FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac / respiratory disease
Maltese: Mard tal-qalb/ respiratorju
English: The active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface.
Maltese: Il-metabolu attiv huwa inibitur selettiv tal-enżimi neuraminidase tal-virus tal-influwenza, li huma glikoproteini li jinstabu fuq is-superfiċje tal-virjon.
English: Prophylaxis of influenza in immunocompromised patients: A double-blind, placebo-controlled, randomised study was conducted for seasonal prophylaxis of influenza in 475 immunocompromised patients (388 patients with solid organ transplantation [195 placebo; 193 oseltamivir], 87 patients with haemopoetic stem cell transplantation [43 placebo; 44 oseltamivir], no patient with other immunosuppressant conditions), including 18 children 1 to 12 years of age.
Maltese: Profilassi tal-influwenza f'pazjenti immunokompromessi : Twettaq studju double-blind, ikkontrollat bil-plaċebo u randomised dwar il-profilassi staġunali tal-influwenza f'475 pazjent immunokompromess (388 pazjent bi trapjant ta' organu solidu [195 plaċebo; 193 oseltamivir], 87 pazjent bi trapjant emopoetiku ta' ċelluli staminali
English: 10 capsules (750 mg)
Maltese: 10 kapsuli (750 mg)
English: Paediatric population (infants less than one year of age)
Maltese: Popolazzjoni pedjatrika (trabi b'età inqas minn sena)
English: Amount of Ebilfumin suspension
Maltese: Ammont ta' suspensjoni Ebilfumin
English: Shelf life of 6 weeks at 2°C - 8°C.
Maltese: Iddum tajba għal 6 ġimgħat meta maħżuna f'temperatura ta' bejn 2°C- 8°C.
English: Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional to declining renal function.
Maltese: Għoti ta' 100 mg oseltamivir phosphate darbtejn kuljum għal ħamest ijiem lil pazjenti b'diversi gradi ta' indebolimenti renali wera li l-espożizzjoni għal oseltamivir carboxylate hija proporzjonali b'mod invers għal tnaqqis fil-funzjoni tal-kliewi.
English: Label for HDPE tablet container and outer carton for tablet container and blister
Maltese: Tikketta għal kontenitur HDPE u Kartuna ta' barra u folja
English: A study in older people in nursing homes, where 80 % of participants received vaccine in the season of the study, oseltamivir 75 mg once daily given for 6 weeks significantly reduced the incidence of clinical influenza illness from 12/272 (4.4 %) in the placebo group to 1/276 (0.4 %) in the oseltamivir group (92 % reduction [95 % CI 1.5 - 6.6; p = 0.0015]).
Maltese: Studju li sar fuq ir-residenti tad-djar tal-anzjani, fejn 80 % tal-parteċipanti ħadu t-tilqima fl-istaġun li fih sar l-istudju, 75 mg oseltamivir mogħti darba kuljum għal 6 ġimgħat naqqas b'mod sinifikanti l-inċidenza tal-marda tal-influwenza klinika minn 12/272 (4.4 %) fil-grupp tal-plaċebo għal 1/276 (0.4 %) fil-grupp ta' oseltamivir (tnaqqis ta' 92 % [95 % CI 1.5 - 6.6; p = 0.0015]).
English: Ebilfumin 30 mg hard capsules
Maltese: Ebilfumin 30 mg kapsuli ibsin
English: Capsule size: 4
Maltese: Daqs tal-kapsuli: 4
English: For storage conditions of the pharmacy compounded suspension, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tas-suspensjoni mħallta fl-ispiżerija, ara sezzjoni 6.3. 6.5
English: The 2009 H1N1 influenza (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.
Maltese: L-influwenza H1N1 tal-2009 (“influwenza tal ħnieżer”) kienet kważi suxxettibbli b'mod uniformi għal oseltamivir, b'rapporti sporadiċi biss ta' reżistenza konnessi ma' korsijiet terapewtiċi u profilattiċi.
