qanastek/EMEA-V3 huggingface dataset:
Following a single dose of NEVANAC in 25 cataract surgery patients, aqueous humour concentrations were measured at 15, 30, 45 and 60 minutes post-dose.
Wara doża waħda ta ’ NEVANAC f’ 25 pazjent li kellhom kirurġija tal- katarretti, konċentrazzjonijiet fl- aqueous humour kienu mkejjla 15, 30, 45 u 60 minuta wara d- doża.
The maximum mean aqueous humour concentrations were observed at the 1 hour time-point (nepafenac 177 ng/ ml, amfenac 44.8 ng/ ml).
Il- konċentrazzjonijiet medji massimi fl- aqueous humour kienu osservati fil- punt ta ’ ħin ta ’ siegħa (nepafenac 177 ng/ ml, amfenac 44. 8 ng/ ml).
These findings indicate rapid corneal penetration.
Dawn is- sejbiet jindikaw penetrazzjoni rapida fil- korneja.
Non-clinical data reveal no special hazard for humans based upon conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il- ġeni ma turi l- ebda periklu speċjali għall- bnedmin.
Nepafenac has not been evaluated in long-term carcinogenicity studies.
Nepafenac ma ġiex evalwat f’ studji fit- tul dwar il- karċinoġeniċità.
In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥ 10 mg/ kg were associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and reduced foetal survival.
Fi studji dwar ir- riproduzzjoni li twettqu b’ nepafenac fil- firien, dożi tossiċi għall- omm ≥ 10 mg/ kg kienu assoċjati ma ’ distoċja, żieda fit- telf wara l- impjantazzjoni, tnaqqis fil- piż u fl- iżvilupp tal- fetu, u sopravivenza tal- fetu mnaqqsa.
In pregnant rabbits, a maternal dose of 30 mg/ kg that produced slight toxicity in the mothers showed a statistically significant increase in the incidence of litter malformations.
Fil- fniek tqal, doża ta ’ l- omm ta ’ 30 mg/ kg li pproduċiet tossiċità ħafifa fl- ommijiet wriet żieda statistikament sinifikanti fl- inċidenza ta ’ malformazzjonijiet fil- frieħ.
Mannitol (E421) Carbomer Sodium chloride Tyloxapol Disodium edetate Benzalkonium chloride Sodium hydroxide and/ or hydrochloric acid (for pH adjustment) Purified water
Mannitol (E421) Carbomer Sodium chloride Tyloxapol Disodium edetate Benzalkonium chloride Sodium hydroxide u/ jew hydrochloric acid (għall- aġġustament tal- pH) Ilma ppurifikat
Discard 4 weeks after first opening.
Armi wara 4 ġimgħat li jinfetaħ l- ewwel darba.
Do not store above 30˚ C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
6.5 Nature and content of container
7 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension.
Flixkun ta ’ 5 ml tond ta ’ densità baxxa tal- polyethylene b’ tapp għall- għoti u b’ għatu bil- kamin abjad tal- polypropylene li fiħ 5 ml ta ’ suspensjoni.
Carton containing 1 bottle.
Kartuna fiha flixkun wieħed.
Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom
Boundary Way Hemel Hempstead HP2 7UD Ir- Renju Unit
Name and address of the manufacturerresponsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
Rijksweg 14 B-2870 Puurs Belgium
Rijksweg 14 B- 2870 Puurs Il- Belġju
• OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRAZ
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 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 ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 4. 0 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija implimentata u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 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 għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 2. 0 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentata f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kull aġġornament sussegwenti ta ’ RMP miftiehem mis- CHMP.
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata wara li tintlaħaq mira ta ’ mportanza (farmakoviġilanza jew tnaqqis ta ’ riskju) • Mat- talba ta ’ l- EMEA
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 5 ml
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NAME OF THE MEDICINAL PRODUCT
KARTUNA GĦALL- FLIXKUN WIEĦED TA ’ 5 ml
NEVANAC 1 mg/ ml eye drops, suspension Nepafenac
ISEM TAL- PRODOTT MEDIĊINALI
Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, sodium hydroxide and/ or hydrochloric acid (to adjust pH) and purified water.
Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, sodium hydroxide u/ jew hydrochloric acid (għall- aġġustament tal- pH) u ilma ppurifikat.
Eye drops, suspension 1 x 5 ml
Qtar għall- għajnejn, suspensjoni 1 x 5 ml
Ocular use.
Użu għall- għajn.
14 PARTICULARS TO APPEAR ON SMALL IMMEDATE PACKAGING UNITS BOTTLE LABEL
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
TIKKETTA TAL- FLIXKUN
NEVANAC 1 mg/ ml eye drops Nepafenac Ocular use
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
NEVANAC 1 mg/ ml eye drops, suspension Nepafenac
NEVANAC 1 mg/ ml qtar għall- għajnejn, suspensjoni Nepafenac
If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
This medicine has been prescribed for you.
M’ għandekx tgħaddiha lil persuni oħra.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What NEVANAC is and what it is used for 2.
X’ inhu NEVANAC u għalxiex jintuża 2.
Before you use NEVANAC 3.
Qabel ma tuża NEVANAC 3.
How to use NEVANAC 4.
Kif għandek tuża NEVANAC 4.
How to store NEVANAC 6.
Kif taħżen NEVANAC 6.
WHAT NEVANAC IS AND WHAT IT IS USED FOR
X’ INHU NEVANAC U GĦALXIEX JINTUŻA
NEVANAC is used to prevent and relieve eye pain and inflammation following cataract surgery on the eye.
NEVANAC jintuża biex jipprevjeni u jtaffi uġigħ u infjammazzjoni fl- għajn wara kirurġija għall- katarretti fl- għajn.
NEVANAC belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
NEVANAC jagħmel parti minn grupp ta ’ mediċini msejjħa mediċini anti- infjammatorji mhux sterojdi (NSAIDs).
