FrancophonIA/ELRC3.0 huggingface dataset:
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 trattament u prevenzjoni fl-adulti/adoloxxenti, l-ARs li seħħew bl-aktar mod frekwenti bid-doża rrakkomandata (75 mg bid għal 5 ijiem għat-trattament u 75 mg od għal perijodu sa 6
English: Up to 15 kg
Maltese: Sa 15-il kg
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: siegħa minn mindu dehru s-sintomi, naqqas 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, tassogħla u tal-koriża) b'1.5 ġranet (95 % CI 0.6 - 2.2 jiem; p < 0.0001) imqabbel mal-plaċebo.
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 n-numru ta' kapsuli u l-ammont ta' likwidu (ilma li fih 0.05% w/v sodium benzoate bħala preservattiv) meħtieġa biex ikun ippreparat il-volum totali (ikkalkutat mit-tabella fuq) tas-suspensjoni ta' 6 mg/ml imħallta fl-ispiżerija kif muri fit-tabella taħt:
English: 9 mg
Maltese: 9mg darbtejn kuljum
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-day- old 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: Use the larger dispenser to draw up 7.5 ml water.
Maltese: Uża d-dispenser il-kbir biex tiġbed 7.5 ml ilma.
English: Caution should be exercised when preparing oseltamivir oral suspension and when administering oseltamivir products to children.
Maltese: Għandu jkun hemm attenzjoni waqt il-preparazzjoni ta' oseltamivir suspensjoni orali u meta jingħataw prodotti b'oseltamivir lit-tfal.
English: Infants 0 - 12 months of age
Maltese: Tfal minn sena sa 12-il sena
English: Agitation,
Maltese: Ekżema,
English: You should use only 30 mg capsules for 30 mg and 60 mg doses.
Maltese: Għad-dożi ta' 30 mg u 60 mg għandek tuża kapsuli ta' 30 mg biss.
English: This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2).
Maltese: Dan huwa bbażat fuq data farmakokinetika u sigurtà li jindika li din id-doża fi trabi ta' 0 - 12 - il xahar tipprovdi konċentrazzjonijiet fil-plażma tal-pro-droga u l-metabolit attiv li huma antiċipati li huma klinikament effikaċi bi profil ta' sigurtà komparabbli ma' dik osservata fi tfal akbar u adulti (ara sezzjoni 5.2).
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: 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: Information for the user
Maltese: Informazzjoni għall-utent
English: Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
Maltese: Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 45 mg oseltamivir.
English: Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.
Maltese: Id-doża rrakkomandata għall-prevenzjoni tal-influwenza waqt tifqigħa tal-influwenza fil-komunità hija ta' 75 mg oseltamivir darba kuljum għal perijodu sa 6 ġimgħat.
English: • Thrombocytopenia (low platelet count)
Maltese: • Tromboċitopenija (għadd ta' plejtlits baxx)
English: Vomiting
Maltese: Dermatite
English: Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
Maltese: Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 75 mg oseltamivir.
English: Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
Maltese: Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 30 mg oseltamivir.
English: For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.
Maltese: Għall-kejl ta' 5.0 ml ta' ilma, għandhom jintużaw dispensers ta' 5 ml jew 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: 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: What you need to know before you take Ebilfumin Do not take Ebilfumin:
Maltese: Tieħux Ebilfumin:
English: Ebilfumin 30 mg hard capsules are available in blister packs or tablet containers of 10.
Maltese: Kapsula iebsa (kapsula) Ebilfumin 30 mg kapsuli ibsin huma disponibbli f'folji ta' 10.
English: The hard capsule consists of a white opaque body and cap bearing the black imprint “OS 45”.
Maltese: Il-kapsula iebsa fiha qiegħ u kappa, ta' lewn abjad opak, bil-marka sewda “OS 45”.
English: Infants less than 1 year (0 to 12 months)
Maltese: Tfal inqas minn sena (0 sa 12-il xahar)
English: • Cough
Maltese: Qiegħ
English: Cough, Sore throat, Rhinorrhea
Maltese: FULJETT TA' TAGĦRIF
English: Ebilfumin 30 mg hard capsules EU/1/14/915/001 (10 hard capsules blister) EU/1/14/915/002 (10 hard capsules container)
Maltese: Ebilfumin 30 mg kapsuli ibsin EU/1/14/915/001 (10 folji capsuli iebsin) EU/1/14/915/002 (10 kontenitur capsuli iebsin) Ebilfumin 45 mg kapsuli ibsin EU/1/14/915/003 (10 kontenitur ta l-kapsuli ibsin) EU/1/14/915/004 (10 folja tal-kapsuli ibsin) Ebilfumin 75 mg kapsuli ibsin EU/1/14/915/005 (10 kontenitur ta l-kapsuli ibsin) EU/1/14/915/006 (10 folja tal-kapsuli ibsin)
English: • One 75 mg Ebilfumin capsule
Maltese: • Kapsula waħda ta' Ebilfumin 75 mg
English: • Tympanic membrane (eardrum) disorder.
