għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] Moxifloxacin
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 treatment-emergent 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: - Avalox may cause a rapid and severe inflammation of the liver which could lead to lifethreatening liver failure (including fatal cases, see section 4.
Maltese: - Avalox 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: Take special care with Avalox
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' AVALOX
English: The Applicant accepted the restriction of cSSSI to a second-line 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: increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
Maltese: Indeboliment fil-funzjoni tal-fwied (inkluż żjieda ta' enzima speċjali tal-fwied fiddemm (LDH)), żjieda tal-bilirubin fid-demm, żjieda ta' enzima speċjali tal-fwied fiddemm (gamma-glutamyl-transferase u/jew alkaline phosphatase)
English: Finally, the Applicant claimed that the superior potency and pharmacokinetics of moxifloxacin avoids the selection of quinolone resistant isolates of S. pneumoniae.
Maltese: Finalment, lApplikant iddikjara li l-qawwa superjuri u l-farmakokinetiċi ta' moxifloxacin jevitaw l-għażla ta' iżolati ta' S. pneumoniae reżistenti għal quinolone.
English: The frequency of possible side effects listed below is defined using the following convention: Very common: affects more than 1 user in 10
Maltese: Il-frekwenza ta' l-effetti sekondarji possibli elenkati taħt hija definita bl-użu tal-konvenzjoni li ġejja:
English: The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion:
Maltese: Il-ko-infużjonijiet li ġejjin instabu li huma kompatibbli ma' moxifloxacin 400 mg soluzzjoni għallinfużjoni:
English: Lithuania:
Maltese: Is-Slovenja:
English: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Maltese: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: HOW TO STORE AVALOX
Maltese: X'INHU AVALOX
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Maltese: Kemm f'investigazzjonijiet prekliniċi kif ukoll fil-bnedmin, wara esponiment għal moxifloxacin, kienu osservati tibdiliet fl-elettrofiżjoloġija kardijaka fil-forma ta' titwil ta' QT. Għalhekk, għarraġunijiet ta' sigurtà tal-mediċina, moxifloxacin huwa kontra-indikat f'pazjenti b': - Titwil ta' QT miksub b'mod konġenitali jew dokumentat - Disturbi fl-elektroliti, partikolarment f'każ ta' ipokalimja mhux ikkoreġuta - Bradikardija ta' rilevanza klinika - Insuffiċjenza tal-qalb ta' rilevanza klinika bi frazzjoni ta' tneħħija ventrikolari tax-xellug imnaqqsa - Passat ta' arritmija sintomatika