qanastek/EMEA-V3 huggingface dataset:
2 During situations when commercially manufactured Tamiflu oral suspension is not readily available, adults, adolescents or children who are unable to swallow capsules may receive appropriate doses of Tamiflu (see section 3 in Package Leaflet) by opening capsules and pouring the contents of capsules into a suitable, small amount (1 teaspoon maximum) of sweetened food product such as regular or sugar-free chocolate syrup, honey (only for children two years or older), light brown or table sugar dissolved in water, dessert toppings, sweetened condensed milk, apple sauce or yogurt to mask the bitter taste.
2 F’ sitwazzjonijiet fejn Tamiflu suspensjoni orali manifatturata b’ mod kummerċjali mhux disponibbli malajr, adulti, adoloxxenti jew tfal li ma jistgħux jibilgħu kapsuli jistgħu jirċievu dożi xierqa ta ’ Tamiflu (ara sezzjoni 3 fil- Fuljett ta ’ Tagħrif) billi jinfetħu l- kapsuli u l- kontenut tal- kapsuli jitferra ’ ġo ammont żgħir (massimu ta ’ kuċċarina), xieraq ta ’ prodott ta ’ l- ikel b’ togħma ħelwa bħall- ġulepp taċ- ċikkulata biz- zokkor jew bla zokkor, għasel (għal tfal b’ età ta ’ sentejn jew akbar), żokkor ismar ċar jew tal- mejda maħlul fl- ilma, toppings għad- deżerta, ħalib magħqud ħelu, meraq tat- tuffieħ jew jogurt, biex tinħeba t- togħma qarsa.
The mixture should be stirred and the entire contents given to the patient.
It- taħlita għandha titħawwad u l- kontenut kollu għandu jingħata lill- pazjent.
The mixture must be swallowed immediately after its preparation.
Wara li tiġi ppreparata t- taħlita għandha tittieħed minnufih.
Tamiflu is not recommended for use in children less than one year of age due to insufficient data on safety and efficacy (see section 5.3).
Tamiflu mhux irrakkomandat għall- użu fi tfal iżgħar minn sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 3).
Treatment of influenza Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Il- kura ta 'l- influwenza Il- kura għandha tinbeda mill- aktar fis possibli fi żmien jumejn mill- bidu tas- sintomi ta' l- influwenza.
For adolescents (13 to 17 years of age) and adults:
Għall- adoloxxenti (b’ età minn 13 sa 17- il sena) u adulti:
The recommended oral dose is 75 mg oseltamivir twice daily for 5 days.
Id- doża orali rrakkomandata hija ta '75 mg oseltamivir darbtejn kuljum għal ħamest ijiem.
For infants older than 1 year of age and for children 2 to 12 years of age:
Għal trabi b’ età ta ’ aktar minn sena u għal tfal b’ età minn sentejn sa 12- il sena:
Tamiflu 30 mg and 45 mg capsules and oral suspension are available.
Hemm disponibbli Tamiflu kapsuli ta ’ 30 mg u ta ’ 45 mg u suspensjoni li tittieħed mill- ħalq.
The following weight-adjusted dosing regimens are recommended
Il- korsijiet ta ’ dożaġġ aġġustati għall- piż li ġejjin huma rrakkomandati:
Recommended dose for 5 days
Doża rrakkomandata għal ħamest ijiem
≤ 15 kg > 15 kg to 23 kg > 23 kg to 40 kg > 40 kg
≤ 15- il kg > 15- il kg sa 23 kg > 23 kg sa 40 kg > 40 kg
30 mg twice daily 45 mg twice daily 60 mg twice daily 75 mg twice daily
30 mg darbtejn kuljum 45 mg darbtejn kuljum 60 mg darbtejn kuljum 75 mg darbtejn kuljum
Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
Tfal li jiżnu > 40 kg u li huma kapaċi jibilgħu l- kapsuli jistgħu jingħataw kura bid- dożaġġ tal- adulti ta '75 mg kapsuli darbtejn kuljum għal ħamest ijiem bħala alternattiva għad- doża rakkomandata ta ’ suspensjoni Tamiflu.
Prevention of influenza Post-exposure prevention For adolescents (13 to 17 years of age) and adults:
Il- prevenzjoni ta 'l- influwenza Il- prevenzjoni wara l- espożizzjoni Għall- adoloxxenti (b’ età minn 13 sa 17- il sena) u adulti:
The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days.
Id- doża rrakkomandata għall- prevenzjoni ta 'l- influwenza wara li jkun sar kuntatt mill- qrib ma' individwu infettat hija ta '75 mg oseltamivir darba kuljum għal għaxart ijiem.
Therapy should begin as soon as possible within two days of exposure to an infected individual.
It- terapija għandha tibda mill- aktar fis possibbli fi żmien jumejn minn meta l- pazjent ikun ġie espost għall- individwu infettat.
Tamiflu 30 mg and 45 mg capsules and oral suspension are available.
Hemm disponibbli kapsuli Tamiflu ta ’ 30 mg u ta ’ 45 mg u suspensjoni orali.
The recommended post-exposure prevention dose of Tamiflu is:
Id- doża ta ’ Tamiflu rrakkomandata għall- prevenzjoni wara espożizzjoni hija:
Recommended dose for 10 days
Doża rakkomandata għal għaxart ijiem
30 mg once daily 45 mg once daily 60 mg once daily 75 mg once daily
30 mg darba kuljum 45 mg darba kuljum 60 mg darba kuljum 75 mg darba kuljum
Children weighing > 40 kg and who are able to swallow capsules may receive prevention with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.
