qanastek/EMEA-V3 huggingface dataset:
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.
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.
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.
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).
47 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).
It is not known whether oseltamivir or the active metabolite are excreted in human milk.
Fil- ġrieden li jkunu qed ireddgħu, oseltamivir u l- metabolu attiv dehru fil- ħalib tas- sider. Mhuwiex magħruf jekk oseltamivir jew il- metabolu attiv jiħorġux fil- ħalib tal- bniedem.
44 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
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.
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.
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.
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.
Bronchitis Bronchitis acute Upper respiratory tract infections Psychiatric disorders Uncommon:
Bronkite Bronkite akuta Infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq
Hallucinationa Nervous system disorders Very Common:
Disturbi psikjatriċi Mhux Komuni:
Headache Common:
Uġigħ ta ’ ras
Insomnia Uncommon:
Komuni:
1%
Insomnja
1%
Mhux komuni:
Convulsiona Disorders of the ear and labyrinth Common:
Konvulżjonia
Vertigo Respiratory, thoracic and mediastinal disorders Common:
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Cough Rhinorrhoea
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Placebo
Rinoreja
(n =
< 1%
1057)
0%
(n = 1050)
2%
(n = 1434)
Disturbi gastro- intestinali Komuni Ħafna:
Nauseab, c Common:
Tqalligħb, c
Vomitingc Abdominal pain Diarrhoea Dyspepsia Skin and subcutaneous tissue disorders Uncommon:
Rimettarc Uġigħ addominali Dijarea Dispepsja
Dermatitisa a
Dermatitea
1%
Raxxa Urtikarjaa Ekżemaa
Rash Urticariaa Eczemaa General disorders Common:
< 1% < 1% < 1% < 1% < 1% < 1% < 1% 0% < 1%
They were also reported in the pooled clinical studies 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:
49 Il- kura u l- prevenzjoni ta 'l- influwenza fit- tfal:
Placebo
(SOC)
b
Kategorija ta ’ Frekwenza Reazzjoni Avversa tal- Mediċina
Infections and infestations Common:
Oseltamivir 30 to 75 mgb
(n
Infezzjonijiet u infestazzjonijiet Komuni:
99)
= 99)
Pneumonia
Pnewmonja Sinusite Bronkite
Sinusitis Bronchitis Otitis media
Otite medja
Disorders of the blood and lymphatic system Common:
Disturbi tad- demm u tas- sistema limfatika Komuni:
46 System Organ Class (SOC) Frequency Category
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Adverse Drug Reaction
Ażżma (inkl. aggravata)
Oseltamivir
4% 4%
2 mg/ kg bid
0%
mgb
1%
(n = 515)
Epistassi
(n
3% 3%
= 517)
1%
Asthma (incl. aggravated) Epistaxis Gastrointestinal disorder Very Common:
Disturbi gastro- intestinali Komuni Ħafna:
Vomiting Diarrhoea Common:
Dijarea
Further post marketing surveillance data on selected serious adverse drug reactions:
50 Aktar data mill- esperjenza ta ’ wara t- tqegħid fis- suq dwar reazzjonijiet avversi serji tal- mediċina magħżula:
47 Cardiac disorders Frequency not known: cardiac arrhythmia.
Disturbi fil- qalb Frekwenza mhux magħrufa: arritmija kardijaka.
There is no experience with overdose.
L- ebda każ ta ’ doza eċċessiva ma ġie rrapurtat.
48 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.
Treatment of influenza infection Oseltamivir is effective only against illnesses caused by influenza virus.
52 Il- kura ta 'l- infezzjoni ta' l- influwenza Oseltamivir huwa effettiv biss kontra l- mard ikkawżat mill- virus ta 'l- influwenza.
49 Treatment of influenza in children:
Il- kura ta 'l- influwenza fit- tfal:
Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly reduced the duration of 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.
Treatment of influenza B infection:
53 Kura ta 'l- infezzjoni ta' l- influwenza B:
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 ta ’ l - 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 konfirmata 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 li hemm bżonn biex tittratta (NNT) sabiex tilqa 'għal każ wieħed tal- marda ta' l- influwenza jvarja.
Post-exposure prevention:
Il- 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 fuq persuni (12. 6% minnhom 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 mindu dehru s- sintomi fil- każ indiċi u tkompliet għal sebat ijiem.
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]).
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 għall- kura (NNT) fil - kuntatti ta 'każijiet veri ta' influwenza kien ta '10 (95% CI 9 – 12) u ta' 16 (95% CI 15 – 19) fil - popolazzjoni kollha (ITT) mingħajr ma ngħata każ ta 'l- istat ta' l- infezzjoni tal- każ indiċi.
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]).
The NNT for the total paediatric population was 9 (95% CI 7 – 24) and
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:
Il- prevenzjoni matul epidemija ta 'l- 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 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 mħallta ta 'żewġ studji oħra li saru fuq adulti li ma kinux imlaqma imma li kienu 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]) matul epidemija ta 'l- influwenza fil- komunità.
