FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Ġunju 2002
English: Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Maltese: Adulti, adoloxxenti jew tfal (> 40 kg) li jistgħu jibilgħu l-kapsuli jistgħu jieħdu dożi adattati ta' kapsuli Tamiflu.
English: Required number of Tamiflu capsules (mg of oseltamivir)
Maltese: Numru meħtieġ ta' kapsuli Tamiflu (mg ta' oseltamivir)
English: A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were influenza-positive.
Maltese: It-tieni studju sar fuq 334 tifel u tifla ażżmatiċi ta' etajiet minn 6 snin sa 12-il sena li minnhom 53.6 % kienu posittivi għall-influenza.
English: Oseltamivir reduced the time to alleviation of all symptoms by 0.7 days (95 % CI 0.1 - 1.6 days; p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza by one day (95 % CI 0.41.7 days; p < 0.001) compared to placebo.
Maltese: Oseltamivir naqqas iż-żmien li damu biex ittaffew is-sintomi kollha b'0.7 ta' jum (95 % CI 0.1 - 1.6 jiem; p = 0.022) u l-perijodu bid-deni (≥ 37.8 °C), bis-sogħla u bil-koriża b'jum (95 % CI 0.4 - 1.7 jiem; p < 0.001), imqabbel mal-plaċebo.
English: Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 years) compared to adults less than 65 years of age given comparable doses of oseltamivir.
Maltese: L-espożizzjoni għall-metabolu attiv fi stat fiss kienet minn 25 % sa 35 % ogħla f'persuni akbar (età minn 65 sa 78 sena) meta mqabbla ma' adulti b'età inqas minn 65 sena li ngħataw dożi komparabbli ta' oseltamivir.
English: Oseltamivir reduced the incidence of acute otitis media from 26.5 % (53/200) in the placebo group to 16 % (29/183) in the oseltamivir treated children (p = 0.013).
Maltese: Oseltamivir naqqas l-inċidenza ta' otite medja akuta minn 26.5 % (53/200) fil-grupp tal-plaċebo għal 16 % (29/183) fit-tfal ikkurati b'oseltamivir (p = 0.013).
English: Each ml of suspension contains 6 mg oseltamivir.
Maltese: Kull ml ta' suspensjoni fih 6 mg oseltamivir.
English: Adverse reactions according to frequency Very common Common
Maltese: Reazzjonijiet avversi skont il-frekwenza Komuni ħafna Komuni
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: Kura tal-infezzjoni tal-influwenza B: 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: 10 capsules (300 mg)
Maltese: 10 kapsuli (300 mg)
English: • phenylbutazone (used to treat pain and inflammation)
Maltese: • phenylbutazone (jintuża biex jikkura uġigħ u infjammazzjoni)
English: The NNT in this study was 25 (95 % CI 23
Maltese: L-NNT f'dan l-istudju kien 25 (95 % CI 23 - 62).
English: > 15 kg to 23 kg 45 mg
Maltese: > 15 kg sa 23 kg 45 mg darbtejn kuljum
English: • chlorpropamide (used to treat diabetes)
Maltese: • chlorpropamide (jintuża għall-kura tad-dijabete)
English: Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of Tamiflu have been evaluated in two uncontrolled open-label studies including influenza infected children less than one year of age (n=135).
Maltese: Il-farmakokinetika, il-farmakodinamika u s-sigurtà ta' Tamiflu kienu evalwati f'żewġ studji open-label mhux ikkontrollati li kienu jinkludu tfal ta' età inqas minn sena infettati bl-influwenza (n=135).
English: Since 2007 naturally occurring resistance associated with the H275Y mutation in seasonal H1N1 strains has been sporadically detected.
Maltese: Minn 2007 reżistenza li seħħet b'mod naturali assoċjata mal-mutazzjoni ta' H275Y f'razez staġjonali ta' H1N1 kienet osservata b'mod sporadiku.
English: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
Maltese: Kapsuli Tamiflu ta' 30 mg u ta' 45 mg huma disponibbli bħala alternattiva għad-doża rakkomandata tas-suspensjoni Tamiflu 6 mg/ml.
