qanastek/EMEA-V3 huggingface dataset:
ed Important information about some of the ingredients of Trudexa
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Trudexa
ris This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium- free’.
ad Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull doża, jiġifieri, huwa prattikament “ mingħajr sodju. ” ’ g ħ 3.
HOW TO USE TRUDEXA
KIF GĦANDEK TUŻA TRUDEXA im
Always take Trudexa exactly as your doctor has told you.
Dejjem għandek tieħu Trudexa skond il- parir tat- tabib.
You should check with your doctor or
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju. li l
Trudexa is injected under the skin (subcutaneous use).
Trudexa 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
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. ina
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 lon 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) diċ
You should continue to inject Trudexa for as long as your doctor has told you.
Għandek tibqa ’ tinjetta Trudexa għaż- żmien li jkun qallek it- tabib tiegħek. me
In rheumatoid arthritis, methotrexate is continued while using Trudexa.
F ’ każ ta ’ artrite rewmatika, methotrexate jibqa ’ jintuża waqt li jkun qiegħed jintuża Trudexa.
If your doctor determines that no
Jekk it - tabib tiegħek jiddeċiedi li methotrexate m’ huwiex adattat, Trudexa jista ’ jingħata waħdu.
methotrexate is inappropriate, Trudexa can be given alone.
Jekk inti tbati minn artrite rewmatika u ma tkunx qiegħed tirċievi methotrexate flimkien mal- kura ott
If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg adalimumab every week. t uc
b’ Trudexa, it- tabib tiegħek jista ’ jiddeċiedi li jagħtik 40 mg adalimumab kull ġimgħa.
Instructions for preparing and giving an injection of Trudexa: rod
Istruzzjonijiet għall- preparamenti u l- għotja ta ’ l- injezzjoni ta ’ Trudexa: od
The following instructions explain how to inject Trudexa.
L- istruzzjonijiet segwenti jispjegaw kif Trudexa jiġi injettat.
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 Pr
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
tiegħu/ tagħha dwar it- teknika ta ’ kif tinjetta lilek innifsek.
After proper training, the injection can be self-administered or given by lP
Tippruvax tinjetta lilek innifsek qabel ma inti tkun ċert li fhimt kif tipprepara għall -, u tagħti l- injezzjoni.
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. na
Din l- injezzjoni m’ għandhiex tiġi mħallta ma ’ xi mediċina oħra fl- istess siringa jew kunjett.
1) Setting up
132 1) Il- preparazzjoni
• Set up the following items on a clean surface
• Aħsel idejk sewwa • Ipprepara dawn l- oġġetti li ġejjin fuq wiċċ nadif
Me
at
One vial of Trudexa for injection One syringe with fixed needle
Kunjett wieħed ta ’ Trudexa għall- injezzjoni Siringa waħda b’ labra imwaħħla
Two alcohol pads
Żewġ kuxxinetti bl- alkoħol
124 ed ris tho • Look at the expiry date on the vial.
ori t aw ux ad • 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.
au 2) Choosing and preparing an injection site
2) Biex tagħżel u tipprepara l- post fejn se tieħu l- injezzjoni ’ g ħ • Agħżel post fuq il- koxxa jew fuq l- istonku im li l ina diċ
• Each new injection should be given at least 3 cm from the last injection site. uc
• Kull injezzjoni ġdida għandha tingħata f’ post li jkun mill- inqas 3 cm ’ il bogħod mill- post fejn tkun ingħatat l- aħħar injezzjoni.
This may mean there is an infection.
Dan jista ’ jfisser li hemm me
Wipe the injection site with the enclosed alcohol pad, using a circular motion. rod
Imsaħ, permezz ta ’ movimenti mdawra, il- post fejn ser tingħata l- injezzjoni bil- kuxxinett bl- alkoħol li ssib fil- pakkett.
o
o ott
3) Injecting Trudexa lP
3) Biex tinjetta Trudexa od
Preparing the Trudexa dose for injection • Do NOT shake the vial. • Remove the plastic cap from the Trudexa vial.
Biex tipprepara id- doża ta ’ Trudexa għall- injezzjoni • TĦAWWADX il- kunjett. • Neħħi l- għatu tal- plastik mill- kunjett ta ’ Trudexa.
