qanastek/EMEA-V3 huggingface dataset:
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jikkommetti ruħu sabiex iwettaq l- istudji u l- attivitajiet farmakoviġilanti addizzjonali li jinsabu imniżżla fil- pjan tal- farmakoviġilanza, kif miftihem f’ verżjoni 2. 0 tal- Pjan Dwar l- Immaniġġar tar- Riskju (RMP) li ġie ppreżentat
111 As per the CHMP guideline on the Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR)
116 f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis- suq u aġġornamenti sussegwenti oħra tal- RMP aċċettati mis- CHMP.
In addition, an updated RMP should be submitted
Skond il- linja gwida CHMP li titratta dwar is- Sistemi ta ’ l- Immaniġjar tar- Riskju għall- prodotti mediċinali magħmula għall- użu mill- bniedem, il- RMP aġġornat għandu jiġi ssottomettat flimkien mar- Rapport Perjodiku ta’ Aġġornamenti dwar is- Sigurtà (PSUR).
- when new information is received that may impact on the current Safety Specification,
Barra minn dan, għandu jiġi ssottomettat RMP aġġornat meta jkun hemm informazzjoni ġdida li tista ’ taffetwa l- Ispeċifikazzjoni dwar is- Sigurtà
- within 60 days of an important (pharmacovigilance or minimisation) milestone being reached
applikabbli bħalissa, Pjan tal- Farmakoviġilanza jew attivitajiet relatati mat- tnaqqis tar - riskju fi żmien 60 ġurnata mid- data meta jseħħ avveniment (relatat ma ’ farmakoviġilanza jew
- at the request of the EMEA
- fuq talba ta ’ l- EMEA
The marketing authorisation holder should submit 6 monthly periodic safety update reports.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jippreżenta kull 6 xhur rapporti li jikkonsistu f’ aġġornament dwar is- sigurtà tal- mediċina.
112 ANNEX III
117 ANNESS III
113 A.
118 A.
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
119 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
IL- KARTUNA TA ’ BARRA
Humira 40 mg solution for injection Adalimumab
Humira 40 mg soluzzjoni għall- injezzjoni Adalimumab
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA 2.
One 0.8 ml vial contains 40 mg adalimumab
Kunjett wieħed ta ’ 0. 8 mg adalimumab
Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Sustanzi mhux attivi: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjonijiet.
PHARMACEUTICAL FORM AND CONTENTS
GĦAMLA FARMAĊEWTIKA U KONTENUT 4.
1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle 2 alcohol pads
Kunjett wieħed fih 40 mg adalimumab Siringa sterili għall- injezzjoni bil- labra mwaħħla 2 kuxxinetti bl- alkoħol
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA 7.
SPECIAL STORAGE CONDITIONS
120 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
Store in a refrigerator (2ºC-8ºC).
Aħżen fi friġġ (2ºC- 8ºC).
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Renju Unit
INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE 16.
116 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
121 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TRAY BACKING TEXT
KITBA FUQ IL- WARA TAT- TREJ
EXPIRY DATE
DATA TA ’ META JISKADI 3.
OTHER
OĦRAJN 5.
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
122 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Humira 40 mg injection Subcutaneous use Adalimumab
Humira 40 mg injezzjoni Użu għal taħt il- ġilda Adalimumab
40 mg/ 0.8 ml
40 mg/ 0. 8 ml
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
123 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Humira 40 mg solution for injection in pre-filled syringe Adalimumab
Humira 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Adalimumab
One 0.8 ml pre-filled syringe contains 40 mg adalimumab
Siringa waħda ta ’ 0. 8 ml mimlija għal- lest fiha 40 mg adalimumab
1 pre-filled syringe containing 40 mg adalimumab 1 alcohol pad
Siringa waħda mimlija għal- lest li fiha 40 mg adalimumab Kuxxinett wieħed bl- alkoħol
Subcutaneous use
Użu għal taħt il- ġilda.
SPECIAL STORAGE CONDITIONS
124 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
Keep the syringe in the outer carton.
Żomm is- siringa fil- kartuna ta ’ barra.
