qanastek/EMEA-V3 huggingface dataset:
Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water
Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat
Nasal spray, suspension 1 bottle - 30 sprays 1 bottle - 60 sprays 1 bottle - 120 sprays
Sprej għal użu fl- imnieħer, suspensjoni Flixkun 1 - 30 sprejjatura Flixkun 1 - 60 sprejjatura Flixkun 1 - 120 sprejjatura
Shake well before use Read the package leaflet before use.
Ħawwad sew qabel tużah Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Nasal use
Għal użu fl- imnieħer
2 months
JIS (XX/ SSSS) Żmien kemm idum tajjeb waqt l- użu: xagħrejn
Do not refrigerate or freeze
Tagħmlux fil- friġġ jew friża
Glaxo Group Ltd Greenford, Middlesex, UB6 0NN United Kingdom
Glaxo Group Ltd Greenford, Middlesex, UB6 0NN Renju Unit
LOT {Number}
LOTT (Numru)
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
INTRANASAL SPRAY/ DEVICE LABEL
SPREJ GĦAL UŻU FL- IMNIEĦER/ TIKKETTA
Fluticasone furoate GSK 27.5 micrograms/ spray nasal spray suspension Fluticasone fuorate
Fluticasone furoate GSK 27. 5 mikrogrammi / sprejjatura ta ’ suspensjoni li jintuża bħala sprej fl - imnieħer Fluticasone furoate
EXP {MM/ YYYY]
DATA META JISKADI JIS (XX/ SSSS)
LOT {Number}
NUMRU TAL- LOTT LOTT (Numru)
30 sprays 60 sprays 120 sprays
30 sprejjatura 60 sprejjatura 120 sprejjatura
Fluticasone furoate GSK 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Fluticasone furoate GSK 27. 5 mikrogrammi/ sprejjatura ta ’ suspensjoni għal użu bħala sprej fl - imnieħer Fluticasone furoate
Never pass it on to others.
Tista ’ tagħmlilhom
symptoms seem the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Fluticasone furoate GSK is and what it is used for 2.
X’ inhu Fluticasone furoate GSK u għalxiex jintuża 2.
Before you use Fluticasone furoate GSK 3.
Qabel ma tuża Fluticasone furoate GSK 3.
How to use Fluticasone furoate GSK 4.
Kif għandek tuża Fluticasone furoate GSK 4.
How to store Fluticasone furoate GSK 6.
Kif taħżen Fluticasone furoate GSK 6.
WHAT FLUTICASONE FUROATE GSK IS AND WHAT IT IS USED FOR
X’ INHU FLUTICASONE FUROATE GSK U GĦALXIEX JINTUŻA
Fluticasone furoate GSK nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Fluticasone furoate GSK sprej nażali jintuża fit- trattament ta ’ sintomi ta ’ rinite allerġika inklużi mnieħer imblukkat jew inixxi, għatis, u għajnejn idemmgħu u ħakk fl- għajnejn fl- adulti u fit- tfal ta ’ 6 snin u l- fuq.
Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year around and be caused by allergy to animals, house-dust mites or moulds.
Is- sintomi jistgħu jseħħu fi żminijiet speċifiċi matul is- sena u jistgħu ikunu kawżati minn allerġiji minn polline tal- ħaxix jew tas- siġar (hay fever) u jistgħu ukoll iseħħu s- sena kollha kawżati minn allerġiji għal annimali, insetti mikroskopiċi fl- arja jew għal moffa.
Fluticasone furoate GSK belongs to a group of medicines called glucocorticoids.
Fluticasone furoate GSK jiforma parti mill- grupp ta ’ mediċini msejħa glucocorticoids.
Fluticasone furoate GSK works to decrease inflammation caused by allergy (rhinitis).
Fluticasone furoate GSK jaħdem biex inaqqas l- infjammazzjoni fl- imnieħer u l- irritazzjoni fl- għajnejn kawżati minn allerġiji (rinite).
BEFORE YOU USE FLUTICASONE FUROATE GSK
QABEL MA TUŻA FLUTICASONE FUROATE GSK
If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Fluticasone furoate GSK.
Tużax Fluticasone furoate GSK Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal fluticasone furoate jew sustanzi oħra ta ’ Fluticasone furoate GSK
If you have any liver problems, tell your doctor or pharmacist.
Oqgħod attent ħafna b ’ Fluticasone furoate GSK Għarraf lit- tabib jew lill- ispiżjar tiegħek jekk għandek xi problemi tal- fwied.
Your doctor may adjust your dose of Fluticasone furoate GSK.
It- tabib jista jaġġusta d - doża ta ’ Fluticasone furoate GSK li qiegħed tieħu.
Taking nasal glucocorticoids (such as Fluticasone furoate GSK) for a long time may cause children to grow more slowly.
It- teħid ta ’ glucocorticoids mill- imnieħer (bħal Fluticasone furoate GSK) għal żmien twil jista ’ jikkawża d- dewmien fl- iżvilupp tat- tfal.
The doctor will check your child’ s height regularly, and make sure he or she is taking the lowest possible effective dose.
It- tabib se jiċċekkja t- tul tat- tifel/ tifla tiegħek regolarment, u jaċċerta ruħu li qed/ qegħda tieħu l- inqas doża effettiva possibbli.
Taking other medicines Tell your doctor if you are taking, or have recently taken, any other medicines, including those bought without a prescription.
Meta tieħu mediċini oħra Għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar, xi mediċini oħra, anki dawk li xtrajt mingħajr riċetta.
