qanastek/EMEA-V3 huggingface dataset:
The symptoms described above can be signs of the below listed side effects, which have been observed with Humira:
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta ’ l- effetti sekondarji mniżżlin hawn taħt, li ġew osservati b’ Humira:
• injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (f’ aktar minn pazjent 1 minn 10): reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk). •
Common (in more than 1 in 100 patients but less than 1 in 10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • viral infections (including influenza, cold blisters and shingles); • bacterial infections (including urinary tract infection; • fungal infection • dizziness, vertigo, headache, sensation disorders; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth inflammation and ulcers; • elevated liver enzymes; • rash, itching; • musculoskeletal pain; • fever, fatigue.
Komuni (f’ aktar minn pazjent 1 minn 100 izda inqas minn pazjent 1 minn 10): infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); • infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - • sinus); infezzjonijiet virali (bħal influenza, infafet kiesħa, ħruq ta ’ Sant’ Antnin); • infezzjonijiet batterjoloġiċi (li jinkludu infezzjonijiet fis- sistema urinarja); • • infezzjonijiet tal- fungu; sturdament, vertigo, uġigħ ta ’ ras, disturbi fis- sensazzjoni; • sogħla, uġigħ fil- griżmejn; • nawseja, dijarea, uġigħ addominali, infjammazzjoni w ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied; • raxx, ħakk; • uġigħ muskoskeletrali; • deni, għeja kbira. •
Uncommon (in more than 1 in 1000 patients but less than 1 in 100 patients): • serious infections (including tuberculosis, histoplasmosis and sepsis [blood poisoning]), joint infection; • skin infections, skin warts, superficial fungal infections; • anaemia, low white blood cell and platelet counts, lymphopaenia (low immune cell counts); • swelling of the lymph nodes; • systemic lupus erythematosus; • allergic reactions (including seasonal and medicines allergy; • increased lipid and uric acid values, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping, shaking; • taste disturbances; • vision disturbances, eye inflammation or infection; • ear discomfort; • sensation of heart beating irregularly, high blood pressure, flushng; • asthma, shortness of breath, hoarseness; • abdominal symptoms (such as vomiting, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing, bruising, hair loss; • muscle weakness;
Mhux komuni (f’ aktar minn pazjent 1 minn 1000 izda inqas minn pazjent 1 minn 100) infezzjonijiet serji (li jinkludu tuberkulożi, ħistoplażmożi u fil- pene [avvelenament tad- demm]), • infezzjoni fil- ġogi; infezzjonijiet u felul fil- ġilda; infezzjonijiet superfiċjali tal- fungu; • anemija, għadd baxx taċ- ċelluli bojod u pjastrini fid- demm; limfopenja (għadd baxx taċ- ċelluli • ta ’ l- immunita ’); nefħa fin- nodi limfatiċi; • • systemic lupus erythematosus; reazzjonijiet allerġiċi (li jinkludu dawk staġonali kif ukoll allerġija għal mediċini); • żieda fil- valuri tal- lipidi u aċtu uriku, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod, rogħoda; • • disturbi fit- togħma disturbi tal- vista, infjammazzjoni jew infezzjoni fl- għajnejn; • • skonfort fil- widnejn; sensazzjoni ta ’ taħbit irregolari tal- qalb, pressjoni għolja tad- demm; fwawar; •
153 • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; • flu-like symptoms, chest pain, swelling of the feet; • accidental injury, impaired healing.
158 ażżma, qtugħ ta ’ nifs, vuċi ħarxa; • sintomi addominali (bħal rimettar, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien • biex ifiqu l- feriti, tbenġil, taqa ’ ix- xagħar; dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn. • korriment aċċidentali, fejqan jieħu iżjed fit- tul •
HOW TO STORE HUMIRA
159 KIF TAĦŻEN HUMIRA 5.
Do not use the Humira vial after the expiry date stated on the label/ blister/ carton after EXP:
Tużax il- kunjett ta ’ Humira wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il- folja/ il- pakkett wara JIS:
Keep the vial in the outer carton
Żomm il- kunjett fil- kartuna ta ’ barra.
What Humira contains
X’ fih Humira:
The active substance is adalimumab.
Is- sustanza attiva hi adalimumab.
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Is- sustanzi l- oħra huma mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjonijiet.
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i. e. essentially ‘ sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodju (23 mg) f’ kull doża ta ’ 0. 8ml, jiġifieri jista jitqies bħala li ma fihx sodju.
What the Humira vial looks like and contents of the pack
Id- Dehra ta ’ Humira u l- kontenuti tal- pakkett:
Humira 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Humira 40 mg soluzzjoni għall- injezzjoni fil- kunjetti hija fornuta bħala soluzzjoni sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml.
The Humira vial is a glass vial containing a solution of adalimumab.
Il- kunjett ta ’ Humira huwa kunjett tal- ħġieġ li fih soluzzjoni ta ’ adalimumab.
Each pack contains 1 vial with an empty sterile syringe and 2 alcohol pads.
Kull pakkett fih kunjett wieħed b’ siringa sterili vojta u 2 kuxxinetti bl- alkoħol.
Humira is also available as a pre-filled syringe or a pre-filled pen.
Humira jista ’ tinxtara ukoll bħala siringa jew pinna mimlija għal- lest.