The NNT in this study was 28 (95% CI 24 – 50).
In- 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 - 54 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).
In- NNT f' dan l- istudju kien 25 (95% CI 23 - 62).
51 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.
Children The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in children aged 1 to 16 years.
55 It- tfal Il- farmakokinetika ta 'oseltamivir ġiet evalwata fi studji farmakokinetiċi b' dożi singoli fi tfal ta ’ eta ’ minn sena sa 16- il sena.
Powder for oral suspension:
Trab għal suspensjoni orali:
Sorbitol (E420), Sodium dihydrogen citrate (E331[a]) Xanthan gum (E415) Sodium benzoate (E211) Saccharin sodium (E954) Titanium dioxide (E171) Tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).
Sorbitol (E420) Sodium dihydrogen citrate (E331[ a]) Xanthan gum (E415) Sodium benzoate, (E211) Saccharin sodium (E954) Titanium dioxide (E171)
2 years for powder for oral suspension.
Sentejn għat- trab għal suspensjoni orali.
After reconstitution, the suspension can be stored either at room temperature (not above 25°C) for 10 days or in a refrigerator (2°C - 8°C) for 17 days.
Taħżinx f' temperatura 'l fuq minn 30°C Wara r- rikostituzzjoni, s- suspensjoni tista ’ tinħażen f’ temperatura tal- kamra (mhux aktar minn 25°C) għal għaxart ijiem jew fi friġġ (2°C - 8°C) għal 17- il ġurnata.
Carton containing a 100 ml amber glass bottle (with child-resistant plastic screw cap) with 30 g of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup.
Kaxxa tal- kartun li fiha flixkun ta '100 ml tal- ħġieġ lewn l- ambra (b' tapp tal- plastik b' kamin li huwa diffiċli għat- tfal biex jiftħuh) bi 30 g trab għal suspensjoni orali, adapter tal- plastik, dispenser tal - plastik għall- użu orali u tazza tal- plastik biex titkejjel id- doża fiha).
After reconstitution with 52 ml of water, the usable volume of oral suspension allows for the retrieval of a total of 10 doses of 75 mg oseltamivir.
Wara r- rikostituzzjoni ma '52 ml ilma, il- volum tas- suspensjoni orali li jista' jintuża jippermetti li joħorġu minnu total ta '10 dożi ta' 75 mg ta 'oseltamivir.
It is recommended that Tamiflu oral suspension should be reconstituted by the pharmacist prior to its dispensing to the patient.
Huwa rrakkomandat li s- suspensjoni orali ta ’ Tamiflu tiġi rrikostitwita mill- ispiżjar qabel ma tingħata lill- pazjent.
Preparation of Oral Suspension 1.
1.
Tap the closed bottle gently several times to loosen the powder.
Tektek bil- mod b' subgħak fuq il- flixkun magħluq għal diversi drabi biex t- trab jintreħa.
Measure 52 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Kejjel 52 ml ilma billi timla t- tazza għall- kejl sal- livell indikat (it- tazza għall- kejl inkluża fil- pakkett).
Add all 52 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
Ferra it- 52 ml ilma kollu fil- flixkun, erġa għalaq il- flixkun u ħawwad sew il- flixkun magħluq għal 15- il sekonda.
Remove the cap and push the bottle adapter into the neck of the bottle.
Neħħi t- tap u daħħal l- adapter tal- flixkun f’ għonq il- flixkun.
Close the bottle tightly with the cap (on the top of the bottle adapter).
Issikka t- tapp fuq il- filxkun (fuq l- adapter).
This will make sure that the bottle adapter fits in the bottle in the right position.
Dan jiżgura li l- adapter jiffitja mal- flixkun kif suppost.
Tamiflu powder for suspension will appear as an opaque and white to light yellow suspension after reconstitution.
It- trab ta ’ Tamiflu wara li jiġi rrikostitwit jidher bħala suspensjoni opaka u bajda sa isfar ċar.
55 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Roche Pharma AG Emil-Barell-Str.
Roche Pharm AG Emil- Barell- Str.
1 D- 79639 Grenzach – Wyhlen Germany
1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
The MAH will continue to submit yearly PSURs (Data Lock Point 21 September) unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq se jkompli jissottometti PSURs ta ’ kull sena (Data Lock Point 21 ta ’ Settembru) sakemm mhux speċifikat mod ieħor mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar Sistemi ta ’ Immaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess waqt mar- Rapport Perjodiku Aġġornat ta ’ Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted
Barra minn hekk, għandu jiġi sottomess RMP aġġornat
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.
Meta tinkiseb informazzjoni ġdida li jista ’ jkollha impatt fuq Speċifikazzjonijiet ta ’ Sigurtà attwali, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskji.
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Fi żmien 60 ġurnata minn meta tintlaħaq mira mportanti (farmakoviġilanza jew tnaqqis ta ’ riskji).