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines: • steroid tablets or injected steroids • steroid creams • medicines for asthma • ritonavir, used to treat HIV • ketoconazole, used to treat fungal infections
Hu speċjalment importanti li tgħid lit- tabib tiegħek jekk tkun qed tieħu jew dan l- aħħar ħadt xi waħda minn dawn il- mediċini li ġejjin: • sterojdi injettati jew mill- ħalq
18 Your doctor will assess whether you should take Fluticasone furoate GSK with these medicines.
18 • sterojdi forma ta ’ dlik • mediċini għall- ażma. • ritonavir, li jintuża għat- trattament ta ’ l- HIV • ketoconazole, li jintuża għat- trattament ta 'infezzjonijiet fungali
Pregnancy and breast-feeding Do not use Fluticasone furoate GSK if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Tqala u Treddigħ Tużax Fluticasone furoate GSK jekk int tqila, jew qed tippjana biex toħroġ tqila, sakemm ma jkunx qallek hekk it- tabib jew l- ispiżjar tiegħek.
Do not use Fluticasone furoate GSK if you are breast feeding unless your doctor or pharmacist tells you to.
Tużax Fluticasone furoate GSK jekk qed tredda ’, sakemm ma jkunx qallek hekk it- tabib jew l- ispiżjar tiegħek.
Driving and using machines Fluticasone furoate GSK is unlikely to affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Mhuwiex probabbli li Fluticasone furoate GSK jaffettwa l- ħila għas- sewqan jew għat- tħaddim ta ’ magni
Important information about some of the ingredients of Fluticasone furoate GSK Fluticasone furoate GSK contains benzalkonium chloride.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Fluticasone furoate GSK Fluticasone furoate GSK fih benzalkonium chloride.
In some patients this can cause irritation in the inside of the nose.
F’ xi pazjenti dan jista ’ jikkawża irritazzjoni ġewwa l- imnieħer.
Tell your doctor or pharmacist if you feel discomfort when using the spray.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk tħoss xi skonfort waqt l- użu ta ’ l- isprej.
HOW TO USE FLUTICASONE FUROATE GSK
KIF GĦANDEK TUŻA FLUTICASONE FUROATE GSK
Always use Fluticasone furoate GSK exactly as your doctor has told you.
Dejjem għandek tuża Fluticasone furoate GSK skond il- parir tat- tabib.
When to use it and how much to use Fluticasone furoate GSK is sprayed into the nose as a fine mist.
Meta għandek tużah u kemm tuża Fluticasone furoate GSK jiġi sprejjat fl- imnieħer bħal raxx ħafif.
It has virtually no taste.
Tista ’ tgħid ma fih togħma ta ’ xejn.
Fluticasone furoate GSK is not for use in the eyes.
Fluticasone furoate GSK m’ għandux jintuża fl- għajnejn.
This will treat your symptoms throughout the day and night.
Meta għandek tuża Fluticasone furoate GSK • Użah darba kuljum • Dejjem użah fl- istess ħin Dan għandu jikkura s- sintomi bil- lejl u bi nhar.
How long Fluticasone furoate GSK takes to work Some people will not feel the full effects until several days after first using Fluticasone furoate GSK.
Kemm idum Fluticasone furoate GSK qabel jibda jaħdem Xi wħud ma jħossux l- effett sħiħ qabel ma jgħaddu xi ġranet mill- ewwel użu ta ’ Fluticasone furoate GSK.
However, it is usually effective within 8 to 24 hours of use.
Madankollu, normalment ikun effettiv wara 8 sa 24 siegħa li jkun ġie wżat.
Adults and children 12 years and over • The usual starting dose is 2 sprays in each nostril once every day. • Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, once every day.
Adulti u tfal ta ’ minn 12- il sena ’ l fuq • Normalment l- ewwel doża tkun ta ’ żewġ sprejjaturi f’ kull minħar darba kuljum. • Meta s- sintomi jkunu kontrollati tista ’ tnaqqas id- doża għal sprejjatura waħda f’ kull minħar, darba kuljum.
Children under 12 years • In children aged 6 to 11 the usual starting dose is 1 spray in each nostril once every day. • If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control.
Tfal taħt it- 12- il sena • Fi tfal ta ’ bejn is- 6 snin u 11- il sena l- ewwel doża normalment tkun ta ’ sprejjatura waħda f’ kull minħar darba kuljum. • Jekk is- sintomi jkunu qawwija ħafna it- tabib tiegħek għandu mnejn iżid id- doża għal żewġ sprejjaturi f’ kull minħar darba kuljum sakemm is- sintomi jiġu kontrollati.
It may then be possible for the dose to be reduced to 1 spray in each nostril once every day. • Do not use in children under 6 years old.
Imbagħad id- doża tista ’ possibilment titnaqqas għal sprejjatura waħda f’ kull minħar darba kuljum. • Tużahx fuq tfal ta ’ taħt is- 6 snin.
If you use more Fluticasone furoate GSK than you should Talk to your doctor or pharmacist.
Jekk tuża Fluticasone furoate GSK aktar milli suppost Kellem lit- tabib jew lill- ispiżjar tiegħek
If you forget to use Fluticasone furoate GSK • If you miss a dose, take it when you remember. • If it is nearly the time for your next dose, wait until then.
19 Jekk tinsa tuża Fluticasone furoate GSK • Jekk tinsa tuża xi doża, agħmel dan malli tiftakar. • Jekk ikun wasal il- ħin għad- doża li jmiss, stenna sakemm ikun sar il- ħin għad- doza illi jmiss.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
19 How to test the nasal spray before use The nasal spray • Your medicine comes in a glass bottle inside a plastic casing. • The glass bottle contains either 30, 60 or 120 sprays. • A window on the side of the casing allows you to see how much medicine is left.
Kif għandek tittestja l- isprej nażali qabel tużah L- isprej nażali • Din il- mediċina tkun fi flixkun tal- ħġieġ f’ kontenitur tal- plastik. • Il- flixkun tal- ħġieġ ikun fih 30, 60, jew 120 sprejjaturi. • Minn fetħa żgħira fil- ġenb tal- kontenitur tista ’ tara kemm għad fadal mediċina.