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D – 65205 Wiesbaden Germany
Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D – 65205 Wiesbaden Ġermanja
155 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
160 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Hadovka Office Park Evropská 2590/ 33d CZ-160 00 Praha 6 Tel: + 420 267 292 111
Evropská 2590/ 33d CZ- 160 00 Praha 6 Tel: + 420 267 292 111
Malta V. J. Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14, Malta.
Marsa HMR 14, Malta.
156 France Abbott France 10, rue d’ Arcueil BP 90233 F-94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
161 France Abbott France 10, rue d’ Arcueil BP 90233 F- 94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
Latvija Abbott Laboratories Baltics Vienī bas 87h LV-1004 Rī ga Tel: + 371 67605580 Lietuva Abbott Laboratories Baltics Vienī bas 87h LV-1004 Rī ga Latvija Tel: + 371 67605580
United Kingdom Latvija Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Tel: + 371 67605580
Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis.
Adalimumab jeħel ma ’ proteina speċifika (fattur tan- nekrosi tat- tumur jew TNFα), li tinsab f’ livelli aktar għolja f’ mard infjammatorju bħal artrite rewmatika, artrite idjopatika poliartikulari taż- żagħżagħ, artrite psorjatika, l- infjammazzjoni tal- vertebri li jirriżulta fil - vertebri jitwaħħlu flimkien (ankylosing spondylitis), il- marda Crohn (Crohn’ s disease) u l- psorajiżi.
158 Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years.
Tista ’ għall- ewwel tingħata
You may first be given other disease-modifying medicines, such as methotrexate.
163 medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
Ankylosing spondylitis is an inflammatory disease of the spine.
L - infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis) hija marda infjammatorja ta ’ l- ispina.
Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or e. g. phototherapy If you do not respond well enough to these treatments, you will be given Humira to reduce the signs and symptoms of your psoriasis.
Jekk ma jkollokx biżżejjed rispons għal dawn il- mediċini, inti tingħata Humira biex tnaqqas is- sinjali u s- sintomi tal- psorajiżi tiegħek.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
164 Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) • kellem lit- tabib tiegħek qabel tibda Humira.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi or
Dawn l- infezzjonijiet jistgħu jkunu serji u jinkludu tuberkulosi, infezzjonijiet ikkawżati minn virus, fungus jew batterji jew infezzjonijiet opportunistiċi u sepsis oħra li, f’ każi rari, jistgħu ipoġġu l- ħajja fil- periklu.
159 bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Huwa importanti li inti tgħid lit- tabib tiegħek jekk ikollok sintomi bħal deni, feriti, tħossok għajjien jew ikollok problemi tas- snien.
It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporary discontinuation of Humira.
It- tabib jista ’ jirrakkomandalek li twaqqaf Humira għal ftit żmien.
If you develop new or worsening symptoms of heart failure (e. g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Jekk inti tiżviluppa sintomi ġodda, jew jiggravawlek is- sintomi preżenti ta ’ insuffiċjenza tal- qalb (eż. qtugħ ta ’ nifs, jew nefħa fis- saqajn), inti għandek tikkuntatja lit- tabib tiegħek immedjatament.
Your doctor will decide if you should receive Humira.
It- tabib tiegħek għandu jiddeciedi jekk għandekx tieħu Humira
• There have been very rare cases of certain kinds of cancer in patients taking Humira or other TNF blockers.
165 Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Humira jew mediċini oħra • li jimblukkaw t- TNF.
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma, which isa kind of cancer that affects the lymph system.
Persuni li għandhom artrite rewmatika aktar serja u li ilhom ibatu minnha għal żmien twil jista ’ jkollhom riskju akbar mill- medja li jaqbadhom lymphoma, li hu kanċer li jaffetwa is- sistema limfatika.
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Humira.
F’ każijiet rari, tip partikolari ta ’ lymphoma aħrax, tfaċċja f ’ pazjenti li kienu qed jieħdu Humira.
The effects of Humira in pregnant women are not known and so the use of Humira in pregnant women is not recommended.
L- effetti ta ’ Humira fuq nisa tqal għadhom m’ humiex maghrufa, u għalhekk l- użu ta ’ Humira min- nisa tqal m’ huwiex irrakomandat.
HOW TO USE HUMIRA
166 KIF GĦANDEK TUŻA HUMIRA 3.
The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Humira for as long as your doctor has told you.
Id- doża li s - soltu tingħata għall- pazjenti adulti li jbatu mill- psorajiżi hija doża inizjali ta ’ 80 mg, segwita b’ doża ta ’ 40 mg li tingħata ġimgħa iva u ġimgħa le, u li tinbeda wara li tgħaddi ġimgħa mid- doża inizjali.
161 In rheumatoid arthritis, methotrexate is continued while using Humira.
F ’ każ ta ’ artrite rewmatika, methotrexate jibqa ’ jintuża waqt li jkun qiegħed jintuża Humira.
One pre-filled syringe of Humira for injection One alcohol pad
Siringa waħda ta ’ Humira għall- injezzjoni, mimlija għal- lest o Kuxxinett wieħed bl- alkoħol o
• Look at the expiry date on the syringe.
167 Iċċekja d- data ta ’ l- iskadenza fuq il- kunjett.
2) Choosing and preparing an injection site
2) Biex tagħżel u tipprepara l- post fejn se tieħu l- injezzjoni
162 • Each new injection should be given at least 3 cm from the last injection site.
