qanastek/EMEA-V3 huggingface dataset:
Remicade is supplied as a lyophilised powder in single-use glass (Type 1) vials with rubber stoppers and aluminium crimps protected by plastic caps.
Remicade jiġi bħala trab lajofilizzat f’ kunjetti tal- ħġieġ (Tip 1) għal użu ta ’ darba b’ tappijiet tal- lasktu u piegi ta ’ aluminium protetti b’ għotjien tal- plastik.
Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Remicade jiġi f’ pakketti ta’ 1, 2, 3, 4 jew 5 kunjetti.
6.6 Special precautions for disposal and other handling
28 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Calculate the dose and the number of Remicade vials needed.
Ikkalkula d- doża u n- numru ta ’ kunjetti ta ’ Remicade.
Each Remicade vial contains 100 mg infliximab.
Kull kunjett ta ’ Remicade fih 100 mg ta ’ infliximab.
Calculate the total volume of reconstituted Remicade solution required.
Ikkalkula l- volum kollu tas- soluzzjoni Remicade rikostitwit illi huwa meħtieġ.
Under aseptic conditions, reconstitute each Remicade vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Taħt kundizzjonijiet asettiċi, irrikostiwixxi kull kunjett ta ’ Remicade b’ 10 ml ilma għall - injezzjonijiet, billi tuża siringa mgħammra b’ labra 21- gauge (0. 8 mm) jew iżgħar.
Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Neħħi t- tapp li jinqala ’ b’ daqqa ta ’ saba ’ mill- kunjett u imsaħ il- wiċċ b’ tajjara b’ 70% alkoħol.
Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Daħħal il - labra tas- siringa fil- kunjett min- nofs tat- tapp tal- lasktu u mmira l- ilma għall- injezzjonijiet lejn il- ġenb tal- ħġieġ tal- kunjett.
Do not use the vial if the vacuum is not present.
Tużax il- kunjett jekk m’ hemmx vakwu.
Gently swirl the solution by rotating the vial to dissolve the lyophilised powder.
Ħallat is- soluzzjoni bil - mod billi ddawwar il- kunjett biex jinħall it- trab lajofilizzat.
Avoid prolonged or vigorous agitation.
Evita li tħawwad fit- tul jew bis - saħħa.
DO NOT SHAKE.
M’ GĦANDEKX TĦAWWDU.
Foaming of the solution on reconstitution is not unusual.
Ġieli jkun hemm ragħwa fis- soluzzjoni meta tiġi rikostitwita.
Allow the reconstituted solution to stand for 5 minutes.
Ħalli s- soluzzjoni rikostitwita toqgħod għal 5 minuti.
Check that the solution is colourless to light yellow and opalescent.
Ikkontrolla illi s- soluzzjoni tkun bejn bla kulur għal isfar ċar u opalexxenti.
The solution may develop a few fine translucent particles, as infliximab is a protein.
Is- soluzzjoni tista ’ tifforma ftit frak transluċidu, peress li infliximab huwa proteina.
Do not use if opaque particles, discolouration, or other foreign particles are present.
Tużahx jekk ikun hemm xi frak mhux ċar, telf tal- kulur jew xi frak ieħor preżenti.
Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium chloride 9 mg/ ml (0.9%) solution for infusion.
Iddilwixxi l- volum totali tad- doża tas- soluzzjoni rikostitwita Remicade għal 250 ml b’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
This can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Remicade.
Dan jista ’ jsir billi jinġibed volum tas- soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) mil- flixkun tal- ħġieġ jew borża ta ’ l- infużjoni ta ’ 250 ml li jkun daqs il- volum ta ’ Remicade rikostitwit.
Slowly add the total volume of reconstituted Remicade solution to the 250-ml infusion bottle or bag.
Żid bil- mod il- volum totali tas- soluzzjoni ta ’ Remicade rikostitwita mal- flixkun jew borża ta ’ l- infużjoni ta ’ 250 ml.
Administer the infusion solution over a period of not less than the infusion time recommended for the specific indication.
Agħti s- soluzzjoni ta ’ l- infużjoni fuq perijodu ta ’ mhux inqas mill- ħin ta ’ infużjoni rakkomandat għal kull indikazzjoni sepċifika.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometer or less).
Uża biss sett ta ’ l- infużjoni li jkollu filtru fil- pajp, sterili, li ma jikkawżax id- deni, u li jeħel miegħu livell baxx ta ’ proteini (daqs tal- pori 1. 2 mikrometru jew inqas).
Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Peress li m’ hemm l- ebda preżervattiv, huwa rakkomandat li s- soluzzjoni għall- infużjoni għandha tibda tingħata kemm jista ’ jkun malajr u sa tliet sigħat minn meta tkun rikostitwita u dilwita.
When reconstitution and dilution are performed under aseptic conditions, Remicade infusion solution can be used within 24 hours if stored at 2°C to 8°C.
Meta tkun rikostitwita u dilwita taħt kundizzjonijiet asettiċi, is- soluzzjoni ta ’ Remicade għall- infużjoni tista ’ tintuża fi żmien 24 siegħa jekk tinħażen f’ temperatura ta ’ 2°C sa 8°C.
Do not store any unused portion of the infusion solution for reuse.
Taħżinx xi parti mis- soluzzjoni biex tużaha darb’ oħra.
No physical biochemical compatibility studies have been conducted to evaluate the co- administration of Remicade with other agents.
Ma sarux studji fiżiċi bijokimiċi dwar il- kompatibilità biex ikun evalwat l- użu ta ’ Remicade ma ’ aġenti oħra meta jingħataw flimkien.
Do not infuse Remicade concomitantly in the same intravenous line with other agents.
L- infużjoni ta ’ Remicade m’ għandiex issir flimkien ma ’ aġenti oħra fl- istess linja intravenuża
Visually inspect parenteral medicinal products for particulate matter or discolouration prior to administration.
Ifli prodotti mediċinali li jingħataw fil- vina għal frak jew telf tal- kulur qabel ma jingħataw.
Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Tużax jekk jidher xi frak mhux ċar, telf tal- kulur jew frak barrani.
