FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolism and nutrition disorders blood lactate dehydrogenase increased decreased appetite, blood albumin decreased, blood chloride increased, blood glucose decreased, blood lactate dehydrogenase decreased, blood potassium increased, blood sodium increased, blood uric acid increased, protein total increased
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni żieda fillattatdeidroġenażi fid-demm tnaqqis fl-aptit, tnaqqis flalbumina tad-demm, żieda fil-klorur tad-demm, tnaqqis fil-glukożju taddemm, tnaqqis fillattatdeidroġenazi taddemm, żieda fil-potassju fid-demm, żieda fis-sodju fid-demm, żieda fl-aċidu uriku fid-demm, żieda fittotal tal-proteina
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of concentrate contains 200 mg peramivir.
Maltese: Kull kunjett ta' 20 mL konċentrat fih 200 mg peramivir.
English: 6.3 Shelf life
Maltese: 6.3 Perjodu ta' stabilità
English: • severe allergic reactions, including severe allergic shock reaction with features such as itchy rash, swelling of the throat and tongue, breathing difficulty, lightheadedness and vomiting
Maltese: • reazzjonijiet allerġiċi severi, inkluża reazzjoni ta' xokk allerġiku severa b'karatteristiċi bħallraxx bil-ħakk, nefħa fil-gerżuma u fl-ilsien, diffikultà fit-teħid tan-nifs, sturdament u rimettar
English: Children aged from 2 years and ≥50 kg body weight
Maltese: Tfal minn sentejn 'il fuq u ≥50 kg
English: • reduced sense of touch or sensation
Maltese: • nuqqas ta' sens tal-mess jew sensazzjoni
English: Available pharmacodynamic/toxicological data in animals have shown excretion of peramivir in milk (see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika disponibbli fl-annimali wriet li kien hemm eliminazzjoni ta' peramivir fil-ħalib tas-sider (ara sezzjoni 5.3).
English: The dose should be reduced for adults and adolescents (13 years and older) with absolute glomerular filtration rate (GFR) below 50 mL/min as shown in Table 2 (see sections 4.4 and 5.2).
Maltese: Id-doża għandha titnaqqas għall-adulti u għall-adolexxenti (minn 13-il sena 'l fuq) b'rata ta' filtrazzjoni glomerulari assoluta (GFR) taħt il-50 mL/min kif muri fit-Tabella 2 (ara sezzjonijiet 4.4 u
English: The most important serious adverse reactions associated with peramivir in patients are anaphylaxis and skin reactions, including erythema multiforme and Stevens-Johnson Syndrome.
Maltese: L-aktar reazzjonijiet avversi serji importanti assoċjati ma' peramivir f'pazjenti huma l-anafilassi u rreazzjonijiet tal-ġilda, inklużi l-eritema multiformi u s-Sindromu ta' Stevens-Johnson.
English: Reduced renal function
Maltese: Tnaqqis fil-funzjoni tal-kliewi
English: Available data do not support a conclusion that peramivir is effective in patients with influenza B or in patients with complicated influenza.
Maltese: Id-data disponibbli ma tappoġġjax konklużjoni li peramivir huwa effettiv f'pazjenti bl-influwenza B jew f'pazjenti b'influwenza kkumplikata.
English: • Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
Maltese: • Agħti s-soluzzjoni dilwita permezz ta' infużjoni ġol-vini għal 15 sa 30 minuta.
English: Use aseptic technique during the preparation of Alpivab to prevent microbial contamination.
Maltese: Uża teknika asettika waqt it-tħejjija ta' Alpivab sabiex tevita l-kontaminazzjoni involontarja millmikrobi.
English: NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion
Maltese: Alpivab 200 mg konċentrat għal soluzzjoni għal infużjoni
English: Renal and urinary disorders blood urea increased, blood present in urine, urobilin present in urine, blood creatinine increased, urine ketone body increased acute kidney injury*, renal impairment*
Maltese: Disturbi fil-kliewi u fis-sistema urinarja żieda fl-urea fid-demm, preżenza ta' demm fl-urina, preżenza ta' urobilina flurina, żieda fil-kreatinina fid-demm, żieda fil-korp tal-ketoni fl-urina ħsara akuta filkliewi*, indeboliment talkliewi*
English: In clinical trials, H275Y was the only resistance-associated treatment-emergent mutation in the neuraminidase gene that occurred in virus obtained from more than one peramivir-treated subject (in 9 of 481[1.9 %] infected with the A/H1N1 influenza virus).