Kull injezzjoni ġdida għandha tingħata f’ post li jkun mill- inqas 3 cm ’ il bogħod mill- post fejn • tkun ingħatat l- aħħar injezzjoni.
• Do NOT shake the syringe. • Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface. • With one hand, gently grasp the cleaned areas of skin and hold firmly
B’ id waħda, aqbad bil- mod il- partijiet tal- ġilda li ġew imnaddfa u żommhom sod •
4) Throwing away supplies
168 4) Biex tarmi l- affarijiet li użajt
NEVER recap a needle. • After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. • Keep this container out of the reach and sight of children
M’ għandek QATT terġa ’ tlibbes l- għatu • fuq il- labra Wara li tinjetta Humira, armi s- siringa użata immedjatament f’ kontenitur speċjali, kif qallek it - • tabib, l- infermier jew l- ispiżjar tiegħek.
Always take the outer carton of medicine with you, even if it is empty.
Dejjem ħu miegħek il- kartuna ta ’ barra jew il- kunjett tal- mediċina, anke jekk ikunu vojta.
Tell your doctor immediately if you notice any of the following: • Severe rash, hives or other signs of allergic reaction; • Swollen face, hands, feet; • Trouble breathing, swallowing; • Shortness of breath with exertion or upon lying down or swelling of the feet; • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika; • Nefħa fil- wiċċ, fl- idejn u fis- saqajn; • Diffikultà biex tieħu n- nifs, biex tibla ’; • Qtugħ ta ’ nifs meta tagħmel l- eżeċizzju jew meta timtedd jew nefħa fis- saqajn; • Sinjali u sintomi li għandhom x’ jaqsmu ma’ disturbi tad- demm bħal deni persistenti, tbenġil, • ħruġ ta ’ demm, tkun pallidu.
Very common (inmore than 1 in 10 patients): • injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (f’ aktar minn pazjent 1 minn 10): reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk). •
Common (in more than 1 in 100 patients but less than 1 in 10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • viral infections (including influenza, cold blisters and shingles) • bacterial infections (including urinary tract infection); • fungal infection; • dizziness, vertigo, headache, sensation disorders; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth inflammation and ulcers; • elevated liver enzymes; • rash, itching; • musculoskeletal pain; • fever fatigue.
169 Komuni (f’ aktar minn pazjent 1 minn 100 izda inqas minn pazjent 1 minn 10): infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); • infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - • sinus); infezzjonijiet virali (bħal influenza, infafet kiesħa, ħruq ta ’ Sant’ Antnin); • infezzjonijiet batterjoloġiċi (li jinkludu infezzjonijiet fis- sistema urinarja); • • infezzjonijiet tal- fungu; sturdament, vertigo, uġigħ ta ’ ras, disturbi fis- sensazzjoni; • sogħla, uġigħ fil- griżmejn; • nawseja, dijarea, uġigħ addominali, infjammazzjoni w ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied; • raxx, ħakk; • uġigħ muskoskeletrali; • deni, għeja kbira. •
Uncommon (in more than 1 in 1000 patients but less than 1 in 100 patients): • serious infections (including tuberculosis, histoplasmosis and sepsis [blood poisoning]), joint infection; • skin infections, skin warts, superficial fungal infections; • anaemia, low white blood cell and platelet counts lymphopaenia (low immune cell counts); • swelling of thelymph nodes; • systemic lupus erythematosus; • allergic reactions(including seasonal and medicines allergy); • increased lipid and uric acid values, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping, shaking; • taste disturbances;
Mhux komuni (f’ aktar minn pazjent 1 minn 1000 izda inqas minn pazjent 1 minn 100) infezzjonijiet serji (li jinkludu tuberkulożi, ħistoplażmożi u fil- pene [avvelenament tad- demm]), • infezzjoni fil- ġogi; infezzjonijiet u felul fil- ġilda; infezzjonijiet superfiċjali tal- fungu; • anemija, għadd baxx taċ- ċelluli bojod u pjastrini fid- demm; limfopenja (għadd baxx taċ- ċelluli • ta ’ l- immunita ’); nefħa fin- nodi limfatiċi; • • systemic lupus erythematosus; reazzjonijiet allerġiċi (li jinkludu dawk staġonali kif ukoll allerġija għal mediċini); • żieda fil- valuri tal- lipidi u aċtu uriku, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod, rogħoda; • • disturbi fit- togħma disturbi tal- vista, infjammazzjoni jew infezzjoni fl- għajnejn; • • skonfort fil- widnejn; sensazzjoni ta ’ taħbit irregolari tal- qalb, pressjoni għolja tad- demm; fwawar; • ażżma, qtugħ ta ’ nifs, vuċi ħarxa; • sintomi addominali (bħal rimettar, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien • biex ifiqu l- feriti, tbenġil, taqa ’ ix- xagħar; dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn. • korriment aċċidentali, fejqan jieħu iżjed fit- tul •
164 • vision disturbances, eye inflammation or infection; • ear discomfort; • sensation of heart beatingirregularly, high blood pressure, flushing; • asthma, shortness of breath, hoarseness; • abdominal symptoms (such as vomiting, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing, bruising, hair loss; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; • flu-like symptoms, chest pain, swelling of the feet; • accidental injury, impaired healing.