Any unused product or waste material; should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Einsteinweg 101 2333 CB Leiden The Netherlands
Einsteinweg 101 2333 CB Leiden L- Olanda
EU/ 1/ 99/ 116/ 001 EU/ 1/ 99/ 116/ 002 EU/ 1/ 99/ 116/ 003 EU/ 1/ 99/ 116/ 004 EU/ 1/ 99/ 116/ 005
EU/ 1/ 99/ 116/ 001 EU/ 1/ 99/ 116/ 002 EU/ 1/ 99/ 116/ 003 29 EU/ 1/ 99/ 116/ 004 EU/ 1/ 99/ 116/ 005
13 August 1999.
13 Awwissu 1999.
Date of latest renewal:
Data ta ’ l- aktar tiġdid riċenti:
13 August 2004.
13 Awissu 2004
30 ANNEX II
30 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U SID( IEN) L- AWTORIZZAZZJONI TAL - MANIFATTURA RISPONSABBLI GĦALL- HRUĠ TAL - LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U SID( IEN) L - AWTORIZZAZZJONI TAL- MANIFATTURA RISPONSABBLI GĦALL- HRUĠ TAL - LOTT
Names and addresses of the manufacturer(s) of the biological active substance(s)
Ismijiet u indirizzi tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i)
Centocor B. V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Einsteinweg 101 Leiden 2333 CB L- Olanda
Centocor Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
200 Great Valley Parkway Malvern, Pennsylvania 19355- 1307 Stati Uniti ta ’ L- Amerka
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) risponsabbli għall- ħruġ tal- lott.
Centocor B. V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Centocor B. V., Einsteinweg 101, 2333 CB Leiden, L- Olanda
Medicinal product subject to restricted medical prescription (See Annex I:
IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2).
- KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The MAH shall develop an educational programme for Remicade to include paediatric Crohn’ s disease patients to ensure that physicians who intend to prescribe Remicade to these patients are aware of:
L- MAH ser jiżviluppa programm edukattiv għal Remicade sabiex jinkludi pazjenti tfal bil- marda ta ’ Crohn biex jiżgura li t- tobba li jkun bi ħseibhom jordnaw Remicade lill- dawn il- pazjenti jkunu jafu:
The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remicade.
• Bir- riskju ta ’ infezzjonijiet opportunistiċi u tuberkulożi (TB) f’ pazjenti ikkurati b’ Remicade.
The need to assess the risk of TB in patients prior to treating with Remicade.
• Il- bżonn li jiġi evalwat ir- riskju ta ’ TB fil- pazjenti qabel tingħata l- kura b’ Remicade.
The risk of acute infusion related reactions and delayed hypersensitivity reactions.
• Ir- riskju ta ’ reazzjonijiet akuti relatati ma ’ l- infużjoni u reazzjonijiet ta ’ sensittività eċċessiva
•
ritardati.
The risk of lymphoma and other malignancies.
• Ir- riskju ta ’ limfoma u tumuri oħrajn.
The patient alert card, which is to be given to patients using Remicade.
• Il- kartuna ta ’ l- Avviż tal- pazjent, li għandha tingħata lill- pazjenti li jkunu qed jużaw Remicade.
That children may be at increased risk of developing infections and the need for immunisations to be up to date.
• Li t- tfal jista ’ jkollhom riskju akbar li jiżviluppaw infezzjonijiet u l- ħtieġa li t- tilqim li kellhom
• OTHER CONDITIONS
- KUNDIZZJONIJIET OĦRA
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan.
L- MAH jintrabat li jgħamel l- istudji u attivitajiet oħrajn ta ’ farmakoviġilanza hekk kif dettaljat fil- pjan ta ’ farmakoviġilanza.
An updated risk management plan should be provided as per the CHMP guideline on the risk management systems for medicinal products for human use.
Pjan ta ’ maniġġar tar- riskju aġġornat għandu jkun ipprovdut skond il- linja gwida tas- CHMP fuq is - sistemi ta ’ maniġġjar tar- riskju għall- prodotti mediċinali għall- użu fil- bniedem.
The Marketing Authorisation Holder will continue to submit annual PSURs.
Id- Detentur Għall- Awtorizzazzjoni għat- Tqegħid fis- Suq ser ikompli jissottometti PSURs kull sena.
32 ANNEX III
32 33 ANNESS III
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
1 VIAL CARTON 2 VIAL CARTON 3 VIAL CARTON 4 VIAL CARTON 5 VIAL CARTON
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Infliximab
Remicade 100 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Infliximab
Each vial contains 100 mg of infliximab
Kull kunjett fih 100 mg ta ’ infliximab
Excipients: sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Sustanzi mhux attivi: sucrose, polysorbate 80, monobasic sodium phosphate u dibasic sodium phosphate
1 vial 100 mg 2 vials 100 mg 3 vials 100 mg 4 vials 100 mg 5 vials 100 mg
Kunjett 1 ta’ 100 mg 2 kunjetti ta ’ 100 mg 3 kunjetti ta ’ 100 mg 4 kunjetti ta ’ 100 mg 5 kunjetti ta ’ 100 mg
Intravenous infusion after reconstitution and dilution.
Infużjoni għal ġol- vina wara li jkun rikostitwit u dilwit.
Read the enclosed package leaflet before reconstitution and use.
Aqra l- fuljett li jinsab ġol- pakkett qabel ir- rikonstituzzjoni u l- użu.
Discard any unused solution.
Armi kull parti mis- soluzzjoni li ma tintużax.
Centocor B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Centocor B. V., Einsteinweg 101, 2333 CB Leiden, l- Olanda
EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg
EU/ 1/ 99/ 116/ 001 kunjett 1 ta ’ 100 mg EU/ 1/ 99/ 116/ 002 2 kunjetti ta ’ 100 mg EU/ 1/ 99/ 116/ 003 3 kunjetti ta ’ 100 mg EU/ 1/ 99/ 116/ 004 4 kunjetti ta ’ 100 mg EU/ 1/ 99/ 116/ 005 5 kunjetti ta ’ 100 mg
INSTRUCTIONS ON USE
Biex jintuża darba biss.
Justification for not including Braille accepted.
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
Remicade 100 mg powder for concentrate for solution for infusion Infliximab For intravenous infusion
Remicade 100 mg trab għal konċentrat li jinħall f’ soluzzjoni għall- infużjoni Infliximab.