Maltese: Fi provi kliniċi, H275Y kienet l-unika mutazzjoni li ħarġet mill-kura assoċjata mar-reżistenza fil-ġene tan-newroamidażi li seħħet fil-virus miksub minn aktar minn suġġett wieħed ikkurat b'peramivir (f'9 minn 481[1.9 %] infettati bil-virus tal-influwenza A/H1N1).
English: The ITTI population included 84 subjects with influenza confirmed by PCR.
Maltese: Il-kura ngħatat jew inbdiet fi żmien 48 siegħa minn meta bdew is-sintomi talinfluwenza.
English: The efficacy of peramivir as a single dose treatment for uncomplicated influenza was demonstrated in a single placebo-controlled study conducted in 300 adult patients in Japan during the 2007/2008 influenza season.
Maltese: L-effikaċja ta' peramivir bħala kura f'doża waħda għall-influwenza mhux ikkomplikata ntweriet fi studju wieħed ikkontrollat bi plaċebo li sar fi 300 pazjent adult fil-Ġappun matul l-istaġun tal-influwenza tal-2007/2008.
English: This medicinal product contains 212.4 mg sodium per 3 vials, equivalent to 10.6% of the World Health Organization (WHO) recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Kull 3 kunjetti ta' dan il-prodott mediċinali fihom 212.4 mg ta' sodju, ekwivalenti għal 10.
English: Hepatobiliary disorders increased gammaglutamyltransferase liver disorder*, alanine aminotransferase increased*, aspartate aminotransferase increased*
Maltese: Disturbi fil-fwied u fil-marrara gamma-glutamyltransferase miżjud disturb filfwied*, żieda flalanina aminotransferażi, żieda flaspartataminotran sferażi*
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
Maltese: • Is-sustanzi l-oħrajn huma klorur tas-sodju, ilma għall-injezzjonijiet, aċidu idrokloriku (għallaġġustament tal-pH), idrossidu tas-sodju (għall-aġġustament tal-pH).
English: How to store Alpivab
Maltese: X'fih Alpivab
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment tal-fwied L-ebda aġġustament tad-doża mhuwa meħtieġ f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: As a precautionary measure, it is preferable to avoid the use of peramivir during pregnancy.
Maltese: Bћala miżura ta' prekawzjoni hu preferribli li jiġi evitat l-użu ta' peramivir waqt it-tqala.
English: There are no or limited amount of data (less than 300 pregnancies outcomes) from the use of peramivir in pregnant women.
Maltese: M'hemmx data jew hemm data limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' peramivir finnisa tqal.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Ilma għall-injezzjonijiet Idrossidu tas-sodju (għall-aġġustament tal-pH) Aċidu idrokloriku (għall-aġġustament tal-pH)
English: Crossresistance between peramivir and each of oseltamivir and zanamivir may also occur.
Maltese: Tista' sseħħ ukoll reżistenza inkroċjata bejn peramivir u kull wieħed minn oseltamivir u zanamivir.
English: The primary endpoint, time to alleviation of symptoms, was defined as the number of hours from initiation of study drug until the start of the 24 hour period in which all seven symptoms of influenza (cough, sore throat, nasal congestion, headache, feverishness, myalgia and fatigue) were either absent or present at a level no greater than mild for at least 21.5 hours.
Maltese: Il-punt ta' tmiem ewlieni, il-ħin sakemm ittaffew is-sintomi, kif definit bħala n-numru ta' sigħat mill-bidu tal-mediċina studjata sal-bidu tal-perjodu ta' 24 siegħa li fih is-seba' sintomi kollha tal-influwenza (sogħla, uġigħ fil-griżmejn, imnieħer miżdud, uġigħ ta' ras, deni, mijalġija u għeja) jew għebu għalkollox jew kienu waqgħu f'livell ta' ‘ħfief' għal mill-inqas 21 siegħa u nofs.
English: No clinically relevant alterations to peramivir pharmacokinetics are expected in patients with hepatic impairment based on the route of peramivir elimination.
