qanastek/EMEA-V3 huggingface dataset:
Dilution requirements for ECALTA administration
11 Rekwiżiti tad- dilwizzjoni għall- għoti ta ’ ECALTA
Dose
Doża
Total
Volum totali
Infusion
Volum ta ’ Volum totali Konċentrazjoni
Total infusion
Volum totali Volum ta ’ Volum totali
Infusion solution
Konċentrazjoni
Rate of
Rata ta ’ l -
of boxes
ta ’
reconstituted volume
l- infużjoni ta ’ l- infużjoni tas- soluzzjoni għal A
volume A volume
infużjoni
concentration
kaxxi
infusion
infużjoni
30 ml (1 box)
30 ml (kaxxa)
0.36 mg/ ml
0. 36 mg/ ml
3.0 ml/ min
3. 0 ml/ min
60 ml (2 boxes)
60 ml (2 kaxxi)
Either 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion.
A Jew 9 mg/ ml (0. 9%) sodium chloride għal infużjoni jew 50 mg/ ml (5%) glukożju għal infużjoni.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Prodotti mediċinali parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal- kulur qabel ma jiġu amministrati, kull meta s- soluzzjoni u l- kontenitur jippermettu.
If either particulate matter or discolouration are identified, discard the solution.
Jekk tidentifika frak jew tidnis tal- kulur, armi s- soluzzjoni.
Waste materials should be disposed of in accordance with local requirements.
Kull skart li jibqa ’ wara li jintuża l- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
11 7 MARKETING AUTHORISATION HOLDER
7 ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Renju Unit
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
12 ANNEX II
12 ANNESS II
Rijksweg 12 BE-2870 Puurs Belgium
Rijksweg 12 BE- 2870 Puurs Belġju
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 (8 November 2007 and included in variation EMEA/ H/ C/ 788/ II/ 06) 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.
Sistema tal- Farmakoviġilanza Id- Detentur ta ’ L- Awtorizazzjoni għat- Tqegħid fis- Suq għandu jassigura li s- sistema tal - farmakoviġilanza, kif huwa spjegat f’ verzjoni 1. 1 (8 Novembru 2007 u inkluża fil- varjazzjoni EMEA/ H/ C/ 788/ II/ 06) ippreżentata fis- sezzjoni 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizazzjoni għat - Tqegħid fis- Suq, qed taħdem qabel u waqt li il- prodott jitqiegħed fuq is- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 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.
Pjan ta ’ Mmaniġġjar tar- Riskju Id- Detentur ta ’ L- Awtorizazzjoni għat- Tqegħid fis- Suq jintrabat li jagħmel studji u jwettaq attivitajiet oħra dwar il- farmakoviġilanza, kif spjegati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 1. 2 tal- Pjan ta ’ Mmaniġġjar tar- Riskju (RMP) ppreżentat f’ sezzjoni 1. 8. 2 ta ’ l- Applikazzjoni għall - Awtorizazzjoni għat- Tqegħid fis- Suq u fi kwalinkwe aġġornament ta ’ l- RMP bi qbil tal- 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).
RMP mġedded għandu jkun mgħoti flimkien mal- PSUR (Periodic Safety Update Report), kif huwa mistqarr fid- dokument tal- CHMP Guideline on Risk Management Systems for medicinal products for human use,
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
Minn barra hekk, RMP aġġornat għandu jkun mogħti • Meta tiġi miġbura xi informazzjoni ġdida li tista taffetwa l- ispeċifikazzjoni attwali dwar is - Sigurta ’, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ Riskji • Fi żmien 60 ġurnata minn meta tkun intlaħqet xi ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis ta ’ riskju) • Meta jkun mitlub mill- EMEA
14 ANNEX III
14 ANNESS III
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ECALTA 100 mg powder and solvent for concentrate for solution for infusion Anidulafungin
Anidulafungin
Powder for concentrate for solution for infusion:
Trab għal konċentrat għal soluzzjoni għall- infużjoni:
Excipients: fructose, mannitol, polysorbate 80, tartaric acid and NaOH and/ or HCl for pH adjustment.
Sustanzi mhux attivi: fructose, mannitol, polysorbate 80, tartaric acid u NaOH u/ jew HCl għal aġġustament tal- pH
Solvent for concentrate for solution for infusion:
Solvent għal konċentrat għal soluzzjoni għall- infużjoni:
Contains ethanol anhydrous and water for injections.
Fih ethanol anhydrous u ilma għall- injezzjonijiet
1 vial of 100 mg powder 1 vial of 30 ml solvent
Kunjett b’ 100mg trab Kunjett bi 30ml solvent
Reconstitute and dilute before use – read the package leaflet before use.
Irrikonstitwixxi u ddilwixxi qabel l- użu - Aqra l- fuljett ta ’ tagħrif qabel l- użu.
For intravenous use only.
Użu għal ġol- vini
EXP {MONTH – YYYY}
JIS XAHAR- SENA
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°C
Pfizer Ltd Ramsgate Road Sandwich KENT CT13 9NJ United-Kingdom
Pfizer Ltd Ramsgate Road Sandwich KENT CT13 9NJ Renju Unit
Lot:
LOTT
[Justification for not including Braille accepted.]
