qanastek/EMEA-V3 huggingface dataset:
• anaemia, low white blood cell counts; • allergic reactions; • increased lipid values, appetite disorders; • lP
• anemija, għadd baxx taċ- ċelluli bojod fid- demm; • reazzjonijiet allerġiċi; • żieda fil- valuri tal- lipidi, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod; ott
anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • na
• disturbi fin- nervituri (bħal sklerosi multipla u infjammazzjoni fin- nervituri ta ’ l- għajnejn), disturbi tat- togħma; • disturbi tal- vista; od
ear discomfort; • sensation of heart beating rapidly, high blood pressure; • asthma, shortness of breath; i
• skonfort fil- widnejn; • sensazzjoni ta ’ taħbit mgħaġġel tal- qalb, pressjoni għolja tad- demm; • ażżma, qtugħ ta ’ nifs; Pr
• 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); Me
• 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 biex ifiqu l- feriti; • dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament);
• increased menstrual bleeding; • flu like symptoms, chest pain, swelling of the feet.
146 • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn.
Rare (< 1/ 1000) • glaucoma; • skin cancer; • thyroid disorders;
Rari (< 1/ 1000) • glawkoma;
138 • protein in urine.
zz • proteina fl- awrina.
Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
ori tuberkulosi u infezzjonijiet opportunistiċi oħra (infezzjonijiet li jiġu kkawżati meta r- reżistenza għall - mard tiddgħajjef); mard tal- pulmun.
ed If any side effects get serious, if you have any unusual effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
t aw 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.
ris 5.
ux 5.
tho Keep out of the reach and sight of children.
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use the Trudexa pre-filled syringe after the expiry date stated on the label/ blister/ carton after
ad Tużax is- siringa ta ’ Trudexa mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il - folja/ il- pakkett wara JIS:.
Store in a refrigerator (2°C – 8°C).
Id- Data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. ’ g ħ Aħżen fi friġġ (2°C - 8°C).
Do not freeze.
Tagħmlux fil- friża. im
Trudexa 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg lon adalimumab dissolved in 0.8 ml solution.
sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml.
What Trudexa contains no
X’ fih Trudexa: ina
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections. t uc
phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjonijiet.
What the Trudexa pre-filled syringe looks like and contents of the pack rod
Id- Dehra tal- prodott u d- daqs tal- pakkett: me
The Trudexa pre-filled syringe is a glass syringe containing a solution of adalimumab.
Is- siringa ta ’ Trudexa mimlija għal- lest hi siringa tal- ħġieġ li fiha soluzzjoni ta ’ adalimumab.
Not all pack sizes may be marketed. lP
għall- skop kummerċjali.
Trudexa is also available as a vial or a pre-filled pen.
Trudexa jista ’ tinxtara ukoll bħala kunjett jew pinna mimlija għal- lest. od
Marketing Authorisation Holder: na
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Abbott Laboratories Ltd Queenborough Kent ME11 5EL i dic
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Renju Unit
United Kingdom
147 Il- Manifattur
Me
Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D - 65205 Wiesbaden Germany
at D – 65205 Wiesbaden Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
zz Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
139 België/ Belgique/ Belgien Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Ottignies/ Louvain-la-Neuve
ori Luxembourg/ Luxemburg België/ Belgique/ Belgien Abbott SA Abbott SA
Belgique/ Belgien Tél/ Tel: + 32 10 475311
aw 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 Tél/ Tel: + 32 10 475311
Teve u.
ad Teve u.
tho София 1504 Teл.: + 359 2 846 8429
Оборище № 45 H- 1139 Budapest София 1504 Tel.: + 36 1 465 2100 Teл.: + 359 2 846 8429 ’ g ħ 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 im
ge Tel: + 420 267 292 111
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Abbott Laboratories A/ S Smakkedalen 6 DK-2820 Gentofte Tlf: + 45 39 77-00-00
Nederland Danmark Abbott BV Abbott Laboratories A/ S ina
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KG Max-Planck-Ring 2 D-65205 Wiesbaden
KG PO Box 1, N- 1330 Fornebu Max- Planck- Ring 2 me
Norge Abbott Norge AS PO Box 1, N-1330 Fornebu Martin Linges vei 25, N-1367 Snarøya
Martin Linges vei 25, N- 1367 Snarøya D- 65205 Wiesbaden Tlf: + 47 81 55 99 20 Tel: + 49 (0) 6122 58- 0
Tel: + 49 (0) 6122 58-0
Eesti Österreich Abbott
Tlf: + 47 81 55 99 20
Laboratories Baltics ott
Österreich
Abbott Ges. m. b. H.
