FrancophonIA/ELRC3.0 huggingface dataset:
English: 28 tablets (PVC/PVDC/alu blisters)
Maltese: 28 pillola (PVC/PVDC/alu folji)
English: 7 tablets (PVC/PVDC/alu blisters)
Maltese: 7 pilloli (PVC/PVDC/alu folji)
English: It can therefore be concluded that darifenacin administration does not alter the pharmacokinetics of CYP3A4 substrates in vivo.
Maltese: Għalhekk tista' tintlaħaq konkluzjoni li l-għoti ta' darifenacin ma jibdilx ilfarmakokinetika tas-sustrati ta' CYP3A4 in vivo.
English: 28 tablets (PVC/CTFE/alu blisters)
Maltese: 28 pillola (PVC/CTFE/alu folji)
English: Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Maltese: Emselex għandu jintuża b'attenzjoni f'pazjenti li qed jiġu kkurati għall-glawkoma tat-tip narrow angle (ara sezzjoni 4.3).
English: 49 tablets (PVC/CTFE/alu blisters)
Maltese: 49 pillola (PVC/CTFE/alu folji)
English: A few percent of the population have increased CYP2D6 enzyme levels (ultrafast metabolisers).
Maltese: Perċentwal żgħir tal-popolazzjoni għandhom livelli għoljin tal-enzima CYP2D6 (metabolizzaturi mgħaġġla ħafna).
English: The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Maltese: Il-farmakokinetika ta' darifenacin fi stat fiss tiddependi mid-doża, minħabba li l-enzima CYP2D6 tkun saturata.
English: Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
Maltese: Dożi terapewtiċi u ogħla ta' darifenacin ma wasslu għall-ebda żieda fl-intervall QT/QTc mill-linja bażi meta mqabbla mal-plaċebo bl-ogħla esponimenti għal darifenacin.
English: Multipack comprising 10 packs, each containing 14 tablets.
Maltese: Pakkett b'ħafna li fih10 pakketti, li kull wieħed fih 14-il pillola.
English: Emselex 7.5 mg and 15 mg doses significantly reduced both the severity and number of urinary urgency episodes and the number of micturitions, while significantly increasing the mean volume voided from baseline.
Maltese: Dożi ta' 7.5 mg u 15 mg Emselex naqqsu b'mod sinifikanti s-severità u n-numru ta' episodji ta' urġenza li tgħaddi l-awrina, u tan-numru ta' drabi li tgħaddi l-awrina, waqt li żdiedet b'mod sinifikanti il-medja tal-volum li tbattal mill-linja bażi.
English: Nasal dryness
Maltese: Nixfa nasali
English: Anticholinergic effects, in general, are dose-dependent.
Maltese: B'mod ġenerali, l-effetti antikolinerġiċi huma dipendenti middoża.
English: There were no effects on fertility in male and female rats treated at oral doses up to 50 mg/kg/day (78 times the AUC0-24h of free plasma concentration at maximum recommended human dose [MRHD]).
Maltese: Ma kienx hemm effetti fuq il-fertilità tal-firien irġiel u nisa mogħtija dożi sa 50 mg/kg kuljum mill-ħalq (78 darba aktar mill-AUC0-24h tal-konċentrazzjoni ta' plażma ħielsa fl-ogħla doża rrakkomandata għall-bniedem).
English: The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Maltese: F'metabolizzaturi dgħajfa ta' CYP2D6 il-metaboliżmu ta' darifenacin huwa medjat prinċipalment permezz ta' CYP3A4.
English: In patients receiving substances that are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily.
Maltese: F'pazjenti li qed jirċievu sustanzi li huma inibituri moderati ta' CYP3A4 bħal fluconazole, meraq talgrejpfrut u erythromycin, id-doża rrakkomandata tal-bidu hija 7.5 mg kuljum.
English: Darifenacin undergoes significant metabolism by cytochrome CYP3A4 and CYP2D6 in the liver and by CYP3A4 in the gut wall.
Maltese: Darifenacin jgħaddi minn metaboliżmu sinifikanti permezz taċ-ċitokroma CYP3A4 u CYP2D6 filfwied u permezz ta' CYP3A4 fis-saff ta' ġewwa fl-intestini.