Rari (f’ aktar minn pazjent 1 minn 10, 000 izda inqas minn pazjent 1 minn 1000) pressjoni għolja fl- għajnejn, infjammazzjoni tal- parti kkulurita tal- għajn, infjammazzjoni • estensiva tal- għajn; kanċer tal- ġilda, kanċer, kanċer li jaffetwa is- sistema limfatika, melanoma malinna; • • distrubi fit- tirojde; • proteina fl- awrina; nuqqas tal- pjastrini fid- demm li jżid ir- riskju ta ’ ħruġ ta ’ demm jew tbenġil, nuqqas taċ- ċelluli • fid- demm li jista jikkawża dgħufija, tbenġil, jew iżid iċ- ċans ta ’ infezzjonijiet; uġigħ fis- sider, il- qalb tieqaf tħabbat, imblukkar fl- arterji tal- qalb, ilma mad- dawra tal- qalb li • jista jwassal għal uġigħ qawwi fis- sider, problemi fil qalb li jistgħu iwasslu għal qtugħ ta ’ nifs jew nefħa fl- aksa, sensazzjoni ta ’ taħbit mgħaġġel tal- qalb; telf ta’ smiegħ, żanżin fil- widnejn • infjammazzjoni tal- frixa li tista tikkawża uġigħ qawwi fiż- żaqq u fid- dahar, infjammazzjoni li • tikkawża uġigħ ta ’ żaqq u dijarea, imblukkar tal- intestini li jikkawżaw dardir u rimettar,
165 If any of the side effects get serious, if you have any unusual effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE HUMIRA
171 KIF TAĦŻEN HUMIRA 5.
Do not use the Humira pre-filled syringe after the expiry date stated on the label/ blister/ carton after EXP:
Tużax is- siringa ta ’ Humira mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il - folja/ il- pakkett wara JIS:
Keep the pre-filled syringe in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
What the Humira pre-filled syringe looks like and contents of the pack
Id- Dehra ta ’ Humira u l- kontenuti tal- pakkett:
Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Humira 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest hija fornuta bħala soluzzjoni sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml.
The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.
Is- siringa ta ’ Humira mimlija għal- lest hi siringa tal- ħġieġ li fiha soluzzjoni ta ’ adalimumab.
Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.
Kull pakkett ikun fih 1, 2, 4 jew 6 siringi mimlijin għal- lest għall- użu mill- pazjent b’ kuxxinett bl - alkoħol 1 (wieħed), 2, 4 jew 6, rispettivament.
Humira is also available as a vial or a pre-filled pen.
Humira jista ’ tinxtara ukoll bħala kunjett jew pinna mimlija għal- lest.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni
Manufacturer:
Il- Manifattur
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D - 65205 Wiesbaden Germany
Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D – 65205 Wiesbaden Ġermanja
166 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
172 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Postę pu 18A PL-02-676 Warszawa Tel.: + 48 22 606-10-50
Polska Abbott Laboratories Poland Sp. z o. o. ul. Postępu 18A PL- 02- 676 Warszawa Tel.: + 48 22 606- 10- 50
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, P-2610-008 Amadora Tel: + 351 (0) 21 472 7100
Estrada de Alfragide, n˚ 67 Alfrapark, Edificio D, P- 2610- 008 Amadora Tel: + 351 (0) 21 472 7100
168 PACKAGE LEAFLET:
174 FULJETT TA ’ TAGĦRIF:
169 Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years.
Tista ’ għall- ewwel tingħata
You may first be given other disease-modifying medicines, such as methotrexate.
175 medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
176 Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) • kellem lit- tabib tiegħek qabel tibda Humira.
170 • You might get infections more easily while you are receiving Humira treatment These infections may be more serious and include tuberculosis, infections caused by viruses, fungi or bacteria, or other opportunistic infections and sepsis that may, in rare case, be life-threatening.
Dawn l- infezzjonijiet jistgħu jkunu serji u jinkludu tuberkulosi, infezzjonijiet ikkawżati minn virus, fungus jew batterji jew infezzjonijiet opportunistiċi u sepsis oħra li, f’ każi rari, jistgħu ipoġġu l- ħajja fil- periklu.
It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Huwa importanti li inti tgħid lit- tabib tiegħek jekk ikollok sintomi bħal deni, feriti, tħossok għajjien jew ikollok problemi tas- snien.
• If you have demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive Humira
Jekk inti tbati minn mard li jaffetwaw il- myelin tan- nervituri bħal sklerosi multipla, it- tabib • tiegħek għandu jiddeċiedi jekk inti għandekx tirċievi Humira.
If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
177 ħafna, ċempel lit- tabib tiegħek immedjatament.
• There have been very rare cases of certain kinds of cancer in patients taking Humira or other TNF blockers.
Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Humira jew mediċini oħra • li jimblukkaw t- TNF.
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma, which is a kind of cancer that affects the lymph system.
Persuni li għandhom artrite rewmatika aktar serja u li ilhom ibatu minnha għal żmien twil jista ’ jkollhom riskju akbar mill- medja li jaqbadhom lymphoma, li hu kanċer li jaffetwa is- sistema limfatika.
171 • There have been cases of cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Kien hemm każijiet ta ’ tipi ta ’ kanċer oħra, minbarra limfoma, f’ pazjenti li jbatu minn marda • speċifika tal- pulmun, li tissejjaħ mard kroniku assoċjat ma ’ imblukkar fis- sistema respiratorja (COPD), u li jirċievu l- kura b’ mediċina oħra li timblokka t- TNF.
If you are a breast-feeding mother, advise you should stop breast-feeding during Humira treatment, and for at least 5 months after the last Humira treatment.
Jekk inti qiegħda tredda ’, int għandek tieqaf tredda ’ matul it- trattamant b’ Humira u għal mill- inqas 5 xhur wara l- aħħar trattament b’ Humira.
HOW TO USE HUMIRA
178 KIF GĦANDEK TUŻA HUMIRA 3.
The usual dose regimen for Crohn’ s disease is 80 mg atWeek 0 and followed by 40 mg every other week starting at week 2.
Id- dożaġġ li jingħata s- soltu għall- marda Crohn (Crohn’ s disease) huwa ta ’ 80 mg f’ Ġimgħa 0 segwit b’ 40 mg ġimgħa iva u ġimgħa le li jinbew minn Ġimgħa 2.
The usual dose
It- tabib tiegħek jista ’ jżidlek id- doża għal 40 mg kull ġimgħa, u dan skond ir- rispons tiegħek għall- mediċina.
172 for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Id- doża li s - soltu tingħata għall- pazjenti adulti li jbatu mill- psorajiżi hija doża inizjali ta ’ 80 mg, segwita b’ doża ta ’ 40 mg li tingħata ġimgħa iva u ġimgħa le, u li tinbeda wara li tgħaddi ġimgħa mid- doża inizjali.
1) Setting up
179 1) Il- preparazzjoni
• Look at the expiry date on the syringe.
Iċċekja d- data ta ’ l- iskadenza fuq il- kunjett.
3) Injecting Humira
180 3) Biex tinjetta Humira
A little bleeding may occur.
B’ moviment wieħed qasir u mgħaġġel, imbotta l- labra kollha fil- ġilda • Itlaq l- ewwel id minn mal- ġilda • Imbotta l- planġer biex tinjetta s- soluzzjoni – tista ’ tieħu minn 2 sa 5 sekondi biex titbattal is - • siringa Meta is- siringa tiżvojta, neħħi l- labra minn ġol- ġilda, u oqgħod attent li żżommha fl- istess • angolu li żammejtha biex daħħaltha Żomm is- siringa f’ id waħda, u bl- id l- oħra żerżaq il- kappa protettiva ta ’ barra fuq il- labra • mikxufa sakemm tinżel f’ postha Bis- saba ’ il- kbir ta ’ idejk, jew b’ biċċa garża, agħfas il- post ta ’ l- injezzjoni għal 10 sekondi. • Jista ’ joħroġlok ftit demm.
NEVER recap a needle • After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. • Keep this container out of the reach and sight of children
M’ għandek QATT terġa ’ tlibbes l- għatu • fuq il- labra Wara li tinjetta Humira, armi s- siringa użata immedjatament f’ kontenitur speċjali, kif qallek it - • tabib, l- infermier jew l- ispiżjar tiegħek.
POSSIBLE SIDE EFFECTS
181 EFFETTI SEKONDARJI LI JISTA ’ JKOLLU 4.
Side effects may occur at least up to 5 months after the lastHumira injection.
L- effetti sekondarji jistgħu ifeġġu sa mill- inqas 5 xhur wara l- aħħar injezzjoni b ’ Humira.
Tell your doctor as soon as possible if you notice any of the following: • Signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; • Feeling weak or tired; • Coughing; • Tingling; • Numbness; • Double vision; • Arm or leg weakness. • A bump or open sore that does n't heal
Sinjali ta ’ infezzjoni bħal deni, tħossok marid, feriti, problemi tas- snien, ħruq waqt għamil ta ’ l - • awrina; Tħossok dgħajjef jew għajjien; • Sogħla; • • Tnemnim; Tirżiħ; • • Tara doppju; Dgħufija fl- idejn jew fir- riġlejn; • Nefħa jew ferita miftuħa li ma tfiqlekx. •
Very common (in more than 1 in 10 patients): • injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (f’ aktar minn pazjent 1 minn 10): reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk). •
Common (in more than 1 in 100 patients but less than 1 in 10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • viral infections (including influenza, cold blisters and shingles); • bacterial infections (including urinary tract infection); • fungal infection; • dizziness, vertigo, headache, sensation disorders; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth inflammation and ulcers; • elevated liver enzymes; • rash, itching; • musculoskeletal pain; • fever, fatigue
Komuni (f’ aktar minn pazjent 1 minn 100 izda inqas minn pazjent 1 minn 10): infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); • infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - • sinus); infezzjonijiet virali (bħal influenza, infafet kiesħa, ħruq ta ’ Sant’ Antnin); • infezzjonijiet batterjoloġiċi (li jinkludu infezzjonijiet fis- sistema urinarja); • • infezzjonijiet tal- fungu; sturdament, vertigo, uġigħ ta ’ ras, disturbi fis- sensazzjoni; • sogħla, uġigħ fil- griżmejn; • nawseja, dijarea, uġigħ addominali, infjammazzjoni w ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied; • raxx, ħakk; • uġigħ muskoskeletrali; • deni, għeja kbira. •
Uncommon (in more than 1 in 1000 patients but less than 1 in 100 patients): • serious infections (including tuberculosis, histoplasmosis and sepsis [blood poisoning]), joint infection; • skin infections, skin warts, superficial fungal infections; • anaemia, low white blood cell and platelet counts, lymphopaenia (low immune cell counts); • swelling of the lymph nodes; • systemic lupus erythematosus; • allergic reactions (including seasonal and medicines allergy); • increased lipid and uric acid values, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping, shaking; • taste disturbances;
Mhux komuni (f’ aktar minn pazjent 1 minn 1000 izda inqas minn pazjent 1 minn 100) infezzjonijiet serji (li jinkludu tuberkulożi, ħistoplażmożi u fil- pene [avvelenament tad- demm]), • infezzjoni fil- ġogi; infezzjonijiet u felul fil- ġilda; infezzjonijiet superfiċjali tal- fungu; • anemija, għadd baxx taċ- ċelluli bojod u pjastrini fid- demm; limfopenja (għadd baxx taċ- ċelluli • ta ’ l- immunita ’); nefħa fin- nodi limfatiċi; • • systemic lupus erythematosus;
175 • vision disturbances, eye inflammation or infection; • ear discomfort; • sensation of heart beating irregularly, high blood pressure; flushing; • asthma, shortness of breath, hoarseness; • abdominal symptoms (such as vomiting, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing, bruising, hair loss; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; • flu-like symptoms, chest pain, swelling of the feet; • accidental injury, impaired healing.