BEFORE YOU USE NEVANAC
QABEL MA TUŻA NEVANAC
Do not use NEVANAC
Tużax NEVANAC
if you are allergic (hypersensitive) to nepafenac or any of the other ingredients in NEVANAC or to other nonsteroidal anti-inflammatory drugs if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs.
jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal nepafenac jew sustanzi oħra f’ NEVANAC jew għal xi mediċini anti- infjammatorji mhux sterojdi oħra. jekk kellek esperjenza ta ’ ażżma, allerġija fil- ġilda, jew infjammazzjoni severa f’ imnieħrek waqt l- użu ta ’ NSAIDs oħra.
Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
Eżempji ta ’ NSAIDs huma: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
Take special care with NEVANAC • In children. • If you bruise easily or have bleeding problems or have had them in the past. • If you have any other eye disorder (e. g. an eye infection) or if you are using other medicines in the eye (especially topical steroids). • • If you have diabetes. • If you have rheumatoid arthritis. • If you have had repeated eye surgery within a short period of time. • Avoid sunlight during treatment with NEVANAC 17 Tell your doctor if any of these apply.
Oqgħod attent ħafna b’ NEVANAC • Fit- tfal. • Jekk titbenġel malajr jew għandek problemi ta ’ fsada jew jekk kellek fil- passat. • Jekk għandek xi disturb ieħor fl- għajnejn (e. ż. infezzjoni fl- għajn) jew jekk qed tuża mediċini oħra fl- għajn (speċjalment sterojdi topiċi). • • Jekk għandek dijabete. • Jekk għandek artrite rewmatojda. • Jekk kellek kirurġja ripetuta fl- għajn f’ perjodu qasir ta ’ żmien. • Evita d- dawl tax- xemx waqt il- kura b ’ Nevanac
You may still be able to use NEVANAC, but discuss it with your doctor first.
Għandu mnejn tkun tista ’ tuża NEVANAC, iżda l- ewwel iddiskuti dan mat- tabib tiegħek.
Using other medicines
17 Meta tuża mediċini oħra
If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC.
Jekk inti tqila jew tista ’ toħroġ tqila, kellem lit- tabib tiegħek qabel tuża NEVANAC.
If you are breast-feeding, NEVANAC may pass into your milk.
Jekk qed tredda ’, NEVANAC jista ’ jgħaddi ġol- ħalib tiegħek.
Do not drive or use machines until your vision is clear.
Issuqx u tħaddimx magni qabel il- vista tiegħk tkun ċara.
You may find that your vision is blurred for a time just after using NEVANAC.
Il- vista tiegħek għandu mnejn tiċċajpar għal xi ħin wara l- użu ta ’ NEVANAC.
Important information about some of the ingredients
Tagħrif importanti dwar xi wħud mis- sustanzi
• There is a preservative in NEVANAC (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation.
• Hemm preservattiv f’ NEVANAC (benzalkonium chloride) li jista ’ jbiddel il- kulur tal- lentijiet rotob u jista ’ jikkawża irritazzjoni ta ’ l- għajn.
Therefore, do not wear contact lenses whilst using NEVANAC.
Barra minn hekk, li tilbes lentijiet tal- kuntatt mhux rakkomandat wara kirurġija tal- katarretti. Għalhekk, tilbisx lentijiet tal- kuntatt waqt li qed tuża NEVANAC.
HOW TO USE NEVANAC
KIF GĦANDEK TUŻA NEVANAC
Always use NEVANAC exactly as your doctor has told you.
Dejjem għandek tuża NEVANAC skond il- parir tat- tabib.
Only use NEVANAC in both eyes if your doctor has told you to.
Uża NEVANAC fiż- żewġ għajnejn biss jekk it- tabib tiegħek qallek biex tagħmel hekk.
Only use NEVANAC as an eye drop.
Uża NEVANAC bħala qtar għall- għajnejn biss.
One drop in the affected eye or eyes, three times a day-morning, midday, and evening.
Qatra waħda fl- għajn jew għajnejn affettwati, tliet darbiet kuljum- filgħodu, f’ nofsinhar, u filgħaxija.
Use at the same time each day.
Uża kuljum fl- istess ħin.
When to take and for how long Begin 1 day before cataract surgery.
Meta tieħu u għal kemm Ibda ġurnata qabel il- kirurġija tal- katarretti.
Continue on the day of surgery.
Kompli fil- ġurnata tal- kirurġija.
Then use it for as long as your doctor tells you to.
Wara użaħ għal kemm jgħidlek it- tabib tiegħek.
This may be up to 3 weeks after your operation.
Dan jista ’ jkun sa 3 ġimgħat wara l- operazzjoni tiegħek.
How to use
Kif tużaħ
Wash your hands before you start.
Aħsel idejk qabel tibda.
Shake well before
• Ħawwad sew qabel tużaħ. • Dawwar l- għatu tal- flixkun biex tneħħieħ.
• Twist off the bottle cap. • Hold the bottle, pointing down, between your thumb and fingers. • Tilt your head back. • Pull down your lower eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye.
18 • Żomm il- flixkun, ippuntat ’ l isfel, bejn is- seba l- kbir u s- swaba l- oħrajn. • Aqleb rasek lura. • Iġbed il- kappel ta ’ taħt ta ’ l- għajn ’ l isfel b’ seba nadif, sakemm ikun hemm ‘ borża ’ bejn il- kappel ta ’ l- għajn u l- għajn tiegħek.
The drop will go in here (picture 1). • Bring the bottle tip close to the eye.
Il- qatra tmur hemm (stampa 1). • Ressaq il- ponta tal- filxkun qrib l- għajn.
Do this in front of a mirror if it helps. • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Għamel dan quddiem mera jekk dan jgħin. • Tmissx l- għajn jew il- kappell ta ’ l- għajn tiegħek, l- erja tal- madwar jew uċuħ oħra bl- applikatur għat- tqattir.
It could infect the drops. • Gently press on the base of the bottle to release one drop of NEVANAC at a time. • Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
Dan jista ’ jinfetta l- qtar. • Għafas bil- mod il- bażi tal- flixkun biex tinżel qatra waħda ta ’ NEVANAC kull darba (stampa 2). • T’ għafasx il- flixkun bis- saħħa: huwa maħsub biex kull m’ għandu bżonn hija għafsa ħafifa fuq il- qiegħ (stampa 2).
If you use drops in both eyes, repeat the steps for your other eye.
Jekk tuża qtar fiż- żewġ għajnejn, irrepeti l- passi għall- għajn l- oħra tiegħek.
Close the bottle cap firmly immediately after use.
Għalaq sew l- għatu tal- flixkun immedjatament wara l- użu.
Now turn over >
Issa aqleb
How to use: see also side 1
Kif tuża: ara wkoll naħa 1
If a drop misses your eye, try again.
Jekk qatra ma tidħolx ġo għajnejk, erġa ’ pprova.
If you use more NEVANAC than you should, rinse your eye out with warm water.
Jekk tuża NEVANAC aktar milli suppost, laħlaħ għajnejk sew b’ ilma fietel.
Do not put in any more drops until it is time for your next regular dose.
T’ applikax aktar qtar sakemm ikun ħin għad- doża tas- soltu li jmiss tiegħek.
If you forget to use NEVANAC, use a single dose as soon as you remember.
Jekk tinsa tuża NEVANAC, uża doża waħda hekk kif tiftakar.
If it is almost time for the next dose, leave out the missed dose and continue with the next dose of your regular routine.
Jekk ikun kważi sar il- ħin għad- doża li jmiss, t’ applikax id- doża minsija u kompli bid- doża li jmiss tar- rutina tas- soltu.
Do not use a double dose to make up for a missed dose.
M’ għandekx tuża doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Do not use more than one drop in the affected eye(s) 3 times daily.
M’ għandekx tuża aktar minn qatra waħda fl- għajn( ejn) affetwata 3 darbiet kuljum.
If you are using other eye drops, wait at least five minutes between using NEVANAC and the other drops.
Jekk qed tuża qtar għall- għajnejn oħra, stenna minn ta ’ l- inqas ħames minuti bejn l- użu ta ’ NEVANAC u l- qtar l- oħra.
> If you have any further questions on the use of this product ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines NEVANAC can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, NEVANAC jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Do not stop taking NEVANAC without speaking to your doctor.
Twaqqafx l- użu ta ’ NEVANAC mingħajr ma tkellem lit- tabib tiegħek.
You can usually carry on using the drops, unless the effects are serious.
Normalment tista ’ tkompli tuża l- qtar, sakemm l- effetti ma jkunux serji.
If you are worried, talk to your doctor or pharmacist.
Jekk inti nkwetat, kellem lit- tabib jew lill- ispiżjar tiegħek.
If your eyes get redder or more painful while using the drops:
Jekk għajnejk jiħmaru jew juġgħu aktar waqt li qed tuża l- qtar:
Contact your doctor immediately.
Kellem lit- tabib tiegħek minnufiħ.
19 Common side effects (1 to 10 users in 100).
Effetti sekondarji komuni (1 sa 10 pazjenti f’ 100)
Effects in the eye: eye surface inflammation with loss or damage of cells, eye pain, blurred vision, itchy eye, dry eye, foreign body sensation in the eyes, eyelid crusting
Effetti fl- għajn: infjammazzjoni tas- superfiċje tal- għajn b’ telf jew ħsara ta ’ ċelluli, uġigħ fl- għajn, vista mċajpra, ħakk fl- għajn, l- għajn tinħass xotta, sensazzjoni ta ’ xi ħaġa barranija fl- għajnejn, qxur fil- kappell ta ’ l- għajn
Uncommon side effects (1 to 10 users in 1,000)
19 Effetti sekondarji mhux komuni (1 sa 10 pazjenti f’ 1, 000)
Effects in the eye: inflammation of the coloured part of the eye (iritis), eye surface inflammation, deposits on the eye surface, fluid or swelling at the back of the eye, eye discharge, sensitivity to light, allergic conjunctivitis (eye allergy), eye irritation or pain, eyelid disorder (swelling) or drooping, increased tear production, eye redness
Effetti fl- għajn: infjammazzjoni tal- parti kkulurita tal- għajn (irite), infjammazzjoni tas- superfiċje tal- għajn, depożiti fuq is- superfiċje ta ’ l- għajn, fluwidu jew nefħa wara l- għajn, tnixxija mill- għajn, sensittività għad- dawl, konġuntivite allerġika (allerġija fl- għajn), irritazzjoni jew uġigħ fl- għajn, disturbi tal- kappell ta ’ l- għajn (nefħa) jew tbaxxija, żieda fil- produzzjoni tad- dmugħ, ħmura ta ’ l- għajn.
General side effects: allergic symptoms, nausea, dry mouth
Effetti sekondarji ġenerali: sintomi allerġiċi, tqalligħ, ħalq xott
Additional side effects may also affect people using NEVANAC including:
Effetti sekondarji oħra ukoll jistgħu jaffettwaw persuni li qed jużaw NEVANAC inkluż:
Effects in the eye: eye surface scar, scratch, clouding, inflammation or infection, inflammation inside the eye, impaired healing of the eye, reduced vision.
Effetti fl- għajn: ċikatriċi, barxa, ċpar, infjammazzjoni jew infezzjoni tas- superfiċje tal- għajn, infjammazzjoni ġo l- għajn, fejqan imnaqqas ta ’ l- għajn, vista mnaqqsa.
You may be at a higher risk for eye surface problems that could result in loss of vision if you have had: • complicated eye surgery • repeated eye surgery within a short period of time • certain disorders of the surface of the eye, such as inflammation or dry eye • certain general diseases, such as diabetes or rheumatoid arthritis
Tista ’ tkun f’ riskju akbar ta ’ problemi fis- superfiċje tal- għajn li jistgħu jwasslu għal telf tal- vista jekk kellek: • kirurġija komplikata tal- għajn • kirurġija ripetuta tal- għajn f’ perjodu qasir ta ’ żmien • ċertu disturbi fis- superfiċje tal- għajn, bħal infjammazzjoni jew l- għajn tinħass xotta • ċertu mard ġenerali, bħal dijabete jew artrite rewmatojda
If any of the side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE NEVANAC
KIF TAĦŻEN NEVANAC
Do not use NEVANAC after the expiry date which is stated on the bottle and the carton after EXP.
Tużax NEVANAC wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- flixkun wara JIS.
Throw away the bottle 4 weeks after first opening, to prevent infections.
Armi l- flixkun 4 ġimgħat wara li jinfetaħ l- ewwel darba, biex tipprevjeni nfezzjonijiet.
Write the date of opening on the bottle and carton label in the space provided.
Ikteb id- data ta ’ meta jinfetaħ fuq il- flixkun u t- tikketta tal- kartuna fl- ispazju pprovdut.
Medicines should not be disposed of via waste water or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What NEVANAC contains
X’ fih NEVANAC:
The active substance is nepafenac.
Is- sustanza attiva hi nepafenac.
One ml of suspension contains 1 mg of nepafenac.
Ml ta ’ suspensjoni fih 1 mg nepafenac.
The other ingredients are benzalkonium chloride, carbomer, disodium edetate, mannitol, purified water, sodium-chloride and tyloxapol.
Is- sustanzi l- oħra huma benzalkonium chloride, carbomer, disodium edetate, mannitol, ilma ppurifikat, sodium- chloride u tyloxapol.
Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels (pH levels) normal.
Ammonti żgħar ta ’ sodium hydroxide u/ jew hydrochloric acid huma miżjuda biex iżommu l- livell ta ’ l- aċidità (livelli tal- pH) normali.
What NEVANAC looks like and the contents of the pack
20 Id- Dehra ta ’ NEVANAC u l- kontenuti tal- pakkett
NEVANAC is a liquid (light yellow to dark yellow suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
NEVANAC huwa likwidu (suspenjoni safra ċara sa safra skura) disponibbli f’ pakkett li fiħ flixkun wieħed tal- plastik ta ’ 5 ml b’ għatu bil- kamin.
Marketing Authorisation Holder Alcon Laboratories (UK) Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Alcon Laboratories (UK) Ltd.
Manufacturer S.A.
L- Manifattur S. A.
Alcon – Couvreur N.V Rijksweg 14 B-2870 Puurs Belgium
Alcon – Couvreur N. V Rijksweg 14 B- 2870 Puurs Il- Belgju
21 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
21 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
België/Belgique/Belgien Luxembourg/Luxemburg SA Alcon-Couvreur NV + 32 (0)3 890 27 11 (België/Belgique/Belgien)
Alcon- Couvreur NV + 32 (0) 3 890 27 11 (België/ Belgique/ Belgien)
България Алкон България ЕООД + 359 2 950 15 65
Magyarország България Алкон България ЕООД + 359 2 950 15 65 Česká republika Alcon Pharmaceuticals (Czech Republic) s. r. o. + 420 225 377 300
Nederland Alcon Nederland BV + 31 (0) 183 654321
Alcon Hungária Gyógyszerkereskedelmi Kft. + 36- 1- 463- 9080 Nederland Alcon Nederland BV + 31 (0) 183 654321
France Laboratoires Alcon + 33 (0)1 47 10 47 10
Slovenija France Laboratoires Alcon + 33 (0) 1 47 10 47 10
22 Italia Alcon Italia S.p.A. + 39 02 81803.1
22 Sverige Italia Alcon Italia S. p. A. + 39 02 81803. 1
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
What is Nexavar?
X’ inhu Nexavar?
Nexavar is a medicine containing the active substance sorafenib.
Nexavar huwa mediċina li fiha s- sustanza attiva sorafenib.
It is available as red, round tablets (200 mg).
Jiġi bħala pilloli ħomor, tondi (200 mg).
What is Nexavar used for?
Għal x’ hiex jintuża Nexavar?
Nexavar is used to treat patients who have: • hepatocellular carcinoma, • advanced renal cell carcinoma (a type of kidney cancer that affects the cells of the renal tubules) when anticancer treatment with interferon alfa or interleukin-2 has failed or cannot be used.
Nexavar jintuża biex jikkura pazjenti li għandhom: • karċinoma epatoċellolari, • karċinoma taċ- ċellola renali avvanzata (tip ta ’ kanċer tal- kilwa li jaffettwa ċ- ċelloli tat- tubuli renali) meta kura kontra l- kanċer b’ interferon alfa jew b’ interleukin- 2 ma tkunx irnexxiet jew ma tistax tintuża.
Because the numbers of patients with hepatocellular carcinoma and renal cell carcinoma are low, the diseases are considered ‘ rare’, and Nexavar was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 11 April 2006 and 29 July 2004.
Minħabba li n- numru ta ’ pazjenti b’ karċinoma epatoċellolari u karċinoma taċ- ċellola renali huwa baxx, il- mard huma ikkunsidrati ‘ rari ’, u Nexavar kien ikklassifikat bħal ‘ mediċina orfni ’ (mediċina li tintuża f’ mard rari) fil- 11 ta ’ April 2006 u fid- 29 ta ’ Lulju 2004.
How is Nexavar used?
Kif jintuża Nexavar?
Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Kura b’ Nexavar għandha tkun sorveljata minn tobba li għandhom esperjenza fil- kuri ta ’ kontra l - kanċer.
Nexavar is given as two tablets (400 mg) twice a day, without food, or with a meal that is low in fat.
Nexavar jingħata bħala żewġ pilloli (400 mg) darbtejn kuljum, fuq stonku vojt, jew ma ’ ikla b’ kontenut ta ’ xaħam baxx.
The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Il- kura titkompla sakemm il- pazjent ikompli jibenifika minnha mingħajr ħafna effetti sekondarji.
How does Nexavar work?
Kif jaħdem Nexavar?
The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Is- sustanza attiva f’ Nexavar, sorafenib, hija inibitur ta ’ protein kinase.
This means that it blocks some specific enzymes, known as protein kinases.
Dan ifisser li timblokka enzimi speċifiċi, magħrufin bħala protein kinases.
These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Dawn l- enzimi jistgħu jinsabu f’ xi riċetturi fuq il- wiċċ taċ - ċelloli tal- kanċer, fejn huma involuti fl- iżvilupp u l- firxa ta ’ ċelloli tal- kanċer, u fl- arterji tad- demm li jagħtu t- tumuri, fejn huma involuti fl- iżvilupp ta ’ arterji tad- demm ġodda.
Nexavar works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Nexavar jaħdem billi jittardja r- rata ta ’ żvilupp ta ’ ċelloli tal- kanċer u jaqta ’ l- fornitura tad- demm li żżomm liċ- ċelloli tal - kanċer milli jikbru.
How has Nexavar been studied?
Kif ġie studjat Nexavar?
The effectiveness of Nexavar in hepatocellular carcinoma has been studied in one main study including 602 patients, and its effectiveness in advanced renal cell carcinoma has been studied in one main study including 903 patients in whom one previous anti-cancer treatment had stopped working.
L- effikaċja ta ’ Nexavar f’ karċinoma epatoċellolari ġiet studjata fi studju wieħed ewlieni li inkluda 602 pazjenti, u l- effikaċja tiegħu f’ karċinoma taċ- ċellola renali avvanzata ġiet studjata fi studju wieħed ewlieni li inkluda 903 pazjenti, f’ liema kura waħda kontra l- kanċer preċedenti ma baqitx taħdem.
In both studies, Nexavar was compared with placebo (a dummy treatment) in a double-blind manner 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fiż - żewġ studji, Nexavar tqabbel ma ’ plaċebo (kura finta) b’ mod double- blind (la t- tabib u lanqas il - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged (neither the doctor nor the patient knew which treatment the patient was receiving).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged pazjent ma kienu jafu liema kura kien qed jirċievi l- pazjent).
The main measure of effectiveness in the hepatocellular carcinoma study was overall patient survival.
Il- miżura ewlenija ta ’ l- effikaċja f’ karċinoma epatoċellolari kienet is- sopravivenza totali tal- pazjent.
The main measures of effectiveness in the advanced renal cell carcinoma study were overall patient survival and how long the patients survived without their disease getting worse.
Il- miżuri ewlenin ta ’ l- effikaċja fl - istudju ta ’ karċinoma taċ- ċellola renali kienu s- sopravivenza totali tal- pazjenti u kemm il- pazjenti damu jgħixu mingħajr ma l- marda tagħhom bdiet tmur għal agħar.
What benefit has Nexavar shown during the studies?
X’ benefiċċju wera Nexavar waqt l- istudji?
Nexavar was more effective than placebo in lengthening the overall survival of the patients.
Nexavar kien aktar effettiv minn plaċebo fit- titwil tas- sopravivenza totali tal- pazjenti.
In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
Fl- istudju ta ’ karċinoma epatoċellolari, il- pazjenti li kienu qed jieħdu Nexavar issopravivew għal medja ta ’ 10. 7 xhur, meta mqabbla ma ’ 7. 9 xhur f’ dawk li kienu qed jieħdu plaċebo.
In the study of renal cell carcinoma, the patients survived an average of 19.3 months on Nexavar compared with 15.9 months on placebo, based on data from 903 patients, including about 200 who had switched from placebo to Nexavar at the time of the analysis.
Fl- istudju ta ’ karċinoma taċ- ċellola renali, il- pazjenti fuq Nexavar issopravivew medja ta ’ 19. 3- il xahar meta mqabbla ma ’ 15. 9- il xahar għal dawk fuq plaċebo, abbażi tad- dejta minn 903 pazjenti, inklużi madwar 200 li qalbu minn plaċebo għal Nexavar fiż- żmien ta ’ l- analiżi.
Time until disease got worse was longer in patients treated with Nexavar (167 days, around five and a half months) than those who took placebo (84 days, around three months), based on data from 726 patients.
Iż- żmien sakemm il - marda marret għall- agħar f’ pazjenti ikkurati b’ Nexavar (167 jum, madwar ħames xhur u nofs) meta mqabbla ma ’ dawk li ħadu plaċebo (84 jum, madwar tliet xhur), abbażi ta ’ dejta minn 726 pazjent.
What is the risk associated with Nexavar?
X’ inhu r- riskju assoċjat ma ’ Nexavar?
In clinical studies, the most common side effects with Nexavar (seen in more than 1 patient in 10) were lymphopenia (low levels of lymphocytes, a type of white blood cell), hypophosphataemia (low levels of phosphate in the blood), haemorrhage (bleeding), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, rash, alopecia (hair loss), ‘ hand foot syndrome’ (rash and pain on the palms and soles), erythema (redness), pruritus (itchiness), fatigue (tiredness), pain, and increased amylase and lipase (enzymes produced by the pancreas).
Fi studji kliniċi, l- aktar effetti sekondarji komuni ma ’ Nexavar (dehru f’ aktar minn pazjent 1 minn kull 10) kienu limfopinja (livelli baxxi ta ’ limfoċiti, tip ta ’ ċellola bajda tad- demm), ipofosfatimja (livelli baxxi ta ’ fosfat fid- demm), emorraġija (fsada), pressjoni tad- demm għolja, dijarea, nawżja (dardir), rimettar, raxx, alopixja (telf ta ’ xagħar), ‘ sindromu ta ’ l- id u s- sieq ’ (raxx u uġigħ fl- uċuh ta ’ l- idejn u l- qiegħan tas- saqajn), eritima (ħmura), prurite (ħakk), għeja kbira, uġigħ, u żieda fl- amylase u lipase (enzimi magħmula mill- frixa).
For the full list of all side effects reported with Nexavar, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji irrapportati b’ Nexavar, ara l - Fuljett ta ’ Tagħrif.
Nexavar should not be used in people who may be hypersensitive (allergic) to sorafenib or any of the other ingredients.
Nexavar m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal sorafenib jew għal xi sustanzi oħra tiegħu.
Caution is needed when it is taken with other medicines.
Jeħtieġ li tintuża l- kawtela meta jittieħed ma ’ mediċini oħra.
See the Package Leaflet for the list of the medicines that may interact with Nexavar.
Ara l- Fuljett ta ’ Tagħrif għal- lista ta ’ mediċini li jista ’ jkollhom effett fuq xulxin ma ’ Nexavar.
Why has Nexavar been approved?
Għaliex ġie approvat Nexavar?
The Committee for Medicinal Products for Human Use (CHMP) decided that Nexavar’ s benefits are greater than its risks for the treatment of hepatocellular carcinoma, and of advanced renal cell carcinoma in patients who have failed prior interferon alfa or interleukin-2 based therapy, or who are considered unsuitable for such therapy.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Nexavar huma akbar mir- riskji tiegħu fil- kura ta ’ karċinoma epatoċellolari, u ta ’ karċinoma taċ- ċellola renali avvanzata f’ pazjenti li ma rnexxietilhomx terapija b’ interferon alfa jew terapija ibbażata fuq interleukin- 2 preċedenti, jew li huma ikkunsidrati mhux tajba għal terapija bħal din.
The Committee recommended that Nexavar be given marketing authorisation.
Il- Kumitat irrikmanda li Nexavar jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Nexavar:
Tagħrif ieħor dwar Nexavar:
The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar to Bayer HealthCare AG on 19 July 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Nexavar lil Bayer HealthCare AG fid- 19 ta ’ Lulju 2006.
The summaries of opinion of the Committee for Orphan Medicinal Products for Nexavar are available here (hepatocellular carcinoma) and here (renal cell carcinoma).
Is- sommarji ta ’ l- opinjoni tal- Kumitat għal Prodotti Mediċinali Orfni għal Nexavar huma disponibbli minn hawnhekk (karċinoma epatoċellulari) u minn hawnhekk (karċinoma taċ- ċelloli renali).
The full EPAR for Nexavar can be found here.
L- EPAR sħiħ għal Nexavar jista ’ jinstab hawnhekk.
Nexavar 200 mg film-coated tablets
Nexavar 200 mg pilloli miksija b’ rita
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
Kull pillola miksija b’ rita fiha 200 mg ta ’ sorafenib (bħala tosylate).
Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Pilloli miksija b’ rita, ħomor, tondi, ibbuzzati fuq iż- żewġ naħat, imnaqqxa bis- salib ta ’ Bayer fuq naħa u "200" fuq in- naħa l- oħra.
Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
Karċinoma epatoċellulari Nexavar huwa indikat għall- kura ta ’ karċinoma epatoċellulari (ara sezzjoni 5. 1).
Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Karċinoma taċ- ċellula renali Nexavar huwa indikat għall- kura ta ’ pazjenti b’ karċinoma avvanzata taċ- ċellola renali li kellhom falliment ta ’ kura minn qabel ibbażata fuq interferon- alpha jew interleukin- 2 jew li huma kkunsidrati bħala mhux tajbin biex jirċievu din it- terapija.
Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Kura b’ Nexavar għandha tiġi sorveljata minn tabib b’ esperjenza fl- użu ta ’ terapiji kontra l- kanċer.
The recommended dose of Nexavar in adults is 400 mg (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Id - doża rakkomandata ta ’ Nexavar fl- adulti hija 400 mg (żewġ pilloli ta ’ 200 mg) darbtejn kuljum (ekwivalenti għal doża totali ta ’ kuljum ta ’ 800 mg).
It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Huwa rakkomandat li sorafenib jingħata mingħajr ikel jew ma ’ ikla li fiha ammont żgħir jew moderat ta ’ xaħam.
If the patient intends to have a high-fat meal, sorafenib tablets should be taken at least 1 hour before or 2 hours after the meal.
Jekk il- pazjent bi ħsiebu jieħu ikla li fiha ammont għoli ta ’ xaħam, il- pilloli ta ’ sorafenib għandhom jittieħdu ta ’ l- inqas siegħa qabel jew sagħtejn wara l- ikla.
The tablets should be swallowed with a glass of water.
Il- pilloli għandhom jinbelgħu ma ’ tazza ilma.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Il- kura għandha titkompla sakemm jibqa jiġi osservat benefiċċju kliniku jew sakemm ikun hemm tossiċità mhux aċċettabli.
Posology adjustments:
Aġġustament fil- pożoloġija:
Management of suspected adverse drug reactions may require temporary interruption or dose reduction of Nexavar therapy.
L- immaniġġjar ta ’ reazzjonijiet avversi suspettati jista ’ jinħtieġ waqfien temporanju jew tnaqqis fid - doża ta ’ kura b’ Nexavar.
When dose reduction is necessary, the Nexavar dose should be reduced to two tablets of 200 mg once daily (see section 4.4).
Meta jkun hemm bżonn ta ’ tnaqqis fid- doża, id- doża ta ’ Nexavar għandha titnaqqas għal żewġ pilloli ta ’ 200 mg darba kuljum (ara sezzjoni 4. 4).
The safety and efficacy in children and adolescents (< 18 years) have not been studied.
Is- sigurtà u l- effikaċja fit- tfal u l- adolexxenti (< 18 sena) ma ġewx studjati.
Nexavar is not recommended for use in children and adolescents due to a lack of data on safety and efficacy (see section 5.3).
Nexavar mhux rakkomandat għall- użu fit- tfal u adolexxenti minħabba nuqqas ta ’ tagħrif dwar is - sigurtà u l- effikaċja (ara sezzjoni 5. 3).
No dose adjustment is required in the elderly (patients above 65 years of age).
L- ebda aġġustament fid- doża ma hija neċessarja fl- anzjani (pazjenti b’ età l’ fuq minn 65 sena).
No dose adjustment is required in patients with mild, moderate or severe renal impairment.
L- ebda aġġustament fid- doża ma hija neċessarja f’ pazjenti b’ indeboliment renali ħafif, moderat jew sever.
