qanastek/EMEA-V3 huggingface dataset:
In the total population, there was a reduction in the incidence of laboratory-confirmed clinical influenza in households from 20% (27/ 136) in the group not receiving prevention to 7% (10/ 135) in the group receiving prevention (62.7% reduction [95% CI 26.0 – 81.2; p = 0.0042]).
Fil- popolazzjoni totali kien hemm tnaqqis fl- inċidenza fid- djar ta ’ influwenza klinika kkonfermata fil- laboratorju minn 20% (27/ 136) fil - grupp li ma kienux qed jirċievu prevenzjoni għal 7% (10/ 135) fil- grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta ’ 62. 7%, [95% CI 26. 0 - 81. 2; p = 0. 0042]).
In households of influenza-infected index cases, there was a reduction in the incidence of influenza from 26% (23/ 89) in the group not receiving prevention to 11% (9/ 84) in the group receiving prevention (58.5% reduction [95% CI 15.6 – 79.6; p = 0.0114]).
Fi djar b’ każijiet indiċi nfettati bl - influwenza, kien hemm tnaqqis fl- inċidenza tal- influwenza minn 26% (23/ 89) fil- grupp li ma kienux qed jirċievu prevenzjoni għal 11% (9/ 84) fil- grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta ’ 58. 5% [95% CI 15. 6 - 79. 6; p = 0. 0114]).
According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratory- confirmed clinical influenza among children was significantly reduced from 19% (21/ 111) in the group not receiving prevention to 7% (7/ 104) in the group receiving prevention (64.4% reduction [95% CI 15.8 – 85.0; p = 0.0188]).
Skond analiżi ta ’ sottogruppi fi tfal b’ età minn 1 sa 12- il sena, l- inċidenza ta ’ influwenza klinika kkonfermata fil- laboratorju kienet immnaqsa b’ mod sinifikanti minn 19% (21/ 111) fil- grupp li ma kienux qed jirċievu prevenzjoni għal 7% (7/ 104) fil- grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta ’ 64. 4% [95% CI 15. 8 - 85. 0; p = 0. 0188]).
Among children who were not already shedding virus at baseline, the incidence of laboratory-confirmed clinical influenza was reduced from 21% (15/ 70) in the group not receiving prevention to 4% (2/ 47) in the group receiving prevention (80.1% reduction [95% CI 22.0 – 94.9; p = 0.0206]).
Fost tfal li ma kienux qed ixerrdu l- virus minn qabel fil - linja bażika, l- inċidenza ta ’ influwenza klinika kkonfermata fil- laboratorju kienet immnaqqsa minn 21% (15/ 70) fil- grupp li ma kienux qed jirċievu prevenzjoni għal 4% (2/ 47) fil- grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta ’ 80. 1%, [95% CI 22. 0 - 94. 9; p = 0. 0206]).
The NNT for the total paediatric population was 9 (95% CI 7 – 24) and 8 (95% CI 6, upper limit not estimable) in the whole population (ITT) and in paediatric contacts of infected index cases (ITTII), respectively.
L- NNT għall - popolazzjoni pedjatrika totali kien ta ’ 9 (95% CI 7 - 24) u 8 (95% CI 6, limitu ta ’ fuq mhux stmat) fil- popolazzjoni kollha (ITT) u f’ kuntatti pedjatriċi ta ’ każijiet indiċi infettati (ITTII), rispettivament.
Prevention during an influenza epidemic in the community:
Prevenzjoni waqt epidemija ta ’ influwenza fil- komunità:
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
F' analiżi kkombinat ta 'żewġ studji oħra li saru fuq adulti li ma kinux imlaqma iżda altrimenti b' saħħithom, 75 mg ta ’ oseltamivir mogħti darba kuljum għal 6 ġimgħat naqqas b' mod sinifikanti l- inċidenza tal- marda ta' l- influwenza klinika minn 25/ 519 (4. 8%) fil- grupp tal- plaċebo għal 6/ 520 (1. 2%) fil- grupp ta 'oseltamivir (tnaqqis ta' 76% [95% CI 1. 6 – 5. 7; p = 0. 0006]) wara tifqigħa tal- influwenza fil- komunità.
The NNT in this study was 28 (95% CI 24 – 50).
L- NNT f' dan l- istudju kien ta '28 (95% CI 24 – 50).
A study in elderly residents of nursing homes, where 80% of participants received vaccine in the season of the study, oseltamivir 75 mg once daily given for 6 weeks significantly reduced the incidence of clinical influenza illness from 12/ 272 (4.4%) in the placebo group to 1/ 276 (0.4%) in the oseltamivir group (92% reduction [95% CI 1.5 – 6.6; p = 0.0015]).