English: Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Maltese: Minħabba kontribuzzjoni akbar ta' CYP3A4 wara li jingħataw dożi aktar għoljin ta' darifenacin, il-qawwa tal-effett tkun mistennija li tkun ferm akbar meta ketoconazole jingħata flimkien ma' darifenacin 15 mg.
English: For both doses of 7.5 mg and 15 mg, the percentage median reduction from baseline in the number of incontinence episodes per week was similar between males and females.
Maltese: Għaż-żewġ dożi ta' 7.5 mg u 15 mg, il-perċentwali tat-tnaqqis medju mill-linja bażi fin-numru ta' episodji ta' inkontinenza kull ġimgħa kienu simili bejn l-irġiel u n-nisa.
English: Effects of darifenacin on other medicinal products CYP2D6 substrates
Maltese: Effetti ta' darifenacin fuq prodotti mediċinali oħra
English: How to store Emselex
Maltese: X'fih Emselex
English: 14 tablets (PVC/PVDC/alu blisters)
Maltese: 14-il pillola (PVC/PVDC/alu folji)
English: The Netherlands
Maltese: Lussemburgu
English: • if you have autonomic neuropathy (damage to the nerves that communicate between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including the heart rate, blood pressure and bowel function) - your doctor will have told you if you have this.
Maltese: • jekk għandek newropatija awtonomika (ħsara fin-nervituri li jikkomunikaw bejn il-moħħ u l organi interni, il-muskoli, il-ġilda u l-vini u l-arterji biex jirregolaw funzjonijiet vitali, li jinkludu r-ritmu tal-qalb, il-pressjoni u l-funzjoni tal-imsaren) - it-tabib tiegħek ikun qallek jekk għandekx din il-marda.
English: 14 tablets (PVC/CTFE/alu blisters)
Maltese: 14-il pillola (PVC/CTFE/alu folji)
English: The effects of darifenacin on the metabolism of CYP2D6 substrates are mainly clinically relevant for CYP2D6 substrates which are individually dose titrated.
Maltese: L-effetti ta' darifenacin fuq ilmetaboliżmu tas-substrat ta' CYP2D6 huma l-aktar rilevanti mil-lat kliniku għal substrat ta' CYP2D6 li d-dożi tagħhom ikunu miżjuda bil-mod, b'mod individwali.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja.
English: Children and adolescents Emselex is not recommended for use in children and adolescents (<18 years).
Maltese: Tfal u adolexxenti Emselex mhuwiex irrakkomandat ghall-użu fit-tfal u adolexxenti (<18-il sena).
English: Only a small percentage of the excreted dose was unchanged darifenacin (3%).
Maltese: Perċentwal żgħir biss tad-doża eskretata kienet darifenacin mhux mibdul (3%).
English: • if you have a digestive motility disorder.
Maltese: • jekk għandek disturb fil-motilità diġestiva.
English: The side effects caused by Emselex are usually mild and temporary.
Maltese: L-effetti sekondarji kkawżati minn Emselex normalment ikunu ħfief u jgħaddu.
English: How to take Emselex 4.
Maltese: Kif għandek tieħu Emselex 4.
English: Grapefruit juice may interact with Emselex.
Maltese: Jekk tieħu Emselex aktar milli suppost
English: Uncontrolled narrow-angle glaucoma.
Maltese: Ħu l-kors tal-kura kif qallek it-tabib.
English: Urinary retention.
Maltese: Użu orali.
English: The interaction with midazolam lacks clinical relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
Maltese: L-effett ma' midazolam mhuwiex klinikament rilevanti, u għalhekk l-ebda aġġustament tad-doża ma huwa meħtieġ għas-substrati ta' CYP3A4.
English: EU/1/04/294/021-026 EU/1/04/294/028
Maltese: EU/1/04/294/021-026
English: • certain antidepressants (e.g. imipramine),
Maltese: • ċerti mediċini kontra d-dipressjoni (eż. imipramine),
English: Not known (frequency cannot be estimated from the available data) Depressed mood/mood alterations, hallucination.
Maltese: Mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli) Burdata depressa/kambjamenti fil-burdata, alluċinazzjoni.
English: Caution should be exercised when darifenacin is used concomitantly with medicinal products that are predominantly metabolised by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine, or tricyclic antidepressants such as imipramine.
