FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Maltese: Il-maġġoranza ta' avvenimenti ta' tip ILD rrapportati kienu minn pazjenti ta' oriġini Ażjatika u l-inċidenza ta' ILDf'pazjenti ta' oriġini Ażjatika li rċevew kura b'gefitinib u plaċebo kienu bejn wieħed u ieħor ta' 3 u 4% rispettivament.
English: How to take IRESSA
Maltese: X'fih IRESSA
English: Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Maltese: L-istudju IPASS tal-ewwel linja tal-fażi
English: At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Maltese: Fi stat fiss, konċentrazzjonijiet jiċċirkulaw fil-plasma jinżammu fil-medda ta' bejn 2 u 3 darbiet fuq intervall ta'dożaġġ ta' 24 siegħa.
English: Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Maltese: Indeboliment fil-funzjoni tal-fwied minħabba ċirrożi jwassal għal żieda fil-konċentrazzjoni ta' gefitinib fil-plasma (ara sezzjoni 5.2).
English: Fever
Maltese: Epatite
English: The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Maltese: Il-fattur għat-tiġdid epidermiku (EGF) u r-riċettur tiegħu (EGFR[HER1; ErbB1]) kienu identifikati bħala l-fatturi prinċipali fil-proċess ta' tkabbir u proliferazzjoni ta' ċelloli normali u dawk tal-kanċer.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Maltese: Pazjenti b'indeboliment epatiku moderat għal sever (Child-Pugh B jew C), minħabba ċirrosi jkollhom żieda fil-konċentrazzjoni ta' gefitinib fil-plasma.
English: Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Maltese: Sustanzi attivi li jistgħu inaqqsu l-konċentrazzjonijiet ta' gefitinib fil-plasma Sustanzi li jħeġġu attività ta' CYP3A4 jistgħu jżidu l-metaboliżmu u jnaqqsu l-konċentrazzjonijiet ta' gefitinib fil-plasma u b'hekk inaqqsu l-effikaċja ta' gefitinib.
English: NC Not calculated for overall survival HR as the number of events is too few NR Not reached
Maltese: Mhux ikkalkolat għas-sopravivenza totali HR peress li n-numru ta' avvenimenti huwa ftit wisq NR Mhux milħuq
English: In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs. carboplatin/paclitaxel (see Table 4).
Maltese: Ir-riżultati tal-indiċi tar-riżultat tal-prova (Trial outcome index) kienu favur ir-riżultati ta' FACT-L u LCS a Valuri ppreżentati huma għal IRESSA versus carboplatin/paclitaxel.
English: Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Maltese: John's wort (Hypericum perforatum, użat għad dipressjoni u ansjetà) - Inibituri proton-pump, antagonisti tal-H2 u anti-aċidi (għal ulċeri, indiġestjoni, ħruq ta' stonku u biex inaqqsu l-aċidi fl-istonku)
English: When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
Maltese: Meta amministrat fil-far tul il-ġestazzjoni u t-twelid kien hemm tnaqqis fis-sopravivenza tal-friegħ f'doża ta' 20 mg/kg/jum.
English: Table 7 Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients*
Maltese: Tabella 7 Sommarju tal-analiżi ta' rigressjoni loġistika multivarjanti sabiex tidentifika fatturi li indipendentament ibassru l-preżenza ta' tibdil fiċ-ċelloli ta' EGFR f'786 pazjent kawkażu*
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Maltese: Il-profil ta' sigurtà ppreżentat f'Tabella 1 huwa bbażat fuq programm ta' żvilupp kliniku u esperjenza ta' wara t-tqegħid fis-suq b'gefitinib.
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Maltese: Sustanzi li jżidu l-attività ta' CYP3A4 jistgħu jżidu l-metabolismu ta' gefitinib u jnaqqsu lkonċentrazzjoni ta' gefitinib fil-plasma.
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitising EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Maltese: L-istudju IFUM kien studju b'aktar minn ċentru wieħed, b'fergħa waħda li sar fost pazjenti Kawkażi (n=106) b'NSCLC pożittiva b'mutazzjoni tal-EGFR attivanti, sensitizzanti, biex jikkonferma li lattività ta' gefitinib hija simili f'popolazzjonijiet Kawkażi u Asjatiċi.