Do NOT remove the grey stopper or aluminium na
TNEĦĦIX it- tapp il- griż jew iċ- ċirku ta ’ l - Pr
ring around the top of the vial. • Use a new alcohol pad to clean the grey stopper on the vial.
Uża kuxxinett bl- alkoħol ġdida biex tnaddaf it- tapp il- griż tal- kunjett.
After cleaning, do not touch the stopper with your hands. i
Neħħi l- għatu mis- siringa, u oqgħod attent li ma tmissx il- labra jew li l- labra ma tmiss ma l - • ebda wiċċ.
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.
133 Kun ċert li l- planġer hija imdaħħla kollha ġos- siringa.
If the needle is correctly lined up, you should feel a slight resistance and then a “ pop” as the Me
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.
needle goes through the centre of the stopper.
Fittex il- ponta tal- labra minn ġot- tieqa tat- tapp.
Look for the needle tip inside the stopper window.
Jekk il- labra ma tkunx qiegħda tidħol f’ postha fiċ- ċentru tat- tapp, inti tibqa ’ tħoss reżistenza
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.
at kontinwa waqt li l- labra tkun qiegħda tgħaddi mit- tapp, u ma tismax “ pop ”.
If this happens, do not use the syringe or vial.
Il- labra tista ’ ma tidħolx dritta f’ dan il- każ, u titgħawweġ, tinqasam, jew ma tħallix il- kontenut tal- kunjett jiġi
125 • With the needle still in the vial, turn the vial upside down at eye level.
Waqt li l- labra tkun għada fil- kunjett, dawwar il- kunjett rasu ’ l isfel u żommu fil- livell ta ’ l - • għajnejn.
Check that the needle is below the surface of the solution.
ori lura biex tiġbed is- soluzzjoni fis- siringa.
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.
Waqt li l- labra tkun għada mdeffsa fil- kunjett, iċċekja s- siringa għall- bżieżaq ta ’ l- arja.
Gently tap the syringe to make any bubbles rise to the top of the syringe near the needle.
Taptap • bis- swaba ’ bil- mod fuq is- siringa biex iġġiegħel lill- bżieżaq ta ’ l- arja jitilgħu fin- naħa ta ’ fuq
Slowly press the plunger to push the bubbles out of the syringe and into the vial.
t tas- siringa ħdejn il- labra.
When you do this, if you
Agħfas il- planġer bil- mod il- mod, biex tinbotta l- bżieżaq ’ il barra mis -
ed 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.
Iġbed il- labra kompletament ’ il barra mill- kunjett.
Again, do NOT touch the needle or let it touch any
Għal darb’ oħra, TMISSX il- labra, u tħalli l - •
ris surface.
ux labra tmiss ma ’ l- ebda wiċċ.
Injecting Trudexa
Biex tinjetta Trudexa
tho • 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.
ad • 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. ’ g ħ im li l ina
no
• B’ moviment wieħed qasir u mgħaġġel, imbotta l- labra kollha fil- ġilda diċ
• With one quick, short motion, push needle all the way into skin • Release the skin with the first hand • Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe • When the syringe is empty, remove the needle from skin, being careful to keep it at the same t
• 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 me
• Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
angolu li żammejtha biex daħħaltha • Bis- saba ’ il- kbir ta ’ idejk, jew b’ biċċa garża, agħfas il- post ta ’ l- injezzjoni għal 10 sekondi.
A little bleeding may occur.
Jista ’ joħroġlok ftit demm.
Use a plaster if you want to. rod
Jekk trid uża impjastru. ott
• The Trudexa syringe should NEVER be reused.
• Is- siringa ta ’ Trudexa m’ għanda QATT terġa ’ tintuża.
NEVER recap a needle • After injecting Trudexa, immediately throw away the used syringe in a special container as lP
M’ għandek QATT terġa ’ tlibbes l- għatu od
instructed by your doctor, nurse or pharmacist. • Keep this container out of the reach and sight of children na
Pr
If you use more Trudexa than you should:
• Żomm dan il- kontenitur fejn ma jintlaħaqx u ma jidhirx mit- tfal.