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
2 pre-filled syringes, each containing 40 mg adalimumab 2 alcohol pads
2 siringi mimlijin għal- lest, li fihom 40 mg adalimumab kull waħda 2 kuxxinetti bl- alkoħol
SPECIAL STORAGE CONDITIONS
126 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
121 KEEP THE SYRINGE IN THE OUTER CARTON.10.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX 10.
122 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
4 pre-filled syringes, each containing 40 mg adalimumab 4 alcohol pads
4 siringi mimlijin għal- lest, li fihom 40 mg adalimumab kull waħda 4 kuxxinetti bl- alkoħol
SPECIAL STORAGE CONDITIONS
128 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
Keep the syringe in the outer carton.
Żomm is- siringa fil- kartuna ta ’ barra
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
129 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads
6 siringi mimlijin għal- lest, li fihom 40 mg adalimumab kull waħda 6 kuxxinetti bl- alkoħol
SPECIAL STORAGE CONDITIONS
130 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
126 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
131 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
127 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
132 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Humira 40 mg injection Adalimumab Subcutaneous use
Humira 40 mg injezzjoni Adalimumab Użu għal taħt il- ġilda
128 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
133 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA, JEW FEJN M’ HEMMX PAKKETT TA ’ BARRA, FUQ IL- PAKKETT EWLIENI
Humira 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab
Humira 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest bil- labra mgħottija Adalimumab
One 0.8 ml pre-filled syringe with needleguard contains 40 mg adalimumab
Siringa waħda ta ’ 0. 8 ml mimlija għal- lest bil- labra mgħottija fiha 40 mg adalimumab
SPECIAL STORAGE CONDITIONS
134 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
130 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
135 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TRAY BACKING TEXT
KITBA FUQ WARA TAT- TREJ
For single use only
Aħżen fi friġġ Għal użu ta ’ darba biss
131 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
136 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
137 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Humira 40 mg solution for injection in pre-filled pen Adalimumab
Humira 40 mg soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Adalimumab
One 0.8 ml pre-filled pen contains 40 mg adalimumab
Pinna waħda ta ’ 0. 8 ml mimlija għal- lest fiha 40 mg adalimumab
1 pre-filled pen, containing 40 mg adalimumab 1 alcohol pad
Pinna waħda mimlija għal- lest, li fiha 40 mg adalimumab Kuxxinett wieħed bl- alkoħol
SPECIAL STORAGE CONDITIONS
138 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
Keep the pre-filled pen in the outer carton.
Żomm il- pinna mimlija għal- lest fil- kartuna ta’ barra.
134 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
139 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads
2 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda 2 kuxxinetti bl- alkoħol
Keep the pre-filled pen in the outer carton.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra.
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
141 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
4 pre-filled pens, each containing 40 mg adalimumab 4 alcohol pads
4 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda 4 kuxxinetti bl- alkoħol
SPECIAL STORAGE CONDITIONS
142 KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN 9.
138 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
143 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
6 pre-filled pens, each containing 40 mg adalimumab 6 alcohol pads
6 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda 6 kuxxinetti bl- alkoħol
Keep the pre-filled pen in the outer carton.
Żomm il- pinna mimlija għal- lest fil- kaxxa ta ’ barra.
140 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
145 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
141 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
146 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAL- PINNA
142 REMINDER STICKERS TEXT (included in pack)
147 KITBA TA ’ TFAKKIR LI TWAĦĦAL FUQ IT- TIKETTA (inkluża fil- pakkett)
Mark your calendar with the stickers provided to remind you of the date for your next dose.
Immarka il- kalendarju bit- tiketti li twaħħal provduti biex iffakruk fid- data ta ’ meta għandek tieħu d - doża li jmiss.
143 PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET)
148 KITBA FUQ IL- KARTUNA TA ’ TWISSIJA GĦALL- PAZJENT (MHUX INKLUŻA FIL - PAKKETT JEW BĦALA PARTI MILL- FULJETT TA ’ TAGĦRIF)
Humira Patient Alert Card
Kartuna ta ’ twissija għal- pazjent fuq Humira
Heart Failure
Insuffiċjenza tal- qalb
This alert card contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira.
Din il- kartuna ta ’ twissija fiha informazzjoni importanti dwar is- sigurtà, li inti għandek tkun taf
Prior to Humira treatment: • Humira should not be used if you have moderate to severe heart failure.
Humira m’ għandux jintuża jekk int tbati •
During Humira treatment:
biha qabel ma tingħata u waqt il- kura b’ Humira.
• Show this card to any doctor involved in your treatment.
minn insuffiċjenza tal- qalb minn moderata sa severa.