English: Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Maltese: Numri fil-parentesi kwadri huma 95 % confidence intervals għal HR N
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Maltese: Deidrazzjoni, li tirriżulta middijarrea, dardir, rimettar jew anoressija
English: Only limited data are available in patients with creatinine clearance  20 ml/min and caution is advised in these patients (see section 5.2).
Maltese: Dejta limitata biss hija disponibbli f'pazjenti bi tneħħija tal-krejatinina ta'  20 ml/min, u f'dawn il-pazjenti hija rrakkomandata l-kawtela (ara sezzjoni 5.2).
English: 0.0397 1.7 times higher in females than males
Maltese: 0.0397 1.7 drabi ogħla fin-nisa milli fl-irġiel
English: 28/70 (40%) of never smokers are M+ 47/716 (7%) of ever smokers are M+
Maltese: 47/716 (7 %) ta' dawk li dejjem pejpu huma M+
English: Elevations in total bilirubin, mainly mild to moderate
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità
English: Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue.
Maltese: Gefitinib għandu volum medju ta' kif jitqassam fi stat stabbli ta' 1,400 l li jindika tqassim estensiv filġisem.
English: IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section
Maltese: IRESSA hija indikata bħala monoterapija għall-kura ta' pazjenti li għandhom kanċer tal-pulmun mhux ta' ċellula żgħira (NSCLC) lokalment avvanzat jew metastatiku u li għandu mutazzjonijiet attivanti ta' EGFR-TK (ara sezzjoni 4.4)
English: 4m p=0.1087
Maltese: 18.8m vs 17.4m P=0.1087
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP miftiehem ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms.
Maltese: Fil-prova ISEL, l-inċidenza ta' avvenimenti ta' tip ILD fil-popolazzjoni kollha kien bejn wieħed u ieħor ta' 1% fiż-żewġ fergħat ta' kura.
English: Proportion of tumour M- that are Mby ctDNA)
Maltese: Proporzjon ta' tumuri M- li huma Mminħabba ctDNA
English: Measure
Maltese: Tqala
English: Cystitis
Maltese: Istoloġija
English: Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index.
Maltese: Żieda bħal din tista' tkun potenzjalment relevanti għal substrati ta' CYP2D6 b'indiċi terapewtiku dejjaq.
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Maltese: Gefitinib u l-metaboliti tiegħu akkumulaw fil-ħalib ta' firien li qed ireddgħu (ara sezzjoni 5.3). Gefitinib hu kontra-indikat waqt it-treddigħ u għalhekk it-treddigħ għandu jitwaqqaf waqt li qed jirċievu l-kura b'gefitinib (ara sezzjoni 4.3)
English: Published studies have shown that genetically modified mice, lacking expression of EGFR, exhibit developmental defects, related to epithelial immaturity in a variety of organs including the skin, gastrointestinal tract and lung.
Maltese: Studji ppubblikati urew li ġrieden ġenetikament modifikati, mingħajr espressjoni għal EGFR, jesibixxu difetti fl-iżvilupp relatati ma' immaturità epiteljali f'varjetà ta' organi bħall-ġilda, il-passaġġ gastro intestinali u l-pulmun.
English: In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Maltese: F'sitwazzjonijiet ta' kura flimkien ma' inibituri qawwija ta' CYP3A4, il-pazjent għandu jiġi osservat mill-qrib għal reazzjonijiet avversi ta' gefitinib.
English: Asymptomatic laboratory elevations in blood creatinine Proteinuria
Maltese: Żieda fil-livelli ta' kreatina fiddemm mingħajr sintomi Proteina fl-awrina Ċistite
English: Pack size of 30 film-coated tablets.
Maltese: Daqs tal-pakkett: 30 pillola miksja b'rita.
English: Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety).
Maltese: John's wort/ Hypericum perforatum)għandhom jiġu evitati.
English: Gastrointestinal disorders
Maltese: Perforazzjoni gastro intestinali
English: In a phase I open-label study of single dose gefitinib 250 mg in patients with mild, moderate or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification), there was an increase in exposure in all groups compared with healthy controls.