English: 8 kg 24 mg 4.0 ml
Maltese: 8 kg x 3 mg kull kg = 24 mg
English: - The other ingredients are: capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), croscarmellose sodium, sodium stearyl fumarate capsule shell: cap: gelatin, yellow iron oxide (E172) and titanium dioxide (E171), body: gelatin, titanium dioxide (E171) printing ink: shellac glaze-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)
Maltese: • Is-sustanzi l-oħra huma: kontenut tal-kapsula: pregelatinized starch starch (derivat minn maize starch), talc, povidone (K-29/32), croscarmellose sodium, u sodium stearyl fumarate qoxra tal-kapsula: gelatin, iron oxide isfar (E172), u titanium dioxide (E171) linka għall-istampar: Shellac Glaze -45% (20% esterifikat), Iron Oxide iswed (E172),Propylene glycol (E1520), u Ammonium hydroxide 28% (E527).
English: Treatment of influenza in immunocompromised adults: A randomized, double blind study, to evaluate safety and characterize the effects of oseltamivir on the development of resistant influenza virus (primary analysis) in influenza-infected adult immunocompromised patients, included 151 patients evaluable for efficacy of oseltamivir (secondary analysis, not powered).
Maltese: Studju randomised u double-blind, biex tiġi evalwata s-sigurtà u jiġu kkaratterizzati l-effetti ta' oseltamivir fuq l-iżvilupp ta' virus tal-influwenza reżistenti (analiżi primarja) f'pazjenti adulti immunokompromessi infettati bl-influwenza, inkluda 151 pazjent li setgħu jiġu evalwati għall-effikaċja ta' oseltamivir (analiżi sekondarja, mhux powered).
English: The proportion of subjects who developed specified lower respiratory tract complications (mainly bronchitis) treated with antibiotics was reduced from 12.7 % (135/1,063) in the placebo group to 8.6 % (116/1,350) in the oseltamivir treated population (p = 0.0012).
Maltese: Il-proporzjon ta' individwi li kellhom kumplikazzjonijiet speċifikati fil-parti t'isfel tal-passaġġ respiratorju (prinċiparjament bronkite) li ġew ittrattati bl-antibijotiċi naqas minn 12.7 % (135/1,063) fil-grupp li ngħata l-plaċebo għal 8.6 % (116/1,350) fil-popolazzjoni li ġew ittrattati b'oseltamivir
English: Results from pharmacokinetic analyses indicate a lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 5.2, Pharmacokinetics, Special Population).
Maltese: Riżultati minn analiżi farmakokinetika jindikaw espożizzjoni aktar baxxa għall-metabolit attiv, madankollu aġġustamenti fid-doża mhumiex rakkomandati għal nisa tqal fit-trattament jew profilassi tal-influwenza (ara sezzjoni 5.2, Tagħrif farmakokinetiku, Popolazzjonijiet Speċjali).
English: Ebilfumin 75 mg hard capsules oseltamivir
Maltese: Ebilfumin 75 mg kapsuli ibsin oseltamivir
English: 21 mg
Maltese: 21mg darbtejn kuljum
English: In addition, 199 immunocompromised adult patients received oseltamivir for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 oseltamivir and 8 placebo) received oseltamivir or placebo for the prophylaxis of influenza.
Maltese: Barra dan, 199 pazjent adult immunokompromess irċevew oseltamivir għat-trattament tal-influwenza u 475 pazjent immunokompromessi (inkluż 18-il tifel u tifla, minn dawn 10 oseltamivir u 8 plaċebo) irċevew oseltamivir jew plaċebo għall-profilassi tal-influwenza.
English: Ebilfumin 30 mg hard capsules oseltamivir
Maltese: Ebilfumin 30 mg kapsuli ibsin oseltamivir
English: 12 capsules (360 mg)
Maltese: 12-il kapsula (360 mg)
English: In a pooled analysis of all influenza-positive adults and adolescents (N = 2,413) enrolled into treatment studies, oseltamivir 75 mg twice daily for 5 days reduced the median duration of influenza illness by approximately one day from 5.2 days (95 % CI 4.9 - 5.5 days) in the placebo group to 4.2 days (95 % CI 4.0 - 4.4 days; p ≤ 0.0001).
