FrancophonIA/ELRC3.0 huggingface dataset:
English: The neuraminidase substitution Q136K (A/H1N1 and A/H3N2), confers high level resistance to zanamivir but is selected during adaptation to cell culture and not during treatment.
Maltese: Is-sostituzzjoni tan-newraminidażi Q136K (A/H1N1 u A/H3N2), tikkonferixxi reżistenza ta' livell għoli għal zanamivir iżda din tintgħażel waqt l-adattament għall-koltura taċ-ċelloli u mhux waqt il kura.
English: Dose proportionality was observed in zanamivir Cmax and AUC and no accumulation of zanamivir in serum was evident after repeated intravenous doses of up to 600 mg.
Maltese: Ġiet osservata proporzjonalità tad-doża fis-Cmax u fl-AUC ta' zanamivir u ma kien hemm l-ebda evidenza ta' akkumulazzjoni ta' zanamivir fis-serum wara dożi ripetuti fil-vini sa 600 mg.
English: Dectova 10 mg/mL solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Dectova 10 mg/mL soluzzjoni għall-infużjoni
English: Begin maintenance dosing 24 hours after the initial dose
Maltese: manutenzjoni 24 siegħa wara d-doża inizjali
English: A doctor or nurse will give you Dectova as an infusion (drip) into a vein.
Maltese: Tabib jew infermier se jagħtik Dectova bħala infużjoni (dripp) ġo vina.
English: Dectova 10 mg/mL solution for infusion zanamivir
Maltese: TAL-PRODOTT MEDIĊINALI Dectova 10 mg/mL soluzzjoni għall-infużjoni zanamivir
English: The primary endpoint was time to clinical response (TTCR); clinical response was defined as a composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and systolic blood pressure) or hospital discharge.
Maltese: Il-punt tat-tmiem primarju kien iż-żmien għal rispons kliniku (TTCR); rispons kliniku kien definit bħala kombinazzjoni ta' stabilizzazzjoni tas-sinjali vitali (temperatura, saturazzjoni tal-ossiġnu, status respiratorju, rata tal-qalb u pressjoni tad-demm sistolika) jew rilaxx mill-isptar.
English: years mg/kg years mg/kg years mg years mg %CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available
Maltese: %CV = perċentwal tal-koeffiċjent tal-varjazzjoni, GM = Medja Ġeometrika, NA = Mhux disponibbli
English: Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and promotes virus spread in the respiratory tract.
Maltese: Zanamivir huwa inibitur tan-newraminidażi tal-virus tal-influwenza, enzim li jirrilaxxa l-partikuli virali mill membrana tal-plażma ta' ċelloli infettati u jippromwovi t-tixrid tal-virus fil-passaġġ respiratorju.
English: This medicinal product contains 70.8 mg sodium per vial, equivalent to 3.54% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 70.8 mg ta' sodju f'kull kunjett, ekwivalenti għal 3.54% tal-ammont massimu rakkomandat mid-WHO ta' 2 g ta' sodju għal adult kuljum.
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Maltese: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL).
Maltese: Kull kunjett fih 200 mg ta' zanamivir (bħala idrat) f'20 mL (10 mg/mL).
English: Neuraminidase inhibition occurred at very low zanamivir concentrations in vitro, with median inhibitory (IC50) values of 0.33 nM to 5.77 nM against influenza A and B strains respectively.
Maltese: L-inibizzjoni tan-newraminidażi seħħet f'konċentrazzjonijiet baxxi ħafna ta' zanamivir in-vitro, b'valuri inibitorji medjani (IC50) ta' 0.33 nM sa 5.77 nM kontra r-razez tal-influwenza A u B rispettivament.
English: CLcr or CLCRRT) (mL/min or mL/min/1.73m
Maltese: (mL/min jew mL/min/1.73m2)*
English: Neuropsychiatric events
Maltese: Avvenimenti newropsikjatriċi
English: Zanamivir is not an inducer of CYP1A2 and 2B6 and, although induction of CYP3A4 in vitro was observed at 50-fold higher than the clinically relevant concentrations, no interaction with CYP3A4 substrates is expected based on physiologically based pharmacokinetic modelling.