English: Exposure to the pro-drug is less than 5 % relative to the active metabolite.
Maltese: L-espożizzjoni għall-pro-droga hija ta' anqas minn 5 % meta mqabbla mal-metabolu attiv.
English: Preventing flu: dose for 10 days
Maltese: Prevenzjoni tal influwenza: doża għal 10 ijiem
English: • probenecid (used to treat gout)
Maltese: • probenecid (jintuża għall-kura tal-gotta)
English: 10 kg to 15 kg 30 mg
Maltese: 10 kg sa 15-il kg 30 mg darbtejn kuljum
English: Dose of Tamiflu Number of capsules
Maltese: Doża ta' Tamiflu Numru ta' kapsuli
English: There are two stages to taking Tamiflu oral suspension.
Maltese: Tamiflu suspensjoni orali.
English: Malta (See Ireland)
Maltese: Malta (ara Renju Unit)
English: Yellow iron oxide (E172) Red iron oxide (E172) Black iron oxide (E172) Titanium dioxide (E171)
Maltese: Iron oxide isfar (E172) Iron oxide aħmar (E172) Iron oxide iswed (E172) Titanium dioxide (E171)
English: The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 23 litres in humans, a volume equivalent to extracellular body fluid.
Maltese: Il-volum medju tad-distribuzzjoni ta' oseltamivir carboxylate fi stat fiss huwa ta' madwar 23 litru filbnedmin, liema volum huwa ekwivalenti għall-fluwidu ekstraċellulari tal-ġisem.
English: By day 6 (the last day of treatment) FEV1 had increased by 10.8 % in the oseltamivir treated group compared to 4.7 % on placebo (p = 0.0148) in this population.
Maltese: Sas-6 jum (l-aħħar jum tal-kura), l-FEV1 kien żdied b'10.8 % fil-grupp ikkurat b'oseltamivir mqabbel ma' 4.7 % fil-grupp tal-plaċebo (p = 0.0148) f'din il-popolazzjoni.
English: Oseltamivir significantly reduced the incidence of clinical influenza illness occurring in the contacts of confirmed influenza cases from 24/200 (12 %) in the placebo group to 2/205 (1 %) in the oseltamivir group (92 % reduction [95 % CI 6 - 16; p ≤ 0.0001]).
Maltese: Oseltamivir naqqas b'mod sinifikanti l-inċidenza tal-marda talinfluwenza klinika f'dawk li kellhom kuntatt ma' każi kkonfermati tal-influwenza minn 24/200 (12 %) fil-grupp tal-plaċebo għal 2/205 (1 %) fil-grupp ta' oseltamivir (tnaqqis ta' 92 %[95 % CI 6 - 16; p ≤ 0.0001]).
English: INFORMATION IN BRAILLE tamiflu 30 mg
Maltese: tamiflu 30 mg
English: Adults and adolescents 13 and over
Maltese: Adulti u adoloxxenti
English: Clinical and surveillance data: Natural mutations associated with reduced susceptibility to oseltamivir in vitro have been detected in influenza A and B viruses isolated from patients without exposure to oseltamivir.
Maltese: Dejta klinika u ta' sorveljanza: Mutazzjonijiet naturali assoċjati ma' suxxettibilità mnaqqsa għal oseltamivir in vitro instabu f'virusis tal-influwenza A u B iżolati minn pazjenti li ma kellhomx esponiment għal oseltamivir.
English: At 500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day administered from 7 to 21 days post partum).
Maltese: Ma kienux osservati reazzjonijiet avversi b'500 mg/kg, inkluż waqt kura kronika (500 mg/kg/kuljum mogħtija minn 7 sa 21 ġurnata wara t-twelid).
English: Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 500 mg/kg/day, respectively.
Maltese: Twettqu studji dwar l-effett teratoġeniku fuq il-firien u l-fniek li ngħataw dożi sa 1,500 mg/kg/jum u 500 mg/kg/jum, rispettivament.