• If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately.
tal- qalb (qtugħ ta ’ nifs jew nefħa fis - saqajn), irrikorri għall- għajnuna medika
Dates of Humira treatment:
Humira jżid ir- riskju illi inti tieħu infezzjonijiet.
Humira increases the risk of getting infections.
immedjatament.
Infections may progress more rapidly and be more severe.
jkunu aktar severi.
This includes tuberculosis.
Dan jinkludi t- tuberkulosi.
Prior to Humira treatment: • You should not be treated with Humira if you have a severe infection.
• Huwa importanti ħafna li int tgħid lit- tabib tiegħek jekk inti kellek xi darba t -
• You should be screened for tuberculosis.
qrib ma ’ xi ħadd li kellu t- tuberkulosi.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Jekk jogħġbok kun żgur li jkollok lista tal - •
Please record the dates of the last screening for tuberculosis below:
Test tat- tuberkolina: _______________ X- ray tas- sider: _______________
• See the Humira package leaflet for more information. • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
Isem il- pazjent: _____________________
Tuberculin test: _______________ Chest X-ray: _______________ During Humira treatment:
Jekk inti tiżviluppa sintomi li huma tipiċi
Patient’ s Name: _____________________ Doctor’ s Name: _____________________ Doctor’ s Phone: _____________________
Isem it- tabib: _____________________
• If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
kwiet fil- ġisem, irrikorri għall- għajnuna medika immedjatament.
• Keep this card with you for 5 months after the last Humira dose, since side effects may occur a long time after your last dose of Humira.
wara li tkun ħadt l- aħħar doża ta’ Humira, minħabba li l- effetti mhux mixtieqa jistgħu jirriżultaw żmien twil wara l- aħħar doża ta ’ Humira.
144 B.
149 B.
145 PACKAGE LEAFLET:
150 FULJETT TA ’ TAGĦRIF:
Humira 40 mg solution for injection in vials Adalimumab
Humira 40 mg soluzzjoni għall- injezzjoni f’ kunjetti Adalimumab
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Żomm dan il- fuljett.
You may need to read it again. − Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira.
importanti dwar is- sigurtà, li inti għandek tkun taf biha qabel tingħata Humira u waqt il- kura b’ Humira.
Keep this Patient Alert Card with you. − If you have any further questions, please ask your doctor or pharmacist. − This medicine has been prescribed for you.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Humira is and what it is used for 2.
X’ inhu Humira u għalxiex jintuża 2.
Before you use Humira 3.
Qabel ma tuża Humira 3.
How to use Humira 4.
Kif għandek tuża Humira 4.
Possible side effects 5 How to store Humira 6.
Kif taħżen Humira 6.
WHAT HUMIRA IS AND WHAT IT IS USED FOR
X’ INHU HUMIRA U GĦALXIEX JINTUŻA 1.
Humira is intended for treatment of rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic 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.
It is a medicine that decreases the inflammation process of these diseases.
Hija mediċina li tnaqqas il- proċess ta ’ infjammazzjoni ta ’ dan il- mard.
The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells.
Is- sustanza attiva, adalimumab, hija anti- korp uman monoklonali magħmul minn ċelluli kkulturati.
Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
L- anti- korpi monoklonali huma proteini li jagħrfu lil u jeħlu ma ’ proteini uniċi oħra.
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, fl- infjammazzjoni tal- vertebri li jirriżulta fil - vertebri jitwaħħlu flimkien (ankylosing spondylitis), il- marda Crohn (Crohn’ s disease) u l- psorajiżi.
Rheumatoid arthritis is an inflammatory disease of the joints.
L- artrite rewmatika hi marda infjammatorja tal- ġogi.
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Jekk inti tbati minn artrite rewmatika attiva li hi minn moderata sa severa, tista ’ għall- ewwel tingħata medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
If you do not respond well enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.
Jekk ma tirrispondix tajjeb biżżejjed ghal dawn il- mediċini, inti tingħata Humira għall- kura ta ’ l- artrite rewmatika.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Humira jista ’ ukoll jintuża għall- kura ta ’ l- artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat kura b’ methotrexate qabel.
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.
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.
Usually, Humira is used with methotrexate.
Ġeneralment, Humira jintuża ma ’ methotrexate.
If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Jekk it- tabib tiegħek jiddeċiedi li methotrexate m’ huwiex adattat, Humira jista ’ jingħata waħdu.