Maltese: Fi studju open-label ta' fażi I, b'doża waħda ta' gefitinib 250 mg f'pazjenti b'indeboliment tal-fwied ħafif, moderat jew qawwi minħabba ċirrożi (skont il-klassifika Child-Pugh), kien hemm żieda flesponiment fil-gruppi kollha meta mqabbel ma' kontrolli f'saħħithom.
English: Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Maltese: Erożjoni tal-kornea, riversibbli u f'xi każijiet ix-xagħar tal-għajnejn ma jikbirx kif suppost Keratite (0.12%)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinjifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: In this study IRESSA exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of IRESSA.
Maltese: F'dan l-istudju l-esponiment għal IRESSA ma żdiedx ma' żieda fid-doża, l-avvenimenti avversi kienu l-aktar ħfief sa moderati fis-severità, u kienu konsistenti mal-profil magħruf ta' sigurtà ta' IRESSA.
English: Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Maltese: Qlib fenotipiku għal kanċer tal-pulmun ta' ċellula żgħira kien ukoll irrappurtat f'5-10% tal-każijiet.
English: In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Maltese: F'pazjenti individwali li għandhom ġenotip ta' metaboliżmu dgħajjef ta' CYP2D6, il-kura b'inibitur potenti ta' CYP3A4 tista' jwassal għal żidiet fil-livelli ta' gefitinib tal-plasma.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: ITT population for biomarker factors
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Maltese: Żieda fl-INR u/jew xi episodju ta' telf ta'demm ġew irapportati f'xi pazjenti li jieħdu l-warfarina (ara sezzjoni 4.4)
English: IRESSA contains lactose.
Maltese: IRESSA fih il-lactose.
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Maltese: III fejn il-pazjenti ntagħżlu b'mod arbitrarju sar f'pazjenti NSCLC lokalment avvanzat jew metastatiku, li qabel kienu rċievew kimoterapija bbażata fuq il-platinu. Filpopolazzjoni totali ma kien hemm l-ebda differenza statistikament sinifikanti, osservata bejn gefitinib u docetaxel (75 mg/m2) għal sopravivenza totali, sopravivenza mingħajr progressjoni u rati oġġettivi tar-rispons (ara Tabella 5)
English: Without crushing it, the tablet should be dropped in half a glass of drinking water.
Maltese: Mingħajr ma tiġi mfarrka, ilpillola għandha tintreħa f'nofs tazza ilma tax-xorb.
English: Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Maltese: • Reazzjoni qawwija fil-ġilda (rari) f'parti kbira tal-ġisem bħal ħmura, uġigħ, ulċeri, infafet, tqaxxir ta' ġilda.
English: 1 bottle +1 adaptor + 3 oral syringes
Maltese: 1 flixkun + 1 adapter + 3 siringi tal-ħalq
English: Bottle (glass)
Maltese: Kontenut (konċentrazzjoni)
English: MA (EU) number Invented name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Ref. EMEA/448660/2009 EMEA/H/C/1041
Maltese: EMEA/H/C/1041
English: London, 23 July 2009 Doc.
Maltese: Londra, it-23 ta' Lulju 2009 Dok. ta' Ref.
English: What is Contusugene Ladenovec Gendux?
Maltese: X'inhu Contusugene Ladenovec Gendux?
English: Contusugene Ladenovec Gendux is a suspension for injection that contains the active substance contusugene ladenovec.
Maltese: Contusugene Ladenovec Gendux huwa sospensjoni għal injezzjoni li fih is-sustanza attiva contusugene ladenovec.
English: Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Contusugene Ladenovec Gendux ġie żviluppat bħala tip ta' mediċina ta' terapija avvanzata msejħa ‘prodott ta' terapija tal-ġeni'.
English: The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
Maltese: Il-proteina p53 tnaqqas ukoll il-formazzjoni tal-kanali tad-demm li jipprovdu liċ-ċelluli tal-kanċer.
English: In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
Maltese: Fi studju ewlieni li kien jinvolvi 123 pazjent b'karċinoma taċ-ċelluli skwamużi reffrattarja jew rikorrenti fir-ras u fl-għonq, Contusugene Ladenovec Gendux tqabbel ma' methotrexate (mediċina oħra kontra l-kanċer).
English: On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Maltese: Fit-12 ta' Ġunju 2009, Gendux Molecular Limited għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għal awtorizzazzjoni għat-tqegħid fis-suq għal Contusugene Ladenovec Gendux għat-trattament ta' karċinoma taċ-ċelluli skwamużi rikorrenti jew reffrattarji fir-ras u fl-għonq.