No data is available in patients requiring dialysis (see section 5.2).
L- ebda tagħrif ma huwa disponibbli f’ pazjenti f’ pazjenti li jinħtieġu d- dijaliżi (ara sezzjoni 5. 2).
Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Hija rrakkomandata sorveljanza tal- bilanċ ta ’ fluwidu u elettroliti f’ pazjenti li għandhom riskju ta ’ funzjoni renali ħażina.
No dose adjustment is required in patients with Child Pugh A and B (mild to moderate) hepatic impairment.
L- ebda aġġustament fid- doża ma hija neċessarja f’ pazjenti b’ indeboliment epatiku Child Pugh A u B (ħafif sa moderat).
No data is available on patients with Child Pugh C (severe) hepatic impairment (see section 4.4 and 5.2).
L- ebda tagħrif ma huwa disponibbli dwar pazjenti b’ indeboliment epatiku Child Pugh C (sever) (ara sezzjoni 4. 4 u 5. 2).
Dermatological toxicities:
Tossiċitajiet dermatoloġiċi:
Hand-foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with Nexavar.
Reazzjoni tal- ġilda fl- id u s- sieq (eritrodisasteżija palmari- plantari) u raxx jirrappreżentaw l- aktar reazzjonijiet avversi komuni tal- mediċina b’ Nexavar.
Rash and hand-foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with Nexavar.
Raxx u reazzjoni tal - ġilda fl- id u s- sieq normalment huma CTC (Kriterji ta ’ Tossiċità Komuni) ta ’ Grad 1 u 2 u ġeneralment jidru waqt l- ewwel sitt ġimgħat tal- kura b’ Nexavar.
Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/ or dose modification of Nexavar, or in severe or persistent cases, permanent discontinuation of Nexavar (see section 4.8).
L- immaniġġjar ta ’ tossiċitajiet dermatoloġiċi jista ’ jinkludi terapiji topikali għas- serħan tas- sintomi, waqfien temporanju tal- kura u/ jew modifikazzjoni tad- doża ta ’ Nexavar, jew f’ każijiet severi jew persistenti, twaqqif permanenti ta ’ Nexavar (ara sezzjoni 4. 8).
Hypertension:
Ipertensjoni:
An increased incidence of arterial hypertension was observed in Nexavar-treated patients.
Żjieda fl- inċidenza ta ’ ipertensjoni arterjali kienet osservata f’ pazjenti kkurati b’ Nexavar.
Hypertension was usually mild to moderate, occurred early in the course of treatment, and was amenable to management with standard antihypertensive therapy.
L- ipertensjoni ġeneralment kienet ħafifa għal moderata, seħħet fil- bidu tal- kors ta ’ kura, u kienet tirrispondi għall- immaniġġjar b’ terapija anti- ipertensiva stàndard.
Blood pressure should be monitored regularly and treated, if required, in accordance with standard medical practice.
Il- pressjoni tad- demm għandha tiġi sorveljata b’ mod regolari u jekk hemm bżonn, kkurata skond il- prattika medika stàndard.
In cases of severe or persistent hypertension, or hypertensive crisis despite institution of antihypertensive therapy, permanent discontinuation of Nexavar should be considered (see section 4.8).
F’ każ ta ’ ipertensjoni severa jew persistent, jew kriżi ipertensiva minkejja l- istituzzjoni ta ’ kura anti- ipertensiva, għandu jiġi kkunsidrat twaqqif permanenti ta ’ Nexavar (ara sezzjoni 4. 8).
Haemorrhage:
Emorraġijja:
An increased risk of bleeding may occur following Nexavar administration.
Żjieda fir- riskju ta ’ fsada tista ’ sseħħ wara amministrazzjoni ta ’ Nexavar.
If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of Nexavar should be considered (see section 4.8).
Jekk xi episodju ta ’ fsada jinħtieġ intervent mediku huwa rakkomandat li jiġi kkunsidrat twaqqif permanenti ta ’ Nexavar (ara sezzjoni 4. 8).
Cardiac ischaemia and/ or infarction:
Iskemija u/ jew infart tal- qalb:
In a randomised, placebo-controlled, double-blind study (study 1, see section 5.1) the incidence of treatment-emergent cardiac ischaemia/ infarction events was higher in the Nexavar group (2.9%) compared with the placebo group (0.4%).
Fi studju randomised, ikkontrollat bil- plaċebo u double- blind (studju 1, ara sezzjoni 5. 1), l- inċidenza ta ’ episodji ta ’ iskemija/ infart tal- qalb li dehru waqt il- kura kienet għola fil- grupp ta ’ Nexavar (2. 9%) meta mqabbel mal- grupp ta ’ plaċebo (0. 4%).
In study 3 (see section 5.1), the incidence of treatment-emergent cardiac ischaemia/ infarction events was 2.7% in Nexavar patients compared with 1.3% in the placebo group.
Fi studju 3 (ara sezzjoni 5. 1), l- inċidenza ta ’ episodji ta ’ iskemija/ infart tal- qalb li tfaċċaw bil- kura kienet 2. 7% fil - pazjenti b’ Nexavar meta mqabbel ma ’ 1. 3% fil- grupp bil- plaċebo.
Patients with unstable coronary artery disease or recent myocardial infarction were excluded from these studies.
Pazjenti b’ mard instabbli ta ’ l - arterja koronarja jew infart mijokardiku reċenti kienu esklużi minn dawn l- istudju.
Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischaemia and/ or infarction (see section 4.8).
Twaqqif temporanju jew permanenti ta ’ Nexavar għandu jiġi kkunsidrat f’ pazjenti li żviluppaw iskemija u/ jew infart tal- qalb (ara sezzjoni 4. 8).
Gastrointestinal perforation:
Perforazzjoni gastro- intestinali:
Gastrointestinal perforation is an uncommon event and has been reported in less than 1% of patients taking sorafenib.
Perforazzjoni gastro- intestinali hija avveniment mhux komuni u ġiet irrappurtata f’ inqas minn 1% tal- pazjenti li qed jieħdu sorafenib.