Maltese: Għandu jkun hemm attenzjoni meta darifenacin jingħata flimkien ma' prodotti mediċinali li fil-parti l-kbira tagħhom ikunu mmetabolizzati minn CYP2D6 u li jkollhom il-medda tal-livelli terapewtiċi żgħira ħafna, bħal flecainide, thioridazine, jew mediċini kontra d-dipressjoni tat-tip triċikliċi bħal imipramine.
English: The recommended starting dose, including for patients aged over 65 years, is 7.5 mg daily.
Maltese: Id-doża tal-bidu rrakkomandata, inkluż għall-pazjenti li għandhom aktar minn 65 sena, hija 7.5 mg kuljum.
English: The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
Maltese: L-effett ta' warfarin fuq il-ħin ta' prothrombin ma nbidilx meta ngħata ma' darifenacin.
English: • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated).
Maltese: • jekk issofri minn retenzjoni tal-awrina (ma tistax tbattal il-bużżieqa tal-awrina).
English: Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Maltese: Studji ċistometriċi b'darifenacin li saru fuq pazjenti li għandhom kontrazzjonijiet involontarji talbużżieqa tal-awrina wrew żieda f'kemm tesa' l-bużżieqa tal-awrina, żieda fil-limitu tal-volum talawrina li twassal għal kontrazzjonijiet instabbli u tnaqqis fil-frekwenza tal-kontrazzjonijiet taddetrusor, li mhumiex stabbli.
English: Keep this leaflet.
Maltese: Popolazzjoni speċjali ta' pazjenti
English: Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.
Maltese: Il-farmakokinetika ta' darifenacin ma ġietx stabbilita fil-popolazzjoni tal-pazjenti pedjatriċi.
English: Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.
Maltese: Emselex għandu jingħata b'attenzjoni lill-pazjenti li jsofru minn newropatija awtonomika, ernja hiatus, sadd tal-ħruġ mill-bużżieqa tal-awrina li jkun klinikament sinifikanti, riskju li ma jkunux jistgħu jgħaddu l-awrina, stitikezza qawwija jew disturbi li jikkawżaw sadd fis-sistema gastrointestinali, bħal stenożi pilorika.
English: Emselex is contraindicated in patients with severe hepatic impairment (Child Pugh C) (see section 4.3).
Maltese: Għal Emselex, dawn l-effetti sekondarji kienu rrapurtati li ma kinux komuni (ara sezzjoni 4).
English: Feline viral rhinotracheitis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Maltese: Tilqima kontra r-rinotrakeite virali felina, il-panlewkopenja felina (ħajja attenwata), il-lewkimja felina u l-kaliċivirosi felina (inattivata)
English: To protect against feline leukaemia the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Maltese: Biex tipproteġi kontra l-lewkimja felina t-tilqima fiha żewġ ġeni mill-FeLV imsejħa env u gag, li ġew inseriti f'virus vettur (trasportatur) ieħor imsejjaħ canarypox li juża ‘teknoloġija tad-DNA rikombinanti'.
English: The CVMP concluded that the benefits of Purevax RCP FeLV exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above approved indicationsand recommended that Purevax RCP FeLV be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' Purevax RCP FeLV huma akbar mir-riskji tiegħu għall-immunizzazzjoni attiva ta' qtates ta' tmien ġimgħat jew aktar kontra l-mard elenkat hawn fuq u għall-indikazzjonijiet approvati u rrakkomanda li Purevax RCP FeLV jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Purevax RCP FeLV is a veterinary vaccine that contains:
Maltese: Purevax RCP FeLV huwa tilqima veterinarja li fiha:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Purevax RCP FeLV on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Purevax RCP FeLV fit-23 ta' Frar 2005.
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Maltese: Il-virusis tal-canarypox ma jinfirxux jew jimmultiplikaw fil-qtates iżda jipproduċu proteini mill-ġeni tal-FeLV.
English: The effectiveness of Purevax RCP FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, parvovirus or leukaemia virus.
Maltese: L-effikaċja ta' Purevax RCP FeLV ġiet studjata f'diversi provi f'kundizzjonijiet tal-laboratorju fejn qtates ġew imlaqqma u infettati bil-virus tal-erpete, bil-kaliċivirus, bil-parvovirus jew bil-virus tal-lewkimja.