English: Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Maltese: Informazzjoni dwar is-sigurtà disponibbli dwar oseltamivir mogħti għall-kura tal-influwenza fi trabi b'età inqas minn sena minn studji ta' osservazzjoni prospettivi u retrospettivi (li flimkien kienu jinkludu aktar minn 2,400 tarbija ta' din il-klassi ta' età), riċerka fid-databażi epidemjoloġiċi u rapporti ta' wara t-tqegħid fis-suq, tissuġġerixxi li l-profil ta' sigurtà fi trabi b'età inqas minn sena huwa simili għall-profil ta' sigurtà stabbilit fi tfal b'età minn sena 'l fuq.
English: For storage conditions of the pharmacy compounded suspension, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin tas-suspensjoni mħallta fl-ispiżerija, ara t-taqsima 6.3.
English: In addition, 199 immunocompromised adult patients received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
Maltese: Barra dan, 475 pazjent immunokompromessi (inkluż 18-il tifel u tifla, minn dawn 10 Tamiflu u 8 plaċebo) irċevew Tamiflu jew plaċebo għall-profilassi talinfluwenza.
English: 1.8 ml twice daily 1.8 ml once daily 2.0 ml or 3.0 ml
Maltese: 1.8 ml darbtejn kuljum 1.8 ml darba kuljum 2.0 ml jew 3.0 ml
English: Tamiflu hard capsules and Tamiflu suspension are bioequivalent formulations.
Maltese: Il-kapsuli ibsin u s-suspensjoni ta' Tamiflu huma sustanzi bioekwivalenti.
English: True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community.
Maltese: Infezzjoni proprja tal-influwenza sseħħ biss waqt li jkun hemm tifqigħa annwali (epidemija) meta lviruses tal-influwenza jkunu qed jinfirxu fil-komunità lokali.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 6 mg/ml powder for oral suspension
Maltese: Tamiflu 6 mg/ml trab għal suspensjoni orali
English: INFORMATION IN BRAILLE tamiflu 75 mg
Maltese: tamiflu 75 mg
English: Marketing Authorisation Holder and Manufacturer Roche Registration GmbH
Maltese: Roche Registration GmbH
English: Oseltamivir resistance
Maltese: Oseltamivir
English: Black iron oxide (E172) Titanium dioxide (E171)
Maltese: Iron oxide iswed (E172) Titanium dioxide (E171)
English: People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension.
Maltese: Persuni li jsibuha diffiċli biex jieħdu l-kapsuli jistgħu jużaw mediċina likwida, Tamiflu suspensjoni orali.
English: Also contains 1 plastic bottle adapter, 1 plastic measuring cup (55 ml), 1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser.
Maltese: Jinkludi wkoll adapter tal-plastik għall-flixkun, tazza tal-plastik għall-kejl (55 ml), dispenser orali talplastik ta' 3 ml u dispenser orali tal-plastik ta' 10 ml
English: The number needed to treat (NNT) in contacts of true influenza cases was 10 (95 % CI 9 - 12) and was 16 (95 % CI 15 - 19) in the whole population (ITT) regardless of infection status in the index case.
Maltese: In-numru meħtieġ biex tikkura (NNT) f'kuntatti ta' każijiet veri ta' influwenza kien ta' 10 (95 % CI 9 - 12) u ta' 16 (95 % CI 15 - 19) fil-popolazzjoni kollha (ITT) kien x'kien l-istat talinfezzjoni tal-każ indiċi.
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 fil-kura jew profilassi tal-influwenza (ara sezzjoni 5.2, Tagħrif farmakokinetiku, Popolazzjonijiet Speċjali).
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 Tamiflu 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'Tamiflu.
English: After reconstitution with 55 ml of water, the usable volume of oral suspension allows for the retrieval of a total of 10 doses of 30 mg oseltamivir.
Maltese: Wara rikostituzzjoni b'55 ml ilma, il-volum li jista' jintuża tas-suspensjoni orali jippermetti l-irkupru ta' total ta' 10 dożi ta' 30 mg oseltamivir.
