FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP, as a consequence, considers that the benefit-risk balance of HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and therefore recommends the maintenance of the marketing authorisations.
Maltese: Konsegwentement, is-CHMP jikkunsidra li l-bilanċ ta' benefiċċju-riskju tal-vaċċini HPV (Cervarix, Gardasil, Gardasil 9 u Silgard) jibqa' favorevoli u għaldaqstant jirrakomanda ż-żamma talawtorizzazzjonijiet għat-tqegħid fis-suq.
English: A diagnosis of POTS cannot solely rely on these criteria; other symptoms (e.g. syncope, fatigue, headaches, lightheadedness, diaphoresis, tremor, palpitations, exercise intolerance, near syncope upon standing upright) vary across patients and are otherwise non-specific.
Maltese: Dijanjożi tal-POTS ma tistax toqgħod biss fuq dawn il-kriterji; sintomi oħra (eż. sinkope, għejja, uġigħ ta' ras, sturdamenti, dijaforesi, rogħda, palpitazzjonijiet, intolleranza għall-eżerċizzju, kważi sinkope fil-ħin ta' meta l-persuna tqum bilwieqfa) ivarjaw minn pazjent għall-ieħor u li b'xi mod ieħor mhumiex speċifiċi.
English: This included the responses submitted by the marketing authorisation holders, published literature, Eudravigilance data, and the outcome of the Scientific advisory group (SAG) on vaccines as well as data submitted by member states and information submitted by the public.
Maltese: Dan inkluda r-rispons imressaq mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, il-letteratura ppubblikata, id-data tal-Eudravigilance, u r-riżultat talGrupp ta' konsulenza xjentifika (SAG) dwar il-vaċċini kif ukoll data sottomessa minn stati membri u informazzjoni mressqa mill-pubbliku.
English: These syndromes have been subject to previous repeated review by PRAC.
Maltese: Dawn is-sindromi kienu soġġetti għal rieżami ripetut preċedenti mill-PRAC.
English: general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Maltese: Madankollu, stimi disponibbli jissuġġerixxu li fil-popolazzjoni ġenerali madwar 150 tifla u mara żagħżugħa għal kull miljun minn 10 sa 19-il sena jistgħu jiżviluppaw is-CRPS kull sena, u mill-anqas 150 tifla u mara żagħżugħa għal kull miljun jistgħu jiżviluppaw il-POTS kull sena.
English: • The PRAC considered that the observed versus expected analyses took into account a wide range of scenarios regarding underreporting and included reports that did not fully meet the diagnostic criteria for the syndromes.
Maltese: • Il-PRAC qies li l-analiżi osservati kontra dawk mistennija qiesu firxa wiesa' ta' xenarji rigward in-nuqqas ta' rapportar u inkluda rapporti li ma ssodisfawx il-kriterji dijanjostiċi tas-sindromi b'mod sħiħ.
English: POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
Maltese: POTS huwa sindromu sistemiku li ilu magħruf għal żmien twil taħt ismijiet differenti u għadu mhux mifhum sew.
English: Available estimates suggest that at least 150 girls and young women per million may develop POTS each year.
Maltese: Stimi disponibbli jissuġġerixxu li tal-anqas 150 tifla u nisa żgħażagħ għal kull miljun jistgħu jiżviluppaw il-POTS kull sena.
English: The PRAC confirmed that the benefit-risk balance of the HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and recommends the maintenance of the marketing authorisations.
Maltese: Il-PRAC ikkonferma li l-bilanċ ta' benefiċċju-riskju tal-vaċċini HPV (Cervarix, Gardasil, Gardasil 9 u Silgard) jibqa' favorevoli u jirrakkomanda ż-żamma tal-awtorizzazzjonijiet għat-tqegħid fis-suq.
English: More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination.
Maltese: Aktar minn 80 miljun tifla u mara fid-dinja kollha rċevew dawn il-vaċċini, u f'xi pajjiżi Ewropej ingħataw lil 90% tal-grupp ta' età rrakkomandat għat-tilqim.
English: The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting.
Maltese: Ir-rieżami ma sab l-ebda evidenza li r-rati b'mod ġenerali ta' dawn is-sindromi fi bniet imlaqqma kienu differenti mir-rati mistennija f'dawn il-gruppi ta' età, anke meta titqies il-possibbiltà ta' nuqqas ta' rapportar.