182 reazzjonijiet allerġiċi (li jinkludu dawk staġonali kif ukoll allerġija għal mediċini); • żieda fil- valuri tal- lipidi u aċtu uriku, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod, rogħoda; • • disturbi fit- togħma disturbi tal- vista, infjammazzjoni jew infezzjoni fl- għajnejn; • • skonfort fil- widnejn; sensazzjoni ta ’ taħbit irregolari tal- qalb, pressjoni għolja tad- demm, fwawar; • ażżma, qtugħ ta ’ nifs, vuċi ħarxa; • sintomi addominali (bħal rimettar, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien • biex ifiqu l- feriti, tbenġil, taqa ’ ix- xagħar; dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn. • korriment aċċidentali, fejqan jieħu iżjed fit- tul •
• Guillain-Barré syndrome, (muscle weakness, abnormal sensations, tingling in the arms and upper body); • intestinal perforation; • hepatosplenic T-cell lymphoma
183 Sklerozi multipla; Dgħufija fil- muskoli tal- wiċċ jew paralisi. • • Sindromu ta ’ Guillain- Barré, (debbolizza fil- muskoli, sensazzjonijiet mhux tas- soltu, tnemnim fl- idejn u fil- parti ta ’ fuq tal- ġisem); • Perforazzjoni tal- intestini. hepatosplenic T- cell lymphoma •
176 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE HUMIRA
KIF TAĦŻEN HUMIRA 5.
Do not use the Humira pre-filled syringe after the expiry date stated on the label/ blister/ carton after EXP:.
Tużax is- siringa ta ’ Humira mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il - folja/ il- pakkett wara JIS:
What Humira contains The active substance is adalimumab.
Is- sustanza attiva hi adalimumab.
What the Humira pre-filled syringe looks like and contents of the pack The Humira pre-filled syringe is a glass syringe with needleguard containing a solution of adalimumab.
Id- Dehra ta ’ Humira u l- kontenuti tal- pakkett:
Each pack contains 1 pre-filled syringe with needleguard for hospital administration or administration by a caregiver, with 1 alcohol pad.
Humira 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest hija fornuta bħala soluzzjoni sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml.
Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Is- siringa ta ’ Humira mimlija għal- lest hi siringa tal- ħġieġ bil- labra mgħottija, li fiha soluzzjoni ta ’ adalimumab.
Humira is also available as a vial or a pre-filled pen.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. Humira jista ’ tinxtara ukoll bħala kunjett jew pinna mimlija għal- lest.
Manufacturer:
184 Il- Manifattur
177 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
España Abbott Laboratories, S. A.
185 Portugal España Abbott Laboratories, S. A.
179 PACKAGE LEAFLET:
186 FULJETT TA ’ TAGĦRIF:
Humira 40 mg solution for injection in pre-filled pen Adalimumab
Humira Pinna mimlija għal- lest 40 mg soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Adalimumab
Keep this Patient Alert Card with you. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Humira is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease, and psoriasis.
Humira huwa intenzjonat għall- kura ta ’ l- artrite rewmatika, artrite psorjatika, artrite attiva idjopatika poliartikulari taż- żagħżagħ u infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), tal- marda Crohn (Crohn’ s Disease), u tal- psorajiżi.
Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis.
Adalimumab jeħel ma ’ proteina speċifika (fattur tan- nekrosi tat- tumur jew TNFα), li tinsab f’ livelli aktar għolja f’ mard infjammatorju bħal artrite rewmatika, artrite idjopatika poliartikulari taż- żagħżagħ, artrite psorjatika u infjammazzjoni tal- vertebri li jirriżulta fil - vertebri jitwaħħlu flimkien (ankylosing spondylitis), il- marda Crohn (Crohn’ s disease) u l- psorajiżi.
Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years.
L- artrite attiva idjopatika poliartikulari taż- żagħżagħ hi marda infjammatorja tal- ġogi li teffetwa ġog wieħed jew aktar li ġeneralment tinduna biha fi tfal taht is- 16 – il sena.
You may first be given other
Tista ’ għall- ewwel tingħata
180 disease-modifying medicines, such as methotrexate.
187 medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Ġie ppruvat li Humira jittardja l- ħsara fuq il- qarquċa u fuq l- għadam tal- ġogi, li tiġi kkawżata mill - marda, u li jtejjeb il- funzjoni fiżika.
Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function. Ankylosing spondylitis
Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
Psoriasis is an inflammatory disease of the skin If you have moderate to severe plaque psoriasis, you will first be given other medicines or e. g. phototherapy. If you do not respond well enough to these treatments, you will be given Humira to reduce the signs and symptoms of your psoriasis.
Jekk ma jkollokx biżżejjed rispons għal dawn il- mediċini, inti tingħata Humira biex tnaqqas is- sinjali u s- sintomi tal- psorajiżi tiegħek.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
188 Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) • kellem lit- tabib tiegħek qabel tibda Humira.
181 • As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira.
Peress illi ġew irrappurtati każi ta ’ tuberkulosi f’ pazjenti kkurati b’ Humira, qabel tibda Humira, • it- tabib tiegħek se jeżaminak għal sinjali u sintomi tat- tuberkulosi.
Your doctor will decide if you should receive Humira.
It- tabib tiegħek għandu jiddeciedi jekk għandekx tieħu Humira.
• There have been very rare cases of certain kinds of cancer in patients taking Humira or other TNF blockers.
189 Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Humira jew mediċini oħra • li jimblukkaw t- TNF.
• There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Kien hemm każijiet ta ’ tipi ta ’ kanċer oħra, minbarra limfoma, f’ pazjenti li jbatu minn marda • speċifika tal- pulmun, li tissejjaħ mard kroniku assoċjat ma ’ imblukkar fis- sistema respiratorja (COPD), u li jirċievu l- kura b’ mediċina oħra li timblokka t- TNF.
182 Using other medicines
Meta tuża mediċini oħra
HOW TO USE THE HUMIRA PRE-FILLED PEN
190 KIF GĦANDEK TUŻA HUMIRA 3.
Always use Humira exactly as your doctor has told you.
Dejjem għandek tieħu Humira skond il- parir tat- tabib.
I n cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at Week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at Week 2, and thereafter as 40 mg (1 injection) every other week.
F’ każi fejn ikun hemm bżonn ta ’ rispons aktar mgħaġġel, it- tabib tiegħek jista ’ jagħtik doża ta ’ 160 mg f’ Ġimgħa 0 (bħala 4 injezzjonijiet f’ ġurnata waħda jew 2 injezzjonijiet kull ġurnata għal jumejn konsekuttivi), 80 mg (2 injezzjonijiet) f’ Ġimgħa 2, u wara dan 40 mg (injezzjoni waħda) ġimgħa iva u ġimgħa le.
The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Id- doża li s - soltu tingħata għall- pazjenti adulti li jbatu mill- psorajiżi hija doża inizjali ta ’ 80 mg, segwita b’ doża ta ’ 40 mg li tingħata ġimgħa iva u ġimgħa le, u li tinbeda wara li tgħaddi ġimgħa mid- doża inizjali.
183 In rheumatoid arthritis, methotrexate is continued while using Humira.
F ’ każ ta ’ artrite rewmatika, methotrexate jibqa ’ jintuża waqt li jkun qiegħed jintuża Humira.
If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg Humira every week.
Jekk inti tbati minn artrite rewmatika u ma tkunx qiegħed tirċievi methotrexate flimkien mal- kura b’ Humira, it- tabib tiegħek jista ’ jiddeċiedi li jagħtik 40 mg adalimumab kull ġimgħa.
Injecting Humira yourself
Biex tinjetta lilek innifsek
The following instructions explain how to give yourself an injection of Humira using the pre-filled pen.
L- istruzzjonijiet segwenti jispjegaw kif tinjetta lilek innifsek b’ Humira bil- pinna mimlija għal- lest.
You will be instructed by your doctor or his/ her assistant on the technique of self-injection.
Inti se tiġi mgħallem mit - tabib tiegħek jew mill- assistent tiegħu/ tagħha dwar it- teknika ta ’ kif tinjetta lilek innifsek.
After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Wara taħriġ xieraq, l- injezzjoni tista ’ tingħata minnek stess jew minn persuna oħra, per eżempju membru tal - familja jew xi ħabib/ a.
What should I do before I give myself a subcutaneous injection of Humira?
191 X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Humira?
Take one dose tray containing a pre-filled pen of Humira from the refrigerator.
Mill- friġġ, ħu trej wieħed tad- doża mimli b’ pinna ta ’ Humira mimlija għal- lest.
Do not shake or drop the pre-filled pen.
Tħawwadx jew twaqqax il- pinna mimlija għal- lest.
Set up the following items on a clean surface.
Poġġi dawn l- affarijiet li ġejjin fuq wiċċ nadif.
One pre-filled pen of Humira One alcohol pad
Pinna waħda ta ’ Humira mimlija għal- lest o Kuxxinett wieħed bl- alkoħol o
Check the expiry date on the pre-filled pen label (EXP:) Do not use the product if the date has passed the month and year shown.
Tużax il- prodott wara x- xahar u s- sena murija.