Maltese: Mhumiex mistennija bidliet klinikament rilevanti fil-farmakokinetiċi ta' peramivir f'pazjenti b'indeboliment talfwied abbażi tar-rotta ta' eliminazzjoni ta' peramivir.
English: • itching
Maltese: L-ISEM
English: • blood tests showing increased levels of lactate dehydrogenase
Maltese: • testijiet tad-demm li juru livelli għolja ta' lattatdeidroġenażi
English: Administer the diluted solution via intravenous infusion over 15 to 30 minutes.
Maltese: Agħti s-soluzzjoni dilwita permezz ta' infużjoni ġol-vini għal 15 sa 30 minuta.
English: • sleeplessness
Maltese: • uġigħ fil-ġogi
English: Geometric Mean
Maltese: Medja Ġeometrika
English: Clear, colourless, solution.
Maltese: Soluzzjoni ċara, mingħajr kulur.
English: Sodium hydroxide (for pH adjustment)
Maltese: Idrossidu tas-sodju (għall-aġġustament tal-pH)
English: Subjects participating in the trial were required to self-assess their influenza symptoms as “none', ‘mild', ‘moderate' or ‘severe' twice daily.
Maltese: Is-suġġetti li ħadu sehem filprova kienu meħtieġa li jivvalutaw huma stess is-sintomi tal-influwenza bħala ‘ebda', ‘ħfief', ‘moderati', jew ‘severi' darbtejn kuljum.
English: Acute renal necrosis was found in rabbits at doses ≥ 200 mg/kg with a clear no observed adverse effect level (NOAEL) established in multiple studies at 100 mg/kg/day.
Maltese: Instabet nekrożi akuta tal-kliewi fil-fniek f'dożi ta' ≥ 200 mg/kg b'livell ċar ta' ebda effett avvers osservat (NOAEL) stabbilit f'għadd ta' studji b'100 mg/kg/kuljum.
English: Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and is also important for viral entry into uninfected cells, which causes further spread of infectious virus in the body.
Maltese: Peramivir huwa inibitur tan-newroaminidażi tal-virus tal-influwenza, enżima li tirrilaxxa partiċelli virali mill-membrana tal-plażma ta' ċelloli infettati u hija importanti ħafna għad-dħul tal-virus fiċċelloli mhux infettati, li jwassal biex il-virus infettiv jinfirex aktar fil-ġisem.
English: Subjects receiving peramivir experienced a median time to alleviation of their combined influenza symptoms of 79.0 hours and the median time to recovery to normal temperature (less than 37 °C) was approximately 40.0 hours.
Maltese: Is-suġġetti li ngħataw peramivir esperjenzaw ħin medjan sakemm ittaffew is-sintomi kkombinati talinfluwenza ta' 79.0 sigħat u l-ħin medjan sal-irkupru tat-temperatura normali (inqas minn 37 °C) kien madwar 40.0 sigħat.
English: Alpivab is a clear, colourless, sterile concentrate for solution for infusion.
Maltese: Alpivab konċentrat għal soluzzjoni għal infużjoni trasparenti, bla kulur u sterili.
English: Uncommon, may affect up to 1 in 100 people
Maltese: Mhux komuni, jistgħu jaffettwaw sa persuna 1 minn kull 100
English: Renal clearance of unchanged peramivir accounts for approximately 90 % of total clearance.
Maltese: Il-klirjanza mill-kliewi ta' peramivir mhux mibdul jammonta għal madwar 90 % tal-klirjanza kollu.
English: • acute kidney injury, reduced kidney function
Maltese: • ħsara akuta fil-kliewi, funzjoni mnaqqsa tal-kliewi
English: The potential for interactions of peramivir with other medicines is low, based on the known elimination pathway of peramivir.
Maltese: Il-potenzjal ta' interazzjoni ta' peramivir ma' mediċini oħrajn huwa baxx, abbażi tal-passaġġ ta' eliminazzjoni magħruf ta' peramivir.
English: Clinical trials in which single intravenous doses of peramivir were administered to patients with uncomplicated influenza included few subjects aged 65 and over (n=10).
Maltese: Il-provi kliniċi li fihom ingħataw dożi waħdiena ta' peramivir ġol-vini lil pazjenti b'influwenza mhux ikkumplikata kienu jinkludu ftit suġġetti ta' 65 sena u akbar (n=10).