For intravenous infusion after reconstitution and dilution
Infużjoni għal ġol- vina wara li jkun rikostitwit u dilwit
Remicade Patient Alert Card
Biljett ta ’ Avviż għal Pazjent fuq Remicade
Heart Failure
Insuffiċjenza tal- Qalb
This alert card contains important safety Prior to Remicade treatment: information that you need to be aware of before • Remicade should not be used if you have you are given Remicade and during treatment with Remicade.
Dan il- biljett ta ’ avviż fih tagħrif importanti dwar sigurtà li inti għandek tkun taf qabel ma tingħata Qabel trattament b’ Remicade: • Remicade m’ għandux jintuża jekk għandek Remicade u waqt it- trattament b ’ Remicade insuffiċjenza tal- qalb moderata jew qawwija. • Uri dan il- biljett lil kwalunkwe tabib involut Waqt trattament b’ Remicade: fil- kura tiegħek. • Jekk tiżviluppa sintomi ta ’ insuffiċjenza tal - Infezzjonijiet Remicade iżid ir- riskju li jaqbduk infezzjonijiet.
moderate to severe heart failure.
qalb (qtugħ ta’ nifs jew nefħa tas- saqajn) mur ara tabib mill- ewwel.
During Remicade treatment: • Show this card to any doctor involved in your • If you develop symptoms of heart failure
L- infezzjonijiet jistgħu jmorru għall- agħar iktar malajr u jkunu iktar qawwija.
treatment.
Dan jinkludi t - tuberkulożi (TB).
(shortness of breath or swelling of the feet) seek medical attention immediately.
L- ewwel infużjoni: ____________________ Infużjonijiet ta ’ wara: _______________________
Infections Dates of Remicade treatment:
Qabel trattament b’ Remicade:
1 st infusion: _______________________ Infections may progress more rapidly and be more severe.
_______________________
Following infusions: _______________________ _______________________ _______________________
• M’ għandekx tingħata Remicade jekk għandek _______________________ _______________________ infezzjoni qawwija. • Għandek tiġi eżaminat għat- TB.
Prior to Remicade treatment: • You should not be treated with Remicade if
qattx kellek it- TB, jew jekk kont f’ kuntatt
_______________________
aktar tagħrif.
you have a severe infection. • You should be screened for TB.
Jekk
Please record the dates of the last screening
jogħġbok għamel nota tad- dati meta l- aħħar kont eżaminat għat- TB hawn taħt.
• See the Remicade 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.
miegħek ukoll lista tal- mediċini l- oħra li tieħu kull meta tmur tara professjonist fil- kura tas -
Tuberculin test: _______________ Chest X-ray: _______________
Test tat- Tuberculin: _______________ Raġġi- X tas- sider: _______________
Patient’s Name: _____________________ Doctor’s Name: _____________________ Doctor’s Phone: _____________________
Isem tal- Pazjent: _____________________ Waqt trattament b’ Remicade:
During Remicade treatment: • If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
_____________________
• Keep this card with you for 6 months after the last Remicade dose, since side effects may occur a long time after your last dose of Remicade.
• Jekk tiżviluppa sintomi ta ’ infezzjonijiet, bħal Telefon tat- Tabib: _____________________ deni, sogħla persistenti, tnaqqis fil- piż, jew • Żomm dan il- biljett miegħek għal 6 xhur nuqqas ta ’ ħeġġa, mur ara tabib mill- ewwel. wara l- aħħar doża ta ’ Remicade, peress li effetti sekondarji jistgħu jseħħu żmien twil wara l- aħħar doża tiegħek ta ’ Remicade.
Remicade 100 mg powder for concentrate for solution for infusion infliximab
Remicade 100 mg trab għal konentrat għal soluzzjoni għal infużjoni infliximab
In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need to know before you are given Remicade and during treatment with Remicade.
Ma’ dan il- fuljett, se tingħata biljett ta ’ avviż tal- pazjent, li fih tagħrif dwar sigurtà importanti li teħtieġ tkun taf qabel ma tingħata Remicade u waqt it- trattament b’ Remicade.
- Keep this leaflet and the patient alert card.
- Żomm dan il- fuljett u l- biljett ta ’ avviż tal- pazjent.
You may need to read them again.
Jista ’ jkollok bżonn terġa ’ taqrahom.
- This medicine has been prescribed for you.
Mgħandekx tgħaddiha lil persuni oħra.
What Remicade is and what it is used for 2.
X’ inhu Remicade u għalxiex jintuża 2.
Before you use Remicade 3.
Qabel ma tuża Remicade 3.
How to use Remicade 4.
Kif għandek tuża Remicade 4.
How to store Remicade 6.
Kif taħżen Remicade 6.
WHAT REMICADE IS AND WHAT IT IS USED FOR
X’ INHU REMICADE U GĦALXIEX JINTUŻA
Remicade is intended for treatment of Crohn’s disease, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis, with the aim to reduce inflammatory activity.
Remicade qiegħed għal trattament tal- marda ta ’ Crohn, għas- sintomi ta ’ l- artrite rewmatika, infjammazzjoni ta ’ l- imsaren, ankylosing spondylitis, artrite bi psorajiżi jew psorajiżi, bl- iskop li titnaqqas l- attività infjammatorja.
The active substance, infliximab, is a human-mouse monoclonal antibody.
Is- sustanza attiva, infliximab, hija antikorp monoklonali uman- ġurdien.
Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Antikorpi monoklonali huma proteini li jagħrfu u jingħaqdu ma ’ proteini uniċi oħra.
Infliximab ties up a special protein in the body called tumour necrosis factor alpha or TNFα, which is involved in inflammation.
Infliximab jintrabat ma ’ proteina speċjali fil- ġisem li tissejjaħ fattur tan- nekrożi tat- tumur alfa jew TNFα, li hija nvoluta fl- infjammazzjoni.
Increased amounts of TNFα are common in inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Żieda fl- ammonti ta ’ TNFα hija komuni waqt mard infjammatorju bħas- sintomi ta ’ l- artrite rewmatika, il- marda ta ’ Crohn, infjammazzjoni ta ’ l- imsaren, ankylosing spondylitis, artrite bi psorajiżi u psorajiżi..
Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints.
Artrite rewmatika L- artrite rewmatika hija marda infjammatorja tal- ġogi.
If you have active rheumatoid arthritis you first will be given other medicines.
Jekk inti għandek sintomi ta ’ l- artrite rewmatika attiva, l- ewwel se tingħata mediċini oħra.