Studju li sar fuq ir- residenti tad- djar ta 'l- anzjani, fejn 80% tal- parteċipanti ħadu t- tilqima fl- istaġun li fih sar l- istudju, 75 mg oseltamivir mogħti darba kuljum għal 6 ġimgħat naqqas b’ mod sinifikanti l - inċidenza tal- marda ta' l- influwenza klinika minn 12/ 272 (4. 4%) fil- grupp tal- plaċebo għal 1/ 276 (0. 4%) fil- grupp ta 'oseltamivir (tnaqqis ta' 92% [95% CI 1. 5 – 6. 6; p = 0. 0015]).
The NNT in this study was 25 (95% CI 23 – 62).
L- NNT f' dan l- istudju kien 25 (95% CI 23 – 62).
Specific studies have not been conducted to assess of the reduction in the risk of complications.
Ma sarux studji speċifiċi biex jiġi assessjat it- tnaqqis fir- riskju ta 'komplikazzjonijiet.
Absorption Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active metabolite (oseltamivir carboxylate).
Assorbiment Oseltamivir jiġi assorbit sew mill- passaġġ gastrointestinali wara li oseltamivir phosphate (il - pro- droga) jittieħed mill- ħalq u jinbidel estensivament fil- metabolu attiv (oseltamivir carboxylate) priċipalment permezz ta 'esterases epatiċi.
At least 75% of an oral dose reaches the systemic circulation as the active metabolite.
Mhux anqas minn 75% tad- doża orali tasal fiċ - ċirkulazzjoni sistemika bħala metabolu attiv.
Exposure to the pro-drug is less than 5% relative to the active metabolite.
L- espożizzjoni għall- pro- droga hija ta 'anqas minn 5% meta mqabbla mal- metabolu attiv.
Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are unaffected by co-administration with food.
Il- konċentrazzjonijiet fil- plażma kemm tal- pro- droga kif ukoll tal - metabolu attiv huma proporzjonali għad- doża u ma jagħmilx effett jekk jittieħed ma 'l- ikel.
Distribution The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 23 litres in humans, a volume equivalent to extracellular body fluid.
Distribuzzjoni Il- volum medju tad- distribuzzjoni ta ’ oseltamivir carboxylate fi stat stabbli huwa ta 'madwar 23 litru fil- bnedmin, liema volum huwa ekwivalenti għall- fluwidu estraċellulari tal- ġisem.
Since neuraminidase activity is extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread.
Billi l- attività ta ’ neuraminidase hija estraċellulari, oseltamivir carboxylate jitqassam fil- postijiet kollha fejn jinfirex il - virus ta 'l- influwenza.
The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3%).
L- irbit oseltamivir carboxylate mal- proteina tal- plażma umana hija negliġibbli (madwar 3%).
Metabolism Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in the liver.
12 Metaboliżmu Oseltamivir jinbidel estensivament f’ oseltamivir carboxylate permezz ta 'l- esterases li fil- biċċa l- kbira tagħhom jinstabu fil- fwied.
In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate for, or an inhibitor of, the major cytochrome P450 isoforms.
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.
No phase 2 conjugates of either compound have been identified in vivo.
L- ebda konjugat ta 'fażi II ta' xi wieħed mis- sustanzi ma ġie identifikat in vivo.
Elimination Absorbed oseltamivir is primarily (> 90%) eliminated by conversion to oseltamivir carboxylate.
Eliminazzjoni Oseltamivir li jiġi assorbit jiġi primarjament (> 90%) eliminat billi jibidel f’ oseltamivir carboxylate.
It is not further metabolised and is eliminated in the urine.
Dan ma jkomplix jiġi metabolizzat u jiġi eliminat ma 'l- urina.
Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Il- konċentrazzjonijiet massimi ta 'oseltamivir carboxylate fil- plażma jitbaxxew b’ half- life ta' bejn 6 sa 10 sigħat fil- biċċa l- kbira tal - individwi.
The active metabolite is eliminated entirely by renal excretion.
Il- metabolu attiv jiġi eliminat kompletament billi jitneħħa mill- kliewi.
Renal clearance (18.8 l/ h) exceeds glomerular filtration rate (7.5 l/ h) indicating that tubular secretion occurs in addition to glomerular filtration.
It- tneħħija mill - kliewi (18. 8 l/ h) teċċedi r- rata ta 'filtrazzjoni glomerulari (7. 5 l/ h) li jindika li s- sekrezzjoni tubulari sseħħ flimkien mal- filtrazzjoni glomerulari.
Less than 20% of an oral radiolabelled dose is eliminated in faeces.
Inqas minn 20% ta 'doża orali, li kienet mmarkata b’ sustanza radjuattiva, tneħħiet ma' l- ippurgar.
Renal impairment Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional to declining renal function.
Indeboliment renali L- għoti ta '100 mg oseltamivir phosphate darbtejn kuljum għal ħamest ijiem lil pazjenti b' indebolimenti renali ta' intensità differenti wera li l- espożizzjoni għal oseltamivir carboxylate hija inversament proporzjonali għat- tnaqqis fil- funzjoni tal- kliewi.
For dosing, see section 4.2.