Maltese: • Konġestjoni tal-imnieħer • Rimettar.
English: Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Ebilfumin capsules for infants less than 1 year of age Body Weight (rounded to the nearest 0.5 kg)
Maltese: Tabella ta' dożaġġ għas-suspensjoni ta' 6 mg/ml imħallta fl-ispiżerija ppreparata minn kapsuli Ebilfumin għal trabi b'età minn (età inqas minn sena)
English: 15 capsules (450 mg)
Maltese: 15-il kapsula (450 mg)
English: Oseltamivir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Maltese: Oseltamivir għandu jiġi użat biss għat-trattament u l-prevenzjoni tal-influwenza meta data epidemjoloġika affidabbli tindika li l-virus tal-influwenza qiegħed jinfirex fil-komunità.
English: • Teaspoon (5 ml spoon) • Water
Maltese: • Skutella żgħira • Kuċċarina (ta' 5 ml)
English: Ebilfumin is indicated in adults and children including full-term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Maltese: Ebilfumin huwa indikat f'adulti u tfal, fosthom trabi li twieldu qabel iż-żmien, li jkollhom is-sintomi tipiċi tal-influwenza, meta jkun hemm il-passa tal-virus tal-influwenza fil-komunità.
English: upper abdominal pain), Dyspepsia
Maltese: Uġigħ addominali (inkluż uġigħ fl addome ta' fuq), Dispepsja
English: Recommended dose for 5 days
Maltese: doża għal 5 ijiem
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: fil-grupp tal-plaċebo għal 2/205 (1 %) fil-grupp ta' oseltamivir (tnaqqis ta' 92 %[95 % CI 6 - 16; p
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 ttrattati 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: Haemodialysis patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were influenza-positive.
Maltese: 53.6 % kienu posittivi għall-influenza.
English: Many of the side effects listed below may also be caused by influenza.
Maltese: Ma jseħħux effetti sekondarji meta inti twaqqaf Ebilfumin.
English: However,
Maltese: Deni,
English: Infants and children 1 year of age or older: The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years of age.
Maltese: Il-farmakokinetika ta' oseltamivir ġiet evalwata fi studji farmakokinetiċi b'dożi singoli fi trabi, tfal u adoloxxenti ta' età minn sena sa 16-il sena.
English: Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment as detailed in the table below.
Maltese: Huwa rrakkomandat tibdil fid-doża għall-adulti u adoloxxenti (b'età minn 13 sa 17-il sena) li jbatu minn indeboliment renali moderat jew sever kif indikat fit-tabella taħt.
English: In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate for, or an inhibitor of, the major cytochrome P450 isoforms.
Maltese: Studji in vitro wrew li la oseltamivir u lanqas il-metabolu attiv m'huma la inibituri u lanqas substrati għall-iżoformi prinċipali taċ-ċitokromju P450.
English: Fulminant hepatitis, Hepatic failure, Hepatitis
Maltese: Insuffiċjenza tal fwied, Epatite
English: Patients who are unable to swallow capsules may receive appropriate extemporaneous formulation, see section 6.6 for preparation.
Maltese: Pazjenti li ma jistgħux jibilgħu kapsuli jistgħu jirċievu dożi xierqa preparazzjoni estemporanja, ara sezzjoni 6.6 għall-metodu ta' preparazzjoni.
English: 5 kg 15 mg 2.5 ml
Maltese: 5 ml darbtejn kuljum 5 ml darba kuljum
English: Peritoneal dialysis patients*
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Maltese: ARs huma miżjuda mal-kategorija rilevanti fit-tabelli skont l-analiżi miġbura minn studji kliniċi.
English: Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Maltese: Bronkite, Herpes simplex,
English: Detailed information on the home preparation can be found in the package leaflet of Ebilfumin capsules under “Making liquid Ebilfumin at home”.
Maltese: Informazzjoni dettaljata dwar preparazzjoni magħmula d-dar tista' tinstab fil-fuljett ta' tagħrif tal kapsuli ta' Ebilfumin taħt “Preparazzjoni tal-likwiduEbilfumin id-dar”.
