FrancophonIA/ELRC3.0 huggingface dataset:
English: Secondary end points included changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease.
Maltese: L-end points sekondarji kienu jinkludu tibdiliet mil-linja bażi: fl-UFC fi żmien 24 siegħa, flACTH fil-plażma, fil-livelli ta' kortisol fis-serum, u fis-sinjali u s-sintomi kliniċi tal-marda ta' Cushing.
English: PRE-FILLED SYRINGE LABEL
Maltese: Testijiet tal-fwied
English: The proportion of patients achieving biochemical control was 15.4% (p-value = 0.0006) and 20.0% (p-value <0.0001) for pasireotide intramuscular use 40 mg and 60 mg, respectively at 24 weeks compared with zero in the active control arm (Table 3).
Maltese: 0% (valur-p ta' <0.0001) għal 20 mg u 60 mg pasireotide użu għal ġol-muskoli, rispettivament f'ġimgħa 24 imqabbel ma' żero fil-grupp ikkontrollat bl-attiv (Tabella 3).
English: 1 ml solution for injection contains 0.6 mg pasireotide (as pasireotide diaspartate).
Maltese: Soluzzjoni għall-injezzjoni ta' 1 ml fiha 0.6 mg pasireotide (bħala pasireotide diaspartate).
English: Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of CYP450.
Maltese: Pasireotide huwa mill-aktar stabbli metabolikament u tagħrif in vitro juri li pasireotide mhuwiex sottostrat, inibitur jew induttur ta' CYP450.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċiniali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Multipack: 18 (3 packs of 6) ampoules.
Maltese: Soluzzjoni għall-injezzjoni Pakkett b'ħafna: 18-il ampulla (3 pakketti ta' 6).
English: Dose increase for efficacy was allowed at the discretion of the investigators after three and six months of treatment if biochemical parameters showed a mean GH ≥2.5 µg/l and/or IGF-1 >ULN (age and sex related).
Maltese: Kienet permessa żieda fid-doża bil-għan li tissaħħaħ l-effikaċja u dan fiddiskrezzjoni tal-investigaturi wara tliet jew sitt xuhur mill-kura jekk il-parametri bijokimiċi kienu juru medja ta' GH ≥2.5 µg/l u/jew IGF-1 >ULN (b'rabta mal-età u s-sess).
English: One vial contains 30 mg pasireotide (as pasireotide pamoate).
Maltese: Kunjett wieħed fih 30 mg pasireotide (bħala pasireotide pamoate).
English: Each ampoule contains 1 ml of solution for injection.
Maltese: Kull ampulla fiha 1 ml soluzzjoni għall-injezzjoni.
English: 1 ml solution for injection contains 0.3 mg pasireotide (as pasireotide diaspartate).
Maltese: Soluzzjoni għall-injezzjoni ta' 1 ml fiha 0.3 mg pasireotide (bħala pasireotide diaspartate).
English: Signifor 30 mg: each vial contains 30 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 30 mg: kull kunjett fih 20 mg pasireotide (bħala pasireotide pamoate).
English: Cholelithiasis is a recognised adverse reaction associated with long-term use of somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Maltese: Il-kolelitijasi hija reazzjoni mhux mixtieqa magħrufa marbuta mal-użu fit-tul ta' analogi ta' somatostatin u kienet irrappurtata spiss waqt studji kliniċi b'pasireotide (ara sezzjoni 4.8).
English: Signifor 40 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 40 mg trab u solvent għal suspensjoni għall-injezzjoni Pasireotide
English: The recommended dose is one ampoule of Signifor 0.6 mg twice a day.
Maltese: Id-doża rakkomandata hija ampulla waħda ta' 0.6 mg Signifor darbtejn kuljum.
English: Missed dose
Maltese: Komuni ħafna
English: Signifor 0.3 mg solution for injection One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate).
Maltese: U KWANTITATTIVA Signifor 0.3 mg soluzzjoni għall-injezzjoni Ampulla waħda ta' 1 ml fiha 0.3 mg pasireotide (bħala pasireotide diaspartate).