Maltese: F'analiżi imħallta tal-adulti u l-adoloxxenti kollha li kienu pożittivi għall-influwenza (N = 2,413) li ħadu sehem fl-istudji dwar it-trattament, l-għoti ta' 75 mg oseltamivir darbtejn kuljum għal ħamest ijiem naqqas il perijodu medjan tal-influwenza b'madwar ġurnata minn 5.2 jiem (95 % CI 4.9 - 5.5 jiem) fil-grupp li ngħataw il-plaċebo għal 4.2 jiem (95 % CI 4.0 - 4.4 jiem; p ≤ 0.0001).
English: In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in oseltamivir prophylaxis clinical studies.
Maltese: Fi studju dwar il-profilassi ta' 12-il ġimgħa f'475 pazjent immunokompromess, inkluż 18-il tifel u tifla b'età minn sena sa 12-il sena u akbar il-profil ta' sigurtà fil-238 pazjent li rċevew oseltamivir kien konsistenti ma' dak osservat qabel waqt studji kliniċi dwar profilassi b'oseltamivir.
English: Children 1 to 12 years of age
Maltese: Tfal minn 1 sa 12-il sena
English: Children 1 to 12 years Very common side effects
Maltese: Tfal minn sena sa 12-il sena Effetti sekondarji komuni ħafna
English: Adults, adolescents and infants and children 1 year of age or older who are unable to swallow intact capsules
Maltese: Adulti, adoloxxenti u trabi u tfal b'età ta' sena jew aktar li ma jistgħux jibilgħu kapsuli intatti
English: 75 mg doses can be administered as either: - one 75 mg capsule or - one 30 mg capsule plus one 45 mg capsule.
Maltese: Dożi ta' 75 mg jistgħu jingħataw jew bħala - kapsula waħda ta' 75 mg jew - kapsula waħda ta' 30 mg flimkien ma' kapsula waħda ta' 45 mg
English: Doses of 2 mg/kg give oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 1 mg/kg).
Maltese: Dożi ta' 2 mg/kg jagħtu espożizzjoni ta' oseltamivir carboxylate komparabbli għal dik miksuba fl-adulti, li jieħdu doża waħda ta' 75 mg (madwar 1 mg/kg).
English: Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active metabolite (oseltamivir carboxylate).
Maltese: Oseltamivir jiġi assorbit sew mill-passaġġ gastrointestinali wara li oseltamivir phosphate (ilpro-droga) jittieħed mill-ħalq u jinbidel estensivament fil-metabolu attiv (oseltamivir carboxylate) priċipalment permezz ta' esterases epatiċi.
English: Among children who were not already shedding virus at baseline, the incidence of laboratory-confirmed clinical influenza was reduced from 21 % (15 / 70) in the group not receiving prevention to 4 % (2 / 47) in the group receiving prevention (80.1 % reduction [95 % CI 22.0 - 94.9; p = 0.0206]).
Maltese: Fost tfal li ma kienux qed ixerrdu l-virus minn qabel fil linja bażi, l-inċidenza ta' influwenza klinika kkonfermata fil-laboratorju kienet immnaqqsa minn 21 % (15/70) fil-grupp li ma kienux qed jirċievu prevenzjoni għal 4 % (2/47) fil-grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta' 80.1 %, [95 % CI 22.0 - 94.9; p = 0.0206]).
English: • Stomach ache
Maltese: • Stonku imdardar
English: 7.5 ml twice daily 7.5 ml once daily
Maltese: 7.5 ml darbtejn kuljum 7.5 ml darba kuljum
English: For adult patients with a weak immune system, treatment will continue for 10 days.
Maltese: Għall-pazjenti adulti li għandhom sistema immuni dgħajfa, it-trattament se jkompli għal 10 ijiem.
English: Post-exposure prevention: The recommended post-exposure prevention dose of Ebilfumin is:
Maltese: Trattament u prevenzjoni tal-influwenza fit-tfal:
English: Adults, adolescents 13 years and over, and children weighing 40 kg and over
Maltese: Adulti, adoloxxenti minn 13-il sena 'il fuq u tfal li jiżmu minn 40 kg 'il fuq
English: Limited data indicate that oseltamivir and the active metabolite are excreted in human milk.