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your i dic
134 Jekk tuża Trudexa aktar milli suppost
doctor and tell him/ her that you have taken more.
Jekk inti aċċidentalment tinjetta Trudexa aktar frekwentament milli ordnalek it- tabib tiegħek, inti għandek iċċempel lit- tabib tiegħek u tgħidlu li ħadt aktar milli suppost.
Me
at Jekk tinsa tieħu Trudexa
If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you remember.
zz Jekk tinsa tinjetta lilek innifsek b’ Trudexa, injetta d- doża ta ’ Trudexa 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
126 4.
t aw 4.
Like all medicines, Trudexa can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Trudexa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate.
ux Ħafna mill- effetti sekondarji huma minn ħfief għal moderati.
Side effects may occur at least up to 5 months after the last treatment.
L- effetti sekondarji jistgħu ifeġġu sa mill- inqas 5 xhur wara l- aħħar trattament.
ed Tell your doctor immediately if you notice any of the following: • Severe rash, hives or other signs of allergic reaction; • Swollen face, hands, feet;
ad Għarraf lit- tabib tiegħek immedjatament jekk inti tinnota xi wieħed minn dawn li ġejjin: • Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika; ’ g ħ • 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; im
ris • 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,
• Sinjali u sintomi li għandhom x’ jaqsmu ma’ disturbi tad- demm bħal deni persistenti, tbenġil, ħruġ ta ’ demm, tkun pallidu.
tho paleness.
Għarraf lit- tabib tiegħek mill- aktar fis possibbli jekk inti tinnota xi wieħed minn dawn li ġejjin: li l
Tell your doctor as soon as possible if you notice any of the following:
• Sinjali ta ’ infezzjoni bħal deni, telqa tal- ġisem mingħajr l- ebda sinjali ta ’ mard, feriti, problemi tas- snien, ħruq waqt għamil ta ’ l- awrina; • Tħossok dgħajjef jew għajjien; ina
au • Signs of infection such as fever, malaise, wounds, dental problems, burning on urination; • Feeling weak or tired; • Coughing; • Tingling;
• Sogħla; • Tnemnim; • Tirżiħ; diċ
r • Numbness;
• Tara doppju; • Dgħufija fl- idejn jew fir- riġlejn. me
ge • Double vision; • Arm or leg weakness. lon The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta ’ l- effetti sekondarji mniżżlin hawn taħt, li ġew osservati b’ Trudexa:
Very common (≥ 1/ 10 patients): no
Komuni ħafna (≥ 1/ 10 pazjent): • reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk). ott
• injection site reactions (including pain, swelling, redness or itching).
Komuni (≥ 1/ 100 u < 1/ 10 pazjent): • infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); od
• lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • urinary tract infection, cold blisters, shingles; rod
• infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - sinus); • infezzjoni fis- sistema urinarja, infafet kiesħa, ħruq ta ’ Sant’ Antnin; Pr
• dizziness, including vertigo, headache; • eye inflammation; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth ulcers; lP
• sturdament, li jinkludi vertigo, uġigħ ta ’ ras; • infjammazzjoni fl- għajnejn; • sogħla, uġigħ fil- griżmejn; • nawseja, dijarea, uġigħ addominali, ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied;
• elevated liver enzymes; • rash, itching, hair loss; • fatigue; na
135 • raxx, ħakk, taqa ’ x- xagħar; • għeja kbira; • deni.
Uncommon (≥ 1/ 1000 and < 1/ 100 patients): i dic
Mhux komuni (≥ 1/ 1000 u < 1/ 100 pazjent):
• serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; • skin wart; • anaemia, low white blood cell counts; • allergic reactions; Me
at • infezzjonijiet serji (bħal fil- pene [avvelenament tad- demm]), infezzjoni fil- ġogi, infezzjonijiet tal- fungu;
• increased lipid values, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • ear discomfort; • sensation of heart beating rapidly, high blood pressure;
aw disturbi tat- togħma; • disturbi tal- vista; • skonfort fil- widnejn; • sensazzjoni ta ’ taħbit mgħaġġel tal- qalb, pressjoni għolja tad- demm;
127 • asthma, shortness of breath; • abdominal symptoms (such as vomiting, indigestion, constipation) rectal bleeding; • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding;
ux • ażżma, qtugħ ta ’ nifs; • sintomi addominali (bħal rimettar, indiġestjoni, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien
ed • flu like symptoms, chest pain, swelling of the feet.
ad biex ifiqu l- feriti; • dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); ’ g ħ • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn.