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial label
Tiketta tal- kunjett
ECALTA 100 mg powder for concentrate for solution for infusion Anidulafungin Intravenous use
Anidulafungin Użu għal ġol- vini
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Solvent Vial label
Tikketta tal- kunjett tas- solvent
Solvent for concentrate for solution for infusion for ECALTA Intravenous use
Solvent għal konċentrat għal soluzzjoni għall- infużjoni ta ’ ECALTA Użu għal ġol- vini
21 PACKAGE LEAFLET:
21 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN JAGĦMEL UŻU MINNU
ECALTA 100 mg powder and solvent for concentrate for solution for infusion Anidulafungin
ECALTA 100 mg trab u solvent għal konċentrat għal soluzzjoni għall- infużjoni Anidulafungin
What ECALTA is and what it is used for 2.
X’ inhu ECALTA u għalxiex jintuża 2.
What you should know before you are treated with ECALTA 3.
Qabel tuża ECALTA 3.
How to use ECALTA 4.
Kif għandek tieħu ECALTA 4.
How to store ECALTA 6.
Kif taħżen ECALTA 6.
WHAT ECALTA IS AND WHAT IT IS USED FOR
X’ INHU ECALTA U GĦALXIEX JINTUŻA
ECALTA is prescribed to treat a type of fungal infection of the blood called candidaemia.
Anidulafungin jingħata sabiex tiġi kkurata tip ta ’ infezzjoni fungali msejjħa candidemia.
The infection is caused by fungal cells (yeasts) called Candida.
L- infezzjoni hija kkawżata minn ċelloli fungali (ħmejjer) msejjħa Candida.
ECALTA belongs to a group of medicines called echinocandins.
ECALTA jappartjeni għal grupp ta ’ mediċini msejjħa echinocandins.
These medicines are used to treat serious fungal infections.
Dawn il- mediċini jintużaw sabiex jiġu kkurati infezzjonijiet fungali serji.
ECALTA prevents normal development of fungal cell walls.
Anidulafungin jinterferixxi ma l- iżvilupp ta ’ ħajt taċ- ċelloli fungali normali.
In the presence of anidulafungin, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Fil- preżenza ta ’ anidulafungin iċ- ċelloli jkollhom ħitan mhux sħaħ jew difettużi, li jagħmluhom fraġli jew mhux kapaċi li jikbru.
WHAT YOU SHOULD KNOW BEFORE YOU ARE TREATED WITH ECALTA
QABEL TUŻA ECALTA
You should not be treated with ECALTA
TUŻAX ECALTA
CANCIDAS), or
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal anidulafungin, echinocandins oħra,
any of the other ingredients of ECALTA
CANCIDAS) jew sustanzi oħra ta ’ ECALTA
Take special care with ECALTA
Oqgħod attent ħafna b’ ECALTA
- if you develop liver problems during your treatment.
- jekk tiżviluppa xi problemi fil- fwied waqt it- trattament.
If this happens, your doctor may decide to
Jekk jiġri dan, it- tabib tiegħek għandu
monitor your liver function more closely.
mnejn ikollu bżonn jimmonitorja il- funzjoni tal- fwied b’ aktar reqqa.
- if you are given anaesthetics during your treatment with ECALTA.
- jekk tkun mogħti xi anestetiċi (loppju) waqt it- trattament b’ ECALTA
Children ECALTA should not be given to patients under 18 years of age.
Tfal ECALTA m’ għandux jingħata lil pazjenti taħt it- 18 il sena.
Taking other medicines There are no known interactions with other medicines likely to be given at the same time as ECALTA (i. e., rifampicin, ciclosporin, tacrolimus, voriconazole and amphotericin B).
Meta tieħu mediċini oħra M’ hemm l- ebda interazzjonijiet magħrufa ma mediċini oħra li hemm ċans jingħataw fl- istess żmien ma ECALTA (i. e. rifampicin, ciclosporin, tacrolimus, voriconazole u amphotericin B).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħrajn, anki dawk mingħajr riċetta.
Do not start or stop any other medicines without your doctor’ s or pharmacist’ s approval.
22 Tibdiex jew twaqqafx mediċini oħrajn mingħajr l- approvazzjoni tat- tabib jew ta ’ l- ispiżjar tiegħek.
22 Pregnancy and breast-feeding The effect of ECALTA in pregnant women is not known.
Tqala u Treddigħ L- effett ta ’ ECALTA f’ nisa tqal mhux magħruf.
Therefore Ecalta is not recommended during pregnancy.
Għalhekk ECALTA mhux rakkomandat għall- użu fit - tqala.
Effective contraception should be used in women of chilbearing age.
Għandha tintuża kontraċezzjoni effettiva min- nisa li jista ’ jkollhom it- tfal.
Contact your doctor immediately if you become pregnant while taking ECALTA.
Ikkuntattja lit- tabib tiegħek immedjatament jekk tinqabad tqila waqt li tkun qiegħda tieħu ECALTA
The effect of ECALTA in breast-feeding women is not known.
L- effett ta ’ ECALTA waqt it- treddigħ mhux magħruf.
Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Saqsi lit- tabib jew l- ispiżjar għal parir qabel ma tieħu ECALTA waqt it- treddigħ.
Ask your doctor or pharmacist for advice before taking any medicines.
Itlob parir mingħand it- tabib jew l- ispiżjar tiegħek qabel ma tieħu kwalunkwe mediċina.
Driving and using machines No studies on the effect on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni L- ebda studji ma saru fuq l- effett fuq sewqan u tħaddim ta ’ magni.