Maltese: Data limitata tindika li oseltamivir u l-metabolit attiv tiegħu jiġu eliminati fil-ħalib uman.
English: Capsule size: 4.
Maltese: Daqs tal-kapsuli: 4.
English: Adults and adolescents 13 and over
Maltese: Adulti u adoloxxenti b'età minn 13-il sena 'l fuq
English: Date of first authorisation: 22 May 2014 Date of latest renewal:
Maltese: Data ta' l-ewwel awtorizzazzjoni: 22 Mejju 2014
English: In the event that oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules.
Maltese: F'każ li t-trab oseltamivir għall-suspensjoni orali ma jkunx disponibbli, lispiżjar jista jagħmel suspensjoni (6 mg/ml) minn kapsuli tal-Ebilfumin.
English: Ebilfumin 75 mg hard capsules
Maltese: Ebilfumin 75 mg kapsuli ibsin
English: 10 to 15 kg
Maltese: 10 sa 15-il kg
English: 10 capsules (450 mg)
Maltese: 10 kapsuli (450 mg)
English: EU/1/14/915/003 (10 hard capsules container) EU/1/14/915/004 (10 hard capsules blister)
Maltese: EU/1/14/915/003 (10 kontenitur kapsuli iebsin) EU/1/14/915/004 (10 folji kapsuli iebsin)
English: Prevention during an influenza epidemic in the community has not been studied in children below 12 years of age.
Maltese: Prevenzjoni waqt epidemija ta' influwenza ma ġietx studjata fi tfal b'età inqas minn 12-il sena.
English: These cases include fatal fulminant hepatitis/hepatic failure.
Maltese: pazjenti f'termini ta' morbożità/mortalità aktar baxxi.
English: 30 mg single dose * Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used.
Maltese: 30 mg darba fil-ġimgħa * Data miksuba minn studji fuq pazjenti li jagħmlu dijalisi ambulatorja kontinwa tal-peritonew (CAPD); it tneħħija ta' oseltamivir carboxylate hija mistennija li tkun ogħla meta jintuża metodu ta' dijalisi awtomatizzata tal-peritonew (APD).
English: 24 mg
Maltese: 24mg darbtejn kuljum
English: Ebilfumin 45 mg hard capsules are available in blister packs or tablet containers of 10.
Maltese: Ebilfumin 45 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone).
Maltese: Madankollu, għandha tingħata attenzjoni meta jiġi ordnat oseltamivir għal individwi li jkunu qegħdin jieħdu prodotti li jiġu eliminati flimkien b'marġni terapewtiku dejjaq (eż. chlorpropamide, methotrexate, phenylbutazone).
English: EU/1/14/915/005 (10 hard capsules blister) EU/1/14/915/006 (10 hard capsules container)
Maltese: EU/1/14/915/005 (10 folji kapsuli iebsin) EU/1/14/915/006 (10 kontenitur kapsuli iebsin)
English: Neuraminidase enzyme IC50 values for oseltamivir for clinically isolated influenza A ranged from 0.1 nM to 1.3 nM, and for influenza B was 2.6 nM. Higher IC50 values for influenza B, up to a median of 8.5 nM, have been observed in published studies.
Maltese: Valuri ogħla ta' IC50 għall-influwenza B, sa medjan ta' 8.5 nM, kienu osservati fi studji li ġew ippubblikati.
English: Ebilfumin 45 mg hard capsules oseltamivir
Maltese: Ebilfumin 45 mg kapsuli ibsin oseltamivir
English: For measuring 12.5 ml of water, a 10 ml dispenser should be used.
Maltese: Għall-kejl ta' 12.5 ml, għandu jintuża dispenser ta' 10 ml.
English: Older people and patients with chronic cardiac and/or respiratory disease The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease).