Rare (< 1/ 1000)
Rari (< 1/ 1000) im
ris • glaucoma; • skin cancer;
• glawkoma; • kanċer tal- ġilda; • distrubi fit- tirojde; li l
tho • thyroid disorders; • protein in urine.
• proteina fl- awrina.
Other side effects that have been observed in patients taking Trudexa:
Effetti sekondarji oħra li ġew osservati f’ pazjenti li jieħdu Trudexa: tuberkulosi u infezzjonijiet opportunistiċi oħra (infezzjonijiet li jiġu kkawżati meta r- reżistenza għall - ina
au tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
mard tiddgħajjef); mard tal- pulmun. diċ
r If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
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. me
HOW TO STORE TRUDEXA
KIF TAĦŻEN TRUDEXA
Keep out of the reach and sight of children.
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal. ott
Do not use the Trudexa vial after the expiry date stated on the label/ blister/ carton after EXP:.
Tużax il- kunjett ta ’ Trudexa wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il- folja/ il- pakkett wara JIS:.
The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. od
Do not freeze. t uc
Pr
FURTHER INFORMATION rod
AKTAR TAGĦRIF
Trudexa 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Trudexa 40 mg soluzzjoni għall- injezzjoni fil- kunjetti hija fornuta bħala soluzzjoni sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml.
What Trudexa contains lP
X’ fih Trudexa:
The active substance is adalimumab.
136 Is- sustanza attiva hi adalimumab.
phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections. i
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.
What the Trudexa vial looks like and contents of the pack dic
at Id- Dehra tal- prodott u d- daqs tal- pakkett:
The Trudexa vial is a glass vial containing a solution of adalimumab.
zz Il- kunjett ta ’ Trudexa huwa kunjett tal- ħġieġ li fih soluzzjoni ta ’ adalimumab.
Me
Kull pakkett fih kunjett wieħed b’ siringa sterili vojta u 2 kuxxinetti bl- alkoħol.
Trudexa is also available as a pre-filled syringe or a pre-filled pen.
ori Trudexa jista ’ tinxtara ukoll bħala siringa jew pinna mimlija għal- lest.
128 Marketing Authorisation Holder
t Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd
ed Manufacturer
ux Queenborough Kent ME11 5EL Renju Unit
ris Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D – 65205 Wiesbaden
ad Il- Manifattur ’ g ħ Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D – 65205 Wiesbaden Ġermanja im
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: li l
au België/ Belgique/ Belgien Abbott SA
Luxembourg/ Luxemburg België/ Belgique/ Belgien Abbott SA Abbott SA ina
Luxembourg/ Luxemburg Abbott SA
Parc Scientifique Parc Scientifique Rue du Bosquet, 2 Rue du Bosquet, 2 B- 1348 Ottignies/ Louvain- la- Neuve B- 1348 Ottignies/ Louvain- la- Neuve Belgique/ Belgien Tél/ Tel: + 32 10 475311 diċ
r Parc Scientifique
Tél/ Tel: + 32 10 475311
Parc Scientifique
България
lon
me
Оборище № 45
Оборище № 45 София 1504 Teл.: + 359 2 846 8429 ott
Abbott Laboratories s. r.
Malta Česká republika V. J. Salomone Pharma Limited Abbott Laboratories s. r. o.
Hadovka Office Park Evropská 2590/ 33d
79, Simpson Street, Hadovka Office Park od
V. J. Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14,
Marsa HMR 14, Evropská 2590/ 33d Malta.
Tel: + 420 267 292
CZ- 160 00 Praha 6 Tel: + 356 22983201 Tel: + 420 267 292 111 Pr
Abbott BV Siriusdreef 51 NL-2132 WT Hoofddorp
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130
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ed This leaflet was last approved in {MM/ YYYY}
ad Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} ’ g ħ im li l ina diċ me ott od Pr
ris tho aur ge lon
139 FULJETT TA ’ TAGĦRIF:
lP
Trudexa 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Adalimumab
rod
at Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
na
zz
131 PACKAGE LEAFLET:
- Żomm dan il- fuljett.
INFORMATION FOR THE USER
Jista ’ jkollok bżonn terġa ’ taqrah.
Trudexa 40 mg solution for injection in pre-filled syringe Adalimumab
- It- tabib tiegħek se jagħtik ukoll Kartuna ta ’ Twissija tal- Pazjent, li fiha informazzjoni importanti
You may need to read it again. − Your doctor will also give you a Patient Alert Card, which contains important safety
dwar is- sigurtà, li inti għandek tkun taf biha qabel tingħata Trudexa u waqt il- kura b’ Trudexa.
ris information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
ori Żomm il- Kartuna ta ’ Twissija tal- Pazjent flimkien mal- fuljett ta ’ tagħrif.
au please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Before you use Trudexa
X’ inhu Trudexa u għalxiex jintuża 2.
How to use Trudexa 4.
ad 4.
WHAT TRUDEXA IS AND WHAT IT IS USED FOR no
X’ INHU TRUDEXA U GĦALXIEX JINTUŻA im
Trudexa is intended for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Trudexa huwa intenzjonat għall- kura ta ’ l- artrite rewmatika, artrite psorjatika u infjammazzjoni tal - vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis).
The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells.
Is- sustanza attiva, adalimumab, hija anti- korp uman li l
proteins that recognise and bind to other unique proteins.
monoklonali magħmul minn ċelluli kkulturati.
Adalimumab binds to a specific protein uc
L- anti- korpi monoklonali huma proteini li jagħrfu lil u jeħlu ma ’ proteini uniċi oħra.
(tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. rod
psorjatika u infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis).
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. lP
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, me
If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis. na
Jekk ma tirrispondix tajjeb biżżejjed ghal dawn il- mediċini, inti tingħata Trudexa għall- kura ta ’ l- artrite rewmatika.
Trudexa can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. i
Trudexa jista ’ ukoll jintuża għall- kura ta ’ l- artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat kura b’ methotrexate qabel. ott
132 Ankylosing spondylitis
140 Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
If you have ankylosing spondylitis you will first be given other medicines.
at jitwaħħlu flimkien (ankylosing spondylitis), tingħata għall- ewwel mediċini oħra.
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
Jekk ma tirrispondix tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Trudexa biex tnaqqas is- sinjali u s- sintomi tal -
ed Crohn’ s disease
zz marda tiegħek.
If you have Crohn’ s disease you will first be given other medicines.
Jekk ma
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
t jkollokx rispons tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Trudexa biex tnaqqas is- sinjali u
• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
ad • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adalimumab jew sustanzi oħra ta ’ Trudexa. ’ g ħ • Jekk għandek infezzjoni severa, inkluż tuberkulosi attiva (ara “ Oqgħod attent ħafna b’ Trudexa ”).
r • If you have a severe infection, including active tuberculosis (see “ Take special care with
Huwa importanti li inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas- snien. im
It is important that you tell your doctor if you have symptoms of infections, e. g. fever, wounds, feeling tired, dental problems. lon • 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 Trudexa”).
Huwa importanti li tgħid lit - tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb (ara “ Oqgħod attent ħafna b’ Trudexa ”). li l
Take special care with Trudexa: no
Oqgħod attent ħafna b’ Trudexa ina
• If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately. t
• Jekk inti tesperjenza reazzjonijiet allerġiċi bħal għafis fis- sider, tħarħir, sturdament, nefħa jew raxx, tinjettax aktar Trudexa, u kkuntatja lit- tabib tiegħek immedjatament. diċ
Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield. rod
Pazjenti li jafu li għandhom sensittività għal- latex għandhom ikunu avżati biex jevitaw li jmissu l- għatu ta ’ ġewwa. me
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa.
• Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) kellem lit- tabib tiegħek qabel tibda Trudexa.
If you are unsure, please contact your doctor. lP
Jekk għandek xi dubju, jekk jogħġbok kellem lit - tabib tiegħek. ott
• You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening.