Abbott Laboratories Vienibas 87h LV-1004 Riia Läti
Vienibas 87h LV- 1004 Riia Läti od
Tel: + 371 7605580
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Ελλάδα
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Me
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at P- 2610- 008 Amadora Tel: + 34 9 1 337- 5200 Tel: + 351 (0) 21 472 7100
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zz France Abbott France
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ux SI- 1000 Ljubljana 4051 Kingswood Drive Tel: + 386 (1) 43 22 322 Citywest Business Campus IRL – Dublin 24,
Tel: + 386 (1) 43 22 322
ad Tel: + 353 (0) 1 469- 1500
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’ g ħ
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im
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r Abbott SpA
li l
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ina
Κύπρος Lifepharma (Z.A.M.) Ltd Θεοτόκη 4Β 1055 Λευκωσία
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Abbott House Unit 2, Vanwall Road Vanwall Business Park
United Kingdom Latvija Abbott Laboratories Ltd Abbott Laboratories Baltics Abbott House Vienibas 87h Unit 2, Vanwall Road LV- 1004 Rīga Vanwall Business Park Tel: + 371 7605580 ott
Maidenhead Berkshire SL6 4XE - UK Tel: + 44 (0) 1628 773355 lP
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Lietuva Abbott Laboratories Baltics Vienibas 87h na
Lietuva Abbott Laboratories Baltics Pr
LV-1004 Rīga Latvia Tel: + 371 7605580 i dic
Vienibas 87h LV- 1004 Rīga Latvia Tel: + 371 7605580
This leaflet was last approved in {MM/YYYY} Me
149 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} FULJETT TA ’ TAGĦRIF:
Trudexa 40 mg solution for injection in pre-fill ed syringe with needleguard Adalimumab
Trudexa 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest bil- labra mgħottija Adalimumab
ed Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
at Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
Keep this Patient Alert Card with the package leaflet. − If you have any further questions, please ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Monoclonal antibodies are t
Is- sustanza attiva, adalimumab, hija anti- korp uman li l
142 Ankylosing spondylitis
150 Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
If you do not respond well enough to these m edicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
at tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Trudexa biex tnaqqas is- sinjali u s- sintomi tal - marda tiegħek.
ed Crohn’s disease
zz Il- marda Crohn (Crohn’ s disease)
ris Crohn’s disease is an inflammatory disease of the digestive tract.
ori 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 a re allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adalimumab jew sustanzi oħra ta ’
It is important that you tell your doc tor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems. lon • If you have moderate or severe heart failure.
• Jekk għandek infezzjoni severa, inkluż tuberkulosi attiva (ara “ Oqgħod attent ħafna ’ g ħ b’ Trudexa ”).
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 inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas- snien.
Take special care with Trudexa: no
Huwa importanti li tgħid lit - im
• If you experience allergic reactions s uch 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 ina
• You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare case, be life-threatening.
kellem lit- tabib tiegħek qabel tibda Trudexa.
It is important to tell your doctor if you get symptoms such as fever, wounds, na
Jekk għandek xi dubju, jekk jogħġbok kellem lit - tabib tiegħek.
feeling tired or dental problems.
• Jista ’ jkun li waqt li tkun qiegħed tirċievi l- kura b’ Trudexa, jaqbduk infezzjonijiet aktar ott
This will include a dic
Dan jinkludi storja medika fid- dettal, X- ray tas- sider u test tat- tuberkolina. It- twettiq ta ’ dawn it- testijiet għandu jiġi Pr
thorough medical history, a chest X-ray and a tuberculin test.
mniżżel fuq il- Kartuna ta ’ Twissija tal- Pazjent.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
151 • 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.
Trudexa can cause reactivation of 143 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
• If you are about to undergo surgery or dental proc edures please inform your doctor that you are taking Trudexa.
zz qiegħed tieħu mediċini oħra li jrażżnu s- sistema immuni, ir- riattivazzjoni ta ’ l- HBV tista ’ tpoġġilek ħajtek fil- periklu.
ed • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa
ori • Jekk inti se tagħmel xi operazzjoni jew se tgħamel xi intervent tas- snien, jekk jogħġbok għarraf lit- tabib tiegħek li inti qiegħed tieħu Trudexa.
Please check with your doctor
t • Jekk inti tbati minn sklerosi multipla, it- tabib tiegħek għandu jiddeċiedi jekk inti għandekx
ris before you receive any vaccines.
aw tirċievi Trudexa.
• If you have mild heart failure and you are being treated with Trudexa, your heart failure status
• Ċerti tilqim m’ għandhomx jingħataw waqt li jkun qiegħed jingħata Trudexa.
It is important to tell your doctor if you have had or have a serious heart condition.
Jekk jogħġbok iċċekkja mat- tabib tiegħek qabel ma tieħu xi tilqim.
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.
ux • 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.
Your
Huwa importanti illi
au doctor will decide if you should receive Trudexa.
ad inti tgħid lit- tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb.
• 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.
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. ’ g ħ • 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 feve r that does not go away,
Jekk tiżviluppa deni li ma im
r bruise or bleed very easily or look very pale, call your doctor right away.
jgħaddilekx, jew tibda titbenġel faċilment jew joħroġlok id- demm faċilment, jew tkun pallidu ħafna, ċempel lit- tabib tiegħek immedjatament.
Your doctor may
It- tabib tiegħek jista ’ jiddeċiedi li jwaqqaf il - kura. li l
• There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other lon TNF blockers.
• Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Trudexa 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 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 - ina
• 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 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 t
Jekk inti tbati minn COPD, jew tpejjep me
whether treatment with a TNF blocker is appropriate for you. uc
ħafna, inti għandek tiddiskuti mat- tabib tiegħek fuq jekk il- kura b’ mediċina li timblokka t- TNF hijiex adattata għalik.
Using other medicines rod
Meta tuża mediċini oħra ott
Trudexa 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. lP
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 od
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. na
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You should not take Trudexa with medicines containing the active substance, anakinra.
M’ għandekx tieħu Trudexa ma ’ mediċini li fihom is- sustanza attiva anakinra.
If you have questions, please ask your doctor. i
Jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib tiegħek.
Using Trudexa with food and drink dic
152 Meta tuża Trudexa ma ’ l- ikel u max- xorb.
Me
Peress li Trudexa jingħata taħt il- ġilda, l- ikel u x- xorb m’ għandhomx jaffetwawh.
Pregnancy and breast-feeding
at 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.
zz L- effetti ta ’ Trudexa fuq nisa tqal għadhom m’ humiex maghrufa, u għalhekk l- użu ta ’ Trudexa min - nisa tqal m’ huwiex irrakomandat.
You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.
Inti għandek tevita li tinqabad tqila u għandek tuża mezz ta ’ kontraċezzjoni adegwat waqt li tkun qiegħda tuża Trudexa u għal mill- inqas 5 xhur wara l- aħħar
144 If you are a breast-feeding mother, advise you should stop breast-feeding during Trudexa treatment, and for at least 5 months after the last Trudexa treatment.
t aw 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.
ed Important information about some of the ingredients of Trudexa
ad 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’.
Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull doża, jiġifieri, huwa prattikament ’ g ħ “ mingħajr sodju. ”
The usual dose fo r 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 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.
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 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.
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. me
If your doctor determines that no
F ’ każ ta ’ artrite rewmatika, methotrexate jibqa ’ jintuża waqt li jkun qiegħed jintuża Trudexa.
methotrexate is inappropriate, Trudexa can be given alone.
Jekk it - tabib tiegħek jiddeċiedi li methotrexate m’ huwiex adattat, Trudexa jista ’ jingħata waħdu. 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
Jekk inti tbati minn artrite rewmatika u ma tkunx qiegħed tirċievi methotrexate flimkien mal- kura b’ Trudexa, it- tabib tiegħek jista ’ jiddeċiedi li jagħtik 40 mg adalimumab kull ġimgħa. od
Instructions for preparing and giving an injection of Trudexa:
Istruzzjonijiet għall- preparamenti u l- għotja ta ’ l- injezzjoni ta ’ Trudexa:
Please read the instructions carefully and rod
Jekk jogħġbok aqra l- istruzzjonijiet Pr
follow them step by step.
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.
After proper training, the injection can be self-administered or given by another person, for example a family member or friend. lP
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.
153 Din l- injezzjoni m’ għandhiex tiġi mħallta ma ’ xi mediċina oħra fl- istess siringa jew kunjett.
1) Setting up na
1) Il- preparazzjoni
• Wash your hands thoroughly • Set up the following items on a clean surface i dic
at • Ipprepara dawn l- oġġetti li ġejjin fuq wiċċ nadif
Me
zz
145 ed ris tho • Look at the expiry date on the syringe.
ori t aw ux ad • Iċċekja d- data ta ’ l- iskadenza fuq il- kunjett.
2) Choosing and preparing an injection site
2) Biex tagħżel u tipprepara l- post fejn se tieħu l- injezzjoni ’ g ħ • Agħżel post fuq il- koxxa jew fuq l- istonku im li l ina diċ
• Each new injecti on 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.
This may mean there is an infecti on.
Dan jista ’ jfisser li hemm me
Wipe the injection site with the enclosed alcohol pad, using a circular motion. t
Imsaħ, permezz ta ’ movimenti mdawra, il- post fejn ser tingħata l- injezzjoni bil- kuxxinett bl- alkoħol li ssib fil- pakkett.
D o not touch the area again before injecting. uc
Terġax tmiss din il- parti qabel tagħti l- injezzjoni.
o
3) Biex tinjetta Trudexa
3) Injecting Trudexa rod
Biex tinjetta Trudexa od
• With one hand, gently grasp the cleaned areas of skin and hold firmly i na dic Me
154 • B’ id waħda, aqbad bil- mod il- partijiet tal- ġilda li ġew imnaddfa u żommhom sod
• 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 • Release the skin with the first hand • Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe
ux • 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
146 • When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted • Hold the syringe in one hand and with the other hand slide the outer protective shield over the exposed needle until it locks in place • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
ad • Meta is- siringa tiżvojta, neħħi l- labra minn ġol- ġilda, u oqgħod attent li żżommha fl- istess angolu li żammejtha biex daħħaltha • Żomm is- siringa f’ id waħda, u bl- id l- oħra żerżaq il- kappa protettiva ta ’ barra fuq il- labra ’ g ħ mikxufa sakemm tinżel f’ postha • Bis- saba ’ il- kbir ta ’ idejk, jew b’ biċċa garża, agħfas il- post ta ’ l- injezzjoni għal 10 sekondi.
Use a plaster if you want to.
Jekk trid uża impjastru. im
ed 4) Throwing away supplies
4) Biex tarmi l- affarijiet li użajt
ris • 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 instructed by your doctor, nurse or pharmacist.
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. ina
tho • Keep this container out of the reach and sight of children
• Żomm dan il- kontenitur fejn ma jintlaħaqx u ma jidhirx mit- tfal.
If you use more Trudexa than you should:
Jekk tuża Trudexa aktar milli suppost diċ
au If you accidentally inject Trudexa 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 Trudexa aktar frekwentament milli ordnalek it- tabib tiegħek, inti għandek iċċempel lit- tabib tiegħek u tgħidlu li ħadt aktar milli suppost.
Always take the oute r carton of medicine with you, even if it is empty.
Dejjem ħu miegħek il- kartuna ta ’ barra jew il- kunjett tal- mediċina, anke jekk ikunu vojta. me
r ge If you forget to take Trudexa:
Jekk tinsa tieħu Trudexa
If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you lon 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 not forgotten a dose.
Imbagħad ħu d- doża ta ’ wara fil- ħin li inti suppost toħodha f’ ġurnata normali, daqs li kieku ma ’ nsejtx ott
If you have any further questions on the use of this product, ask your doctor or pharmacist. no
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek. od
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Pr
Most side t uc
Bħal kull mediċina oħra, Trudexa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
effects are mild to moderate.
Ħafna mill- effetti sekondarji huma minn ħfief għal moderati.
Side effects may occur at least up to 5 months after the last treatment. rod
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; lP
155 Għarraf lit- tabib tiegħek immedjatament jekk inti tinnota xi wieħed minn dawn li ġejjin: • Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika; • Nefħa fil- wiċċ, fl- idejn u fis- saqajn; • Diffikultà biex tieħu n- nifs, biex tibla ’;
• 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. na
at • 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,
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; i
Għarraf lit- tabib tiegħek mill- aktar fis possibbli jekk inti tinnota xi wieħed minn dawn li ġejjin:
• Feeling weak or tired; dic
ori • 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;
• Coughing; • Tingling; • Numbness; Me
t aw • Sogħla; • Tnemnim; • Tirżiħ; • Tara doppju;
• Double vision; • Arm or leg weakness.
ux • Dgħufija fl- idejn jew fir- riġlejn.
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
Very common (≥ 1/10 patients):
ad osservati b’ Trudexa:
147 • injection site reactions (including pain, swelling, redness or itching).
Komuni ħafna (≥ 1/ 10 pazjent): ’ g ħ • reazzjonijiet fil- post ta ’ l- injezzjoni (li jinkludu uġigħ, nefħa, ħmura jew ħakk).
Common (≥ 1/100 and < 1/10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection);
Komuni (≥ 1/ 100 u < 1/ 10 pazjent): • infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); im
ed • urinary tract infection, cold blisters, shingles; • dizziness, including vertigo, headache; • eye inflammation;
• 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; li l
ris • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth ulcers;
• sturdament, li jinkludi vertigo, uġigħ ta ’ ras; • infjammazzjoni fl- għajnejn; • sogħla, uġigħ fil- griżmejn; ina
tho • elevated liver enzymes; • rash, itching, hair loss; • fatigue; • fever.
• nawseja, dijarea, uġigħ addominali, ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied; • raxx, ħakk, taqa ’ x- xagħar; diċ
au Uncommon (≥ 1/1000 and < 1/100 patients): • se rious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; •
• għeja kbira; • deni.
r skin wart;
Mhux komuni (≥ 1/ 1000 u < 1/ 100 pazjent): me
ge • anaemia, low white blood cell counts; • allergic reactions; • increased lipid values, appetite disorders; lon • anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • ear discomfort; no
• infezzjonijiet serji (bħal fil- pene [avvelenament tad- demm]), infezzjoni fil- ġogi, infezzjonijiet tal- fungu; • felul fil- ġilda; • anemija, għadd baxx taċ- ċelluli bojod fid- demm; ott
• sensation of heart beating rapidly, high blood pressure; • 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; t
• reazzjonijiet allerġiċi; • żieda fil- valuri tal- lipidi, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod; od
• muscle weakness; uc
• disturbi fin- nervituri (bħal sklerosi multipla u infjammazzjoni fin- nervituri ta ’ l- għajnejn), disturbi tat- togħma; • disturbi tal- vista; Pr
• urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; rod
• skonfort fil- widnejn; • sensazzjoni ta ’ taħbit mgħaġġel tal- qalb, pressjoni għolja tad- demm; • ażżma, qtugħ ta ’ nifs; • sintomi addominali (bħal rimettar, indiġestjoni, stitikezza), ħruġ ta ’ demm mir- rektum;
• flu like symptoms, chest pain, swelling of the feet.
at • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn.
Rare (< 1/1000) • glaucoma; lP
zz Rari (< 1/ 1000) • glawkoma; • kanċer tal- ġilda;
• skin cancer; • thyroid disorders; • protein in urine. na
ori • distrubi fit- tirojde; • proteina fl- awrina.
Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is i
t aw Effetti sekondarji oħra li ġew osservati f’ pazjenti li jieħdu Trudexa: tuberkulosi u infezzjonijiet opportunistiċi oħra (infezzjonijiet li jiġu kkawżati meta r- reżistenza għall - mard tiddgħajjef); mard tal- pulmun.
If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your Me
ux 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.
5.
ad 5.
HOW TO STORE TRUDEXA
KIF TAĦŻEN TRUDEXA ’ g ħ Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Keep out of the reach and sight of children.
Tużax is- siringa ta ’ Trudexa mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il - im
148 Do not use the Trudexa pre-filled syringe after the expiry date stated on the label/blister/carton after EXP:.
folja/ il- pakkett wara JIS:.
Do not freeze.
Tagħmlux fil- friża. li l
FURTHER INFORMATION
AKTAR TAGĦRIF ina
Trudexa 40 mg solution for injection in pre-filled syringe with needleguard is supplied as a sterile
Trudexa 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest hija fornuta bħala soluzzjoni sterili ta ’ 40 mg adalimumab imdewba f’ soluzzjoni ta ’ 0. 8 ml. diċ
What Trudexa contains
X’ fih Trudexa:
tho The active substance is adalimumab.
Is- sustanza attiva hi adalimumab.
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Is- sustanzi l- oħra huma mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen me
au What the T rudexa pre-filled syringe looks like and contents of the pack The Trudexa pre-filled syringe is a glass syringe with needleguard containing a solution of
phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjonijiet.
r adalimumab.
Id- Dehra tal- prodott u d- daqs tal- pakkett: ott
Each pack contains 1 pre-filled syrin ge with needleguard for hospital administration or
Kull pakkett ikun fih siringa waħda mimlija għal- lest, bil- labra mgħottija għall- użu fl - od
ge administration by a caregiver, with 1 alcohol pad.
isptarijiet jew biex jingħata minn persuna kwalifikata, b’ kuxxinett wieħed bl- alkoħol.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. Trudexa jista ’ tinxtara Pr
Trudexa is also available as a vial or a pre-filled pen. lon Marketing Authorisation Holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Abbott Laboratories Ltd no
Id- detentur ta ’ l- awtorizzazzjoni
Queenborough Kent ME11 5EL United Kingdom t uc
Abbott Laboratories Ltd 157 Queenborough Kent ME11 5EL Renju Unit
Abbott Biotechnology Deutschland GmbH rod
at Abbott Biotechnology Deutschland GmbH
Max-Planck-Ring 2 D - 65205 Wiesbaden Germany lP Me
zz Max- Planck- Ring 2 D – 65205 Wiesbaden Ġermanja
149 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
ori Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
België/Belgique/Belgien Abbott SA Parc Scientifique
t aw Luxembourg/ Luxemburg België/ Belgique/ Belgien Abbott SA Abbott SA Parc Scientifique Parc Scientifique Rue du Bosquet, 2 Rue du Bosquet, 2
ed Rue du Bosquet, 2 B-1348 Ottignies/ Louvain-la-Neuve Tél/Tel: + 32 10 475311
ux B- 1348 Ottignies/ Louvain- la- Neuve B- 1348 Ottignies/ Louvain- la- Neuve Belgique/ Belgien Tél/ Tel: + 32 10 475311 Tél/ Tel: + 32 10 475311
България
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tho Tel: + 353 (0) 1 469-1500
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’ g ħ
au Hö rgatún 2 IS-210 Garðabær Tel: + 354 535 7000
im
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159 Tel: + 371 7605580
151 PACKAGE LEAFLET:
160 FULJETT TA ’ TAGĦRIF:
Trudexa Pre-filled Pen 40 mg solution for injection in pre-filled pen Adalimumab
Trudexa Pinna mimlija għal- lest 40 mg soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Adalimumab
Keep this Patient Alert Card together with the package leaflet. − If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Adalimumab binds to a specific protein uc
jeħlu ma ’ proteini uniċi oħra.
152 Ankylosing spondylitis
161 Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
If you have ankylosing spondylitis you will first be given other m edicines.
Jekk ma tirrispondix
au Do not use T rudexa:
ux Tużax Trudexa
r • If you have a severe infection, including active tuberculosis (see “Take special care with
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adalimumab jew sustanzi oħra ta ’
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 għandek infezzjoni severa, inkluż tuberkulosi attiva (ara “ Oqgħod attent ħafna ’ g ħ b’ Trudexa ”).
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 inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas- snien.
• 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.
kellem lit- tabib tiegħek qabel tibda Trudexa.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
162 • 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.
Trudexa can cause reactivation of 153 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 m edicines that suppress the immune system, reactivation of HBV can be life-threatening.
F’ xi każi rari, speċjalment jekk tkun
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
zz qiegħed tieħu mediċini oħra li jrażżnu s- sistema immuni, ir- riattivazzjoni ta ’ l- HBV tista ’ tpoġġilek ħajtek fil- periklu.
ed • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
ori • Jekk inti se tagħmel xi operazzjoni jew se tgħamel xi intervent tas- snien, jekk jogħġbok għarraf lit- tabib tiegħek li inti qiegħed tieħu Trudexa.
• In some patients the body may fail to p roduce enough of the blood cells that help your body fight infections or help you to stop bleeding.
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. ’ g ħ • 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,
Jekk tiżviluppa deni li ma im
Using Trudexa with food and drink dic
163 Meta tuża Trudexa ma ’ l- ikel u max- xorb.
154 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.
t Jekk inti qiegħda tredda ’, int għandek tieqaf tredda ’ matul it- trattamant b’ Trudexa u għal mill- inqas 5
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 THE TRUDEXA PRE-FILLED PEN
KIF GĦANDEK TUŻA TRUDEXA im
Always use Trudexa exactly as your doctor has told you.
Dejjem għandek tieħu Trudexa skond il- parir tat- tabib.
T rudexa 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 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.
le. 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.
I n cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at week 2, and thereafter as 40 mg (1 injection) every other 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 diċ
If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg Trudexa every week. t uc
b’ Trudexa, it- tabib tiegħek jista ’ jiddeċiedi li jagħtik 40 mg adalimumab kull ġimgħa.
Injecting Trudexa yourself rod
Biex tinjetta lilek innifsek od
The following instructions explain how to give yourself an injection of Trudexa using the pre-filled pen.
L- istruzzjonijiet segwenti jispjegaw kif tinjetta lilek innifsek b’ Trudexa bil- pinna mimlija għal- lest.
You will be instructed by your doctor or his/her assistant on the technique of self-injection.
tabib tiegħek jew mill- assistent tiegħu/ tagħha dwar it- teknika ta ’ kif tinjetta lilek innifsek.
After proper training, the lP
Tippruvax tinjetta lilek innifsek qabel ma inti tkun ċert li fhimt kif tipprepara għall -, u tagħti l- injezzjoni.
injection can be self-administered or given by another person, for example a family member or friend.
Wara taħriġ xieraq, l- injezzjoni tista ’ tingħata minnek stess jew minn persuna oħra, per eżempju membru tal - familja jew xi ħabib/ a.
What should I do before I give myself a subcutaneous injection of Trudexa? na
164 X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Trudexa?
Take one dose tray containing a pre-filled pen of Trudexa from the refrigerator.
Mill- friġġ, ħu trej wieħed tad- doża mimli b’ pinna ta ’ Trudexa mimlija għal- lest.
Do not shake or drop the pre-filled pen. i dic
Tħawwadx jew twaqqax il- pinna mimlija għal- lest.
One pre-filled pen of Trudexa One alcohol pad
Pinna waħda ta ’ Trudexa mimlija għal- lest Kuxxinett wieħed bl- alkoħol
155 ed ris tho au 5.
ori t aw ux ad ’ g ħ 5.
Check the expiry date on the pre-filled pen label (EXP:).
Iċċekja d- data ta ’ l- iskadenza fuq it- tikketta tal- pinna mimlija għal- lest (JIS:).
Do not use the product if the date has passed the month and year shown.
Tużax il- prodott wara x- xahar u s- sena murija. im
Check the appearance of
Żomm il- pinna mimlija għal- lest bl- għatu l- griż (immarkat ‘ 1 ’) iħares ’ il fuq.
ge the Trudexa solution through the windows on the sides of the pre-filled pen.
Iċċekja d- dehra tas- soluzzjoni Trudexa mit- twieqi tal- ġnub tal- pinna mimlija għal- lest.
If it is cloudy or discoloured or has flakes or particles in it, you must not use it.
Jekk tkun imċajpra jew tkun bidlet il- kulur jew ikollha xi biċċiet irqaq jew li l
Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight. lon
Tużax pinna mimlija għal- lest li tkun iffriżata jew li tkun tħalliet f’ xemx diretta fuqha. ina diċ me ott od
lP
Pr
Choose a site on the top of your thigh or stomach (except the area around the navel). i dic Me
Agħżel post fuq in- naħa ta ’ fuq tal- koxxa jew ta ’ l- istonku (ħlief il- parti ta ’ madwar iż- żokkra).
156 2.
165 at zz ori 2.
Each new injection should be given at least 3 cm from the last injection site.
Biddel il- post ta ’ l- injezzjoni kull darba, biex inti ma jkollokx uġigħ fl- istess parti.
ed How do I give my injection?
Kif nagħti l- injezzjoni?
1.
ux 1.
Do not touch the
Imsaħ il- ġilda, permezz ta ’ movimenti mdawra, bil- kuxxinett bl- alkoħol li ssib fil- pakkett.