Maltese: Pazjenti anzjani u pazjenti b'mard kardijaku u/jew respiratorju kroniku Il-popolazzjoni inkluża fl-istudji dwar trattament tal-influwenza kienet tikkonsisti minn adulti/adoloxxenti li minbarra l-influwenza kienu f'saħħithom u pazjenti “f'riskju” (pazjenti li għandhom riskju akbar li jiżviluppaw kumplikazzjonijiet assoċjati mal-influwenza, eż. pazjenti anzjani u pazjenti b'mard tal-qalb jew mard respiratorju kroniku).
English: • Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
Maltese: • Reazzjonijiet fil-ġilda (infjammazzjoni tal-ġilda, raxx ħamra u bil-ħakk, qxur fil-ġilda).
English: The safety profile of oseltamivir observed in this study was consistent with that observed in previous clinical trials where oseltamivir was administered for treatment of influenza in nonimmunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac co-morbidities]).
Maltese: Il-profil tas-sigurtà ta' oseltamivir osservat f'dan l-istudju kien konsistenti ma' dak osservat fi provi kliniċi preċedenti fejn oseltamivir ngħata għat-trattament tal influwenza f'pazjenti mhux immunokompromessi (pazjenti li minbarra l-influwenza kienu f'saħħithom jew pazjenti “f'riskju” [jiġifieri, dawk b'komorbiditajiet respiratorji u/jew kardijaċi]).
English: 0 - 12 months
Maltese: 0 - 12-il xahar
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakokinetiku Informazzjoni Ġenerali
English: Exposure does not exceed that for treatment of infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see Section 4.8).
Maltese: L-espożizzjoni ma jaqbiżx dik ta' trattament ta' trabi ta' < sena (3 mg/kg darbtejn kuljum) u hija mistennija li twassal għall-profil tas-sigurtà komparabbli (ara Sezzjoni 4.8).
English: Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33 % in individual studies.
Maltese: B'kollox, 15 % tal-pazjenti posittivi għall-influwenza kienu infettata bl-influwenza B, bil-proporzjonijiet li kienu jvarjaw minn 1 sa 33 % fl-istudji individwali.
English: 12.5 mg
Maltese: 12.5 ml darba kuljum
English: Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Maltese: Il-metodu tat-trattament jista' jinbidel minn APD għal CAPD jekk ikun ikkunsidrat neċessarju minn nefroloġista.
English: Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
Maltese: L-għoti ta' Ebilfumin lil trabi b'età inqas minn sena għall-prevenzjoni waqt pandemija tal-influwenza għandu jkun ibbażat fuq il-ġudizzju ta' tabib wara kunsiderazzjoni tal-benefiċċju potenzjali kontra kwalunkwe riskju potenzjali għat-tarbija.
English: In patients with influenza who were receiving oseltamivir, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes.
Maltese: F'pazjenti bl-influwenza li kienu qed jirċievu oseltamivir, kien hemm rapporti wara t-tqegħid fis-suq ta' konvulżjonijiet u thewdin (inkluż sintomi bħal bidla fil-livell ta' koxjenza, konfużjoni, mġiba mhux normali, delużjonijiet, alluċinazzjonijiet, aġitazzjoni, ansjetà, inkubi), li f'xi każijiet rari ħafna wasslu għall-ħsara lill-persuna nnifisha jew riżultati fatali.
English: Capsule shell Cap:
Maltese: Daqs tal-kapsuli:
English: A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza.
Maltese: Total ta' 1473 tifel u tifla (inkluż tfal li minbarra l-influwenza huma f'saħħithom b'età minn sena sa 12-il sena u tfal ażżmatiċi b'età minn 6 sa 12-il sena) ipparteċipaw fi studji kliniċi dwar oseltamivir mogħti għat-trattament tal-influwenza.
English: • Heart rhythm abnormalities
Maltese: • Anormalitajiet fir-ritmu tal-qalb
English: Ebilfumin 75 mg hard capsules are available in blister packs or tablet containers of 10.
Maltese: 2 Ebilfumin 75 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: 12 capsules (540 mg)
Maltese: 12-il kapsula (540 mg)
English: Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1).
Maltese: Is suxxettibilità ta' razez tal-virus tal-influwenza li qed jiċċirkolaw għal oseltamivir intweriet li hija varjabbli ħafna (ara sezzjoni 5.1).