Tfal b’ piż > 40 kg u li jistgħu jibilgħu l- kapsuli jistgħu jirċievu prevenzjoni b’ kapsula ta ’ 75 mg darba kuljum għal għaxart ijiem bħala alternattiv għad- doża rakkomandata tas- suspensjoni Tamiflu.
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.
3 Il- prevenzjoni waqt epidemiji ta 'l- influwenza fil- komunità Id- doża rrakkomandata għall- prevenzjoni ta' l- influwenza waqt epidemija fil- komunità hija ta '75 mg oseltamivir darba kuljum sa 6 ġimgħat.
3 Special populations Hepatic impairment No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction.
Individwi speċjali Indeboliment epatiku M' hemm bżonn ta ’ ebda tibdil fid- doża la għall- kura u lanqas għall- prevenzjoni, f' pazjenti li għandhom disfunzjoni epatika.
No studies have been carried out in paediatric patients with hepatic disorder.
Ma sarux studji f’ pazjenti pedjatriċi b’ disturbi epatiċi.
Renal impairment Treatment of influenza:
Indeboliment renali Il- kura ta 'l- influwenza:
Dose adjustment is recommended for adults with severe renal impairment.
Huwa rrakkomandat tibdil fid- doża fl- adulti li jbatu minn indeboliment renali serju.
Recommended doses are detailed in the table below.
Id- dettalji tad- dożi rrakkomandati jidhru fit- tabella li ġejja.
Creatinine clearance > 30 (ml/ min) > 10 to ≤ 30 (ml/ min)
Tneħħija tal- krejatinina > 30 (ml/ min) > 10 sa ≤ 30 (ml/ min)
Recommended dose for treatment 75 mg twice daily 75 mg once daily, or 30 mg suspension twice daily, or 30 mg capsules twice daily
rrakkomandata għall- kura 75 mg darbtejn kuljum 75 mg darba kuljum,
Not recommended Not recommended
Mhux irrakkomandat
Prevention of influenza:
Il- prevenzjoni ta 'l- influwenza:
Dose adjustment is recommended for adults with severe renal impairment as detailed in the table below.
Huwa rrakkomandat tibdil fid- doża fl- adulti li jbatu minn indeboliment renali serju kif indikat fit- tabella li ġejja.
Recommended dose for prevention 75 mg once daily 75 mg every second day, or 30 mg suspension once daily, or 30 mg capsules once daily
Doża rrakkomandata għall- prevenzjoni 75 mg darba kuljum 75 mg kull jumejn, jew 30 mg suspensjoni darba kuljum, jew kapsuli ta ’ 30 mg darba kuljum
≤ 10 (ml/ min) dialysis patients
≤ 10 (ml/ min) pazjenti fuq dijalisi
Not recommended Not recommended
Mhux irrakkomandat Mhux irrakkomandat
Elderly No dose adjustment is required, unless there is evidence of severe renal impairment.
L- anzjani M' hemm bżonn l- ebda tibdil fid- doża, sakemm m' hemmx evidenza ta 'indeboliment renali serju.
Children There is insufficient clinical data available in children with renal impairment to be able to make any dosing recommendation.
Tfal M’ hemmx tagħrif biżżejjed dwar tfal b’ indeboliment renali biex tista ’ ssir xi rakkomandazzjoni ta ’ dożaġġ.
Oseltamivir is effective only against illness caused by influenza viruses.
Oseltamivir huwa effettiv biss kontra l- mard ikkawżat mill- virus ta 'l- influwenza.
There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses.
M' hemm l- ebda evidenza ta 'effikaċja ta' oseltamivir f' mard ieħor ikkawżat minn aġenti oħra barra l- virus ta 'l - influwenza.
The safety and efficacy of oseltamivir for the treatment and prevention of influenza in children of less than one year of age have not been established (see section 5.3).
Is- sigurtà u l- effikaċja ta 'oseltamivir għall- kura u l- prevenzjoni ta' l- influwenza fi tfal iżgħar minn sena ma ġewx stabbiliti (ara sezzjoni 5. 3).
No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
M' hemm l- ebda informazzjoni rigward is- sigurtà u l- effikaċja ta 'oseltamivir f' pazjenti b' xi kondizzjoni medika li hija serja jew instabbli biżżejjed li jiġu kkunsidrati li qegħdin f' riskju imminenti li jintbagħtu l- isptar.
The safety and efficacy of oseltamivir in either treatment or prevention of influenza in immunocompromised patients have not been established.
4 Is- sigurtà u l- effikaċja ta 'oseltamivir kemm għall- kura kif ukoll għall- prevenzjoni ta' l influwenza f' pazjenti immunokompromessi ma ġewx stabbiliti.
4 Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/ or respiratory disease has not been established.
L- effikaċja ta 'oseltamivir fil- kura ta' pazjenti b' mard tal- qalb kroniku u/ jew mard respiratorju ma ġietx stabbilita.
No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).
F’ din il- kategorija ta ’ pazjenti ma ġiet osservata l- ebda differenza fl- inċidenza ta 'kumplikazzjonijiet bejn gruppi li ngħataw it- trattament u oħrajn li ngħataw plaċebo (ara sezzjoni 5. 1).
Tamiflu is not a substitute for influenza vaccination.
Tamiflu m' huwiex sostitut għat- tilqima kontra l- influwenza.
Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination.
L- użu ta ’ Tamiflu m' għandux jeffetwa l - evalwazzjoni ta 'l- individwi rigward it- tilqim annwali kontra l- influwenza.
The protection against influenza lasts only as long as Tamiflu is administered.
Il- protezzjoni kontra l - influwenza iddum biss sakemm ikun qed jingħata Tamiflu.
Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Tamiflu għandu jiġi użat biss għall- kura u l- prevenzjoni ta 'l- influwenza meta informazzjoni epidemijoloġika ta' min joqgħod fuqha tindika li l - virus ta 'l- influwenza qiegħed jinfirex fil- komunità.
Severe renal impairment Dose adjustment is recommended for both treatment and prevention in adults with severe renal insufficiency.
Indeboliment renali serju Tibdil fid- doża huwa rrakkomandat kemm għall- kura kif ukoll għall- prevenzjoni f' adulti li jbatu minn insufiċċjenza renali serja.
There is insufficient clinical data available in children with renal impairment to be able to make any dosing recommendation. (see sections 4.2 and 5.2).
M’ hemmx tagħrif kliniku biżżejjed dwar tfal b’ indeboliment renali biex tista ’ ssir xi rakkomandazzjoni ta ’ dożaġġ( ara sezzjoni 4. 2 u 5. 2).
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.
Tagħrif farmakokinetiku dwar oseltamivir, bħal- livell baxx fl- irbit mal- proteini u l- metaboliżmu indipendenti minn CYP450 u mis- sistemi glukuronidażi (ara sezzjoni 5. 2), jissuġerixxi li l- interazzjonijiet klinikament sinifikanti bejn il- mediċini permezz ta 'dawn il- mekkaniżmi huma improbabbli.
No dose adjustment is required when co-administering with probenecid in patients with normal renal function.
M' hemm bżonn ta 'ebda tibdil fid- doża meta jingħata flimkien ma ’ probenecid lil pazjenti b' funzjoni renali normali.
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.
Meta jingħata flimkien ma ’ probenecid, li huwa inibitur qawwi tal- passaġġ anijoniku ta ’ sekrezzjoni tubulari renali, jirriżulta f’ espożizzjoni bejn wieħed u ieħor darbtejn akbar għall- metabolu attiv ta 'oseltamivir.
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Dan jissuġerixxi li l- interazzjoni ta 'oseltamivir ma' dan il- passaġġ hi dgħajfa.
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.
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.
However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e. g., chlorpropamide, methotrexate, phenylbutazone).
Madankollu, għandha tingħata attenzjoni meta jiġi ordnat oseltamivir għal individwi li jkunu qegħdin jieħdu prodotti li jiġu eliminati flimkien b' marġni terapewtiku dejjaq (eż., chlorpropamide, methotrexate, phenylbutazone).
No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetyl-salicylic acid, cimetidine or with antacids (magnesium and aluminium hydroxides and calcium carbonates).
Ma ġew osservati l- ebda interazzjonijiet farmakokinetiċi bejn oseltamivir u l- metabolu prinċipali tiegħu meta oseltamivir ingħata flimkien ma ’ paracetamol, ma 'acetyl- salicylic acid, ma ’ cimetidine jew ma' l- antaċidi (magnesium u aluminium hydroxides u calcium carbonates).
There are no adequate data from the use of oseltamivir in pregnant women.
M' hemmx tagħrif biżżejjed dwar l- użu ta 'oseltamivir waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embrjoniku/ fetu jew żvilupp wara t - twelid (ara sezzjoni 5. 3).
Oseltamivir should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Oseltamivir m' għandux jintuża waqt it- tqala sakemm il- benefiċċju potenzjali għall- omm ma jiġġustifikax ir- riskju potenzjali għall- fetu.
In lactating rats, oseltamivir and the active metabolite are excreted in the milk.
Fil- ġrieden li jkunu qed ireddgħu, oseltamivir u l- metabolu attiv dehru fil- ħalib tas- sider.
It is not known whether oseltamivir or the active metabolite are excreted in human milk.
Mhuwiex magħruf jekk oseltamivir jew il- metabolu attiv jiħorġux fil- ħalib tal- bniedem.
Oseltamivir should be used during breast-feeding only if the potential benefit for the mother justifies the potential risk for the breast-fed infant.
Waqt it- treddigħ oseltamivir għandu jintuża biss jekk il- benefiċċju potenzjali għall- omm jiġġustifika r- riskju potenzjali għat- tarbija mreddgħa.
Tamiflu has no influence on the ability to drive and use machines.
Tamiflu m' għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
The overall safety profile of Tamiflu is based on data from 2107 adult and 1032 paediatric patients treated for influenza, and on data from 2914 adult and 99 paediatric patients receiving Tamiflu for the prophylaxis of influenza in clinical trials.
Il- profil ta ’ sigurtà globali ta ’ Tamiflu huwa bbażat fuq tagħrif minn 2107 pazjent adult u 1032 pazjent pedjatriku kkurati għall- influwenza, u fuq tagħrif ieħor minn 2914 pazjent adult u 99 pazjent pedjatriku li rċevew Tamiflu għall- profilassi ta ’ l- influwenza fi provi kliniċi.
The majority of these ADRs
Fl- adulti l- aktar reazzjonijiet avversi tal- mediċina rrapportati b’ mod komuni (ADRs) fl- adulti, fl - istudji ta ’ kura, kienu rimettar u tqalligħ, u fl- istudji ta ’ prevenzjoni kienu tqalligħ u uġigħ ta ’ ras.
5 were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
Il - maġġoranza ta ’ dawn l- ADRs kienu rrapportati f’ okkażjoni waħda fl- ewwel jew fit- tieni ġurnata ta ’ kura u għaddew spontanjament fi żmien ġurnata sa tnejn.
In children, the most commonly reported adverse drug reaction was vomiting.
L- aktar reazzjoni avversa tal- mediċina rrapportata b’ mod komuni fit- tfal, kienet rimettar.