Maltese: Zanamivir mhuwiex induttur ta' CYP1A2 u ta' 2B6 u, għalkemm in vitro kienet osservata induzzjoni tasCYP3A4 f'konċentrazzjonijiet 50 darba ogħla minn dawk klinikament rilevanti, abbażi ta' mmudellar farmakokinetiku bbażat fuq il-fiżjoloġija, ma hija mistennija l-ebda interazzjoni mas-sottostrati ta' CYP3A4.
English: Each mL of Dectova contains 10 mg of zanamivir (as hydrate).
Maltese: Kull mL ta' Dectova fih 10 mg ta' zanamivir (bħala idrat).
English: Begin twice daily maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Maltese: 48 siegħa wara d-doża inizjali *Unitajiet tas-CLcr jew tas-CLCRRT f'mL/min għal adolexxenti minn 13-il sena sa taħt it-18-il sena, jew f'mL/min/1.73m2 għal tfal minn 6 snin sa taħt it-13-il sena.
English: Begin maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Maltese: manutenzjoni 48 siegħa wara d-doża inizjali *Unitajiet tas-CLcr jew tas-CLCRRT f'mL/min għal adolexxenti minn 13-il sena sa taħt it-18-il sena, jew f'mL/min/1.73m2 għal tfal minn 6 snin sa taħt it-13-il sena.
English: • acting strangely
Maltese: • aċċessjonijiet
English: 600 mg 250 mg twice daily
Maltese: 600 mg 250 mg darbtejn kuljum
English: Initial dose Maintenance Dose Maintenance Dose Schedule
Maltese: manutenzjoni 12-il siegħa wara d-doża inizjali
English: Overall, the safety profile in paediatric patients was similar to that observed in adults in the clinical studies.
Maltese: B'mod ġenerali, il-profil tas-sigurtà f'pazjenti pedjatriċi kien simili għal dak osservat fl-adulti fl-istudji kliniċi.
English: Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected.
Maltese: Zanamivir ma jiġix metabolizzat, għalhekk mhu mistenni l-ebda effett ta' indeboliment epatiku.
English: There are limited data on zanamivir exposure during concomitant continuous renal replacement therapy and very limited data with dialysis.
Maltese: Id-data dwar l-esponiment għal zanamivir waqt terapija konkomitanti ta' sostituzzjoni renali kontinwa hija limitata u d-data fil-każ ta' dijaliżi hija limitata ħafna.
English: Zanamivir is not a substrate, inhibitor or inducer of cytochrome P450 isoenzymes nor a substrate or inhibitor of renal and hepatic transporters at clinically relevant concentrations (see section 5.2).
Maltese: Zanamivir mhux sottostrat, inibitur jew induttur ta' isoenzimi taċ-ċitokromju P450 u lanqas ma huwa sottostrat jew inibitur tat-trasportaturi tal-kliewi u tal-fwied f'konċentrazzjonijiet klinikament rilevanti (ara sezzjoni 5.2).
English: Zanamivir had a significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by the low infection rate (14% vs. 100% positive serology in placebo group, p <0.005), isolation of virus by viral culture (0% vs. 100% in placebo group, p <0.005), as well as reductions in fever (14% vs. 88% in placebo group, p <0.05), upper respiratory tract illness (0% versus 100% in placebo group, p<0.005) and total symptom scores (1 vs. 44 median score in placebo group, p<0.001).
Maltese: Zanamivir kellu effett profilattiku sinifikanti kontra sfida esperimentali bil-virus tal-influwenza A kif muri mir-rata baxxa ta' infezzjoni (seroloġija pożittiva ta' 14% kontra 100% fil-grupp tal-plaċebo, p <0.
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Maltese: Id-doża rakkomandata hija ta' 600 mg darbtejn kuljum għal bejn 5 u 10 ijiem.
English: 600 mg 150 mg twice daily
Maltese: 600 mg 150 mg darbtejn kuljum
English: Česká republika GlaxoSmithKline, s.r.o.
Maltese: GlaxoSmithKline, s.r.o.
English: The H275Y substitution is the most common neuraminidase resistance substitution and is associated with reduced susceptibility to peramivir and oseltamivir.
