qanastek/EMEA-V3 huggingface dataset:
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 any have 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 jew lil tifel/ tifla li tinsab taħt il- kura tiegħek.
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 jew tat- tifel/ tifla li jinsabu taħt il- kura 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.
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.
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 and 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.
312 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.
2.
299 2.
Some vaccines, such as oral polio vaccine, should not be given while receiving Enbrel.
Xi vaċċinazzjonijiet, bħal vaċċin tal- poljo orali, m' għandhomx jingħataw meta jkun qed jintuża Enbrel.
Tell you doctor if you are exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk inti espost għal ġidri r- riħ meta tieħu Enbrel.
313 Taking other medicines
300 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 jew tat- tfal 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 tal- pazjenta.
Always use Enbrel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma l- ispiżjar jekk ikollok xi dubju.
314 Dosing for children and adolescents
301 Doża għat- tfal u l- adoloxxenti
If you use more Enbrel than you should:
Jekk tieħu Enbrel aktar milli suppost
 Trouble swallowing or breathing.
• 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.
315  Swelling of the face, throat, hands, or feet.  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).
302 • 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 jew it- tifel/ tifla tiegħek għandkom mnejn ikollkom bżonn l- attenzjoni medika minnufih.
 Not known: excessive activation of white blood cells associated with inflammation (macrophage activation syndrome).
303 • Mhux magħrufa: attivazzjoni eċċessiva ta ’ ċelluli bojod tad- demm assoċjati ma ’ infjammazzjoni (sindrome ta ’ l- attivazzjoni tal- makrofagu).
These measures will help to protect environment.
Dawn il- miżuri jgħinu jipproteġu l - ambjent.
Each vial of Enbrel 50 mg contains 50 mg of etanercept.
Kull fjala ta 'Enbrel 50 mg fiha 50 mg ta' etanercept.
Enbrel 50 mg is supplied as a white powder and solvent for solution for injection.
Enbrel 25 mg jiġi bħala trab abjad u solvent għal soluzzjoni għall- injezzjoni.
Each pack contains 2, 4 or 12 single dose vials, 2, 4 or 12 pre-filled syringes of water for injections, 2, 4 or 12 needles, 2, 4 or 12 vial adaptors and 4, 8 or 24 alcohol swabs.
Kull pakkett fih 2, 4, jew 12- il fjala ta ’ doża waħda kull wieħed, 2, 4 jew 8 siringi mimlija għal- lest bl- ilma għall- injezzjonijiet 2, 4 jew 12- il labra, 2, 4 jew 8 adaptors tal- fjali u 4, 8 jew 24 swabs għal qabel l- injezzjoni.
Not all pack sizes may be marketed.
Mhux il - qisien tal- pakketti kollha jistgħu jitqiegħdu fis- suq.
317 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
304 Polska België/ Belgique/ Belgien Luxembourg/ Luxemburg
France Wyeth Pharmaceuticals France Tél: + 33 1 41 02 70 00 Fax: + 33 1 41 02 70 10
Wyeth Pharmaceuticals France Tél: + 33 1 41 02 70 00 Fax: + 33 1 41 02 70 10
7.
305 7.
319  The dose tray should contain the items listed below.
• Aħsel idejk sew. • 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.
1 fjala ta 'Enbrel 1 siringa mimlija għal- lest b’ solvent ċar u mingħar kulur (ilma għall- injezzjonijiet) 1 labra 1 adapter tal- fjala 2 swabs ta ’ l- alkoħol • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- fjala kif ukoll it- tiketta tas- siringa.
 Remove the contents of the tray.  Remove the plastic cap from the Enbrel vial.
• Neħħi l- oġġetti minn ġot- trej.
DO NOT remove the grey stopper or aluminium ring around the top of the vial (see Diagram 1).
• Neħħi t- tapp tal- plastik mill- fjala taEnbrel.
Diagram 1.
Tneħħix it- tapp griż jew iċ- ċirku tal- aluminju ta ’ mad - dawra ta ’ fuq tal- fjala (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- fjala 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- fjala f’ pożizzjoni wieqfa fuq superfiċje ċatta u nadifa. • Meħħi l- karta li hemm fuq wara ta ’ pakkett ta ’ l- adaptor tal- fjala. • Kif ikun għadu fil- pakkett tal- plastik, poġġi l- adapter tal- fjala fuq il- fjala ta ’ Enbrel biex l- ispike ta ’ l- adapter tal- fjala jinsab iċċentrat biċ- risku mgħolli fuq l- istopper tal- fjala (ara Dijagrama 2). • Żomm il- fjala b’ id waħda fis- sod fuq il- 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).
It is important that the vial adaptor spike completely penetrates the vial stopper.
Hu importanti li l- ispike ta ’ l- adaptor tippenetra kompletament l- istopper tal- fjala.
320  While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
• Waqt li żżomm il- fjala f’ id waħda, neħħi il- pakkett tal- plastik mill- adaptor tal- fjala (ara Dijagramma 5).
 Remove the protective rubber 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.
 Do not use the syringe if this perforation is already broken.
• Tużax is- siringa jekk din il- perforazzjoni tkun diġa maqsuma.
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).
Erġa ’ ibda mill- ġdid billi tuża trej ieħor tad- doża. • Filwaqt li żżomm il- bittija tal- ħġieġ tas- siringa (mhux l- għonq abjad) f’ id waħda, u l- adapter tal - fjala (mhux il- fjala) fl- oħra, waħħal is- siringa ma ’ l- adaptor tal- fjala billi ddaħħal il- ponta fil- fetħa u ddawwar skond kif jimxi l- arloġġ sakemm ikun kompletament magħluq (ara Dijagramma 7).
Adding solvent
Dan iseħħ minħabba l- pressjoni ta ’ l- arja u m’ għandhiex tkun ta ’ tħassib.
 While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial (see Diagram 8).
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- fjala f’ ċirku għal ftit drabi biex jinħall it- trab (ara Dijagramma 9).
DO NOT shake the vial.
Iċċaqlaqx bil- qawwi l- fjala.
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.
Diagram 9.
Dijagramma 9.
e.
308 e.
 With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
• Bis- siringa għadha mwaħħla mal- fjala u l- adaptor tal- fjala, aqleb il- fjala rasha ’ l isfel għall- livell t’ għajnejk.
322  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).
Withdraw the entire volume.
Iġbed il- volum kollu.
After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Wara li tkun ġbidt Enbrel minn ġol- fjala, jista ’ jkun li jibqa ’ xi arja fis- siringa.
 With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti- clockwise (see Diagram 12).
• Bil- fjala rasha ‘ l isfel, ħoll is- siringa mill- adaptor tal- fjala billi ddawru fid- direzzjoni ta ’ kontra l- arloġġ (ara Dijagramma 12).
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).
• 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.
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).
 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.
309 Dijagramma 13.
323  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).
Diagram 14.
Dijagramma 14.
 While holding the syringe upright, remove any air bubbles by slowly pushing on the plunger until the air is removed (see 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).
Diagram 16.
Dijagramma 16.
g.
310 g.
324 Diagram 17.
Dijagramma 17.
(It may be helpful to keep notes on the location of the previous injections.)  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 - injezzjonjiet 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 ”).
Preparing the injection site and injecting the Enbrel solution
Kif tipprepara s- sit ta 'l- injezzjoni u tinjetta s- soluzzjoni ta ’ Enbrel
DO NOT touch this area again before giving the injection.
Terġax tmiss din l- erja qabel tagħti l- injezzjoni.
 When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
• Meta l- post imnaddaf ta 'fuq il- ġilda ikun nixef, oqorsu u żommu sew b' id waħda.
With the other hand, hold the syringe like a pencil.
Bl- id l- oħra żomm is- siringa bħal lapes.
 With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
• 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.
Dijagramma 18.
325  When the needle is completely inserted into the skin, release the skin that you are holding.
311 • Meta l- labra tkun iddaħħlet kompletament ġol- ġilda, erħi l- ġilda li tkun qed iżżomm.
Diagram 19.
Dijagramma 19.
DO NOT rub the injection site.
Togħrokx is- sit fejn tajt l- injezzjoni.
326 PACKAGE LEAFLET:
312 FULJETT TA ’ TAGĦRIF:
Enbrel 25 mg/ ml powder and solvent for solution for injection for paediatric use Etanercept
Enbrel 25 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni għal- użu pedjatriku 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 a child in your care.
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 jew lil tifel/ tifla li tinsab taħt il- kura tiegħek.
It may harm them, even if their symptoms are the same as those of the child you are caring for.  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 jew tat - tifel/ tifla li jinsabu taħt il- kura 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.
Etanercept works by reducing the inflammation associated with the disease that the child under your care has.
Etanercept jiffunzjona billi jnaqqas l- infjammazzjoni assoċjata ma 'ċertu mard li għandu/ għandha t- tifel/ tifla taħt il- kura tiegħek.
 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.  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 tal- mard li ġej fit- tfal u fl- adolexxenti: • 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. • Psorjasi severa f’ pazjenti mill- età ta ’ 8 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
Enbrel is not effective in the treatment of Wegener’ s granulomatosis, a rare inflammatory disease.
Enbrel mhux effettiv fit- trattament tal- granulomatożi ta ’ Wegener, marda rari ta ’ infjammazzjoni.
If the child you are caring for has Wegener’ s granulomatosis talk to your doctor.
Jekk it- tifel/ tifla li qed tieħu ħsieb għandu/ għandha l- granulomatożi ta ’ Wegener, kellem lit- tabib tiegħek.
If the child you are caring for is allergic to etanercept or any of the other ingredients of Enbrel.
Jekk it- tifel/ tifla li qed tieħu ħsieb, i/ tkun allerġiku/ a għal etanercept jew xi wieħed mis- sustanzi ta 'Enbrel.
If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.  Serious blood infection:
313 • Infezzjoni serja tad- demm:
If the child has, or is at risk of developing, a serious blood infection called sepsis.
Jekk it- tifel/ tifla għandu/ ha, jew j/ tinsab f' riskju li j/ tiżviluppa infezzjoni tad- demm serja li tissejjaħ sepsis.
If the child has an infection of any kind.
Jekk it- tifel/ tifla għandu/ ha xi infezzjoni ta 'kwalunkwe tip.
If you are unsure, please talk to your doctor.  Newborn babies:
Jekk m' intix żgur, jekk jogħġbok kellem lit- tabib tiegħek. • Trabi li għadhom kif jitwieldu:
In premature or newborn babies, because it contains benzyl alcohol.
Fi trabi prematuri jew li għadhom kif jitwieldu, peress li fih il - benzyl alkoħol.
If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with Enbrel.  Infections/ diabetes:
Jekk it- tifel/ tifla j/ tiżviluppa xi infezzjoni ġdida, jew se jkollu/ ha intervent kirurġiku maġġur, it- tabib tiegħek għandu mnejn ikun jixtieq jissorvelja t- trattament tiegħu/ tagħha b' Enbrel. • Infezzjonijiet/ dijabete:
Tell your doctor if the child has a history of recurrent infections, or suffers from diabetes or other conditions that increase the risk of infection.  Infections/ monitoring:
Għid lit- tabib tiegħek jekk it- tifel/ tifla għandu/ ha storja ta 'infezzjonijiet rikorrenti, jew i/ tbati mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
If the child develops symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Jekk it- tifel/ tifla tiegħek tiżviluppaw sintomi ta ’ infezzjoni bħal deni, tertir ta ’ bard jew sogħla, avża lit- tabib tiegħek immedjatament.
Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using Enbrel.  Tuberculosis:
It- tabib tiegħek jista ’ jiddeċiedi li jkompli jimmonitorja lit- tifel/ tifla tiegħek għall- preżenza ta ’ infezzjonijiet wara li t- tifel/ tifla j/ tieqaf j/ tużaEnbrel. • Tuberkulosi:
This may include a thorough medical history, a chest X-ray and a tuberculin test.
Dan jista ’ jinkludi storja medika dettaljata, raġġ- X tas- sider u test ta ’ tuberculin.
It is very important that you tell your doctor if the child has ever had tuberculosis, or has been in close contact with someone who has had tuberculosis.
Hu importanti ħafna li tgħid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek qatt kellu/ ha it- tuberkulosi, jew kien/ et qrib ta ’ xi ħadd li kellu t- tuberkulosi.
Your doctor may decide to test for the presence of hepatitis B infection before the child begins treatment with Enbrel.  Hepatitis C:
It- tabib tiegħek jista ’ jiddeċiedi li jagħmel test għall- preżenza ta ’ infezzjoni ta ’ epatite B qabel it- tifel/ tifla tiegħek j/ tibda l- kura b’ Enbrel. • Epatite Ċ:
Tell your doctor if the child has hepatitis C.
Għid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek għandu/ ha epatite Ċ.
Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.  Blood disorders:
Għandu mnejn li t- tabib tiegħek ikun jixtieq li jsir monitoraġġ tal- kura b’ Enbrel f’ każ li l- infezzjoni tmur għall - agħar. • Disturbi tad- demm:
Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Fittex għal parir mediku minnufih jekk it- tifel/ tifla għandu/ ha xi sinjali jew sintomi bħal ta 'deni persistenti, uġigħ fil- griżmejn, tbenġil, fsada jew sfurija.
Tell your doctor if the child has multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Għid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek għandu/ ha l- isklerożi multipla, newrite ottika (infjammazzjoni tan- nervi ta 'l- għajnejn) jew majelite trasversali (infjammazzjoni tal- korda spinali).
Tell your doctor if the child has a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.  Vaccinations:
Għid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek għandu/ ha storja ta 'insuffiċjenza tal- qalb konġestiva, peress li Enbrel jeħtieġ li jintuża b' kawtela f' dawn iċ - ċirkostanzi. • Vaċċinazzjonijiet:
If possible, children should be up to date with all vaccinations before using Enbrel.
It- tifel/ tifla, jekk possibbli, għandu/ ha j/ tkun aġġornat/ a bil- vaċċinazzjonijiet kollha qabel ma jintuża Enbrel.
Please consult the child's doctor before the child receives any vaccines.  Chickenpox:
Jekk jogħġbok ikkonsulta mat- tabib tat- tifel/ tifla qabel ma ’ dan/ din j/ tirċievi xi vaċċinazzjonijiet. • Ġidri r- riħ:
Tell your doctor if the child is exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk it- tifel/ tifla hu/ hi espost/ a għal ġidri r- riħ meta jieħdu Enbrel.
Your doctor will determine if preventative treatment for chickenpox is appropriate.  Babies and young children:
It - tabib tiegħek ser jistabilixxi jekk trattament preventiv għal ġidri r- riħ hux adattat. • Trabi u tfal żgħar:
Enbrel contains the ingredient benzyl alcohol, which may cause toxic and allergic reactions in infants and children up to 3 years old.
Enbrel fih l- ingredjent benzyl alkoħol, li jista ’ jikkawża reazzjonijiet tossiċi u allerġiċi fi trabi jew tfal sa 3 snin.
Enbrel must not be given to premature or newborn babies.
Enbrel m’ għandux jingħata lil trabi prematuri jew li għadhom kif jitwieldu.
328 Using other medicines
314 Meta tuża mediċini oħra
Tell the doctor or pharmacist if the child is taking, or has recently taken any other medicines, even those not prescribed by the child's doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jew tat- tifel/ tifla tiegħek qed jieħdu jew ħadu dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta mit- tabib tat- tifel/ tifla.
The effects of Enbrel in pregnant women are not known, and so the use of Enbrel during pregnancy is not recommended.
L- effetti ta 'Enbrel fuq nisa tqal mhux magħrufa, u għalhekk l- użu ta' Enbrel waqt it- tqala mhux irrakkomandat.
Important information about some of the ingredients of Enbrel
Użu importanti dwar xi ingjedrenti ta ’ Enbrel
Dosing for children and adolescents
Dożaġġ għat- tfal u l- adoloxxenti
329 Method and route of administration
Mod ta ’ kif u mnejn jingħata
The powder must be dissolved before use.
315 It- trab għandu jinħall qabel ma jintuża.
Detailed instructions on how to prepare and inject Enbrel are provided in section 7, "INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL".
Struzzjonijiet dettaljati dwar kif għandek tipprepara u tinjetta Enbrel huma pprovduti f' sezzjoni 7, “ STRUZZJONIJIET GĦALL- PREPARAZZJONI U KIF TAGĦTI INJEZZJONI TA ’ ENBREL ”.
To help you remember, it may be helpful to write in a diary which days of the week Enbrel should be used.
Sabiex jgħinek tiftakar, jista 'jkun utli li tikteb fi djarju liema ġranet tal- ġimgħa għandu jittieħed Enbrel.
If you forget to use Enbrel
Jekk tinsa tuża Enbrel
Then continue to inject the medicine on the usual days.
Imbagħad issokta billi tinjetta l- mediċina fil- jum/ jiem li suppost.
If you do not remember until the day that the next injection is due, do not give the child a double dose (2 doses on the same day) to make up for a forgotten dose.
Jekk ma tiftakarx il- jum li fiha trid tieħu d- doża li jmiss, tagħtix lit- tifel/ tifla żewġ dożi f' daqqa (żewġ dożi fl- istess jum) sabiex tagħmel tajjeb għad- doża mitlufa.
If any of the following happen to the child, do not give the child more Enbrel.
Jekk xi wieħed minn dawn li ġejjin iseħħ fuq it- tifel/ tifla tiegħek, tagħtix aktar Enbrel.
Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Għarraf lit - tabib tiegħek minnufih, jew mur fid- dipartiment ta 'l- emerġenza fl- aktar sptar fil- qrib.
 Trouble swallowing or breathing.  Swelling of the face, throat, hands, or feet.  Feeling nervous or anxious, throbbing sensations, or 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).
• Problemi biex jibilgħu jew jieħdu n- nifs. • Jekk il- wiċċ, il- ġriżmejn, l- idejn jew is- saqajn jintefħu. • Jekk iħossuhom nervużi jew anzjużi, sensazzjonijiet ta 'taħbit il- qalb, ħmura f' daqqa fil- ġilda u/ jew sensazzjoni ta ’ sħana. • Raxx, ħakk jew ħurrieqa qawwija (rqajja' elevati ta 'ġilda ħamra jew pallida li xi kultant iġġagħlom iħokku).
If the child has any of the above symptoms he/ she may be having an allergic reaction to Enbrel, so you should seek immediate medical attention.
Jekk it- tifel/ tifla għandu/ għandha xi waħda minn dawn is- sintomi, hu/ hi jista ’ / tista ’ jkollu/ jkollha reazzjoni allerġika għal Enbrel, u għaldaqstant għandek tfittex għajnuna medika immedjata.
330 Serious side effects
Effetti sekondarji serji
If you notice any of the following, the child may need urgent medical attention.
Jekk tinduna b' xi wieħed minn dawn li ġejjin, it- tifel/ tifla tiegħek għandkom mnejn ikollhom bżonn l - attenzjoni medika minnufih.
 Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the child's skin or joints.  Signs of blood disorders, such as bleeding, bruising, or paleness.  Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg.  Signs of worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the child's nails or around the child's lips.
316 • Sinjali ta 'disturbi fis- sistema nervuża, bħal tirżiħ jew tnemnim, bidla fil- vista, uġigħ fl - għajnejn, jew bidu ta' għejja fi driegħ jew riġel. • Sinjali ta 'insuffiċjenza kardijaka li tiħżin, bħal għejja jew qtugħ ta ’ nifs b' attività, nefħa fl - għakiesi, sensazzjoni fejn tħoss l- għonq jew iż- żaqq mimlija, qtugħ ta ’ nifs matul il- lejl jew sogħla, id- dwiefer jew ix- xofftejn tat- tifel/ tifla jsiru lewn blu.
If these signs occur, tell your doctor immediately, or take the child to the casualty department at your nearest hospital.
Jekk dawn is- sinjali jidhru, għid lit- tabib tiegħek minnufih, jew ħu lit- tifel/ tifla tiegħek id- dipartiment ta 'emerġenza fl- aktar sptar fil- qrib.
Reactions at the injection site are very common but do not occur as often after the first month of treatment.
Reazzjonijiet fis- sit ta 'l- injezzjoni huma komuni ħafna, imma ma jseħħux daqshekk ta' spiss wara l- ewwel xahar ta 'trattament.
 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 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.
• 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.
331  Not known: excessive activation of white blood cells associated with inflammation (macrophage activation syndrome).
• Mhux magħrufa: attivazzjoni eċċessiva ta ’ ċelluli bojod tad- demm assoċjati ma ’ infjammazzjoni (sindrome ta ’ l- attivazzjoni tal- makrofagu).
After preparing the Enbrel solution, it may be stored upright in a refrigerator (2 C – 8 C) for up to 14 days.
Wara li tipprepara s- soluzzjoni ta 'Enbrel, tista ’ taħżinha ’ il fuq fi friġġ (2°C – 8°C) sa 14- il ġurnata.
If you are using a previously prepared Enbrel solution that has been stored in a refrigerator, wait 15 to 30 minutes to allow the Enbrel in the vial to reach room temperature before use.
317 Jekk qed tuża soluzzjoni ta ’ Enbrel li kienet ippreparata minn qabel u li nħażnet fi friġġ, agħti minn 15 sa 30 minuta ċans lil Enbrel fil- fjala biex jikseb it- temperatura tal- kamra qabel l- użu.
Do not warm Enbrel in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Enbrel bl- ebda mod (per eżempju, issaħnux fil- microwave jew fl- ilma sħun).
Full instructions for storage between doses and re-use of the prepared solution are provided in subsections i and j of section 7, 'INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL '
Struzzjonijiet dwar il- ħażna bejn id- dożaġġ u l- użu mill- ġdid ta ’ soluzzjoni preparata huma disponibbli fis- subsezzjonijiet i u j tas- sezzjoni 7 ‘ STRUZZJONIJIET GĦALL - PREPARAZZJONI U KIF TAGĦTI INJEZZJONI TA ’ ENBREL '.
Each vial of Enbrel 25 mg/ ml should be used for a maximum of 2 doses, administered to the same child.
Kull fjala ta ’ Enbrel 25 mg/ ml għandha tintuża għal massimu ta ’ 2 dożi, mogħtija lill- istess tifel/ tifla.
Both doses should be used within 14 days of preparing the Enbrel solution.
Iż- żewġ dożi għandhom jintużaw sa 14- il ġurnata wara l- preparazzjoni tas- soluzzjoni ta ’ Enbrel.
If there is insufficient Enbrel solution in the vial for the second dose, discard the vial and start again with a new tray.
Jekk m’ hemmx biżżejjed soluzzjoni ta ’ Enbrel fil- fjala għat- tieni doża, armi l- fjala u ibda mill- ġdid bi trej ġdid.
The active ingredient in Enbrel is etanercept.
Is- sustanza attiva f' Enbrel hi etanercept.
Each vial of Enbrel 25 mg/ ml contains 25 mg of etanercept.
Kull fjala ta 'Enbrel 25 mg/ ml fiha 25 mg ta' etanercept.
When reconstituted, the solution contains 25 mg/ ml of etanercept.
Meta rikostitwita, is- soluzzjoni fiha 25 mg ta 'etanercept.
Mannitol, sucrose, and trometamol.
Mannitol, sucrose u trometamol.
Water for injections and benzyl alcohol.
Ilma għall- injezzjonijiet u benzyl alkoħol.
Enbrel is supplied as a white powder and solvent for solution for injection for paediatric use.
Enbrel jiġi bħala trab abjad u solvent għal soluzzjoni għall- injezzjoni għall- użu pedjatriku.
Each pack contains 4 vials, 4 pre-filled syringes of solvent, 8 empty syringes, 20 needles and 24 alcohol swabs.
Kull pakkett fih 4 fjali, 4 siringi mimlijin għal- lest bis- solvent, 8 siringi vojta, 20 labra u 24 swab ta 'l - alkoħol.
332 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
318 Polska België/ Belgique/ Belgien Luxembourg/ Luxemburg
France Wyeth Pharmacurticals France Tél: + 33 1 41 02 70 00 Fax: + 33 1 41 02 70 10
Wyeth Pharmaceuticals France Tél: + 33 1 41 02 70 00 Fax: + 33 1 41 02 70 10
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}
Placing the needle on the syringe e.
It- tqegħid tal- labra fuq is- siringa e.
Adding solvent to the powder f.
Iż- żieda tas- solvent mat- trab f.
Withdrawing the Enbrel solution from the vial g.
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol- fjala g.
Preparing the injection site and injecting the Enbrel solution i.
Kif tipprepara s- sit ta 'l- injezzjoni u tipprepara d- doża ta ’ Enbrel għall- injezzjoni i.
Storing the Enbrel solution between doses j.
Kif taħżen is- soluzzjoni ta ’ Enbrel bejn id- dożi j.
Withdrawing a second dose of Enbrel from a vial that was previously prepared k.
Kif tiġbed it- tieni doża ta ’ Enbrel minn fjala li tkun ġiet ippreparata qabel k.
You will be instructed by the child's doctor or his/ her assistant on the technique of giving an injection and the amount to be given to the child.
Inti ser tiġi mgħallem mit- tabib tat- tifel/ tifla tiegħek jew l- assistent/ a tiegħu dwar tekniċi ta 'awto- injezzjoni jew kif tagħti injezzjoni lit- tifl/ tifla tiegħek.
Do not attempt to give the child an injection until you are sure that you understand how to prepare and give the injection.
Tipprovax tamministra l- injezzjoni lit- tifel/ tifla tiegħek qabel ma tkun żgur/ a li fhimt kif tiprepara u kif tagħti l- injezzjoni.
This injection should not be mixed in the same syringe or vial with any other medicine..
Din l- injezzjoni m' għandix titħallat fl- istess siringa jew fjala ma ’ xi mediċina oħra.
See section 5 for instructions on how to store Enbrel.
Ara sezzjoni 5 għall- Struzzjonijiet dwar kif taħżen Enbrel.
 Wash your hands thoroughly.  Select a clean, well-lit, flat working surface.  Remove one Enbrel dosing tray from the refrigerator.
• Aħsel idejk sew. • Agħżel superfiċje ċatta, nadifa u mdawwla fejn tipprepara l- injezzjoni. • Oħroġ trej tad- dożi ta ’ Enbrel mill- friġġ.
Replace the other trays in the refrigerator.  The dose tray should contain all the items needed for one dose.
Ibdel it- trejs l- oħra fil- friġġ. • It- trej tad- dożi għandu jkun fih l- oġġetti kollha msemmija hawn taħt.
The contents of the tray are listed below.
L- oġġetti kollha tat- trej huma elenkati hawn taħt.
DO NOT use any other syringe.
Uża biss l- oġgetti ndikati fil- lista.
334 1 pre-filled syringe containing clear, colourless solvent 2 Empty syringes 5 Needles 6 Alcohol swabs  If any of the items listed above are missing, do not use the dose tray, but consult your pharmacist.  Inspect the expiry dates on both the vial label and the syringe label.
TUŻAX l- ebda siringa oħra. fjala ta 'bit- trab ta ’ Enbrel siringa mimlija għal- lest li fiha solvent ċar u mingħar kulur 2 siringi vojta 5 labar 6 swabs bl- alkoħol • Jekk xi wieħed minn dawn l- oġġetti huwa nieqes, tużax it- trej tad- doża iżda kkonsulta ma ’ l - ispiżjar tiegħek. • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- fjala kif ukoll it- tiketta tas- siringa.
Preparing the Enbrel dose for injection
Kif tipprepara d- doża ta 'Enbrel għall- injezzjoni
 Remove the Enbrel vial from the tray  Remove the pink plastic cap from the Enbrel vial.
• Neħħi l- fjala ta ’ Enbrel mit- trej • Neħħi t- tapp tal- plastik roża mill- fjala taEnbrel.
Diagram 1.
Tneħħix it- tapp griż jew iċ- ċirku tal- aluminju ta ’ mad- dawra ta ’ fuq tal- fjala (ara Dijagramma 1).
 Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
• Uża swab bl- alkoħol ġdida biex tnaddaf it- tapp griż tal- fjala 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.  Unscrew the cap from the syringe containing the solvent taking care not to touch the tip of the syringe or allowing it to touch any surface.
Terġax tmiss it- tapp griż b’ idejk wara li tkun naddaftu. • Agħżel wiċċ nadif, imdawwal sew u ċatt. • Ħoll l- għatu mis- siringa li fiha s- solvent u oqgħod attent li ma tmissx il- ponta tas- siringa u li ma tħallihiex tmiss ma ’ l- ebda wiċċ.
 Remove one of the needles from the tray.
• Oħroġ waħda mil- labar mit- trej.
The needle has been placed in a plastic container to keep it sterile.
Il- labra tpoġġiet fil- kontenitur tal- plastik biex tinżamm sterilizzata.
To open the plastic container, hold the short, wide end in one hand.
Biex tiftaħ il- kontenitur tal- plastik żomm it- tarf il- qasir u wiesa ’ f’ id waħda.
Place your other hand on the longer portion of the container.  To break the seal, bend the longer end down and then up until broken.  Once the seal is 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.  Attach the syringe to the needle by turning the syringe clockwise until completely secured (see Diagram 2).
Poġġi l- id l- oħra fuq il- parti itwal tal- kontenitur. • Biex tkisser is- siġill irwi l- parti l- kbira ‘ l isfel u wara ‘ l fuq sakemm jinkiser • Wara li jinkiser is- siġill neħħi t- tarf il- qasir u wiesa ’ tal- kontenitur tal- plastik. • Il- labra se tibqa ’ fil- parti t- twila tal- pakkett. • Filwaqt li żżomm il- labra u l- kontenitur f’ id waħda, aqbad is- siringa u daħħal il- ponta tas - siringa fil- fetħa tal- labra. • Qabbad is- siringa mal- labra billi ddawwarha fid- direzzjoni ta ’ dawran lemini sakemm tissikka kompletament (ara Dijagramma 2).
335  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 3).
• 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 3).
e.
321 e.
Adding solvent to the powder
Iż- żieda tas- solvent mat- trab
Diagram 4.
• 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 4).
Diagram 5.
Fittex it- tarf tal- labra mit- tieqa żgħira tat- tapp (ara Dijagramma 5).
 Push the plunger in VERY SLOWLY until all the solvent is in the vial.
• Mbotta l- planġer BIL- MOD ĦAFNA sakemm l- ilma għall- injezzjonijiet kollu jidħol ġol- fjala.
This will help reduce foaming (lots of bubbles) (see Diagram 7).
Dan jgħin biex titnaqqas r- ragħwa (ħafna bżieżaq) (ara Dijagramma 7).
336  Remove the solvent syringe and needle from the vial and discard them.
• Neħħi s- siringa u l- labra tas- solvent mill- kunjett u armihom.
DO NOT shake the vial (see Diagram 8).
Ċaqlaq kemm kemm bil- mod il - gwida għall- preparazzjoni tad- doża f’ ċirku għal ftit drabi biex jinħall it- trab.
Wait until all the powder dissolves (usually less than 10 minutes).
Iċċaqlaqx bil - qawwi l- gwida għall- preparazzjoni tad- doża (ara Dijagramma 8) Stenna sakemm jinħall it- trab kollu (ġeneralment inqas minn 10 minuti).
The solution should be clear and colourless to pale yellow, with no lumps, flakes, or particles.
Is- soluzzjoni għandha tkun ċara u bla kulur sa isfar ċar, mingħajr ċapep, biċċiet jew frak.
Some white foam may remain in the vial – this is normal.
Jista ’ jkun li jibqa ’ xi ftit ragħwa bajda fil- fjala – dawn huwa normali.
Start again with another dose tray.
Ibda mill - ġdid b’ trej tad- doża ieħor.
Diagram 8.
322 Dijagramma 8.
Withdrawing the Enbrel solution from the vial
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol- fjala
 The doctor or his/ her assistant should have instructed you on the proper amount of solution to be withdrawn from the vial.
• It- tabib jew l- assistant/ a tiegħu għandhom ikunu spjegawlek dwar l- ammont xieraq ta ’ soluzzjoni li għandha titneħħa mill- fjala.
If the doctor has not given this instruction, please contact him/ her.  Take one of the empty syringes from the tray and remove the plastic wrap.
Jekk it- tabib ma takx din l- istruzzjoni, jekk jogħġbok ikkuntattjah/ a. • Ħu waħda mis- siringi l- vojta mit- trej u neħħi l- plastik.
Take care not to let anything touch the tip of the syringe.  Take a new needle from the tray and attach it to the empty syringe in the same way as for the solvent syringe (see d.
Oqgħod attent li ma tħalli xejn imiss mal- ponta tas- siringa. • Ħu labra ġdida mit- trej u waħħalha mas- siringa l- vojta bl- istess mod bħas- siringa tas- solvent (ara d.
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.
It- tqegħid tal- labra fuq is- siringa). • Bil- fjala wiċċha ‘ l fuq, fuq wiċċ ċatt, daħħal il- labra tas- siringa dritt ġoċ- ċurkett ċentrali ta ’ l - għatu l- griż ta ’ fuq il- fjala 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.
Fittex it- tarf tal- labra mit- tieqa żgħira tat- tapp.
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 withdrawal of the solution from the vial.  With the needle still in the vial, hold the vial upside down at eye level.
Iddaħħalx il- labra b’ mod immejjel, għax dan jista ’ jikkawża li l- labra titgħawweġ u/ jew ma jħallix li s- soluzzjoni tinġibed kif suppost fil- kunjett. • Waqt li l- labra tkun għadha fil- fjala, żomm il- gwida għall- preparazzjoni tad- doża bil- fjala rasha l- isfel bi dritt għajnejk.
Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 9).
Bil- mod iġbed il- planġer lura biex tiġbed it- taħlita ġos- siringa (ara Dijagramma 9).
 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.  With the needle still inserted in the vial, check the syringe for air bubbles.
• 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. • Waqt li l- labra tkun għadha fil- fjala 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 10). għfas il- planġer bil- mod biex tagħfas il- bżieżaq baraa mis- siringa għal ġol- fjala.
337 Diagram 10.
Dijagramma 10.
 Slide the needle out of the vial.
323 • Żerżaq is- siringa mill- fjala.
If you notice that you have withdrawn too much solution, do not re-insert the needle once it has been removed from the vial.
Jekk tinnota li ġbidt iżżejjed mis- soluzzjoni, terġax iddaħħal il- labra la darba tkun neħħejtha mill- fjala.
If there is too much solution in the syringe, hold the syringe with the needle pointing upwards at eye level and push the plunger in gently until the syringe contains the proper amount of liquid.
Jekk hemm soluzzjoni żejda fis- siringa, żomm is- siringa bil - labra tħares ‘ il fuq fil- livell ta ’ l- għajnejn u nbotta l- planġer ‘ il ġewwa bil- mod sakemm is - siringa jkun fiha l- ammont meħtieġ ta ’ likiwdu.
Remove and discard the needle.  Take a new needle from the tray and attach it to the syringe as described above (see d.
Neħħi u armi l- labra. • Aqbad labra ġdida mit- trej u waħħilha mas- siringra kif deskritt hawn fuq (ara d.
Placing the needle on the syringe).
It- tqegħid tal - labra fuq is- siringa).
This will be the needle you use to inject Enbrel.
Din se tkun il- labra li se tuża biex tinjetta Enbrel.
 The three recommended injection sites for Enbrel using a pre-filled syringe include:
It- tliet sitii rakkomandati għall- injezzjoni ta ’ Enbrel bl- użu ta ’ siringa mimlija għal- lest 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 11).
(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 11).
If the child is self injecting, the outer area of the upper arms should not be used.
Jekk it- tifel/ tifla jkunu qed jagħtu l- injezzjoni lilhom infushom, in- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn m’ għandhiex tintuża.
(It may be helpful to keep notes on the location of the previous injections.)  If the child has psoriasis, 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 it- it- tifel/ tifla għandhom il- psorjasi, ipprova tinjettax direttament ġo kwalunkwe rqajja ’ tal - ġilda li jkunu mtellgħin, ħoxnin, ħomor, jew bil- qxur (“ leżjonijiet tal- psorjasi fil- ġilda ”).
Preparing the injection site and injecting the Enbrel solution
Kif tipprepara s- sit ta 'l- injezzjoni u tipprepara d- doża ta ’ Enbrel għall- injezzjoni
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 12).
324 • B’ moviment mgħaġġel u qasir, imbotta l- labra ’ l isfel kemm tista ’ ġol- ġilda f’ angolu bejn 45° u 90° (ara Dijagramma 12).
With experience, you will find the angle that is most comfortable for the child.
Bl- esperjenza, għandek issib l- angolu li jkun l- aktar komdu għat - tifel/ tifla.
Diagram 12
Dijagramma 12.