Għad- dożaġġ, ara sezzjoni 4. 2.
Hepatic impairment In vitro studies have concluded that exposure to oseltamivir is not expected to be increased significantly nor is exposure to the active metabolite expected to be significantly decreased in patients with hepatic impairment (see section 4.2).
Indeboliment epatiku Studji in vitro kkonkludew li la l- espożizzjoni għal oseltamivir m' hi mistennija li tiżdied b’ mod sinifikanti u lanqas l- espożizzjoni għall- metabolu attiv m' hi mistennija li tonqos b’ mod sinifikanti f' pazjenti b' indeboliment epatiku (ara sezzjoni 4. 2).
Elderly Exposure to the active metabolite at steady state was 25 to 35% higher in elderly (age 65 to 78 years) compared to adults less than 65 years of age given comparable doses of oseltamivir.
L- anzjani L- espożizzjoni għall- metabolu attiv fi stat stabbli kienet minn 25% sa 35% ogħla fl- anzjani (etajiet minn 65 sa 78 sena) meta mqabbla ma 'l- adulti ta' taħt il- 65 sena, li ngħataw dożi komparabbli ta 'oseltamivir.
Half-lives observed in the elderly were similar to those seen in young adults.
Il- half- lives li ġew osservati fl- anzjani kienu simili għal dawk li dehru fl- adulti żgħażagħ.
On the basis of drug exposure and tolerability, dosage adjustments are not required for elderly patients unless there is evidence of severe renal impairment (creatinine clearance below 30 ml/ min) (see section 4.2).
Fuq bażi ta 'espożizzjoni u tollerabbiltà, m' hemm bżonn l- ebda tibdil tad- doża għall- anzjani sakemm ma jkunx hemm evidenza ta' indeboliment renali serju (tneħħija tal- krejatinina taħt it- 30 ml/ min) (ara sezzjoni 4. 2).
12 Children The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in children aged 1 to 16 years.
It- tfal Il- farmakokinetika ta 'oseltamivir ġiet evalwata fi studji farmakokinetiċi b' dożi singoli fi tfal ta ’ età minn sena sa 16- il sena.
Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical efficacy study.
Il- farmakokinetika b' dożi multipli ġiet studjata f' numru żgħir ta 'tfal li ħadu sehem fi studju dwar l- effikaċja klinika.
Younger children cleared both the pro-drug and its active metabolite faster than adults, resulting in a lower exposure for a given mg/ kg dose.
It- tfal iż- żgħar neħħew kemm il- pro- droga kif ukoll il - metabolu attiv b' aktar ħeffa mill- adulti, li rriżulta f' espożizzjoni aktar baxxa għad- doża mg/ kg li ngħatat.
Doses of 2 mg/ kg give oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 1 mg/ kg).
Dożi ta '2 mg/ kg jagħtu espożizzjoni ta' oseltamivir carboxylate komparabbli għal dik miksuba fl- adulti, li jieħdu doża waħda ta '75 mg (madwar 1 mg/ kg).
The pharmacokinetics of oseltamivir in children over 12 years of age are similar to those in adults.
Il- farmakokinetika ta 'oseltamivir fi tfal' il fuq minn 12- il sena hija simili għal dik fl- adulti.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
Tagħrif ta ’ qabel l- użu kliniku bbażat fuq studji konvenzjonali dwar is- sigurtà farmakoloġika, l- effett tossiku minn dożi ripetuti u fuq il- ġenotossiċita, ma juri l- ebda periklu speċjali għall- bnedmin.
Results of the conventional rodent carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some tumours that are typical for the rodent strains used.
Ir- riżultati ta 'studji konvenzjonali dwar il- karċinoġeniċità magħmula fuq ir- rodenti, urew tendenza lejn żjieda, li hija proporzjonata mad- doża, fl- inċidenza ta' xi tumuri li huma tipiċi fir- razez tar- rodenti li ntużaw.
Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of Tamiflu in its adopted therapeutic indications.
Meta jiġu kkunsidrati l- marġni ta 'espożizzjoni mqabbla ma' l- espożizzjoni mistennija fl- użu mill- bnedmin, dawn is- sejbiet ma jbiddlux il- benefiċċji u r- riskji ta ’ Tamiflu kif addottati fl- indikazzjonijiet terapawtiċi.
No effects on foetal development were observed.
Fi studji teratoloġiċi li saru fuq il- firien u l- fniek li ngħataw dożi sa 1500 mg/ kg/ jum u 500 mg/ kg/ jum, rispettivament, l- ebda effetti ma ġew osservati fuq l- iżvilupp tal- feti.
A rat fertility study up to a dose of 1500 mg/ kg/ day demonstrated no adverse effects on either sex.
Fi studju dwar il- fertilità tal - firien li ngħataw doża sa 1500 mg/ kg/ jum ma ntwerew ebda effetti avversi fuq l- ebda wieħed mis - 13 sessi.