English: Linearity and time dependency
Maltese: Linearità u dipendenza fuq il-ħin
English: - The other ingredients are mannitol, tartaric acid, sodium hydroxide and water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, tartaric acid, sodium hydroxide u ilma għallinjezzjonijiet.
English: Pasireotide administered via the subcutaneous route did not affect fertility in male rats but, as expected from the pharmacology of pasireotide, females presented abnormal cycles or acyclicity, and decreased numbers of corpora lutea and implantation sites.
Maltese: Pasireotide ma affettwax il-fertilità tal-firien irġiel imma, kif mistenni mill-farmakoloġija ta' pasireotide, in-nisa ppreżentaw ċikli mhux normali jew aċikliċità, u nuqqas fl-għadd ta' corpora lutea u ta' postijiet ta' impjantazzjoni.
English: Abdominal distension, vomiting
Maltese: Distensjoni addominali, rimettar
English: Decreases in sitting systolic and diastolic blood pressure, body mass index (BMI) and total cholesterol were observed in both dose groups at month 6.
Maltese: Kien hemm tnaqqis fil-pressjoni tad-demm sistolika u dijastolilka tal-pazjenti bilqiegħda, fl-indiċi talmassa tal-ġisem (BMI) u fil-kolesterol totali fiż-żewġ gruppi fis-6 xahar.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in acromegaly and pituitary gigantism, and in pituitary dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Signifor f'kull sett tal-popolazzjoni pedjatrika b'akromegalija u ġgantiżmu pitwitarju morda bilmarda ta' Cushing dipendenti fuq il-pitwitarja, bi produzzjoni eċċessiva tal-pitwitarja tal-ACTH u b'iperadrenokortisiżmu dipendenti fuq il-pitwitarja (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4).
Maltese: Huwa rrakkomant monitoraġġ tal-livelli tal-glukosju fid-demm f'pazjenti ttrattati b'Signifor (ara sezzjoni 4.4).
English: Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Maltese: Instab li l-età kienet kovarjant fl-analiżi farmakokinetika tal-popolazzjoni f'pazjenti morda bil-marda ta' Cushing.
English: These measures will help protect the environment.
Maltese: Aqla' t-tokka protettiva minnufih mil-labra.
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including GH in acromegaly and ACTH in Cushing's disease.
Maltese: Ir-riċetturi ta' somatostatin joħorġu f'ħafna tessuti, b'mod speċjali f'tumuri newroendokrini li fihom lormoni jnixxu b'qawwa, inkluż il-GH f'akromegalija u ACTH fil-marda ta' Cushing.
English: Further decrease in tumour volume was observed at month 12 after crossover for both treatment groups, and was higher in patients who crossed over to pasireotide intramuscular use (-24.7%) than in patients who crossed over to octreotide intramuscular use (-17.9%).
Maltese: Kien hemm aktar tnaqqis fil-volum tat-tumur fit-12-il xahar wara l-bidla fiż-żewġ gruppi ta' kura, u kien ogħla fost il-pazjenti li qalbu għal pasireotide użu għal ġol-muskoli (-24.7%) milli fost il-pazjenti li qalbu għal octreotide użu għal ġol-muskoli (-17.9%).
English: Cushing's disease study G2304
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: The suppression of ACTH (adrenocorticotropic hormone) secretion can result in hypocortisolism in patients treated with Signifor.
Maltese: It-trażżin tat-tnixxija ta' ACTH (l-ormon tal-adrenokortikotropiku) jista' jwassal għal ipokortisliżmu f'pazjenti ttratti b'Signifor.
English: Signifor 0.9 mg solution for injection pasireotide
Maltese: Signifor 0.9 mg soluzzjoni għal injezzjoni pasireotide
English: Renal impairment No dose adjustment is required in patients with impaired renal function (see section 5.2).
Maltese: Mhux meħtieġ aġġustament tad-doża f'pazjenti b'indeboliment fil-funzjoni tal-kliewi (ara sezzjoni 5.2).
English: Signifor 0.3 mg solution for injection EU/1/12/753/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Signifor 0.3 mg soluzzjoni għal injezzjoni EU/1/12/753/001-004
English: As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than GH and/or IGF-1 in patients with acromegaly and ACTH/cortisol in patients with Cushing's disease cannot be ruled out.