A bottle containing 30 sprays will not appear full when you first receive it. • The medicine sprays out of the nozzle when the button on the side is firmly pressed. • The nozzle is protected by a removable cap.
Flixkun ta ’ 30 sprejjaturi ma jkunx jidher mimli malli tarah l- ewwel darba. • Il- mediċina toħroġ bħala sprej miż- żennuna meta tagħfas sew il- buttuna li hemm fil- ġenb. • Iż- żennuna hi protetta minn b’ tapp li jista ’ jerġa ’ jitqiegħed f’ postu.
Cap
Tapp
Nozzle
Żennuna
Window
Buttuna
Front
Tieqa
Testing the nasal spray
Kif tittestja l- isprej nażali
The first time you use the nasal spray, you must test that it is working properly.
L- ewwel darba li tuża l- isprej nażali, għandek tittestjah biex tkun żgur li qed jaħdem tajjeb.
If you have left the cap off or have not used your spray for nearly a month, follow steps 1-4 below.
Jekk ħallejt it- tapp barra jew jekk ma tkunx użajt l- isprej għal xi xahar, erġa ’ ttestjah billi ssegwi l - passi 1- 4 hawn taħt.
With the cap on, shake the nasal spray.
Bit- tapp f’ postu, ħawwad l- isprej nażali.
Remove the cap by gently squeezing the sides of the cap with your thumb and forefinger and pull it straight off – see picture a.
Neħħi t- tapp billi tagħfas bil- mod il- ġnub tat- tapp b’ sabgħak il- kbir u s- saba ’ l- werrej u tiġbdu ’ l barra mill- ewwel – ara l- istampa ‘ a ’.
Holding the nasal spray upright, point the nozzle away from you and firmly press the button on the side at least 6 times to release a fine spray into the air – see picture b.
Żomm iż- żennuna mhux lejk u agħfas sew il- buttuna tal- ġenb mill- inqas għal 6 darbiet biex toħroġ sprej irqiqa fl- arja – ara l- istampa ‘ b ’.
The nasal spray is now ready for use.
L- isprej nażali issa lest biex jintuża.
If you drop the spray, check for damage and test it again (steps 1-4 above).
Jekk twaqqa ’ l- isprej, ara jekk għamiltlux xi ħsara u erġa ’ ttestjah.
Return it to your pharmacist.
Jekk tkun saritlu xi ħsara, jekk ma joħroġx ħlief sprej irqiq (bħal xi likwidu waħdu) jew jekk ma tħossokx komdu/ a tużah; Ħudu lura għand l- ispiżjar.
20 Using your nasal spray
20 Użu ta ’ l- isprej nażali tiegħek
Blow your nose to clear your nostrils.
Omħot biex tnaddaf imnieħrek minn ġewwa.
Shake the spray gently before each use.
Ħawwad l- isprej bil- mod qabel kull darba li tużah.
Tilt your head forward a little bit.
Mejjel rasek ftit ’ il quddiem.
Hold the nasal spray upright and carefully place the nozzle in one of your nostrils – see picture c.
Żomm l- isprej nażali ’ l fuq u qiegħed b’ attenzjoni ż- żennuna f’ minħar minnhom – ara l- istampa ‘ c ’.
Point the end of the nozzle toward the outside of your nose, away from the centre ridge of your nose.
Ipponta t- tarf taż- żennuna lejn il- barra ta ’ mnieħrek, lil hinn mill- parti tan- nofs ta ’ mnieħrek.
This helps to get the medicine to the right part of your nose.
Dan jgħin biex il- mediċina tilħaq il- parti ta ’ mnieħrek li għandha tasal fuqha.
As you breathe in through your nose, firmly press the button once to spray the medicine into your nose – see picture d.
Waqt li tieħu n- nifs ’ il ġewwa minn imnieħrek, agħfas darba sew il- buttuna biex tisprejja l - mediċina fi mnieħrek – ara l- istampa ‘ d ’.
Be careful not to get any spray into your eyes.
Oqgħod attent li l- isprej ma ddaħħlux f’ għajnejk.
If you do, rinse your eyes with water.
Jekk tagħmel dan, laħlaħ għajnejk bl- ilma.
Take the nozzle out and breathe out through your mouth.
Oħroġ iż- żennuna ’ l barra u ħu n- nifs minn ħalqek.
Repeat steps 1 to 5 for your other nostril.
Irrepeti l- istruzzjonijiet 1 sa 5 fil- minħar l- ieħor.
If your doctor has told you to use 2 sprays per nostril, repeat all the 6 steps above.
Jekk it- tabib ikun qallek biex tuża żewġ sprejjaturi f’ kull minħar, irrepeti is- sitt istruzzjonijiet kollha t’ hawn fuq.
Cleaning your nasal spray
Kif tnaddaf l- isprej nażali tiegħek
After each use, wipe the nozzle and the inside of the cap – see pictures e and f.
Wara kull darba li tużah, imsaħ iż- żennuna u l- ġewwieni tat- tapp – ara l- istampi ‘ e ’ u ‘ f ’.
Don ’ t use water to do this, wipe with a clean, dry tissue.
Biex tagħmel dan tużax ilma; imsaħ b’ karta assorbenti nadifa u xotta.
If the spray becomes blocked, do not try and unblock the nozzle with a pin or sharp object as this will damage the spray mechanism:
Jekk l- isprej jiġi mblukkat, tippruvax tiżblukkah b’ xi labra jew b’ xi oġġett li jtaqqab għax dan jagħmel ħsara lill- mekkaniżmu ta ’ l- isprej:
Return it to your pharmacist.
Ħudu lura għand l- ispiżjar.
Always replace the cap once you have finished to keep out dust.
Dejjem poġġi t- tapp f’ postu wara l- użu biex ma jidħolx it- trab.
If you use more Fluticasone furoate GSK than you should Talk to your doctor or pharmacist.
Jekk tuża Fluticasone furoate GSK aktar milli suppost Kellem lit- tabib jew lill- ispiżjar tiegħek.
If you forget to use Fluticasone furoate GSK • If you miss a dose take it when you remember. • If it is nearly the time for your next dose, wait until then.
Jekk tinsa tuża Fluticasone furoate GSK * Jekk taqbeż xi doża ħudha malli tiftakar. * Jekk ikun kważi wasal il- ħin għad- doża li jmissek, stenna sakemm ikun sar il- ħin għad- doza illi jmiss.
Like all medicines, Fluticasone furoate GSK can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fluticasone furoate GSK jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Possible side effects are listed below:
Effetti sekondarji possibbli huma elenkati hawn taħt:
Very common side effects (These can affect more than 1 person in 10) • Nosebleeds (generally minor), particularly if you use Fluticasone furoate GSK for more than 6 weeks continuously.
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) • Ħruġ ta ’ demm mill- imnieħer (ġeneralment ftit), partikolarment jekk tuża Fluticasone furoate GSK għal aktar minn 6 ġimgħat kontinwament.
Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100) • Irritation or discomfort in the inside of the nose – you may also get streaks of blood when you blow your nose.
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw inqas minn persuna waħda minn kull 10 u aktar minn persuna waħda minn kull 100) • Irritazzjoni jew xi uġigħ ħafif fil- ġewwieni ta ’ l- imnieħer – jistgħu ukoll joħorġu ħjut tad- demm meta tomħot.
This may be due to nasal ulceration.
Dan jista ’ jkun minħabba xi ulċeri fl- imnieħer
Tell your doctor or pharmacist.
Jekk ikollok xi effetti sekondarji Jekk xi wieħed mill- effetti sekondarji jiggrava jew idejqek, 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 FLUTICASONE FUROATE GSK
KIF TAĦŻEN FLUTICASONE FUROATE GSK
Do not use Fluticasone furoate GSK after the expiry date which is stated on the label and carton.
Tużax Fluticasone furoate GSK wara d- data ta ’ l- iskadenza li tidher fuq it- tikketta u fuq il- kaxxa.
The expiry date refers to the last day of the month.
Id - data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
Fluticasone furoate GSK nasal spray should be used within 2 months after first opening.
L- isprej għall- imnieħer Fluticasone furoate GSK għandu jintuża fi żmien xagħrejn wara li jinfetaħ..
What Fluticasone furoate GSK contains The active substance is fluticasone furoate.
X’ fih Fluticasone furoate GSK:
Each spray delivers 27.5 micrograms of fluticasone furoate.
Is- sustanza attiva hi fluticasone furoate (27. 5 mikrogrammi kull doża).
The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Is- sustanzi l- oħra huma glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat.
What Fluticasone furoate GSK looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Il- mediċina hi suspensjoni bajda li tkun fi flixkun tal- ħġieġ ta ’ lewn safrani, b’ pompa mwaħħla miegħu.
The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever.
Il- kontenitur fih fetħa żgħira biex tkun tista ’ tara x’ hemm fil- flixkun.
The casing has a window for viewing the bottle contents.
Kull doża/ sprejjatura toħroġ madwar 27. 5 mikrogrammi ta ’ fluticasone furoate.
Fluticasone furoate GSK is available in pack sizes 30, 60 and 120 sprays.
Fluticasone furoate GSK ikun f’ pakketti ta ’ 30, 60 u 120 sprejjaturi.
Marketing authorisation holder Marketing authorisation:
L- awtorizzazzjoni għat- tqegħid fis- suq:
Glaxo Group Ltd Greenford, Middlesex, UB6 0NN United Kingdom
Glaxo Group Ltd Greenford, Middlesex, UB6 0NN UK
Manufacturer:
22 Il- manifattur:
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT United Kingdom
Glaxo Operations UK, Ltd, (fil- kummerċ Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
22 For information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- suq:
Nederland GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk. com
Malta GlaxoSmithKline Malta Tel: + 356 21 238131
Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk. no
Nederland GlaxoSmithKline BV Tel: + 31 (0) 30 6938100 nlinfo@ gsk. com
Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk. com
Eesti Norge GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@ gsk. com
Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at. info@gsk. com
GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@ gsk. no
Tel.: + 48 (0)22 576 9000 Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel.: + 48 (0) 22 576 9000
România GlaxoSmithKline (GSK) S. R. L.
Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 4021 3028 208
Tel: + 351 21 412 95 00 FI. PT@ gsk. com
Ísland GlaxoSmithKline ehf.
23 Ísland GlaxoSmithKline ehf.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
EPAR summary for the public
FOCETRIA Sommarju ta ’ l- EPAR għall- pubbliku
What is Focetria?
X’ inhu Focetria?
Focetria is a vaccine.
Focetria hija vaċċin.
It is a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus.
Hija sospensjoni għall- injezzjoni li fiha xi partijiet (membrani ta ’ barra) tal- virus ta ’ l- influwenza.
It contains a flu strain called A/ Viet Nam/ 1194/ 2004 (H5N1).
Fiha r- razza ta ’ l- influwenza msejjħa A/ Viet Nam/ 1194/ 2004 (H5N1).
What is Focetria used for?
Għalxiex jintuża Focetria?
Focetria is a vaccine that can only be used once a flu ‘ pandemic’ has been officially declared by the World Health Organization (WHO) or European Union (EU).
Focetria hija vaċċin li tista ’ tintuża biss ladarba tkun ġiet iddikjarata uffiċjalment influwenza ‘ pandemika ’ mill- Għaqda Dinjija tas- Saħħa (WHO) jew mill- Unjoni Ewropea (EU).
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it.
Influwenza pandemika sseħħ meta joħroġ tip ta ’ virus ġdid (razza) tal- virus ta ’ l- influwenza li jista ’ jinfirex faċilment minn persuna għal oħra peress li n- nies ma jkollom l- ebda immunità (protezzjoni) kontra tiegħu.
A pandemic can affect most countries and regions around the world.
Pandemija tista ’ taffettwa l- parti l- kbira tal- pajjiżi u r- reġjuni madwar id- dinja. rakkomandazzjonijiet uffiċjali.
Focetria would be given according to official recommendations.
Il- vaċċin jista ’ jingħata biss b’ riċetta ta ’ tabib.
The vaccine can only be obtained with a prescription.
Focetria tingħata skond ir -
How is Focetria used?
Kif jintuża Focetria?
Focetria is given in two doses, at least three weeks apart.
Focetria jingħata f’ żewġ dożi, għallinqas tliet ġimgħat ’ il bogħod minn xulxin.
It is given by injection into the upper arm muscle.
Jingħata ġol- muskolu tal - parti ta ’ fuq tad- driegħ.
How does Focetria work?
Kif jaħdem Focetria?
Focetria is a ‘ mock-up’ vaccine.
Focetria huwa vaċċin tat- tip “ finta ”.
This is a special type of vaccine that can be developed to help with the management of a pandemic.
Dan huwa tip speċjali ta ’ vaċċin li jista ’ jiġi żviluppat biex jgħin fil - ġestjoni ta ’ pandemija.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance.
Qabel tibda pandemija, ħadd ma jkun jaf liema razza ta ’ virus ta ’ l- influwenza se jkun involut, għalhekk il- kumpaniji ma jistgħux jippreparaw il- vaċċin korrett minn qabel.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Minflok, huma jistgħu jippreparaw vaċċin li fih ir- razza ta ’ virus ta ’ l- influwenza magħżul speċifikament peress li ħadd ma kien espost għalih, u għal liema ħadd ma jkun immuni.
They can test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included.
Huma jistgħu jittestjaw dan il- vaċċin biex jaraw kif in- nies jistgħu jirreaġġixxu għalih, li tħallihom ibassru kif in- nies se jirreaġġixxu meta r- razza ta ’ l- influwenza li tikkaġuna l- pandemija tkun inkluża.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nifisha kontra l- mard.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf lill- virus bħala “ barrani ” u tagħmel antikorpi kontrih.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Is- sistema immunitarja imbagħad tkun tista ’ tagħmel antikorpi aktar malajr meta terġa ’ tkun esposta għal virus darb’ oħra.
This helps to protect against the disease.
Dan jgħin biex jilqa ’ kontra l- mard.
Focetria contains small amounts of parts of a virus called H5N1.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The virus has been first inactivated (killed) so that it does not cause any disease.
Il- virus l- ewwel ġie inattivat (maqtul) sabiex ma jikkaġuna l- ebda mard.
The outer membranes that contain the ‘ surface antigens ’ (proteins on the outer membrane of the virus that the body recognises as foreign) have then been extracted and purified.
Il- membrani ta ’ barra li fihom l - ‘ antiġeni tal- wiċċ ’ (proteini fuq il - membrana ta ’ barra tal- virus li l- ġisem jagħraf bħala barranin) imbagħad kienu maħruġin u ppurifikati.
The vaccine also contains an ‘ adjuvant ’ (a compound containing oil) to stimulate a better response.
Il - vaċċin fih ukoll adjuvantat (taħlita li fiha ż- żejt) biex jistimola reazzjoni aħjar.
If a pandemic starts, the virus strain in Focetria will be replaced by the strain causing the pandemic before the vaccine can be used.
Jekk tibda pandemija, ir- razza ta ’ virus f’ Foceria tinbidel bir- razza li tikkaġuna l- pandemija qabel ma ’ l - vaċċin ikun jista ’ jintuża.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kif ġie studjat Focetria?
The effects of Focetria were first tested in experimental models before being studied in humans.
L- effetti ta ’ Focetria kienu l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il- bnedmin.
The main study of Focetria included 486 healthy subjects (a third of whom were over the age of 60) and compared the ability of two doses of Focetria to trigger the production of antibodies (immunogenicity).
L- istudju ewlieni ta ’ Focetria kien jinkludi 486 suġġett b’ saħħtu (terz minnhom kienu ’ l fuq minn 60 sena) u qabbel l- abbiltà ta ’ żewġ dożi ta ’ Focetria fit- tqanqil tal- produzzjoni ta ’ antikorpi (immunoġeniċità).
The participants received two injections of Focetria, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Il - partiċipanti ngħataw żewġ injezzjonijiet ta ’ Foceria, li fihom jew 7. 5 mikrogrammi jew 15- il mikrogramm ta ’ haemagglutinin (proteina li tinstab fil- virusijiet ta ’ l- influwenza), 21 jum ’ il bogħod minn xulxin.
The main measures of effectiveness were the levels of antibodies against the flu virus in the patients’ blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).
Il - miżuri ewlenin ta ’ l- effettività kienu l- livelli ta ’ antikorpi kontra l- virus ta ’ l- influwenza fid- demm tal - pazjenti qabel il- vaċċinazzjoni, fil- jum tat- tieni injezzjoni (jum 22), u 21 jum aktar tard (jum 43).
What benefit has Focetria shown during the studies?
X’ benefiċċju wera Foceria waqt l- istudji?
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Skond il- kriterji stabbiliti mill- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP), vaċċin ‘ finta ’ jeħtieġ li joħloq livelli ta ’ protezzjoni ta ’ antikorpi f’ għallinqas 70% tal- persuni biex jitqies stabbli.
The study showed that Focetria produced an antibody response that satisfies these criteria.
L- istudju wera li Focetria jipproduċi reazzjoni ta ’ antikorpi li tissodisfa dawn il- kriterji.
Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1.
Wieħed u għoxrin jum wara t- tieni injezzjoni, 86% tal- persuni li ngħataw il- vaċċin b’ 7. 5 mikrogrammi haemagglutinin kellhom livelli ta ’ antikorpi li jipproteġuhom kontra H5N1.
The figure was 85% in the patients who received the 15-micrograms dose.
Il- figura kienet 85% fil- pazjenti li ngħataw id - doża ta ’ 15- il mikrogramma.
What is the risk associated with Focetria?
X’ inhu r- riskju assoċjat ma ’ Focetria?
The most common side effects with Focetria (seen in between 1 and 10 people in 100) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, malaise (feeling unwell), fatigue (tiredness) and shivering.
L- aktar effetti sekondarji komuni b’ Focetria (jidhru f’ bejn 1 u 10 persuni f’ 100 persuna) huma uġigħ ta ’ ras, ħruġ ta ’ għaraq, artralġja (uġigħ fil- ġoġi), mijalġja (uġigħ fil- muskoli), reazzjonijiet fis- sit ta ’ l - injezzjoni (ħmura, nefħa, ebusija, tbenġil, uġigħ), deni, ħedla, għeja kbira u tertir ta ’ bard.
For the full list of all side effects reported with Focetria, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Focetria, ara l- Fuljett tat- Tagħrif.
Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein, kanamycin or neomycin sulphate (two antibiotics), formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Focetria m’ għandhiex tingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill- komponenti tal- vaċċin, jew għal kwalunkwe sustanza li tinsab f’ livelli ta ’ traċċi, bħal bajd, proteina tat- tiġieġ, kanamycin jew neomycin sulphate (żewġ antibijotiċi), formaldehyde, cetyltrimethylammonium bromide (CTAB) u polysorbate 80.
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Madankollu, jekk tkun bdiet pandemija, jista ’ jkun xieraq li dawn il- pazjenti jingħataw il- vaċċin, diment li jkun hemm preżenti faċilitajiet għar - rianimazzjoni.
Why has Focetria been approved?
Għaliex ġie approvata Focetria?
The Committee for Medicinal Products for Human Use (CHMP) decided that Focetria’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Focetria huma akbar mir- riskji tagħha għal profilassi ta ’ l- influwenza f’ sitwazzjoni pandemika ddikjarata uffiċjalment.
The committee recommended that Focetria be given marketing authorisation.
Il- kumitat irrakkomanda li Focetria tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Focetria has been authorised under “ Exceptional Circumstances”.
Focetria ġie awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Dan ifisser li minħabba li r- razza tal- virus ta ’ l - influwenza li jista ’ jikkaġuna pandemija mhijiex magħrufa, ma kienx possibbli li jinkiseb tagħrif sħiħ dwar il- vaċċin ta ’ pandemija futura.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea dwar il- Mediċini (EMEA) tirrevedi kull tagħrif ġdid li jista ’ jsir disponibbli u dan is- sommarju jiġi aġġornat kif meħtieġ.
What information is still awaited for Focetria?
X’ tagħrif għadu mistenni għal Focetria?
If a pandemic is declared, the company that makes Focetria will include the flu strain responsible in the vaccine.
Jekk tiġi ddikjarata pandemija, il- kumpanija li tagħmel Focetria għandha tinkludi fil- vaċċin ir- razza ta ’ l - influwenza li tkun responsabbli.
It will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Imbagħad, hija tiġbor it- tagħrif dwar is- sigurtà u l- effettività tal- vaċċin pandemiku finali, u tisottomettih lis- CHMP għal evalwazzjoni.
Which measures are being taken to ensure the safe use of Focetria?
X’ miżuri qed jittieħdu biex jassiguraw l- użu sikur ta ’ Focetria?
If Focetria is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Jekk Focetria tintuża waqt pandemija, il- kumpanija li tagħmilha trid tiġbor tagħrif dwar is- sigurtà tal - vaċċin waqt li jkun qed jintuża.
This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Dan jinkludi tagħrif fuq l- effetti sekondarji tiegħu u s- sigurtà tiegħu fit - tfal, nisa tqal, pazjenti b’ kundizzjonijiet serji, u nies li għandhom problemi bis- sistemi immunitarji tagħhom.
Other information about Focetria:
Tagħrif ieħor dwar Focetria:
The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S. r. l. on 2 May 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Focetria lil Novartis Vaccines and Diagnostics S. r. l. fl- 2 ta ’ Mejju 2007.
The full EPAR for Focetria can be found here.
L- EPAR sħiħ għal Focetria jista ’ jinstab hawn.
This summary was last updated in 05-2007.
Dan is- sommarju kien aġġornat l- aħħar f’ 05- 2007.
Name
Isem
Route of Administration
Għamla farmaċewtika Mnejn jingħata
Suspension for injection
Suspensjoni għall - Użu għal ġol - injezzjoni muskoli
pre-filled syringe (glass)
Siringa mimlija għal- lest (ħġieġ)
vial (glass)
Kunjett (ħġieġ)
0.5 ml (1 dose = 0.5ml)
0. 5 ml (1 doża = 0. 5 ml)
10 vials (monodose)
10 kunjetti (doża waħda)
5.0 ml (1 dose = 0.5 ml)
5. 0 ml (1 doża = 0. 5 ml)
10 vials (multidose:
10 kunjetti (għadd ta ’ dożi:
10 doses)
10 dożi)
Focetria suspension for injection in pre-filled syringe Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- influwenza pandemika (antiġeni tal- wiċċ, inattivati, adjuvantat)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Antiġeni tal- wiċċ tal- virus ta 'l- influwenza (haemagglutinin u neuraminidase) * tar- razza:
7.5 micrograms** per 0.5 ml dose
7. 5 mikrogrammi ** għal kull doża ta '0. 5 ml
* propagated in eggs ** expressed in microgram haemagglutinin.
* propagat fil- bajd ** imfissra f' mikrogrammi ta 'haemagglutinin.
Adjuvant MF59C.1 containing: squalene
Adjuvant MF59C. 1 li fih squalene
9.75 milligrams
9. 75 milligrammi
polysorbate 80 sorbitan trioleate
polysorbate 80 sorbitan trioleate
1.175 milligrams 1.175 milligrams
1. 175 milligrammi 1. 175 milligrammi
This vaccine complies with the WHO recommendations and EU
Dan il- vaċċin jikkonforma mar- rakkomandazzjonijiet tal- WHO u mad- deċiżjoni ta 'l- UE għall - pandemija.
Suspension for injection in pre-filled syringe.
Suspensjoni għall- injezzjoni f' siringa mimlija għal- lest.
Milky-white liquid.
Likwidu bajdani lewn il- ħalib.
Prophylaxis of influenza in an officially declared pandemic situation.
Profilassi ta 'l- influwenza f' sitwazzjoni pandemika ddikjarata b' mod uffiċjali.
Pandemic influenza vaccine should be used in accordance with Official Guidance (see sections 4.2 and 5.1).
Il- vaċċin kontra l - influwenza pandemika għandu jintuża biss skond il- Gwida Uffiċjali (ara sezzjonijiet 4. 2 u 5. 1).
Focetria has been evaluated in adults aged 18-60 years and elderly over 60 years following a 0, 21 day schedule.
Focetria ġie evalwat f’ adulti li għandhom 18- 60 sena u anzjani fuq is- 60 sena wara skeda ta ’ 0, 21 ġurnata
Adults and elderly:
Adulti u anzjani:
0.5 ml.
0. 5 ml.
A second dose of vaccine should be given after an interval of at least 3 weeks.
Għandha tingħata doża oħra tal- vaċċin wara intervall ta 'mill- anqas 3 ġimgħat.
Immunisation should be carried out by intramuscular injection into the deltoid muscle.
It- tilqim għandu jsir permezz ta 'injezzjoni intramuskolari fil- muskolu tad- deltoid.
No data are available in subjects below 18 years or in children.
M’ hemmx informazzjoni disponibbli fuq suġġetti li għandhom anqas minn 18- il sena jew fuq it- tfal.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine in that population.
Għalhekk persuni li jipprovdu l- kura tas- saħħa għandhom bżonn iqisu is- siwi u r- riskji potenzjali għall- amministrazzjoni tal- vaċċin f’ din il- popolazzjoni
For pregnant women, see section 4.6.
Għal nisa tqal ara sezzjoni 4. 6.
For further information, see section 5.1.
2 Għal aktar tagħrif ara sezzjoni 5. 1
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Storja ta 'reazzjoni anafilattika (jiġifieri ta' periklu għall- ħajja) għal xi wieħed mill- kostitwenti jew traċċi residwi tal- bajd, proteini tat- tiġieġ, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB) ta 'dan il- vaċċin.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Madankollu, f' sitwazzjoni pandemika, jista 'jkun f' waqtu li jingħata l- vaċċin, bil- kundizzjoni li l- faċilitajiet għar- risuxxitazzjoni jkunu disponibbli minnufih f' każ ta' bżonn.
See section 4.4. for Special warnings and special precautions for use.
Ara sezzjoni 4. 4 għal Twissijiet speċjali u prekawzjonijiet għall- użu
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Hija meħtieġa attenzjoni meta dan il- vaċċin jingħata lil persuni b' sensittività eċċessiva magħrufa (apparti r- reazzjoni anafilattika) għas- sustanza attiva, għal xi sustanza mhux attiva u għall- bajd, proteini tat- tiġieġ, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil- każ ta 'kull vaċċin ieħor li jiġi injettat, trattament mediku u sorveljanza adattata għandhom ikunu dejjem disponibbli, fil- każ rari li sseħħ reazzjoni anafilattika wara l- għoti tal- vaċċin.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Jekk is- sitwazzjoni pandemika tippermetti, it- tilqim għandu jiġi pospost f' pazjenti li jkollhom mard bid- deni sever jew infezzjoni akuta.
The vaccine should under no circumstances be administered intravascularly or subcutaneously.
Taħt l- ebda ċirkostanza il- vaċċin ma għandu jingħata ġol- vini jew taħt il- ġilda.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Ir- rispons ta 'l- antikorpi f' pazjenti b' immunosoppressjoni endoġenika jew jatroġenika tista' ma tkunx suffiċjenti.
A protective response may not be induced in all vaccines (see section 5.1).
Mhux kull vaċċin jista ’ jkollu rispons protettiv (ara sezzjoni 5. 1)
Focetria should not be given at the same time as other vaccines.
Focetria m' għandux jingħata fl- istess ħin ma 'vaċċini oħra.
However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Madankollu, jekk l- għoti ma 'vaċċin ieħor ikun indikat, it- tilqim għandu jitwettaq fuq dirgħajn jew riglejn separati.
It should be noted that the adverse reactions may be intensified.
Ta 'min jinnota li r - reazzjonijiet avversi jistgħu jiġu intensifikati.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- rispons immunoloġiku jista 'jonqos jekk il- pazjent ikun qed jieħu trattament immunosoppressiv.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Wara tilqim kontra l- influwenza, kienu osservati riżultati pożittivi foloz f' testijiet tas- seroloġija li użaw il- metodu ELISA biex jirrilevaw antikorpi kontra HIV1, l- Epatite Ċ u speċjalment HTLV1.
The Western Blot technique disproves the results.
It- teknika tal- Western Blot tgiddeb ir- riżultati.
The transient false positive reactions could be due to the IgM response by the vaccine.
Ir- reazzjonijiet pożittivi foloz temporanji jistgħu jkunu dovuti għar- reazzjoni ta ’ IgM mill- vaċċin.
No data have been generated with Focetria in pregnant women.
L- ebda informazzjoni ma ġiet iġġenerata b’ Focetria f’ nisa tqal.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Għalhekk persuni li jipprovdu l- kura tas- saħħa għandhom bżonn iqisu is- siwi u r- riskji potenzjali għall- għoti tal- vaċċin f’ nisa tqal u jikkonsidraw ir- rakkomandazzjonijiet uffiċjali.
Data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
It- tagħrif minn tilqim b' vaċċini interpandemiċi staġjonali trivalenti mhux attivati f' nisa tqal ma jindikax li r- riżultati avversi fuq l- omm u l- fetu kienu attribwibbli għall- vaċċin.
The vaccine may be used during lactation.
Il- vaċċin jista 'jintuża waqt it- treddigħ.
Focetria is unlikely to produce any effect on the ability to drive and use machines.
Focetria mhux probabbli li jipproduċi xi effett fuq il- ħila biex issuq u tħaddem magni.
• Clinical trials
• Provi kliniċi
In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
Fi provi kliniċi b’ fomulazzjonijiet differenti (H5N3, H9N2 u H5N1) 542 suġġetti kienu esposti għall— vaċċin li kien qed jiġi studjat.
Of theses subjects, 464 subjects received the mock-up vaccine (A/ H5N1).
Minn dawn, 464 suġġetti irċevew il- vaċċini mock- up (A/ H5N1).
From the clinical trials with the pandemic vaccine, most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
3 Mit- testijiet kliniċi bil- vaċċin pandemiku, il- biċċa l- kbira tar- reazzjonijiet kienu ta 'natura ħafifa, damu żmien qasir u kienu kwalitattivament simili għal dawk ikkawżati minn vaċċini konvenzjonali kontra l - influwenza staġjonali.
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Huwa ġeneralment aċċettat li l- effett adjuvanti li jwassal għal immunoġeniċità akbar huwa assoċjat ma 'frekwenza kemm xejn akbar ta' reazzjonijiet lokali (fil- biċċa l- kbira uġigħ ħafif) meta mqabbel ma 'vaċċini konvenzjonali, mhux adjuvanti kontra l- influwenza.
There were fewer reactions after the second vaccination compared with the first.
Kien hemm anqas reazzjonijiet wara t- tieni tilqima meta mqabbel ma 'l- ewwel waħda.
3 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
Reazzjonijiet avversi minn testijiet kliniċi bil- vaċċin mock- up huma elenkati hawn isfel (ara sezzjoni 5. 1 għal aktar informazzjoni dwar il- vaċċini mock- up).
The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
L- inċidenza ta ’ sintomi osservati f’ suġġetti li għandhom ’ il fuq minn 60 sena ta ’ età kien inqas meta mqabbel mal- popolazzjoni ta ’ bejn it- 18 – 60 sena.
Nervous system disorders Common (> 1/ 100, < 1/ 10): headache
Disturbi fis- sistema nervuża Komuni (> 1/ 100, < 1/ 10): uġigħ ta 'ras
Skin and subcutaneous tissue disorders Common (> 1/ 100, < 1/ 10): sweating
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni (> 1/ 100, < 1/ 10): tagħriq
Muscoskeletal, connective tissue and bone disorders Common (> 1/ 100, < 1/ 10): arthralgia and myalgia
Disturbi muskolu- skeltrali u tal- connective tissue Komuni (> 1/ 100, < 1/ 10): artralġja u majalaġja
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni (> 1/ 100, < 1/ 10): ħmura fil- post ta' l- injezzjoni, nefħa fil- post ta 'l- injezzjoni, ebusija fil- post ta' l- injezzjoni, ekkimosi fil- post ta 'l- injezzjoni u uġigħ fil- post ta' l- injezzjoni, deni, telqa, għeja u rogħda
These reactions usually disappear within 1-2 days without treatment.
Dawn ir- reazzjonijiet ġeneralment jgħibu f' ġurnata jew tnejn mingħajr kura.
• Post-marketing surveillance
• Sorveljanza ta ’ wara t- tqegħid fis- suq
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), the following adverse events have been reported:
Minn sorveljanza ta 'wara l- kummerċjalizzazzjoni b' vaċċini interpandemiċi trivalenti adjuvanti, bil - kompożizzjoni simili għal Focetria (antiġen tal- wiċċ, inattivat, adjuvanti b’ MF59C. 1) kienu rrapportati l- episodji avversi li ġejjin:
Uncommon (> 1/ 1,000, < 1/ 100):
Mhux komuni (> 1/ 1, 000, < 1/ 100):
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Reazzjonijiet tal- ġilda ġeneralizzati fosthom ħakk, urtikarja jew raxx mhux speċifiku.
Rare (> 1/ 10,000, < 1/ 1,000):
Rari (> 1/ 10, 000, < 1/ 1, 000):
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Nevralġija, parasteżija, konvulżjonijiet, trombocitopenia temporanja.
Allergic reactions, in rare cases leading to shock, have been reported.
Kienu rrapportati reazzjonijiet allerġiċi, li f' każijiet rari jwasslu għal xokk.
Very rare (< 1/ 10,000):
Rari ħafna (< 1/ 10, 000):
Vasculitis with transient renal involvement and exudative erythema multiforme.
Vaskulite b' involviment renali temporanju u eritema multiformi li tnixxi.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Mard newroloġiku, bħal enċefalomajelite, nevrite u s- sindrome ta 'Guillain Barré.