At the request of the EMEA.
Mat- talba ta ’ l- EMEA.
Outer carton
Kartuna ta 'barra
Tamiflu 30 mg hard capsules Oseltamivir
Tamiflu 30 mg kapsuli ibsin Oseltamivir
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 30 mg oseltamivir.
Oral use Read package leaflet before use
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu
60 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tamiflu 30 mg capsules Oseltamivir
Tamiflu 30 mg kapsuli Oseltamivir
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Tamiflu 45 mg hard capsules Oseltamivir
Tamiflu 45 mg kapsuli ibsin Oseltamivir
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 45 mg oseltamivir.
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma ’ jidhirx mit- tfal
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tamiflu 45 mg capsules Oseltamivir
Tamiflu 45 mg kapsuli Oseltamivir
Tamiflu 75 mg hard capsules Oseltamivir
Tamiflu 75 mg kapsuli ibsin Oseltamivir
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
Kull kapsula iebsa fiha oseltamivir phosphate, ekwivalenti għal 75 mg oseltamivir.
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tamiflu 75 mg capsules Oseltamivir
Tamiflu 75 mg kapsuli Oseltamivir
Tamiflu 12 mg/ml powder for oral suspension Oseltamivir
Tamiflu 12 mg/ ml trab għal suspensjoni orali Oseltamivir
1 bottle with 30 g powder for oral suspension contains 900 mg of oseltamivir.
Flixkun ta '30 g trab għal suspensjoni orali fih 900 mg oseltamivir.
Final volume of the bottle after reconsitution with 52 ml of water is 75 ml.
Il- volum finali tal- flixkun wara li jiġi rikostitwit ma '52 ml ilma huwa 75 ml.
Each ml of suspension contains 12 mg oseltamivir.
Kull ml ta 'suspensjoni fih 12 mg oseltamivir.
Also contains sorbitol and sodium benzoate.
Fih ukoll sorbitol u sodium benzoate.
1 bottle Also contains 1 plastic bottle adapter, 1 plastic measuring cup (52 ml) and 1 plastic oral dispenser
Flixkun wieħed Jinkludi wkoll adapter tal- plastik għall- flixkun, tazza tal- plastik għall- kejl (52 ml) u dispenser orali tal - plastik.
For oral administration after constitution Shake bottle well before use Read the enclosed leaflet before use and also for the method of preparation
Għall- amministrazzjoni orali wara li jiġi rikostitwit Ħawwad il- flixkun sew qabel l- użu Aqra l- fuljett ta ’ tagħrif qabel l- użu u wkoll għall- metodu ta ’ preparazzjoni
Do not store above 30°C After reconstitution, the suspension can be stored either at room temperature (not above 25°C) for 10 days or in a refrigerator (2°C - 8°C) for 17 days
Taħżinx f' temperatura 'l fuq minn 30°C Wara r- rikostituzzjoni, s- suspensjoni tista ’ tinħażen f’ temperatura tal- kamra (mhux aktar minn 25°C) għal għaxart ijiem jew fi friġġ (2°C - 8°C) għal 17- il ġurnata
Label for bottle
Tikketta għall- flixkun
Tamiflu 12 mg/ml powder for oral suspension Oseltamivir
Tamiflu 12 mg/ ml Trab għal suspensjoni orali Oseltamivir
For oral administration after constitution Shake bottle well before use Read the enclosed leaflet before use and also for the method of preparation
Għall- amministrazzjoni orali wara li jiġi kostitwit Ħawwad il- flixkun sew qabel l- użu Aqra l- fuljett ta 'tagħrif qabel l- użu u wkoll għall- metodu ta ’ preparazzjoni
Tamiflu 30 mg hard capsules Tamiflu 45 mg hard capsules Oseltamivir
Tamiflu 30 mg kapsuli ibsin Tamiflu 45 mg kapsuli ibsin Oseltamivir
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il fuljett kollu qabel tibda tieħu din il- mediċina.
What Tamiflu is and what it is used for 2.
X’ inhu Tamiflu u għalxiex jintuża 2.
Before you take Tamiflu 3.
Qabel ma tieħu Tamiflu 3.
How to take Tamiflu 4.
Kif għandek tieħu Tamiflu 4.
How to store Tamiflu 6.
Kif taħżen Tamiflu 6.
WHAT TAMIFLU IS AND WHAT IT IS USED FOR
X’ INHU TAMIFLU U GĦALXIEX JINTUŻA
- Tamiflu is prescribed to you for treating or preventing influenza.
- Tamiflu jiġi ordnat lilek mit- tabib sabiex tikkura jew tipprevjeni l- influwenza.
These medicines
- Tamiflu jagħmel parti minn grupp ta 'mediċini msejħa “ inibituri tan- neuraminidase. ” Dawn il -
prevent the influenza virus from spreading inside the body and so help to ease or prevent the symptoms arising from the influenza virus infection.
mediċini jipprevjenu l- virus ta 'l- influwenza milli jinxtered ġol- ġisem u b' hekk jgħinu sabiex jittaffew jew jiġu pprevenuti s- sintomi li ġġib magħha l- infezzjoni tal- virus ta' l- influwenza.