If you are given other medicines and you still have signs and symptoms of your disease, you will be given Remicade in combination with methotrexate to: • reduce the signs and symptoms of your disease. • slow down the damage to your joints • improve your physical function
Jekk tingħata mediċini oħra u għad għandek sinjali u sintomi tal- marda tiegħek, ser tingħata Remicade flimkien ma ’ methotrexate biex: • jonqsu s- sinjali u s- sintomi tal- marda tiegħek • titnaqqas il- ħsara lill- ġogi tiegħek • titjieb il- funzjoni fiżika tiegħek
Crohn’s disease Crohn’s disease is an inflammatory disease of the bowel.
Il- marda ta ’ Crohn Il- marda ta ’ Crohn hija marda infjammatorja tal- musrana.
If you have Crohn’s disease and you are an adult (≥18 years) or a child (6 to 17 years), you will first be given other medicines.
Jekk inti għandek il- marda ta ’ Crohn u int adult (≥18- il sena) jew tifel/ tifla (6 sa 17- il sena), l- ewwel se tingħata mediċini oħra.
If you still have signs and symptoms of your disease, Remicade will be given to: • treat severe, active disease not controlled by a corticosteroid and/or an immunosuppressant; or if you have not been able to tolerate these types of medicines; • lower the number of draining enterocutaneous fistulae (abnormal openings through the skin from the bowel) that have not been controlled by other medicines or surgery.
Jekk ikun għad għandek sinjali u sintomi tal- marda tiegħek, Remicade se jingħata biex: • jikkura mard sever u attiv li ma jkunx kontrollat b’ kortikosterojdi u/ jew immunosoppressiv; jew jekk ma stajtx tittollera dawn it- tipi ta’ mediċini; • jonqos in- numru ta ’ fistli enterokutanji li jnixxu (toqob anormali mill- musrana għal fuq il- ġilda) li ma kienux ikkontrollati b’ mediċini oħra jew b’ kirurġija.
40 Ulcerative colitis Ulcerative colitis is an inflammatory disease of the bowel.
41 Infjammazzjoni ta ’ l- imsaren Infjammazzjoni ta ’ l- imsaren hija marda infjammatorja tal- musrana.
If you have ulcerative colitis you will first be given other medicines.
Jekk għandek infjammazzjoni ta ’ l- imsaren, l- ewwel se tingħata mediċini oħra.
If you do not respond well enough to these medicines, you will be given Remicade to treat your disease.
Jekk ma jkollokx rispons xieraq għal dawn il- mediċini, se tingħata Remicade biex tittrata l- marda tiegħek.
Ankylosing spondylitis Ankylosing spondylitis is an inflammatory disease of the spine.
Ankylosing spondylitis Ankylosing spondylitis hija marda infjammatorja tax- xewka tad- dahar.
If you have ankylosing spondylitis, you will first be given other medicines.
Jekk inti għandek ankylosing spondylitis, l- ewwel se tingħata mediċini oħra.
If you do not respond well enough to these medicines, you will be given Remicade to: • reduce the signs and symptoms of your disease. • improve your physical function
Jekk ma jkollokx rispons xieraq għal dawn il- mediċini, inti se tingħata Remicade biex: • jonqsu s- sinjali u s- sintomi tal- marda tiegħek • titjieb il- funzjoni fiżika tiegħek
Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Artrite bi psorajiżi L- artrite bi psorajiżi hija marda infjammatorja tal- ġogi, li normalment magħha jkun hemm ukoll prorajiżi.
If you have active psoriatic arthritis you will first be given other medicines.
Jekk għandek artrite bi- psorajiżi attiva l- ewwel se tingħata mediċini oħra.
If you do not respond well enough to these medicines, you will be given Remicade to: • reduce the signs and symptoms of your disease. • slow down the damage in your joints • improve your physical function
Jekk ma jkollokx rispons xieraq għal dawn il- mediċini, se tingħata Remicade biex: • tnaqqas is- sinjali u s- sintomi tal- marda tiegħek • il- ħsara fil- ġogi tiegħek iddum aktar biex tavvanza • titjieb il- funzjoni fiżika tiegħek
Psoriasis Psoriasis is an inflammatory disease of the skin.
Psorajiżi 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 għandek plakka ta ’ psorajiżi moderata għal severa, l - ewwel se tingħata mediċini oħra jew eż. fototerapija.
If you do not respond well enough to these treatments, you will be given Remicade to reduce the signs and symptoms of your psoriasis.
Jekk ma jkollokx rispons xieraq għal dawn it - trattamenti, se tingħata Remicade biex tnaqqas is- sinjali u s- sintomi tal- psorajiżi tiegħek.
BEFORE YOU USE REMICADE
QABEL MA TUŻA REMICADE
Do not use Remicade • if you are allergic (hypersensitive) to infliximab, to any of the other ingredients of Remicade (see section 6 “What Remicade contains”) or to mouse (murine) proteins.
• jekk jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal infliximab, jew għal xi sustanza oħra ta ’ Remicade (ara sezzjoni 6 “ X’ fih Remicade ”) jew għall- proteini tal- ġurdien (murini).
• if you have a severe infection, including tuberculosis (see: “Take special care with Remicade”).
• jekk għandek infezzjoni qawwija, inkluż tuberkulożi (ara: “ Oqgħod attent ħafna b’ Remicade ”).
It is important that you tell your doctor if you have symptoms of infection, e.g. fever, malaise, wounds, dental problems.
Huwa importanti li inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni eż. deni, telqa, ġrieħi, problemi fi snienek.
• if you have moderate or severe heart failure.
• Jekk għandek insuffiċjenza tal- qalb moderata jew severa.
It is important to tell your doctor if you have had or have a serious heart condition.
Importanti li tgħid lit- tabib tiegħek jekk kellek jew għandek kundizzjoni serja f’ qalbek.
If you think you have any of the above, it is important that you discuss it with your doctor.
Jekk taħseb li għandek waħda minn dawn, huwa importanti li titkellem dwarha mat- tabib tiegħek
Take special care with Remicade Some patients had allergic reactions within 2 hours of receiving Remicade.
Oqgħod attent ħafna b’ Remicade Xi pazjenti kellhom reazzjonijiet allerġiċi fi żmien sagħtejn wara li ngħataw Remicade.
