qanastek/EMEA-V3 huggingface dataset:
13 An initial daily dose of 10 mg/ kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/ kg/ month of packed red blood cells (approximately < 2 units/ month for an adult).
F’ pazjenti li ma jkollhomx bżonn tnaqqis fil- livelli tal- ħadid fil- ġisem u li qed jirċievu anqas minn 7 ml/ kg/ xahar ta ’ ċelluli ħomor tad- demm ippakkjat (madwar < 2 unitajiet/ xahar għal bniedem adult),
Hepatic function in all patients should be monitored before treatment then every month (see section 4.4).
Il- funzjoni tal- fwied għandha tkun monitorata qabel ma tingħata l- kura u kull xahar minn hemm ’ il quddiem (ara sezzjoni 4. 4).
14 4.4 Special warnings and precautions for use
14 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
U U
15 Funzjoni epatika:
16 The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
Ir- riżultati tat- testijiet għall- krejatinina fis- serum, ferritin fis- serum u transaminase fis- serum għandhom jinżammu u jintużaw sabiex joħorġu t- tendenzi.
In the 1-year clinical studies growth and sexual development of paediatric patients treated with EXJADE were not affected.
16 Fi studji kliniċi ta ’ sena, l- iżvilupp fiżiku u sesswali ta ’ pazjenti pedjatriċi kurati b’ EXJADE ma kienux effettwati.
The concomitant use of deferasirox with aluminium-containing antacid preparations is not recommended.
L- użu ta ’ deferasirox flimkien ma ’ mediċini ta ’ kontra l- aċidu fl- istonku li jkun fihom l- aluminium mhux rakkomandat.
Caution should be exercised when deferasirox is combined with strong UDP- glucuronosyl transferase (UGT) inducers, or CYP2C8 substrates (see section 4.5).
Ghandha issir attenzjoni meta deferasirox jingħata ma ’ indutturi qawwija ta ’ UDP- glucuronosyl transferase (UGT), jew ma ’ sottostrati ta ’ CYP2C8 (ara sezzjoni 4. 5).
In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/ kg/ daily), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and C max about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI
Fi studju b’ voluntiera b’ saħħithom, l- għoti f’ daqqa ta ’ deferasirox bħala inibitur moderat ta ’ CYP2C8 (30 mg/ kg), u repaglinide, substrat ta ’ CYP2C8, mogħti bħala doża waħda ta ’ 0. 5 mg, żied l- AUC u s - Cmax ta ’ repaglinide b’ madwar 2. 3 drabi aktar (90% CI [2. 03- 2. 63]) u b’ 1. 6 drabi aktar (90% CI [1. 42- 1. 84]), rispettivament.
17 (see section 4.4).
17 sezzjoni 4. 4).
An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded (see section 4.4).
Mhux eskluż li deferasirox u substrati ohrajn ta ’ CYP2C8 bħal paclitaxel ma jaqblux bejniethom (ara sezzjoni 4. 4).
The concomitant administration of EXJADE with substances that have known ulcerogenic potential, such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4).
L- għoti fl- istess ħin ta ’ EXJADE ma ’ sustanzi li għandhom potenzjal ulċeroġeniku, bħal NSAIDs (inkluż acetylsalicylic acid f’ dożaġġi għoljin), kortikosterojdi, jew bisfosfonati orali, jista ’ jżid ir - riskju ta ’ tossiċità gastrointestinali (ara sezzjoni 4. 4).
Close clinical monitoring is required when deferasirox is combined with these substances.
L- għoti f’ daqqa ta ’ EXJADE u antikoagulanti jista ’ jżid ukoll ir- riskju ta ’ emorraġija gastro- intestinali., Monitoraġġ kliniku mill- qrib huwa meħtieġ meta deferasirox jiġi kkombinat ma ’ dawn is- sustanzi.
18 Gallstones and related biliary disorders were reported in about 2% of patients.
Kalkli u disturbi tal- marrara kienu rapurtati f’ madwar 2% tal- pazjenti.
During postmarketing experience, hepatic failure, sometimes fatal, has been reported with EXJADE, especially in patients with pre-existing liver cirrhosis (see section 4.4).
18 għall- mewt, kienet irrappurtata b’ EXJADE, l- aktar f’ pazjenti li kellhom minn qabel ċirrożi tal- fwied (ara sezzjoni 4. 4).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjeta ’ tagħhom, bl- aktar serji jitniżżlu l - ewwel.
