FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Tamiflu, 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' Tamiflu, deskritti fis-sezzjoni 4.8 Effetti mhux mixtieqa.
English: 12.5 ml twice daily 12.5 ml once daily 12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose
Maltese: 12.5 ml jikkonsisti minn doża ta' 5 ml flimkien ma' doża ta' 7.5 ml
English: Adverse reactions according to frequency
Maltese: Reazzjonijiet avversi skont il-frekwenza Komuni ħafna
English: 75 mg doses can be administered as either - one 75 mg capsule or - one 30 mg capsule plus one 45 mg capsule or - by administering one 30 mg dose plus one 45 mg dose of suspension.
Maltese: Dożi ta' 75 mg jistgħu jingħataw bħala - kapsula waħda ta' 75 mg jew - kapsula waħda ta' 30 mg flimkien ma' kapsula oħra ta' 45 mg jew - billi tingħata doża waħda ta' 30 mg flimkien ma' doża oħra ta' 45 mg ta' suspensjoni.
English: According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratoryconfirmed clinical influenza among children was significantly reduced from 19 % (21/111) in the group not receiving prevention to 7 % (7/104) in the group receiving prevention (64.4 % reduction [95 % CI 15.8 - 85.0; p = 0.0188]).
Maltese: Skont analiżi ta' sottogruppi fi tfal b'età minn 1 sa 12-il sena, l-inċidenza ta' influwenza klinika kkonfermata fil-laboratorju kienet immnaqsa b'mod sinifikanti minn 19 % (21/111) fil-grupp li ma kienux qed jirċievu prevenzjoni għal 7 % (7/104) fil-grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta' 64.4 %[95 % CI 15.8 - 85.
English: Volume per dose (6 mg/ml)
Maltese: Volum għal kull doża (6 mg/ml)
English: Peritoneal dialysis patients*
Maltese: Pazjenti fuq dijalisi tal-peritonew*
English: Tamiflu 75 mg hard capsules oseltamivir
Maltese: Tamiflu 75 mg kapsuli Oseltamivir
English: Tamiflu 6 mg/ml powder for oral suspension is available in a bottle containing 13 g powder for mixing with 55 ml of water.
Maltese: Tamiflu 6 mg/ml trab għal suspensjoni orali huwa disponibli fi flixkun li fih 13 g ta' trab biex jitħallat ma' 55 ml ilma.
English: • Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir
Maltese: • Kull kapsula iebsa fiha oseltamivir ekwivalenti għal 75 mg ta' oseltamivir
English: A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children 0 - 12 months of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension.
Maltese: Għad-dożaġġ ta' tfal b'età ta' 0 - 12-il xahar li jeħtieġu 1 ml sa 3 ml ta' Tamiflu 6 mg/ml suspensjoni orali għandu jintuża dispenser orali ta' 3 ml (immarkat bi gradi kull 0.1 ml).
English: For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
Maltese: Il-kapsuli Tamiflu ta' 30 mg u ta' 45 mg huma disponibbli bħala alternattiva għad-doża rakkomandata tas-suspensjoni Tamiflu 6 mg/ml.
English: In influenza-positive patients with chronic cardiac and/or respiratory disease, the combined incidence of lower respiratory tract complications (mainly bronchitis) treated with antibiotics was 17 % (22/133) in the placebo group and 14 % (16/118) in the oseltamivir treated population (p = 0.5976).
Maltese: Fost il-pazjenti pożittivi għall-influwenza li kellhom mard kroniku tal-qalb u/jew mard respiratorju, linċidenza kombinata ta' komplikazzjonijiet fil-parti t'isfel tal-passaġġ tan-nifs (prinċiparjament bronkite) li ġew ikkurati bl-antibijotiċi kienet ta' 17 % (22/133) fil-grupp li ngħata il-plaċebo u 14 % (16/118) fil-popolazzjoni kkurata b'oseltamivir (p = 0.5976).
English: LIST OF EXCIPIENTS Also contains sorbitol.
Maltese: TA' EĊĊIPJENTI Fih ukoll sorbitol.
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) FD and C Blue 2 (indigo carmine E132).
Maltese: • L-ingredjenti l-oħra huma: kontenut tal-kapsula: pregelatinized starch, talc, povidone, croscarmellose sodium, u sodium stearyl fumarate qoxra tal-kapsula: gelatin, iron oxide isfar (E172), iron oxide aħmar (E172), iron oxide iswed (E172), u titanium dioxide (E171) linka għall-istampar: shellac (E904), titanium dioxide (E171) u FD u C Blu 2 (indigo carmine, E132).
English: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”.
Maltese: Il-kapsula iebsa hija opaka, ta' lewn griż u għandha l-marka “ROCHE” u kappa griża, opaka li għandha l-marka “45 mg”.
English: Tamiflu 30 mg hard capsules 10 years
Maltese: Tamiflu 30 mg kapsuli ibsin 10 snin
English: Tamiflu 45 mg hard capsules oseltamivir
Maltese: Tamiflu 45 mg kapsuli Oseltamivir
English: Shown on the oral dispenser are millilitre (ml) markings of the medicine (see figures in Instructions for the user).
Maltese: Fuq id-dispenser orali hemm marki ta' millilitri (ml) tal-mediċina (ara l-figuri f'Istruzzjonijiet għall-utent).
English: 2.8 ml twice daily 2.8 ml once daily 3 ml
Maltese: 2.8 ml darbtejn kuljum 2.8 ml darba kuljum 3 ml
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: 4.0 ml twice daily 4.0 ml once daily 10 ml
Maltese: 4.0 ml darbtejn kuljum 4.0 ml darba kuljum 10 ml
English: Paediatric population (infants less than one year of age) In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was similar among age cohorts with vomiting, diarrohea and diaper rash being the most frequently reported adverse events (see section 5.2).
Maltese: F'żewġ studji biex jiġu karatterizzati l-farmakokinetika, il-farmakodinamika u l-profil tas-sigurtà ta' terapija b'oseltamivir f'135 tifel/tifla b'età ta' inqas minn sena infettati bl-influwenza, il-profil tassigurtà kien simili fost koorti ta' età b'rimettar, dijarea u raxx tal-ħrieqi jkunu l-avvenimenti avversi rrappurtati b'mod l-aktar frekwenti (ara sezzjoni 5.2).
English: • Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
Maltese: • Tamiflu jintuża għall-adulti, adolexxenti, tfal u trabi (inkluż trabi tat-twelid li twieldu meta kien imisshom) għall-kura tal-influwenza.
English: • The plastic bottle adapter (in the medicine pack)
Maltese: • L-adapter tal-plastik tal-flixkun (fil-pakkett tal-mediċina)
English: Giving Tamiflu to infants less than 1 year old for preventing flu during 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' Tamiflu lil trabi b'età inqas minn sena għall-prevenzjoni tal-influwenza 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 Tamiflu, 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 Tamiflu, 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: Prevention during an influenza epidemic in the community: In a pooled analysis of two other studies conducted in unvaccinated otherwise healthy adults, oseltamivir 75 mg once daily given for 6 weeks significantly reduced the incidence of clinical influenza illness from 25/519 (4.8 %) in the placebo group to 6/520 (1.2 %) in the oseltamivir group (76 % reduction [95 % CI 1.6 - 5.7; p = 0.0006]) during a community outbreak of influenza.
Maltese: F'analiżi kkombinat ta' żewġ studji oħra li saru fuq adulti li ma kinux imlaqma iżda altrimenti b'saħħithom, 75 mg ta' oseltamivir mogħti darba kuljum għal 6 ġimgħat naqqas b'mod sinifikanti l-inċidenza tal-marda tal-influwenza klinika minn 25/519 (4.8 %) fil-grupp tal-plaċebo għal 6/520 (1.2 %) fil-grupp ta' oseltamivir (tnaqqis ta' 76 % [95 % CI 1.6 - 5.7; p = 0.0006]) wara tifqigħa tal-influwenza fil-komunità.
English: Tamiflu 75 mg hard capsules 10 years
Maltese: Tamiflu 75 mg kapsuli ibsin 10 snin
English: Treatment and prevention of influenza in adults and adolescents:
Maltese: Il-kura u l-prevenzjoni tal-influwenza fl-adulti u l-adoloxxenti:
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 26.0 - 81.2; p = 0.0042]).
Maltese: Fil-popolazzjoni totali kien hemm tnaqqis fl-inċidenza fid-djar ta' influwenza klinika kkonfermata fil-laboratorju minn 20 % (27/136) filgrupp 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.
English: Post-exposure prevention: The recommended post-exposure prevention dose of Tamiflu is:
Maltese: Id-doża ta' Tamiflu rakkomandata għall-prevenzjoni tal-influwenza wara espożizzjoni hija:
English: Tamiflu 30 mg hard capsules
Maltese: Tamiflu 30 mg kapsuli ibsin
English: 12.5 ml twice daily 12.5 ml once daily
Maltese: 12.5 ml darbtejn kuljum 12.5 ml darba kuljum
English: • One large oral dose dispenser to measure out water - a 5 ml dispenser or 10 ml dispenser
Maltese: • Dispenser kbir wieħed għal doża orali biex tkejjel l-ilma - dispenser ta' 5 ml jew dispenser ta' 10 ml
English: Tympanic membrane disorder
Maltese: Id-dożi rakkomandati
English: • Tamiflu may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances - for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Maltese: • Tamiflu jista' jiġi preskritt għall-adulti, adolexxenti, tfal u trabi (inkluż trabi tat-twelid li twieldu meta kien imisshom) bħala kura preventiva f'ċirkustanzi eċċezzjonali - per eżempju, jekk ikun hemm epidemija globali tal-influwenza (pandemija ta' influwenza) u l-vaċċin tal-influwenza staġjonali jista' jkun li ma jipprovdix protezzjoni biżżejjed.
English: 3 mg/kg once daily
Maltese: 3 mg/kg darba kuljum
English: BATCH NUMBER
Maltese: ml darba kuljum
English: Roche Pharma AG Emil-Barell-Str. 1
Maltese: Roche Pharm AG
English: 23 to 40 kg
Maltese: 23 kg sa 40 kg
English: Tamiflu 45 mg hard capsules 10 years
Maltese: Tamiflu 45 mg kapsuli ibsin 10 snin
English: • Each hard capsule contains oseltamivir equivalent to 30 mg of oseltamivir
Maltese: • Kull kapsula iebsa fiha oseltamivir ekwivalenti għal 30 mg ta' oseltamivir
English: INFORMATION IN BRAILLE tamiflu
Maltese: Jekk tinsa tieħu Tamiflu
English: Prevention during an influenza epidemic in the community: Prevention during an influenza epidemic has not been studied in children below 12 years of age.
Maltese: Il-prevenzjoni waqt epidemija ta' influwenza fil-komunità ma ġietx studjata fi tfal taħt l-età ta' 12-il sena.
English: 2.3 ml twice daily 2.3 ml once daily 3 ml
Maltese: 2.3 ml darbtejn kuljum 2.3 ml darba kuljum 3 ml
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 għall-kura tal-influwenza.
English: Infants less than 1 year (0 to 12 months)
Maltese: Trabi inqas minn sena (0 sa 12-il xahar)
English: Treatment of influenza in pregnant women: No controlled clinical studies have been conducted on the use of oseltamivir in pregnant women, however, there is evidence from post-marketing and retrospective observational studies showing benefit of the current dosing regimen in this patient population in terms of lower morbidity/mortality.
Maltese: Kura tal-influwenza f'nisa tqal: Ma sarux studji kliniċi kkontrollati dwar l-użu ta' oseltamivir f'nisa tqal, madankollu hemm evidenza minn studji ta' wara t-tqegħid fis-suq u minn studji ta' osservazzjoni retrospettiva li juru benefiċċju tal-kors ta' dożaġġ attwali f'din il-popolazzjoni ta' pazjenti f'termini ta' morbidità/mortalità aktar baxxi.
English: In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the recommended dose (75 mg bid for 5 days for treatment and 75 mg od for up to 6 weeks for prophylaxis) are shown in Table 1.
Maltese: Fi studji dwar kura u prevenzjoni fl-adulti/adoloxxenti, l-ARs li seħħew bl-aktar mod frekwenti biddoża rakkomandata (75 mg bid għal 5 ijiem għall-kura u 75 mg od għal perijodu sa 6 ġimgħat għallprofilassi), huma murija f'Tabella 1.
English: 1.8 ml twice daily 1.8 ml once daily 3 ml
Maltese: 1.8 ml darbtejn kuljum 1.8 ml darba kuljum 3 ml
English: Dose of Tamiflu
Maltese: Doża ta' Tamiflu
English: Measure 55 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Maltese: Kejjel 55 ml ilma billi timla t-tazza għall-kejl sal-livell indikat (it-tazza għall-kejl inkluża fil-pakkett).
English: • A bottle of prepared Tamiflu oral suspension
Maltese: • Flixkun ippreparat ta' Tamiflu suspensjoni orali
English: • Depending on the required dose you will need the 3 ml oral dispenser (yellow plunger, 0.1 ml graduation) or the 10 ml oral dispenser (white plunger 0.5 ml graduation) from the medicine pack.
Maltese: • Skont id-doża meħtieġa se jkollok bżonn id-dispenser orali ta' 3 ml (planġer isfar, gradazzjonijiet kull 0.1 ml) jew id-dispenser orali ta' 10 ml (planġer abjad, gradazzjonijiet kull 0.5 ml) mill-pakkett tal-mediċina.
English: Push the tip of the dispenser into the bottle adapter.
Maltese: Inbotta il-ponta tad-dispenser fl-adapter tal-flixkun.
English: 15 to 23 kg
Maltese: 15 kg sa 23 kg
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).
Maltese: • L-ingredjenti l-oħra huma: kontenut tal-kapsula: pregelatinized starch, talc, povidone, croscarmellose sodium, u sodium stearyl fumarate qoxra tal-kapsula: gelatin, iron oxide iswed (E172), u titanium dioxide (E171) linka għall-istampar: shellac (E904), titanium dioxide (E171) u FD u C Blu 2 (indigocarmine, E132).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/004
Maltese: EU/1/02/222/004
English: • Each hard capsule contains oseltamivir equivalent to 45 mg of oseltamivir
Maltese: • Kull kapsula iebsa fiha oseltamivir ekwivalenti għal 45 mg ta' oseltamivir
English: • Thrombocytopenia (low platelet count)
Maltese: • L-għatu tal-flixkun (fil-pakkett tal-mediċina)
English: Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 neuraminidases.
Maltese: Virusis reżistenti għal oseltamivir iżolati minn pazjenti kkurati b'oseltamivir u razez tal-laboratorju ta' virusis tal-influwenza reżistenti għal oseltamivir instabu li għandhom mutazzjonijiet f'neuraminidases N1 u N2. Mutazzjonijiet ta' reżistenza għandhom tendenza li jkunu speċifiċi għal sotto-tip ta' virus.
English: 2.0 ml twice daily 2.0 ml once daily 3 ml
Maltese: 2.0 ml darbtejn kuljum 2.0 ml darba kuljum 3 ml
English: Tamiflu 45 mg hard capsules
Maltese: Tamiflu 45 mg kapsuli ibsin
English: upper abdominal pain), Dyspepsia
Maltese: Uġigħ addominali (inkluż uġigħ fladdome ta' fuq), Dispepsja
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).
Maltese: • L-ingredjenti l-oħra huma: kontenut tal-kapsula: pregelatinized starch, talc, povidone, croscarmellose sodium, u sodium stearyl fumarate qoxra tal-kapsula: gelatin, iron oxide isfar (E172), iron oxide aħmar (E172), u titanium dioxide (E171) linka għall-istampar: shellac (E904), titanium dioxide (E171) u FD u C Blu 2 (indigo carmine, E132).
English: 30 mg (suspension or capsules) 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: * Dejta miksuba minn studji fuq pazjenti li jagħmlu dijalisi ambulatorja kontinwa tal-peritonew (CAPD); ittneħħija ta' oseltamivir carboxylate hija mistennija li tkun ogħla meta jintuża metodu ta' dijalisi awtomatizzata tal-peritonew (APD).
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: Il-popolazzjoni inkluża fl-istudji dwar kura 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. persuni akbar u pazjenti b'mard tal-qalb jew mard respiratorju kroniku).
English: Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, cough and coryza) by 1.5 days (95 % CI 0.6 - 2.2 days; p < 0.0001) compared to placebo.
Maltese: Il-kura b'oseltamivir, li nbdiet fi żmien 48 siegħa minn mindu dehru s-sintomi, naqqset b'mod sinifikanti ż-żmien sal-ħelsien mill-marda (li hu definit bħala r-ritorn tal-pazjent f'sikktu u lura lejn l-attivitajiet normali tiegħu, u t-taffija tad-deni, tas-sogħla u tal-koriża) b'1.5 ġranet (95 % CI 0.6 - 2.2 jiem; p < 0.0001) imqabbel mal-plaċebo.
English: Tamiflu 75 mg hard capsules
Maltese: Tamiflu 75 mg kapsuli ibsin
English: Caution should be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to children.
Maltese: Għandu jkun hemm attenzjoni meta wieħed jipprepara Tamiflu suspensjoni orali u meta prodotti Tamiflu jingħataw lit-tfal.
English: Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment.
Maltese: Huwa rakkomandat aġġustament fid-doża għall-adulti u adoloxxenti (b'età minn 13 sa 17-il sena) li jbatu minn indeboliment renali moderat jew serju.
English: Patients who are unable to swallow capsules:
Maltese: Pazjenti li ma jistgħux jibilgħu kapsuli:
English: For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg
Maltese: 8 kg x 3 mg kull kg = 24 mg
English: Oseltamivir is effective only against illness caused by influenza viruses.
Maltese: Oseltamivir huwa effettiv biss kontra mard ikkawżat mill-virusis tal-influwenza.
English: Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested (1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-dayold rat pups, including death.
Maltese: Filwaqt li l-għoti tal-melħ ta' oseltamivir phosphate bħala doża orali waħda għolja ħafna, sal-ogħla doża ttestjata (1,310 mg/kg), ma kellu l-ebda reazzjoni avvera fuq firien adulti, dożi bħal dawn wasslu għal tossiċità fi frieħ tal-firien żgħar, ta' 7 ijiem, inkluż mewt.
English: In case of a pandemic, a 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension.
Maltese: F'każ ta' pandemija, għad-dożaġġ ta' tfal b'età inqas minn sena li jeħtieġu 1 ml sa 3 ml ta' Tamiflu 6 mg/ml suspensjoni orali għandu jintuża dispenser orali ta' 3 ml (immarkat bi gradi kull 0.1 ml).
English: The MAH shall ensure that at the launch of Tamiflu 6 mg/ml powder for oral suspension, all physicians who are expected to prescribe or use Tamiflu are provided with a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Maltese: L-MAH għandu jiżgura li meta Tamiflu 6 mg/ml trab għal suspensjoni orali jitqiegħed fis-suq, it-tobba kollha li huma mistennija li jippreskrivu jew jużaw Tamiflu jiġu pprovduti b'ittra ta' Komunikazzjoni Diretta għall-Professjonisti fil-qasam mediku, li it-test tagħha huwa mehmuż mar-rapport ta' valutazzjoni tas-CHMP.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/003
Maltese: EU/1/02/222/003
English: Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45 mg capsules.
Maltese: Tippruvax tagħmel doża ta' 30 mg, 60 mg jew ta' 75 mg billi tuża l-kontenut tal-kapsuli ta' 45 mg.
English: Treatment: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily.
Maltese: Id-doża ta' kura rakkomandata għal trabi b'età ta' 0 - 12-il xahar hija ta' 3 mg/kg darbtejn kuljum.
English: 2.5 ml twice daily 2.5 ml once daily 3 ml
Maltese: 2.5 ml darbtejn kuljum 2.5 ml darba kuljum 3 ml
English: The available data indicates that the exposure following a 3 mg/kg dose in infants 012 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' 012-il xahar jipprovdi esponimenti għall-pro-droga u l-metabolit li mistennija li jkunu effikaċi bi profil tas-sigurtà komparabbli ma' dak osservat fi tfal akbar u f'adulti li jkunu qed jużaw id-doża approvata
English: See 5 How to store Tamiflu, overleaf.
Maltese: Tamiflu imniżżla f'taqsima 6.