Maltese: Minħabba li l-attività farmakoloġika ta' pasireotide tixbah lil dik ta' somatostatin, wieħed ma jistax jeskludi l-inibizzjoni tal-ormoni pitwitarji ħlief tal-GH u/jew IGF-1 f'pazjenti b'akromegalija u ACTH/kortisol f'pazjenti bil-marda ta' Cushing.
English: The study met the primary efficacy objective for the 0.9 mg twice-daily group as the lower limit of the 95% CI is greater than the pre-specified 15% boundary.
Maltese: L-istudju laħaq l-objettiv primarju tal-effikaċja għall-grupp mogħti 0.9 mg darbtejn kuljum minħabba li l-anqas limitu tal-95% CI hu akbar mill-fruntiera ta' 15% speċifikata minn qabel.
English: (hypoglycaemia) such as:
Maltese: * Termini miġmugħa:
English: Dose reduction by decrements of 0.3 mg twice a day is suggested.
Maltese: Huwa ssuġġerit tnaqqis tad-doża ta' 0.3 mg darbtejn kuljum.
English: Most (83.3%) patients had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
Maltese: Ħafna mill-pazjenti (83.3%) kellhom sintomi persistenti jew rikorrenti tal-marda ta' Cushing u ftit kienu dawk (≤5%) fiż-żewġ gruppi ta' kura li ngħataw minn qabel irradjazzjoni pitwitarja.
English: Vomiting, abdominal pain upper
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Female acromegaly patients had a higher exposure of 32% and 51% compared to male patients in studies with medical treatment naïve patients and inadequately controlled patients, respectively; these differences in exposure were not clinically relevant based on efficacy and safety data.
Maltese: Pazjenti nisa b'akromegalija kellhom espożizzjoni akbar ta' 32% u 51% imqabbel mal-pazjenti rġiel fi studji b'pazjenti naivi għall-kura medika u pazjenti mhux ikkontrollati kif jixraq, rispettivament; dawn id-differenzi fl-espożizzjoni ma kenux relevanti klinikament skont l-informazzjoni dwar leffikaċja u s-sigurtà.
English: Patients uncontrolled at both month 1 and month 2 are likely (90%) to remain uncontrolled at months 6 and 12.
Maltese: Pazjenti mhux ikkontrollati kemm fl-1 xahar u fit-2 xahar x'aktarx (90%) li jibqgħu mhux ikkontrollati fis-6 u t-12-il xahar.
English: Decreases were also demonstrated by the overall percentage change from baseline in mean and median mUFC levels at month 7 and 12.
Maltese: Deher ukoll tnaqqis fil-perċentwali sħiħa ta' tibdil mil-linja bażi fillivelli mUFC medjani u medji fis-7 u t-12-il xahar.
English: Unit packs (all strengths): each unit pack contains a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety-engineered needle for injection).
Maltese: Pakketti b'wieħed (il-qawwiet kollha): kull pakkett b'wieħed fih sett b'injezzjoni waħda f'folja (kunjett wieħed u, f'parti separata ssiġillata, siringa waħda mimlija għal-lest, adattur wieħed għallkunjett u b'labra għall-injezzjoni b'sistema protettiva).
English: The primary efficacy endpoint was the proportion of patients with a reduction of mean GH level to <2.5 μg/l and the normalisation of IGF-1 to within normal limits (age and sex related) at month 12.
Maltese: L-endpoint primarju tal-effikaċja kien il-proporzjon ta' pazjenti bi tnaqqis fil-medja tal-livell ta' GH għal <2.5 μg/l u bin-normalizzazzjoni ta' IGF-1 fi ħdan il-limiti normali (b'rabta mal-età u s-sess) fit12-il xahar.
English: 81 patients were crossed over from octreotide intramuscular use to pasireotide intramuscular use, and 38 patients were crossed over from pasireotide intramuscular use to octreotide intramuscular use.
Maltese: 81 pazjent għaddew minn octreotide użu għal ġol-muskoli għal pasireotide użu għal ġol-muskoli, u 38 pazjent qalbu minn pasireotide użu għal ġol-muskoli għal octreotide użu għal ġolmuskoli.