English: EMA/487404/2018 EMEA/H/C/003727
Maltese: EMA/487404/2018
English: Further information on Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine is available as capsules (4 mg and 10 mg).
Maltese: Il-mediċina tiġi bħala kapsuli (4 mg u 10 mg).
English: Differentiated thyroid carcinoma
Maltese: Karċinoma tat-tirojde differenzjata
English: Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015.
Maltese: Lenvima ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Mejju 2015.
English: The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (speech disturbances), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles).
Maltese: L-effetti sekondarji l-aktar komuni b'Lenvima (li jistgħu jaffettwaw aktar minn 3 persuni minn kull 10) huma pressjoni għolja (pressjoni għolja tad-demm), dijarea, tnaqqis fl-aptit u fil-piż, għeja, nawsja (tħossok ma tiflaħx), proteinurja (proteina fl-awrina), stomatite (infjammazzjoni tal-kisja tal-ħalq), rimettar, disfonja (disturbi fid-diskors), uġigħ ta' ras u sindrome ta' eritrodisasteżija palmari-plantari (PPE - raxx u tnemnim fuq il-pali u l-qiegħ tas-saqajn).
English: The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Maltese: Is-sustanza attiva f'Lenvima, il-lenvatinib, hija “inibitur tat-tirożina kinażi”.
English: Lenvima contains the active substance lenvatinib.
Maltese: Lenvima fih is-sustanza attiva lenvatinib.
English: The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack, bleeding in the brain, a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack.
Maltese: L-effetti sekondarji serji l-aktar importanti huma insuffiċjenza u indeboliment tal-kliewi; problemi bilqalb u biċ-ċirkolazzjoni bħal insuffiċjenza tal-qalb, emboli tad-demm fl-arterji li jwasslu għal puplesija jew attakk tal-qalb; fsada fil-moħħ; sindrome magħrufa bħala “sindrome tal-enċefalopatija riversibbli posterjuri” ikkaratterizzata minn uġigħ ta' ras, konfużjoni, aċċessjonijiet u telf tal-vista, insuffiċjenza tal-fwied, enċefalopatija epatika (ħsara fil-moħħ ikkawżata mill-insuffiċjenza tal-fwied), puplesija u attakk tal-qalb.
English: The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of progression in the previous year and did not respond to treatment with radioactive iodine.
Maltese: L-istudju involva 392 pazjent adult b'karċinoma tat-tirojde differenzjata li kienu wrew sinjali ta' progressjoni fis-sena preċedenti u li ma rrispondewx għall-kura b'jodju radjuattiv.
English: • adults with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland.
Maltese: • adulti b'karċinoma tat-tirojde differenzjata, tip ta' kanċer li joriġina miċ-ċelluli follikolari talglandola tat-tirojde.
English: • adults with hepatocellular carcinoma (a type of liver cancer) who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery.
Maltese: • adulti b'karċinoma epatoċellulari (tip ta' kanċer tal-fwied) li qabel ma ngħatawx mediċina ta' kontra l-kanċer mill-ħalq jew b'injezzjoni u li l-kanċer tagħhom huwa avvanzat jew li ma jistax jitneħħa b'kirurġija.
English: Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.
Maltese: Il-pazjenti li ngħataw Lenvima għexu madwar 13.6 xhur, meta mqabbel ma' 12.3 xhur f'pazjenti li ngħataw sorafenib.
English: What are the risks associated with Lenvima?
Maltese: X'inhuma r-riskji assoċjati ma' Lenvima?
English: The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm il-pazjenti għexu mingħajr ma l-marda tagħhom aggravat; fil-pazjenti li ngħataw Lenvima, din kienet medja ta' 18.3 xhur, meta mqabbel ma' 3.6 xhur f'dawk li ngħataw plaċebo.
English: Other information about Lenvima
Maltese: Informazzjoni oħra dwar Lenvima
English: As for all medicines, data on the use of Lenvima are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Lenvima hija ssorveljata kontinwament.
English: The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery.
Maltese: L-istudju involva 954 pazjent b'karċinoma epatoċellulari li kienu għadhom ma ngħatawx kura għall-kanċer tagħhom, u li l-kanċer tagħhom ma setax jitneħħa b'kirurġija.
English: Lenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study.
Maltese: Lenvima ntwera li huwa aktar effettiv minn plaċebo (kura finta) biex inaqqas ir-ritmu tal-progressjoni tal-marda fi studju ewlieni wieħed.
English: For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight.
Maltese: Għall-kura ta' karċinoma epatoċellulari, id-doża rakkomandata ta' kuljum hija 8 jew 12 mg skont il-piż tal-ġisem.
English: For treatment of differentiated thyroid carcinoma, the recommended dose is 24 mg taken once a day at approximately the same time every day.
Maltese: Għall-kura ta' karċinoma tat-tirojde differenzjata, id-doża rakkomandata hija 24 mg meħuda darba kuljum bejn wieħed u ieħor fl-istess ħin kuljum.
English: For the full list of side effects with Lenvima, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Lenvima, ara l-fuljett ta' tagħrif.
English: Lenvima is a cancer medicine used on its own to treat:
Maltese: Lenvima huwa mediċina ta' kontra l-kanċer, li jintuża waħdu għall-kura ta':
English: Lenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study.
Maltese: Biex jiġu ġestiti l-effetti sekondarji, it-tabib jista' jiddeċiedi li jnaqqas id-doża jew iwaqqaf il-kura temporanjament.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Maltese: Dan ifisser li timblokka lattività tal-enzimi magħrufin bħala tirożina kinażi.
English: Treatment is continued as long as the patient continues to benefit from it without too many side effects.
Maltese: Il-kura titkompla sakemm il-pazjent ikun qed jibbenefika minnha mingħajr ħafna effetti sekondarji.
English: How does Lenvima work?
Maltese: Kif jintuża Lenvima?
English: By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth.
Maltese: Billi jimblokka dawn l-enzimi, il-lenvatinib jista' jimblokka lformazzjoni ta' vażi ġodda u b'hekk iwaqqaf il-provvista tad-demm li tippermetti liċ-ċelloli tal-kanċer jikbru, u jnaqqas it-tkabbir tagħhom.
English: System Organ Class (SOC)
Maltese: Organi (SOC)
English: Dermatitis (including allergic and atopic dermatitis)
Maltese: Dermatite (inkluż dermatite allerġika u atopika)
English: Date of last renewal: 22 May 2012
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2012
English: Titanium dioxide (E171) FD and C Blue 2 (indigo carmine, E132)
Maltese: Titanium dioxide (E171) FD u C Blu 2 (indigo carmine, E132)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 November 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Novembru 2011
English: Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil).
Maltese: Pakkett b'folja triplex (PVC/PE/PVDC, issiġillat b'fojl tal-aluminju).
English: Eczema, Dermatitis, Rash, Urticaria
Maltese: Ekżema, Dermatite, Raxx, Urtikarja
English: Renal elimination
Maltese: Eliminazzjoni renali
English: In 2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe.
Maltese: Fl-2008, H275Y instab f'> 99 % taliżolati tal-influwenza H1N1 fiċ-ċirkolazzjoni fl-Ewropa.
English: This medicine contains sorbitol, which is a form of fructose.
Maltese: Din il-mediċina fiha sorbitol, li huwa forma ta' fructose.
English: Angioneurotic oedema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis
Maltese: Edima anġjonewrotika, Eritema multiforme, Sindrome StevensJohnson, Nekroliżi epidermika tossika
English: Warnings and precautions:
Maltese: Prevenzjoni wara espożizzjoni:
English: Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury
Maltese: • Delużjonijiet, alluċinazzjonijiet, aġitazzjoni, ansjetà, incubi
English: Store the medicine below 25 º C for up to 10 days.
Maltese: Aħżen il-mediċina taħt 25 ºC sa 10 ijiem.
English: • Prepare the oral dispenser
Maltese: • Ipprepara id-dispenser orali
English: • The active substance is oseltamivir (6 mg/ml oseltamivir after reconstitution).
Maltese: • Is-sustanza attiva hija oseltamivir (6 mg/ml oseltamivir wara r-rikostituzzjoni).
English: The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Maltese: (≥ 1/100 sa < 1/10 ), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), u rari ħafna
English: 1 capsule
Maltese: 11-il kapsula
English: Do not take Tamiflu:
Maltese: Tiħux Tamiflu:
English: D- 79639 Grenzach -Wyhlen Germany
Maltese: D-79639 Grenzach-Wyhlen
English: • The other ingredients are sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).