These reactions were generally mild to moderate; however, on rare occasions they were severe.
Dawn ir - reazzjonijiet ġeneralment kienu ħfief għal moderati; madankollu, f’ okkażjonijet rari kienu severi.
The symptoms of such reactions were most often skin rash, hives, fatigue, wheezing, difficulty in breathing and/or low blood pressure.
Is - sintomi ta ’ dawn ir- reazzjonijiet kienu l- aktar ta ’ spiss raxx fil- ġilda, urtikarja, għeja, tħarħir, problemi bin- nifs u/ jew pressjoni baxxa.
If you notice any of these symptoms, tell your doctor.
Jekk tinnota xi sintomi minn dawn, għid lit- tabib tiegħek.
If the symptoms occur during your infusion, your doctor may slow down the speed of the infusion.
Jekk is- sintomi joħorġu waqt li qed tieħu l- infużjoni, it- tabib tiegħek jista ’ jnaqqas ir- rata ta ’ l - infużjoni.
Your doctor may also stop giving the medicine until the symptoms go away and then begin giving the medicine again.
It- tabib tiegħek jista ’ wkoll iwaqqaf il- mediċina sakemm is- sintomi jitilqu u mbagħad jerġa ’ jibda jagħti l- mediċina.
Your doctor may also treat your symptoms with other medicines (paracetamol, antihistamines, corticosteroids, bronchodilators and/or adrenaline).
It- tabib tiegħek jista ’ wkoll jikkura s- sintomi tiegħek b’ mediċini oħra (paracetamol, anti- istaminiċi, kortikosterojdi, bronkodilataturi u/ jew adrenalina).
Most of the time you can still get Remicade even if the symptoms occur.
Fil- parti l- kbira tal - każijiet xorta tkun tista ’ tieħu Remicade anki jekk joħorġu s- sintomi.
However, in some cases your doctor may decide that it is best not to give you Remicade anymore.
Madankollu, f’ xi każijiet it- tabib tiegħek jista ’ jiddeċiedi li aħjar jekk inti ma tieħux Remicade aktar.
41 There is an increased risk of hypersensitivity reactions if you are retreated after an interval of more than 16 weeks.
42 Hemm riskju akbar ta ’ sensittività eċċessiva jekk terġa ’ tingħata l- mediċina wara interval itwal minn 16- il ġimgħa.
Therefore, taking Remicade again after a Remicade-free period of more than 16 weeks is not recommended.
Għalhekk, mhux rakkomandat li terġa ’ tieħu Remicade wara li tkun ilek perijodu ta ’ aktar minn 16- il ġimgħa ma tieħu Remicade.
An allergic reaction may occur up to 12 days after your infusion.
Reazzjoni allerġika tista ’ sseħħ sa 12- il jum wara l- infużjoni tiegħek.
This reaction can be serious.
Din ir- reazzjoni tista ’ tkun serja.
Signs and symptoms are tenderness or pain in the muscles, rash, fever, joint or jaw pain, hand and face swelling, swallowing difficulties, itching, sore throat and/or headache.
Is- sinjali u s- sintomi huma sensittività jew uġigħ fil- muskoli, raxx, deni, uġigħ fil- ġogi jew fix- xedaq, nefħa fil- wiċċ jew fl- idejn, problemi biex tibla ’, ħakk, uġigħ fil- grieżem u/ jew uġigħ ta ’ ras.
If you notice any of these symptoms, tell your doctor immediately.
Jekk tinnota xi wieħed minn dawn is- sintomi, għid lit- tabib tiegħek mill- ewwel.
You might get infections more easily while you are receiving Remicade treatment.
Jistgħu jaqbduk infezzjonijiet aktar malajr waqt li tkun qed tirċievi kura b’ Remicade.
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 tuberkolożi, infezzjonijiet ikkawżati minn vajruses, fungi jew batteri, jew infezzjonijiet opportunistiċi oħra u sepsi li jistgħu, f’ każijiet rari, jkunu ta ’ theddida għall- ħajja.
It is important that you tell your doctor if you get any symptoms of infection, for example fever, feeling generally unwell, wounds, dental problems.
Huwa importanti li tgħid lit- tabib tiegħek jekk ikollok xi sintomi ta ’ infezzjoni, bħal deni, tħossok ma tiflaħx, ġrieħi, problemi fi snienek.
Your doctor may recommend temporary discontinuation of Remicade.
It- tabib tiegħek jista ’ jirrakkomanda it- twaqqif temporanju ta ’ Remicade.
Before receiving treatment with Remicade, you should tell your doctor if you have lived in or traveled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Qabel tirċievi l- kura b’ Remicade, għandek tgħid lit- tabib tiegħek jekk kont tgħix jew mort f’ zona fejn infezzjonijiet imsejjħa istoplasmożi, kokkidjodomikożi, jew blastomikożi huma komuni.
These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Dawn l- infezzjonijiet huma ikkawżati minn tipi speċifiċi ta ’ fungi li jistgħu jeffettwaw il- pulmun jew partijiet oħra ta ’ ġismek.
If you have fistulas that are leaking pus, please inform your doctor.
Jekk għandek fistli li qed inixxu l- materja, jekk jogħġbok għid lit- tabib tiegħek.
As cases of tuberculosis have been reported in patients treated with Remicade, you will be screened for tuberculosis before starting Remicade.
Peress li kienu rappurtati każijiet ta ’ tuberkulożi f’ pażjenti li ngħataw Remicade, se tkun eżaminat għat- tuberkulożi qabel ma tibda Remicade.
This includes a thorough medical history and 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.
Dan jinkludi passat mediku dettaljat u huwa importanti ħafna li tgħid lit- tabib tiegħek jekk qattx kellek tuberkulożi, jew jekk kontx f’ kuntatt mill- qrib ma ’ xi ħadd li kellu t- tuberkulożi.
In addition, you will have a tuberculin skin test and a chest X-ray.
Barra minn dan isirlek test tal- ġilda bit- tuberculin u raġġi- X tas- sider.
Your doctor must record the conduct of these tests on your alert card.
It - tabib tiegħek għandu jagħmel nota li saru dawn it- testijiet fuq il- biljett ta ’ twissija tiegħek.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, fever), or any other infection appear during therapy notify your doctor immediately.