English: Once injected into the tumour, Contusugene Ladenovec Gendux was expected to carry the p53 gene into the cancer cells, where the gene was expected to make the cell increase the production of the p53 protein.
Maltese: Ladarba jiġi injettat fit-tumur, Contusugene Ladenovec Gendux kien mistenni jġorr il-ġene p53 fiċċelluli tal-kanċer, fejn il-ġene kien mistenni jġiegħel liċ-ċelluli jżidu l-produzzjoni tal-proteina p53.
English: The active substance in Contusugene Ladenovec Gendux, contusugene ladenovec, is a type of virus that has been modified so that it can carry the p53 gene into the cells of the body.
Maltese: Is-sustanza attiva fi Contusugene Ladenovec Gendux, contusugene ladenovec, hija tip ta' vajrus li ġie mmodifikat sabiex ikun jista' jġorr il-ġene p53 fiċ-ċelluli tal-ġisem.
English: By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
Maltese: Billi jżid il-produzzjoni tal-proteina p53, Contusugene Ladenovec Gendux kien mistenni li jfejjaq jew iġiegħel lill-kanċer jikber aktar bil-mod.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Contusugene Ladenovec Gendux could not have been approved for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Maltese: Abbażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Contusugene Ladenovec Gendux ma setax jiġi approvat għat-trattament tal-karċinoma taċ-ċelluli skwamużi rikorrenti jew reffrattarja fir-ras u fl-għonq.
English: The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Contusugene Ladenovec Gendux għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: What was Contusugene Ladenovec Gendux expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Contusugene Ladenovec Gendux?
English: Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Maltese: L-ittra mill-kumpanija li tgħarraf lill-EMEA dwar l-irtirar tal-applikazzjoni tinsab hawnhekk.
English: Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Maltese: Contusugene Ladenovec Gendux kien mistenni li jintuża għat-trattament tal-karċinoma taċ-ċelluli skwamużi fir-ras u fl-għonq (tip ta' kanċer li jibda fiċ-ċelluli li jiksu l-ħalq, l-imnieħer, il-ġriżmejn jew il-widnejn).
English: In 2008, the CHMP had formulated a list of questions to be answered by the company.
Maltese: Fl-2008, is-CHMP kien fassal lista ta' mistoqsijiet biex jitwieġbu mill-kumpanija.
English: Section 4.3 - Contraindications
Maltese: Sezzjoni 4.3 - Kontra-indikazzjonijiet
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-kumitat qies ir-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: Acute exacerbation of chronic bronchitis (AECB)
Maltese: Aggravar akut ta' bronkite kronika (AECB)
English: Tavanic, solution for infusion, 5 mg/ml
Maltese: Tavanic, soluzzjoni għal infużjoni, 5 mg/ml
English: Acute bacterial sinusitis (ABS)
Maltese: Sinożite batterjali akuta (ABS)
English: • Chronic bacterial prostatitis
Maltese: • Prostatite batterjali kronika
English: Chronic bacterial prostatitis
Maltese: Prostatite batterjali kronika
English: Tavanic (levofloxacin) is a synthetic antibacterial agent of the fluoroquinolone class and is the S(-) enantiomer of the racemic drug substance ofloxacin.
Maltese: Tavanic (levofloxacin) huwa aġent sintetiku antibatterjali tal-klassi fluorokwinolon u huwa S(-) enantiomer tas-sustanza mediċinali raċemika ofloxacin.
English: Complicated urinary tract infections (cUTIs) including pyelonephritis (PN)
Maltese: Infezzjonijiet ikkumplikati fl-apparat tal-awrina (cUTIs) inkluża pjelonefrite (PN)
English: Hence, Tavanic was included in the list of products for PI harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: B'hekk, Tavanic ġie inkluż fil-lista ta' prodotti għal armonizzazzjoni tal-PI, imfassla mis-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata.
English: Community-acquired pneumonia (CAP)
Maltese: Pulmonite meħuda mill-komunità (CAP)
English: In conclusion, the CHMP adopted a harmonised wording for section 5.1
Maltese: Bħala konklużjoni, is-CHMP adotta test armonizzat għassezzjoni 5.1
English: A harmonised Module 3 was also adopted.