- Influenza is an infection caused by the influenza virus.
- L- influwenza hija infezzjoni li tiġi kkawżata mill- virus ta 'l- influwenza.
The signs (symptoms) of influenza
Is- sinjali (sintomi) ta 'l -
include the sudden onset of fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and often extreme fatigue.
influwenza jinkludu d- deni (aktar minn 37. 8°C) li jibda tiela ’ f' daqqa waħda, is- sogħla, mnieħer inixxi jew misdud, uġigħ ta 'ras, uġigħ fil- muskoli u spiss għeja kbira.
These symptoms may also be caused by infections other than influenza.
Dawn is- sistomi jistgħu jiġu kkawżati minn infezzjonijiet oħra minbarra l- influwenza.
True influenza infection only occurs during annual outbreaks (epidemics) at times when influenza viruses are spreading in the local community.
Infezzjonijiet ta 'l- influwenza proprja jiġru biss waqt li jkun hemm tifqigħa annwali (epidemija) fi żminijiet meta l- viruses ta' l- influwenza jkunu qed jinfirxu fil- komunità lokali.
Outside of the epidemic period, these symptoms will mainly be caused by a different type of infection or illness.
Barra mill- perjodu meta jkun hemm epidemija, dawn is- sintomi ikunu fil- maġġor parti tagħhom ikkawżati minn tip differenti ta 'infezzjoni jew marda.
BEFORE YOU TAKE TAMIFLU
QABEL MA ’ TIEĦU TAMIFLU
Do not take Tamiflu
Tieħux Tamiflu
- if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu.
- jekk int allerġiku/ a (tbagħti minn sensittività eċċessiva) għal oseltamivir jew xi wieħed mis -
Take special care with Tamiflu Before you take Tamiflu, make sure your prescribing doctor knows if you
Oqgħod attent ħafna b’ Tamiflu Qabel tieħu Tamiflu, aċċerta ruħek li t- tabib li qiegħed jordnaħulek ikun jaf jekk inti:
- are allergic to other medicines
- allerġiku għal xi mediċini oħrajn
- have problems with your kidneys.
- għandek problemi bil- kliewi
Tamiflu can be taken with paracetamol, ibuprofen or acetylsalicylic acid (Aspirin).
Tamiflu jista 'jittieħed ma ’ paracetamol, ibuprofen jew acetylsalicylic acid (Aspirin).
Tamiflu is not expected to alter the effect of any other medicines.
Tamiflu mhux mistenni jibdel l- effett ta 'mediċini oħrajn.
73 Are there any interactions with an influenza vaccination?
77 Tilqima kontra l- influwenza tikkawża xi bidla fuq l- effett farmaċewtiku tal- prodott?
Tamiflu is not a substitute for influenza vaccination.
Tamiflu mhux sostitut għal tilqima kontra l- influwenza.
Tamiflu will not change the effectiveness of the influenza vaccine.
Tamiflu ma jbiddilx l- effettività tat - tilqima kontra l- influwenza.
Even if a vaccination against influenza has been given to you Tamiflu may be prescribed by your doctor.
Anki jekk ġejt mogħti tilqima kontra l- influwenza, Tamiflu jista ’ jiġi preskritt mit- tabib tiegħek.
Taking Tamiflu with food and drink Swallow Tamiflu with water.
Meta tieħu Tamiflu ma ’ l- ikel u max- xorb Ibla 'l- kapsula ta ’ Tamiflu bl- ilma.
Tamiflu can be taken with or without food, although it is recommended to take Tamiflu with food to reduce the chance of feeling or being sick (nausea or vomiting).
Tamiflu jista 'jittieħed kemm ma' l- ikel kif ukoll fuq stonku vojt, għalkemm huwa rrakkomandat li tieħu Tamiflu ma 'l- ikel sabiex tnaqqas il- possibiltà li tħoss dardir jew tirremetti.
The possible effects of Tamiflu on unborn children are unknown.
L- effetti li Tamiflu jista 'jkollu fuq it- trabi fil- ġuf m' humiex magħrufa.
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu is right for you.
Inti għandek tgħarraf lit- tabib tiegħek jekk tinsab tqila, jekk taħseb li tinsab tqila jew jekk qed tipprova tinqabad tqila, sabiex it- tabib tiegħek ikun jista 'jiddeċiedi jekk Tamiflu huwiex adattat għalik.
The effects on nursing infants are unknown.
L- effetti fuq it- trabi li qed jieħdu l- ħalib tas- sider m' humiex magħrufin.
You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.
Inti għandek tgħarraf lit- tabib tiegħek jekk qed tredda ’ lit- tarbija, sabiex it- tabib tiegħek ikun jista 'jiddeċiedi jekk Tamiflu huwiex adattat għalik.
Driving and using machines Tamiflu has no effect on your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Tamiflu m’ għandu l- ebda effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
HOW TO TAKE TAMIFLU
KIF GĦANDEK TIEĦU TAMIFLU
Always take Tamiflu exactly as your doctor has told you.
Dejjem għandek tieħu Tamiflu eżatt skond il- parir tat- tabib.
Take Tamiflu as soon as you get the prescription as this will help to slow the spread of the influenza virus in the body.
Ħu Tamiflu mill- aktar fis possibli malli tingħata r- riċetta għax b' hekk tgħin ħalli tnaqqas ir- rata tat - tixrid tal- virus ta 'l- influwenza mal- ġisem.
Swallow Tamiflu capsules whole with water.
Ibla 'il- kapsuli ta ’ Tamiflu sħaħ ma' l- ilma.
Do not break or chew Tamiflu capsules.
Tkissirx jew tomgħodx il- kapsuli ta ’ Tamiflu.
The usual dose is as follows:
Id- doża tas- soltu hija kif ġej:
Treatment Adolescents (13 to 17 years of age) and adults:
Għall- kura Adoloxxenti (13 sa 17- il sena) u adulti:
30 mg and 45 mg capsules can be used by adults and adolescents as an alternative to 75 mg capsules.
Kapsuli ta ’ 30 mg u ta ’ 45 mg jistgħu jintużaw minn adulti u adoloxxenti flok kapsuli ta ’ 75 mg.
For treatment of influenza take one 30 mg and one 45 mg capsule as soon as you get the prescription and then take one 30 mg and one 45 mg capsule twice a day (usually it is convenient to take one 30 mg and one 45 mg in the morning and one30 mg and one 45 mg in the evening for five days).
Għal kura ta 'l- influwenza ħu kapsula waħda ta ’ 30 mg u waħda ta ’ 45 mg malli tingħata r- riċetta u mbagħad kompli b' kapsula waħda ta ’ 30 mg u oħra ta ’ 45 mg darbtejn kuljum (normalment huwa konvenjenti li tieħu waħda ta ’ 30 mg u waħda ta ’ 45 mg fil- għodu u waħda ta ’ 30 mg u oħra ta ’ 45 mg fil- għaxija għal ħamest ijiem).
It is important to complete the whole 5 day course, even if you start to feel better quickly.
Huwa importanti li ttemm il- kors kollu ta 'ħamest ijiem, anke jekk tħossok ġej għall- aħjar mill- ewwel.
Infants 1 year of age and older and children 2 to 12 years of age:
Trabi minn sena 'l fuq u tfal b’ età minn sentejn sa 12- il sena:
Tamiflu oral suspension can be used instead of capsules.
Tista ’ tintuża Tamiflu suspensjoni orali minflok il- kapsuli.
Children weighing more than 40 kg and who can swallow capsules may take a 75 mg dose of Tamiflu capsules twice daily for 5 days.
Tfal li jiżnu aktar minn 40 kg u li jistgħu jibilgħu l- kapsuli jistgħu jieħdu doża ta ’ 75 mg ta ’ kapsuli Tamiflu darbtejn kuljum għal ħamest ijiem.
You must give the amount of capsules to your child as prescribed by your doctor.
Għandek tagħti l- ammont ta ’ kapsuli lit- tifel/ tifla tiegħek kif preskritt mit- tabib tiegħek.
The usual dose for treatment of influenza in children depends on the body weight of the child (see table below):
78 Id- doża tas- soltu għall- kura ta ’ l- influwenza fit- tfal tiddependi fuq il- piż tal- ġisem tat- tifel/ tifla (ara t - tabella taħt):
Recommended dose for 5 days (Treatment)
Doża rakkomandata għal ħamest ijiem (Kura)
Less than or equal to 15 kg
15- il kg jew anqas
30 mg twice daily
45 mg darbtejn kuljum
More than 15 kg and up to 23 kg More than 23 kg and up to 40 kg More than 40 kg
Aktar minn 23 kg u sa 40 kg Aktar minn 40 kg
45 mg twice daily 60 mg twice daily 75 mg twice daily
60 mg darbtejn kuljum 75 mg darbtejn kuljum
(75 mg is made up of a 30 mg dose plus a 45 mg dose)
(75 mg hija magħmula minn doża ta ’ 30 mg flimkien ma ’ doża ta ’ 45 mg)
Prevention Tamiflu can also be used for prevention of influenza following exposure to an infected individual, such as family members.
Għall- prevenzjoni Wara espożizzjoni għall- individwu infettat, bħal membri tal- familja, Tamiflu jista 'jintuża wkoll sabiex jipprevjeni l- influwenza.
Adolescents (13 to 17 years of age) and adults:
Adoloxxenti (13 sa 17- il sena) u adulti:
Tamiflu should be taken once daily for 10 days.
Tamiflu għandu jittieħed darba kuljum għal għaxart ijiem.