Polyarticular juvenile idiopathic arthritis
Artrite attiva idjopatika poliartikulari taż- żagħżagħ
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 146 disease-modifying medicines, such as methotrexate.
151 medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
If you do not respond well enough to these medicines, you will be given Humira to treat your polyarticular juvenile idiopathic arthritis.
Jekk ma tirrispondix tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Humira għall- kura tal- artrite attiva idjopatika poliartikulari taż - żagħżagħ.
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
L- artrite psorjatika hija infjammazzjoni tal- ġogi assoċjata mal- psorajiżi.
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.
If you have ankylosing spondylitis you will first be given other medicines.
Jekk inti għandek infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), tingħata għall- ewwel mediċini oħra.
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.
Jekk ma tirrispondix tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Humira biex tnaqqas is- sinjali u s- sintomi tal - marda tiegħek.
Crohn’ s disease is an inflammatory disease of the digestive tract.
Il- marda Crohn (Crohn’ s disease) hija marda infjammatorja tal- parti tal- ġisem minn fejn jgħaddi l - ikel.
If you have Crohn’ s disease you will first be given other medicines.
Jekk inti tbati mill- marda Crohn (Crohn’ s disease), inti tingħata l- ewwel mediċini oħra.
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.
Jekk ma jkollokx rispons tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Humira biex tnaqqas is- sinjali u s - sintomi tal- marda tiegħek.
Psoriasis is an inflammatory disease of the skin.
Il- psorajiżi hija marda infjammatorja tal- ġilda.
If you have moderate to severe plaque psoriasis, you will first be given other medicines or e. g. phototherapy.
Jekk inti għandek psorajiżi tat- tip li tikkawża qoxra mhux normali fuq il- ġilda, li hi minn moderata sa severa, inti tingħata l- ewwel mediċini oħra jew eż. fototerapija.
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.
BEFORE YOU USE HUMIRA
QABEL MA TUŻA HUMIRA 2.
Do not use Humira
Tużax Humira
• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Humira.
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adalimumab jew sustanzi oħra ta ’ • Humira.
It is important that you tell your doctor if you have symptoms of infections, e. g. fever, wounds, feeling tired, dental problems.
Jekk għandek infezzjoni severa, inkluż tuberkulosi attiva (ara “ Oqgħod attent ħafna b’ Humira ”). • Huwa importanti li inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas- snien.
• If you have moderate or severe heart failure.
Jekk inti tbati minn insuffiċjenza moderata jew severa tal- qalb.
It is important to tell your doctor if you have had or have a serious heart condition (see “ Take special care with Humira”).
Huwa importanti li tgħid lit - • tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb (ara “ Oqgħod attent ħafna b’ Humira ”).
Take special care with Humira
Oqgħod attent ħafna b’ Humira
• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately.
Jekk inti tesperjenza reazzjonijiet allerġiċi b’ sintomi bħal għafis fis- sider, tħarħir, sturdament, • nefħa jew raxx, tinjettax aktar Humira, u kkuntatja lit- tabib tiegħek immedjatament.
• The needle cover of the syringe contains natural rubber (latex).
L- għatu tal- labra tas- siringa fih lastku naturali (latex).
This may cause severe allergic reactions in patients sensitive to latex.
Dan jista ’ jikkaġuna reazzjonijiet allerġiċi • severi f’ pazjenti li huma sensittivi għal- latex.
Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield.
Pazjenti li jafu li għandhom sensittività għal- latex għandhom ikunu avżati biex jevitaw li jmissu l- għatu ta ’ ġewwa.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
152 Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) • kellem lit- tabib tiegħek qabel tibda Humira.
If you are unsure, please contact your doctor.
Jekk għandek xi dubju, jekk jogħġbok kellem lit - tabib tiegħek.
• You might get infections more easily while you are receiving Humira treatment.
Jista ’ jkun li waqt li tkun qiegħed tirċievi l- kura b’ Humira, jaqbduk infezzjonijiet aktar • faċilment.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi or bacteria, or other opportunistic infections and sepsis that may, in rare cases, 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.
147 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.
Your doctor may recommend temporary discontinuation of Humira.
It- tabib jista ’ jirrakkomandalek li twaqqaf Humira għal ftit żmien.
• 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.
The conduct of these tests should be recorded on your Patient Alert Card.