English: • Children aged from 2 years weighing less than 50 kg receive 12 mg per kg body weight.
Maltese: • It-tfal ta' sentejn u akbar li jiżnu inqas minn 50 kg jingħataw 12 mg għal kull kg ta' piż tal-ġisem.
English: • restlessness
Maltese: • aġitazzjoni
English: There is no preservative or antibacterial agent in the solution.
Maltese: M'hemmx preservattiv jew sustanza antibatterika fis-soluzzjoni.
English: • red ear drum
Maltese: • Żomm dan il-fuljett.
English: Once diluted, administer the prepared Alpivab solution immediately; otherwise, store in a refrigerator (2 °C - 8 °C) for up to 24 hours.
Maltese: Ladarba tkun dilwita, is-soluzzjoni mħejjija ta' Alpivab għandha tingħata minnufih; inkella aħżinha fil-friġġ (2 °C sa 8 °C) għal massimu ta' 24 siegħa.
English: There are insufficient clinical data available in children and adolescents aged less than 13 years or with body weight less than 50 kg with renal impairment to be able to make any dosing recommendation.
Maltese: M'hemmx data klinika suffiċjenti disponibbli fit-tfal u fl-adolexxenti ta' inqas minn 13-il sena jew b'piż tal-ġisem inqas minn 50 kg b'indeboliment tal-kliewi biex tkun tista' ssir rakkomandazzjoni taddoża.
English: In adults and adolescents (from 13 years and 50 kg) with chronic renal impairment maintained on haemodialysis, peramivir should be administered after dialysis at a dose adjusted for renal function (Table 2).
Maltese: Fl-adulti u fl-adolexxenti (minn 13-il sena u minn 50 kg 'l fuq) b'indeboliment tal-kliewi kroniku miżmuma fuq id-dijalisi tad-demm, peramivir għandu jingħata wara d-dijalisi f'doża aġġustanta għallfunzjoni tal-kliewi (Tabella 2).
English: • very severe skin reactions, including Steven-Johnson syndrome and dermatitis exfoliative These skin reactions are life-threatening rashes with fever and blisters and can effect the lining of the mouth and genitals.
Maltese: • reazzjonijiet severi ħafna fil-ġilda, inkluża s-sindrome ta' Steven-Johnson u dermatite esfoljattiva
English: • upper abdominal pain, abdominal discomfort
Maltese: • uġigħ fin-naħa ta' fuq tal-addome, skonfort addominali
English: Cross resistance
Maltese: Atlantic Avenue
English: Add the measured volume of Alpivab concentrate into the infusion container.
Maltese: Żid il-volum imkejjel ta' konċentrat ta' Alpivab fil-kontenitur tal-infużjoni.
English: Peramivir was not teratogenic in embryo-fetal development studies in rats and rabbits and had no effects on mating or fertility in rats up to 600 mg/kg/day, at which exposures were approximately 8-fold of those in humans at the clinically recommended dose.
Maltese: Peramivir ma kienx teratoġeniku fl-istudji dwar l-iżvilupp tal-embriju-fetu fil-firien u fil-fniek u ma kellu ebda effett fuq it-tgħammir jew il-fertilità fil-firien sa 600 mg/kg/kuljum, fejn l-esponimenti kienu madwar 8-darbiet aktar minn dawk fil-bnedmin fid-doża klinikament rakkomandata.
English: There is no specific antidote to treat an overdose of this medicine.
Maltese: M'hemmx antidotu speċifiku għall-kura ta' doża eċċessiva ta' din il-mediċina.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 3 vials
Maltese: Konċentrat għal soluzzjoni għal infużjoni 3 kunjetti
English: • Add the measured volume of peramivir concentrate into the infusion container.
Maltese: • Żid il-volum imkejjel ta' konċentrat ta' peramivir fil-kontenitur tal-infużjoni.
English: Efficacy (time to resolution of fever; time to resolution of influenza symptoms, viral shedding, virus susceptibility) was a secondary endpoint.
Maltese: L-effikaċja (il-ħin sakemm niżel id-deni; il-ħin sakemm għebu s-sintomi tal-influwenza, it-tixrid virali, is-suxxettibbiltà tal-virus) kienet punt ta' tmiem sekondarju.