The ADRs listed in the tables below fall into the following categories:
L- ADRs imniżżla fit- tabelli isfel jaqgħu taħt il- kategoriji li ġejjin:
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), Very rare (< 1/ 10,000) and not known (cannot be estimated from the available data).
Komuni Ħafna (≥ 1/ 10), Komuni (≥ 1/ 100 sa < 1/ 10), Mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), Rari (≥ 1/ 10, 000 sa < 1/ 1, 000), Rari ħafna (< 1/ 10, 000) u mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
ADRs are added to the appropriate category in the tables according to the pooled analysis from clinical trials.
ADRs huma miżjuda mal- kategorija rilevanti fit- tabelli skond l- analiżi miġbura mill- provi kliniċi.
Within each frequency grouping ADRs are presented in the order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- ADRs huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Treatment and prevention of influenza in adults and adolescents:
Il- kura u l- prevenzjoni ta 'l- influwenza fl- adulti u l- adoloxxenti:
Most Frequent Adverse Drug Reactions (≥ 1% in the oseltamivir group) in Studies Investigating Tamiflu for Treatment and Prevention of Influenza in Adults and Adolescents or Through Post- Marketing Surveillance
L- Aktar Reazzjonijiet Avversi tal- Mediċina Frekwenti (≥ 1% fil- grupp ta ’ oseltamivir) fl - Istudji li Nvestigaw Tamiflu għall- Kura u l- Prevenzjoni ta ’ l- Influwenza fl- Adulti u fl - Adoloxxenti jew Minn Sorveljanza ta ’ Wara t- Tqegħid fis- Suq
System Organ Class (SOC) Frequency Category
Sistema tal- Klassifika tal- Organi (SOC)
Percentage of Patients Experiencing the ADR Treatment Prevention
Persentaġġ ta ’ Pazjenti li Kellhom l- ADR Kura Prevenzjoni
Adverse Drug Reaction
Kategorija ta ’ Frekwenza Reazzjoni Avversa tal- Mediċina
Placebo Oseltamivir 75 mg od
Plaċebo Oseltamivir 75 mg od
Bronchitis Bronchitis acute Upper respiratory tract infections Psychiatric disorders Uncommon:
Bronkite Bronkite akuta Infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq Disturbi psikjatriċi Mhux Komuni:
Hallucinationa
Alluċinazzjonijieta Disturbi fis- sistema nervuża Komuni Ħafna:
Nervous system disorders Very Common:
Uġigħ ta ’ ras Komuni:
Common:
Insomnja Mhux komuni:
Convulsiona
Konvulżjonia Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Disorders of the ear and labyrinth Common:
Vertigo Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Cough Rhinorrhoea
Sogħla Rinoreja
6% 1%
6 Sistema tal- Klassifika tal- Organi (SOC)
Gastrointestinal disorders Very Common:
Disturbi gastro- intestinali Komuni Ħafna:
Nauseab, c
Tqalligħb, c Komuni:
Vomitingc Abdominal pain Diarrhoea Dyspepsia
Rimettarc Uġigħ addominali Dijarea Dispepsja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux Komuni:
Adverse Drug Reaction
Dermatitea
Skin and subcutaneous tissue disorders Uncommon:
Raxxa Urtikarjaa a
Dermatitisa Rasha Urticariaa Eczemaa General disorders Common:
Disturbi ġenerali Komuni:
< 1% < 1% < 1% < 1%
Sturdament Għeja
2% 1% < 1%
Uġigħ
These are events identified during post-marketing surveillance.
Dawn huma avvenimenti identifikati waqt is- sorveljanza ta ’ wara t- tqegħid fis- suq.
They were also reported in the pooled clinical studies at the incidence presented in the table above. b Subjects who experienced nausea alone; excludes subjects who experienced nausea in association with vomiting. c The difference between the placebo and oseltamivir groups was statistically significant.
Huma kienu irrapportati wkoll fl- istudji kliniċi miġbura fl- inċidenza ppreżentata fit- tabella fuq. b Individwi li kellhom tqalligħ biss; individwi li kellhom tqalligħ flimkien ma ’ rimettar huma esklużi. c Id- differenza bejn il- gruppi ta ’ plaċebo u ta ’ oseltamivir kienet statistikament sinifikanti.
Treatment and prevention of influenza in children:
Il- kura u l- prevenzjoni ta 'l- influwenza fit- tfal:
The table below shows the most frequently reported ADRs from paediatric clinical trials.
It- tabella isfel turi l- ADRs irrapportati b’ mod l- aktar frekwenti minn provi kliniċi fit- tfal.
Most Frequent Adverse Drug Reactions (≥ 1% in the oseltamivir group in the treatment studies and ≥ 10% in the oseltamivir group in the prophylaxis study) in Children
L- Aktar Reazzjonijiet Avversi tal- Mediċina Frekwenti (≥ 1% fil- grupp ta ’ oseltamivir) fl- istudji ta ’ kura u ≥ 10% fil- grupp ta ’ oseltamivir fl- istudju ta ’ profilassi) fit- Tfal
System Organ Class (SOC) Frequency Category
Sistema tal- Klassifika tal- Organi
Percentage of Patients Experiencing the ADR Treatment Treatment Preventiona
Persentaġġ ta ’ Pazjenti li Kellhom l- ADR Prevenzjonia
Adverse Drug Reaction
Kategorija ta ’ Frekwenza
Placebo Oseltamivir
Oseltamivir 30 to 75 mgb
Oseltamivir Placebo Oseltamivir
Reazzjoni Avversa tal- Mediċina
Oseltamivir
2 mg/ kg bid
Pneumonia Sinusitis Bronchitis Otitis media Disorders of the blood and lymphatic system Common:
Pnewmonja Sinusite Bronkite Otite medja Disturbi tad- demm u tas- sistema limfatika Komuni:
Lymphadenopathy Respiratory, thoracic and mediastinal disorders Common:
Limfadenopatija
7 System Organ Class (SOC) Frequency Category
7 Sistema tal- Klassifika tal- Organi
Oseltamivir
Kura Kura
Placebo Oseltamivir
Kategorija ta ’ Frekwenza Reazzjoni Avversa tal- Mediċina
Oseltamivir Placebo Oseltamivir
Oseltamivir 2 mg/ kg bid
Common:
Oseltamivir 30 to 75 mgb
2
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Nausea Abdominal pain Disorders of the eye Common:
Ażżma (inkl. aggravata) Epistassi Disturbi gastro- intestinali Komuni Ħafna:
Conjunctivitis Disorders of the ear and labyrinth Common:
Disturbi fl- għajnejn Komuni:
Ear disorderc Tympanic membrane disorder Skin and subcutaneous tissue disorders Common:
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
a
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni: a
The prevention study did not contain a placebo arm, i. e. was an uncontrolled study. b Unit dose = weight-based dosing (see section 4.2). c Patients experienced ear ache and ear pain.