English: Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8).
Maltese: Huwa rrakkomandat monitoraġġ tal-enzimi tal-fwied qabel u waqt il-kura b'Signifor (ara sezzjoni 4.4), skont kif jixraq klinikament.
English: Signifor 0.6 mg solution for injection pasireotide
Maltese: Signifor 0.6 mg soluzzjoni għal injezzjoni pasireotide
English: - Inflammation of the gallbladder (cholecystitis).
Maltese: - Uġigħ fil-ġogi (artralġja)
English: Doses up to 2.1 mg twice a day have been used in healthy volunteers, with the adverse reaction diarrhoea being observed at a high frequency.
Maltese: Dożi sa 2.1 mg darbtejn kuljum intużaw f'voluntiera b'saħħithom, bir-reazzjoni mhux mixtieqa osservata bl-aktar frekwenza tkun id-dijarrea.
English: 4 vials + 8 swabs
Maltese: 4 kunjetti + 8 swabs
English: 24 vials + 24 prefilled syringes + 24 needles + 24 vial adaptors + 48 swabs
Maltese: 24 kunjett + 24 siringa mimlija għal-lest + 24 labra + 24 adapter talkunjetti + 48 swab
English: 25 mg Powder for solution for injection
Maltese: 25 mg Trab għal soluzzjoni għall-injezzjoni trab: kunjett (ħġieġ)
English: Subcutaneous use vial (glass)
Maltese: 12-il siringa mimlija għallest + 12-il swab
English: Section 4.8.
Maltese: Taqsima 4.8.
English: Olanzapine - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 18534)
Maltese: Olanzapine - Reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS)(EPITT nru 18534)
English: Adopted at the 11-14 April 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-11 u l-14 ta' April 2016
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (frequency unknown)
Maltese: Reazzjoni għall-Mediċina b'Esinofilja u Sintomi Sistemiċi (DRESS) (il-frekwenza mhijiex magħrufa)
English: Skin and subcutaneous tissue disorders
Maltese: Effetti mhux mixtieqa
English: DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
Maltese: Fil-bidu DRESS tidher b'sintomi bħal tal-influwenza b'raxx fuq il-wiċċ imbagħad b'raxx estiż, temperatura għolja, glandoli limfatiċi minfuħin, livelli ogħla tal-enzimi tal-fwied li jidhru fit-testijiet tad-demm u żieda f'tip ta' ċellola bajda tad-demm (esinofilja).
English: New product information wording - Extracts from PRAC recommendations on signals
Maltese: Kliem ġdid tal-informazzjoni dwar il-prodott - Siltiet mirrakkomandazzjonijiet tal-PRAC dwar is-sinjali
English: • Chronic sinusitis (CRS)
Maltese: • Sinusite kronika (CRS)
English: Vaginal infections (AV)
Maltese: Infezzjonijiet vaġinali (AV)
English: Prostatitis, epididymo-orchitis
Maltese: Prostatite, epididimo-orkite
English: A review of its antibacterial activity, pharmacokinetic properties and therapeutic use.
Maltese: A review of its antibacterial activity, pharmacokinetic properties and therapeutic use (Rieżami tal-attività antibatterika, tal-proprjetajiet farmakokinetiċi u tal-użu terapewtiku tiegħu).
English: Pefloxacin.
Maltese: Pefloksaċina.
English: Acute exacerbation of chronic bronchitis (AECB) and COPD
Maltese: Aggravar akut ta' bronkite kronika (AECB) u COPD
English: Chronic sinusitis
Maltese: Sinusite kronika
English: Table 2 - Category 2 indications
Maltese: Tabella 2 - Indikazzjonijiet tal-Kategorija 2
English: Group B streptococci (GBS), Escherichia coli, Staphylococcus aureus and Enterococcus faecalis are the organisms most frequently associated with Aerobic Vagnitis (Rampersaud et al 2012).
Maltese: Streptococci tal-Grupp B (GBS), Escherichia coli, Staphylococcus aureus u Enterococcus faecalis huma l-organiżmi l-aktar assoċjati ma' Vaġinite Aerobika (Rampersaud et al 2012).