19 4.9 Overdose
19 4. 9 Doża eċċessiva
Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels of these metals.
Deferasirox għandu affinità baxxa għaż - żingu u r- ram, u ma jikkawżax livelli baxxi kostanti ta ’ dawn il- metallifis- serum.
However, in patients with liver iron concentration < 7 mg Fe/ g dw treated with EXJADE (5 and 10 mg/ kg) or deferoxamine (20 to 35 mg/ kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Madankollu, f’ pazjenti li kellhom konċentrazzjoni tal- ħadid fil- fwied < 7mg Fe/ g dw kurati b’ EXJADE (5 u 10 mg/ kg) jew deferoxamine (20 sa 35 mg/ kg), ma ġiex stabbilit jekk ma kienx 20 inferjuri minħabba żbilanċ fid- dużaġġi taż- żewġ kelaturi.
20 It appeared from preclinical and clinical studies that EXJADE could be as active as deferoxamine when used in a dose ratio of 2:1 (i. e. a dose of EXJADE that is numerically half of the deferoxamine dose).
Minn studji ta ’ qabel l- użu kliniku u studji kliniċi deher li EXJADE jista ’ jkun attiv daqs deferoxamine meta jintuża f’ proporzjon ta ’ doża ta ’ 2: 1 (i. e. doża ta ’ EXJADE li tiġi numerikament nofs dik tad- doża ta ’ deferoxamine).
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
21 Sess In- nisa għandhom tneħħija apparenti moderatament aktar baxxa (b’ 17. 5%) għal deferasirox meta mqabbla ma ’ l- irġiel.
21 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Indeboliment renali jew tal- fwied Il- farmakokinetika ta ’ deferasirox ma kienetx studjata f’ pazjenti b’ indeboliment renali jew tal- fwied.
6.4 Special precautions for storage
22 6. 4 Prekawzjonijiet speċjali għall- ħażna
22 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
EXJADE 500 mg dispersible tablets
EXJADE 500 mg pilloli li jinxterdu
Each dispersible tablet contains 500 mg deferasirox.
Kull pillola li tinxtered fiha 500 mg deferasirox.
Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Pilloli offwajt, tondi, ċatti b’ xifer imżerżaq u timbri (NVR fuq naħa u J 500 fuq l- oħra).
24 An initial daily dose of 10 mg/ kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/ kg/ month of packed red blood cells (approximately < 2 units/ month for an adult).
F’ pazjenti li ma jkollhomx bżonn tnaqqis fil- livelli tal- ħadid fil- ġisem u li qed jirċievu anqas minn 7 ml/ kg/ xahar ta ’ ċelluli ħomor tad- demm ippakkjat (madwar < 2 unitajiet/ xahar għal bniedem adult),
25 4.4 Special warnings and precautions for use
25 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
U U
26 Funzjoni epatika:
27 The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
Ir- riżultati tat- testijiet għall- krejatinina fis- serum, ferritin fis- serum u transaminase fis- serum għandhom jinżammu u jintużaw sabiex joħorġu t- tendenzi.
In the 1-year clinical studies growth and sexual development of paediatric patients treated with EXJADE were not affected.
27 Fi studji kliniċi ta ’ sena, l- iżvilupp fiżiku u sesswali ta ’ pazjenti pedjatriċi kurati b’ EXJADE ma kienux effettwati.
Caution should be exercised when deferasirox is combined with strong UDP- glucuronosyl transferase (UGT) inducers, or CYP2C8 substrates (see section 4.5).
Għandha ssir attenzjoni meta deferasirox jingħata ma ’ indutturi qawwija ta ’ UDP - glucuronosyl transferase (UGT), jew ma ’ sottostrati ta ’ CYP2C8 (ara sezzjoni 4. 5).
28 (see section 4.4).
28 sezzjoni 4. 4).
Close clinical monitoring is required when deferasirox is combined with these substances.
Monitoraġġ kliniku mill- qrib huwa meħtieġa meta deferasirox jiġi kkombinat ma ’ dawn is- sustanzi..
29 Gallstones and related biliary disorders were reported in about 2% of patients.
Kalkli u disturbi tal- marrara kienu rapurtati f’ madwar 2% tal- pazjenti.
During postmarketing experience, hepatic failure, sometimes fatal, has been reported with EXJADE, especially in patients with pre-existing liver cirrhosis (see section 4.4).
29 għall- mewt, kienet irrappurtata b’ EXJADE, l- aktar f’ pazjenti li kellhom minn qabel ċirrożi tal- fwied (ara sezzjoni 4. 4).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjeta ’ taghhom, bl- aktar serji jitniżżlu l - ewwel.