English: The available data indicates that the exposure following a 3 mg/kg dose in infants 0-12 months of age provides pro-drug and metabolite exposures anticipated to be efficacious with a safety profile comparable to that seen in older children and adults using the approved dose (see sections 4.1 and 4.2).The reported adverse events were consistent with the established safety profile in older children.
Maltese: Id-dejta disponibbli tindika li l-esponiment wara doża ta' 3 mg/kg fi trabi b'età ta' 0 - 12il xahar jipprovdi esponimenti għall-pro-droga u l-metabolit li mistennija li jkunu effikaċi bi profil tassigurtà komparabbli ma' dak osservat fi tfal akbar u f'adulti li jkunu qed jużaw id-doża approvata (ara sezzjonijiet 4.1 u 4.2).
English: Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Maltese: Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium dioxide (E171)
English: 7.5 ml oseltamivir suspension delivers 1.3 g of sorbitol.
Maltese: 7.5 ml ta' suspensjoni oseltamivir tagħti 1.3 g ta' sorbitol. 10 ml ta' suspensjoni oseltamivir tagħti 1.7 g ta' sorbitol.
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: Il-valuri tal-enżima neuraminidase IC50 meta ngħata oseltamivir, għall-influwenza A iżolata klinikament varjaw minn 0.1 nM sa 1.3 nM, u għall-influwenza B kienu 2.6 nM.
English: Recommended dose for prevention
Maltese: Prevenzjoni wara espożizzjoni
English: Extrapolation of the animal data provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.
Maltese: Estrapolazzjoni ta' dejta dwar l-annimali twassal għal stimi ta' 0.01 mg/jum u 0.3 mg/jum rispettivament għaż-żewġ sustanzi rispettivi.
English: Tamiflu 75 mg hard capsules are available in blister packs of 10.
Maltese: Tamiflu 75 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: Limited data indicate that oseltamivir and the active metabolite are excreted in human milk.
Maltese: Dejta limitata tindika li oseltamivir u l-metabolit attiv tiegħu jiġu eliminati fil-ħalib uman.
English: Volume per dose 6 mg/ml
Maltese: Volum f'kull doża 6 mg/ml
English: In the overall treatment population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited patients.
Maltese: Fil-popolazzjoni kollha li ngħatat l-kura, l-infezzjoni tal-influwenza ġiet ikkonfermata f'67 % (firxa minn 46 % sa 74 %) talpazjenti.
English: In this study, the rate of major congenital heart defects following oseltamivir exposure during the first trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98).
Maltese: F'dan l-istudju, ir-rata ta' difetti konġenitali maġġuri fil-qalb wara esponiment għal oseltamivir matul l-ewwel trimestru kienet ta' 1.76% (7 trabi minn 397 tqala) meta mqabbla ma' 1.01% fi tqaliet mhux esposti mill-popolazzjoni ġenerali (Proporzjon ta' Probabbiltà 1.75, Intervall ta' Kunfidenza ta' 95% 0.51 sa 5.98).
English: 3.0 ml twice daily 3.0 ml once daily 3.0 ml (or 5.0 ml)
Maltese: 3.0 ml darbtejn kuljum 3.0 ml darba kuljum 3.0 ml (jew 5.0 ml)
English: Infants 0 - 12 months of age
Maltese: Trabi b'età ta' 0 - 12-il xahar
English: Do not take Tamiflu.
Maltese: Tieħux Tamiflu.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 6 mg/ml powder for oral suspension Oseltamivir
Maltese: Informazzjoni għall-utent Tamiflu 6 mg/ml trab għal suspensjoni orali oseltamivir
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 ikkurati 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 ikkurati b'oseltamivir (p = 0.
English: INFORMATION IN BRAILLE tamiflu 45 mg
Maltese: tamiflu 45 mg
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 f'individwi akbar fi 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: Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects.
Maltese: L-influwenza hija assoċjata ma' riżultati avversi fit-tqala u fuq il-fetu, b'riskju ta' malformazzjonijiet konġenitali maġġuri, inklużi difetti konġenitali fil-qalb.