Dan jinkludi storja medika fid- dettal, X- ray tas- sider u test tat- tuberkolina. It- twettiq ta ’ dawn it- testijiet għandu jiġi mniżżel fuq il- Kartuna ta ’ Twissija tal- Pazjent.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Huwa importanti ħafna li inti tgħid lit- tabib tiegħek jekk inti kellek xi darba t- tuberkulosi, jew jekk kellek kuntatt mill- qrib ma ’ xi ħadd li kellu t - tuberkulosi.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Jekk jitfaċċaw sintomi tat- tuberkulosi (sogħla persistenti, tnaqqis fil- piż, nuqqas ta ’ kwiet fil- ġisem, deni ħafif), jew titfaċċa xi infezzjoni oħra waqt jew wara t- terapija, għid lit - tabib tiegħek immedjatament.
• Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomysis or blastomycosis are endemic.
Għarraf lit- tabib tiegħek jekk toqgħod jew ser tivvjaġġa f’ postijiet fejn infezzjonijiet fungali • bħal histoplasmosis coccidioidomysis jew blastomycosis huma endemiċi.
• Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Għarraf lit- tabib tiegħek f’ każ illi inti għandek storja medika ta ’ infezzjonijiet li jaqbduk minn • żmien għal żmien, jew kundizzjonijiet oħra li jżidu r- riskju ta ’ infezzjonijiet.
• Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
Jekk int iġġorr il- virus ta ’ l- epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li • għandek riskju li jaqbdek l- HBV, għarraf lit- tabib tiegħek.
Humira can cause reactivation of HBV in people who carry this virus.
Humira jista ’ jikkaġuna riattivazzjoni ta ’ HBV f’ pazjenti li jġorru dan il- virus.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
F’ xi każi rari, speċjalment jekk tkun qiegħed tieħu mediċini oħra li jrażżnu s- sistema immuni, ir- riattivazzjoni ta ’ l- HBV tista ’ tpoġġilek ħajtek fil - periklu.
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Humira.
Jekk inti se tagħmel xi operazzjoni jew se tgħamel xi intervent tas- snien, jekk jogħġbok għarraf • lit- tabib tiegħek li inti qiegħed tieħu Humira.
Your doctor may recommend temporary discontinuation.
It- tabib jista ’ jirrakkomandalek li twaqqaf Humira għal ftit żmien.
• 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.
• Some vaccines should not be given while receiving Humira.
Ċerti tilqim m’ għandhomx jingħataw waqt li jkun qiegħed jingħata Humira.
Please check with your doctor before you receive any vaccines.
Jekk jogħġbok • iċċekkja mat- tabib tiegħek qabel ma tieħu xi tilqim.
It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Hu rrakomandat li pazjenti b ’ artrite idjopatika poliartikulari taż- żagħżagħ, jekk jista ’ jkun, jieħdu t- tilqim kollu li jifdal skond il - pariri kurrenti ta ’ tilqim qabel ma jibdew il- kura b’ Humira.
• If you have mild heart failure and you are being treated with Humira, your heart failure status must be closely monitored by your doctor.
Jekk tbati minn insuffiċjenza moderata tal- qalb u qiegħed tingħata l- kura b’ Humira, l- istat ta ’ l - • insuffiċjenza ta ’ qalbek għandu jiġi monitorjat mill- qrib mit- tabib tiegħek.
It is important to tell your doctor if you have had or have a serious heart condition.
Huwa importanti illi inti tgħid lit- tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb.
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. Your doctor will decide if you should receive Humira.
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.
• In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
F’ ċerti pazjenti, il- ġisem ma jipproduċix biżżejjed ċelluli tad- demm li jgħinu lill- ġisem jiġġieled • l- infezzjonijiet, jew li jgħinu fit- twaqqif tal- ħruġ tad- demm.
If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Jekk tiżviluppa deni li ma jgħaddilekx, jew tibda titbenġel faċilment jew joħroġlok id- demm faċilment, jew tkun pallidu ħafna, ċempel lit- tabib tiegħek immedjatament.
Your doctor may decide to stop treatment.
It- tabib tiegħek jista ’ jiddeċiedi li jwaqqaf il - kura.
• There have been very rare cases of certain kinds of cancer in patients taking Humira or other TNF blockers.
153 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 ymphoma, 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.
If you take Humira your risk may increase.
Jekk tieħu Humira, ir- riskju jista ’ jiżdied.
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.