English: Purevax RCP FeLV is used to vaccinate cats from the age of 8 weeks against:
Maltese: Purevax RCP FeLV jintuża għat-tilqim ta' qtates mill-età ta' 8 ġimgħat kontra:
English: Other information about Purevax RCP FeLV:
Maltese: Informazzjoni oħra dwar Purevax RCP FeLV:
English: Purevax RCP FeLV is a vaccine.
Maltese: Purevax RCP FeLV huwa tilqima.
English: For a full list of the side-effects reported with Purevax RCP FeLV, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Purevax RCP FeLV, ara l-fuljett ta' tagħrif.
English: Purevax RCP FeLV contains small amounts of weakened or killed viruses that cause feline viral rhinotracheitis, calicivirosis and panleucopenia.
Maltese: Purevax RCP FeLV fih ammonti żgħar ta' virusis imdgħajfa jew maqtula li jikkawżaw ir-rinotrakeite virali, il-kaliċivirosi u l-panlewkopenja tal-qtates.
English: What is Purevax RCP FeLV?
Maltese: Kif ġie studjat Purevax RCP FeLV?
English: The benefit-risk balance may be found in the scientific discussion 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu 6 tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Why has Purevax RCP FeLV been approved?
Maltese: Għaliex ġie approvat Purevax RCP FeLV?
English: In laboratory conditions Purevax RCP FeLV was demonstrated to provide protection against the diseases listed above.
Maltese: F'kundizzjonijiet tal-laboratorju Purevax RCP FeLV intwera li jipprovdi protezzjoni kontra l-mard elenkat hawn fuq.
English: What is the risk associated with Purevax RCP FeLV?
Maltese: X'inhuma r-riskji assoċjati ma' Purevax RCP FeLV?
English: 11 March 2019 EMA/175398/2019
Maltese: Il-11 ta' Marzu 2019 EMA/175398/2019
English: The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.
Maltese: Ir-reviżjoni kopriet mediċini li fihom l-antibijotiċi fluoroquinolone u b'quinolone li ġejjin: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin u rufloxacin.
English: The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' fluoroquinolones u quinolones inbdiet fid-9 ta' Frar 2017 fuq talba tal-awtorità talmediċini tal-Ġermanja (BfArM), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
Maltese: • fil-kura ta' infezzjonijiet mhux batterjali, eż. prostatite mhux batterjali (kronika);
English: • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
Maltese: • Mediċini bi fluoroquinolone (li fihom ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) jistgħu jikkawżaw effetti sekondarji li jdumu, li jiddiżabilitaw u li huma potenzjalment permanenti li jinvolvu l-għeruq, il-muskoli, il-ġogi u s-sistema nervuża.
English: Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic.
Maltese: Importanti li, fluoroquinolones ġeneralment għandhom jiġu evitati f'pazjenti li qabel kellhom effetti sekondarji serji b'antibijotiku fluoroquinolone jew quinolone.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU countries.
Maltese: L-opinjoni tas-CHMP intbagħtet lillKummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti fl-14 ta' Frar 2019 għal Quinsair u fil-11 ta' Marzu 2019 għal antibijotiċi oħra bi quinolone u bi fluoroquinolone li ngħataw mill-ħalq u b'injezzjoni, li hija applikabbli fl-Istati Membri kollha tal-UE.
English: Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes.
Maltese: Fluoroquinolones u quinolones huma klassi ta' antibijotiċi b'firxa wiesa' li huma attivi kontra batterji kemm ta' klassijiet Gramm-negattivi kif ukoll ta' Gramm-pożittivi.
English: • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine.
Maltese: • Sommarju aġġornat tal-karatteristiċi tal-prodott għandu jiġi kkonsultat għal indikazzjonijiet awtorizzati meta tiġi kkunsidrata kura b'mediċina bi fluoroquinolone.
English: On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation.
Maltese: Fil-15 ta' Novembru 2018, l-EMA ffinalizzat reviżjoni ta' effetti sekondarji serji, li jiddiżabilitaw u li huma potenzjalment permanenti bl-antibijotiċi quinolone u fluoroquinolone mogħtija mill-ħalq, mogħtija b'injezzjoni jew li jittieħdu man-nifs.
English: • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
Maltese: • L-effetti sekondarji serji jinkludu tendonite, qtugħ tal-għerq, artralġja, uġigħ fl-estremitajiet, disturb fil-mixi, newropatiji assoċjati mal-paraesthesia, dipressjoni, għeja, indeboliment talmemorja, disturbi fl-irqad, u indeboliment tas-smigħ, tal-vista, tat-togħma u tax-xamm.
English: You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
Maltese: Jista' jkun li inti tkun suxxettibli għal dannu fl-għerq jekk qed tieħu kortikosterojde u mediċina bi fluoroquinolone flistess ħin.
English: • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
Maltese: • Fluoroquinolones huma assoċjati ma' reazzjonijiet imtawla (sa xhur jew snin), serji, li jiddiżabilitaw u potenzjalment irriversibbli li jaffettwaw diversi sistemi, kultant multipli, klassijiet ta' organi u sensi.
English: • Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases:
Maltese: • Waqqaf it-teħid tal-mediċina bi fluoroquinolone u kkuntattja lit-tabib tiegħek minnufih fil-każijiet li ġejjin:
English: EMA's human medicines committee (CHMP) endorsed the recommendations of EMA's safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended.
Maltese: Il-Kumitat tal-EMA għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) approva rrakkomandazzjonijiet tal-kumitat tas-sikurezza tal-EMA (PRAC) u kkonkluda li l-awtorizzazzjoni għattqegħid fis-suq ta' mediċini li fihom cinoxacin, flumequine, nalidixic acid, u pipemidic acid għandha tiġi sospiża.
English: The final PRAC recommendations were adopted on 4 October 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Maltese: Ir-rakkomandazzjonijiet finali tal-PRAC ġew adottati fl-4 ta' Ottubru 2018 u mbagħad intbagħtu lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem, li adotta l-opinjoni tal-Aġenzija.
English: Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
Maltese: Kura fl-istess ħin bi fluoroquinolone u b'kortikosterojde għandha tiġi evitata.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Maltese: Ir-rieżami sar l-ewwel mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà tal-mediċini għall-użu millbniedem.
English: Fluoroquinolones are of value in certain infections, including some life-threatening ones, where alternative antibiotics are not sufficiently effective.
Maltese: Il-fluoroquinolones huma ta' valur f'ċerti infezzjonijiet, inklużi xi wħud li jheddu l-ħajja, fejn antibijotiċi alternattivi mhumiex effettivi biżżejjed.
English: • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
Maltese: • M'għandekx tieħu mediċina ta' fluoroquinolone jekk qatt kellek effett sekondarju serju b'mediċina bi fluoroquinolone jew bi quinolone u għandek titkellem mat-tabib tiegħek minnufih.
English: The review incorporated the views of patients, healthcare professionals and academics presented at EMA's public hearing on fluoroquinolone and quinolone antibiotics in June 2018.
Maltese: Ir-reviżjoni inkorporat il-fehmiet tal-pazjenti, talprofessjonisti tal-kura tas-saħħa u tal-akkademiċi ppreżentati fis-smigħ pubbliku tal-EMA dwar lantibijotiċi quinolone u fluoroquinolone f'Ġunju 2018.
English: The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted.
Maltese: Is-CHMP ikkonferma li l-użu tal-antibijotiċi fluoroquinolone li jifdal għandu jkun ristrett.
English: • Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines.
Maltese: • Ġeneralment, fluoroquinolones m'għandhomx jintużaw f'pazjenti li kellhom reazzjonijiet avversi serji assoċjati mal-użu ta' mediċini bi quinolone jew bi fluoroquinolone.
English: • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
Maltese: • Nefħa u korriment fl-għerq jistgħu jseħħu fi żmien jumejn mill-bidu tal-kura bi fluoroquinolone iżda jistgħu jseħħu bosta xhur wara li titwaqqaf il-kura.
English: • for preventing traveller's diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
Maltese: • għall-prevenzjoni tad-dijarea tal-vjaġġaturi jew ta' infezzjonijiet fil-parti t'isfel tal-passaġġ talawrina rikorrenti (infezzjonijiet fl-awrina li ma jestendux lil hinn mill-borża tal-awrina);