Important information about some of the ingredients of ECALTA This medicinal product contains fructose (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ECALTA Dan il- prodott mediċinali fih il- fructose (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
This medicinal product contains 24 vol% ethanol (alcohol), i. e. up to 6 g per dose consumed over a 1.5 – hour period (12 g loading dose consumed over a 3-hour period); this is equivalent to 144 ml beer (288 ml beer for the loading dose) or 60 ml wine (120 ml wine for the loading dose).
Dan il- prodott mediċinali fih 24% bil- volum ethanol (alkoħol), jiġifieri sa 6 g kull doża kkunsmata fuq perjodu ta ’ siegħa u nofs (loading dose ta ’ 12 g ikkunsmati fuq perjodu 3 siegħat); dan huwa ekwivalenti għal 144 ml birra (288 ml għal- loading dose) jew 60 ml inbid (120 ml inbid għad- doża qawwija tal- bidu l- loading dose) ikkunsmati fuq perjodu ta ’ 1. 5 sa 3 sigħat.
Harmful for those suffering from alcoholism.
L- ethanol jista ’ jagħmel ħsara lil dawk li jbatu mill- alkoħoliżmu.
To be taken into account in pregnant or breast-feeding women, children, and in high-risk groups such as those with liver disease or epilepsy.
Dan għandu jiġi kkunsidrat fil- każ ta ’ nisa tqal jew ireddgħu, tfal, u fi gruppi f’ riskju għoli bħal persuni li jbatu minn mard tal- fwied jew epilessija.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
L- ammont ta ’ alkoħol f’ dan il- prodott mediċinali jista jkollu effetti fuq il- ħila tas- sewqan jew tħaddim ta ’ magni.
HOW TO USE ECALTA
KIF GĦANDEK TIEĦU ECALTA
ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
ECALTA dejjem se jiġi ppreparat u mogħti lilek minn tabib jew professjonist fil- kura tas- saħħa (hemm aktar tagħrif dwar il- metodu ta ’ preparazzjoni fl- aħħar ta ’ dan il- fuljett fit- taqsima għal professjonisti mediċi u tal- kura tas- saħħa biss).
The treatment starts with 200 mg on the first day (loading dose).
Il- kura tibda b’ 200 mg fl- ewwel jum (loading dose).
This will be followed by a daily dose of 100 mg (maintenance dose).
Din se tkun segwita minn doża ta ’ kuljum ta ’ 100 mg (doża ta ’ manutenzjoni).
ECALTA should be given to you once a day, by slow infusion (a drip) into your vein.
ECALTA għandu jiġi mogħti lilek darba kuljum, b’ infużjoni bil- mod (dripp) ġol- vina.
This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Dan għandu jieħu bejn siegħa u nofs għal doża ta ’ manutenzjoni u 3 sigħat fl- ewwel jum (loading dose).
Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
It- tabib tiegħek se jistabbilixxi t- tul tal- kura tiegħek u l- ammont ta ’ ECALTA li għandek tirċievi kuljum u se jimmonitorja r- rispons u l- kundizzjoni tiegħek.
In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
B’ mod ġenerali, il- kura tiegħek għandha tissokta għal mill- anqas 14- il jum wara s- sejba ta ’ Candida fid- demm tiegħek.
If you receive more ECALTA than you should
Jekk tieħu aktar ECALTA milli suppost
If you are concerned that you may have been given too much ECALTA, tell your doctor or another healthcare professional immediately.
Jekk tkun inkwetat li forsi ngħatajt aktar ECALTA milli suppost, għid lit- tabib tiegħek jew lil professjonist ieħor tal- kura tas- saħħa immedjatament.
If a dose of ECALTA has been forgotten
23 Jekk tinsa tieħu doża ta ’ ECALTA
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Billi inti se tingħata din il- mediċina taħt sorveljanza medika mill- qrib, mhux probabbli li tista ’ tintesa doża.
However tell your doctor or pharmacist if you think that a dose has been forgotten.
Madankollu għid lit- tabib jew lill- ispiżjar tiegħek jekk taħseb li nqabżet doża.
Do not take a double dose to make up for a forgotten dose.
Tieħux doża doppja biex tpatti għal doża minsija.
Effects when treatment with ECALTA is stopped
Effetti li jista ’ jkun hemm meta l- kura b’ ECALTA tiġi mwaqqfa
23 You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Inti m’ għandu jkollok l- ebda effett jekk it- tabib tiegħek iwaqqaf il- kura b’ ECALTA.
Your doctor may prescribe another medicine following your treatment with ECALTA to continue treating your fungal infection or prevent it from returning.
It- tabib tiegħek jista ’ jordnalek mediċina oħra wara l- kura tiegħek b’ ECALTA biex tkompli titratta l - infezzjoni fungali jew biex timpedixxi l- infezzjoni fungali tiegħek milli terġa ’ titfaċċa.
If your original symptoms come back, tell your doctor or another healthcare professional immediately.
Jekk is- sintomi oriġinali tiegħek jerġgħu jitfaċċaw, għid lit- tabib tiegħek jew lil professjonist ieħor tal - kura tas- saħħa immedjatament.
Like all medicines, ECALTA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ECALTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (likely to occur in fewer than 1 in 10 patients):
Effetti sekondarji komuni (jistgħu jiġru f’ inqas minn wieħed (1) minn kull għaxra (10)
- Disorder of blood clotting system
- Disturb tas- sistema ta ’ tagħqid tad- demm
- Low blood potassium (hypokalaemia)
- Potassju baxx fid- demm (ipokalimja)
- Convulsion (seizure)
- Konvulżjoni (aċċessjoni)
- Flushing
- Fwawar
- Diarrhoea, vomiting, nausea
- Dijarea, rimettar, dardir
- Changes in blood tests of liver function
- Bidliet fit- testijiet tad- demm dwar il- funzjoni tal- fwied
- Rash, pruritis (itching)
- Raxx, prurite (ħakk)
- Changes in blood tests of kidney function
- Bidliet fit- testijiet tad- demm dwar il- funzjoni tal- kliewi
Uncommon side effects (likely to occur in fewer than 1 in 100 patients):
Effetti sekondarji mhux komuni (jistgħu jiġru f’ inqas minn wieħed minn kull mija (100)
- High blood sugar
- Zokkor għoli fid- demm
- High blood pressure
Pressjoni tad- demm għolja
- Hot flush
Ħmura fil- wiċċ bil- fwawarUġigħ fl- istonku, rimettar (tħossok
- Stomach pain
marid), dardir (tħossok marid)
- Abnormal flow of bile from the gallbladder into the intestine (cholestasis)
- Fluss abnormali ta ’ bili mill- bużżieqa tal- marrara għal ġo l- imsaren (kolestażi)
- Hives
- Urtikarja (ħorriqija)
- Pain at injection site
- Uġigħ fis- sit ta ’ l- injezzjoni
If any of the side effects you experience are severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti sekondarji li tesperjenza jkunu qawwija, jew jekk tinnota xi effetti sekondarji mhux imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ECALTA
KIF TAĦŻEN ECALTA
Do not use ECALTA after the expiry date which is stated on the label.
Tużax ECALTA wara d- data ta ’ skadenza li tidher fuq it- tikketta.
The expiry data refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar.
The reconstituted solution should not be stored above 25ºC.
Taħżinx ECALTA f’ temperatura ’ l fuq minn 25°C Is- soluzzjoni rikostitwita m’ għandhiex tinħażen f’ temperatura ’ l fuq minn 25ºC.
The infusion solution should not be stored above 25ºC.
Tagħmlux fil- friża Is- soluzzjoni għall- infużjoni m’ għandhiex tinħażen f’ temperatura ’ l fuq minn 25ºC.
Do not refrigerate or freeze.
Tagħmlux fil - friġġ jew friża
Medicines should not be disposed of via wastewater or household waste.
24 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What ECALTA contains
X’ fih ECALTA
- The active substance is anidulafungin.
- Is- sustanza attiva hija anidulafungin.
Each vial with powder contains 100 mg anidulafungin.
Kull kunjett bit- trab fih 100 mg anidulafungin.
- The other ingredients are
- Is- sustanzi l- oħra huma
24 Powder: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment)
Trab: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (għal aġġustament tal- pH), hydrochloric acid (għal aġġustament tal- pH)
Solvent: ethanol anhydrous, water for injections
Solvent: ethanol anhydrous, ilma għall- injezzjonijiet
What ECALTA looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett:
ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion and 1 vial of 30 ml solvent.
ECALTA jiġi bħala kaxxa li fiha kunjett b’ 100 mg trab għal konċentrat għal soluzzjoni għal infużjoni u kunjett ta ’ 30 ml solvent.
The powder for concentrate for solution for infusion is white to off-white.
It- trab għal konċentrat għal soluzzjoni għal infużjoni hu abjad għal abjad fil- griż.
The solvent is a clear colourless solution.
Is- solvent hu soluzzjoni ċara bla kulur.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
The marketing authorisation for ECALTA is held by:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ta ’ ECALTA hu:
Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, United Kingdom
Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, Ir- Renju Unit
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Il- Belġju
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull informazzjoni dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
< -------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< -------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku u tal- kura tas- saħħa:
The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion has not been established.
Il- kompatibilità ta ’ ECALTA rikostitwit ma ’ sustanzi, addittivi, jew mediċini għal ġol - vina għajr 9 mg/ ml ma ġietx stabilita.
Reconstitution Aseptically reconstitute each vial with the solvent (20% (w/ w) ethanol anhydrous in water for injections) to provide a concentration of 3.33 mg/ ml.
26 Rikostituzzjoni Irrikostitwixxi b’ mod asettiku kull kunjett bis- solvent (20% (w/ w) ethanol anhydrous f’ ilma għall - injezzjonijiet) biex jipprovdi konċentrazzjoni ta ’ 3. 33 mg/ ml.
The reconstituted solution must be further diluted within an hour and administered within 24 hours.
Is- soluzzjoni rikostitwita trid tiġi dilwita aktar u mogħtija fi żmien 24 siegħa.
26 Dilution and infusion Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion obtaining an anidulafungin concentration of 0.36 mg/ ml.
Dilwizzjoni u infużjoni Ittrasferixxi b’ mod asettiku l- kontenut tal- kunjett( i) rikostitwit( i) ġo borża (jew flixkun) għal ġol- vini li jkun fiha 9 mg/ ml (0. 9%) sodium chloride għal infużjoni jew 50 mg/ ml (5%) glukożju għal infużjoni biex tinkiseb konċentrazzjoni ta ’ anidulafungin ta ’ 0. 36 mg/ ml.
Dilution requirements for ECALTA administration
Rekwiżiti tad- dilwizzjoni għall- għoti ta ’ ECALTA
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Prodotti mediċinali parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal- kulur qabel ma jiġu amministrati, kulmeta s- soluzzjoni u l- kontenitur jippermettu.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta 'CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Effentora?