English: 1.5 ml twice daily 1.5 ml once daily 2.0 ml or 3.0 ml
Maltese: 1.5 ml darbtejn kuljum 1.5 ml darba kuljum 2.0 ml jew 3.0 ml
English: Tamiflu 45 mg hard capsules are available in blister packs of 10.
Maltese: Tamiflu 45 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: Tamiflu 30 mg hard capsules are available in blister packs of 10.
Maltese: Tamiflu 30 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: After reconstitution, store below 25 °C for 10 days.
Maltese: Wara r-rikostituzzjoni, aħżen f'temperatura taħt 25°C għal 10 ijiem.
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 ta' influwenza li sseħħ b'mod naturali fejn l-infezzjoni predominanti kienet l-influwenza A.
English: In households of influenza-infected index cases, there was a reduction in the incidence of influenza from 26 % (23/89) in the group not receiving prevention to 11 % (9/84) in the group receiving prevention (58.5 % reduction [95 % CI 15.6 - 79.6; p = 0.0114]).
Maltese: Fi djar b'każijiet indiċi nfettati blinfluwenza, kien hemm tnaqqis fl-inċidenza tal-influwenza minn 26 % (23/89) fil-grupp li ma kienux qed jirċievu prevenzjoni għal 11 % (9/84) fil-grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta' 58.5 % [95 % CI 15.6 - 79.6;
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 fillinja 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: 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: In influenza-positive older people , oseltamivir significantly reduced the incidence of specified lower respiratory tract complications (mainly bronchitis) treated with antibiotics from 19 % (52/268) in the placebo group to 12 % (29/250) in the oseltamivir treated population (p = 0.0156).
Maltese: F'individwi akbar li kellhom l-influwenza, oseltamivir naqqas b'mod sinifikanti linċidenza ta' kumplikazzjonijiet speċifikati fil-parti t'isfel tal-passaġġ respiratorju (prinċiparjament bronkite) li ġew ikkurati bl-antibijotiċi minn 19 % (52/268) fil-grupp li ngħata l-plaċebo għal 12 % (29/250) fil-popolazzjoni kkurata b'oseltamivir (p = 0.0156).
English: • For doses from 1.0 ml to 3.0 ml, the 3 ml oral dispenser should be used.
Maltese: • Għal dożi minn 1.0 ml sa 3.0 ml, għandu jintuża d-dispenser orali ta' 3 ml.
English: For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days.
Maltese: Għall-adoloxxenti (b'età minn 13 sa 17-il sena) u l-adulti d-doża orali rakkomandata hija ta' 75 mg oseltamivir darbtejn kuljum għal ħamest ijiem.
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: 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal web Ewropew tal-mediċini.
English: Remove the dispenser from the bottle.
Maltese: Neħħi d-dispenser minn ġol-flixkun.
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 il-kura, l-għoti ta' 75 mg oseltamivir darbtejn kuljum għal ħamest ijiem naqqas ilperijodu 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: For doses above 3.0 ml to 10 ml, 10 ml oral dispenser should be used.
Maltese: Għal dożi ta' aktar minn 3.0 ml sa 10 ml, għandu jintuża d-dispenser orali ta' 10 ml.
English: In the event thatTamiflu powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Tamiflu capsules.
Maltese: F'każ li Tamiflu trab għal suspensjoni orali ma jkunx disponibbli, l-ispiżjar jista' jipprepara suspensjoni (6 mg/ml) minn kapsuli Tamiflu.
English: Tamiflu 30 mg hard capsules oseltamivir
Maltese: Tamiflu 30 mg kapsuli Oseltamivir
English: Sorbitol can have a mild laxative effect.
Maltese: Sorbitol jista' jkollu effett lassattiv ħafif.
English: Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Maltese: Fit-tieni pass, iddetermina in-numru ta' kapsuli u l-ammont ta' likwidu (ilma li għandu miżjud 0.05% w/v sodium benzoate bħala preservattiv) meħtieġa għall-preparazzjoni tal-volum totali (ikkalkulat mit-tabella fuq) tas-suspensjoni ta' 6 mg/ml imħallta fl-ispiżerija kif muri fit-tabella taħt: