qanastek/EMEA-V3 huggingface dataset:
To get the most benefit from the medicine, it should be used regularly and at the same time every day.
Sabiex il- mediċina tintuża sal - massimu tagħha, għandha tintuża regolarment u fl- istess ħin kuljum.
It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit.
Is- soltu jibda jkollha effett minn tmien sigħat wara l- ewwel sprejjatura, iżda sabiex jinkiseb il- benefiċċju massimu jista ’ jkun li jgħaddu ġranet.
Fluticasone Furoate GSK should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
Fluticasone Furoate GSK għandu jintuża biss għall- perjodu ta ’ żmien li l- pazjent ikun espost għall- kawża tal- allerġija, bħal polline, insetti mikroskopiċi tat- trab li jinsabu fid- djar jew annimali oħra.
How does Fluticasone Furoate GSK work?
Kif jaħdem Fluticasone Furoate GSK?
The active substance in Fluticasone Furoate GSK, fluticasone furoate, is a corticosteroid.
Is- sustanza attiva fi Fluticasone Furoate GSK, fluticasone furoate hija kortikosterojde.
It works in a similar way to naturally-occurring corticosteroid hormones, dampening down the activity of the immune system by attaching to receptors in various types of immune cell.
Taħdem b’ mod simili għall- ormoni kortikosterojdi preżenti fin- natura, billi ddgħajjef l- attività tas- sistema immunitarja billi teħel ma ’ riċetturi f’ diversi tipi ta ’ ċelloli immuni.
This leads to a reduction of the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
Dan iwassal għal tnaqqis fir- rilaxx ta ’ sustanzi li huma involuti fil- proċess ta ’ infjammazzjoni, bħal istamina, li tnaqqas is- sintomi ta ’ allerġija.
How has Fluticasone Furoate GSK been studied?
Kif ġie studjat Fluticasone Furoate GSK?
The effects of Fluticasone Furoate GSK were first tested in experimental models before being studied in humans.
L- effetti ta ’ Fluticasone Furoate GSK ġew l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il- bnedmin.
The effectiveness of Fluticasone Furoate GSK was studied in six main studies involving almost 2,500 patients, which compared Fluticasone Furoate GSK with placebo (a dummy treatment).
L- effikaċja ta ’ Fluticasone Furoate GSK ġiet studjata f’ sitt studji ewlenin li kienu jinvolvu kważi 2, 500 pazjent, fejn tqabbel Fluticasone Furoate GSK ma ’ plaċebo (trattament finta).
The first four studies looked at Fluticasone Furoate GSK used in adults and adolescents aged 12 years or over.
L- ewwel erba ’ studji eżaminaw l- użu ta ’ Fluticasone Furoate GSK f’ adulti u adolexxenti ta ’ 12- il sena u ‘ l fuq.
Three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (non- seasonal) allergies, such as allergies to animal dander (skin and hair).
Tliet studji twettqu fuq żmien qasir ta ’ ġimagħtejn u kienu jinvolvu 886 pazjent b’ rinite allerġika (riħ tal - ħuxlief - hay fever), filwaqt li r- raba ’ studju dam erba ’ ġimgħat u kien jinvolvi 302 pazjenti b’ allerġiji perenni (mhux skont l- istaġun), bħal allerġiji għall- pil u s- suf/ xahar ta ’ annimali.
The last two studies were carried out in children aged between two and 11 years, in which two doses of Fluticasone Furoate GSK were compared with placebo.
L- aħħar żewġ studji twettqu fi tfal ta ’ età bejn sentejn u 11- il sena, li fihom żewġ dożi ta ’ Fluticasone Furoate GSK tqabblu ma ’ plaċebo.
The first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
L- ewwel twettaq fuq 558 tifel u tifla b’ rinite allerġija perenni u t - tieni fuq 554 tifel u tifla b’ rinite allerġija staġjonali.
In all studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose.
Fl- istudju kollha, il- kejl ewlieni tal- effikaċja kien il- bidla f’ erba ’ sintomi ta ’ allerġija li jaffettwaw l - imnieħer.
Each symptom was measured on a scale from 0 to 3, with a maximum total score of 12.
Kull sintomu tkejjel fuq skala bejn 0 u 3, b’ total massimu ta ’ 12.
What benefit has Fluticasone Furoate GSK shown during the studies?
X ’ benefiċċju wera Fluticasone Furoate GSK matul l- istudji?
Fluticasone Furoate GSK was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Fluticasone Furoate GSK kien iktar effikaċi mill- plaċebo fit- tnaqqis ta ’ sintomi ta ’ rinite allerġika f’ pazjenti ta ’ sitt snin jew iktar.
In the studies of seasonal allergic rhinitis in adults and adolescents, Fluticasone Furoate GSK reduced symptom scores from a starting point of around 9 points by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Fl- istudji ta ’ rinite allerġika staġjonali fl- adulti u l- adolexxenti, Fluticasone Furoate GSK naqqas is- sintomi mill- ammont inizjali ta ’ madwar 9 punti b’ 3. 6 u 5. 4 punti fuq ġimagħtejn, meta mqabbel mat- tnaqqis ta ’ 2. 3 u 3. 7 punti bi plaċebo.
In the study of perennial allergic rhinitis, Fluticasone Furoate GSK reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Fl- istudji ta ’ rinite allerġija perenni, Fluticasone Furoate GSK naqqas l- ammonti bi 3. 6 punti wara erba ’ ġimgħat, meta mqabbel ma ’ tnaqqis ta ’ 2. 8 punti bil- plaċebo.
Similar results were seen in children aged six years and above.
Riżultati simili dehru fi tfal ta ’ sitt snin ‘ il fuq.
However, it was not possible to determine if Fluticasone Furoate GSK worked in children below the age of six years, because there were too few children below this age included in the studies.
Madankollu, ma kienx possibbli li jkun determinat jekk Fluticasone Furoate GSK ħadem fi tfal iżgħar minn sitt snin, minħabba li kienx hemm biżżejjed tfal iżgħar minn din l- età inklużi fl- istudji.
What is the risk associated with Fluticasone Furoate GSK?
X’ inhuma r- riskji assoċjati ma ’ Fluticasone Furoate GSK?
The most common side effect with Fluticasone Furoate GSK (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
L- iktar effett sekondarju komuni mat- teħid ta 'Fluticasone Furoate GSK (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu epistassi (fġir l- imnieħer).
This is generally mild or moderate and tends to affect adults who have used Fluticasone Furoate GSK for more than six weeks.
Ġeneralment dan ikun ħafif jew moderat u s - soltu jaffettwa l- adulti li jkunu użaw Fluticasone Furoate GSK għal iktar minn sitt ġimgħat.
For the full list of all side effects reported with Fluticasone Furoate GSK, see the Package Leaflet.
Għal lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Fluticasone Furoate GSK, ara l- Fuljett ta ’ Tagħrif.
Fluticasone Furoate GSK should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
Fluticasone Furoate GSK m’ għandux jintuża f’ nies li huma allerġiċi għal fluticasone furoate jew għal xi sustanzi oħra tiegħu.
Why has Fluticasone Furoate GSK been approved?
Għaliex ġie approvat Fluticasone Furoate GSK?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fluticasone Furoate GSK’ s benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Fluticasone Furoate GSK huma akbar mir- riskji tiegħu għat- trattament ta ’ sintomi ta ’ rinite allerġika f’ pazjenti ta ’ sitt snin jew ‘ il fuq.
The Committee recommended that Fluticasone Furoate GSK be given marketing authorisation.
Il- Kumitat irrakkomanda li Fluticasone Furoate GSK jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fluticasone Furoate GSK:
Tagħrif ieħor dwar Fluticasone Furoate GSK:
The European Commission granted a marketing authorisation valid throughout the EU for Fluticasone Furoate GSK to Glaxo Group Ltd. on 6 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Fluticasone Furoate GSK valida fl- UE kollha lil Glaxo Group Limited fi 6 ta ’ Ottubru 2008.
The full EPAR for Fluticasone Furoate GSK can be found here.
L- EPAR sħiħ għal Fluticasone Furoate GSK jista ’ jiġi kkonsultat hawn.
27.5 micrograms/ spray
27. 5 mikrogrammi/ sp rejjatura
Nasal spray suspension
Sprej ta ’ l- imnieħer, suspensjoni
Intranasal use
Għal użu bħala sprej fl- imnieħer
Bottle (glass) in plastic device
Flixkun (ħġieġ) f’ apparat tal- plastik
30 sprays
30 sprejjatura
1 bottle
Flixkun 1
60 sprays
60 sprejjatura
120 sprays
120 sprejjatura
FLUTICASONE FUROATE GSK 27.5 micrograms/ spray nasal spray suspension
Fluticasone furoate GSK 27. 5 mikrogrammi f’ kull sprej.
Each spray actuation delivers 27.5 micrograms of fluticasone furoate.
Kull sprejjatura li tiġi attwata tagħti 27. 5 mikrogrammi ta ’ fluticasone furoate
Nasal spray, suspension.
Sprej ta ’ l- imnieħer, suspensjoni.
White suspension.
Suspensjoni bajda.
Adults, adolescents (12 years and over) and children (6 – 11 years)
Adulti u adolexxenti (minn 12- il sena ‘ l fuq) u tfal (minn 6 snin sa 11- il sena).
Fluticasone furoate GSK is indicated for the treatment of: • the symptoms of allergic rhinitis
Fluticasone furoate GSK hu indikat għat- trattament: • tas- sintomi ta ’ rinite allerġika.
Fluticasone furoate nasal spray is for administration by the intranasal route only.
L- isprej ta ’ l- imnieħer bil- fluticasone furoate għandu jintuża mill- imnieħer biss.
For full therapeutic benefit regular, scheduled usage is recommended.
Biex jinkiseb l- aħjar benefiċċju terapewtiku hu rakkomandat l- użu regolari u skond programm stabbilit.
Onset of action has been observed as early as 8 hours after initial administration.
Il- bidu ta ’ l- effett tiegħu ġie osservat 8 sigħat biss wara li jintuża l- ewwel darba.
However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1).
Madankollu, għandhom mnejn jgħaddu numru ta ’ ġranet ta ’ trattament biex jinkiseb l- aħjar benefiċċju, u l- pazjenti għandhom ikunu nfurmati li biex jgħaddulhom is- sintomi li jkollhom għandhom jużaw il - mediċina regolarment (ara sezzjoni 5. 1).
The duration of treatment should be restricted to the period that corresponds to allergenic exposure.
It- tul tat- trattament għandu jkun limitat skond il- perjodu li wieħed idum espost għall- kawża ta ’ l- allerġija.
Adults and Adolescents (12 years and over) The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Adulti u adolexxenti (12- il sena u ikbar) Id- doża rakkomandata għall- bidu hi ta ’ żewġ sprejjaturi (27. 5 mikrogrammi ta ’ fluticasone furoate f’ kull sprejjatura li tiġi attwata) f’ kull minħar darba kuljum (doża totali tal- ġurnata, 110 mikrogrammi).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.
Darba li jinkiseb kontroll adegwat tas- sintomi, tnaqqis għal sprejjatura waħda attwata f’ kull minħar (doża totali ta ’ 55 mikrogrammi kuljum) jista ’ jkun biżżejjed għall- kontroll tal- kundizzjoni.
Children (6 to 11 years of age) The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Tfal (6 snin sa 11- il sena) Id- doża rakkomandata hi ta ’ sprejjatura waħda (27. 5 mikrogrammi ta ’ fluticasone furoate f’ kull sprejjatura li tiġi attwata) f’ kull minħar kuljum (doża totali ta ’ 55 mikrogrammi kuljum).
Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Pazjenti li ma jkunux juru titjib adegwat bi sprejjatura waħda li tiġi attwata f’ kull minħar darba kuljum (doża totali ta ’ 55 mikrogrammi kuljum) jistgħu jagħmlu żewġ sprejjaturi li jiġu attwati f’ kull minħar darba kuljum (total ta ’ 110 mikrogrammi kuljum).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended.
Darba li jkun inkiseb kontroll adegwat tas- sintomi, hu rakkomandat li d- doża titnaqqas għal sprejjatura waħda attwata f’ kull minħar darba kuljum (doża totali ta ’ 55 mikrogrammi kuljum).
2 Children under 6 years of age:
2 Tfal taħt is- 6 snin:
The experience in children under the age of 6 years is limited (see section 5.1 and 5.2).
L- esperjenza fi tfal ta ’ taħt 6 snin hija limitata (ara sezzjonijiet 5. 1 u 5. 2).
Safety and efficacy in this group has not been well established.
Is- sigurtà u l- effikaċja għadhom mhumiex stabbiliti tajjeb.
Elderly Patients:
Pazjenti anzjani:
No dose adjustment is required in this population (see section 5.2).
M’ hemmx bżonn ta’ aġġustament ta ’ dożi f’ din il- popolazzjoni (ara sezzjoni 5. 2).
Renal Impaired Patients:
Pazjenti b’ indeboliment tal- kliewi:
No dose adjustment is required in this population (see section 5.2).
M’ hemmx bżonn ta ’ aġġustament ta ’ dożi f’ din il- popolazzjoni (ara sezzjoni 5. 2).
Hepatic Impaired Patients:
Pazjenti b’ indeboliment tal- fwied:
No dose adjustment is required in mild to moderate hepatic impairment.
M’ hemmx bżonn ta ’ aġġustament ta ’ dożi f’ każijiet ta ’ indeboliment ħafif jew moderat tal- fwied.
There are no data in patients with severe hepatic impairment (see section 4.4 and 5.2).
M’ hawnx tagħrif dwar pazjenti b’ indeboliment sever tal - fwied (ara sezzjonijiet 4. 4 u 5. 2)
The intranasal device should be shaken before use.
Ħawwad l- apparat tal l- imnieħer tajjeb qabel tużah.
The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.
Biex tlesti l- apparat għall- użu, żommu wieqaf u agħfas il- buttuna tal- ħruġ ta ’ l- isprej għal madwar 6 sprejjaturi (sakemm jidher il- ħruġ ta ’ sprej fin).
Re-priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.
Sprejjaturi mill- ġdid qabel l- użu mill- ġdid (madwar 6 sprejjaturi sakemm jidher il- ħruġ ta ’ sprej fin) ikunu meħtieġa biss jekk it- tapp ma kienx imqiegħed f’ postu għal ħamest ijiem jew jekk l- isprej ma jkunx intuża għal 30 jum jew aktar.
The device should be cleaned after each use and the cap replaced.
Wara l- użu, l- apparat għandu jitnaddaf u t- tapp għandu jitqiegħed f’ postu.
Hypersensitivity to the active substance or to any of the excipients of Fluticasone furoate GSK.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi ta ’ Fluticasone furoate GSK.
Fluticasone furoate undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone furoate in patients with severe liver disease is likely to be increased.
Fluticasone furoate jinbidel estensivament bil- metaboliżmu first- pass, u għalhekk f’ pazjenti b’ mard serju tal- fwied huwa probabbli li l- ammont mill- imnieħer ta ’ fluticasone furoate fid- demm jiżdied.
This may result in a higher frequency of systemic adverse events (see section 4.2 and 5.2).
Dan jista ’ jwassal għal frekwenza ogħla ta ’ effetti mhux mixtieqa (ara sezzjonijiet 4. 2 u 5. 2).
Caution is advised when treating these patients.
Dawn il - pazjenti għandhom jiġu trattati b’ kawtela.
Ritonavir Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Ritonavir L- amministrazzjoni flimkien ma ’ ritonavir mhux rakkomandat minħabba r- riskju li jiżdied l- ammont ta ’ fluticasone furoate fid- demm (ara sezzjoni 4. 5).
Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods.
Jistgħu iseħħu effetti sistemiċi tal- corticosteroid nażali, partikolarment fil- każ ta ’ dożi kbar meta preskritti għal perijodi twal.
These effects vary between patients and different corticosteroids (see section 5.2).
Dawn l- effetti jvarjaw bejn pazjenti u corticosteroids differenti (ara sezzjoni 5. 2).
Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
It- trattament b’ dożi ta ’ corticosteroids nażali akbar minn dawk rakkomandati jista ’ jirriżulta ’ f’ soppressjoni adrenali klinika ta ’ ċerta sinifikanza.
If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Jekk ikun jidher il- bżonn ta ’ dożi akbar minn dawk rakkomandati, għandha tiġi kkunsidrata żieda fil- kopertura sistemika ta ’ corticosteroid matul perijodi ta ’ stress jew f’ każ ta ’ xi operazzjoni mhux urġenti.
Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
110 mikrogrammi ta ’ fluticasone furoate darba kuljum ma ġewx assoċjati ma ’ hypothalamic- pituitary- adrenal (HPA) axis suppression f’ suġġetti adulti, adolexxenti jew pedjatriċi.
However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.
Madankollu, id- doża nażali ta ’ fluticasone furoate għandha titnaqqas għall- aktar doża baxxa li biha jista ’ jinżamm kontroll effettiv tas- sintomi ta ’ rinite.
As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
Bħal ma ’ jiġri b’ corticosteroids intranasali kollha, id- doża totali ta ’ corticosteroids fid- demm għandha tiġi kkalkulata, meta kwalunkwe tip ta ’ trattament b’ corticosteroid tiġi prescritta fl- istess ħin.
Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses.
Kien hawn każi ta ’ dewmien fl- iżvilupp fi tfal li ħadu xi dożi liċenzjati ta ’ corticosteroids nażali.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Hu rakkomandat li tfal fuq trattament fit- tul b’ corticosteroids nażali jiġu monitorjati għall- iżvilupp tat- tul tagħhom.
If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Jekk dan l- iżvilupp ikun bil- mod, wieħed għandu jirrevedi t- terapija bl- għan li titnaqqas kemm jista ’ jkun id- doża ta ’ corticosteroids nażali, jekk possibbli, mingħajr ma jintilef il- kontroll effettiv tas- sintomi.
In addition, consideration should be given to referring the patient to a paediatric specialist (see section 5.1).
Barra dan, għandu jiġi kkunsidrat jekk il- pazjent jiġix riferut lil xi speċjalista fil - pedjatrija (ara sezzjoni 5. 1).
If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.
3 Jekk jidher li għal xi raġuni l- funzjoni adrenali ddgħajfet, għandha tingħata attenzjoni meta pazjenti jaqilbu minn trattament bi sterojdi sistemiċi għal wieħed bi fluticasone furoate.
Fluticasone furoate GSK contains benzalkonium chloride.
Fluticasone furoate GSK fih benzalkonium chloride.
It may cause irritation of the nasal mucosa.
Dan jista ’ jikkawża irritazzjoni tal- mukoża ta ’ l - imnieħer.
3 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Fluticasone fuorate jitneħħa malajr b’ metaboliżmu first pass estensiv medjat biċ- ċitokromju P450 3A4.
Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, co- administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Fuq il- bażi ta ’ tagħrif ma ’ glucocorticoid ieħor (fluticasone propionate), li hu metabolizzat bi CYP3A4, mhuwiex rakkomandat li jingħata flimkien ma ’ ritonavir minħabba r- riskju ta ’ esponiment sistemiku akbar ta ’ fluticasone furoate.
Caution is recommended when co-administering fluticasone furoate with potent CYP3A4 inhibitors as an increase in systemic exposure cannot be ruled out.
Fluticasone furoate għandu jintuża b' kawtela meta jittieħed flimkien ma 'inibituri qawwija ta' CYP3A4 għaliex wieħed ma 'jistax jeskludi żieda fl- esponiment sistemiku.
In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects).
Fi studju dwar interazzjoni ta ’ fluticasone furoate fl- imnieħer bl- inibitur potenti CYP3A4 ketoconazole, kien hemm aktar suġġetti b’ konċentrazzjonijiet jitkejlu ta ’ fluticasone furoate fil- grupp ketoconazole (6 minn 20 suġġett) meta mqabbla ma ’ dawk bi plaċebo (1 minn 20 suġġett).
This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups (see section 4.4).
Din iż- żjieda żgħira f’ esponiment ma rriżultatx f’ differenza statistikament sinifikanti f’ livelli ta ’ kortisol fis- serum f’ 24 siegħa bejn iż- żewġ gruppi (ara sezzjoni 4. 4).
The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses.
It- tagħrif dwar l- inibizzjoni u l- induzzjoni ta ’ enzimi jindika li m’ hemmx bażi teoretika li fuqha wieħed jantiċipa interazzjonijiet metaboliċi bejn fluticasone furoate u l- metaboliżmu medjat biċ - ċitokromu P450 ta ’ komposti oħra f’ dożi fl- imnieħer klinikament rilevanti.
Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Għaldaqstant, ebda studji kliniċi ma twettqu biex jiġu mistħarrġa interazzjonijiet ta ’ fluticasone furoate ma ’ mediċini oħra.
There are no adequate data from the use of fluticasone furoate in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ fluticasone furoate waqt it- tqala.
In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation.
F ’ studji fuq annimali ntwera li glucocorticoids jistgħu jwasslu għal deformazzjonijiet inklużi cleft palate u żvilupp ritardat ġewwa l- utru.
This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure (see section 5.2).
Dan mhux mistenni li jkun rilevanti għal bnedmin meta wieħed jikkunsidra d- dożi mill - imnieħer li jwasslu għal esponiment sistemiku minimu (ara sezzjoni 5. 2).
Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
Fluticasone furoate għandu biss jintuża waqt it- tqala meta l- benefiċċji għall- omm ikunu akbar mir- riskji potenzjali għall- fetu jew għat- tarbija.
It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Mhux magħruf jekk fluticasone furoate meta jittieħed mill- imnieħer jitneħħiex fil- ħalib tas- sider ta 'l - omm.
Administration of fluticasone furoate to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
L- amministrazzjoni ta 'fluticasone furoate lin- nisa waqt it- treddigħ għandu jiġi kkunsidrat biss meta l- benefiċċju għall- omm ikun akbar minn kull riskju possibbli għat- tarbija.
No studies on the effects on the ability to drive and use machines have been performed as fluticasone furoate is not expected to affect this ability.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni għax fluticasone furoate mhuwiex mistenni li għandu jaffettwa din il- ħila.
Data from large clinical trials were used to determine the frequency of adverse reactions.
Tagħrif miġbur minn provi kliniċi kbar intuża biex tkun stabbilita l- frekwenza ta ’ reazzjonijiet avversi.
The following convention has been used for the classification of frequencies:
Il- metodu li ġej intuża fil- klassifikazzjoni ta ’ frekwenzi:
Very common > 1/ 10; Common > 1/ 100 to < 1/10; Uncommon > 1/1000 to< 1/100; Rare > 1/10,000 to < 1/ 1000; Very rare < 1/10,000.
Komuni ħafna > 1/ 10; Komuni > 1/ 100 sa < 1/ 10; Mhux komuni > 1/ 1000 sa < 1/ 100; Rari > 1/ 10, 000 sa < 1/ 1000; Rari ħafna < 1/ 10, 000.
Respiratory, thoracic and mediastinal disorders Very common Common
Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna Komuni
Epistaxis Nasal ulceration
Epistassi Ulċeri fl- imnieħer
Epistaxis was generally mild to moderate in intensity.
4 Epistassi kienet ġeneralment ħafifa sa moderata f’ dik li hi intensita`.
In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).
F’ adulti u adolexxenti, l - inċidenza ta ’ epistassi kienet akbar fil- każijiet ta ’ użu fit- tul (aktar minn 6 ġimgħat) milli f’ użu fil - qosor (sa 6 ġimgħat).
In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Fi studji kliniċi pedjatriċi b’ tul sa 12- il- ġimgħa l- inċidenza ta ’ epistassi kienet qiesha l- istess bħal dik f’ pazjenti fuq fluticasone furoate u pazjenti bi plaċebo.
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three
Fi studju dwar bijodisponibilta`, ittieħdu dożi fl- imnieħer sa 2640 mikrogrammi kuljum għal tlett ijiem mingħajr ma ġew osservati ebda effetti sistemiċi avversi (ara sezzjoni 5. 2).
Acute overdose is unlikely to require any therapy other than observation.
Doża eċċessiva ħafna aktarx li ma toħloqx il- bżonn ta ’ xi terapija għajr osservazzjoni.
Corticosteroids.
Corticosteroids.
Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
Fluticasone furoate huwa corticosteroid trifluworinat sintetiku b’ affinita` kbira ħafna għar- riċettur tal - glucocorticoid u għandu effett qawwi kontra l- infjammazzjoni.
Seasonal Allergic Rhinitis in adults and adolescents Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/ burning, tearing/ watering and redness of the eyes) in all 4 studies.
Rinite Allerġika ta ’ l- Istaġun f’ adulti u adolexxenti Meta mqabbla ma ’ plaċebo, 110 mikrogrammi kuljum ta ’ l- isprej nażali fluticasone furoate tejbu s - sintomi nażali (li jinkludu rinorrea, konġestjoni nażali, għatis u ħakk fl- imnieħer) u sintomi fl- għajnejn (li jinkludu ħakk/ ħruq, dmugħ u ħmura fl- għajnejn) f’ kull wieħed mill- erba ’ studji.
Efficacy was maintained over the full 24-hours dosing period with once daily administration.
Effikaċja nżammet matul il- perijodu kollu tad- dożaġġ għal 24 siegħa darba kuljum.
Onset of therapeutic benefit was observed as early as 8 hours after initial administration, with further improvement observed for several days afterwards.
Il- bidu ta ’ benefiċċju terapewtiku kien osservat sa 8 siegħat wara l- ewwel użu tal- mediċina, u b’ titjib ieħor osservat għal numru ta ’ ġranet wara.
Fluticasone furoate nasal spray significantly improved the patients’ perception of overall response to therapy, and the patients’ disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire – RQLQ), in all 4 studies.
L- isprej nażali fluticasone furoate għamel titjib sinifikanti f’ dik li hi perċezzjoni tal- pazjenti tar - rispons ġenerali għat- terapija, u f’ dik li hi kwalita` ta ’ ħajja relattiva għall- marda (Kwistjonarju dwar Kwalita` tal- Ħajja b’ Rinokonġuntivite – RQLQ), f’ kull wieħed mill- erba ’ studji.
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients’ perception of overall response to therapy compared to placebo in both studies.
Rinite Allerġika li ddum għal tul ta ’ żmien f’ adulti u adolexxenti Meta mqabbla ma ’ plaċebo, 110 mikrogrammi kuljum ta ’ sprej nażali fluticasone furoate ġabu titjib sinifikanti tas- sintomi nażali kif ukoll tal- perċezzjoni ġenerali tal- pazjenti għat- terapija meta mqabbla ma ’ plaċebo fiż- żewġ studji.
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms as well as improving patients’ disease-related quality of life (RQLQ) compared to placebo in one study.
110 mikrogrammi kuljum ta ’ sprej nażali fluticasone furoate ġabu titjib sinifikanti tas- sintomi fl - għajnejn kif ukoll f’ dik li hi perċezzjoni tal- pazjenti tal- kwalita` ta ’ ħajja relattiva għall- marda (RQLQ) meta mqabbla ma ’ plaċebo fi studju wieħed.
Efficacy was maintained over the full 24-hour dosing period with once daily administration.
Effikaċja nżammet matul il- perijodu kollu ta ’ dożaġġ għal 24 siegħa darba kuljum.
Seasonal and perennial allergic rhinitis in children:
Rinite Allerġika ta ’ l- Istaġun u fuq tul ta ’ żmien fit- tfal:
The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis population in children.
Il- pożoloġija pedjatrika hi bbażata fuq stima ta ’ tagħrif dwar effikaċja fil- popolazzjoni ta ’ tfal b’ rinite allerġika.
In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms once daily and placebo on any endpoint.
Fil- każ ta ’ rinite allerġika ta ’ l- istaġun, 110 mikrogrammi darba kuljum ta ’ sprej fluticasone furoate kienu effettivi iżda ma kienu osservati ebda differenzi sinifikanti fil- każ ta ’ 55 mikrogrammi darba kuljum ta ’ sprej nażali fluticasone furoate u plaċebo fuq l- ebda endpoint.
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment.
Fil- każ ta ’ rinite allerġika fuq tul ta ’ żmien, 55 mikrogrammi kuljum ta ’ sprej nażali fluticasone furoate irriżultaw fi profil ta ’ effikaċja aktar konsistenti minn 110 mikrogrammi darba kuljum ta ’ l - isprej nażali fluticasone furoate fi trattament ta ’ erba ’ ġimgħat.
Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.
Analiżi post- hoc matul 6 u 12- il ġimgħa fl- istess studju, kif ukoll studju ta ’ 6 ġimgħat dwar sigurta` ta ’ HPA axis, urew tisħiħ fl - effikaċja ta ’ 110 mikrogrammi ta ’ sprej nażali fluticasone furoate darba kuljum.
A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.
Studju ta ’ 6 ġimgħat li fih saret stima ta ’ l- effett ta ’ 110 mikrogrammi ta ’ sprej nażali fluticasone furoate darba kuljum fuq il- funzjoni adrenali fi tfal ta ’ bejn sentejn u 11- il sena wera li ma kien hemm ebda effett sinifikanti fuq il- profili ta ’ serum cortisol f’ 24 siegħa, meta mqabbel ma ’ plaċebo.
Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate in children (6 to 11 years).
5 Riżultati minn studju dwar nemometrija kontrollat bi plaċebo b’ 110 mikrogrammi ta ’ sprej nażali ta ’ fluticasone furoate darba kuljum ma wrew ebda effetti kliniċi rilevanti fl- iżvilupp f’ perijodu qasir tal - parti t’ isfel tas- saqajn fi tfal (6 snin sa 11- il sena).
Safety and efficacy studies were performed in a total of 271 patients from 2 to 5 years of age in both seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate.
Rinite Allerġika ta ’ l- Istaġun u fuq tul ta ’ żmien fit- tfal (taħt 6 snin) Studji ta ’ sigurta ’ w efficaċja ġew magħmula f’ total ta ’ 271 pazjent ta ’ eta ’ minn sentejn sa 5 snin, b’ rinite allerġika ta ’ l- istaġun kif ukoll b’ dik fit- tul, illi minnhom 176 pazjent gew esposti għall flucitasone furoate.
Safety and efficacy in this group has not been well established.
Is- sigurtà u l- effikaċja f’ dan il- grupp għadhom mhumiex stabbiliti.
5 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Fluticasone furoate jiġi assorbit mhux kompletament u metabolizzat b’ mod first- pass estensivament fil- fwied u l- imsaren li jirriżulta f’ esponiment sistemiku negliġibbli.
The intranasal dosing of 110 micrograms once daily does not typically result in measurable plasma concentrations (< 10 pg/ ml).
L- użu ta ’ dożi ta ’ 110 mikrogrammi fl- imnieħer darba kuljum ma jirriżultax tipikament f’ konċentrazzjonijiet ta ’ plażma li jistgħu jitkejlu (< 10 pg/ mL).
The absolute bioavailability for intranasal fluticasone furoate is 0.50%, such that less than 1 microgram of fluticasone furoate would be systemically available after administration of 110 micrograms (see section 4.9).
Il- bijodisponibilta` assoluta ta ’ fluticasone furoate fl- imnieħer hi ta ’ 0. 50% jiġifieri wara l- amministrazzjoni ta ’ 110 mikrogrammi ta ’ fluticasone furoate, anqas minn mikrogramm wieħed ikun jinsab fid- demm.
The plasma protein binding of fluticasone furoate is greater than 99%.
Dak li jeħel mal- proteini tad- demm fi fluticasone furoate hu aktar minn 99%.
Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.
Fluticasone furoate jitferrex ħafna b’ volum medju ta ’ distribuzzjoni steady- state ta ’ 608 l.
Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/ h) from systemic circulation principally by hepatic metabolism to an inactive 17β -carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4.
Fluticasone furoate jitneħħa malajr (tneħħija totali ta ’ 58. 7 l/ s ta ’ plażma) miċ - ċirkolazzjoni sistemika prinċipalment b’ metaboliżmu tal- fwied għal metabolit 17β- carboxylic mhux attiv (GW694301X), bl- enzima CYO3A4 taċ- ċitokromu P450.
The principal route of metabolism was hydrolysis of the S- fluoromethyl carbothioate function to form the 17β -carboxylic acid metabolite.
Ir- rotta prinċipali ta ’ metaboliżmu kienet l- idrolisi tal- funzjoni S- fluoromethyl carbothioate biex tifforma l- metabolit 17β- carboxylic acid.
In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone.
Studji in vivo ma wrew ebda evidenza ta ’ qsim tal- fuorate moiety li jifforma fluticasone.
Elimination was primarily via the faecal route following oral and intravenous administration indicative of excretion of fluticasone furoate and its metabolites via the bile.
Eliminazzjoni kienet prinċipalment mir- rotta tal- purgar wara l- użu tal- mediċina mill - ħalq jew mill- vina li jindika li t- tneħħija ta ’ fluticasone furoate u l- metaboliti tiegħu permezz tal- bili.
Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Wara l- użu mill- vina, il- fażi ta ’ eliminazzjoni half- life kienet b’ medja ta ’ 15. 1 sigħat.
Urinary excretion accounted for approximately 1% and 2% of the orally and intravenously administered dose, respectively.
Tneħħija mill - awrina kienet ta ’ madwar 1% u 2% tad- doża wżata mill- ħalq jew mill- vina rispettivament.
In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ ml) following intranasal dosing of 110 micrograms once daily.
Fil- maġġoranza ta ’ pazjenti fluticasone furoate ma jistax jiġi kwantifikat (< 10 pg/ mL) wara dożaġġ fl - imnieħer ta ’ 110 mikrogrammi darba kuljum.
Quantifiable levels were observed in 15.1% of paediatric patients following intranasal dosing of 110 micrograms once daily and only 6.8% of paediatric patients following 55 micrograms once daily.
Livelli kwantifikabbli ġew osservati f’ 15. 1% ta ’ pazjenti pedjatriċi wara dożaġġ fl- imnieħer ta ’ 110 mikrogrammi darba kuljum u f’ 6. 8% biss ta ’ pazjenti pedjatriċi wara doża ta ’ 55 mikrogrammi darba kuljum.
There was no evidence for higher quantifiable levels of fluticasone furoate in younger children (less than 6 years of age).
Ma kien hemm ebda evidenza ta ’ livelli kwantifikabbli ta ’ fluticasone furoate ogħla fi tfal iżgħar (ta ’ inqas minn 6 snin).
Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ ml and 18.9 pg/ ml for 2-5 yrs and 6-11 yrs, respectively.
Il- medja ta ’ konċentrazzjonijiet ta ’ fluticasone furoate f’ dawk il- persuni b’ livelli kwantifikabbli wara doża ta ’ 55 mikrogrammi, kienet ta ’ 18. 4 pg/ ml u 18. 9 pg/ ml għal sentejn sa 5 snin u għal 6 snin sa 11- il sena, rispettivament.
At 110 micrograms, median concentrations in those subjects with quantifiable levels were 14.3 pg/ ml and 14.4 pg/ ml for 2-5 yrs and 6-11 yrs, respectively.
Wara doża ta ’ 110 mikrogrammi, il- medja ta ’ konċentrazzjonijiet f’ dawk il- persuni b’ livelli kwantifikabbli kienet ta ’ 14. 3 pg/ ml u 14. 4 pg/ ml għal sentejn sa 5 snin u għal 6 snin sa 11- il sena, rispettivament.
The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/ ml and 21.8 pg/ ml at 55 micrograms and 110 micrograms, respectively.
Dawn il- valuri huma simili għal dawk li dehru fl- adulti (12+) fejn il- medja ta ’ konċentrazzjonijiet f’ dawk il- persuni b’ livelli kwantifikabbli kienet ta ’ 15. 4 pg/ ml u 21. 8 pg/ ml wara doża ta ’ 55 mikrogrammi u 110 mikrogrammi, rispettivament.
Only a small number of elderly patients (≥ 65 years, n=23/ 872; 2.6%) provided pharmacokinetic data.
Ħareġ tagħrif farmakokinetiku minn numru tassew żgħir ta ’ pazjenti anzjani (≥ 65 sena, n=23/ 872; 2. 6%).
There was no evidence for a higher incidence of patients with quantifiable fluticasone furoate concentrations in the elderly, when compared with the younger patients.
Ma kien hemm ebda evidenza ta ’ inċidenza akbar ta ’ pazjenti b’ konċentrazzjonijiet kwantifikabbli ta ’ fluticasone furoate fl- anzjani meta mqabbla ma ’ pazjenti ta ’ eta` aktar żgħira.
Renal Impairment:
Indeboliment tal- kliewi:
Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing.
Ma dehrux traċċi ta ’ fluticasone furoate fl- awrina ta ’ pazjenti f’ saħħithom wara li ntużaw dożi mill - imnieħer.
Less than 1% of dose-related material is excreted in urine and therefore renal impairment would not be expected to affect the pharmacokinetics of fluticasone furoate.
Inqas minn 1% ta ’ sustanzi relatati mad- dożi joħorġu ma ’ l- awrina u għalhekk indeboliment tal- kliewi mhuwiex mistenni li jaffettwa l- farmakokinetiċi ta ’ fluticasone furoate.
Hepatic Impairment:
6 Indeboliment tal- fwied:
There are no data with intranasal fluticasone furoate in patients with hepatic impairment.
M’ hawnx tagħrif dwar l- użu ta ’ fluticasone furoate mill- imnieħer minn pazjenti b’ indeboliment tal - fwied.
A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42%) and AUC(0- ∞) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subjects.
Studju fuq doża waħda ta ’ 400 mikrogrammi ta ’ fluticasone furoate meħuda mill- ħalq minn pazjenti b’ indeboliment moderat tal- fwied wera żieda ta ’ Cmax (42%) u AUC( 0- ∞) (172%) u tnaqqis moderat (medja ta ’ 23%) fil- livelli ta ’ kortisol fil- pazjenti meta mqabbla ma ’ suġġetti f’ saħħithom.
From this study the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in patients with moderate hepatic impairment would not be expected to result in suppression of cortisol.
Minn dan l- istudju il- medja ta ’ esponiment antiċipat ta ’ 110 mikrogrammi ta ’ fluticasone furoate f’ pazjenti b’ indeboliment moderat tal- fwied mhijiex mistennija li tirriżulta f’ soppressjoni ta ’ kortisol.
Therefore moderate hepatic impairment is not predicted to result in a clinically relevant effect for the normal adult dose.
Għaldaqstant indeboliment moderat tal- fwied mhuwiex mistenni li għandu jirriżulta f’ xi effett klinikament rilevanti fl- użu ta ’ doża normali għal adulti.
There are no data in patients with severe hepatic impairment.
M’ hawnx tagħrif dwar pazjenti b’ indeboliment qawwi tal- fwied.
The exposure of fluticasone furoate is likely to be further increased in such patients.
L- esponiment għal fluticasone furoate huwa mistenni li jkompli jiżdied f’ dawn il- pazjenti.
6 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity.
Sejbiet fi studji tossikoloġiċi ġenerali kienu jixbħu lil dawk osservati bi glucocorticoids oħra u huma assoċjati ma ’ attività farmakoloġika eżaġerata.
No genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests.
Mhux probabbli li dawn is- sejbiet ikunu rilevanti għal bnedmin meta wieħed jikkunsidra d- dożi mill- imnieħer rakkomandati li jwasslu għal esponiment sistemiku minimu Ma ġewx osservati l- ebda effetti ġenotossiċi ta ’ fluticasone furoate f’ testijiet konvenzjonali ta ’ ġenotossiċità.
Further, there were no treatment-related increases in the incidence of tumours in two year inhalation studies in rats and mice.
Ukoll, ma kien hemm ebda żjidiet marbuta ma ’ dan it- trattament fl - inċidenza ta ’ tumuri f’ żewġ studji ta ’ sentejn dwar l- użu mill- imnieħer fuq ġrieden u firien.
Glucose anhydrous Dispersible cellulose Polysorbate 80 Benzalkonium chloride Disodium edetate Purified water
Glucose anhydrous Dispersible Cellulose Polysorbate 80 Benzalkonium Chloride Disodium Edetate Ilma Purifikat
2 months
3 snin Żmien kemm idum tajjeb waqt l- uzu: xagħrejn.
Do not refrigerate or freeze.
Tagħmlux fil- friġġ jew friża
Fluticasone furoate GSK nasal spray is a predominantly off-white plastic device with a dose indicator window, light blue side actuated lever and lid which contains a stopper.
L- isprej ta ’ l- imnieħer Fluticasone furoate GSK huwa apparat tal- plastik ta 'kulur bajdani, li fih indikatur tad- doża, lieva ta ’ kulur blu ċar ikkontrollata mill- ġenb u għatu b’ tapp miegħu.
The plastic device contains the nasal spray suspension within a Type I amber bottle (glass) fitted with a metering spray pump.
L- apparat tal- plastik fih is- suspensjoni ta ’ l- isprej għal- imnieħer li jinsab fi flixkun safrani ta ’ Tip I (tal- ħġieġ) li għamdu miegħu pompa atomizzatur li tirregola l- isprej.
The medicinal product is available in three pack sizes:
Il- prodott mediċinali jinsab f’ pakketti ta ’ tliet daqsijiet:
30, 60 and 120 sprays.
30, 60 u 120 sprejjaturi.
Not all pack sizes may be marketed.
7 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) tas- sustanza bijoloġika attiva
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
(fil- kummerċ Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT Renju Unit
The MAH must ensure that the system of pharmacovigilance, as described in version YM2007/ 00033/ 00 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni YM2007/ 00033/ 00, preżentata fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq.
Risk Management plan
Pjan dwar il- Maniġġjar ta ’ Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 04 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil - Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 04 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP), preżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl - aġġornamenti sussegwenti tal- RMP mifthema mas- 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).
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport Perjodikament Aġġornat dwar Sigurta` (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal- Maniġġjar ta ’ Riskji għal - prodotti mediċinali għall- użu fil- bniedem.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat: • Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurta` kurrenti, fuq il- Pjan ta ’ Farmakoviġilanza kurrenti jew fuq l- attivitajiet għat- tnaqqis tar- riskji. • F’ żmien ta ’ 60 ġurnata wara li tkun tlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta 'riskji) • Fuq talba ta ’ l- EMEA
The PSUR submission cycle based on the International Birth Date (IBD =27 April 2007), until otherwise specified by the CHMP, will be as follows:
Sakemm mhux speċifikat mod ieħor mis- CHMP, iċ- ċiklu ta ’ sottomissjoni tal- PSUR li huwa bbażat fuq id- Data Internazzjonali tal- Bidu (IBD =27 ta ’ April 2007), jkun kif imniżżel hawn taħt:
27 December 2008 PSUR 2:
27 ta ’ Diċembru 2008 PSUR 2:
27 June 2009 PSUR 3:
27 ta ’ Ġunju 2009 PSUR 3:
27 December 2009 PSUR 4:
27 ta ’ Diċembru 2009 PSUR 4:
27 June 2010 PSUR 5:
27 ta ’ Ġunju 2010 PSUR 5:
27 December 2010 PSUR 6:
27 ta ’ Diċembru 2010 PSUR 6:
27 December 2011 PSUR 7:
27 ta ’ Diċembru 2011 PSUR 7:
27 December 2012
27 ta ’ Diċembru 2012
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13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Fluticasone furoate GSK 27.5 micrograms/ spray nasal spray suspension Fluticasone furoate
Fluticasone furoate GSK 27. 5 mikrogrammi/ sprejjatura ta ’ suspensjoni li jintuża bħala sprej fl - imnieħer Fluticasone furoate
Each spray delivers 27.5 micrograms of fluticasone furoate
Kull sprejjatura fiha 27. 5 mikrogrammi ta ’ fluticasone furoate
Also contains:
Fih ukoll: