qanastek/EMEA-V3 huggingface dataset:
Method and route of administration
Mod ta ’ kif u mnejn jingħata
Enbrel is administered by an injection under the skin (by subcutaneous injection).
Enbrel għandu jingħata b' injezzjoni taħt il- ġilda (b' injezzjoni subkutanea).
The powder must be dissolved before use.
It- trab għandu jinħall qabel ma jintuża.
Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “ INSTRUCTIONS FOR PREPARTING 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 ”.
Do not mix the Enbrel solution with any other medicine.
Tħallatx is- soluzzjoni ta 'Enbrel ma' xi mediċina oħra.
To help you remember, it may be helpful to write in a diary which day(s) of the week Enbrel should be used.
Sabiex jgħinek tiftakar, jista 'jkun utli li tikteb fi djarju liema ġurnata (ġranet) tal- ġimgħa għandu jittieħed Enbrel.
If you use more Enbrel than you should
Jekk tieħu Enbrel aktar milli suppost
If you have used more Enbrel than you should (either by injecting too much on a single occasion, or by using it too frequently), talk to a doctor or pharmacist immediately.
Jekk ħadt aktar Enbrel milli suppost (jew billi f' okkażżjoni waħda injettajt aktar milli suppost, jew billi użajtu aktar ta 'spiss milli suppost), kellem lit- tabib jew lill- ispiżjar tiegħek minnufih.
Always have the outer carton of the medicine with you, even if it is empty.
Dejjem żomm il - kartuna tal- mediċina miegħek, anke meta tkun vojta.
260 If you forget to inject Enbrel
Jekk tinsa tinjetta Enbrel
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day, in which case you should skip the missed dose.
Jekk tinsa tieħu doża, inti għandek tinjettaha hekk kif tiftakar, ħlief meta d- doża skedata li jmiss tkun l- għada, f' liema każ inti għandek taqbeż id- doża maqbuża.
Then continue to inject the medicine on the usual day(s).
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 take a double dose (two doses on the same day) to make up for a forgotten dose.
Jekk ma tiftakarx sal- jum li fih imissek tieħu l- injezzjoni, tiħux doża doppja (żewġ dożi fl- istess jum) sabiex tagħmel tajjeb għad- doża mitlufa.
Like all medicines, Enbrel can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Enbrel jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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 effect, 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.
Allergic reactions
Reazzjonijiet allerġiċi
If any of the following happen, do not inject more Enbrel.
Jekk xi wieħed minn dawn li ġejjin iseħħ, tinjettax 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, 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).
• 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. • Raxx, ħakk jew ħurrieqa qawwija (rqajja' elevati ta 'ġilda ħamra jew pallida li xi kultant iġġagħlek tħokk).
Serious allergic reactions are uncommon.
Reazzjonijiet allerġiċi serji mhumiex komuni.
However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Madankollu, xi sintomi minn dawn ta 'hawn fuq jistgħu jindikaw reazzjoni allerġika għal Enbrel, u allura inti għandek tfittex l- attenzjoni medika minnufih.
Serious side effects
Effetti sekondarji serji
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.
 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 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 nails or the lips.
• Sinjali ta 'infezzjonijiet serji, bħal deni għoli li jista' jkun akkumpanjat minn sogħla, qtugħ ta ’ nifs, sirdat, debolezza, jew xi parti sħuna, ħamra, tenera u bl- uġigħ fuq il- ġilda jew fil- ġogi. • Sinjali ta 'disturbi fid- demm, bħal fsada, tbenġil, jew sfurija. • Sinjali ta' disturbi fis- sistema nervuża, bħal tirżiħ jew tnemnim, bidla fil- vista, uġigħ fl - għajnejn, jew bidu ta 'dgħjufija fi driegħ jew riġel. • Sinjali ta' insuffiċjenza kardijaka li tiħżien, 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 isiru lewn blu.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Dawn huma effetti rari jew mhux komuni, imma huma kundizzjonijiet serji (fejnxi wħud jistgħu rarement ikunu fatali).
If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
Jekk dawn is- sinjali jidhru, għid lit- tabib tiegħek minnufih, jew żur id - dipartiment ta 'emerġenza fl- aktar sptar fil- qrib.
261 Other side effects
Effetti sekondarji oħra li jista ’ jkollu
The side effects and frequencies (likelihood of occurring) listed below are those that have been seen in adult patients.
L- effetti sekondarji u l- frekwenzi (il- probabilità li jseħħu) elenkati hawn isfel huma dawk murija f' pazjenti adulti.
The side effects seen in children and adolescents are similar to those seen in adults.
L- effetti sekondarji li jidhru fit- tifel/ tifla u adoloxxenti huma simili għal fil- kbar.
 Very common (may occur in more than 1 in 10 patients):
• Komuni ħafna (jistgħu jseħħu f' aktar minn 1 f' 10 pazjenti):
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Infezzjonijiet (li jinkludu rjiħat, sinożite, bronkite, infezzjonijiet ta 'l- apparat urinarju u infezzjonijiet tal- ġilda); reazzjonijiet tas - sit ta' l- injezzjoni (li jinkludu fsada, tbenġil, ħmura, ħakk, uġigħ u nefħa).
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.
Some patients have developed a reaction at an injection site that was used before.
Xi pazjenti żviluppaw reazzjoni fis- sit ta 'l- injezzjoni li kienet intużat qabel.
 Common (may occur in less than 1 in 10, but more than 1 in 100 patients): allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).
• Komuni (jistgħu jseħħu f' inqas minn 1 f' 10, imma aktar minn 1 f' 100 pazjent): reazzjonijiet allerġiċi; deni; ħakk; antikorpi diretti kontra tessut normali (il- formazzjoni ta 'awto- antikorpi).
 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.
250 • 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 - ġogi, 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 iqabbduk 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 nefħa lokalizzata qawwija 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.
 Very rare (may occur in less than 1 in 10,000 patients): failure of the bone marrow to produce crucial blood cells.
• Rari ħafna (jistgħu jseħħu f' inqas minn 1 f' 10, 000 pazjent): il- mudullun jonqos milli jipproduċi ċelloli tad- demm kruċjali.
 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).
HOW TO STORE ENBREL
KIF TAĦŻEN ENBREL
Do not use Enbrel after the expiry date (EXP), which is stated on the carton.
Tużax Enbrel wara d- data ta 'skadenza (JIS), li hi ddikjarata fuq il- kartuna.
After preparing the Enbrel solution, immediate use is recommended.
Wara li tipprepara s- soluzzjoni ta 'Enbrel, huwa rrakkomandat li din tintuża minnufih.
However, the solution may be used for up to 6 hours if stored in the refrigerator (2 C – 8 C).
Madankollu, is- soluzzjoni tista 'tintuża sa 6 sigħat wara jekk tinżamm fil- friġġ (2°C – 8°C).
Do not use Enbrel if you notice the solution is not clear or contains particles.
Tużax Enbrel jekk tinduna li s- soluzzjoni mhix ċara jew fiha l- frak.
The solution should be clear, colourless or pale yellow, with no lumps or flakes or particles.
Is- soluzzjoni għandha tkun ċara, mingħajr kulur jew isfar ċar, mingħajr biċċiet jew frak.
Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Armi b' attenzjoni s- soluzzjoni Enbrel li ma ġietx injettata fi żmien 6 sigħat.
262 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu jipproteġu l - ambjent.
What Enbrel contains
X' fih ENBREL
The active substance in Enbrel is etanercept.
Is- sustanza attiva f' Enbrel hi etanercept.
Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Kull fjala ta 'Enbrel 25 mg fiha 25 mg ta' etanercept.
Mannitol, sucrose and trometamol.
Mannitol, żukrosju u trometamol.
Water for injections.
Ilma għall- injezzjoni
What Enbrel looks like and contents of the pack
Id- dehra ta 'ENBREL u l- kontenuti tal- pakkett
Enbrel 25 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 4 single dose vials, 4 pre-filled syringes of water for injections and 8 alcohol swabs.
Kull pakkett fih 4 fjali ta 'doża waħda, 4 siringi mimlijin għal- lest b' ilma għall- injezzjonijiet u 8 swabs ta' l- alkoħol.
Marketing Authorisation Holder and Manufacturer
251 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Wyeth Europa Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Wyeth Europa Ltd.
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom
Wyeth Pharmaceuticals New Lane Newbridge Hampshire, PO9 2NG Renju Unit
Tel: +420 2 67 294 111 Fax: +420 2 67 294 199
Portugal Wyeth Lederle Portugal
Ísland Icepharma hf.
Tel: +420 2 67 294 111
263 Deutschland Wyeth Pharma GmbH Tel: +49 180 2 29 93 84 384 Fax: +49 251 204 1128
Deutschland Wyeth Pharma GmbH
Suomi/ Finland Wyeth Puh/ Tel: + 358 20 7414 870 Fax: + 358 20 7414 879
870 Fax: + 358 20 7414 879
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
Magyarország 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
Magyarország Wyeth Kft Tel: +36 1 453 33 30 Fax: +36 1 240 4632
Wyeth Kft Tel: +36 1 453 33 30 Fax: +36 1 240 4632
This leaflet was last approved on {date}
Dan il- fuljett kien l- aħħar appruvat fil {data}.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL
STRUZZJONIJIET GĦALL- PREPARAZZJONI U KIF TAGĦTI INJEZZJONI TA ’ ENBREL
This section is divided into the following sub-sections:
Din is- sezzjoni hi maqsuma fis- sub- sezzjonijiet li ġejjin:
Introduction b.
Introduzzjoni b.
Setting up for an injection c.
Kif tlesti għall- injezzjoni ċ.
Preparing the Enbrel dose for injection using the “ dose preparation guide” (underside of the dose tray) d.
Kif tippreparara d- doża ta ’ Enbrel għall- injezzjoni billi tuża l - “ gwida tal- preparazzjoni tad- doża ” (il- parti ta ’ taħt tat- trej tad- doża) d.
Adding solvent e.
Iż- żieda tas- solvent e.
Withdrawing the Enbrel solution from the vial f.
Kif tiġbed is- soluzzjoni ta 'Enbrel minn ġol kunjett f.
Choosing an injection site g.
Kif tagħżel is- sit ta 'l- injezzjoni ġ.
Preparing the injection site and injecting the Enbrel solution h.
Kif tipprepara s- sit ta 'l- injezzjoni u tinjetta s- soluzzjoni ta' Enbrel h.
Disposing of supplies
Kif tiddisponi mill- oġġetti wżati għall- injezzjoni
Introduction
Introduzzjoni
The following instructions explain how to prepare and inject Enbrel.
Dawn l- istruzzjonijiet jispjegaw kif tipprepara u tinjetta Enbrel.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra dawn l - istruzzjoniet sewwa u imxi magħhom pass pass.
You will be instructed by your doctor or his/ her assistant on the techniques of self-injection or on giving an injection to a child.
Inti ser tkun mgħallem mit- tabib tiegħek jew l - assistent tiegħu/ tagħha kif għandek tinjetta lilek innifsek jew kif tinjetta lit- tifel/ tifla tiegħek.
A “ dose preparation guide” (specially designed 264 underside of the tray) is provided to assist you with aligning the vial and the solvent syringe.
"Gwida tal- preparazzjoni tad- doża ” (iddisinjat speċjalment fuq il- parti t' isfel tat- trej) qed jiġi provdut sabiex jassistik biex tallinja l- kunjett u s- siringa tas- solvent.
Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Tipprovax tagħti l- injezzjonijiet qabel ma tkun żgur li fhimt kif tipprepara u tagħti l- injezzjoni.
This injection should not be mixed with any other medicine.
Din l- injezzjoni m' għandix titħallat ma mediċini oħra.
Setting up for an injection
Kif tlesti għall- injezzjoni b.
 Wash your hands thoroughly.  The dose tray should contain the items listed below.
• Aħsel idejk sewwa. • It- trej tad- doża għandu jkollu dawn l- oġġetti ndikati f’ din il- lista ta ’ hawn taħt.
(If not, don’ t use the dose tray and consult your pharmacist).
(Jekk ma ssibx dawn, tużax it- trej tad- doża u kkonsulta l- ispiżjar tiegħek).
Use only the items listed.
Uża biss l- oġgetti ndikati fil- lista.
DO NOT use any other syringe.
TUŻAX l- ebda siringa oħra.
Enbrel vial pre-filled syringe containing clear, colourless solvent (water for injections) syringe plunger 2 alcohol swabs dose preparation guide (underside of the dose tray)  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) Planġer tas- siringa Żewġ swabs bl- alkoħol Gwida għall- preparazzjoni tad- doża (li tinsab taħt it- trej tad- doża). • Iċċekkja sew id- data meta jiskadi, fuq it- tiketta tal- kunjett kif ukoll it- tiketta tas- siringa.
They should not be used after the month and year shown.
M’ għandhomx jintużaw wara x- xahar u s- sena murija.
c.
ċ.
Preparing the Enbrel dose for injection using the “ dose preparation guide” (underside of the dose tray)
Kif tippreparara d- doża ta ’ Enbrel għall- injezzjoni billi tuża l - “ gwida tal- preparazzjoni tad- doża ” (il- parti ta ’ taħt tat- trej tad- doża)
 Remove the contents of the tray and turn the tray over.
• Neħħi l- oġġetti minn ġot- trej u aqilbu wiċċu l- isfel.
The underside of the tray is a “ dose preparation guide .” It is specially designed to hold the vial and syringe in place while preparing the Enbrel solution.  Remove the plastic cap from the Enbrel vial.
Fuq in- naħa ta ’ taħt tat- trej issib “ Gwida għall- preparazzjoni tad- doża ”.
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.
It- trej hu diżinjat apposta biex iżomm fih il- kunjett u s- siringa f’ posthom waqt il- preparazzjoni tas- soluzzjoni ta ’ Enbrel. • Neħħi l- għatu tal- plastik mill- kunjett ta ’ Enbrel.
After cleaning, do not touch the stopper with your hands.  Press the Enbrel vial into the space to the right of the  mark in the dose preparation guide; the grey stopper will face the centre of the tray (see Diagram 1).
Tneħħix it- tapp griż jew iċ- ċirku ta ’ l- aluminju mad- dawra ta ’ fuq il- kunjett. • Uża swab bl- alkoħol ġdida biex tnaddaf it- tapp griż tal- kunjett ta ’ Enbrel.
Diagram 1.
Terġax tmiss it- tapp griż b’ idejk wara li tkun naddaftu. • Daħħal il- kunjett ta ’ Enbrel fl- ispazju fuq il- lemin tal- marka ∧ fil- gwida għall- preparazzjoni għad- doża: it- tapp griż ikun iħares lejn in- nofs tat- trej (ara Dijagramma 1).
 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 2).
• 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 2).
Be careful not to bend or twist the cover during removal to avoid damage to the needle.
Oqgħod attent/ a li ma tgħawwiġx jew tilwi l- għatu waqt li tkun qed tneħħih biex tevita li tagħmel ħsara lil- labra.
Diagram 2.
Dijagramma 2.
265 Turn the vial so that the stopper window is up and visible.
Dawwar il- kunjett sakemm tiġi tidher tieqa żgħira tat- tapp.
With the needle pointed at the vial align the “ 0.5 ml” mark on the syringe with the edge of the dose preparation guide.
Waqt li l- labra tkun tħares lejn il- kunjett ġib il- marka “ 0. 5 ml ” tas- siringa mat- tarf tal- gwida għall- preparazzjoni tad- doża.
Keep the syringe and needle level, so the needle does not touch the tray.
Żomm is- siringa u l - labra fl- istess livell biex il- labra ma tmissx mat- trej.
Slide the syringe into the dose preparation guide until the needle goes through the centre ring of the grey stopper of the vial (see Diagram 3).
Żerżaq is- siringa fil- gwida għall- preparazzjoni tad- doża sakemm il- labra tidħol fiċ- ċirku tan- nofs tat- tapp griż tal- kunjett (ara Dijagramma 3).
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 4).
Fittex it- tarf tal- labra mit- tieqa żgħira tat- tapp (ara Dijagramma 4).
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 5).
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 5).
Diagram 3.
Dijagramma 3
Diagram 4.
Dijagramma 4.
Diagram 5.
Dijagramma 5.
 Slide the plunger into the syringe.
Spazju miftuh fl - ghatu
 Turn the plunger clockwise until a slight resistance is felt (see Diagram 6).
Ghatu tal - gomma Siringa
Diagram 6.
• Żerżaq il- planġer ġos- siringa. • Dawwar il- planġer b’ dawran lemini sakemm tħoss reżistenza ħafifa (ara Dijagramma 6).
Adding solvent
Iż- żieda tas- solvent
 Push the plunger in VERY SLOWLY until all the solvent is in the vial.
• Mbotta l- planġer BIL- MOD ĦAFNA sakemm is- solvent kollu jidħol ġol- kunjett.
This will help reduce foaming (lots of bubbles) (see Diagram 7).
Dan jgħin biex titnaqqas r- ragħwa (ħafna bżieżaq) (ara Dijagramma 7)
266 Diagram 7.
Dijagramma 7.
 Leave the syringe in place.
• Ħalli s- siringa f’ postha.
Gently move the dose preparation guide in circles a few times, to dissolve the powder (see Diagram 8).
Ċaqlaq kemm kemm bil- mod il- gwida għall- preparazzjoni tad- doża f’ ċirku għal ftit drabi biex jinħall it- trab (ara Dijagramma 8).
Do NOT shake the dose preparation guide.
Iċċaqlaqx bil- qawwi l- gwida għall - preparazzjoni tad- doża.
Wait until all the powder dissolves (usually less than 10 minutes).
Stenna sakemm jinħall it- trab kollu (ġeneralment inqas minn 10 minuti).
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.
Some white foam may remain in the vial - this is normal.
Jista ’ jkun li jibqa ’ xi ftit ragħwa bajda fil- kunjett – 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- kunjett ma jkunx inħall kollu f’ 10 minuti.
Start again with another dose tray.
Erġa ’ ibda bi trej ta ’ doża ieħor.
Diagram 8.
Dijagramma 8.
Withdrawing the Enbrel solution from the vial
Kif tiġbedi is- soluzzjoni ta 'Enbrel minn ġol kunjett
Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 9).
• Waqt li l- labra tkun għadha fil- kunjett, żomm il- gwida għall- preparazzjoni tad- doża bil- kunjett rasu l- isfel bi dritt għajnejk.
Diagram 9.
Bil- mod iġbed il- planġer lura biex tiġbed it- taħlita ġos- siringa (ara Dijagramma 9).
 With the needle still inserted in the vial, check the syringe for air bubbles.
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.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 10).
Għat- tfal iġbed biss dak l- ammont tal- likwidu li jkun ordnalek it- tabib tat- tifel/ tifla tiegħek.
Slowly press the
256 Dijagramma 9.
267 plunger to push bubbles out of the syringe and into the vial.
Agħfas il- planġer bil- mod biex tagħfas il- bżieżaq barra mis- siringa għal ġol- kunjett.
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- kunjett, erġa ’ iġbed il- planġer biex terġa ’ ddaħal il- likwidu fis- siringa.
Diagram 10.
Dijagramma 10.
 Slide the syringe out of the dose preparation guide.
• Żerżaq is- siringa ’ l barra mill- gwida għall- preparazzjoni tad- doża.
Again, do not touch the needle or allow it to touch any surface (see Diagram 11).
(ara Dijagramma 11).
Diagram 11.
Dijagramma 11.
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- kunjett.
This is normal.)
Din hi ħaġa normali)
Choosing an injection site
Kif tagħżel is- sit ta 'l- injezzjoni
 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 12).
(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 12).
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.
Diagram 12.
257 Dijagramma 12.
268  A different site should be used for each new injection.
• Għal kull injezzjoni għandek tuża sit ġdid.
Each new injection should be given at least 3 cm from an old site.
Kull injezzjoni ġdida għandha tingħata mill- inqas 3 cm- il bogħod minn fejn kienet ingħatat l- injezzjoni ta’ qabilha.
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 ”).
Preparing the injection site and injecting the Enbrel solution
Kif tipprepara s- sit ta 'l- injezzjoni u tinjetta s- soluzzjoni ta' Enbrel
 Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
• Imsaħ bi swabs bl- alkoħol is- sit fejn ser tagħti l- injezzjoni ta ’ Enbrel, waqt li tuża movimenti ċirkulari.
DO NOT touch this area again before giving the injection.  When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Terġax tmiss din l- erja qabel tagħti l- injezzjoni. • 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.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 13).