English: Ebilfumin 45 mg hard capsules
Maltese: Ebilfumin 45 mg kapsuli ibsin
English: BATCH NUMBER
Maltese: 0ml darba kuljum
English: Elevated liver enzymes
Maltese: Enżimi tal-fwied elevati
English: The median time to resolution of symptoms (TTRS) was similar between the standard dose group (103 hours [90% CI 75.4-110.0]) and double dose group (104 hours [90% CI 65.8-131.0]).
Maltese: Iż-żmien medjan sakemm għaddew is-sintomi (TTRS - time to resolution of symptoms) kien simili bejn il-grupp ta' doża standard (103 sigħat [CI ta' 90% 75.4-110.0]) u l-grupp ta' doża doppja
English: In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies.
Maltese: Fl-adulti/adoloxxenti, l-aktar reazzjonijiet avversi rrappurtati b'mod komuni (ARs), fl-istudji ta'
English: The indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A.
Maltese: L-indikazzjoni hija bbażata fuq studji kliniċi tal-influwenza li jseħħu b'mod naturali u li fihom l infezzjoni predominanti kien influwenza A.
English: once daily mg per kg = mg for each kilogram of the infant's body weight.
Maltese: darba kuljum mg kull kg = mg għal kull kilogramma ta' piż tal-ġisem tat-tarbija.
English: EU/1/14/915/001 (10 hard capsules blister) EU/1/14/915/002 (10 hard capsules container)
Maltese: EU/1/14/915/001 (10 folji kapsuli iebsin) EU/1/14/915/002 (10 kontenitur kapsuli iebsin)
English: No phase 2 conjugates of either compound have been identified in vivo.
Maltese: II ta' xi wieħed mis-sustanzi ma ġie identifikat in vivo.
English: 27 mg twice daily
Maltese: 30 mg bħala doża waħda
English: Oseltamivir resistance
Maltese: Reżistenza għal oseltamivir
English: Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of oseltamivir have been evaluated in two uncontrolled open-label studies including influenza infected children less than one year of age (n=135).
Maltese: Il-farmakokinetika, farmakodinamiċi u s-sigurtà tal-oseltamivir ġiet evalwata f'żewġ studji open-label li ma kienux ikkontrollati u li kienu jinkludu tfal b'età taħt is-sena (n-135), infettati bl-influwenza.
English: Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of oseltamivir, described in section 4.8 Undesirable effects.
Maltese: Avvenimenti avversi rrappurtati wara doża eċċessiva kienu simili fin-natura u d-distribuzzjoni għal dawk osservati b'dożi terapewtiċi ta' oseltamivir, deskritti fis-sezzjoni 4.8 Effetti mhux mixtieqa.
English: Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Maltese: Il-konċentrazzjonijiet massimi ta' oseltamivir carboxylate fil-plażma jitbaxxew b'half-life ta' 6 sa 10 sigħat fil-biċċa l-kbira tal-individwi.
English: Treatment of influenza
Maltese: It-trattament tal-influwenza
English: Recommended dose for 10 days
Maltese: doża għal 10 ijiem
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Ebilfumin suspension involves additional steps.
Maltese: Meta jkun hemm disponibbli kapsuli ta' 75 mg biss u jkunu meħtieġa dożi ta' 30 mg jew 45 mg, il preparazzjoni tas-suspensjoni Ebilfumin tinvolvi passi addizzjonali.
English: • Upper abdominal fullness
Maltese: Uġigħ addominali
English: In the total population, there was a reduction in the incidence of laboratory-confirmed clinical influenza in households from 20 % (27 / 136) in the group not receiving prevention to 7 % (10 / 135) in the group receiving prevention (62.7 % reduction [95 % CI 26.081.2; p = 0.0042]).
Maltese: Fil-popolazzjoni totali kien hemm tnaqqis fl-inċidenza fid-djar ta' influwenza klinika kkonfermata fil-laboratorju minn 20 % (27/136) fil grupp li ma kienux qed jirċievu prevenzjoni għal 7 % (10/135) fil-grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta' 62.7 %, [95 % CI 26.0 - 81.