English: Mainly CRS is caused by the following pathogens: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobes, and Chlamydia spp.
Maltese: Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus spp., Streptococcus pyogenes, Moraxella catarrhalis, Klebsiella pneumoniae, anaerobes, u Chlamydia spp.
English: Almost 95% of MOE cases reported in the literature are attributed to Pseudomonas aeruginosa (Bovo et al. 2012).
Maltese: Kważi 95 % tal-każijiet ta' MOE rrapportati fil-letteratura huma attribwiti għal Pseudomonas aeruginosa (Bovo et al. 2012).
English: Pefloxacin
Maltese: Pefloksaċina
English: • Acute sinusitis
Maltese: • Sinusite akuta
English: Acute bacterial rhinosinusitis (ABS)
Maltese: Rinosinusite batterika akuta (ABS)
English: Table 3 - Category 3 indications
Maltese: Tabella 3 - Indikazzjonijiet tal-Kategorija 3
English: Pneumonia due to Gram-negative bacteria
Maltese: Pulmonite minħabba batterji Gram-negattivi
English: AOM is regarded as a multifactorial and polymicrobial disease, which usually occurs as a complication of viral upper respiratory tract infection (Marom et al 2012).
Maltese: L-AOM hija meqjusa bħala marda multifattorjali u polimikrobika, li normalment tiżviluppa bħala komplikazzjoni ta' infezzjoni virali fl-apparat respiratorju ta' fuq (Marom et al 2012).
English: Typical microorganisms that can cause infective endocarditis include Viridans streptococci, Streptococcus bovis, HACEK group, Staphylococcus aureus or enterococci.
Maltese: Mikroorganiżmi tipiċi li jistgħu jikkawżaw endokardite infettiva jinkludu Viridans streptococci, Streptococcus bovis, ilgrupp HACEK, Staphylococcus aureus jew enterococci.
English: Acute bronchitis
Maltese: Bronkite akuta
English: Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catharralis were isolated from sputum samples in up to 45% of patients with acute bronchitis (Macfarlane et al. 1993) but their role is difficult to distinguish because of potential oropharyngeal colonization in healthy individuals (Laurenzi et al. 1961; Smith and Lockwood 1986).
Maltese: Streptococcus pneumoniae, Haemophilus influenzae u Moraxella catharralis kienu iżolati minn kampjuni ta' sputum f'sa 45 % tal-pazjenti bi bronkite akuta (Macfarlane et al. 1993) iżda minħabba l-potenzjal ta' kolonizzazzjoni orofarinġali f'individwi b'saħħithom, huwa diffiċli li wieħed jagħmel distinzjoni bejn irrwol tagħhom (Laurenzi et al. 1961;
English: Pefloxacin antimicrobial activity against bacterial strains relevant for this indication is low (Hoogkamp-Korstanje 1997).
Maltese: L-attività antimikrobika ta' pefloksaċina kontra razez batteriċi rilevanti għal din l-indikazzjoni hija baxxa (Hoogkamp-Korstanje 1997).
English: The PRAC adopted a recommendation on 16 October 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni fis-16 ta' Ottubru 2018 li mbagħad ġiet ikkunsidrata mis-CHMP, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: In addition, pefloxacin has low urinary excretion (34% of pefloxacin dose including its active metabolite norfloxacin) (Naber 2001).
Maltese: Barra minn hekk, pefloksaċina għandu eliminazzjoni baxxa fl-awrina (34 % tad-doża ta' pefloksaċina inkluż il-metabolit attiv tiegħu norfloksaċina) (Naber 2001).
English: While the efficacy of topical antibacterial therapy was confirmed in clinical trials, the use of systemic therapy is questionable (Freedman 1978; Yelland 1993; Cannon 1970) and should be limited to persistent otitis externa or local or systemic spread of the infection (Sander 2001).
Maltese: Filwaqt li l-effikaċja ta' terapija antibatterika topika ġiet ikkonfermata fi provi kliniċi, l-użu ta' terapija sistemika huwa dubjuż (Freedman 1978; Yelland 1993; Cannon 1970) u għandha tkun limitata għal otite esterna persistenti jew għal tixrid lokali jew sistemiku tal-infezzjoni (Sander 2001).
English: Based on the available data, approximately 90% cases of pharyngitis and 70% cases of tonsillitis in adults and children are of viral origin (Zoorob et al 2012).
Maltese: Abbażi tad-data disponibbli, madwar 90 % tal-każijiet ta' farinġite u 70 % tal-każijiet ta' tonsillite fladulti u fit-tfal huma ta' oriġini virali (Zoorob et al 2012).
English: Streptococcus species have only moderate sensitivity to pefloxacin, with MIC90 values ranging from 3.1 to 32 mg/L (Gonzalez JP, Henwood JM.
Maltese: L-ispeċi Streptococcus għandhom biss sensittività moderata għal pefloksaċina, b'valuri MIC90 li jvarjaw bejn 3.1 u 32 mg/L (Gonzalez JP, Henwood JM.
English: The pathogens associated with pyelonephritis consists mainly of E. coli (75% to 95%), with occasional other species of Enterobacteriaceae, such as P. mirabilis and K. pneumoniae, and of Staphylococci.
Maltese: Il-patoġeni assoċjati ma' pajelonefrite jikkonsistu prinċipalment minn E. coli (75 % sa 95 %), b'xi kultant speċi oħra ta' Enterobacteriaceae, bħal P. mirabilis u K. pneumoniae, u ta' Staphylococci.
English: In case of atypical sexually transmitted pathogens, such as Mycoplasma hominis and Chlamydia trachomatis or Ureaplasma urealyticum, pefloxacin antimicrobial activity is low (Gonzales and Henwood 1989).
Maltese: Fil-każ ta' patoġeni atipiċi li jiġu trażmessi sesswalment, bħal Mycoplasma hominis u Chlamydia trachomatis jew Ureaplasma urealyticum, l-attività antimikrobika ta' pefloksaċina hija baxxa (Gonzales u Henwood 1989).
English: These indications shall be amended.
Maltese: Dawn lindikazzjonijiet għandhom jiġu emendati.
English: Pharyngitis-Tonsillitis
Maltese: Farinġite-Tonsillite
English: Chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
Maltese: Infezzjonijiet pulmonari kroniċi kkawżati minn Pseudomonas aeruginosa f'pazjenti adulti b'fibrożi ċistika
English: Apart from that, the available data shows a poor antimicrobial activity of pefloxacin against Pseudomonas (King and Phillips 1986) and no updated susceptibility data on pefloxacin are available as the European Committee on Antimicrobial Susceptibility Testing (EUCAST) has not defined clinical breakpoints for pefloxacin (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.9.pdf).
Maltese: Barra minn dan, id-data disponibbli turi attività antimikrobika fqira ta' pefloksaċina kontra Pseudomonas (King u Phillips 1986) u ma hemm l-ebda data aġġornata disponibbli dwar is-suxxettibilità dwar pefloksaċina minħabba li l-Kumitat Ewropew dwar it-Testijiet tas-Suxxettibbiltà (EUCAST) ma ddefinixxiex valuri kliniċi kritiċi għal pefloksaċina (http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Rationale_documents/Ciproflo xacin_rationale_1.
English: • Exacerbation of chronic obstructive pulmonary disease Acute bacterial sinusitis
Maltese: • Aggravar ta' mard pulmonari ostruttiv kroniku Sinusite batterika akuta
English: Infection of the digestive system and bile ducts Prevention of infection in surgical procedures Prophylaxis of systemic urinary tract infections Prevention of systemic urinary tract infections
Maltese: Infezzjoni tas-sistema diġestiva u tal-kanali tal-bili Prevenzjoni ta' infezzjoni fi proċeduri kirurġiċi Profilassi ta' infezzjonijiet urinarji sistemiċi Prevenzjoni ta' infezzjonijiet urinarji sistemiċi
English: In the EU, the indication endocarditis is approved exclusively for pefloxacin.
Maltese: Fl-UE, pefloksaċina huwa approvat esklussivament għall-indikazzjoni ta' endokardite.