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 13).
With experience, you will find the angle that is most comfortable for you or the child.
Bl- esperjenza, għandek issib l- angolu li jkun l- aktar komdu għalik jew għat- tifel/ tifla.
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 13
Dijagramma 13.
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.
With your free hand, hold the syringe near its base to stabilise it.
Bl- id libera tiegħek, żomm is- siringa qrib il- bażi tagħha biex tistabbilizzaha.
Diagram 14.
Imbagħad imbotta l- planġer biex tinjetta s- soluzzjoni kollha b’ rata kostanti u bil- mod, u fissa (ara Dijagramma 14).
 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.
Slight bleeding may occur.
Jista ’ jkun li joħroġ ftit demm.
Do NOT rub the injection site.
Togħrokx is- sit fejn tajt l- injezzjoni.
A bandage is optional.
Jekk trid tista ’ tinfaxxa.
 The syringe and needle should NEVER be re-used.
• Is- siringa u l- labra qatt m’ għandhom jerġgħu jintużaw.
Never recap a needle.
Qatt m’ għandek terġa ’ tgħatti l- labra.
Dispose of the needle 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.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Jekk għandek xi mistoqsijiet, jekk jogħġbok kellem lil tabib, infermier jew spiżjar li hu familjari ma 'Enbrel.
270 PACKAGE LEAFLET:
259 FULJETT TA ’ TAGĦRIF:
Enbrel 25 mg powder for solution for injection Etanercept
Etanercept
Read all (both sides) of this leaflet carefully before you start using this medicine.  Keep this leaflet.
Aqra (iż- żewġ naħat) dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
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 or 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.
Do not pass it on to others.
M’ għandekx tagħtiha lil persuni oħra.
It may harm them, even if their symptoms are the same as yours or 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. • 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.
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)
Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis, and improve your ability to do normal daily activities.
Kemm jekk jintuża waħdu jew flimkien ma 'methotrexate, Enbrel jista' jnaqqas il- ħsara lil ġogi tiegħek ikkawżati mill- artrite rewmatojde, u jttejjeb il- ħila tiegħek biex tagħmel l- attivitajiet normali ta 'kuljum.
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 multiplu 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 li għandhom 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.
271  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. • 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.
260 Enbrel mhux effettiv għat- trattament tal- granulomatosi ta 'Wegener, marda infjammatorja rari.
If you, or the child you are caring for, 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 or the child 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 or the child 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 are not sure, please contact your doctor.  Infections:
Jekk inti m' intiex żgur, jekk jogħġbok ikkuntattja lit- tabib tiegħek. • Infezzjonijiet:
If you or the child have an infection of any kind.
Jekk int għandek xi infezzjoni ta 'kwalunkwe tip.
If you are unsure, please talk to your doctor.
Jekk m' intx żgur, jekk jogħġbok kellem lit- tabib tiegħek.
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 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 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 għandek storja ta 'infezzjonijiet rikorrenti, jew tbatu mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
This may include a thorough medical history, a chest X-ray and a tuberculin test.
Dan jista ’ jinkludi storja medika dettaljata, raġġi X tas- sider u test ta ’ tuberculin.
It is very important that you tell your doctor if you or the child 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.
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 għandek 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 għandek 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:
It- tabib tiegħek ser jistabilixxi jekk Enbrel hux it- trattament adattat. • Insuffiċjenza tal- qalb konġestiva:
Tell your doctor if you or the child 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.
If possible, children should be up to date with all vaccinations before using Enbrel.
261 • Vaċċinazzjonijiet:
Please consult your doctor before you or the child receive any vaccines.  Chickenpox:
Jekk jogħġbok ikkonsulta mat- tabib qabel ma int tiirċievi xi vaċċinazzjonijiet. • Ġidri r- riħ:
Tell your doctor if you or the child are exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk inti espost għal ġidri r- riħ meta tieħu Enbrel.
Your doctor will determine if preventive treatment for chickenpox is appropriate.
It- tabib tiegħek ser jistabilixxi jekk trattament preventiv għal ġidri r- riħ hux adattat.
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 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 tiegħek.