Some of those patients were also treated with azathioprine or 6- mercaptopurine.
Xi wħud minn - dawn il- pazjenti kienu wkoll qed jiġu ttrattati b ’ azathioprine jew 6 - mercaptopurine.
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Humira.
Barra minn hekk, f’ pazjenti li jieħdu Humira, ġew osservati każi rari ħafna ta ’ kanċer tal- ġilda mhux tat- tip melonoma.
If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Għid lit- tabib tiegħek fil- każ li matul jew wara t- terapija, joħorġulek feriti ġodda fil- ġilda jekk jekk xi feriti li inti diġà għandek jibdlu d- dehra tagħhom.
• 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
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 have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Jekk inti tbati minn COPD, jew tpejjep ħafna, inti għandek tiddiskuti mat- tabib tiegħek fuq jekk il- kura b’ mediċina li timblokka t- TNF hijiex adattata għalik.
Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDS).
Humira jista ’ jittieħed flimkien ma ’ methotrexate jew ċerti tipi ta ’ aġenti anti- rewmatiċi li jaffetwaw il- proċess tal- mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad- deheb li jingħata b ’ injezzjoni), sterojdi jew medikazzjonijiet għall- uġigħ, li jinkludu mediċini anti - infjammatorji mhux sterojdi (NSAIDS).
You should not take Humira with medicines containing the active substance, anakinra or abatacept.
M’ għandekx tieħu Humira ma ’ mediċini li fihom is- sustanza attiva anakinra jew abatacept.
If you have questions, please ask your doctor.
Jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib tiegħek.
Using Humira with food and drink
Meta tuża Humira ma ’ l- ikel u max- xorb.
Since Humira is injected under the skin (subcutaneously), food and drink should not affect Humira.
Peress li Humira jiġi injettat taħt il- ġilda, l- ikel u x- xorb m’ għandhomx jaffetwawh.
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 irrakkomandat.
You are advised to avoid becoming pregnant and must use adequate contraception while using Humira and for at least 5 months after the last Humira treatment.
Inti għandek tevita li tinqabad tqila u għandek tuża mezz ta ’ kontraċezzjoni adegwat waqt li tkun qiegħda tuża Humira u għal mill- inqas 5 xhur wara l- aħħar trattament b’ Humira.
It is not known whether adalimumab passes into breast milk.
M’ huwiex magħruf jekk adalimumab jgħaddix fil- ħalib tas- sider.
If you are a breast-feeding mother, 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.
Humira may have a minor influence on your ability to drive and use machines.
Humira jista ’ jkollu effett zgħir fuq il- ħila biex issuq u tħaddem magni.
Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Humira.
Jista jkun hemm sturdament (li jinkludi sensazzjoni li l- kamra qed iddur bik, disturbi fil- vista u għejja) wara li tingħata Humira.
HOW TO USE HUMIRA
154 KIF GĦANDEK TUŻA HUMIRA 3.
Always take Humira exactly as your doctor has told you.
Dejjem għandek tieħu Humira skond il- parir tat- tabib.
Humira is injected under the skin (subcutaneous use).
Humira jiġi injettat taħt il- ġilda (użu għal taħt il- ġilda).
The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as a single dose.
Id- doża li s- soltu tingħata għall- adulti b’ artrite rewmatika, artrite psorjatika u għal infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis) hija 40 mg adalimumab bħala doża waħda ġimgħa iva u ġimgħa le.
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above, is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Id- doża ta ’ Humira rrakkomandata għal pazjenti b ’ artrite idjopatika poliartikulari taż- żagħżagħ li għandhom 13 il- sena u fuqhom hi 40mg adalimumab, mogħtija b’ injezzjoni taħt il- ġilda, ġimgħa iva u ġimgħa le, bħala doża waħda.
The usual dose regimen for Crohn’ s disease is 80 mg at Week 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.
In 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.
Depending on your response, your doctor may increase the dose to 40 mg every week.
It- tabib tiegħek jista ’ jżidlek id- doża għal 40 mg kull ġimgħa, u dan skond ir- rispons tiegħek għall- mediċina.
The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting
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.
You should continue to inject Humira for as long as your doctor has told you.
Għandek tibqa ’ tinjetta Humira għaż- żmien li jkun qallek it- tabib tiegħek.
In rheumatoid arthritis, methotrexate is continued while using Humira.