Hold the pre-filled pen with the grey cap (labelled ‘1’) pointing up.
Żomm il- pinna mimlija għal- lest bl- għatu l- griż (immarkat ‘ 1 ’) iħares ’ il fuq.
Check the appearance of the Humira solution through the windows on the sides of the pre-filled pen.
Iċċekja d- dehra tas- soluzzjoni Humira mit- twieqi tal- ġnub tal- pinna mimlija għal- lest.
It must be clear and colourless.
Din għandha tkun ċara u mingħajr kulur.
If it is cloudy or discoloured or has flakes or particles in it, you must not use it.
Jekk tkun imċajpra jew tkun bidlet il- kulur jew ikollha xi biċċiet irqaq jew partiċelli fiha, tużahiex.
Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight.
Tużax pinna mimlija għal- lest li tkun iffriżata jew li tkun tħalliet f’ xemx diretta fuqha.
184 Where should I give my injection?
192 Fejn għandi nagħti l- injezzjoni?
Choose a site on the top of your thigh or stomach (except the area around the navel).
Agħżel post fuq in- naħa ta ’ fuq tal- koxxa jew ta ’ l- istonku (ħlief il- parti ta ’ madwar iż- żokkra).
Change the place that you inject each time so that you do not become sore in one area.
Biddel il- post ta ’ l- injezzjoni kull darba, biex inti ma jkollokx uġigħ fl- istess parti.
This may mean there is an infection.
Kull injezzjoni ġdida għandha tingħata f’ post li jkun mill- inqas 3 cm ’ il bogħod mill- post fejn tkun ingħatat l- aħħar injezzjoni.
How do I give my injection?
Kif nagħti l- injezzjoni?
Wipe your skin by using the enclosed alcohol pad, using a circular motion.
Imsaħ il- ġilda, permezz ta ’ movimenti mdawra, bil- kuxxinett bl- alkoħol li ssib fil- pakkett.
Do not touch the area again before injecting.
Terġax tmiss din il- parti qabel tagħti l- injezzjoni.
Hold the pre-filled pen with one hand with the grey cap (1) pointed down.
B’ id waħda żomm il- pinna mimlija għal- lest bl- għatu l- griz (1) iħares ’ l isfel.
With your other hand, pull the grey cap (1) straight off and discard cap.
Bl- id l- oħra, neħħi l- għatu l- griż (1) u armih.
Check that the small grey needle cover of the syringe has been removed with the cap.
Ara li l- għatu l- griż iż- żgħir li jgħatti l- labra tas- siringa tneħħa ukoll ma ’ l- għatu.
The white needle sleeve will now be exposed.
Il- biċċa l- bajda li tgħatti l- labra issa tkun mikxufa.
Do not try to touch the needle housed in the barrel.
Tippruvax tmiss il- labra li jkun hemm fil- bettija.
DO NOT RECAP as you may damage the needle inside.
TERĠAX TLIBBES L- GĦATU għax tista ’ tagħmel ħsara lil- labra.
Pull the plum safety cap (labelled ‘2’) straight off to expose the plum coloured activation button at the top.
Neħħi l- għatu tas- sigurtà ta ’ kulur l- għanbaqra (immarkat ‘ 2 ’) biex tikxef il- buttuna ta ’ kulur l - għanbaqra li tattiva, u li qiegħda fuq nett.
The pre-filled pen is now ready to use.
Il- pinna mimlija għal- lest hija lesta għall- użu.
Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Sakemm issib il- pożizzjoni t- tajba, tafasx il- buttuna ta ’ kulur l- għanbaqra li tattiva, għax inkella toħroġ il- medikazzjoni.
DO NOT RECAP as this could cause the unit to discharge.
TERĠAX TLIBBES L- GĦATU, għax dan jista jikkawża l- ħruġ tal - medikazzjoni mill- unità.
185 Giving the injection
Biex tagħti l- injezzjoni
With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and hold firmly (see below).
Bl- id il- vojta, aqbad bil- mod parti kbira mhux ħażin mill- ġilda li int tkun naddaft fil- post ta’ fejn tkun se tingħata l- injezzjoni, u żommha sod (ara hawn taħt).
Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window.
Poġġi t- tarf l- abjad tal- pinna mimlija għal- lest f’ angolu rett (90 grad) mill- ġilda, biex inti tkun tista ’ tara t- tieqa.
Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding in place without moving).
Żomm il- bettija tal- pinna mimlija għal- lest, u agħfas ftit ’ l isfel fuq il- post fejn se tingħata l - injezzjoni (żommha f’ postha mingħajr ma ċċaqlaqha).
With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Kif inti tkun lest biex tagħti l- injezzjoni, bis- suba ’ l- werrej jew il- kbir, agħfas il- buttuna ta ’ kulur l- għanbaqra li tinsab fuq nett (ara hawn taħt).
You will then hear a ‘click’ as the needle is released, and you will feel a small prick as the needle advances.
Hekk kif il- labra tkun meħlusa, inti tisma ’ ‘ klick ’, u tħoss tingiża żgħira kif il- labra tidħol.
Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection.
Ibqa ’ agħfas u kompli żomm il- pinna mimlija għal- lest f’ postha bi pressjoni kostanti għal bejn wieħed u ieħor 10 sekondi biex tkun żgur illi l- injezzjoni ingħatat kollha.