In some cases this was not associated with apparent intra- abdominal tumor.
F’ ċertu każijiet dan ma kienx assoċjat ma ’ tumur intra- addominali apparenti.
Sorafenib therapy should be discontinued (see section 4.8).
Kura b’ sorafenib għanda titwaqqaf (ara sezzjoni 4. 8).
Hepatic impairment:
3 Indeboliment epatiku:
No data is available on patients with Child Pugh C (severe) hepatic impairment.
M’ hemmx tagħrif disponibbli dwar pazjenti b’ indeboliment epatiku Child Pugh C (sever).
Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see section 4.2 and 5.2).
Minħabba li sorafenib jiġi eliminat prinċipalment mir- rotta epatika, l- espożizzjoni tista ’ tiżdied f’ pazjenti b’ indeboliment epatiku sever (ara sezzjoni 4. 2 u 5. 2).
Warfarin co-administration:
Amministrazzjoni flimkien ma ’ warfarin:
Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on Nexavar therapy.
Episodji infrekwenti ta ’ fsada jew elevazzjonijiet fil - Proporzjon Normalizzat Internazzjonali (INR) ġew irrappurtati f’ xi pazjenti li qed jieħdu warfarin waqt terapija b’ Nexavar.
Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Pazjenti li qed jieħdu warfarin jew phenprocoumon fl- istess waqt għandhom jiġu sorveljati regolarment għal tibdil fil- ħin prothrombin, INR jew episodji ta ’ fsada kliniċi (ara sezzjoni 4. 5 u 4. 8).
3 Wound healing complications:
Kumplikazzjonijiet tal- fejqan tal- feriti:
No formal studies of the effect of sorafenib on wound healing have been conducted.
Ma sarux studji formali dwar l- effett ta ’ sorafenib fuq il- fejqan tal- feriti.
Temporary interruption of Nexavar therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Waqfien temporanju ta ’ terapija b’ Nexavar huwa rakkomandat għal raġunijiet ta ’ prekawzjoni f’ pazjenti li se jkollhom proċeduri maġġuri kirurġiċi.
Therefore, the decision to resume Nexavar therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.
Hemm esperjenza klinika limitata dwar il- waqt li għandha terġa tinbeda t- terapija wara intervent kirurġiku maġġur. Għalhekk, id - deċiżjoni li titkompla t- terapija b’ Nexavar wara intervent kirurġiku maġġur għandha tiġi bbażata fuq il- ġudizzju kliniku ta ’ fejqan adegwat tal- ferita.
The experience with the use of Nexavar in elderly patients is limited.
L- esperjenza dwar l- użu ta ’ Nexavar f’ pazjenti anzjani hija limitata.
Cases of renal failure have been reported.
Każijiet ta ’ falliment renali kienu rrappurtati.
Monitoring of renal function should be considered.
Sorveljanza tal- funzjoni renali għandha tiġi kkunsidrata.
Renal cell carcinoma:
Karċinoma taċ- ċellula renali:
High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1); and benefit-risk in these patients has not been evaluated.
Pazjenti b’ Riskju Għoli, skondl il- grupp pronostku MSKCC (Ċentru tal - Kanċer Memorjal Sloan Kettering), ma kinux inklużi fl- istudju kliniku ta ’ fażi III ta ’ karċinoma taċ - ċellula renali (ara sezzjoni 1 f’ sezzjoni 5. 1); u l- benefiċċju- riskju ta ’ dawn il- pazjenti ma ġewx evalwati.
Drug-drug interactions:
Interazzjonijiet ma ’ mediċina oħra:
Caution is recommended when administering Nexavar with compounds that are metabolised/ eliminated predominantly by the UGT1A1 (e. g. irinotecan) or UGT1A9 pathways (see section 4.5).
Kawtela hija rakkomandata meta Nexavar jiġi mogħti ma ’ prodotti li huma metabolizzati/ eliminati prinċipalment mir- rotot UGT1A1 (e. ż. irinotecan) jew UGT1A9 (ara sezzjoni 4. 5).
Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.5).
Kawtela hija rakkomandata meta sorafenib jingħata flimkien ma ’ docetaxel (ara sezzjoni 4. 5).
Inducers of metabolic enzymes:
Indutturi ta ’ enżimi metaboliċi:
Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37% reduction of sorafenib AUC.
L- amministrazzjoni ta ’ rifampicin għal 5 ijiem qabel amministrazzjoni ta ’ doża waħda ta ’ sorafenib wasslet għal tnaqqis medju ta ’ 37% fl- AUC ta ’ sorafenib.
Other inducers of CYP3A4 activity and/ or glucuronidation (e. g.
Indutturi oħra ta ’ l- attività ta ’ CYP3A4 u/ jew glukuronidazzjoni (e. ż.
Hypericum perforatum also known as St.
Hypericum perforatum magħruf ukoll bħala St.
John’ s wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) may also increase metabolism of sorafenib and thus decrease sorafenib concentrations.
John’ s wort, phenytoin, carbamazepine, phenobarbital, u dexamethasone) ukoll jistgħu jżidu l - metaboliżmu ta ’ sorafenib u għalhekk inaqqsu l- konċetrazzjonijiet ta ’ sorafenib.
CYP3A4 inhibitors:
Inibituri ta ’ CYP3A4:
Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Ketoconazole, inibitur potenti ta ’ CYP3A4, mogħti darba kuljum għal 7 ijiem lill- volontiera rġiel f’ saħħithom ma biddilx l- AUC medja ta ’ doża waħda ta ’ sorafenib ta ’ 50 mg.
These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Dan it- tagħrif jissuġġerixxi li nterazzjonijiet farmakokinetiċi kliniċi ta ’ sorafenib ma ’ inibituri ta ’ CYP3A4 mhumiex probabbli.
CYP2C9 substrates:
Substrati ta ’ CYP2C9:
Sorafenib inhibited CYP2C9 in vitro.
Sorafenib jinibixxi CYP2C9 in vitro.