L- istudju ta ’ prevenzjoni ma kienx fih grupp bil- plaċebo, i. e. kien studju mhux ikkontrollat. b Doża waħda = dożaġġ ibbażat fuq l- użin (ara sezzjoni 4. 2). c Pazjenti esperjenzaw weġgħat fil- widnejn u uġigħ fil- widnejn.
In general, the adverse event profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Ġeneralment, il- profil ta ’ avvenimenti avversi ta ’ tfal b’ ażżma fil- bronki eżistenti minn qabel kien simili b’ mod kwalitattiv għal dak ta ’ tfal b’ saħħithom.
Further post marketing surveillance data on selected serious adverse drug reactions:
Aktar data mill- esperjenza ta ’ wara t- tqegħid fis- suq dwar reazzjonijiet avversi serji tal- mediċina magħżula:
Immune system disorder Frequency not known: hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions.
Disturbi fis- sistema immuni Frekwenza mhux magħrufa: reazzjonijiet ta ’ sensittività eċċessiva, inkluż reazzjonijiet anafilattiċi/ anafilattojdi.
Psychiatric disorders and nervous system disorders Frequency not known: influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Disturbi psikjatriċi u disturbi fis- sistrma nervuża Frekwenza mhux magħrufa: l- influwenza tista ’ tkun assoċjata ma ’ varjetà ta ’ sintomi newroloġiċi u ta ’ mġiba li jistgħu jinkludu avvenimenti bħal alluċinazzjonijiet, thewdin, u mġiba mhux normali, li f’ xi każijiet iwasslu għal riżultati fatali.
These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Dawn l- avvenimenti jistgħu jseħħu f’ sitwazzjoni ta ’ enċefalite jew enċefalopatija iżda jistgħu jseħħu mingħajr marda serja ovvja.
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 accidental injury or fatal outcomes.
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 għal korriment aċċidentali jew riżultati fatali.
These events were reported primarily among pediatric and adolescent patients and often had an abrupt onset and rapid resolution.
8 kontribuzzjoni ta ’ Tamiflu għal dawn l- avvenimenti mhux magħrufa.
Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
Avvenimenti newropsikjatriċi bħal dawn kienu rrapportati wkoll f’ pazjenti bl- influwenza li ma kienux qed jieħdu Tamiflu.
Eye disorders Frequency not known: visual disturbance.
Disturbi fl- għajnejn Frekwenza mhux magħrufa: disturbi fil- vista.
Cardiac disorders Frequency not known: cardiac arrhythmia.
Disturbi fil- qalb Frekwenza mhux magħrufa: arritmija kardijaka.
Gastrointestinal disorders Frequency not known: gastrointestinal bleedings and hemorrhagic colitis.
Disturbi gastro- intestinali Frekwenza mhux magħrufa: fsad gastro- intestinali u kolite emorraġika.
Hepato-biliary disorders Frequency not known: hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness.
Disturbi fil- fwied u fil- marrara Frekwenza mhux magħrufa: disturbi fis- sistema tal- fwied u l- marrara, inkluż epatite u żjieda fl- enżimi tal- fwied f’ pazjenti b’ marda li tixbaħ lill- influwenza.
These cases include fatal fulminant hepatitis/ hepatic failure.
Dawn il- każijiet jinkludu epatite li tiżviluppa f’ daqqa/ insuffiċjenza tal- fwied fatali.
8 Skin and subcutaneous tissue disorders Frequency not known: severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and angioneurotic oedema.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Frekwenza mhux magħrufa: reazzjonijiet severi fil- ġilda, inkluż is- sindrome ta ’ Stevens- Johnson, nekrolisi tossika ta ’ l- epidermide, eritema multiforme u edima anġjonewrotika.
Additional information on special populations:
Aktar tagħrif dwar popolazzjonijiet speċjali:
There were no clinically relevant differences in the safety population of the elderly subjects who received oseltamivir or placebo compared with the adult population aged up to 65 years.
Ma kien hemm l- ebda differenzi klinikament rilevanti fil- popolazzjoni ta ’ sigurtà ta ’ individwi anzjani li rċevew oseltamivir jew plaċebo meta mqabbel mal- popolazzjoni adulta ta ’ età sa 65 sena.
The adverse event profile in adolescents and patients with chronic cardiac and/ or respiratory disease was qualitatively similar to those of healthy young adults.
Il- profil ta ’ avvenimenti avversi fl- adoloxxenti u pazjenti b’ marda kardijaka u/ jew respiratorja kronika kien kwalitattivament simili għal dak ta ’ adulti żgħażagħ b’ saħħithom.
There is no experience with overdose.
L- ebda każ ta ’ doza eċċessiva ma ġie rrappurtat.
However, the anticipated manifestations of acute overdose would be nausea, with or without accompanying vomiting, and dizziness.
Madankollu, il- manifestazzjoni mistennija f' każ ta 'doża eċċessiva akuta tkun dardir, bir- rimettar jew mingħajr rimettar, u sturdament.
Patients should discontinue the treatment in the event of overdose.
F' każ ta 'doża eċċessiva, l- pazjenti għandhom iwaqqfu l- kura.
No specific antidote is known.
M' hemm l- ebda antidotu speċifiku.
Antiviral ATC code:
Antivirali Kodiċi ATC:
Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate).
Oseltamivir phospate huwa pro- droga tal- metabolu attiv (oseltamivir carboxylate).
The active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface.
Il- metabolu attiv huwa inibitur selettiv ta ’ l- enżimi neuraminidase tal- virus ta 'l- influwenza, li huma glikoproteini li jinstabu fuq is- superfiċje tal- virjon.
Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.
L- attività ta 'l- enżimi neuraminidase virali hija mportanti kemm għad- dħul tal- virus f’ ċelloli mhux infettati kif ukoll għat- tluq tal- partiċelli tal- virus ffurmati riċentament miċ- ċelloli infettati u għat- tkomplija tal- firxa tal- virus infettiv fil- ġisem.
Oseltamivir carboxylate inhibits influenza A and B neuraminidases in vitro.
Oseltamivir carboxylate jinibixxi n- neuraminidases ta 'l- influwenza A u B in vitro.
Oseltamivir phosphate inhibits influenza virus infection and replication in vitro.
Oseltamivir phosphate jinibixxi l- infezzjoni b’ virus tal- influwenza u r- replikazzjoni in vitro.
Oseltamivir given orally inhibits influenza A and B virus replication and pathogenicity in vivo in animal models of influenza infection at antiviral exposures similar to that achieved in man with 75 mg twice daily.
Oseltamivir mogħti mill- ħalq jinibixxi r- replikazzjoni u l- patoġeniċità tal- virus ta 'l- influwenza A u B in vivo f' mudelli ta' annimali b’ infezzjoni ta ’ l- influwenza b' espożizzjonijiet antivirali simili għal dik miksuba fil- bniedem b' 75 mg darbtejn kuljum.
Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge studies in healthy volunteers.
L- attività antivirali ta 'oseltamivir għall- influwenza A u B ġiet sostnuta minn studji sperimentali li fihom voluntiera f' saħħithom ħadu sehem fi studji ta ’ ċalinġ.
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.
9 Il- valuri ta 'l- 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.
Higher IC50 values for influenza B, up to a median of 8.5 nM, have been observed in published trials.
Valuri ogħla ta ’ IC50 għall- influwenza B, sa medjan ta '8. 5 nM, kienu osservati fi provi li ġew ippubblikati.
Reduced sensitivity of viral neuraminidase There has been no evidence for emergence of drug resistance associated with the use of Tamiflu in clinical studies conducted to date in post-exposure (7 days), post-exposure within household groups (10 days) and seasonal (42 days) prevention of influenza.
Sensittività mnaqqsa tan- neuraminidase virali Ma kien hemm l- ebda evidenza ta ’ żvilupp ta ’ reżistenza għall- mediċina assoċjat ma ’ l- użu ta ’ Tamiflu fl- istudji kliniċi wara espożizzjoni (sebat ijiem), wara espożizzjoni fi gruppi ta ’ nies fl- istess dar (għaxart ijiem) u tal- istaġun (42 jum) magħmula sal- lum għall- prevenzjoni tal- influwenza.
The risk of emergence of influenza viruses with reduced susceptibility or frank resistance to oseltamivir has been examined during Roche-sponsored clinical studies.
Ir- riskju ta ’ żvilupp ta ’ virusis ta ’ l- influwenza b’ suxxettibilità mnaqqsa jew b’ reżistenza ċara għal oseltamivir kien eżaminat waqt studji kliniċi sponsorjati minn Roche.
All patients who were found to carry oseltamivir-resistant virus did so transiently, cleared the virus normally and showed no clinical deterioration.
Il- pazjenti kollha li nstab li kellhom virus reżistenti għal oseltamivir kellhom dan għal xi żmien, ħelsu mill- virus b’ mod normali u ma wrew l- ebda deterjorament kliniku.
9 Patients with Resistance Mutations (%)
Pazjenti b’ Mutazzjonijiet Reżistenti (%)
Patient Population
Popolazzjoni ta ’ Pazjenti
Phenotyping*
Determinazzjoni tal - Fenotip *
Geno- and Phenotyping*
Determinazzjoni tal - Ġenotip u l- Fenotip *
Adults and adolescents Children (1-12 years)
Adulti u adoloxxenti Tfal (1- 12- il sena)
4/ 1245 (0.32%) 19/ 464 (4.1%)
4/ 1245 (0. 32%) 19/ 464 (4. 1%)
5/ 1245 (0.4%) 25/ 464 (5.4%)
5/ 1245 (0. 4%) 25/ 464 (5. 4%)
* Full genotyping was not performed in all studies.
* Ma kienx determinat il- ġenotip sħiħ fl- istudji kollha
The rate of emergence of resistance may be higher in the youngest age groups, and in immunosupressed patients.
Ir- rata ta ’ żvilupp ta ’ reżistenza tista ’ tkun għola fil- gruppi ta ’ l- iżgħar età, u f’ pazjenti mmunosoppressi.
Resistance mutations tend to be viral sub-type specific (including those found in H5N1 variants).
Viruses reżistenti għal oseltamivir iżolati minn pazjenti kkurati b’ oseltamivir u minn razez tal- laboratorju ta ’ viruses ta ’ l- 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 (inkluż dawk li nstabu fil- varjanti ta ’ H5N1).
Naturally occurring mutations in influenza A/ H1N1 virus associated with reduced susceptibility to oseltamivir in vitro have been detected in patients who, based on the reported information, have not been exposed to oseltamivir.
Mutazzjonijiet li jseħħu b’ mod naturali fil- virus ta ’ l- influwenza A/ H1N1 assoċjati ma ’ suxxettibilità mnaqqsa għal oseltamivir in vitro instabu f’ pazjenti li, bbażat fuq l- informazzjoni rrapportata, ma ġewx esposti għal oseltamivir.
The extent of reduction in susceptibility to oseltamivir and the prevalence of such viruses appears to vary seasonally and geographically.
L- ammont ta ’ tnaqqis fis- suxxettibilità għal osteltamivir u l- prevalenza ta ’ virusis bħal dawn jidher li jvarja ma ’ l- istaġuni u ġeorafikament.
Treatment of influenza infection Oseltamivir is effective only against illnesses caused by influenza virus.
Il- kura ta 'l- infezzjoni ta' l- influwenza Oseltamivir huwa effettiv biss kontra l- mard ikkawżat mill- virus ta 'l- influwenza.
Statistical analyses are therefore presented only for influenza-infected subjects.
Għalhekk, l- analiżi statistiċi huma ppreżentati biss għal individwi infettati bl- influwenza.
In the pooled treatment study population, which included both influenza-positive and -negative subjects (ITT), primary efficacy was reduced proportional to the number of influenza-negative individuals.
Fil- kampjun ta 'popolazzjoni mħallta għall- istudju fuq il- kura, li kien jinkludi kemm pazjenti pożittivi kif ukoll oħrajn negattivi għall- influwenza (ITT), l- effikaċja primarja tnaqqset proporzjonalment skond n- numru ta' individwi negattivi għall- influwenza.
In the overall treatment population, influenza infection was confirmed in 67% (range 46% to 74%) of the recruited patients.
Fil- popolazzjoni kollha li ngħatat l- kura, l- infezzjoni ta 'l- influwenza ġiet ikkonfermata f' 67% (medda ta' bejn 46% u 74%) tal- pazjenti.
Of the elderly subjects, 64% were influenza-positive and of those with chronic cardiac and/ or respiratory disease 62% were influenza-positive.
Fost l- anzjani, 64% kienu pożittivi għall- influwenza u fost dawk li għandhom mard tal- qalb kroniku u/ jew mard resipiratorju 62% kienu pożittivi għall- influwenza.
In all phase III treatment studies, patients were recruited only during the period in which influenza was circulating in the local community.
Fl- istudji kollha fuq il- kura tal- fażi III, il- pazjenti ġew reklutati biss waqt perijodu meta kien hemm il- passa ta 'l- influenza fil- komunità lokali tagħhom.
Adults and adolescents 13 years of age and older:
L- adulti u l- adoloxxenti b’ età minn 13- il sena 'l fuq:
Patients were eligible if they reported within 36 hours of onset of symptoms, had fever ≥ 37.8 °C, accompanied by at least one respiratory symptom (cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia, chills/ sweats, malaise, fatigue or headache).
Il- pazjenti kienu eliġibbli għall- istudju jekk irrapportaw is- sintomi fi żmien 36 siegħa, jekk kellhom deni ta '≥ 37. 8 °C, flimkien ma' ta 'lanqas sintomu respiratorju wieħed (sogħla, sintomi fl- imnieħer jew griżmejn jaħarqu) u almenu sintomu sistemiku wieħed (uġigħ fil- muskoli, tkexkix tal- bard/ għaraq, telqa, għeja jew uġigħ ta' ras).
In a pooled analysis of all influenza-positive adults and adolescents (N = 2413) 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).
F' analiżi imħallta ta 'l- adulti u l- adoloxxenti li kienu kollha pożittivi għall- influwenza (N = 2413) li ħadu sehem fl- istudji dwar il- kura, l- għoti ta ’ 75 mg oseltamivir darbtejn kuljum għal ħamest ijiem naqqas il - perijodu medjan ta' l- 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).
The proportion of subjects who developed specified lower respiratory tract complications (mainly bronchitis) treated with antibiotics was reduced from 12.7% (135/ 1063) in the placebo group to 8.6% (116/ 1350) in the oseltamivir treated population (p = 0.0012).
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/ 1063)
Treatment of influenza in high risk populations:
Il- kura ta 'l- influwenza f’ individwi li huma f' riskju ogħli:
The median duration of influenza illness in elderly subjects (≥ 65 years) and in subjects with chronic cardiac and/ or respiratory disease receiving oseltamivir 75 mg twice daily for 5 days was not reduced significantly.
Il- perjodu medjan ta ’ kemm damet il- marda ta 'l- influwenza fl- anzjani (≥ 65 sena) u f' pazjenti b' mard tal- qalb kroniku u/ jew mard respiratorju li ngħataw oseltamivir 75 mg darbtejn kuljum għal ħamest ijiem ma tnaqqasx b’ mod sinifikanti.
The total duration of fever was reduced by one day in the groups treated with oseltamivir.
Il - perijodu totali li damu bid- deni tnaqqas b' ġurnata waħda fil- gruppi fejn kien qed jingħata oseltamivir.
In the influenza-positive elderly, 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).