In pre- and post-natal rat studies, prolonged parturition was noted at 1500 mg/ kg/ day: the safety margin between human exposure and the highest no-effect dose (500 mg/ kg/ day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
Fi studju li sar kemm qabel kif ukoll wara t- twelid, ġie nnotat li l- proċess tat- twelid ittawwal meta ngħataw 1500 mg/ kg/ jum; il- marġni ta 'sigurtà bejn l- espożizzjoni umana u l- ogħla doża li ma ħalliet l- ebda effett (500 mg/ kg/ jum) fil- ġrieden hija ta' 480 darba għal oseltamivir u ta '44 darba għall - metabolu attiv, rispettivament.
Foetal exposure in the rats and rabbits was approximately 15 to 20% of that of the mother.
L- espożizzjoni tal- feti tal- firien u tal- fniek kienet ta 'madwar 15 sa 20% ta' dik ta 'l- omm.
In lactating rats, oseltamivir and the active metabolite are excreted in the milk.
Fil- firien li kienu qed jreddgħu, oseltamivir u l- metabolu attiv għaddew mal- ħalib.
It is not known whether oseltamivir or the active metabolite is excreted in human milk, but extrapolation of the animal data provides estimates of 0.01 mg/ day and 0.3 mg/ day for the respective compounds.
Mhux magħruf jekk oseltamivir u l- metabolu attiv jiħorġux fil- ħalib tal- bnedmin, iżda estrapolazzjoni tat- tagħrif dwar l- annimali twassal għal stimi ta '0. 01 mg/ jum u 0. 3 mg/ jum rispettivament għaż- żewġ sustanzi.
A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs.
F' test ta '“ massimizzazzjoni ” fuq il- fniek ta' l- Indi ġiet osservata l- possibbilta ’ ta 'sensitizzazzjoni fil - ġilda b’ oseltamivir.
Approximately 50% of the animals treated with the unformulated active ingredient showed erythema after challenging the induced animals.
Wara li l- annimali li ngħataw il- mediċina reġgħu ngħataw l- ingredjent attiv mhux formulat, dehret eritema f' madwar 50% ta 'l- annimali.
Reversible irritancy of rabbits' eyes was detected.
Ġiet osservata wkoll xi irritazzjoni riversibbli f' għajnejn il- fniek.
Whereas very high oral single doses of oseltamivir phosphate had no effect in adult rats, such doses resulted in toxicity in juvenile 7-day-old rat pups, including death.
Filwaqt li l- għoti ta ’ oseltamivir phosphate bħala doża orali waħda għolja ħafna ma kellu l- ebda effett fuq firien adulti, dożi bħal dawn wasslu għal tossiċità fi frieħ tal- firien żgħar, ta ’ 7 ijiem, inkluż mewt.
These effects were seen at doses of 657 mg/ kg and higher.
Dawn l- effetti kienu osservati b’ dożi ta ’ 657 mg/ kg jew aktar.
At 500 mg/ kg, no adverse effects were seen, including upon chronic treatment (500 mg/ kg/ day administered from 7 to 21 days post partum).
Ma kienux osservati effetti avversi b’ 500 mg/ kg, inkluż waqt kura kronika (500 mg/ kg/ kuljum mogħtija minn 7 sa 21 ġurnata wara t - twelid).
Capsule core:
Qalba tal- kapsula:
Pregelatinized starch (derived from maize starch) Talc Povidone Croscarmellose sodium Sodium stearyl fumarate
Pregelatinized starch (idderivat minn maize starch) Talc Povidone Croscarmellose sodium Sodium stearyl fumarate
Gelatin Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Gelatin Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium dioxide (E171)
13 Printing ink:
Linka għall- istampar:
Shellac Titanium dioxide (E171) FD and C Blue 2 (indigo carmine, E132)
Shellac Titanium dioxide (E171) FD u C Blu 2 (indigo carmine, E132)
One box contains 10 capsules in a triplex blister pack (PVC/ PE/ PVDC, sealed with aluminium foil).
Kaxxa waħda fiha 10 kapsuli f' pakkett b’ folja triplex (PVC/ PE/ PVDC, issiġillat bil- fojl ta 'l- aluminju).
20 June 2002 Date of last renewal:
20 ta ’ Ġunju 2002 Data ta ’ l- aħħar tiġdid:
20 June 2007
20 ta ’ Ġunju 2007
Tamiflu 45 mg hard capsule.
Tamiflu 45 mg kapsula iebsa.
For a full list of excipients, see section 6.1.
Kull kapsula iebsa fiha oseltamivir phosphate ekwivalenti għal 45 mg oseltamivir Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Imprints are blue.
Kapsula iebsa Il- kapsula iebsa hija ta 'lewn griż opak u turi l- marka “ ROCHE ” u għandha kappa griża, opaka li turi l - marka “ 45 mg. ” Il- marki huma ta' lewn blu.
Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
L- effikaċja ntweriet meta t- trattament nbeda fi żmien jumejn mill - bidu tas- sintomi.