English: Volume per dose (6 mg/ml)
Maltese: (6 mg/ml)
English: Oseltamivir is effective only against illnesses caused by influenza virus.
Maltese: Oseltamivir huwa effettiv biss kontra l-mard ikkawżat mill-virus tal-influwenza.
English: In the majority of patients, these ARs did not lead to discontinuation of oseltamivir.
Maltese: Ħawwad l-ikel ħelu u Ebilfumin suspensjonisew.
English: Patients with Resistance Mutations (%) Phenotyping* Geno- and Phenotyping*
Maltese: Pazjenti b'Mutazzjonijiet Reżistenti (%)
English: Ear and labyrinth disorders:
Maltese: Il-prevenzjoni tal-influwenza:
English: • One 45 mg Ebilfumin capsule
Maltese: • Kapsula waħda ta' Ebilfumin 45 mg
English: The following dosing regimen is recommended for treatment of infants 0 - 12 months of age:
Maltese: Trabi mill-eta' ta' 0 sa 12-il xahar Trattament:
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: 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 aħmar (E172)
English: Prophylaxis of Influenza
Maltese: Il-prevenzjoni tal-influwenza
English: • Tiredness
Maltese: • Sturdament • Deni
English: Pregnancy and breast-feeding
Maltese: Preparazzjoni fl-ispiżerija
English: 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: terapija oseltamivir, f'135 tifel u tifla infettati bl-influwenza u li għandhom inqas minn sena, il- profil tas-sigurtà kien simili fost gruppi ta' etajiet ghal rimettar , diarrohea u raxx tal-ħrieqi.
English: • Sharp scissors
Maltese: • Skutella żgħira
English: Therefore, dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation).
Maltese: Għalhekk, aġġustamenti fid-doża mhumiex rakkomandati għal nisa tqal fittrattament jew profilassi tal-influwenza (ara sezzjoni 4.6 Fertilità, tqala u treddigħ).
English: To make a 30 mg or a 60 mg dose, you need:
Maltese: Biex tipprepara doża ta' 30 mg jew 60 mg, għandek bżonn:
English: Simulation of once daily dosing of 3mg/kg in infants <1 year shows an exposure in the same range or higher than for once daily dosing of 75 mg in adults.
Maltese: Simulazzjoni ta' dożaġġ ta' darba kuljum ta' 3 mg/kg fi trabi ta' < sena turi espożizzjoni fl-istess firxa jew ogħla minn dożaġġ darba kuljum ta' 75 mg fl-adulti.
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: Trattament 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'
English: Vomiting Abdominal pain (incl.
Maltese: Il-kapsula fiha trab abjad iggranulat.
English: Table 1 Adverse reactions in studies investigating oseltamivir for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance System Organ Class (SOC)
Maltese: Tabella 1 Reazzjonijiet avversi fi studji li nvestigaw oseltamivir għat-trattament u lprevenzjoni tal-influwenza fl-adulti u fl-adoloxxenti jew minn sorveljanza ta' wara t-tqegħid fis-suq
English: The majority of patients that developed resistance were transplant recipients (8/10 patients in the standard dose group and 2/2 patients in the double dose group).
Maltese: Il-maġġoranza tal-pazjenti li żviluppaw reżistenza kienu riċevituri ta' trapjant (8/10 pazjenti fil-grupp ta' doża standard u 2/2 pazjenti fil-grupp ta' doża doppja).
English: The reported adverse events were consistent with the established safety profile in older children.
Maltese: L-avvenimenti avversi rrappurtati kienu konsistenti mal- profil tas-sigurtà stabbilit fi tfal akbar .
English: Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge studies in healthy volunteers.
Maltese: L-attività antivirali ta' oseltamivir għall-influwenza A u B ġiet sostnuta minn studji sperimentali li fihom ħadu sehem voluntiera f'saħħithom .
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 ta' 10 ml
English: To make a 75 mg dose, you need:
Maltese: 75 mg darba kuljum Prevenzjoni waqt epidemija ta' influwenza fil-komunità:
English: • Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
Maltese: • Ebilfumin huwa użat għall-adulti, addoloxxenti, tfal u trabi (inkluż trabi tat-twelid li twieldu meta kien imisshom) għat-trattament tal-influwenza.
English: Angioneurotic oedema,
Maltese: GĦALL-ĦRUĠ TAL
English: Warnings and precautions
Maltese: Prevenzjoni wara espożizzjoni:
English: Third, follow the procedure below for compounding the 6 mg/ml suspension from Ebilfumin capsules: In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v sodium benzoate added as a preservative.
Maltese: F'buqar tal-ħġieġ ta' daqs adattat poġġi l-ammont iddikjarat ta' ilma li għandu miżjud 0.05 % w/v sodium benzoate bħala preservattiv.
English: (may affect up to 1 in 10 people)
Maltese: (jistgħu jaffettwaw sa persuna waħda minn kull 10)
English: Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.
Maltese: Eliminazzjoni renali Interazzjonijiet klinikament importanti ma' mediċini li jinvolvu kompetizzjoni għas-sekrezzjoni tubulari renali huma improbabbli, minħabba l-marġni ta' sigurtà magħrufa għall-biċċa l-kbira ta' dawn is-sustanzi, il-karatteristiċi ta' kif jiġi eliminat il-metabolu attiv (filtrazzjoni glomerulari u sekrezzjoni anijonika tubulari) u l-kapaċità ta' l-eliminazzjoni ta' dawn il-passaġġi.
English: Open the stated amount of Ebilfumin capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Maltese: Iftaħ l-ammont iddikjarat ta' kapsuli Ebilfumin u ttrasferixxi l-kontenut ta' kull kapsula direttament ġol-ilma ippreservat fil-buqar tal-ħġieġ.
English: Cough, Nasal congestion
Maltese: Konġestjoni flimnieħer
English: • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
Maltese: • Reazzjonijiet anafilattiċi u anafilaktojdi: reazzjonijiet allerġiċi severi, b'nefħa fil-wiċċ u l ġilda, raxx bil-ħakk, pressjoni baxxa u diffikultajiet fit-teħid tan-nifs
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 rrakkomandat tibdil fid-doża għall-adulti u adoloxxenti (b'età minn 13 sa 17-il sena) li jbatu minn indeboliment renali moderat jew sever.
English: Pharmacy compounding
Maltese: IL-PRODOTT MEDIĊINALI
English: These medicines prevent the flu virus from spreading inside the body.
Maltese: L-influwenza hija infezzjoni kkawżata minn virus.
English: No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids (magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects stable on warfarin and without influenza).
Maltese: Ma ġew osservati l-ebda interazzjonijiet farmakokinetiċi bejn oseltamivir u l-metabolu prinċipali tiegħu meta oseltamivir ingħata flimkien ma' paracetamol, acetyl-salicylic acid, cimetidine, antaċidi
English: Resistant strains selected during oseltamivir treatment have been isolated from both immunocompetent and immunocompromised patients.
Maltese: Razez reżistenti magħżula waqt it-trattament b'oseltamivir kienu iżolati kemm minn pazjenti immunokompetenti kif ukoll minn dawk immunokompromessi.
English: There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation (see sections 4.2 and 5.2).
Maltese: M'hemmx data klinika suffiċjenti dwar trabi u tfal (b'età ta' sena jew aktar) b'indeboliment renali biex tista' ssir xi rakkomandazzjoni ta' dożaġġ (ara sezzjonijiet 4.2 u 5.2).
English: Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical efficacy study.
Maltese: Il farmakokinetika b'dożi multipli ġiet studjata f'numru żgħir ta' tfal li ħadu sehem fi studju dwar leffikaċja klinika.
English: This leaflet was last revised in {MM/YYYY} {month YYYY}.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
Maltese: Din il-proċedura tiddeskrivi l-preparazzjoni ta' suspensjoni ta' 6 mg/ml li ser tipprovdi pazjent wieħed b'medikazzjoni biżżejjed għall-kors ta' trattament ta' 5 ijiem jew kors ta' profilassi ta' 10 ijiem.
English: vertigo), Fatigue, Pyrexia , Pain in limb
Maltese: (inkluż vertigo), Għeja,
English: There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Maltese: M'hemmx data klinika suffiċjenti disponibbli dwar trabi u tfal (b'età ta' 12-il sena u anqas)
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Rappurtar ta 'reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali hija importanti.
English: • Bronchitis
Maltese: • Tqalligħ
English: Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.
Maltese: Tfal li nstab li kellhom virus reżistenti għal oseltamivir, xerrdu il-virus għal perijodu itwal meta mqabbla ma suġġetti b'virus suxxettibli.
English: Specifar ΑΒΕΕ
Maltese: Specifar ABEE
English: 12 mg twice daily
Maltese: 12mg darbtejn kuljum
English: More than 15 kg and up to 23 kg 45 mg twice daily
Maltese: 30 mg darbtejn kuljum 30 mg darba kuljum Aktar minn 15-il kg u sa 23 kg 45 mg darbtejn kuljum 45 mg darba kuljum Aktar minn 23 kg u sa 40 kg