Maltese: • L-ingredjenti l-oħra huma sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) u benna ta' tutti frutti (inkluż maltodextrins [maize], propylene glycol, arabic gum E414 u sustanzi ta' benna naturali identiċi [li fil-biċċa l-kbira jikkonsistu minn benna tal-banana, ananas u ħawħ]).
English: • methotrexate (used to treat e.g. rheumatoid arthritis)
Maltese: • methotrexate (jintuża biex jikkura eż. artrite rewmatika)
English: - Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Maltese: - Tamiflu huwa ndikat għall-prevenzjoni tal-influwenza wara espożizzjoni fi trabi b'età inqas minn sena waqt tifqigħa ta' influwenza pandemika (ara sezzjoni 5.2).
English: Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations.
Maltese: Is-suspensjoni Tamiflu u l-kapsuli ibsin Tamiflu huma formulazzjonijiet bioekwivalenti.
English: Table 2 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.])
Maltese: Tabella 2 Reazzjonijiet avversi fi studji li nvestigaw Tamiflu għall-kura u l-prevenzjoni talinfluwenza fit-tfal (dożaġġ ibbażat fuq l-età/piż [30 mg sa 75 mg o.d.])
English: General Information
Maltese: Informazzjoni Ġenerali
English: Powder: Do not store above 30 ºC Oral suspension: Store below 25 °C for 10 days
Maltese: Taħżinx 'l fuq minn 30 ºC Suspensjoni orali: Aħżen taħt 25 °C għal 10 ijiem
English: Tamiflu contains fructose
Maltese: Tamiflu fih fructose
English: 2.0 ml (or 3.0 ml)
Maltese: 2.0 ml (jew 3.0 ml)
English: Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Maltese: Herpes simplex, Nażofarinġite, Infezzjonijiet fl apparat respiratorju ta' fuq,
English: The incidence of laboratory-confirmed clinical influenza was 2.9 % (7/238) in the placebo group and 2.1 % (5/237) in the oseltamivir group (95 % CI -2.3 %4.1 %; p = 0.772).
Maltese: L-inċidenza ta' influwenza klinika kkonfermata fil-laboratorju kienet 2.9 % (7/238) fil-grupp tal-plaċebo u 2.1 % (5/237) fil-grupp ta' oseltamivir (95 % CI -2.3 % - 4.1 %; p = 0.772).
English: Amount of Tamiflu suspension
Maltese: Ammont ta' suspensjoni Tamiflu
English: 100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic adapter (low density polyethylene) , plastic 3 ml oral dispenser (0.1 ml graduation) and 10 ml oral dispenser (0.5 ml graduation) (barrel and plunger: polypropylene, silicon based seal ring) and a plastic measuring cup (polypropylene).
Maltese: Flixkun ta' 100 ml tal-ħġieġ lewn l-ambra (b'għatu tal-polypropylene b'kamin li huwa diffiċli għat-tfal biex jiftħuh, parti ta' barra: polyethylene; parti ta' ġewwa: polypropylene; kisja: polyethylene) bi 13 g ta' trab għal suspensjoni orali, adapter tal-plastik (polyethylene ta' densità baxxa), dispenser tal-plastik għall-użu orali ta' 3 ml (gradazzjonijiet kull 0.1 ml) u dispenser tal-plastik għall-użu orali ta' 10 ml (gradazzjonijiet kull 0.5 ml) (tubu u planġer: polypropylene, ċirku li jissiġilla magħmul minn silikon) u tazza tal-plastik biex titkejjel id-doża fiha (polypropylene).
English: 3.0 ml (or 5.0 ml)
Maltese: 3.0 ml (jew 5.0 ml)
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 (magnesium u aluminium hydroxides u calcium carbonates), rimantadine jew warfarin (f'individwi stabbli fuq warfarin u mingħajr influwenza).
English: 5 ml oseltamivir suspension delivers 0.9 g of sorbitol.
Maltese: 5 ml ta' suspensjoni oseltamivir tagħti 0.9 g ta' sorbitol.
English: Hypersensitivity reaction
Maltese: sensittività eċċessiva
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH02
Maltese: Antivirali għall-użu sistemiku, inibituri ta' neuraminidase, kodiċi ATC:
English: PHARMACEUTICAL FORM AND CONTENTS 10 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 10 kapsuli ibsin
English: 12.5 ml oseltamivir suspension delivers 2.1 g of sorbitol.
Maltese: 12.5 ml ta' suspensjoni oseltamivir tagħti 2.1 g ta' sorbitol.
English: Tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).
Maltese: Togħma ta' tutti frutti (li fih maltodextrins [maize], propylene glycol, arabic gum E414 u sustanzi naturali identiċi għal dawn it-togħmit [li prinċiparjament jikkonsistu f'togħmiet tal-banana, tal-pajnepil u tal-ħawħ])
English: Cough, Sore throat, Rhinorrhea
Maltese: Sogħla, Uġigħ filgriżmejn, Rinoreja
English: Developing oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from less than 1% in adults to 18% in infants aged below 1 year.
Maltese: L-iżvilupp ta' virus reżistenti għal oseltamivir waqt it-trattament kien aktar frekwenti fit-tfal milli fl-adulti, li varja minn inqas minn 1% fl-adulti għal 18% fit-trabi ta' età inqas minn sena.
English: One bottle of reconstituted suspension (65 ml) contains 390 mg of oseltamivir.
Maltese: Flixkun wieħed ta' suspensjoni rikostitwita (65 ml) fih 390 mg ta' oseltamivir.
English: Data from 504 influenza B infected subjects were pooled across all studies for analysis.
Maltese: Dejta nġabret minn 504 individwi infettati bl-influwenza B minn fost l-istudji kollha sabiex tiġi analizzata.
English: Final volume of the bottle after reconstitution is 65 ml.
Maltese: Il-volum finali tal-flixkun wara li jiġi rikostitwit huwa 65 ml.
English: 2 capsules
Maltese: 20 kapsula
English: 3 kg to 10+ kg,
Maltese: 3 kg sa 10+ kg
English: Prophylaxis Dose (for 10 days)
Maltese: Doża ta' Profilassi (għal 10 ijiem)
English: The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in clinical trials.
Maltese: Il-profil ta' sigurtà globali ta' Tamiflu huwa bbażat fuq dejta minn 6049 pazjent adult/adoloxxenti u 1473 pazjent pedjatriku kkurati b'Tamiflu jew plaċebo għall-influwenza, u fuq dejta minn 3990 pazjent adult/adoloxxenti u 253 pazjent pedjatriku li rċevew Tamiflu jew plaċebo/l-ebda kura għallprofilassi tal-influwenza fi studji kliniċi.
English: Fulminant hepatitis, Hepatic failure, Hepatitis
Maltese: Epatite fulminati, Insuffiċjenza talfwied, Epatite
English: Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Maltese: Proprjetajiet farmakokinetiċi ta' oseltamivir, bħal-livell baxx ta' irbit mal-proteini u metaboliżmu indipendenti minn CYP450 u mis-sistemi ta' glucuronidase (ara sezzjoni 5.2), jissuġerixxu li interazzjonijiet klinikament sinifikanti bejn il-mediċini permezz ta' dawn il-mekkaniżmi huma improbabbli.
English: > 23 kg to 40 kg 60 mg
Maltese: > 23 kg sa 40 kg 60 mg darbtejn kuljum
English: A total of 158 children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Maltese: Total ta' 158 tifel u tifla rċevew id-doża rakkomandata ta' Tamiflu darba kuljum fi studju dwar il-profilassi wara espożizzjoni fi djar (n = 99), fi studju pedjatriku dwar profilassi tal-istaġun li dam 6 ġimgħat (n = 49) u fi studju pedjatriku dwar profilassi tal-istaġun li dam 12-il ġimgħa f'individwi immunokompromessi (n = 10).
English: Of those, 851 children received treatment with oseltamivir suspension.
Maltese: Minn dawn, 851 tifel u tifla rċevew kura b'suspensjoni ta' oseltamivir.
English: 4 capsules (300 mg)
Maltese: 4 kapsuli (300 mg)
English: The pharmacist may compound a 6 mg/ml suspension from Tamiflu 30 mg, 45 mg or 75 mg capsules using water containing 0.05 % w/v sodium benzoate added as a preservative.
Maltese: L-ispiżjar jista' jħallat suspensjoni ta' 6 mg/ml minn kapsuli Tamiflu ta' 30 mg, 45 mg jew 75 mg blużu ta' ilma li għandu miżjud 0.05% w/v sodium benzoate bħala preservattiv.