qanastek/EMEA-V3 huggingface dataset:
 Wash your hands thoroughly.  Select a clean, well-lit, flat working surface.  Take the ENBREL vial out of the refrigerator and place it on a flat surface.  You will also need the following items:
• Aħsel idejk sew. • Agħżel superfiċje ċatta, nadifa u mdawwla fejn tipprepara l- injezzjoni. • Oħroġ il- kunjett ta ’ ENBREL minn ġol- friġġ u poġġiha fuq is- superfiċje ċatta. • Ikollok bżonn ukoll ta ’ dawn l- oġġetti:
A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs  Inspect the expiry dates on both the Enbrel vial label and the water for injections.
Siringa sterili u labra (labar) ta ’ 25 guage X 16 mm jew simili Kunjett jew ampulla ta ’ ilma għall- injezzjonijiet 2 swabs bl- alkoħol • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- fjala kif ukoll it- tiketta tas- siringa.
278 c.
ċ.
Preparing the Enbrel dose for injection
Kif tipprepara d- doża ta ’ Enbrel għall- injezzjoni
 Remove the plastic cap from the Enbrel vial.
• Neħħi t- tapp tal- plastik mill- kunjett taEnbrel.
Do NOT remove the grey stopper or aluminium ring around the top of the vial.  Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Tneħħix it- tapp griż jew iċ- ċirku tal- aluminju ta ’ mad- dawra ta ’ fuq tal- kunjett. • Uża swab bl- alkoħol ġdida biex tnaddaf it- tapp griż tal- kunjett ta ’ Enbrel.
After cleaning, do not touch the stopper with your hands.  Check that a needle is on your syringe; if you are not sure how to attach a needle ask your doctor or nurse.  Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 1).
Terġax tmiss it- tapp griż b’ idejk wara li tkun naddaftu. • Iċċekja li hemm labra fuq is- siringa tiegħek, jekk mintix ċert kif twaħħal il- labra saqsi lit- tabib jew lill- infermier tiegħek. • Neħħi l- għatu tal- labra billi tiġbdu dritt ’ il barra b’ mod sod minn fuq is- siringa u toqgħod attent/ a li ma tmissx il- labra jew tħalli l- labra tmiss kwalunkwe wċuħ (ara Dijagramma 1).
Diagram 1.
267 Dijagramma 1.
 Check your syringe contains 1 ml of water for injections.  If you are not sure how to fill your syringe ask your doctor or nurse.  Make sure your syringe does not contain any air bubbles.  With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
• Ara li s- siringa fiha 1ml ta ’ ilma għall- injezzjonijiet. • Jekk m’ intix żgur kif timla s- siringa tiegħek staqsi lit- tabib jew lill- infermier tiegħek. • Kun żgur li s- siringa ma tkunx fiha bżieżaq ta ’ l- arja. • Bil- kunjett ta ’ Enbrel fuq superfiċje ċatta, bħal per eżempju mejda, daħħal il- labra tas- siringa fiċ - ċirku tan- nofs tat- tapp griż tal- kunjett (ara Dijagramma 2).
If the needle is correctly lined up, you should feel a slight resistance and then a “ pop” as the needle goes through the centre of the stopper.
Jekk il- labra tkun daħlet kif suppost, tħoss daqsxejn reżistenza u mbagħad tfaqqiegħa żgħira malli l- labra tidħol fin- nofs tat- tapp.
Look for the needle tip inside the stopper window (see Diagram 3).
Fittex it- tarf tal- labra mit- tieqa żgħira tat- tapp (ara Dijagramma 3).
If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “ pop”.
Jekk il- labra ma tkunx daħlet sewwa tħoss reżistenza kontinwa u l- ebda ħoss ta ’ tfaqqigħ.
Do not insert the needle at an angle, this may cause the needle to bend and/ or prevent proper addition of the solvent into the vial (see Diagram 4).
Iddaħħalx il- labra b’ mod immejjel, għax dan jista ’ jikkawża li l- labra titgħawweġ u/ jew ma jħallix li s- solvent jinġibed kif suppost fil- kunjett (ara Dijagramma 4).
Diagram 3.
Dijagramma 3.
CORRECT
Fjala
INCORRECT
Labra
Adding water for injections
Iż- żieda ta ’ l- ilma għall- injezzjonijiet
 Push the plunger in VERY SLOWLY until all the water for injections is in the vial.
• Mbotta l- planġer BIL- MOD ĦAFNA sakemm l- ilma għall- injezzjonijiet kollu jidħol ġol - kunjett.
This will help reduce foaming (lots of bubbles) (see Diagram 5).
Dan jgħin biex titnaqqas r- ragħwa (ħafna bżieżaq) (ara Dijagramma 5).
Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6).
Ċaqlaq kemm kemm bil- mod il- gwida għall- preparazzjoni tad- doża f’ ċirku għal ftit drabi biex jinħall it- trab (ara Dijagramma 6).
Do NOT shake the vial.
Iċċaqlaqx bil- qawwi l- gwida għall - preparazzjoni tad- doża.
The solution should be clear and colourless, with no lumps, flakes, or particles.
Is - soluzzjoni għandha tkun ċara u bla kulur, mingħajr ċapep, biċċiet jew frak.
Do NOT use Enbrel if all the powder in the vial is not dissolved within 10 minutes.
268 inħall kollu f’ 10 minuti.
Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
Erġa ’ ibda bi kunjett ġdid ta ’ Enbrel, ilma għall- injezzjonijiet, siringa, labra u swabs.
Diagram 6.
Dijagramma 6.
Withdrawing the Enbrel solution from the vial
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol kunjett
 With the needle still in the vial, hold the vial upside down at eye level.
• Waqt li l- labra tkun għadha fil- kunjett, żomm il- gwida għall- preparazzjoni tad- doża bil- kunjett rasha l- isfel bi dritt għajnejk.
Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 7).
Bil- mod iġbed il- planġer lura biex tiġbed it- taħlita ġos- siringa (ara Dijagramma 7).
As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Kif il- livell tal- likwidu jibda jinżel fil- kunjett, jista ’ jkun li jkollok tiġbed ftit il - labra lura biex b’ hekk il- ponta tal- labra tibqa ’ dejjem fil- likwidu.
For adult patients, withdraw the entire volume.
Għall- pazjenti adulti iġbed il - volum kollu.
For children, remove only the portion of liquid as directed by your child’ s doctor.
Għat- tfal iġbed biss dak l- ammont tal- likwidu li jkun ordnalek it- tabib tat- tifel/ tifla tiegħek.
280 Diagram 7.
Dijagramma 7.
 With the needle still inserted in the vial, check the syringe for air bubbles.
• Waqt li l- labra tkun għadha fil- kunjett iċċekja s- siringa għal xi bżieżaq ta ’ l- arja.
Slowly press the plunger to push bubbles out of the syringe and into the vial.
Bil- mod taptap is - siringa biex xi bżieżaq jitilgħu lejn in- naħa ta ’ fuq tas- siringa, ħdejn il- labra (ara Dijagramma 8 Agħfas il- planġer bil- mod biex tagħfas il- bżieżaq baraa mis- siringa għal ġol- kunjett.
Diagram 8.
269 Dijagramma 8
 Pull the needle completely out of the vial.
• Iġbed il- labra kompletament minn ġol- kunjett.
Again, do not touch the needle or allow it to touch any surface.
Għal darb’ oħra, tmissx il- labra u lanqas ħalliha tmiss ma ’ xi oġġett.
This is normal.)
Din hi ħaġa normali.)
 The three recommended injection sites for Enbrel include:
It- tliet siti rakkomandati għall- injezzjoni ta ’ Enbrel jinkludu:
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
(1) in- naħa ta ’ quddiem tan- naħa tan - nofs tal- koxox; (2) iż- żaqq, ħlief għaż- żona ta ’ 5 ċm madwar iż- żokra; u (3) in- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn (ara Dijagramma 9).
If you are self injecting, you should not use the outer area of the upper arms..
Jekk tkun qed tagħti l- injezzjoni lilek innifsek, m’ għandekx tuża n- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn.
281 Diagram 9.
Dijagramma 9
 A different site should be used for each new injection.
• Għal kull injezzjoni għandek tuża sit ġdid.
With the other hand, hold the syringe like a pencil.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 10).
270 • B’ moviment mgħaġġel u qasir, imbotta l- labra ’ l isfel kemm tista ’ ġol- ġilda f’ angolu bejn 45° u 90° (ara Dijagramma 10).
Be careful not to push the needle into the skin too slowly, or with great force.
Oqgħod attent/ a li ma timbuttax il- labra ġol- ġilda bil- mod wisq, jew bis - saħħa ħafna.
Diagram 10.
Dijagramma 10
 When the needle is completely inserted into the skin, release the skin that you are holding.
• Meta l- labra tkun iddaħħlet kompletament ġol- ġilda, erħi l- ġilda li tkun qed iżżomm.
Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Imbagħad imbotta l- planġer biex tinjetta s- soluzzjoni kollha b’ rata kostanti u bil- mod, u fissa (ara Dijagramma 11).
282 Diagram 11
Dijagramma 11
 When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was when it was inserted.
• Meta s- siringa tiżvojta, oħroġ il- labra mill- ġilda waqt li toqgħod attent li tibqa ’ żżommha angolata kif kienet meta daħħaltha.
 Press a cotton ball over the injection site for 10 seconds.
• Agħfas tajjara fuq is- sit fejn tajt l- injezzjoni għal 10 sekondi.
Disposing of supplies
Kif tiddisponi mill- oġġetti wżati għall- injezzjoni.
283 PACKAGE LEAFLET:
271 FULJETT TA ’ TAGĦRIF:
Enbrel 25 mg powder and solvent for solution for injection Etanercept
Etanercept
Instructions for preparing and giving an injection of Enbrel (See overleaf)
Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ Enbrel (Ara l- folja ta 'wara)
For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities.
Għal pazjenti li għandhom atrite psorjatika b’ involviment f’ ħafna tal- ġogi, Enbrel jista ’ jtejjeb il- ħila tiegħek biex twettaq l- attivitajiet normali ta ’ kuljum.
For patients with multiple symmetrical painful or swollen joints (e. g. hands, wrists and feet), Enbrel can slow down the structural damage to those joints caused by the disease.
Għal pazjenti li għandhom ħafna mill - ġogi multipli u simmetriċi li juġgħuhom jew li jkunu minfuħin (eż. l- idejn, il- polz u s- saqajn), Enbrel jgħin biex il- ħsara strutturali kkawżata mill- marda lil dawk il- ġogi ssir aktar bil- mod.
284  Polyarticular juvenile idiopathic arthritis (a type of juvenile arthritis that affects many joints) in patients from the age of 4 years who have had an inadequate response to (or are unable to take) methotrexate.
• Artrite idjopatika ġuvenili poliartikulari (tip ta ’ artrite ġuvenili li taffettwa ħafna ġogi) f’ pazjenti mill- età ta ’ 4 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) methotrexate.
 Severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take), phototherapies or other systemic therapies.
272 • Psorjasi severa f’ pazjenti mill- età ta ’ 8 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Enbrel.  Infections/ diabetes:
Jekk int jew it- tifel/ tifla tiżviluppaw xi infezzjoni ġdida, jew ser ikollok intervent kirurġiku maġġur, it- tabib tiegħek għandu mnejn ikun jixtieq jissorvelja t - trattament tiegħek b' Enbrel. • Infezzjonijiet/ dijabete:
Tell your doctor if you or the child have a history of recurrent infections, or suffer from diabetes or other conditions that increase the risk of infection.  Infections/ monitoring:
Għid lit- tabib tiegħek jekk int jew t- tfal għandkom storja ta 'infezzjonijiet rikorrenti, jew tbatu mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.  Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Fittex għal parir mediku minnufih jekk inti jew it- tifel/ tifla tiegħek għandkom xi sinjali jew sintomi bħal ta 'deni persistenti, uġigħ fil- griżmejn, tbenġil, fsada jew sfurija.
Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Għid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek għandkom is- sklerożi multipla, newrite ottika (infjammazzjoni tan- nervi ta 'l- għajnejn) jew majlite trasversali (infjammazzjoni tal- korda spinali).
Your doctor will determine if Enbrel is an appropriate treatment.  Congestive heart failure:
273 • Insuffiċjenza tal- qalb konġestiva:
Tell the doctor or pharmacist if you or the child are taking or have recently taken any other medicines, even those not prescribed by the doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jew tat- tfal tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If the patient becomes pregnant, you should consult the patient's doctor.
Jekk il- pazjent tinqabad tqila, inti għandek tikkonsulta t- tabib tal- pazjenta.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or doctor or pharmacist.
Jekk inti tħoss li l- effett ta 'Enbrel huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill - ispiżjar tiegħek dwar dan.
286 Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
274 Inkella, 50 mg jistgħu jingħataw darbtejn fil- ġimgħa sa 12- il ġimgħa, segwiti minn 25 mg mogħtija darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
287 Other side effects that are not listed in this leaflet may occur.
275 Jista ’ jkun hemm xi effetti sekondarji, li m’ humiex imniżżla f’ dan il- fuljett.
If you notice any of the following, you or the child may need urgent medical attention.
Jekk tinduna b' xi wieħed minn dawn li ġejjin, inti jew it- tifel/ tifla tiegħek għandkom mnejn ikollkom bżonn l- attenzjoni medika minnufih.
 Rare (may occur in less than 1 in 1,000 patients): serious allergic reactions (including severe localized swelling of the skin and wheezing); combined low platelet, red, and white blood cell count; nervous system disorders (with signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; worsening congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); inflammation of the blood vessels; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; elevated liver blood tests; skin rash which may lead to severe blistering and peeling of the skin..
276 • Rari (jistgħu jseħħu f' inqas minn 1 f' 1, 000 pazjent): reazzjonijiet allerġiċi serji (li jinkludu tinfih lokalizzat qawwi tal- ġilda u tħarħir); għadd baxx ta ’ plejtlets, taċ- ċelloli ħomor u ċ- ċelloli bojod; disturbi tas- sistema nervuża (b' sinjali u sintomi simili għal dawk ta 'sklerożi multipla jew infjammazzjoni tan- nervi ta' l- għajnejn jew l- korda spinali); tuberkolożi; tiħżin tal- insuffiċjenza konġestiva tal- qalb, aċċessjonijiet, sindromu ta 'lupus jew bħal ta' lupus (sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil- ġogi u għejja); infjammazzjoni tal- kanali tad- demm; għadd totali baxx taċ- ċelloli ħomor tad- demm, għadd baxx totali taċ- ċelloli bojod tad- demm, għadd baxx ta 'newtrofili (tip ta' ċelloli bojod tad- demm); l- enżimi tal- fwied fid- demm ikunu ogħla; raxx tal - ġilda li jista ’ jwassal għal infafet u tqaxxir sever tal- ġilda.
Store in a refrigerator (2 – 8 C).
Aħżen fi friġġ (2°C – 8°C).
Do not use if you notice the solution is not clear or contains particles.
Tużax Enbrel jekk tinduna li s- soluzzjoni mhix ċara jew fiha l- frak.
Medicines should not be disposed of via waster water or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Kull kunjett ta 'Enbrel 25 mg fiha 25 mg ta' etanercept.
289 What Enbrel looks like and contents of the pack
Id- dehra ta 'ENBREL u l- kontenuti tal- pakkett
Not all pack sizes may be marketed.
Kull pakkett fih 4, 8 jew 24 kunjett ta ’ doża waħda kull wieħed, 4, 8 jew 24 siringa mimlija għal- lest bl- ilma għall - injezzjonijiet, 4, 8 jew 24 labra, 4, 8 jew 24 adaptors tal- fjali u 8, 16 jew 48 swabs għal qabel l - injezzjoniJista ’ jkun li mhux tal- pakketti tad- daqsijiet kollha ikunu għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer
277 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
España Wyeth Farma S. A.
278 España Wyeth Farma S. A.
Setting up for an injection c.
Kif tlesti għall- injezzjoni c.
Preparing the Enbrel dose for injection d.
Kif tipprepara d- doża ta 'Enbrel għall- injezzjoni d.
Placing the needle on the syringe g.
It- tqegħid tal- labra fuq is- siringa g.
Choosing an injection site h.
Kif tagħżel is- sit ta 'l- injezzjoni h.
Preparing the injection site and injecting the Enbrel solution i.
Kif tipprepara s- sit ta 'l- injezzjoni u tinjetta s- soluzzjoni ta' Enbrel i.
291  The dose tray should contain the items listed below.
• Aħsel idejk sewwa. • Agħżel superfiċje ċatta, nadifa u mdawwla fejn tipprepara l- injezzjoni. • It- trej tad- doża għandu jkollu dawn l- oġġetti ndikati f’ din il- lista ta ’ hawn taħt.
1 Enbrel vial 1 Pre-filled syringe containing clear, colourless solvent (water for injections) 1 Needle 1 Vial adaptor 2 Alcohol swabs  Inspect the expiry dates on both the vial label and the syringe label.
Il- kunjett ta ’ Enbrel Siringa mimlija għal- lest li fiha solvent ċar u bla kulur (ilma għall- injezzjonijiet) Labra Adaptor tal- kunjett Żewġ swabs bl- alkoħol • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- kunjett kif ukoll it- tiketta tas- siringa.
Diagram 1.
• Neħħi l- oġġetti minn ġot- trej. • Neħħi l- għatu tal- plastik mill- kunjett ta ’ Enbrel (ara Dijagramma 1).
 Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
• Uża swab ġdida bl- alkoħol biex tnaddaf it- tapp il- griż tal- kunjett ta ’ Enbrel.
After cleaning, do not touch the stopper with your hands or allow it to touch any surface.  Place the vial upright on a clean, flat surface.  Remove the paper backing from the vial adaptor package.  While still in the plastic package, place the vial adaptor on top of the Enbrel vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper (see Diagram 2).  Hold the vial firmly on the flat surface with one hand.
Wara li tkun naddaft it- tapp il- griż, terġax tmissu b’ idejk jew tħallihx imiss ma xi ħaġa oħra. • Poġġi l- kunjett f’ pożizzjoni wieqfa fuq superfiċje ċatta u nadifa. • Meħħi l- karta li hemm fuq wara ta ’ pakkett ta ’ l- adaptor tal- kunjett. • Kif ikun għadu fil- pakkett tal- plastik, poġġi l- adaptor tal- kunjett fuq il- kunjett ta ’ Enbrel biex il - ponta ta ’ l- adaptor tal- kunjett jinsab iċċentrat biċ- ċirku mgħolli fuq l- istopper tal- kunjett (ara Dijagrama 2). • Żomm il- fjala b’ id waħda fis- sod fuq is- superfiċje ċatta.
With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE (see Diagram 3).
B’ idejk l- oħra, agħfas fis- sod fuq l - adaptor sakemm tħoss li l- adaptor ippenetra t- tapp tal- fjala u TĦOSS U TISMA R- RIM LOCK TA ’ L- ADAPTOR JIDĦOL F’ POSTU (ara Dijagramma 3).
DO NOT push down the adaptor at an angle (see Diagram 4).
TIMBUTTAX l- adapter ‘ l isfel f’ anglu (ara Dijagramma 4).
It is important that the vial adaptor spike completely penetrates the vial stopper.
Hu importanti li l- ponta ta ’ l- adaptor tippenetra kompletament l- istopper tal- kunjett.
Diagram 2.
Djiagramma 2.
CORRECT
KORRETT
INCORRECT
INKORETT
 While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
• Waqt li żżomm il- kunjett f’ id waħda, neħħi il- pakkett tal- plastik mill- adaptor tal- kunjett (ara Dijagramma 5).
292 Diagram 5.
Dijagramma 5.
 Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
• Neħħi l- għatu protettiv mill- ponta tas- siringa billi tkisser il- kappa l- bajda mal- perforazzjoni.
Diagram 6.
Dan isir billi żżomm l- għonq tal- kappa l- bajda filwaqt li taqbad it- tarf tal- kappa l- bajda bl- id l - oħra u tgħawwiġha ‘ l isfel sakemm tinkiser (ara Dijagramma 6).
 Do not use the syringe if this perforation is already broken.
Erġa ’ ibda mill- ġdid billi tuża trej tad- doża ieħor.
Start again with another dose tray.  Holding the glass barrel of the syringe (not the white collar) in one hand, and the vial adaptor (not the vial) in the other, connect the syringe to the vial adaptor by inserting the tip into the opening and turn clockwise until completely secured (see Diagram 7).
Filwaqt li żżomm il- bittija tal- ħġieġ tas- siringa (mhux l- għonq abjad) f’ id waħda, u l- adapter tal- kunjett (mhux il- kunjett) fl- oħra, waħħal is- siringa ma ’ l- adaptor tal- kunjett billi ddaħħal il- ponta fil- fetħa u ddawwar skond kif jimxi l- arloġġ sakemm ikun kompletament magħluq (ara Dijagramma 7)
Diagram 7.
Dijagramma 7.
 While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial.
(ara Dijagramma 8). • Kif tkun lestejt iż- żieda tas- solvent ma ’ Enbrel, il- planġer jista ’ jitla ’ ’ l fuq waħdu.
This will help to reduce foaming (lots of bubbles) (see Diagram 8).  Once the solvent is added to the Enbrel, the plunger may move up by itself.
Dijagramma 8.
 With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder (see Diagram 9).
• Bis- siringa għadha mwaħħla, ċaqlaq kemm kemm bil- mod il- kunjett f’ ċirku għal ftit drabi biex jinħall it- trab. jinħall (ara Dijagramma 9).
Do NOT shake the vial.
Iċċaqlaqx bil- qawwi l- kunjett.
Wait until all the powder dissolves (usually less than 10 minutes).
Stenna sakemm jinħall it - trab kollu (ġeneralment inqas minn 10 minuti).
Diagram 9.
282 Dijagramma 9.
 With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
• Bis- siringa għadha mwaħħla mal- kunjett u l- adaptor tal- kunjett, aqleb il- kunjett rasha ’ l isfel għall - livell t’ għajnejk.
Push the plunger all the way into the syringe (see Diagram 10).
Imbotta l- plunġer kollu ġos- siringa (ara Dijagramma 10).
 Then, slowly pull the plunger back to draw the liquid into the syringe (see Diagram 11).
• Imbagħad, bil- mod iġbed il- planġer lura biex tiġbed il- likwidu fis- siringa (ara Dijagramma 11).
For adult patients, withdraw the entire volume.
Għall- pazjenti adulti iġbed il- volum kollu.
For children, remove only the portion of liquid as directed by your child’ s doctor.
Għat- tfal iġbed biss dak l- ammont li jkun ordnalek it - tabib tat- tifel/ tifla tiegħek.
After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Wara li tkun ġbidt Enbrel minn ġol- kunjett, jista ’ jkun li jibqa ’ xi arja fis- siringa.
Do not be concerned, as you will remove the air in a later step.
M’ hemmx għalfejn tinkwieta għaliex l- arja titneħħa f’ pass aktar ’ l quddiem.
294 Diagram 11.
Dijagramma 11.
 With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti- clockwise (see Diagram 12).
• Bil- kunjett rasha ‘ l isfel, ħoll is- siringa mill- adapter tal- kunjett billi ddawwarha fid- direzzjoni ta ’ dawran xellugi (ara Dijagramma 12).
Diagram 12.
Dijagramma 12.
 Place the filled syringe on the clean, flat surface.
• Qiegħed is- siringa mimlija fuq is- superfiċje ċatta u nadifa.
Make sure that the tip does not touch anything.
Ara li l- ponta ma tmiss ma ’ xejn.
Be careful not to push down on the plunger.
Oqgħod attent li ma timbuttax il- planġer ’ l isfel.
(Note:
283 (Nota:
Placing the needle on the syringe
It- tqegħid tal- labra fuq is- siringa
 The needle has been placed in a plastic container to keep it sterile.  To open the plastic container, hold the short, wide end in one hand.
• Il- labra ġiet imqegħda f’ kontenitur tal- plastik biex iżżommha sterelizzata. • Biex tiftaħ il- kontenitur tal- plastik, żomm in- naħa l- qasira u wiesgħa f’ id waħda.
Place your other hand on the longer portion of the container.  To break the seal, bend the larger end down and then up until broken (see Diagram 13).
Poġġi idejk l- oħra fuq il- parti t- twil tal- kontenitur. • Biex taqsam is- siġill, għawweġ it- tarf it- twil ’ l fuq u ’ l isfel sakemm jinqasam (ara Dijagramma 13).
Diagram 13.
Dijagramma 13.
 Once the seal has been broken, remove the short, wide end of the plastic container.  The needle will remain in the long part of the package.  While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.  Attach the syringe to the needle by turning it clockwise until completely secured (see Diagram 14).
• Meta tkisser is- siġġill, neħħi t- tarf il- qasir u wiesgħa tal- kontejner tal- plastik, • Il- labra tibqa ’ fil- parti t- twila tal- pakkett. • Waqt li żżomm il- labra u l- kontenitur f’ id waħda, erfa s- siringa u daħħal it- tarf tas- siringa fil- fetħa tal- labra. • Waħħal is- siringa mal- labra billi ddawwar skond kif jimxi l- arloġġ sakemm tkun kompletament magħluqa (ara Dijagramma 14).
295 Diagram 14.
Dijagramma 14.
 Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
• Neħħi l- għatu tal- labra billi tiġbdu dritt ’ il barra b’ mod sod minn fuq is- siringa u toqgħod attent/ a li ma tmissx il- labra jew tħalli l- labra tmiss kwalunkwe wċuħ (ara Dijagramma 15).
Diagram 15.
Dijagramma 15.
Diagram 16.
• Waqt li żżomm is- siringa ’ l fuq, neħħi xi bżieżaq ta ’ l- arja billi timbotta bil- mod il- planġer sakemm titneħħa l- arja (ara Dijagramma 16).
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
(1) in- naħa ta ’ quddiem tan- naħa tan- nofs tal- koxox; (2) iż- żaqq, ħlief għaż- żona ta ’ 5 ċm madwar iż- żokra; u (3) in- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn (ara Dijagramma 17).
296 Diagram 17.
Dijagramma 17.
 A different site should be used for each new injection.
Għal kull injezzjoni għandek tuża sit ġdid.
DO NOT inject into areas where the skin is tender, bruised, red, or hard.
TINJETTAX f’ postijiet fejn il- ġilda hija tenera, mbenġla, ħamra jew iebsa.
Avoid areas with scars or stretch marks.
Evita żoni li jkun fihom ċikatriċi jew marki jew sinjali ta ’ ġbid fil - ġilda.
(It may be helpful to keep notes on the location of the previous injections.)  If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
(Tista ’ tkun ta ’ għajnuna jekk iżżomm kont tal- postijiet fejn jingħataw l- injezzjonijiet ta ’ qabel.) • Jekk inti jew it- tifel/ tifla għandkom il- psorjasi, m’ għandekx tinjetta direttament ġo kwalunkwe rqajja ’ tal- ġilda li jkunu mtellgħin, ħoxnin, ħomor, jew bil- qxur (“ leżjonijiet tal- psorjasi fil - ġilda ”).
With the other hand, hold the syringe like a pencil.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
Bl- id l- oħra, żomm is- siringa bħal lapes. • B’ moviment mgħaġġel u qasir, imbotta l- labra ’ l isfel kemm tista ’ ġol- ġilda f’ angolu bejn 45° u 90° (ara Dijagramma 18).
Diagram 18.
285 Dijagramma 18.
Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
Imbagħad imbotta l - planġer biex tinjetta s- soluzzjoni kollha b’ rata kostanti u bil- mod, u fissa (ara Dijagramma 19).
297 Diagram 19.
Dijagramma 19
 When the syringe is empty, remove the needle from the skin; being careful to keep it at the same angle it was when it was inserted.  Press a cotton ball over the injection site for 10 seconds.
• Meta s- siringa tiżvojta, oħroġ il- labra mill- ġilda waqt li toqgħod attent li tibqa ’ żżommha angolata kif kienet meta daħħaltha. • Agħfas tajjara fuq is- sit fejn tajt l- injezzjoni għal 10 sekondi.
 The syringe and needles should NEVER be re-used.
• Is- siringa u l- labra qatt m’ għandhom jerġgħu jintużaw.
Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
Iddisponi mill- labra u s- siringa skond kif jgħidlek it- tabib, l- infermier jew l- ispiżjar.
298 PACKAGE LEAFLET:
286 FULJETT TA ’ TAGĦRIF:
Enbrel 50 mg powder for solution for injection Etanercept
Enbrel 50 mg trab għal soluzzjoni għall- injezzjoni. etanercept
You may need to read it again.  Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Jista jkollok bżonn terġa ’ taqrah. • It- tabib tiegħek ser jagħtik ukoll Patient Alert Card, li fiha informazzjoni importanti dwar is - sigurtà li inti jeħtieġ li tkun taf dwarha qabel u matul il- kura b’ Enbrel. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
Do not pass it on to others.
Tagħtihiex lil persuni oħra.
It may harm them, even if their symptoms are the same as yours.  If you are concerned about any side effect, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk inti imħasseb dwar xi effetti sekondarji, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew spiżjar tiegħek.
Enbrel is also prescribed for the treatment of severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Enbrel jingħata wkoll b’ riċetta għall- kura ta ’ psorjasi severa f’ pazjenti mill- età ta ’ 8 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
299 Enbrel is not effective in the treatment of Wegener’ s granulomatosis, a rare inflammatory disease.
Enbrel mhux effettiv għat- trattament tal- granulomatosi ta 'Wegener, marda infjammatorja rari.
If you have Wegener’ s granulomatosis talk to your doctor.
Jekk int jew it- tifel/ tifla tiegħek għandhom il- granulomatosi ta 'Wegener kellem lit- tabib tiegħek.
2.
287 2.
If you are allergic to etanercept or any of the other ingredients of Enbrel.
Jekk int allerġiku/ a għal etanercept jew xi wieħed mis- sustanzi ta 'Enbrel.
If you experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.  Serious blood infection:
Jekk inti jkollok reazzjonijiet allerġiċi bħal għafis tas- sider, tħarħir, sturdamenti jew raxx, tinjettax aktar Enbrel, u kkuntattja lit- tabib tiegħek minnufih. • Infezzjoni serja tad- demm:
If you have or are at risk of developing a serious blood infection called sepsis.
Jekk int għandek jew tinsab f' riskju li tiżviluppa infezzjoni tad - demm serja li tissejjaħ sepsis.
If you have an infection of any kind.
Jekk int għandek xi infezzjoni ta 'kwalunkwe tip.
If you develop a new infection, or are about to have any major surgery, your doctor may wish to monitor your treatment with Enbrel.  Infections/ diabetes:
Jekk int tiżviluppa xi infezzjoni ġdida, jew ser ikollok intervent kirurġiku maġġur, it- tabib tiegħek għandu mnejn ikun jixtieq jissorvelja t- trattament tiegħek b' Enbrel. • Infezzjonijiet/ dijabete:
Tell your doctor if you have a history of recurrent infections, or suffer from diabetes or other conditions that increase the risk of infection.  Infections/ monitoring:
Għid lit- tabib tiegħek jekk int għandek storja ta 'infezzjonijiet rikorrenti, jew tbatu mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
Your doctor may decide to continue to monitor you for the presence of infections after you stop using Enbrel.  Tuberculosis:
It- tabib tiegħek jista ’ jiddeċiedi li jkompli jimmonitorja lilek jew lit- tifel/ tifla tiegħek għall- preżenza ta ’ infezzjonijiet wara li inti jew it- tifel/ tifla tieqfu tużaw Enbrel. • Tuberkulosi:
It is very important that you tell your doctor if you have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Hu importanti ħafna li tgħid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek qattx kellkom it - tuberkulosi, jew kontu qrib ta ’ xi ħadd li kellu t- tuberkulosi.
Your doctor may decide to test for the presence of hepatitis B infection before you begin treatment with Enbrel.  Hepatitis C:
It- tabib tiegħek jista ’ jiddeċiedi li jagħmel test għall- preżenza ta ’ infezzjoni ta ’ epatite B qabel int jew it- tifel/ tifla tiegħek tibdew il- kura b’ Enbrel. • Epatite Ċ:
Tell your doctor if you have hepatitis C.
Għid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek għandkom epatite Ċ.
Seek medical advice immediately if you have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Fittex għal parir mediku minnufih jekk inti għandek xi sinjali jew sintomi bħal ta 'deni persistenti, uġigħ fil- griżmejn, tbenġil, fsada jew sfurija.
Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.  Nervous system and eye disorders:
Sintomi bħal dawn jistgħu jindikaw eżistenza ta 'disturbi tad- demm li jistgħu jkunu ta' periklu għal ħajja, li jistgħu jinħtieġu li jitwaqqaf Enbrel. • Disturbi tas- sistema nervuża u ta 'l- għajnejn:
Tell your doctor if you have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Għid lit- tabib tiegħek jekk inti għandek is - sklerożi multipla, newrite ottika (infjammazzjoni tan- nervi ta 'l- għajnejn) jew majlite trasversali (infjammazzjoni tal- korda spinali).
Tell your doctor if you have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.  Vaccinations:
Għid lit- tabib tiegħek jekk int għandek storja ta 'insuffiċjenza tal- qalb konġestiva, peress li Enbrel jeħtieġ li jintuża b' kawtela f' dawn iċ - ċirkostanzi. • Vaċċinazzjonijiet:
Please consult your doctor before you receive any vaccines.  Chickenpox:
Jekk jogħġbok ikkonsulta mat- tabib qabel ma int tiirċievi xi vaċċinazzjonijiet. • Ġidri r- riħ:
Tell your doctor if you are exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk inti espost għal ġidri r- riħ meta tieħu Enbrel.
300 Taking other medicines
288 Meta tuża mediċini oħra
Tell the doctor or pharmacist if you are taking, or have recently taken any other medicines, even those not prescribed by the doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You should not use Enbrel with medicines that contain the active ingredients anakinra or abatacept..
M' ghandekx tuza Enbrel ma 'medicini li fihom is- sustanzi attivi anakinra jew abatacept.
If you become pregnant, you should consult your doctor.
Jekk il- pazjent tinqabad tqila, inti għandek tikkonsulta t- tabib tiegħek.
You have been prescribed a 50 mg strength of Enbrel.
Int ġejt preskritt qawwa ta ’ 50 mg ta ’ Enbrel.
A 25 mg strength of Enbrel is available for doses of 25 mg (or less).
Qawwa ta ’ 25 mg hija disponibbli għal dożi ta ’ 25 mg (jew anqas).
Dosing for adult patients (age 18 years or older)
Doża għal pazjenti adulti (ta '18- il sena jew aktar)
301 Dosing for children and adolescents
289 Doża għat- tfal u l- adoloxxenti
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU 4.
Other side effects that are not listed in this leaflet may occur.
Jista ’ jkun hemm xi effetti sekondarji, li m’ humiex imniżżla f’ dan il- fuljett.
If you are concerned about any side effects, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
Jekk inti imħasseb dwar xi effetti sekondarji, jew jekk tinduna b’ xi effetti sekondarji li m' humiex elenkati f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew l- ispiżjar tiegħek.
 Trouble swallowing or breathing.  Swelling of the face, throat, hands, or feet.
• Jekk issib problemi biex tibla jew tieħu n- nifs. • Jekk il- wiċċ, il- ġriżmejn, l- idejn jew is- saqajn jintefħu. • Tħossok nervuż/ a jew anzjuż/ a, sensazzjonijiet ta 'taħbit il- qalb, ħmura f' daqqa fil- ġilda u/ jew sensazzjoni ta ’ sħana.
302  Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/ or a warm feeling.  Severe rash, itching, or hives (elevated patches of red or pale skin that often itch).
290 • Raxx, ħakk jew ħurrieqa qawwija (rqajja 'elevati ta' ġilda ħamra jew pallida li xi kultant iġġagħlek tħokk).
If you notice any of the following, you may need urgent medical attention.
Jekk tinduna b' xi wieħed minn dawn li ġejjin, inti għandu mnejn ikollok bżonn l- attenzjoni medika minnufih.
 Uncommon (may occur in less than 1 in 100, but more than 1 in 1,000 patients): serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); localized swelling of the skin (angioedema); low blood platelet count; hives (elevated patches of red or pale skin that often itch); psoriasis; rash; inflammation or scarring of the lungs.
• Mhux komuni (jistgħu jseħħu f' inqas minn 1 f' 100, imma aktar minn 1 f' 1, 000 pazjent): infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet fil- fond tal- ġilda, infezzjonijiet tal - ġog, infezzjoni tad- demm, u infezzjonijiet f' siti differenti); nefħa lokalizzata tal- ġilda (anġjoedema); għadd baxx ta 'plejtlets fid- demm; ħorriqija (irqajja' elevati ta 'ġilda ħamra jew pallida li ħafna drabi iqabduk il- ħakk); psorjasi; raxx; infjammazzjoni jew ċikatriċi tal- pulmun.
 Rare (may occur in less than 1 in 1,000 patients): serious allergic reactions (including severe localized swelling of the skin and wheezing); combined low platelet, red, and white blood cell count; nervous system disorders (with signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; worsening congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); inflammation of the blood vessels; low red blood cell count, low white blood
• Rari (jistgħu jseħħu f' inqas minn 1 f' 1, 000 pazjent): reazzjonijiet allerġiċi serji (li jinkludu tinfih lokalizzat qawwi tal- ġilda u tħarħir); għadd baxx ta ’ plejtlets, taċ- ċelloli ħomor u ċ- ċelloli bojod; disturbi tas- sistema nervuża (b' sinjali u sintomi simili għal dawk ta 'sklerożi multipla jew infjammazzjoni tan- nervi ta' l- għajnejn jew l- korda spinali); tuberkolożi; tiħżin tal- insuffiċjenza konġestiva tal- qalb, aċċessjonijiet, sindromu ta 'lupus jew bħal ta' lupus (sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil- ġogi u għejja); infjammazzjoni tal- kanali tad- demm; għadd totali baxx taċ- ċelloli ħomor tad- demm, għadd baxx totali taċ- ċelloli bojod tad- demm, għadd baxx ta 'newtrofili (tip ta' ċelloli bojod tad- demm); l- enżimi tal- fwied fid- demm ikunu ogħla; raxx tal - ġilda li jista ’ jwassal għal infafet u tqaxxir sever tal- ġilda.
 Not known: excessive activation of white blood cells associated with inflammation (macrophage activation syndrome).
291 • Mhux magħrufa: attivazzjoni eċċessiva ta ’ ċelluli bojod tad- demm assoċjati ma ’ infjammazzjoni (sindrome ta ’ l- attivazzjoni tal- makrofagu).
Each vial of Enbrel 50 mg contains 50 mg of etanercept.
Kull kunjett ta 'Enbrel 50 mg fiha 50 mg ta' etanercept.
Enbrel 50 mg is supplied as a white powder for solution for injection.
Enbrel 50 mg jiġi bħala trab abjad għal soluzzjoni għall- injezzjoni.
Each pack contains 2, 4 or 12 single dose vials and 4, 8 or 24 alcohol swabs.
Kull pakkett fih 2, 4 jew 12- il kunjett ta ’ doża waħda kull wieħed, 4, 8 jew 24 swabs ta ’ l- alkoħol.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għall- skop kummerċjali.
304 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Ireland Wyeth Pharmaceuticals Tel: + 353 1 449 3500 Fax: + +353 1 449 3522
Fax: + 353 1 449 3522 292
Deutschland Wyeth Pharma GmbH Tel: + 49 180 2 29 93 84 Fax: +49 251 204 1128
Kύπρος Deutschland Wyeth Pharma GmbH
България / Eesti/ Latvija/ Lietuva/ Österreich/ România/ Slovenija Wyeth-Lederle Pharma GmbH Tel/ Tãlr: +43 1 89 1140 Факс / Faks/ Fakss/ Faksas/ Fax: +43 1 89 114600
България/ Eesti/ Latvija/ Lietuva / Österreich/ România/ Slovenija Wyeth- Lederle Pharma GmbH Tel/ Tãlr: +43 1 89 1140 Факс/ Faks/ Fakss/ Faksas/ Fax: +43 1 89 114600
7.
293 7.
Withdrawing the Enbrel solution from the vial f.
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol fjala f.
Choosing an injection site g.
Kif tagħżel is- sit ta 'l- injezzjoni g.
You will be instructed by your doctor or his/ her assistant on the techniques of self-injection.
Inti ser tkun mgħallem mit- tabib tiegħek jew l - assistent tiegħu/ tagħha kif għandek tinjetta lilek innifsek jew kif tinjetta lit- tifel/ tifla tiegħek.
 Wash your hands thoroughly.  Select a clean, well-lit, flat working surface.  Take the ENBREL vial out of the refrigerator and place it on a flat surface.  You will also need the following items:
• Aħsel idejk sew. • Agħżel superfiċje ċatta, nadifa u mdawwla fejn tipprepara l- injezzjoni. • Oħroġ il- fjala ta ’ ENBREL minn ġol- friġġ u poġġiha fuq is- superfiċje ċatta. • Ikollok bżonn ukoll ta ’ dawn l- oġġetti:
A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs  Inspect the expiry dates on both the Enbrel vial label and the water for injections.
Siringa sterili u labra (labar) ta ’ 25 guage X 16 mm jew simili Fjala jew ampulla ta ’ ilma għall- injezzjonijiet 2 swabs bl- alkoħol • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- fjala kif ukoll it- tiketta tas- siringa.
306 c.
ċ.
 Remove the plastic cap from the Enbrel vial.
• Neħħi t- tapp tal- plastik mill- fjala taEnbrel.
Do NOT remove the grey stopper or aluminium ring around the top of the vial.  Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Tneħħix it- tapp griż jew iċ- ċirku tal- aluminju ta ’ mad - dawra ta ’ fuq tal- fjala. • Uża swab bl- alkoħol ġdida biex tnaddaf it- tapp griż tal- fjala ta ’ Enbrel.
Diagram 1.
294 Dijagramma 1.
 Check your syringe contains 1 ml of water for injections.  If you are not sure how to fill your syringe ask your doctor or nurse.  Make sure your syringe does not contain any air bubbles.  With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
• Ara li s- siringa fiha 1ml ta ’ ilma għall- injezzjonijiet. • Jekk m’ intix żgur kif timla s- siringa tiegħek staqsi lit- tabib jew lill- infermier tiegħek. • Kun żgur li s- siringa ma tkunx fiha bżieżaq ta ’ l- arja. • Bil- fjala ta ’ Enbrel fuq superfiċje ċatta, bħal per eżempju mejda, daħħal il- labra tas- siringa fiċ - ċirku tan- nofs tat- tapp griż tal- fjala (ara Dijagramma 2).
This will help reduce foaming (lots of bubbles) (see Diagram 5).
• Mbotta l- planġer BIL- MOD ĦAFNA sakemm l- ilma għall- injezzjonijiet kollu jidħol ġol- fjala.
Diagram 5.
Dan jgħin biex titnaqqas r- ragħwa (ħafna bżieżaq) (ara Dijagramma 5).
Some white foam may remain in the vial - this is normal.
Jista ’ jkun li jibqa ’ xi ftit ragħwa bajda fil- fjala – dawn huwa normali.
Do NOT use Enbrel if all the powder in the vial is not dissolved within 10 minutes.
Tużax Enbrel jekk it- trab fil- fjala ma jkunx inħall kollu f’ 10 minuti.
Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
Erġa ’ ibda bi fjala ġdid ta ’ Enbrel, ilma għall- injezzjonijiet, siringa, labra u swabs.
Withdrawing the Enbrel solution from the vial
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol fjala
 With the needle still in the vial, hold the vial upside down at eye level.
• Waqt li l- labra tkun għadha fil- fjala, żomm il- gwida għall- preparazzjoni tad- doża bil- fjala rasha l - isfel bi dritt għajnejk.
As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Kif il- livell tal- likwidu jibda jinżel fil- fjala, jista ’ jkun li jkollok tiġbed ftit il- labra lura biex b’ hekk il- ponta tal- labra tibqa ’ dejjem fil- likwidu.
Withdraw the entire volume.
Oħroġ il- likwidu kollu.
308  With the needle still inserted in the vial, check the syringe for air bubbles.
• Waqt li l- labra tkun għadha fil- fjala iċċekja s- siringa għal xi bżieżaq ta ’ l- arja.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
Bil- mod taptap is - siringa biex xi bżieżaq jitilgħu lejn in- naħa ta ’ fuq tas- siringa, ħdejn il- labra (ara Dijagramma 8).
Slowly press the plunger to push bubbles out of the syringe and into the vial.
Agħfas il- planġer bil- mod biex tagħfas il- bżieżaq baraa mis- siringa għal ġol- fjala.
When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Waqt li qed tagħmel dan, jekk aċċidentalment jerġa jidħol xi likwidu fil- fjala, erġa ’ iġbed il- planġer biex terġa ’ ddaħal il- likwidu fis- siringa.
 Pull the needle completely out of the vial.
Dijagramma 8 296 • Iġbed il- labra kompletament minn ġol- fjala.
After you have completed these steps, a small amount of liquid may remain in the vial.
Wara li tkun imxejt ma ’ dawn il- passi, jista ’ jibqa ’ ammont zgħir ta ’ likwidu fil- fjala.
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
(1) in- naħa ta ’ quddiem tan - naħa tan- nofs tal- koxox; (2) iż- żaqq, ħlief għaż- żona ta ’ 5 ċm madwar iż- żokra; u (3) in- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn (ara Dijagramma 9).
Diagram 9.
Dijagramma 9
Do NOT inject into areas where the skin is tender, bruised, red, or hard.
Tinjettax f’ postijiet fejn il- ġilda hija tenera, mbenġla, ħamra jew iebsa.
(It may be helpful to keep notes on the location of the previous injections.)
Evita żoni li jkun fihom ċikatriċi jew marki jew sinjali ta ’ ġbid fil- ġilda.
309  If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
(Tista ’ tkun ta ’ għajnuna jekk iżżomm kont tal- postijiet fejn jingħataw l - injezzjonijiet ta ’ qabel.) • Jekk inti għandek il- psorjasi, m’ għandekx tipprova tinjetta direttament ġo kwalunkwe rqajja ’ tal - ġilda li jkunu mtellgħin, ħoxnin, ħomor, jew bil- qxur (“ leżjonijiet tal- psorjasi fil- ġilda ”).
With the other hand, hold the syringe like a pencil.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram10).
297 • B’ moviment mgħaġġel u qasir, imbotta l- labra ’ l isfel kemm tista ’ ġol- ġilda f’ angolu bejn 45° u 90° (ara Dijagramma 10).
With experience, you will find the angle that is most comfortable for you.
Bl- esperjenza, għandek issib l- angolu li jkun l- aktar komdu għalik.
Diagram 10
Dijagramma 10
Diagram 11
Dijagramma 11
311 PACKAGE LEAFLET:
298 FULJETT TA ’ TAGĦRIF:
Enbrel 50 mg powder and solvent for solution for injection Etanercept
Enbrel 50 mg trab u solvent għal soluzzjoni għall- injezzjoni. etanercept