15 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.
16 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 following weight-adjusted dosing regimens are recommended:
Il- korsijiet ta ’ dożaġġ aġġustati għall- piż li ġejjin huma rrakkomandati:
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.
17 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.
16 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.
Creatinine clearance > 30 (ml/ min) > 10 to ≤ 30 (ml/ min)
Tneħħija tal- krejatinina > 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
The safety and efficacy of oseltamivir in either treatment or prevention of influenza in immunocompromised patients have not been established.
18 Is- sigurtà u l- effikaċja ta 'oseltamivir kemm għall- kura kif ukoll għall- prevenzjoni ta' l influwenza f' pazjenti immunokompromessi ma ġewx stabbiliti.
17 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.
4.8 Undesirable effects
19 4. 8 Effetti mhux mixtieqa
18 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.
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
Adverse Drug Reaction
Kura Kura
Oseltamivir Placebo Oseltamivir
Kategorija ta ’ Frekwenza
30 to 75 mgb
Oseltamivir 30 to 75 mgb
30
2 mg/ kg bid
to 75 mgb
30 to 75 mg
3%
2%
Sinusitis Bronchitis Otitis media
21 Sistema tal- Klassifika tal- Organi
2% 2% 9%
(SOC)
3% 2% 11%
Kura Kura
0% 2% 1%
Placebo
0% 0% 2%
Oseltamivir 30 to 75 mgb
Disorders of the blood and lymphatic system Common:
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Lymphadenopathy
(n = 517)
2%
158)
< 1%
(n
0%
= 99)
Respiratory, thoracic and mediastinal disorders Common:
Ażżma (inkl. aggravata) Epistassi Disturbi gastro- intestinali Komuni Ħafna:
(n = 158)
Komuni:
Nausea Abdominal pain Disorders of the eye Common:
Tqalligħ Uġigħ addominali
Immune system disorders Frequency not known: hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions.
Disturbi fis- sistema immuni Frekwenza mhux magħrufa: reazzjonijiet ta ’ sensittività eċċessiva, inkluż reazzjonijiet anafilattiċi/ anafilattojdi.
These events were reported primarily among pediatric and adolescent patients and often had an abrupt onset and rapid resolution.
Il -
The contribution of Tamiflu to those events is unknown.
22 kontribuzzjoni ta ’ Tamiflu għal dawn l- avvenimenti mhux magħrufa.
21 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.
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- bniedm b' 75 mg darbtejn kuljum.
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.
23 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.
22 Patients with Resistance Mutations (%)
Pazjenti b’ Mutazzjonijiet Reżistenti (%)
23 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).
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 – 25 16; p ≤ 0. 0001]).
Metabolism Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in the liver.
26 Metaboliżmu Oseltamivir jinbidel estensivament f’ oseltamivir carboxylate permezz ta 'l- esterases li fil- biċċa l- kbira tagħhom jinstabu fil- fwied.
25 Children The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in children aged 1 to 16 years.
It- tfal Il- farmakokinetika ta 'oseltamivir ġiet evalwata fi studji farmakokinetiċi b' dożi singoli fi tfal ta ’ età minn sena sa 16- il sena.
A rat fertility study up to a dose of 1500 mg/ kg/ day demonstrated no adverse effects on either sex.
Fi studju dwar il- fertilità tal - firien li ngħataw doża sa 1500 mg/ kg/ jum ma ntwerew ebda effetti avversi fuq l- ebda wieħed mis - 27 sessi.
Gelatin Black iron oxide (E172) Titanium dioxide (E171)
Gelatin Iron oxide iswed (E172) Titanium dioxide (E171)
26 Printing ink:
Linka għall- istampar:
Tamiflu 75 mg hard capsule.
Tamiflu 75 mg kapsula iebsa.
For a full list of excipients, see section 6.1.
Kull kapsula iebsa fiha oseltamivir phosphate ekwivalenti għal 75 mg oseltamivir Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Imprints are blue.
Kapsula iebsa Il- kapsula iebsa hija ta 'lewn griż opak u turi l- marka “ ROCHE ” u għandha kappa safra ċara, opaka li turi l- marka “ 75 mg. ” Il- marki huma ta' lewn blu.
- one 30 mg capsule plus one 45 mg capsule or
- kapsula waħda ta '30 mg flimkien ma' kapsula oħra ta '45 mg jew
- by administering one 30 mg dose plus one 45 mg dose of suspension.
- billi tingħata doża waħda ta ’ 30 mg flimkien ma ’ doża oħra ta ’ 45 mg ta ’ suspensjoni.
28 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.
30 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.
It is not necessary to administer any undissolved white powder as this is inert material.
M’ hemmx bżonn li tagħti t - trab abjad li ma jkunx inħall għax dan ma jikkawża l- ebda reazzjoni.
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’ eta ’ 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 orali.