X' inhu Effentora?
Effentora is a medicine containing the active substance fentanyl.
Effentora huwa mediċina li fiha s- sustanza attiva fentanyl.
It is available as buccal tablets (tablets that dissolve in the mouth), containing 100, 200, 400, 600 or 800 micrograms of fentanyl.
Huwa disponibbli bħala pilloli li jinħallu fil- ħalq, li fihom 100, 200, 400, 600 jew 800 mikrogramma fentanyl.
What is Effentora used for?
Għalxiex jintuża Effentora?
Effentora is used to treat ‘ breakthrough’ pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain. ‘ Breakthrough pain’ is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Effentora jintuża fit- trattament ta 'wġigħ li jiżdied f' daqqa (breakthrough pain) f' adulti b' kanċer li diġà f' terapija b' mediċini oppjojdi (grupp ta' mediċini ta 'kontra l- uġigħ li jinkludu l- morfina u fentanyl) biex jikkontrolla l- uġigħ fit- tul ikkawżat mill- kanċer.
How is Effentora used?
Kif jintuża Effentora?
Treatment with Effentora should be initiated and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
It- trattament b' Effentora għandu jinbeda u jinżamm taħt il- gwida ta 'tabib li jkollu esperjenza fit - trattament tat- terapija b' oppjojdi f' pazjenti b' kanċer.
Effentora is taken at the start of a breakthrough pain episode.
Effentora jittieħed kif jibda l- episodju ta 'wġigħ li jiżdied f' daqqa.
The tablets should be removed from the packaging immediately before being placed between the gum and the cheek at the back of the mouth.
Il- pilloli għandhom jitneħħew mill - pakkett eżatt qabel ma jitqiegħdu bejn il- ħanek u l- ħadd fuq wara tal- ħalq.
The tablet usually dissolves in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Il- pillola ġeneralment iddum bejn 14 u 25 minuta biex tinħall u terħi s- sustanza attiva, li tiġi assorbita direttament fiċ - ċirkolazzjoni tad- demm.
After 30 minutes, any pieces of the tablet remaining can be swallowed with a glass of water.
Wara 30 minuta, residwi eventwali tal- pillola li tibqa 'ma tinħallx ikunu jistgħu jinbelgħu b' tazza ilma.
The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole.
Il- pilloli m' għandhomx jitkissru jew jitfarrku, u m' għandhomx jintredgħu, jintmagħdu jew jinbelgħu sħaħ.
Patients should not eat or drink anything while the tablet is in the mouth.
Il- pazjenti m' għadhom jieklu jew jixorbu xejn waqt li l - pillola tkun fil- ħalq.
When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects.
Meta pazjent jibda jieħu Effentora, it- tabib ikollu jaħdem id- doża individwali li tipprovdi serħan adegwat mill- uġigħ għall- pazjent partikolari bi ftit effetti sekondarji.
The usual starting dose is one 100 microgram tablet, but this can be increased until the appropriate maintenance dose is found.
Ġeneralment id- doża tal- bidu tkun pillola waħda tal- 100 mikrogramma, iżda din tista 'tiżdied sakemm tinstab id- doża xierqa għall - manteniment.
The patient should be monitored carefully while the dose is increased.
Il- pazjent għandu jiġi sorveljat b' attenzjoni kbira sakemm tiżdied id- doża.
The final individual dose must include no more than two tablets, but it can be adjusted if a patient consistently has more than four episodes of breakthrough pain per day.
Id- doża individwali finali ma għandhiex tinkludi iktar minn żewġ pilloli, iżda tista 'tiġi aġġustata jekk il- pazjent konsistentament ikollu iktar minn erba' episodji ta 'wġigħ li jiżdied f' daqqa kuljum.
Doses above 800 micrograms have not been tested.
Id- dożi ta '' l fuq minn 800 mikrogramma ma ġewx ittestjati.
There must be a gap of at least four hours between treating each episode of pain.
Teħtieġ waqfa ta 'mill- anqas erba' sigħat bejn it - trattament ta 'kull episodju ta' wġigħ.
See the Package Leaflet for further information.
Ara l- Fuljett ta 'Tagħrif għal aktar tagħrif.
Effentora, fentanyl is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Is- sustanza attiva f' Effentora, fentanyl, huwa oppjojde (mediċina qawwija ta 'kontra l- uġigħ marbuta mal- morfina).
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain.
Ladarba jidħol fiċ- ċirkolazzjoni tad- demm, il- fentanyl jaħdem fuq ir- riċetturi fil- moħħ u fin- nerv li jgħaddi minn ġos- sinsla (spinal cord) biex jipprevjeni l- uġigħ.
How has Effentora been studied?
Kif ġie studjat Effentora?
Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.
Billi fentanyl ilu jintuża għal ħafna snin, il- kumpanija se tippreżenta d- dejta mil- letteratura xjentifika, kif ukoll minn studji li kienet għamlet hija stess.
The effectiveness of Effentora in treating breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
L- effikaċja ta 'Effentora fit- trattament ta' l- uġigħ li jiżdied f' daqqa ġiet studjata f' żewġ studji ewlenin li fihom b' kollox ħadu sehem 150 adult bil- kanċer li kienu qed jiġu ttrattati bl- oppjojdi.
The first study included 72 patients and the second included 78.
Fl- ewwel studju ħadu sehem 72 pazjent u fit- tieni ħadu sehem 78.
In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
Fiż- żewġ studji, kull pazjent ġie ttrattat waqt 10 episodji separati ta 'wġigħ li jiżdied f' daqqa: f' sebgħa minn dawn l- episodji, kull pazjent ingħata Effentora, u fit- tliet episodji l- oħra, kull pazjent irċieva plaċebo (pillola finta).
The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fl- intensità ta' l- uġigħ matul l- ewwel 30 jew 60 minuta wara t- teħid ta 'kull pillola.
Each patient ranked their pain intensity on an 11-point scale.
Kull pazjent indika l- intensità ta 'l- uġigħ fuq skala bi 11- il punt.
What benefit has Effentora shown during the studies?
Liema benefiċċju wera Effentora waqt l- istudji mwettqa?
Effentora was more effective than placebo in reducing pain in both studies.
Effentora kellu aktar effett mill- plaċebo fit- tnaqqis ta 'l- uġigħ fiż- żewġ studji.
In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
Fl- ewwel studju, l - intensità ta 'l- uġigħ naqset b' medja ta' 3. 2 punti wara 30 minuta minn meta l- pazjenti ħadu Effentora u b' 2. 0 punti wara li ħadu l- plaċebo.
In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
Fit- tieni studju, l- intensità ta 'l- uġigħ naqset b' 9. 7 punti wara 60 minuta wara Effentora u b' 4. 9 punti wara l- plaċebo.
What is the risk associated with Effentora?
X' inhu r- riskju assoċjat ma 'Effentora?
The most common side effects with Effentora (seen in more than 1 patient in 10) are dizziness, nausea (feeling sick) and reactions at the site of application including pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
L- iktar effetti sekondarji komuni ma 'Effentora (li dehru f' iktar minn pazjent wieħed minn kull 10) huma sturdament, nawżea (dardir) u reazzjonijiet fil- punt ta' l- applikazzjoni fosthom uġigħ, ulċeri, irritazzjoni, sensazzjonijiet mhux tas- soltu, tnemnim, ħmura, infiħ u tbajja '.
Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use.
Effentora jista 'jikkawża wkoll effetti sekondarji tipiċi li jidhru ma' oppjojdi oħra, iżda dawn għandhom it- tendenza li jnaqqsu jew iwaqqfu l- użu kontinwat.
The most serious of these are respiratory depression (slow or shallow breathing), circulatory depression (slow heart beat), hypotension (low blood pressure) and shock (insufficient blood flow to the tissues).
L- iktar effetti sekondarji gravi ta 'dawn huma d- depressjoni respiratorja (nifsijiet bil- mod jew mhux fil- fond), depressjoni ċirkolatorja (tnaqqis fil- frekwenza tat- taħbit tal - qalb), ipotensjoni (pressjoni tad- demm baxxa) u xokk (provvista insuffiċjenti ta' demm fit- tessuti).
Patients should be closely monitored for these side effects.
Il - pazjenti għandhom jiġu sorveljati mill- qrib għal dawn l- effetti sekondarji.
For the full list of all side effects reported with Effentora, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rappurtati ma' Effentora, ara l- Fuljett ta 'Tagħrif.
Effentora should not be used in people who may be hypersensitive (allergic) to fentanyl or any of the other ingredients.
Effentora m' għandux jintuża f' persuni ipersensittivi (allerġiċi) għal fentanyl jew għal kwalunkwe ingredjent ieħor.
It should also not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have a severe disease involving obstruction of the lungs.
Lanqas m' għandu jintuża f' pazjenti li ma jkunux qed jieħdu xi oppjojde minn qabel biex iżommu kontroll fuq l- uġigħ, li jkollhom depressjoni resporatorja gravi, jew li jkollhom marda severa li fiha jkun hemm ostruzzjoni tal- pulmuni.
Effentora should be used with caution in patients who have moderate or severe problems with their liver or kidneys.
Effentora għandu jintuża b' kawtela f' pazjenti bi problemi moderati jew gravi fil- fwied jew kliewi.
Why has Effentora been approved?
Għaliex ġie aprovat Effentora?
The Committee for Medicinal Products for Human Use (CHMP) decided that Effentora’ s benefits are greater than its risks for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) iddeċieda li l- benefiċċji ta 'Effentora huma ikbar mir- riskji tiegħu fit- trattmanent ta' wġigħ li jiżdied f' daqqa f' adulti bil- kanċer li diġà jkunu qed jieħdu terapija bl- oppjojdi għall- uġigħ kroniku mill- kanċer.
The Committee recommended that Effentora be given marketing authorisation.
Il- Kumitat irrakkomanda li Effentora jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Effentora?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Effentora?
The company that makes Effentora will provide educational materials to make sure that healthcare workers are aware of the fact that the medicine could be abused.
Il- kumpanija li tagħmel Effentora se tipprovdi materjali edukattivi biex ikun żgurat li ħaddiema fil - qasam tal- kura tas- saħħa huma konxji mill- fatt li jista 'jkun hemm abbuż mill- mediċina.
The company will also remind healthcare workers about how the medicine should be used safely and the risks of accidental exposure to fentanyl.
Il- kumpanija se tfakkar lill- ħaddiema fil- qasam tal- kura tas- saħħa dwar kif il- mediċina tista 'tintuża b' mod sigur u r - riskji ta' meta wieħed jesponi ruħu b' mod aċċidentali għal fentanyl.
Other information about Effentora:
Informazzjoni oħra dwar Effentora:
The European Commission granted a marketing authorisation valid throughout the European Union for Effentora to Cephalon Europe on 4 April 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha, għal Effentora lil Cephalon Europe fi 4 April 2008.
The full EPAR for Effentora can be found here.
L- EPAR sħiħ għal Effentora jista 'jiġi kkonsultat hawn.
Strength
4 pilloli
Pharmaceutical Form
Pillola għall- ħalq
Route of Administration
Pillola għall- ħalq
Package size
28 pillola
Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora
Folja (PVC/ alu/ polyamid/ PVC)
100 micrograms 100 micrograms 200 micrograms 200 micrograms 400 micrograms 400 micrograms 600 micrograms 600 micrograms 800 micrograms 800 micrograms
400 mikrogramma
Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet
Pillola għall- ħalq
Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use
Użu għall- mukuża tal- ħalq
Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC)
Folja (PVC/ alu/ polyamid/ PVC)
4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets
Folja (PVC/ alu/ polyamid/ PVC)
Effentora 100 micrograms buccal tablets
Effentora 100 mikrogramma pilloli għall- ħalq
Each buccal tablet contains 100 micrograms fentanyl (as citrate).
Kull pillola għall- ħalq fiha 100 mikrogramma fentanyl (bħala citrate).
Each tablet contains 8 mg of sodium.
Kull pillola fiha 8 mg ta ’ sodju.
Buccal tablet.
Pillola għall- ħalq.
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 1”.
Pillola b’ uċuħ ċatti, bajda, tonda bix- xfar imtajjra, fuq naħa waħda b ’ “ C ” imqabbża u fuq in- naħa l - oħra b ’ “ 1 ”.
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Effentora huwa ndikat għall- kura ta ’ uġigħ li jinħass (BTP) f’ adulti bil- kanċer li diġa qed jirċievu terapija ta ’ manteniment b’ opioid għall- uġigħ kroniku tal- kanċer.
BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
BTP huwa aggravament transitorju ta ’ uġigħ li jseħħ fuq sfond ta ’ uġigħ persistenti li altrimenti jkun ikkontrollat.
Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Pazjenti li qed jirċievu terapija ta ’ manteniment b’ opioid huma dawk li qed jieħdu ta ’ l- inqas 60 mg ta ’ morphine orali kuljum, ta ’ l- inqas 25 mikrogramma ta ’ fentanyl transdermali kull siegħa, ta ’ l- inqas 30 mg ta ’ oxycodone kuljum, ta ’ l- inqas 8 mg ta ’ hydromorphone orali kuljum jew doża ekwianalġeżika ta ’ opioid ieħor għal ġimgħa jew aktar.
Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients.
Il- kura għandha tinbeda u tibqa ’ taħt id- direzzjoni ta ’ tabib b’ esperjenza fl- immaniġġjar ta ’ terapija b’ opioid f’ pazjenti bil- kanċer.
Physicians should keep in mind the potential of abuse of fentanyl.
It- tobba għandhom iżommu f’ moħħhom il- potenzjal ta ’ abbuż ta ’ fentanyl.
Effentora should be individually titrated to an “ effective” dose that provides adequate analgesia and minimises undesirable effects.
Effentora għandu jiġi ttitrat individwalment għal doża “ effettiva ” li tipprovdi analġeżija xierqa u li tnaqqas l- effetti mhux mixtieqa.
In clinical studies, the effective dose of Effentora for BTP was not predictable from the daily maintenance dose of opioid.
Fi studji kliniċi, id- doża effettiva ta ’ Effentora għal BTP ma setgħetx tiġi mbassra mid- doża ta ’ manteniment ta ’ kuljum ta ’ opioid.
Patients should be carefully monitored until an effective dose is reached.
Pazjenti għandhom jiġu sorveljati b’ attenzjoni sakemm tintlaħaq doża effettiva.
Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms).
Titrazzjoni f’ pazjenti li mhux ha jaqilbu minn prodotti oħra li fihom fentanyl Id- doża tal- bidu ta ’ Effentora għandha tkun 100 mikrogramma, b’ titrazzjoni ’ l fuq skond il- bżonn fil - firxa ta ’ qawwa tal- pilloli disponibbli (100, 200, 400, 600, 800 mikrogramma).
Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Titrazzjoni f’ pazjenti li ħa jaqilbu minn prodotti oħra li fihom fentanyl Minħabba l- profili ta ’ assorbiment differenti, il- bidla m’ għandiex issir f’ proporzjon ta ’ 1: 1.
If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Jekk ħa jaqilbu minn prodott ta ’ fentanyl citrate orali ieħor, hija meħtieġa titrazzjoni ndipendenti tad- doża b’ Effentora peress li l- biodisponibiltà tvarja b’ mod sinifikanti bejn il- prodotti.
However, in these patients, a starting dose higher than 100 micrograms may be considered.
Iżda, f’ dawn il- pazjenti, doża tal- bidu ogħla minn 100 mikrogramma tista ’ tiġi kkunsidrata.
2 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
2 Metodu ta ’ titrazzjoni Waqt it- titrazzjoni, jekk ma tinkisibx analġeżija xierqa fi 30 minuta wara l- bidu ta ’ l- għoti ta ’ pillola waħda, tista ’ tintuża pillola oħra ta ’ Effentora ta ’ l- istess qawwa.