Maltese: Is-sostituzzjoni H275Y hija l-aktar sostituzzjoni komuni għar-reżistenza għan-newraminidażi u hija assoċjata ma' tnaqqis fis-suxxettibilità għal peramivir u oseltamivir.
English: • very severe skin reactions such as: o a skin rash, which may blister, and looks like small targets (erythema multiforme) o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) o extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis).
Maltese: • reazzjonijiet tal-ġilda severi ħafna bħal: o raxx tal-ġilda, li jista' jifforma nfafet, li jidher qisu miri żgħar (eritema multiforme)
English: • Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
Maltese: • Iddeċiedi l-volum tas-soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) ta' klorur tas-sodju li se tintuża għall-infużjoni.
English: The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to <18 years in the Phase II study.
Maltese: Il-profil tar-reazzjonijiet avversi fil-popolazzjoni pedjatrika huwa bbażat fuq 71 pazjent ta' ≥6 xhur sa <18-il sena fl-istudju tal-Fażi II.
English: Serious hypersensitivity reactions
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva
English: Neuraminidase substitutions conferring reduced susceptibility to zanamivir have emerged during treatment with zanamivir in human viruses and those with zoonotic potential: E119D, E119G, I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
Maltese: E119G, I223R, R368G, G370D, N434S (A/H1N1);
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Maltese: Tel: + 371 67312687 lv-epasts@gsk.com
English: It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.
Maltese: Mhuwiex probabbli li tingħata aktar milli suppost, iżda jekk taħseb li ngħatajt wisq Dectova, għid lit-tabib jew lill-infermier tiegħek minnufih.
English: Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Maltese: Disturbi fil-fwied u fil-marrara żieda fl-alanina aminotransferażi (ALT) u/jew flaspartata aminotransferażi (AST)
English: Cmin (g/mL)
Maltese: (µg/mL)
English: Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
Maltese: Indeboliment tal-kliewi Adulti u tfal (ta' aktar minn 6 snin b'piż tal-ġisem ta' aktar minn 50 kg) bi tneħħija tal-kreatinina (CLcr) jew tneħħija permezz ta' terapija ta' sostituzzjoni renali kontinwa (CLCRRT) < 80 mL/min għandhom jingħataw doża inizjali ta' 600 mg segwita minn doża ta' manutenzjoni darbtejn kuljum skont il-funzjoni tal-kliewi tagħhom (Tabella 2).
English: Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1).
Maltese: Il-kura b'Dectova għandha tinbeda mill-aktar fis possibbli u normalment fi żmien sitt ijiem mill-bidu tas sintomi tal-influwenza (ara sezzjoni 5.1).
English: 12 mg/kg 8 mg/kg twice daily
Maltese: 12 mg/kg 8 mg/kg darbtejn kuljum
English: Weight-based dose regimen
Maltese: Wara d-dilwizzjoni
English: Sodium chloride Water for injections
Maltese: Klorur tas-sodju Ilma għall-injezzjonijiet
English: 600 mg 400 mg twice daily
Maltese: 600 mg 400 mg darbtejn kuljum
English: The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric patients between 6 months and <6 years and 12 mg/kg for those between 6 years and <18 years of age were similar to those seen in adults who received 600 mg twice daily intravenously.
Maltese: bejn is-6 xhur u <6 snin u ta' 12 mg/kg lil dawk ta' bejn is-6 snin sa <18-il sena kienet simili għal dik osservata fl-adulti li ngħataw 600 mg darbtejn kuljum fil-vini.
English: Solution for infusion 200 mg/20 mL 1 vial
Maltese: 200 mg/20 mL kunjett 1
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
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 mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Zanamivir is eliminated unchanged in urine by glomerular filtration.
Maltese: Zanamivir jiġi eliminat mhux mibdul fl-awrina permezz ta' filtrazzjoni glomerulari.
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: 12 mg/kg 5 mg/kg twice daily
Maltese: 12 mg/kg 5 mg/kg darbtejn kuljum
English: Dose N Cmax (g/mL)
Maltese: Doża N Cmax
English: 12 mg/kg 3 mg/kg twice daily
Maltese: 12 mg/kg 3 mg/kg darbtejn kuljum
English: In the population pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni, l-età ma kellha l-ebda effett sinifikanti fuq il-farmakokinetika ta' zanamivir.
English: A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection
Maltese: Studju osservazzjonali retrospettiv ta' reviżjoni tar-rekords mediċi biex tiġi vvalutata l effikaċja klinika tal-kura b'zanamivir 10mg/ml soluzzjoni għall-infużjoni f'korti ta'
English: Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL.
Maltese: Dectova huwa soluzzjoni għall-infużjoni ċara u bla kulur li fiha 200 mg ta' zanamivir (bħala idrat) f'20 mL.
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Intensive Care Unit/Mechanical Ventilation subgroup, N Median TTCR, days
Maltese: Sottogrupp fl-Unità ta' Kura Intensiva/Ventilazzjoni Mekkanika, N TTCR Medjan, jiem Differenza medjana bejn il-kuri, jiem (95% CI)
English: A prospective observational study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection
Maltese: Studju osservazzjonali prospettiv biex tiġi vvalutata l-effikaċja klinika tal-kura b'zanamivir 10 mg/ml soluzzjoni għall-infużjoni f'pazjenti b'infezzjoni kkomplikata tal influwenza.
English: Begin twice daily maintenance dosing 24 hours after the initial dose
Maltese: manutenzjoni darbtejn kuljum24 siegħa wara d-doża inizjali
English: Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Maltese: Tfal u adolexxenti (6 snin sa taħt it-18-il sena b'piż tal-ġisem ta' inqas minn 50 kg), u trabi u tfal (6 xhur sa taħt is-6 snin) bi tneħħija tal-kreatinina (CLcr) jew tneħħija permezz ta' terapija ta' sostituzzjoni renali kontinwa (CLCRRT) <80 mL/min għandhom jingħataw doża inizjali segwita minn doża ta' manutenzjoni xierqa darbtejn kuljum kif muri fit-Tabelli 3, 4 u 5.
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion.
Maltese: Id-doża rakkomandata hija ta' 600 mg darbtejn kuljum għal bejn 5 u 10 ijiem li tingħata permezz ta' infużjoni fil-vini.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar id-dilwizzjoni tal-prodott mediċinali qabel l-għoti, ara sezzjoni 6.6.
English: Renal impairment
Maltese: • imġiba stramba
English: Dectova contains sodium
Maltese: Kif jidher Dectova u l-kontenut tal-pakkett
English: It is supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off cap.
Maltese: Jiġi f'kunjett tal-ħġieġ ċar ta' 26 mL b'tapp tal-lasktu u siġill addizzjonali tal-aluminju b'għatu tal-plastik tat tip flip-off.
English: Patients were stratified at randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days).
Maltese: Il pazjenti ġew stratifikati mar-randomizzazzjoni abbażi taż-żmien mill-bidu tas-sintomi għall-bidu tal-kura (≤4 ijiem u 5 sa 6 ijiem).
English: Unopened vials
Maltese: Doża inizjali
English: Each vial contains 200 mg of zanamivir (as hydrate).
Maltese: Kull kunjett fih 200 mg ta' zanamivir (bħala idrat).
English: Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known
Maltese: Disturbi fis-sistema immuni edema orofarinġeali edema tal-wiċċ reazzjonijiet anafilattiċi/anafilattojdi mhux magħruf
English: • The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2 of the SmPC).
Maltese: • Il-volum ta' Dectova u l-volum totali għall-infużjoni jiddependu fuq l-età, il-piż u l-funzjoni tal-kliewi tal-pazjent (ara sezzjoni 4.2 tal-SmPC).
English: Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility.
Maltese: Studji fuq l-annimali ma jindikaw ebda effetti klinikament sinifikanti ta' zanamivir fuq il-fertilità maskili jew femminili.
English: • fits (seizures)
Maltese: • ħsieb konfuż
English: The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Maltese: In-nofs ħajja ta' zanamivir fis-serum tiżdied għal madwar 12-20 siegħa f'pazjenti b'indeboliment sever talkliewi (tneħħija tal-kreatinina ta' < 30 mL/min).