For recommended treatment dose of Tamiflu for infants older than 1 year of age and for children 2 to 12 years of age, see SmPC of Tamiflu suspension and Tamiflu 30 and 45 mg capsules.
Għad- doża rakkomandata ta ’ kura ta ’ Tamiflu għal trabi b’ età ta ’ aktar minn sena u għal tfal b’ eta ’ minn sentejn sa 12- il sena, ara l- SmPC tas- suspensjoni Tamiflu u tal- kapsuli Tamiflu ta ’ 30mg u 45 mg.
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 or Tamiflu 30 mg and 45 mg capsules.
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 jew il- kapsuli Tamiflu ta ’ 30 mg u ta ’ 45 mg.
For recommended post-exposure prevention dose of Tamiflu for infants older than 1 year of age and for children of 2 to 12 years of age, see SmPC of Tamiflu suspension and Tamiflu 30 mg and 45 mg capsules.
Għad- doża rrakkomandata għall- prevenzjoni wara espożizzjoni ta ’ Tamiflu għal trabi b’ età ta ’ aktar minn sena u għal tfal b’ eta ’ minn sentejn sa 12- il sena, ara l- SmPC tas- suspensjoni Tamiflu u tal - kapsuli Tamiflu ta ’ 30 mg u ta ’ 45 mg.
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 or Tamiflu 30 mg and 45 mg capsules.
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 jew kapsuli Tamiflu ta ’ 30 mg u ta ’ 45 mg.
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.
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.
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.
29 Renal impairment Treatment of influenza:
31 Indeboliment renali Il- kura ta 'l- influwenza:
The safety and efficacy of oseltamivir in either treatment or prevention of influenza in immunocompromised patients have not been established.
Is- sigurtà u l- effikaċja ta 'oseltamivir kemm għall- kura kif ukoll għall- prevenzjoni ta' l influwenza f' pazjenti immunokompromessi ma ġewx stabbiliti.
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.
Tamiflu is not a substitute for influenza vaccination.
32 Tamiflu m' huwiex sostitut għat- tilqima kontra l- influwenza.
The protection against influenza lasts only as long as
Il- protezzjoni kontra l - influwenza iddum biss sakemm ikun qed jingħata Tamiflu.
In adults, the most commonly reported adverse drug reactions (ADRs) were vomiting and nausea in the treatment studies, and nausea and headache in the prevention studies.
Il -
The majority of these ADRs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
33 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.
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
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).
1480)
= 1480)
Hallucinationa
Alluċinazzjonijieta
Nervous system disorders Very Common:
Disturbi fis- sistema nervuża Komuni Ħafna:
Convulsiona
Konvulżjonia
Disorders of the ear and labyrinth Common:
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
1% < 1%
Sogħla
1% 0%
1% 1%
6% 2%
6%
6% 1%
6%
Nauseab, c
Tqalligħb, c
Vomitingc Abdominal pain Diarrhoea Dyspepsia
Rimettarc Uġigħ addominali Dijarea Dispepsja
32 System Organ Class (SOC) Frequency Category
34 Sistema tal- Klassifika tal- Organi (SOC)
General disorders Common:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux Komuni:
Dizziness Fatigue Pain
Sturdament Għeja Uġigħ
Placebo Oseltamivir
Kura Kura
Oseltamivir Placebo Oseltamivir
Kategorija ta ’ Frekwenza Reazzjoni Avversa tal- Mediċina
Oseltamivir
Oseltamivir 2 mg/ kg bid
30 to 75 mgb 30 to 75
Oseltamivir 30 to 75 mgb
mgb
Oseltamivir 30 to 75 mgb
Sinusitis Bronchitis Otitis media
Pnewmonja Sinusite Bronkite Otite medja Disturbi tad- demm u tas- sistema limfatika Komuni:
Asthma (incl. aggravated) Epistaxis
Ażżma (inkl. aggravata) Epistassi
Gastrointestinal disorder Very Common:
Disturbi gastro- intestinali Komuni Ħafna:
Common:
(n = 515)
Nausea Abdominal pain
Tqalligħ Uġigħ addominali Disturbi fl- għajnejn Komuni:
33 System Organ Class (SOC) Frequency Category
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Disorders of the ear and labyrinth Common:
Disturbi fil- widnac Disturbi fil- membrana timpanika
These events were reported primarily among pediatric and adolescent patients and often had an abrupt onset and rapid resolution.
Dawn l- avvenimenti kienu rrapportati primarjament fost pazjenti pedjatriċi u adoloxxenti u ħafna drabi kellhom bidu f’ daqqa u għaddew malajr.
The contribution of Tamiflu to those events is unknown.
Il - kontribuzzjoni ta ’ Tamiflu għal dawn l- avvenimenti mhux magħrufa.
Hepato-biliary disorders Frequency not known: hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness.
36 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.
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.
34 Additional information on special populations:
Aktar tagħrif dwar popolazzjonijiet speċjali:
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.
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.