If treatment of a BTP episode requires more than one tablet, an increase in dose to the next higher available strength should be considered to treat the next BTP episode.
Jekk kura ta ’ episodju ta ’ BTP tinħtieġ aktar minn pillola waħda, żieda fid- doża għall- qawwa ogħla suċċessiva disponibbli għandha tiġi kkunsidrata biex tikkura l- episodju ta ’ BTP ta ’ wara.
During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule: • If the initial 100 micrograms tablet is not efficacious, the patient can be instructed to treat the next episode of BTP with two 100 micrograms tablets.
Waqt titrazzjoni, pilloli multipli jistgħu jintużaw: sa erba ’ pilloli ta ’ 100 mikrogramma jew sa erba ’ pilloli ta ’ 200 mikrogramma jistgħu jintużaw għall- kura ta ’ episodju wieħed ta ’ BTP waqt titrazzjoni tad- doża skond il- programm li ġej: • Jekk il- pillola tal- bidu ta ’ 100 mikrogramma ma tkunx effikaċi, il- pazjent jista ’ jiġi rakkomandat biex jikkura l- episodju ta ’ BTP ta ’ wara b’ żewġ pilloli ta ’ 100 mikrogramma.
It is recommended that one tablet should be placed in each side of the mouth.
Huwa rakkomandat li pillola waħda għandha titpoġġa f’ kull naħa tal- ħalq.
If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 200 micrograms tablet of Effentora. • If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
Jekk din id- doża hija kkunsidrata li hija d - doża effettiva, kura ta ’ episodji suċċessivi ta ’ BTP titsta ’ titkompla b’ pillola waħda ta ’ 200 mikrogramma ta ’ Effentora. • Jekk pillola waħda ta ’ 200 mikrogramma ta ’ Effentora (jew żewġ pilloli ta ’ 100 mikrogramma) m’ hijiex ikkunsidrata bħala effikaċi, l- pazjent jista ’ jiġi rakkomandat biex juża żewġ pilloli ta ’ 200 mikrogramma (jew erba ’ pilloli ta ’ 100 mikrogramma) għall- kura ta ’ l- episodju ta ’ BTP ta ’ wara.
It is recommended that two tablets should be placed in each side of the mouth.
Huwa rakkomandat li żewġ pilloli għandhom jitpoġġew f’ kull naħa tal- ħalq.
If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 400 micrograms tablet of Effentora. • For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used.
Jekk din id- doża hija kkunsidrata li hija d- doża effettiva, kura ta ’ episodji suċċessivi ta ’ BTP tista ’ titkompla b’ pillola waħda ta ’ 400 mikrogramma ta ’ Effentora. • Għal titrazzjoni sa 600 mikrogramma u 800 mikrogramma, għandhom jintużaw pilloli ta ’ 200 mikrogramma.
Doses above 800 micrograms were not evaluated in clinical studies.
Dożi ’ l fuq minn 800 mikrogramma ma kienux ivvalutati fi studji kliniċi.
No more than two tablets should be used to treat any individual BTP episode, except when titrating using up to four tablets as described above.
M’ għandhomx jintużaw aktar minn żewġ pilloli għall- kura ta ’ kull episodju individwali ta ’ BTP, ħlief waqt titrazzjoni bl- użu sa erba ’ pilloli kif deskritt fuq.
Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration.
Waqt it- titrazzjoni l- pazjenti għandhom jistennew ta ’ l- inqas 4 sigħat qabel jikkuraw episodju ieħor ta ’ BTP b’ Effentora.
Maintenance therapy
Terapija ta ’ manteniment
Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength.
Ladarba tkun ġiet stabbilita doża effettiva waqt it- titrazzjoni, l- pazjenti għandhom ikomplu jieħdu din id- doża bħala pillola waħda ta ’ dik il- qawwa partikolari.
Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy.
Waqt terapija ta ’ manteniment il- pazjenti għandhom jistennew ta ’ l- inqas 4 sigħat qabel jikkuraw episodju ieħor ta ’ BTP b’ Effentora.
Dose readjustment
Aġġustament mill- ġdid tad- doża
Generally, the maintenance dose of Effentora should be increased when a patient requires more than one dose per BTP episode for several consecutive BTP episodes.
Ġeneralment, id- doża ta ’ manteniment ta ’ Effentora għandha tiżdied meta pazjent ikollu bżonn aktar minn doża waħda kull episodju ta ’ BTP għall diversi episodji konsekuttivi ta ’ BTP.
Dose readjustment of Effentora and/ or of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Aġġustament mill- ġdid tad- doża ta ’ Effentora u/ jew tat- terapija b’ opioid fl- isfond tista ’ tkun meħtieġa jekk pazjenti jkollhom b’ mod konsistenti aktar minn erba ’ episodji ta ’ BTP kull 24 siegħa.
Effentora should be immediately discontinued if no longer required.
Twaqqif tat- terapija Effentora għandu jitwaqqaf għal kollox immedjatament jekk mhux meħtieġ aktar.
Use in children and adolescents:
Użu fit- tfal u l- adoloxxenti:
Effentora is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Effentora mhux irrakkomandat għall- użu fit- tfal u adoloxxenti taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Use in the elderly (older than 65 years):
Użu fl- anzjani (’ l fuq minn 65 sena):
In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
3 Fi studji kliniċi pazjenti ’ l fuq minn 65 sena kellhom tendenza li jittitraw għal doża effettiva aktar baxxa minn pażjenti iżgħar.