English: Clear glass vial (Type I) with a coated bromobutyl-rubber stopper, aluminium overseal and flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ (Tip I) trasparenti b'tapp tal-gomma bromobutyl miksi, b'siġill tal-aluminju u b'tapp li tifflippjah biex tiftħu.
English: Following intravenous administration of a single dose of peramivir 600 mg over 30 minutes, Cmax was reached at the end of infusion.
Maltese: Wara l-għoti minn ġol-vina ta' doża waħda ta' 600 mg ta' peramivir fuq 30 minuta, Cmax intlaħqet fit-tmiem tal-infużjoni.
English: Peramivir is not significantly metabolised in humans.
Maltese: Peramivir ma jiġix metabolizzat b'mod sinifikanti fil-bnedmin.
English: A. LABELLING
Maltese: 3. LISTA
English: • Discard any unused diluted solution of peramivir after 24 hours.
Maltese: • Armi kwalunkwe soluzzjoni dilwita ta' peramivir li ma tkunx intużat wara 24 siegħa.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara ‘JIS'.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alpivab in one or more subsets of the paediatric population for the treatment of influenza (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Alpivab f'wieħed jew iktar subsettijiet tal-popolazzjoni pedjatrika għall-kura tal-influwenza (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: In general, nephrotoxicity was observed in rabbits, no unexpected toxicity was observed, and no other target organ toxicity was identified in juvenile animals.
Maltese: B'mod ġenerali, ġiet osservata nefrotossiċità fil-fniek, ma kinitx osservata tossiċità mhux mistennija, u ebda tossiċità oħra tal-organi fil-mira ma ġietidentifikata fl-annimali li kienu għadhom qed jikbru.
English: Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.
Maltese: Il-virusijiet tal-inflwuenza A/H1N1 li fihom il-mutazzjoni H275Y naqqsu s-suxxettibbiltà għal peramivir u għal oseltamivir.
English: (see section 5.1).
Maltese: (ara sezzjoni 5.2).
English: Teva Italia S.r.l Tel:.
Maltese: Italia S.r.l Tel:.
English: Tobramycin ( Mean)
Maltese: Tobramycin (Medja)
English: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA United Kingdom
Maltese: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA Ir-Renju Unit
English: Date of first authorisation: 13/02/2012 Date of latest renewal: 26/09/2016
Maltese: Data tal-ewwel awtorizzazzjoni: 13/02/2012 Data tal-aħħar tiġdid: 26/09/2016.
English: The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers).
Maltese: Is-sigurtà ta Colobreathe ġiet evalwata f'total ta' 237 individwu (225 pazjent b'fibrożi ċistika u 12-il voluntier b'saħħtu).
English: Treatment with colistimethate sodium or colistin did not induce the activity of any enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5).
Maltese: Il-kura b'colistimethate sodium jew colistin ma kkawża l-ebda attività ta' kwalunkwe enzima ttestjata (CYP1A2, 2B6, 2C8, 2C9, 2C19 u 3A4/5).
English: Components of the PEG-gelatin hard capsules:
Maltese: Komponenti tal-kapsuli tal-ġelatina PEG ibsin:
English: • Raised temperature
Maltese: • Temperatura ogħla
English: The active substance is colistimethate sodium.
Maltese: Is-sustanza attiva hi colistimethate sodium.
English: Polyethylene glycol Purified water Sodium lauryl sulfate
Maltese: Polyethylene glycol Ilma ppurifikat Sodium lauryl sulfate
English: To pierce the capsule:
Maltese: Biex ittaqqab il-kapsula:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare ((≥1/10,000 to <1/1,000), very rare <1/10,000), not known (cannot be estimated from the available data).
Maltese: Frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥ 1/10,000 sa <1/1000), rari ħafna <1/10, 000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 0.39 (n=153) 0.78 (n=171) -0.29
Maltese: 0.78 (n=171)
English: The estimated mean terminal half-lives for total CMS and total free colistin were 3.0 and 6.4 h, respectively.
Maltese: Il-half-lives terminali stmati għal CMS totali u colistin totali ħieles kienu ta' 3.0 u 6.4 sigħat, rispettivament.
English: • Protein in the urine (found by testing)
Maltese: • Proteina fl-awrina (misjuba permezz ta' testijiet)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċina: http://www.ema.europa.eu/.
English: Hypersensitivity to the active substance, colistin sulphate or polymyxin B.
Maltese: Sensittività eċċessiva għas-sustanza attiva, colistin sulphate jew polymyxin B.
English: The most commonly reported adverse reactions as a percent of all Colobreathe treated patients were: unpleasant taste (62%), cough (59.4%), throat irritation (43.9%), dyspnoea (16.6%) and dysphonia (10.7%).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati bħala perċentwali tal-pazjenti kollha kkurati b'Colobreathe kienu: togħma ħażina (62%), sogħla (59.4%), irritazzjoni fil-griżmejn, (43.9%), dispnea (16.6%) u disfonja (10.7%).
English: EU/1/11/747/001 56 hard capsules (4 blisters of 14 capsules) EU/1/11/747/002 8 hard capsules (1 blister of 8 capsules) EU/1/11/747/003 56 hard capsules (7 blisters of 8 capsules)
Maltese: EU/1/11/747/001 56 kapsula iebsa (4 folji ta' 14-il kapsula) EU/1/11/747/002 8 kapsula iebsa (folja waħda ta' 8 kapsuli) EU/1/11/747/003 56 kapsula iebsa (7 folji ta' 8-il kapsula)
English: Acute respiratory exacerbation
Maltese: Disturbi respiratorji,
English: Oral fungal super-infection
Maltese: Superinfezzjoni fungali orali
English: • Diarrhoea, wind
Maltese: • Dijarea, gass
English: The subjects were aged 6 years and above and had an FEV1% predicted of 25-75%.
Maltese: L-individwi kellhom 6 snin u aktar u kellhom % prevedibbli ta' FEV1 ta' 25-75%.
English: The above side effects have been seen in people of all ages with similar frequency.
Maltese: L-effetti sekondarji t'hawn fuq ġew osservati f'individwi ta' kull età bi frekwenza simili.
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials.
Maltese: Kategorija farmakoterapewtika: antibatteriċi għal użu sistemiku, antibatteriċi oħrajn.
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Maltese: Batterji naturali reżistenti li huma Gram negattivi , bħal Proteus mirabilis u Burkholderia cepacia, juru sostituzzjoni sħiħa tal-lipid phosphate tagħhom b'ethanolamine jew aminoarabinose.
English: The Phase 3 clinical study was a randomised, open-label active comparator study comparing the efficacy of colistimethate sodium 1,662,500 IU dry powder for inhalation to tobramycin nebuliser solution for inhalation, 300 mg/5 ml, in 380 subjects with documented cystic fibrosis complicated by chronic pulmonary infection with Pseudomonas aeruginosa.
Maltese: L-istudju kliniku ta' Fażi 3 kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label attiv komparatur li qabbel l-effikaċja ta' colistimethate sodium 1,662,500 IU trab xott li jittieħed man-nifs ma' soluzzjoni nebulizzanti li tittieħdet man-nifs ta' 300 mg/5 ml ta' tobramycin fi 380 individwu b'fibrożi ċistika dokumentata u kkumplikata b'infezzjoni pulmonari kronika ta' Pseudomonas aeruginosa.
English: Nephrotoxicity/neurotoxicity
Maltese: Nefrotossiċità/newrotossiċità
English: Change in FEV1 (% predicted) from baseline at Week 24 (ITT Population) Patient group Colobreathe
Maltese: Bidla fl-FEV1 (% prevista) mil-linja bażi f'Ġimgħa 24 (Popolazzjoni ITT) Grupp ta' pazjenti
English: The ITT population excluded patients who had been treated but demonstrated no evidence of chronic infection.
Maltese: Il-popolazzjoni ITT kienet teskludi pazjenti li kienu trattati imma ma wrew ebda evidenza ta' infezzjoni kronika.
English: An embryo-fetal study in rabbits reported no effects at intravenous doses up to 80 mg/kg colistimethate sodium (32 mg colistin base/kg).
Maltese: Studju embrijofetali fil-fniek ma rrapporta l-ebda effetti fid-dożi ta' colistimethate sodium (32 mg bażi ta' colistin/kg) ġol-vina sa' 80 mg/kg.