• Jista ’ jkun li waqt li tkun qiegħed tirċievi l- kura b’ Trudexa, jaqbduk infezzjonijiet aktar faċilment, inkluż infezzjonijiet serji, tuberkulosi, infezzjonijiet opportunistiċi u sepsis 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, na
Huwa importanti li inti tgħid lit- tabib tiegħek jekk ikollok od
feeling tired or dental problems.
sintomi bħal deni, feriti, tħossok għajjien jew ikollok problemi tas- snien.
• As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will i
• Peress illi ġew irrappurtati każi ta ’ tuberkulosi f’ pazjenti kkurati b’ Trudexa, qabel tibda Pr
This will include a dic
Trudexa, it- tabib tiegħek se jeżaminak għal sinjali u sintomi tat- tuberkulosi.
thorough medical history, a chest X-ray and a tuberculin test.
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 Me
Jekk jitfaċċaw sintomi tat- tuberkulosi (sogħla persistenti, tnaqqis fil- piż,
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
141 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 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.
at • Jekk int iġġorr il- virus ta ’ l- epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li
Trudexa can cause reactivation of 133 HBV in people who carry this virus.
Trudexa 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 ’
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
ori tpoġġilek ħajtek fil- periklu.
ed • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
• Jekk inti se tagħmel xi operazzjoni jew se tgħamel xi intervent tas- snien, jekk jogħġbok għarraf
• Some vaccines should not be given while receiving Trudexa.
t lit- tabib tiegħek li inti qiegħed tieħu Trudexa.
ris before you receive any vaccines.
aw • Jekk inti tbati minn sklerosi multipla, it- tabib tiegħek għandu jiddeċiedi jekk inti għandekx tirċievi Trudexa.
• If you have mild heart failure and you are being treated with Trudexa, your heart failure status
ux • Ċerti tilqim m’ għandhomx jingħataw waqt li jkun qiegħed jingħata Trudexa.
tho must be closely monitored by your doctor.
ad • Jekk tbati minn insuffiċjenza moderata tal- qalb u qiegħed tingħata l- kura b’ Trudexa, l- istat ta ’ l - insuffiċjenza ta ’ qalbek għandu jiġi monitorjat mill- qrib mit- tabib tiegħek.
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 ’ g ħ 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. im
au • 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.
Your doctor may
It- tabib tiegħek jista ’ jiddeċiedi li jwaqqaf il - li l
r decide to stop treatment.
kura.
ge • There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers.
• Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Trudexa jew mediċini oħra ina
People with more serious rheumatoid arthritis that have had the disease for a lon long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Persuni li għandhom artrite rewmatika aktar serja u li ilhom ibatu minnha għal żmien twil jista ’ jkollhom riskju akbar mill- medja li jaqbadhom kanċer li jaffetwa is - sistema limfatika, u li jissejjaħ limfoma.
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa. no
hekk, f’ pazjenti li jieħdu Trudexa, ġew osservati każi rari ħafna ta ’ kanċer tal- ġilda mhux tat- tip melonoma.
• 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.
• Tipi ta ’ kanċer oħra, minbarra limfoma, ġew irrappurtati f’ pazjenti li jbatu minn marda speċifika me
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. t uc
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. ott
Using other medicines
Meta tuża mediċini oħra od
(sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.
Trudexa 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 - Pr
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, lP
infjammatorji mhux sterojdi.
including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you have na
142 M’ għandekx tieħu Trudexa ma ’ mediċini li fihom is- sustanza attiva anakinra.
Using Trudexa with food and drink i dic
Meta tuża Trudexa ma ’ l- ikel u max- xorb.
Since Trudexa is given subcutaneously, food and drink should not affect Trudexa.
at Peress li Trudexa jingħata taħt il- ġilda, l- ikel u x- xorb m’ għandhomx jaffetwawh.
Pregnancy and breast-feeding Me
zz Tqala u Treddigħ
The effects of Trudexa in pregnant women are not known and so the use of Trudexa in pregnant women is not recommended.
L- effetti ta ’ Trudexa fuq nisa tqal għadhom m’ humiex maghrufa, u għalhekk l- użu ta ’ Trudexa min -
It is not known whether adalimumab passes into breast milk.
t aw M’ huwiex magħruf jekk adalimumab jgħaddix fil- ħalib tas- sider.
134 If you are a breast-feeding mother, you should stop breast-feeding during Trudexa treatment and for at least 5 months after the last Trudexa treatment.
Jekk inti qiegħda tredda ’, int għandek tieqaf tredda ’ matul it- trattamant b’ Trudexa u għal mill- inqas 5 xhur wara l- aħħar trattament b’ Trudexa.
Driving and using machines
ux Sewqan u tħaddim ta ’ magni
Trudexa should not affect your ability to drive or use machinery.
ad Trudexa m’ għandux jaffetwa l- abilità tiegħek li ssuq jew tħaddem magni.
ris This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium- free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Trudexa ’ g ħ Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull doża, jiġifieri, huwa prattikament “ mingħajr sodju. ” im
HOW TO USE TRUDEXA
KIF GĦANDEK TUŻA TRUDEXA li l
You should check with your doctor or
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju. ina
The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as
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. Id- dożaġġ li jingħata s- soltu għall- marda Crohn (Crohn’ s disease) huwa ta ’ 80 mg f’ ġimgħa 0 diċ
r ge a single dose.
segwit b’ 40 mg ġimgħa iva u ġimgħa le li jinbew minn ġimgħa 2.
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.
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 me
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 lon week.
injezzjonijiet) f’ ġimgħa 2, u wara dan 40 mg (injezzjoni waħda) ġimgħa iva u ġimgħa le.
You should continue to inject Trudexa for as long as your doctor has told you.
Għandek tibqa ’ tinjetta Trudexa għaż- żmien li jkun qallek it- tabib tiegħek.
In rheumatoid arthritis, methotrexate is continued while using Trudexa.
Jekk it - ott
If your doctor determines that no
tabib tiegħek jiddeċiedi li methotrexate m’ huwiex adattat, Trudexa jista ’ jingħata waħdu.
methotrexate is inappropriate, Trudexa can be given alone.
Jekk inti tbati minn artrite rewmatika u ma tkunx qiegħed tirċievi methotrexate flimkien mal- kura od
Instructions for preparing and giving an injection of Trudexa: rod
Pr
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
After proper training, the injection can be self-administered or given by lP
143 inti tkun ċert li fhimt kif tipprepara għall -, u tagħti l- injezzjoni.
1) Setting up
at 1) Il- preparazzjoni
• Set up the following items on a clean surface
zz • Aħsel idejk sewwa • Ipprepara dawn l- oġġetti li ġejjin fuq wiċċ nadif
Me
ori
One pre-filled syringe of Trudexa for injection One alcohol pad
Siringa waħda ta ’ Trudexa għall- injezzjoni, mimlija għal- lest Kuxxinett wieħed bl- alkoħol
135 ed ris tho • Look at the expiry date on the syringe.
t aw ux ad ’ g ħ • 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. im
au 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 li l ina diċ me
This may mean there is an infection.
Dan jista ’ jfisser li hemm
Wipe the injection site with the enclosed alcohol pad, using a circular motion. rod
infezzjoni.
3) Injecting Trudexa lP
3) Biex tinjetta Trudexa Pr
136 ed ris tho • With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up. • With one quick, short motion, push needle all the way into skin •
Biex tinjetta Trudexa • TĦAWWADX is- siringa. • Neħħi l- għatu mis- siringa, u oqgħod attent li ma tmissx il- labra jew li l- labra ma tmiss ma l - ebda wiċċ. • B’ id waħda, aqbad bil- mod il- partijiet tal- ġilda li ġew imnaddfa u żommhom sod 144 at zz ori t aw • Bl- id l- oħra, żomm is- siringa mgħawwġa f’ angolu ta ’ 45° mal- ġilda, bin- naħa fejn għandha l - gruvijiet ’ il fuq. • B’ moviment wieħed qasir u mgħaġġel, imbotta l- labra kollha fil- ġilda • Itlaq l- ewwel id minn mal- ġilda •
au Release the skin with the first hand • Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe • When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted
ux 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
A
ad angolu li żammejtha biex daħħaltha • Bis- saba ’ il- kbir ta ’ idejk, jew b’ biċċa garża, agħfas il- post ta ’ l- injezzjoni għal 10 sekondi.
ge little bleeding may occur.
Jista ’ joħroġlok ftit demm.
4) Throwing away supplies lon • The Trudexa syringe should NEVER be reused.
Jekk trid uża impjastru. ’ g ħ 4) Biex tarmi l- affarijiet li użajt
NEVER recap a needle. • After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. no
M’ għandek QATT terġa ’ tlibbes l- għatu im
• Keep this container out of the reach and sight of children
fuq il- labra • Wara li tinjetta Trudexa, armi s- siringa użata immedjatament f’ kontenitur speċjali, kif qallek it - tabib, l- infermier jew l- ispiżjar tiegħek. • li l
If you use more Trudexa than you should: t
Żomm dan il- kontenitur fejn ma jintlaħaqx u ma jidhirx mit- tfal.
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your uc
Jekk tuża Trudexa aktar milli suppost ina
Always take the outer carton of medicine with you, even if it is empty. rod
Dejjem ħu miegħek il- kartuna ta ’ barra jew il- kunjett tal- mediċina, anke jekk ikunu vojta. diċ
If you forget to take Trudexa:
Jekk tinsa tieħu Trudexa me
If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you remember.
Jekk tinsa tinjetta lilek innifsek b’ Trudexa, injetta d- doża ta ’ Trudexa li jkun imissek eżatt kif tiftakar.
Then take your next dose as you would have on your originally scheduled day, had you lP
Imbagħad ħu d- doża ta ’ wara fil- ħin li inti suppost toħodha f’ ġurnata normali, daqs li kieku ma ’ nsejtx doża.
If you have any further questions on the use of this product, ask your doctor or pharmacist. na
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek. ott
POSSIBLE SIDE EFFECTS i dic
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU od
However, some may be serious and require treatment.
jkunu serji u jirrikjedu l- kura.
Me
L- effetti sekondarji jistgħu ifeġġu sa mill- inqas 5 xhur wara l- aħħar trattament.
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;
Għarraf lit- tabib tiegħek immedjatament jekk inti tinnota xi wieħed minn dawn li ġejjin: • Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika;
137 • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
145 • 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, malaise, wounds, dental problems, burning on urination; • Feeling weak or tired;
zz • Sinjali ta ’ infezzjoni bħal deni, telqa tal- ġisem mingħajr l- ebda sinjali ta ’ mard, feriti, problemi tas- snien, ħruq waqt għamil ta ’ l- awrina; • Tħossok dgħajjef jew għajjien;
ed • Coughing; • Tinglings; • Numbness;
ori • Sogħla; • Tnemnim; •
ris • Double vision; • Arm or leg weakness.
aw • Tara doppju; • Dgħufija fl- idejn jew fir- riġlejn.
tho The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta ’ l- effetti sekondarji mniżżlin hawn taħt, li ġew
au Very common (≥ 1/ 10 patients): • injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (≥ 1/ 10 pazjent):
Common (≥ 1/ 100 and < 1/ 10 patients):
ad • reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk).
r • lower respiratory tract infections (such as bronchitis, pneumonia);
Komuni (≥ 1/ 100 u < 1/ 10 pazjent): ’ g ħ • 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); • infezzjoni fis- sistema urinarja, infafet kiesħa, ħruq ta ’ Sant’ Antnin; im
ge • upper respiratory tract infections (including cold, runny nose, sinus infection); • urinary tract infection, cold blisters, shingles; • lon dizziness, including vertigo, headache; • eye inflammation; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth ulcers; • elevated liver enzymes; no
• sturdament, li jinkludi vertigo, uġigħ ta ’ ras; • infjammazzjoni fl- għajnejn; • sogħla, uġigħ fil- griżmejn; li l
• rash, itching, hair loss; • fatigue; • fever. t uc
• għeja kbira; • deni. diċ
Uncommon (≥ 1/ 1000 and < 1/ 100 patients): • serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; • skin wart; rod
Mhux komuni (≥ 1/ 1000 u < 1/ 100 pazjent): • infezzjonijiet serji (bħal fil- pene [avvelenament tad- demm]), infezzjoni fil- ġogi, infezzjonijiet tal- fungu; • felul fil- ġilda; me