English: Zanamivir solution for infusion 300 mg
Maltese: Zanamivir soluzzjoni għallinfużjoni
English: Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V. 4.9 Doża eċċessiva
English: The efficacy of Dectova for the treatment of complicated influenza A or B virus infection in adults and children aged from 6 months has been inferred from:
Maltese: L-effikaċja ta' Dectova għall-kura ta' infezzjoni kkomplikata bil-virus tal-influwenza A jew B f'adulti u fi tfal ta' aktar minn 6 xhur ġiet dedotta minn:
English: A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg zanamivir twice daily intravenously in hospitalised patients (>16 years of age) with influenza.
Maltese: zanamivir 600 mg darbtejn kuljum fil-vini meta mqabbel ma' oseltamivir 75 mg darbtejn kuljum mill-ħalq u zanamivir 300 mg darbtejn kuljum fil-vini fuq pazjenti rikoverati l-isptar (>16-il sena) bl-influwenza.
English: • levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
Maltese: • Prodotti mediċinali antivirali oħra għall-kura tal-influwenza, inkluż zanamivir li jittieħed man-nifs,
English: Begin twice daily maintenance dosing 48 hours after the initial dose
Maltese: 48 siegħa wara d-doża inizjali
English: The volume of distribution of zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water.
Maltese: Il-volum ta' distribuzzjoni ta' zanamivir fl-adulti huwa ta' madwar 16-il litru, li jqarreb il-volum ta' ilma ekstraċellulari.
English: The frequency of adverse reactions is based on the number of reports in the adult population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies.
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija bbażata fuq l-għadd ta' rapporti fil-popolazzjoni adulta li kienet qed tingħata zanamivir 600 mg darbtejn kuljum fil-vini fl-istudji tal-Fażi II u tal-Fażi III.
English: Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection.
Maltese: Riskju ta' infezzjonijiet batteriċi Dectova ma ntweriex li jnaqqas ir-riskju ta' komplikazzjonijiet batteriċi assoċjati ma' infezzjoni tal influwenza.
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in ICU-treated influenza patients, the MAH should submit the results of an observational chart review effectiveness study of IV zanamivir in ICU-treated influenza patients.
Maltese: Sabiex tiġi vvalutata l-effikaċja klinika tal-kura b'zanamivir 10mg/ml soluzzjoni għallinfużjoni f'pazjenti bl-influwenza kkurati fl-ICU, il-MAH għandu jissottometti r-riżultati ta' studju osservazzjonali ta' reviżjoni tar-rekords mediċi dwar l-effikaċja ta' zanamivir fil-vini f'pazjenti bl-influwenza kkurati fl-ICU.
English: County Durham
Maltese: Harmire Road Barnard Castle County Durham
English: Following twice-daily administration of zanamivir solution for infusion, pulmonary epithelial lining fluid concentrations were 60 - 65 % of the serum concentrations at the corresponding sampling time 12 hours after dosing.
Maltese: Wara l-għoti ta' zanamivir soluzzjoni għall-infużjoni darbtejn kuljum, il-konċentrazzjonijiet fil-fluwidu fil kisja epiteljali tal-pulmun kienu ta' 60 - 65% tal-konċentrazzjonijiet fis-serum fil-ħin tal-kampjunar korrispondenti 12-il siegħa wara l-għoti tad-doża.
English: There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Maltese: Tqabbil bejn ilkuri differenti ma wera l-ebda differenza sinifikanti fit-TTCR fl-IPP ġenerali jew f'żewġ sottogruppi speċifikati minn qabel (Tabella 6).
English: • The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for injection down to any concentration greater than or equal to 0.2 mg/mL.
Maltese: • Bl-użu ta' labra sterili u siringa, iġbed u armi volum ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) ta' klorur tas-sodju (ekwivalenti għall-volum ta' Dectova) mill-borża tal infużjoni.
English: Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate.
Maltese: F'pazjenti immunokompromessi hemm probabbiltà akbar ta' selezzjoni ta' viruses reżistenti tal-influwenza wara kura bi prodotti mediċinali antivirali, fosthom kura b'Dectova; għalhekk, huwa importanti li l-pazjenti jiġu mmonitorjati għal reżistenza u jiġi kkunsidrat li jinqalbu fuq terapiji alternattivi fejn xieraq.
English: • Using a sterile needle and syringe, withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
Maltese: • Permezz ta' labra sterili u siringa, iġbed il-volum ta' Dectova mill-kunjett(i) u żidu mal-borża talinfużjoni.