It is best to take this dose in the mornings with breakfast.
L- aħjar ħin biex tieħu din id- doża huwa filgħodu mal- kolazzjon.
The usual dose for prevention of influenza in children depends on the body weight of the child (see table below):
Id- doża tas- soltu għall- kura ta ’ l- influwenza fit- tfal tiddependi fuq il- piż tal- ġisem tat- tifel/ tifla (ara t - tabella taħt):
Recommended dose for 10 days (Prevention)
Doża rrakkomandata għal ħamest ijiem (Kura)
30 mg once daily
45 mg darbtejn kuljum
45 mg once daily 60 mg once daily 75 mg once daily
60 mg darbtejn kuljum 75 mg darbtejn kuljum
Your doctor will recommend the length of time to continue taking Tamiflu, if it is prescribed to prevent influenza.
Jekk Tamiflu jingħatalek għall- prevenzjoni ta 'l- influwenza, it- tabib tiegħek jirrakkomandalek għal kemm tul ta' żmien għandek tkompli tieħdu.
When Tamiflu oral suspension is not available 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 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.
Meta Tamiflu suspensjoni orali mhux disponibbli 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 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 must be swallowed immediately after its preparation.
Wara li tiġi ppreparata t - taħlita għandha tittieħed minnufih.
Please follow these instructions to ensure proper dosing.
Jekk jogħġbok segwi dawn l- istruzzjonijiet biex ikun assigurat dożaġġ xieraq.
Determine the number of capsules that are needed to prepare a mixture with this procedure:
Iddetermina n- numru ta ’ kapsuli meħtieġa għall- preparazzjoni tat- taħlita b’ din il- proċedura:
Required number of
Numru ta ’ kapsula( i)
capsule(s) needed to obtain
Numru ta ’ kapsula( i)
capsule(s) needed to obtain
meħtieġa biex jinkisbu d- dożi meħtieġa biex jinkisbu d- dożi
the recommended doses for
rrakkomandati għal ħamest
the recommended doses for
rrakkomandati għall -
Body Weight*
Piż tal- Ġisem *
5 days treatment
ijiem ta ’ kura
prevention
prevenzjoni
Less than or equal to 15 kg
15- il kg jew inqas
1 capsule of 30 mg twice daily
Kapsula waħda ta ’ 30 mg darbtejn kuljum
1 capsule of 30 mg once daily
Kapsula waħda ta ’ 30 mg darba kuljum
More than 15 kg and up to 23 kg 1 capsule of 45 mg twice daily
Aktar minn 15- il kg u sa 23 kg
1 capsule of 45 mg once daily
Kapsula waħda ta ’ 45 mg darba kuljum
More than 23 kg and up to 40 kg 2 capsules of 30 mg twice daily 2 capsules of 30 mg once daily * Children weighing more than 40 kg may receive medication with the adult dosage of Tamiflu 75 mg capsules twice daily for 5 days for treatment or once daily for prevention.
* Tfal li jiżnu aktar minn 40 kg jistgħu jirċievu medikazzjoni bid- dożaġġ adult permezz ta ’ kapsuli Tamiflu 75 mg darbtejn kuljum għal ħamest ijiem għall- kura jew darba kuljum għall- prevenzjoni.
Check that you are using the correct dose according to the table above.
Iċċekkja li qed tuża d- doża korretta skond it- tabella fuq.
Hold the capsule(s) over a small bowl, carefully pull the capsule(s) open and pour the powder into the bowl.
Żomm il- kapsula( i) fuq skutella żgħira, b’ attenzjoni iftaħ il- kapsula( i) billi tiġbed u ferra ’ it- trab ġol- iskutella.
Add a suitable, small amount (1 teaspoon maximum) of sweetened food product (to mask the bitter taste) to the bowl and mix well.
Żid ammont żgħir (massimu ta ’ kuċċarina), xieraq ta ’ prodott ta ’ l- ikel b’ togħma ħelwa (biex tgħatti t- togħma qarsa) ġol- iskutella u ħawwad sew.
Stir the mixture and give the entire contents of the bowl to the patient.
Ħawwad it- taħlita u għati l- kontenut kollu ta ’ l- iskutella lill- pazjent.
If there is some mixture left inside the bowl, rinse the bowl with a small amount of water and have the patient drink this remaining mixture.
Jekk jibqa ’ xi taħlita fl- iskutella, laħlaħ l- iskutella b’ ammont żgħir ta ’ ilma u ġiegħel lill- pazjent jixrob din it- taħlita li jkun fadal.
Repeat this procedure every time you need to take the medicine.
Irrepeti din il- proċedura kull darba li għandek bżonn tieħu l- mediċina.
If you take more Tamiflu, than you should
Jekk tieħu Tamiflu aktar milli suppost
Contact your doctor or pharmacist immediately.
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek immedjatement.
If you have forgotten to take Tamiflu
Jekk tinsa tieħu Tamiflu
Do not take a double dose to make up for a forgotten capsule.
M’ għandekx tieħu doża doppja biex tpatti għall- kapsula li tkun insejt tieħu.
If you stop taking Tamiflu
Jekk tieqaf tieħu Tamiflu
There are no side effects when Tamiflu is discontinued prior to advice from your doctor.
M' hemm l- ebda effetti sekondarji li jinħassu meta Tamiflu jitwaqqaf qabel il- parir li tak it- tabib tiegħek.
If Tamiflu is stopped earlier than your doctor told you, the symptoms of influenza may reoccur.
Jekk Tamiflu jitwaqqaf qabel iż- żmien li qallek it- tabib tiegħek, is- sintomi ta 'l- influwenza għandhom mnejn jerġgħu jitfaċċaw.
Like all medicines, Tamiflu can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tamiflu jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
- Common side effects of Tamiflu
- Effetti sekondarji komuni ta ’ Tamiflu
The most common side effects of Tamiflu are nausea, vomiting, diarrhoea, stomach ache and headache.
L- aktar effetti oħra komuni ta ’ Tamiflu huma, dardir, rimettar, dijarea, uġigħ fl- istonku u uġigħ ta ’ ras.
These side effects mostly occur only after the first dose of the medicine and will usually stop as treatment continues.
Dawn l- effetti fil- biċċa l- kbira tagħhom jiġru biss wara l- ewwel doża tal- mediċina u normalment jgħaddu mat- tkomplija tal- kura.
The frequency of these effects is reduced if the medicinal product is taken with food.
Il- frekwenza ta 'dawn l- effetti titnaqqas jekk il- prodott mediċinali jittieħed ma' l- ikel.
- Less common side effects of Tamiflu
- Effetti sekondarji anqas komuni ta ’ Tamiflu
Adults and adolescents (children aged 13 years and older) Other less common side effects, which may also be caused by influenza, are upper abdominal fullness, bleeding in the gastrointestinal tract, bronchitis, upper respiratory tract infections, dizziness, tiredness, sleeping difficulties, skin reactions, mild to severe liver function disorders, visual disturbances and heart rhythm abnormalities.
Adulti u adoloxxenti (tfal ta 'etajiet' il fuq minn 13- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma imbulmar tal- parti addominali ta ’ fuq, fsada fl- apparat gastro- intestinali, bronkite, infezzjonijiet ta ’ l- apparat respiratorju
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.
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.
During Tamiflu treatment, events like convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares) have been reported, in a very few cases resulting in accidental injury, in some instances with fatal outcome.
Waqt kura b’ Tamiflu kienu rrapportati avvenimenti bħal 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, f’ xi okkażjonijiet b’ riżultat fatali.
These events were reported primarily among children and adolescents and often had an abrupt onset and rapid resolution.
Dawn l- avvenimenti kienu rrapportati primarjament fost tfal 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.
76 Children (aged 1 to 12 years) Other less common side effects, which may also be caused by influenza, are ear inflammation, inflammation of the lungs, sinusitis, bronchitis, aggravation of pre-existing asthma, nose bleeding, ear disorders, inflammation of the skin, swelling of the lymph nodes, conjunctivitis visual disturbances and heart rhythm abnormalities.
Tfal (ta 'etajiet minn sena sa 12- il sena) Effetti oħrajn anqas komuni, li jistgħu jkunu kkawżati wkoll mill- influwenza, huma infjammazzjoni fil- widnejn, infjammazzjoni fil- pulmuni, sinusite, bronkite, ażżma li kienet diġà teżisti taggrava, fsada mill- imnieħer, disturbi fil- widnejn, infjammazzjoni tal- ġilda, nefħa tal- glandoli limfatiċi, konġuntivite, disturbi fil- vista u anormalitajiet fir- ritmu tal- qalb.
If you or your child are often sick, you should inform your doctor.
Jekk int jew ibnek/ bintek spiss tħossukhom ma tifilħux, għandek tgħarraf lit- tabib tiegħek.
You should also tell your doctor if the influenza symptoms get worse or the fever continues.
Għandek ukoll tgħid lit- tabib tiegħek jekk is- sintomi ta 'l- influwenza jeħżienu jew jekk id- deni jibqa ’ għoli.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TAMIFLU
KIF TAĦŻEN TAMIFLU
Do not use Tamiflu after the expiry date which is stated on the carton and blister after EXP.
Tużax Tamiflu wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja wara {abbrevjazzjoni li tintuża għad- data ta ’ skadenza}.
There are no special storage conditions.
M' hemm l- ebda struzzjonijiet għal ħażna speċjali.
What Tamiflu contains
X’ fih Tamiflu:
- The active substance is oseltamivir phosphate (30 mg and 45 mg oseltamivir in each hard
- Is- sustanza attiva hi oseltamivir phosphate (30 mg u 45 mg oseltamivir f' kull kapsula iebsa).
capsule contents, 30 mg and 45 mg: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell, 30 mg capsules: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171) capsule shell, 45 mg capsules: gelatin, black iron oxide (E172) and titanium dioxide (E171) printing ink, 30 mg and 45 mg capsules: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigocarmine, E132).
kontenut tal- kapsula, 30 mg u 45 mg: pregelatinized starch, talc, povidone, croscarmellose sodium, u sodium stearyl fumarate qoxra tal- kapsula, kapsuli ta ’ 30 mg: gelatin, iron oxide isfar (E172), iron oxide aħmar (E172), u titanium dioxide (E171) qoxra tal- kapsula, kapsuli ta ’ 45 mg: gelatin, iron oxide iswed (E172) u titanium dioxide (E171) linka għall- istampar, kapsuli ta ’ 30 mg u 45 mg: shellac (E904), titanium dioxide (E171) u FD u C Blu 2 (indigocarmine, E132).
What Tamiflu looks like and contents of the pack
81 Id- Dehra ta ’ Tamiflu u l- kontenuti tal- pakkett
30 mg hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”.
Kapsula iebsa ta ’ 30 mg hija magħmula minn ġisem safrani ċar u opâk li għandu stampat “ ROCHE ” u għatu isfar ċar u opâk li għandu stampat “ 30 mg ”.
Imprints are blue.
L- istampar huwa bil- blu.
45 mg hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”.
Il- kapsula iebsa ta ’ 45 mg hija magħmula minn ġisem griż u opâk li għandu stampat “ ROCHE ” u għatu griż u opâk li għandu stampat “ 45 mg ”.
Tamiflu 30 mg and 45 mg hard capsules are available in blister packs of 10.
Tamiflu 30 mg u 45 mg kapsuli ibsin huma disponibbli f’ folji ta ’ 10.
77 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Malta (See United Kingdom)
Malta (ara Renju Unit)
España Roche Farma S.A.
82 España Roche Farma S. A.
BEFORE YOU TAKE TAMIFLU
QABEL MA TIEĦU TAMIFLU
80 Are there any interactions with an influenza vaccination?
84 Tilqima kontra l- influwenza tikkawża xi bidla fuq l- effett farmaċewtiku tal- prodott?
HOW TO TAKE TAMIFLU
KIF GĦANDEK TIEĦU TAMIFLU 3.
For treatment of influenza take one capsule as soon as you get the prescription and then take one capsule twice a day (usually it is convenient to take one in the morning and one in the evening for five days).
Għal kura ta 'l- influwenza ħu kapsula waħda mill- aktar fis possibbli malli tingħata r- riċetta u mbagħad kompli b' kapsula waħda darbtejn kuljum (normalment, l - aktar konvenjenti huwa li tieħu waħda fil- għodu u l- oħra fil- għaxija għal ħamest ijiem).
30 mg and 45 mg capsules can be used by adults and adolescents as an alternative to 75 mg capsules.
Kapsuli ta ’ 30 mg u ta ’ 45 mg jistgħu jintużaw mill- adulti u l- adoloxxenti bħala alternattiva għall - kapsuli ta ’ 75 mg.
Tamiflu oral suspension or 30 mg and 45 mg capsules can be used instead.
Minflok jistgħu jintużaw Tamiflu suspensjoni orali jew il- kapsuli ta ’ 30 mg u ta ’ 45 mg..
Children weighing more than 40 kg and who can swallow capsules may take Tamiflu 75 mg capsules twice daily for 5 days.
Tfal li jiżnu aktar minn 40 kg u li jistgħu jibilgħu l- kapsuli jistgħu jieħdu kapsuli Tamiflu ta ’ 75 mg darbtejn kuljum għal ħamest ijiem.
When used to prevent influenza following exposure to an infected individual, such as family members, Tamiflu should be taken once daily for 10 days.
Meta jintuża biex jipprevjeni l- influwenza wara espożizzjoni għall- individwu infettat, bħal membri tal- familja, Tamiflu għandu jittieħed darba biss kuljum għal għaxart ijiem.
It is best to take this dose in the mornings with breakfast.
85 jingħatalek għall- prevenzjoni ta 'l- influwenza, it- tabib tiegħek jirrakkomandalek għal kemm tul ta' żmien għandek tkompli tieħdu.
Infants 1 year of age and older and children 2 to 12 years of age:
Trabi minn sena 'l fuq u tfal b’ eta ’ minn sentejn sa 12- il sena:
Tamiflu oral suspension or 30 mg and 45 mg capsules can be used instead.
Minflok jistgħu jintużaw Tamiflu suspensjoni orali jew il- kapsuli ta ’ 30 mg u ta ’ 45 mg
81 Children weighing more than 40 kg and can swallow capsules may take Tamiflu 75 mg capsules once daily for 10 days.
Tfal li jiżnu aktar minn 40 kg u li jistgħu jibilgħu l- kapsuli jistgħu jieħdu kapsuli Tamiflu ta ’ 75 mg darba kuljum għal għaxart ijiem.