Fl- anzjani li kellhom l- influwenza, oseltamivir naqqas b’ mod sinifikanti l- inċidenza 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- grupp li ngħata oseltamivir (p = 0. 0156).
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).
Fost il- pazjenti pożittivi għall- influwenza li kellhom mard tal- qalb kroniku u/ jew mard respiratorju, l - inċidenza magħquda ta 'komplikazzjonijiet speċifikati 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 ttrattata b’ oseltamivir (p = 0. 5976).
Treatment of influenza in children:
Il- kura ta 'l- influwenza fit- tfal:
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.
Fi studju li sar fuq tfal li kienu altrimenti f' saħħithom (65% pożittivi għall- influwenza), ta 'etajiet minn sena sa 12- il sena (età medja ta' 5. 3 snin), li kellhom id- deni (≥ 37. 8 °C) flimkien ma 'sogħla jew koriża, 67% tal- pazjenti posittivi għall- influwenza kienu infettati bl- influwenza A u 33% bl- influwenza B.
Oseltamivir
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.
10 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).
Oseltamivir naqqas l- inċidenza ta 'l- otite medja akuta minn 26. 5% (53/ 200) fil- grupp tal- plaċebo għal 16% (29/ 183) fit- tfal li ngħataw oseltamivir (p = 0. 013).
A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6% were influenza-positive.
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.
In the oseltamivir treated group, the median duration of illness was not reduced significantly.
Fil- grupp fejn ingħataw oseltamivir, il- perijodu medjan tal - marda ma tnaqasx b' mod sinifikanti.
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.
Sas- 6 jum (l- aħħar jum tal- kura), l- FEV1 kien żdied b' 10. 8% fil - grupp fejn ngħataw oseltamivir mqabbel ma '4. 7% fil- grupp tal- plaċebo (p = 0. 0148) f' din il - popolazzjoni.
Treatment of influenza B infection:
Kura ta 'l- infezzjoni ta' l- influwenza B:
Overall, 15% of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33% in individual studies.
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.
The median duration of illness in influenza B infected subjects did not differ significantly between the treatment groups in individual studies.
Il - perijodu medjan ta ’ kemm damet il- marda fl- individwi infettati bl- influwenza B ma kienx differenti b' mod sinifikanti bejn il- gruppi ttrattati fl- istudji individwali.
Data from 504 influenza B infected subjects were pooled across all studies for analysis.
Informazzjoni nġabret minn 504 individwi infettati bl- influwenza B minn fost l- istudji kollha sabiex tiġi analizzata.
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 0.4 – 1.7 days; p < 0.001) compared to placebo.
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.
Prevention of influenza The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households and two seasonal prevention studies.
Il- prevenzjoni ta 'l- influwenza L- effikaċja ta' oseltamivir fil- prevenzjoni tal- marda ta 'l- influwenza li tittieħed b' mod naturali ntweriet fi studju ta' prevenzjoni ta ’ wara l- espożizzjoni li sar fid- djar u f' żewġ studji ta 'prevenzjoni fl- istaġun.
The primary efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza.
Il- parametru prinċipali ta 'l- effikaċja għal dawn l- istudji kollha kien l- inċidenza ta' influwenza kkonfermata fil- laboratorju.
The virulence of influenza epidemics is not predictable and varies within a region and from season to season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness varies.
Il- ħruxija ta 'l- epidemiji ta' l- influwenza ma tistax titbassar u tvarja fl - istess reġjun u minn staġun għal ieħor, għalhekk in- numru meħtieġ biex tikkura (NNT) sabiex tipprevjeni każ wieħed tal- marda ta 'l- influwenza jvarja.
Post-exposure prevention:
Prevenzjoni wara l- espożizzjoni:
In a study in contacts (12.6% vaccinated against influenza) of an index case of influenza, oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in the index case and continued for seven days.
Fi studju f’ persuni (12. 6% imlaqmin kontra l- influwenza) li kellhom kuntatt ma 'każ indiċi ta' influwenza, il- kura b’ 75 mg oseltamivir mogħtija darba kuljum, inbdiet fi żmien jumejn minn meta dehru s- sintomi fil- każ indiċi u tkompliet għal sebat ijiem.
Influenza was confirmed in 163 out of 377 index cases.
L- influwenza ġiet ikkonfermata f' 163 mit- 377 każ indiċi.
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]).
Oseltamivir naqqas b’ mod sinifikanti l- inċidenza tal- marda ta 'l- influwenza klinika f' dawk li kellhom kuntatt ma' każi kkonfermati ta 'l- influwenza minn 24/ 200 (12%) fil- grupp tal- plaċebo għal 2/ 205 (1%) fil- grupp ta' oseltamivir (tnaqqis ta '92% [95% CI 6 – 11 16; p ≤ 0. 0001]).
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.
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 ta 'l - infezzjoni tal- każ indiċi.
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households that included adults, adolescents, and children aged 1 to 12 years, both as index cases and as family contacts.
L- effikaċja ta ’ Oseltamivir li jipprevjeni l- marda tal- influwenza li sseħħ b’ mod naturali ġiet demonstrata fi studju ta ’ prevenzjoni wara espożizzjoni fi djar li nkluda adulti, adoloxxenti u tfal b’ età ta ’ sena sa 12- il sena, kemm bħala każijiet indiċi kif ukoll bħala kuntatti tal- familja.
The primary efficacy parameter for this study was the incidence of laboratory-confirmed clinical influenza in the households.
Il- parametru primarju tal- effikaċja f’ dan l- istudju kien l- inċidenza fid- djar ta ’ influwenza klinika kkonfermata fil - laboratorju.
Oseltamivir prophylaxis lasted for 10 days.
Profilassi b’ Oseltamivir damet għal għaxart ijiem.