Jekk sintomi ta ’ tuberkulożi (sogħla persistenti, telf fil- piż, nuqqas ta ’ ħeġġa, deni), jew ta ’ infezzjonijiet oħra joħorġu waqt it- terapija, għid lit- tabib tiegħek mill- ewwel.
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.
Avża lit- tabib tiegħek jekk ikollok il- vajrus ta ’ l- epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li jista ’ jkun għandek riskju li tinfetta ruħek bl- HBV.
Remicade can cause reactivation of HBV in people who carry this virus.
Remicade jista ’ jikkawża riattivazzjoni ta ’ HBV f’ nies li jġorru dan il- vajrus.
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 każijiet rari, l- aktar jekk qed tieħu mediċini oħra li jdgħajjfu s - sistema immuni, ir- riattivazzjoni ta ’ HBV tista ’ tpoġġi l- ħajja fil- periklu.
If you have recently received, or are scheduled to receive a vaccine, please inform your doctor.
Jekk dan l- aħħar ingħatajt xi tilqima, jew jekk għandek tingħata xi tilqim, jekk jogħġbok għid lit- tabib tiegħek.
If you are about to undergo surgery or dental procedures please inform your doctor or dentist that you are taking Remicade.
Jekk se ssirlek operazzjoni jew proċeduri fi snienek, jekk jogħġbok għid lit- tabib tiegħek jew lid - dentist li inti qed tieħu Remicade.
If you have mild heart failure and you are being treated with Remicade, your heart failure status must be closely monitored by your doctor.
Jekk għandek insuffiċjenza tal- qalb ħafifa u qed tingħata Remicade, l- istat ta ’ insuffiċjenza tal- qalb tiegħek għandha tkun osservata mill- qrib mit- tabib tiegħek.
If you develop new or worsening symptoms of heart failure (for example shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Jekk tiżviluppa sintomi ġodda jew is - sintomi ta ’ insuffiċjenza tal- qalb imorrulek għall- agħar (per eżempju qtugħ ta ’ nifs, jew nefħa f’ saqajk), għandek tkellem lit- tabib tiegħek mill- ewwel.
On rare occasions, you may develop signs and symptoms of a disease called lupus (persistent rash, fever, joint pain and tiredness).
F’ okkażjonijiet rari, tista ’ tiżviluppa sinjali u sintomi ta ’ marda li tissejjaħ lupus (raxx persistenti, deni, uġigħ fil- ġogi u għeja).
If these symptoms occur, contact your doctor.
Jekk iseħħu dawn is- sintomi, kellem lit- tabib tiegħek.
Before you use Remicade, tell your doctor if you have had lymphoma (a type of blood cancer) or any other cancer.
Qabel tuża Remicade, għid lit- tabib tiegħek jekk kellek limfoma (tip ta ’ tumur tad- demm) jew xi tumur ieħor.
If you take Remicade, your risk for developing lymphoma or another cancer may increase.
Jekk tieħu Remicade, għandek riskju akbar li taqbdek limfoma jew xi tip ta ’ tumur ieħor.
You should also tell your doctor if you develop lymphoma or other cancers while you are taking Remicade.
Għandek tgħid lit- tabib tiegħek jekk taqbdek limfoma jew xi tipi ta ’ tumuri oħrajn waqt li tkun qed tieħu Remicade.
Reports of lymphoma in patients on Remicade are rare but occur more often than expected for people in general.
Rapporti ta ’ limfoma f’ pazjenti fuq Remicade huma rari iżda jseħħu aktar ta ’ spiss milli mistenni fin - nies b’ mod ġenerali.
A patient with more serious rheumatoid arthritis who has had the disease for a long time may be more prone to develop lymphoma.
Pazjenti li jkollu artrite rewmatika aktar serja li kellu l- marda għal żmien twil jista ’ jkun aktar pridispost li jiżviluppa limfoma.
42 Some patients with Crohn's disease or ulcerative colitis who have received Remicade have developed a rare type of cancer called Hepatosplenic T-cell Lymphoma.
43 Xi pazjenti bil- marda ta ’ Crohn jew infjammazzjoni ta ’ l- imsaren li irċievew Remicade żviluppaw kanċer rari li jissejjaħ Limfoma Epatosplenika taċ- ċelluli- T.
Most of these patients were adolescent or young adult males.
Ħafna minn dawn il- pazjenti kienu adolexxenti jew irġiel adulti żagħżagħ.
This type of cancer has usually resulted in death.
Dan it- tip ta ’ kanċer normalment wassal għall- mewt.
All of these patients had also received drugs known as azathioprine or 6-mercaptopurine.
Dawn il - pazjenti kollha kienu irċievew mediċini magħrufa bħala azathioprine jew 6- mercaptopurine.
Cancers, other than lymphoma, have also been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD).
Tumuri oħra, apparti limfoma, kienu rappurtati wkoll f’ pazjenti b’ tip ta ’ marda speċifika tal- pulmun imsejjħa Marda Kronika Ostruttiva tal- Pulmun (COPD).
Patients with COPD and/or patients who are heavy smokers may be at increased risk for cancer with Remicade treatment.
Pazjenti b’ COPD u/ jew pazjenti li jpejjpu ħafna jista ’ jkollhom riskju akbar għal tumur bit- trattament b’ Remicade.
If you have COPD or are a heavy smoker you should discuss with your doctor whether Remicade is appropriate for you.
Jekk għandek COPD jew tpejjep ħafna għandek tiddiskuti mat- tabib dwar jekk Remicade jgħoddx għalik.
Using other medicines You need to inform your doctor about any medicine or treatment that you are taking, have been given or are planning to have.
Meta tuża mediċini oħra Għandek tavża lit- tabib tiegħek dwar kwalunkwe mediċina jew kura li qed tieħu, ingħatajt jew biħsiebek tieħu.
Generally, patients who have rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis, already take several medicines to treat their disease such as methotrexate, azathioprine or 6-mercaptopurine.
Ġeneralment, pazjenti li għandhom sintomi ta ’ l- artrite rewmatika, il- marda ta ’ Crohn, infjammazzjoni ta ’ l- imsaren, ankylosing spondylitis, artrite bi psorajiżi jew psorajiżi diġà jieħdu bosta mediċini biex jikkuraw il- marda tagħhom bħal methotrexate, azathioprine jew 6- mercaptopurine.
These medicines may themselves cause side effects.