F ’ każ ta ’ artrite rewmatika, methotrexate jibqa ’ jintuża waqt li jkun qiegħed jintuża Humira.
If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Jekk it - tabib tiegħek jiddeċiedi li methotrexate m’ huwiex adattat, Humira jista ’ jingħata waħdu.
If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg adalimumab 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.
Instructions for preparing and giving an injection of Humira:
Istruzzjonijiet għall- preparamenti u l- għotja ta ’ l- injezzjoni ta ’ Humira:
The following instructions explain how to inject Humira.
L- istruzzjonijiet segwenti jispjegaw kif Humira jiġi injettat.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet b’ attenzjoni u imxi pass, pass magħhom.
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.
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Tippruvax tinjetta lilek innifsek qabel ma inti tkun ċert li fhimt kif tipprepara għall -, u tagħti l- injezzjoni.
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.
This injection should not be mixed in the same syringe or vial with any other medicine.
Din l- injezzjoni m’ għandhiex tiġi mħallta ma ’ xi mediċina oħra fl- istess siringa jew kunjett.
1) Setting up
1) Il- preparazzjoni
• Wash your hands thoroughly • Set up the following items on a clean surface
Aħsel idejk sewwa • Ipprepara dawn l- oġġetti li ġejjin fuq wiċċ nadif •
One vial of Humira for injection One syringe with fixed needle Two alcohol pads
Kunjett wieħed ta ’ Humira għall- injezzjoni o Siringa waħda b’ labra imwaħħla o Żewġ kuxxinetti bl- alkoħol o
• Look at the expiry date on the vial.
155 Iċċekja d- data ta ’ l- iskadenza fuq il- kunjett.
Do not use the product after the month and year shown.
Tużax il- prodott wara x- xahar u s- sena murija. •
150 2) Choosing and preparing an injection site
2) Biex tagħżel u tipprepara l- post fejn se tieħu l- injezzjoni
• Choose a site on your thigh or stomach
Agħżel post fuq il- koxxa jew fuq l- istonku •
• 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 inject in an area where the skin is reddened, bruised, or hard.
Tinjettax f’ post fejn il- ġilda hija ħamra, imbenġla jew iebsa.
This may mean there is an infection.
Dan jista ’ jfisser li hemm o infezzjoni.
Wipe the injection site with the enclosed alcohol pad, using a circular motion.
Imsaħ, permezz ta ’ movimenti mdawra, il- post fejn ser tingħata l- injezzjoni bil- kuxxinett o bl- alkoħol li ssib fil- pakkett.
Do not touch the area again before injecting.
Terġax tmiss din il- parti qabel tagħti l- injezzjoni. o
3) Injecting Humira
3) Biex tinjetta Humira
Preparing the Humira dose for injection • Do NOT shake the vial. • Remove the plastic cap from the Humira vial.
Biex tipprepara id- doża ta ’ Humira għall- injezzjoni TĦAWWADX il- kunjett. • Neħħi l- għatu tal- plastik mill- kunjett ta ’ Humira.
Do NOT remove the grey stopper or aluminium ring around the top of the vial. • Use a new alcohol pad to clean the grey stopper on the vial.
Wara li tnaddaf, tmissx it - • tapp b’ idejk.
After cleaning, do not touch the stopper with your hands. • Remove cap from needle syringe, being careful not to touch needle or let it touch any surface. • Make sure that the plunger is fully inserted into the syringe.
Kun ċert li l- planġer hija imdaħħla kollha ġos- siringa.
With the vial upright on a flat surface, such as a table, insert the needle straight through the centre ring of the grey stopper.
Bil- kunjett miżmum wiċċu ’ il fuq, fuq • wiċċ ċatt, daħħal il- labra dritt minn ġoċ- ċirku tan- nofs tat- tapp il- griż.
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 imdeffsa f’ postha, inti għandek tħoss ftit reżistenza u mbagħad tisma ’ “ pop ”, waqt li l- labra tkun qiegħda tgħaddi minn ġoċ- ċentru tat- tapp.
Look for the needle tip inside the stopper window.
Fittex il- ponta tal- labra minn ġot- tieqa tat- tapp.
If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “ pop .” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents.
Jekk il- labra ma tkunx qiegħda tidħol f’ postha fiċ- ċentru tat- tapp, inti tibqa ’ tħoss reżistenza kontinwa waqt li l- labra tkun qiegħda tgħaddi mit- tapp, u ma tismax “ pop ”.
If this happens, do not use the syringe or vial. • With the needle still in the vial, turn the vial upside down at eye level.
Il- labra tista ’ ma tidħolx dritta f’ dan il- każ, u titgħawweġ, tinqasam, jew ma tħallix il- kontenut tal- kunjett jiġi miġbud kollu.
Check that the needle is below the surface of the solution.
Jekk jiġri hekk, tużax is- siringa jew il- kunjett.
Slowly pull the plunger back to draw solution into the syringe. • With the needle still inserted in the vial, check the syringe for air bubbles.
Iċċekja li l- labra qiegħda taħt il- wiċċ tas- soluzzjoni.
Gently tap the syringe to make any bubbles rise to the top of the syringe near the needle.
Bil- mod il- mod iġbed il- planġer lura biex tiġbed is- soluzzjoni fis- siringa.
Slowly press the plunger to push the bubbles out of the syringe and into the vial.
Waqt li l- labra tkun għada mdeffsa fil- kunjett, iċċekja s- siringa għall- bżieżaq ta ’ l- arja.
When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe. • Pull the needle completely out of the vial.
Meta tagħmel dan, jekk inti aċċidentalment tinbotta xi ftit mis - soluzzjoni lura għal ġol- kunjett, iġbed il- planġer lura bil- mod biex terġa ’ ddaħħal lura fis - siringa l- kontenut kollu tal- kunjett.
Again, do NOT touch the needle or let it touch any surface.
Għal darb’ oħra, TMISSX il- labra, u tħalli l - • labra tmiss ma ’ l- ebda wiċċ.
151 Injecting Humira • With one hand, gently grasp the cleaned areas of skin and hold firmly • With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
156 Biex tinjetta Humira B’ id waħda, aqbad bil- mod il- partijiet tal- ġilda li ġew imnaddfa u żommhom sod • Bl- id l- oħra, żomm is- siringa mgħawwġa f’ angolu ta ’ 45° mal- ġilda, bin- naħa fejn għandha l - • gruvijiet ’ il fuq.
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 Bis- saba ’ il- kbir ta ’ idejk, jew b’ biċċa garża, agħfas il- post ta ’ l- injezzjoni għal 10 sekondi. • Jista ’ joħroġlok ftit demm.
Do not rub the injection site.
Togħrokx il- post ta ’ l- injezzjoni.
Use a plaster if you want to.
Jekk trid uża impjastru.
4) Throwing away supplies
4) Biex tarmi l- affarijiet li użajt
• The Humira syringe should NEVER be reused.
Is- siringa ta ’ Humira m’ għanda QATT terġa ’ tintuża.
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
Wara li tinjetta Humira, armi s- siringa użata immedjatament f’ kontenitur speċjali, kif qallek it - • tabib, l- infermier jew l- ispiżjar tiegħek.
If you use more Humira than you should:
Jekk tuża Humira aktar milli suppost
If you accidentally inject Humira more frequently than told to by your doctor, you should call your doctor and tell him/ her that you have taken more.
Jekk inti aċċidentalment tinjetta Humira aktar frekwentament milli ordnalek it- tabib tiegħek, inti għandek iċċempel lit- tabib tiegħek u tgħidlu li ħadt aktar milli suppost.
Always take the outer carton or the vial 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.
If you forget to take Humira:
Jekk tinsa tieħu Humira
If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember.
Jekk tinsa tinjetta lilek innifsek b’ Humira, injetta d- doża ta ’ Humira li jkun imissek eżatt kif tiftakar.
Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Imbagħad ħu d- doża ta ’ wara fil- ħin li inti suppost toħodha f’ ġurnata normali, daqs li kieku ma ’ nsejtx doża.
Like all medicines, Humira can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Humira jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate.
Ħafna mill- effetti sekondarji huma minn ħfief għal moderati.
However, some may be serious and require treatment.
Madanakollu, uħud minnhom jistgħu jkunu serji u jirrikjedu l- kura.
Side effects may occur at least up to 5 months after the last Humira injection.
L- effetti sekondarji jistgħu ifeġġu sa mill- inqas 5 xhur wara l- aħħar injezzjoni b ’ Humira.
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;
157 Għarraf lit- tabib tiegħek immedjatament jekk inti tinnota xi wieħed minn dawn li ġejjin:
152 • 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.
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. •