The risk of emergence of influenza viruses with reduced susceptibility or frank resistance to oseltamivir has been examined during Roche-sponsored clinical studies.
37 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.
Patients with Resistance Mutations (%)
Pazjenti b’ Mutazzjonijiet Reżistenti (%)
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and
Ir- rata ta ’ żvilupp ta ’ reżistenza tista ’ tkun għola fil- gruppi ta ’ l- iżgħar età, u f’ pazjenti mmunosoppressi.
Adults and adolescents 13 years of age and older:
L- adulti u l- adoloxxenti b’ eta ’ minn 13- il sena 'l fuq:
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) fil- grupp li ngħata l- plaċebo għal 8. 6% (116/ 1350) fil- kampjun tal- popolazzjoni li ngħataw oseltamivir (p = 0. 0012).
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).
38 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).
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.
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.
Oseltamivir reduced the incidence of acute otitis media from 26.5% (53/ 200) in the placebo group to 16% (29/ 183) in the oseltamivir treated children (p = 0.013).
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).
36 Treatment of influenza B infection:
Kura ta 'l- infezzjoni ta' l- influwenza B:
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 – 16; p ≤ 0. 0001]).
In the total population, there was a reduction in the incidence of laboratory-confirmed clinical influenza in households from 20% (27/ 136) in the group not receiving prevention to 7% (10/ 135) in the group receiving prevention (62.7% reduction [95% CI 26.0 – 81.2; p = 0.0042]).
Fil- popolazzjoni totali kien hemm 39 tnaqqis fl- inċidenza fid- djar ta ’ influwenza klinika kkonfermata fil- laboratorju minn 20% (27/ 136) fil - grupp li ma kienux qed jirċievu prevenzjoni għal 7% (10/ 135) fil- grupp li kienu qed jirċievu prevenzjoni (tnaqqis ta ’ 62. 7%, [95% CI 26. 0 - 81. 2; p = 0. 0042]).
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.
F' analiżi kkombinat ta 'żewġ studji oħra li saru fuq adulti li ma kinux imlaqma iżda altrimenti b' saħħithom, 75 mg ta ’ oseltamivir mogħti darba kuljum għal 6 ġimgħat naqqas b' mod sinifikanti l- inċidenza tal- marda ta' l- influwenza klinika minn 25/ 519 (4. 8%) fil- grupp tal- plaċebo għal 6/ 520 (1. 2%) fil- grupp ta 'oseltamivir (tnaqqis ta' 76% [95% CI 1. 6 – 5. 7; p = 0. 0006]) wara tifqigħa tal- influwenza fil- komunità.
Metabolism Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in the liver.
Metaboliżmu Oseltamivir jinbidel estensivament f’ oseltamivir carboxylate permezz ta 'l- esterases li fil- biċċa l- kbira tagħhom jinstabu fil- fwied.
Elimination Absorbed oseltamivir is primarily (> 90%) eliminated by conversion to oseltamivir carboxylate.
40 Eliminazzjoni Oseltamivir li jiġi assorbit jiġi primarjament (> 90%) eliminat billi jibidel f’ oseltamivir carboxylate.
Children The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in children aged 1 to 16 years.
It- tfal Il- farmakokinetika ta 'oseltamivir ġiet evalwata fi studji farmakokinetiċi b' dożi singoli fi tfal ta ’ eta ’ minn sena sa 16- il sena.
38 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
A rat fertility study up to a dose of 1500 mg/ kg/ day demonstrated no adverse effects on either sex.
Fi studju dwar il- fertilità tal - firien li ngħataw doża sa 1500 mg/ kg/ jum ma ntwerew ebda effetti avversi fuq l- ebda wieħed mis - sessi.
In lactating rats, oseltamivir and the active metabolite are excreted in the milk.
41 Fil- firien li kienu qed jreddgħu, oseltamivir u l- metabolu attiv għaddew mal- ħalib.
Gelatin Yellow iron oxide (E172) Red iron oxide (E172) Black iron oxide (E172) Titanium dioxide (E171)
Gelatin Iron oxide isfar (E172) Iron oxide aħmar (E172) Iron oxide iswed (E172) Titanium dioxide (E171)
6.6 Special precautions for disposal
42 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
20 June 2002 Date of last renewal:
20 ta 'Ġunju 2002 Data ta ’ l- aħħar tiġdid:
20 June 2007
20 ta 'Ġunju 2007
Tamiflu 12 mg/ ml powder for oral suspension.
Tamiflu 12mg/ ml trab għal suspensjoni orali.
1 g of powder for oral suspension contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
1 g ta ’ trab għal suspensjoni orali fiha oseltamivir phosphate ekwivalenti għal 30 mg ta ’ oseltamivir.
After reconstitution, each ml of suspension contains 12 mg oseltamivir.
Wara r- rikostituzzjoni, kull 1 ml ta ’ suspensjoni fih 12 mg oseltamivir.
One bottle of reconstituted suspension (75 ml) contains 900 mg of active substance (oseltamivir).