Dawn il- mediċini jistgħu huma stess joħolqu effetti sekondarji.
If you get any additional side effects or any new symptoms, please tell your doctor.
Jekk tħoss xi effetti sekondarji oħrajn jew kwalunkwe sintomu ġdid, jekk jogħġbok għid lit- tabib tiegħek.
Pregnancy Use of Remicade is not recommended during pregnancy.
Tqala L- użu ta ’ Remicade waqt it- tqala mhux rakkomandat.
If you are being treated with Remicade, you must avoid getting pregnant by using adequate contraception during your treatment and for at least 6 months after the last Remicade infusion.
Jekk qed tingħata Remicade, għandek tevita li tinqabad tqila billi tuża kontraċettiv xieraq tul il- perijodu tat- trattament tiegħek u għall- inqas 6 xhur wara l- aħħar infużjoni ta ’ Remicade.
Breast-feeding It is not known if infliximab is excreted in human milk.
Jekk qed tredda Mhux magħruf jekk infliximab joħroġx mal- ħalib tal- mara.
If you are a nursing mother, you must stop breast-feeding if you are to be given Remicade.
Jekk inti omm li qed tredda, għandek tieqaf tredda jekk se tingħata Remicade.
Before starting breast-feeding, your last treatment with Remicade must be at least 6 months ago.
Qabel ma tibda tredda jridu jkunu għaddew mill- inqas 6 xhur mill- aħħar trattament tiegħek b’ Remicade
Special patient groups Due to insufficient data on safety and efficacy, Remicade is not recommended for use in children aged 17 years or younger, except in Crohn’s disease.
Gruppi speċjali ta ’ pazjenti Minħabba li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja, Remicade mhux irrikkmandat għall- użu fit- tfal ta ’ taħt is- 17- il sena, ħlief għall- marda ta ’ Crohn.
Remicade has not been studied in children with Crohn’s d isease below the age of 6 years.
Remicade ma ġiex studjat fi tfal ta ’ taħt is- 6 snin bil- marda ta ’ Crohn.
Specific studies with Remicade have not been conducted in elderly patients, or in patients with hepatic or renal disease.
Ma sarux studji speċifiċi b’ Remicade f’ pazjenti anzjani, jew f’ pazjenti b’ mard tal- fwied jew tal- kliewi.
Driving and using machines It is not known if Remicade affects the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Mhux magħruf jekk Remicade jaffettwax il- ħila biex ssuq jew tħaddem magni.
If you are feeling tired or unwell after receiving Remicade, do not drive or use any tools or machines.
Jekk qed tħossok għajjien jew ma tiflaħx wara li ħadt Remicade, issuqx u tużax għodod jew magni.
HOW TO USE REMICADE
KIF GĦANDEK TUŻA REMICADE
Remicade is supplied as a powder for concentrate for solution for infusion.
Remicade jiġi bħala trab għal konċentrat li jinħall f’ soluzzjoni għall- infużjoni.
This means that before Remicade is given to you, it is first dissolved in water for injections.
Dan ifisser illi qabel ma jingħatalek Remicade, l- ewwel jinħall f’ ilma għall- injezzjonijiet.
The resulting solution is then further diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Is- soluzzjoni li tirriżulta mbagħad tiġi dilwita iktar b’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- infużjoni.
Remicade is given to you in a vein, usually in your arm, over a 2-hour period in a health care facility.
Remicade jingħatalek ġo vina, li s- soltu tkun f’ dirgħajk, fuq perijodu ta ’ sagħtejn f’ ċentru tas- saħħa.
If you are a patient with rheumatoid arthritis, after the third infusion your doctor may decide to give you Remicade over a 1-hour period.
Jekk int pazjent b’ artrite rewmatika, wara t- tielet infużjoni, t- tabib tiegħek jista ’ jiddeċiedi li jtik Remicade fuq perijodu ta ’ siegħa.
Your doctor or assistant will be monitoring you while you receive your Remicade dose and 1 to 2 hours thereafter.
It- tabib jew l- assistent tiegħek ikun qed iżommok taħt osservzzjoni waqt li qed tieħu d- doża tiegħek ta ’ Remicade u għal siegħa jew sagħtejn wara.
Depending on your disease and if you respond, your doctor will decide on your individual dose and dosing interval.
Skond il- marda tiegħek u skond jekk turix rispons, it- tabib tiegħek se jiddeċiedi d- doża individwali tiegħek u l- intervall bejn id- dożi.
This may include additional doses at 2 and 6 weeks after your first dose.
Dan jista ’ jinkludi dożi oħra ġimgħatejn u 6 ġimgħat wara l- ewwel
Treatment may also be continued thereafter.
It- trattament tiegħek jista ’ wkoll jitkompla xi darba aktar tard.
The total amount of infliximab given to you is based on the dose and your body weight.
L- ammont totali ta ’ infliximab li tingħata huwa bbażat fuq id- doża u l- piż tiegħek.
Your doctor will advise you what other medicines you must continue to take while on Remicade.
It- tabib tiegħek itik parir dwar liema mediċini oħra għandek tkompli tieħu waqt li tkun fuq Remicade.
43 Rheumatoid arthritis:
Sintomi ta ’ l- artrite rewmatika:
The recommended starting dose is 3 mg of infliximab for every kg of body weight.
Id- doża rakkomandata tal- bidu hija ta ’ 3 mg ta ’ infliximab għal kull kg piż tal- ġisem.
Crohn's Disease:
Il- marda Crohn:
The recommended dose for severe, active Crohn's disease is 5 mg of infliximab for every kg of body weight.
Id- doża rakkomandata għal marda ta ’ Crohn severa u attiva hija ta ’ 5 mg ta ’ infliximab għal kull kg piż tal- ġisem.
The recommended dose for closure of enterocutaneous f istulas is 5 mg of infliximab for every kg of body weight.
Id- doża rakkomandata biex jingħalqu fistli enterokutanji hija ta ’ 5 mg ta ’ infliximab għal kull kg piż tal- ġisem.
Ankylosing spondylitis:
Ankylosing spondylitis:
The recommended dose is 5 mg of infliximab for every kg of body weight.
Id- doża rakkomandata hija ta ’ 5 mg ta ’ infliximab għal kull kg piż tal- ġisem.
Ulcerative colitis:
Infjammazzjoni ta ’ l- imsaren:
The recommended dose is 5 mg of infliximab for every kg of body weight.