Maltese: Ġie adottat Modulu 3 armonizzat ukoll.
English: Tablets - Inhalation Anthrax: post-exposure prophylaxis and curative treatment IV solution - Inhalation Anthrax: curative treatment
Maltese: Pilloli -Anthrax bin-Nifs: profilassi ta' wara l-espożizzjoni u trattament kurattiv Soluzzjoni IV - Anthrax bin-Nifs: trattament kurattiv
English: Levofloxacin has a broad in vitro antibacterial spectrum that includes Gram-positive organisms such as Streptococcus pneumoniae regardless of resistance phenotype, methicillin-susceptible Staphylococcus aureus and Streptococci spp., fastidious Gram-negative bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Enterobacteriaceae such as Escherichia coli and Klebsiella spp., and organisms responsible for atypical infection such as Legionella, Mycoplasma and Chlamydophila.
Maltese: Levofloxacin għandu spettru antibatterjali in vitro wiesa' li jinkludi organiżmi Gram-pożittivi bħal Streptococcus pneumoniae indipendentement mill-fenotip tar-reżistenza, Staphylococcus aureus u Streptococci spp. suxxettibbli għall-metiċillin, batterji Gram-negattivi fastidjużi bħal Haemophilus influenzae, Moraxella catarrhalis u Enterobacteriaceae bħal Escherichia coli u Klebsiella spp., u organiżmi responsabbli għal infezzjoni atipika bħal Leġjonella, Mycoplasma u Chlamydophila.
English: Section 4.6 - Fertility, Pregnancy and Lactation
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: • Hypoglycaemic coma, in line with the CCSI version 4 for levofloxacin submitted as part of the PSUR 27;
Maltese: • Koma ipoglikemika, b'konformità mal-verżjoni 4 tas-CCSI għal levofloxacin sottomessa bħala parti mill-PSUR 27;
English: • cSSTIs (IV solution): 500 mg twice daily;
Maltese: • cSSTIs (soluzzjoni IV): 500 mg darbtejn kuljum;
English: Tavanic, film-coated tablets, 250 mg and 500mg
Maltese: Tavanic, pilloli miksija b'rita, 250 mg u 500 mg
English: Tavanic is available as film coated tablets (250 mg and 500 mg) and as solution for infusion (5mg/ml in presentations of 250mg/50ml and 500mg/100ml).
Maltese: Tavanic huwa disponibbli bħala pilloli miksija b'rita (250 mg u 500 mg) u bħala soluzzjoni għal infużjoni (5mg/ml fi preżentazzjonijiet ta' 250mg/50ml u 500mg/100ml).
English: The Cmax/MIC ration of 10 and an AUC/MIC ratio of 100 are recommended in the literature to represent a rapid bactericidal activity.
Maltese: Il-proporzjon ta' Cmax/MIC ta' 10 u proporzjon ta' AUC/MIC ta' 100 huma rakkomandati fit-tagħrif sabiex tiġi rappreżentata attività batteriċidali mgħaġġla.
English: In the EU the approval of levofloxacin was first granted in the United Kingdom (UK) in 1997 followed by eleven other Member States (MS): Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain through the mutual recognition procedure (MRP) with UK as reference MS. Tavanic is also approved nationally in thirteen other MS: Bulgaria, Cyprus, Czech Republic, Estonia, France, Greece, Hungary, Lithuania, Malta, Poland, Slovakia, Slovenia and Sweden.
Maltese: Tavanic huwa approvat ukoll b'mod nazzjonali fi tlettax-il SM ieħor: il-Bulgarija, Ċipru, irRepubblika Ċeka, l-Estonja, Franza, il-Greċja, l-Ungerija, il-Litwanja, Malta, il-Polonja, is-Slovakkja, is-Slovenja u l-Isvezja.
English: Respiratory Tract Infections (RTIs)
Maltese: Infezzjonijiet fl-Apparat tal-Awrina (RTIs)
English: • Chronic bacterial prostatitis (tablets and IV solution): 500 mg for 28 days;
Maltese: • Prostatite batterjali kronika (pilloli u soluzzjoni IV): 500 mg għal 28 jum;