Dosing for adult patients (aged 18 years or over)
Doża għal pazjenti adulti (ta '18- il sena jew aktar)
The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Id- doża ġenerali hi 25 mg li tingħata darbtejn kuljum jew 50 mg darba fil- ġimgħa bħala injezzjoni taħt il- ġilda.
The usual dose is25 mg twice a week or 50 mg once a week.
Id- doża normali hi ta ’ 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
273 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.
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.
Dosing for children and adolescents
262 Doża għat- tfal u l- adoloxxenti
For psoriasis in patients from the age of 8 years, the dose recommended is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50mg), and should be given once weekly.
Għal psorjasi f’ pazjenti mill- età ta ’ 8 snin, id- doża rakkomandata hi ta ’ 0. 8 mg ta ’ Enbrel għal kull kg ta ’ piż tal- ġisem (sa massimu ta ’ 50 mg), u għandha tingħata darba f’ ġimgħa.
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 ”.
If you have used more Enbrel than you should (either by injecting too much on a single occasion, or by using it too frequently), talk to a doctor or pharmacist immediately.
Jekk ħadt aktar Enbrel milli suppost (jew billi f' okkażżjoni waħda injettajt aktar milli suppost, jew billi użajtu aktar ta ’ spiss milli suppost), kellem lit- tabib jew lill- ispiżjar tiegħek minnufih.
Always have the outer carton of the medicine with you, even if it is empty.
Dejjem żomm il- kartuna tal- mediċina miegħek, anke meta tkun vojta.
If you forget to inject Enbrel
Jekk tinsa tinjetta Enbrel
274 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 effect, 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.  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).
263 • 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. • Raxx, ħakk jew ħurrieqa qawwija (rqajja' elevati ta 'ġilda ħamra jew pallida li xi kultant iġġagħlek tħokk).
However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Madankollu, xi sintomi minn dawn ta ’ hawn fuq jistgħu jindikaw reazzjoni allerġika għal Enbrel, u allura inti għandek tfittex l- attenzjoni medika minnufih.
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 għandu mnejn ikollok 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 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 nails or the lips.
• Sinjali ta 'infezzjonijiet serji, bħal deni għoli li jista' jkun akkumpanjat minn sogħla, qtugħ ta ’ nifs, sirdat, debolezza, jew xi erja sħuna, ħamra, tenera u bl- uġigħ fuq il- ġilda jew fil- ġogi. • Sinjali ta 'disturbi fid- demm, bħal fsada, tbenġil, jew sfurija. • 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 isiru lewn blu.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Dawn huma effetti rari jew mhux komuni, imma huma kundizzjonijiet serji (fejn xi wħud jistgħu rarement ikunu fatali).
Other side effects
Effetti sekondarji oħra li jista ’ jkollu
 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
• 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 '264 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.
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tifel/ tifla.
Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Kull kunjett ta 'Enbrel 25 mg fih 25 mg ta' etanercept.
Mannitol, sucrose and trometamol.
Mannitol, sucrose u trometamol.
276 What Enbrel looks like and contents of the pack
Id- dehra ta 'ENBREL u l- kontenuti tal- pakkett
Enbrel 25 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 4 single dose vials and 8 alcohol swabs.
Kull pakkett fih 4 fjali ta ’ doża waħda kull wieħed u 8 swabs ta ’ l- alkoħol.
Marketing Authorisation Holder:
Manifattur:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
265 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
Polska België/ Belgique/ Belgien Luxembourg/ Luxemburg
Deutschland Wyeth Pharma GmbH Tel: + 49 180 2 29 93 84 Fax: +49 251 204 1128
Deutschland Wyeth Pharma GmbH
7.
266 7.
Preparing the Enbrel dose for injection d.
Kif tipprepara d- doża ta ’ Enbrel għall- injezzjoni d.
Adding water for injections e.
Iż- żieda ta ’ l- ilma għall- injezzjonijiet e.
The following instructions explain how to prepare and inject Enbrel.
Dawn l- istruzzjonijiet jispjegaw kif tiprepara u tinjetta Enbrel.
Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Tippruvax tagħti l- injezzjonijiet lilek innifsek jew lil ibnek/ bintek qabel ma tkun żgur/ a li fhimt kif tiprepara u kif tagħti l- injezzjoni.
Setting up for an injection
Kif tlesti għall- injezzjoni