Id- doża rakkomandata hija ta ’ 5 mg ta ’ infliximab għal kull kg piż tal- ġisem
Like all medicines, Remicade can cause side effects, although not everybody gets them.
Bħal kull mediina oħra, Remicade jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate.
Il- biċċa l- kbira ta ’ l- effetti sekondarji huma ħfief jew moderati.
However some may be serious and may require treatment.
Madankollu, xi wħud jistgħu jkunu serji u jistgħu jeħtieġu kura.
Side effects may appear up to six months after the last infusion.
Effetti sekondarji jistgħu joħorġu sa sitt xhur wara l- aħħar infużjoni.
Tell your doctor immediately if you notice any of the following: • pain or tenderness in chest, muscles, joints or jaw • swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing • hives or other signs of an allergic reaction • fever • rash • itching • shortness of breath with exertion or upon lying down or swelling of the feet
Kellem lit- tabib tiegħek mill- ewwel jekk tinnota xi wieħed minn dawn: • uġigħ jew tenerezza f’ sidrek, fil- muskoli, ġogi jew xedaq • nefħa ta ’ l- idejn, saqajn, għekiesi, wiċċ, xofftejn, ħalq jew grieżem li jistgħu joħolqu diffikultajiet biex tibla ’ jew biex tieħu n- nifs. • ħorriqija jew sinjali oħra ta ’ reazzjoni allerġika • deni • raxx • ħakk • qtugħ ta ’ nifs ma ’ l- eżerċizzju jew meta timtedd jew nefħa fis- saqajn
Tell your doctor as soon as possible if you notice any of the following: • signs of infection • difficulty breathing and non-productive cough • problems with urination • changes in the way your heart beats, for example, if you notice it beating faster • light-headedness • tiredness • hoarseness • coughing • headache • signs of neurological problems: seizures, tingling or numbness in any part of your body, weakness in arms and/or legs, eye problems, changes in vision • signs of liver or spleen problems: eyes or skin turning yellow, dark-brown coloured urine, upper abdominal pain • loss of weight
Kellem lit- tabib tiegħek kemm jista ’ jkun malajr jekk tinnota xi wieħed minn dawn: • sinjali ta ’ infezzjoni • tbati biex tieħu n- nifs u sogħla fil- vojt • problemi biex tgħaddi l- awrina • bdil fil- mod kif tħabbat qalbek, per eżempju, jekk tinnota li qed tħabbat iktar mgħaġġla • rasek ħafifa • għeja • ħanqa • sogħla • uġigħ ta ’ ras • sinjali ta ’ problemi newroloġiċi: aċċessjonijiet, tingiż jew tnemnim fi kwalunkwe parti ta ’ ġismek, dgħjufija fid- dirgħajn u/ jew fir- riġlejn, problemi fl- għajnejn, tibdil fil- vista
44 • night sweating
45 • sinjali ta ’ problemi tal- fwied: għajnejk jew il- ġilda jisfaru, l- awrina jkollha lewn kannella- skur, uġigħ fil- parti ta ’ fuq ta ’ l- addome • titlef il- piż • issir għarqan bil- lejl
The symptoms described above can be signs of the below listed side effects, which have been observed with Remicade.
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta ’ l- effetti sekondarji elenkati hawn taħt, li kienu osservati b ’ Remicade
Common side effects (likely to occur in fewer than 1 in 10 patients): headache, dizziness, nausea, abdominal symptoms, allergic reactions, rash, urticaria, viral infections (for example herpes), respiratory infections (cold, sinus infections, bronchitis, pneumonia).
Effetti sekondarji komuni (x’ aktarx iseħħu f’ anqas minn 1 f’ kull 10 pazjenti): uġigħ ta ’ ras, sturdament, tqallih, sintomi fl- addome, reazzjonijiet allerġiċi, raxx, urtikarja, infezzjonijiet virali (per eżempju herpes), infezzjonijiet respiratorji (riħ, infezzjonijiet fis- sinus, bronkite, pulmonite).
Depression, agitation, sleep disturbances, impaired wound heeling, bacterial infections, (for example tuberculosis, urinary tract infections, deep skin infections, sepsis), fungal infections, asthma, abnormal liver function, low blood cell counts including anemia, worsening of demyelinating nerve disease, autoimmune disease activation (SLE, lupus), worsening of heart failure, hair loss, bleedings, allergic anaphylactic reactions, injection site reactions.
Effetti sekondarji mhux komuni (x’ aktarx iseħħu f’ anqas minn 1 f’ kull 100 pazjent): depressjoni, aġitazzjoni, disturbi ta ’ l- irqad, dewmien fil- fejqan ta ’ ġrieħi, infezzjonijiet ta ’ batteri (per eżempju tuberkulożi, infezzjonijiet fis- sistema awrinarja, infezzjonijiet fondi fil- ġilda, sepsis), infezzjonijiet tal - moffa, ażma, funzjoni mhux normali tal- fwied, valuri baxxi taċ- ċelluli fid- demm inkluż anemija, mard li jneħħi l- majelin tan- nervi jmur għall- agħar, bidu ta ’ mard awtoimmuni (SLE, lupus), insuffiċjenza tal- qalb tmur għall- agħar, jintilef ix- xagħar, emorraġġiji, reazzjonijiet allerġiċi anafilattiċi, reazzjonijiet mnejn tingħata l- injezzjoni.
Gastrointestinal bleedings or perforation, circulatory failure, multiple sclerosis, lymphoma.
Effetti sekondarji rari (x’ aktarx iseħħu f’ anqas minn 1 f’ kull 1, 000 pazjent): fsada jew titqib fil - musrana, insuffiċjenza ċirkolatorja, sklerożi multipla, limfoma.
Your doctor may also do tests to examine your liver function and/or blood values.
It- tabib tiegħek jista ’ wkoll jagħmel testijiet biex jeżamina l- funzjoni tal- fwied tiegħek u/ jew il- valuri fid- demm.
If any of the side effects gets serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE REMICADE
KIF TAĦŻEN REMICADE
• Keep out of the reach and sight of children. • Do not use Remicade after the expiry date which is stated on the label and the carton.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • M’ għandekx tuża Remicade wara d- data li jiskadi li tidher fuq it- tikketta u l- kartuna.