Flixkun wieħed ta ’ suspensjoni rikostitwita (75 ml) fih 900 mg tas- sustanza attiva (oseltamivir).
A bottle of 30 g Tamiflu powder for oral suspension contains 25.713 g of sorbitol.
Flixkun ta ’ Tamiflu 30 g trab għal supensjoni orali fih 25. 713 g ta ’ sorbitol.
One dose of 45 mg oseltamivir administered twice daily delivers 2.6 g of sorbitol.
Doża waħda ta ’ 45 mg oseltamivir amministrata darbtejn kulljum tagħti 2. 6 g ta ’ sorbitol.
Powder for oral suspension The powder is a granulate or clumped granulate with a white to light yellow colour.
It- trab huwa mrammel jew mrammel f' ċapep ta 'lewn abjad jagħti fl- isfar ċar.
4.2 Posology and method of administration
44 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Tamiflu suspension and Tamiflu capsules are bioequivalent formulations.
Il- kapsuli u s- suspensjoni ta ’ Tamiflu huma sustanzi bioekwivalenti.
- one 30 mg capsule plus one 45 mg capsule or
- kapsula waħda ta ’ 30 mg flimkien ma ’ kapsula oħra ta ’ 45 mg jew
- by administering one 30 mg dose plus one 45 mg dose of suspension.
- billi tingħata doża waħda ta '30 mg flimkien ma' doża oħra ta '45 mg ta' suspensjoni.
41 Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Dawk l- adulti, adoloxxenti u tfal (> 40 kg) li ma jistgħu jibilgħu l- kapsuli jistgħu jieħdu dożi adattati ta ’ kapsuli ta ’ Tamiflu.
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.
The recommended dose of Tamiflu oral suspension is indicated in the table below.
Id- doża rrakkomandata tas- suspensjoni orali ta ’ Tamiflu hija indikata fit- tabella ta 'hawn taħt.
Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu suspension.
Il- kapsuli Tamiflu ta ’ 30 mg u ta ’ 45 mg huma disponibbli bħala alternattiva għad- doża rakkomandata tas - suspensjoni Tamiflu.
The following weight-adjusted dosing regimens are recommended:
Ir- regoli li ġejjin ta 'dożi rranġati skond il- piż huma rrakkomandati:
Body Weight
Piż tal- ġisem
≤ 15 kg > 15 kg to 23 kg > 23 kg to 40 kg > 40 kg
15 kg 15 kg sa 23 kg 23 kg sa 40 kg 40 kg
For dosing, an oral dispenser with 30 mg, 45 mg and 60 mg graduations is provided in the box.
Biex tiġi kkalkulata d- doża, fil- kaxxa qed jiġi pprovdut dispenser orali bi gradazzjonijiet ta '30 mg, 45 mg, u 60 mg.
For accurate dosing, the oral dispenser supplied should be used exclusively.
Għal kalkulazzjonijiet preċiżi tad- doża m' għandu jintuża l- ebda dispenser orali ieħor għajr dak ipprovdut.
Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu suspension.
45
For dosing, an oral dispenser with 30 mg, 45 mg and 60 mg graduations is provided in the box.
Għad- dożaġġ, dispenser għall- ħalq immarkat b’ 30 mg, 45 mg, u 60 mg huwa pprovdut fil- kaxxa.
For accurate dosing, the oral dispenser supplied should be used exclusively.
Għal dożaġġ preċiż għandu jintuża biss id- dispenser għall- ħalq ipprovdut.
It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient (see section 6.6).
Huwa rakkomandat li trab Tamiflu għal suspensjoni orali jiġi rikonstitwit minn spiżjar qabel ma jiġi mogħti lill- pazjent (ara sezzjoni 6. 6).
42 Children weighing > 40 kg and who are able to swallow capsules may receive prophylaxis 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, li jistgħu jibilgħu l- kapsuli, jistgħu jirċievu profilassi 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.
Prevenzjoni waqt epidemija ta ’ influwenza fil- komunità Id- doża rrakkomandata għall- prevenzjoni ta 'l- influwenza waqt tifqigħ fil- komunità hija ta' 75 mg oseltamivir darba kuljum sa 6 ġimgħat.
Special populations Hepatic impairment No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction.
Popolazzjonijiet speċjali Indeboliment epatiku M' hemm bżonn ta ’ aġġustament fid- doża la għall- kura u lanqas għall- prevenzjoni, f' pazjenti b’ disfunzjoni epatika.
Dose adjustment is recommended for adults with severe renal impairment.
Huwa rrakkomandat aġġustament fid- doża fl- adulti li jbatu minn indeboliment renali serju.
Creatinine clearance > 30 (ml/ min) > 10 to ≤ 30 (ml/ min)
Tneħħija ta ’ krejatinina > 30 (ml/ min) > 10 to ≤ 30 (ml/ min)
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.
4.3 Contraindications
46 4. 3 Kontra- indikazzjonijiet
43 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.