30 4.9 Overdose
30 4. 9 Doża eċċessiva
However, in patients with liver iron concentration < 7 mg Fe/ g dw treated with EXJADE (5 and 10 mg/ kg) or deferoxamine (20 to 35 mg/ kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Madankollu, f’ pazjenti li kellhom konċentrazzjoni tal- ħadid fil- fwied < 7mg Fe/ g dw kurati b’ EXJADE (5 u 10 mg/ kg) jew deferoxamine (20 sa 35 mg/ kg), ma ġiex stabbilit jekk ma kienx 31 inferjuri minħabba żbilanċ fid- dużaġġi taż- żewġ kelaturi.
31 It appeared from preclinical and clinical studies that EXJADE could be as active as deferoxamine when used in a dose ratio of 2:1 (i. e. a dose of EXJADE that is numerically half of the deferoxamine dose).
Minn studji ta ’ qabel l- użu kliniku u studji kliniċi deher li EXJADE jista ’ jkun attiv daqs deferoxamine meta jintuża f’ proporzjon ta ’ doża ta ’ 2: 1 (i. e. doża ta ’ EXJADE li tiġi numerikament nofs dik tad- doża ta ’ deferoxamine).
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
32 Sess In- nisa għandhom tneħħija apparenti moderatament aktar baxxa (b’ 17. 5%) għal deferasirox meta mqabbla ma ’ l- irġiel.
32 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Indeboliment renali jew tal- fwied Il- farmakokinetika ta ’ deferasirox ma kienetx studjata f’ pazjenti b’ indeboliment renali jew tal- fwied.
Preclinical data reveal no special hazard for patients with iron overload, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Informazzjoni ta ’ qabel l- użu kliniku, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni jew riskju ta ’ kanċer, ma ’ turi l- ebda periklu speċjali għall- pazjenti b’ tagħbija żejda tal- ħadid.
6.4 Special precautions for storage
33 6. 4 Prekawzjonijiet speċjali għall- ħażna
33 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
34 ANNEX II
34 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT B.
Name and address of the manufacturer responsible for batch release U U
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Il- Ġermanja
The MAH shall set up a surveillance programme to collect information on the demographics of patients prescribed Exjade, any adverse reactions and reasons for discontinuation of Exjade.
L- MAH se jniedi programm ta ’ sorveljanza biex jiġbor tagħrif fuq id- demografiji tal- pazjenti li jingħataw Exjade, kwalunkwe effetti avversi u raġunijet għalxiex kellha titwaqqaf il- kura b’ Exjade.
The formal protocols for the sentinel monitoring surveillance should be reviewed by the CHMP.
Il - protokolli formali għas- sorveljanza ta ’ monitoraġġ mgħasses għandhom jiġu riveduti mis- CHMP.
The MAH must ensure that, at launch, all physicians who are expected to prescribe Exjade are provided with a physician information pack containing the following:
L- MAH għandu jaċċerta ruħu li, meta joħroġ għall- ewwel darba fuq is- suq, it- tobba li huma mistennija li joħorġu r- riċetti għal Exjade, jingħataw pakkett ta ’ tagħrif tat- tobba li jkun fih:
Product information Physician information about Exjade (brochure and pocket card) Patient information pack
Informazzjoni dwar il- prodott Informazzjoni għat- tabib dwar Exjade (ktieb żgħir u kartuna li toqgħod fil- but) Fuljett ta ’ tagħrif għall- pazjenti
The need to monitor serum ferritin monthly
Il- bżonn li ferritin fis- serum ikun monitorat kull xahar
That Exjade causes rises in serum creatinine in some patients o The need to monitor serum creatinine • On two occasions prior to initiation of treatment • Every week during the first month of initiation of treatment or after therapy modification • Monthly thereafter
Li Exjade jikkawża żieda tal- krejatinina fis- serum f’ xi pazjenti o Il- bżonn li l- krejatinina fis- serum tkun monitorata • F’ żewġ okkażjonijiet qabel tibda l- kura • Kull ġimgħa waqt l- ewwel xahar ta ’ meta tkun bdiet il- kura jew wara tibdil fit - terapija • Kull xahar minn hemm ‘ il quddiem
The need to reduce by 10 mg/kg the dose if serum creatinine rises: • Adults: > 33% above baseline and creatinine clearance < LLN (90 ml/min) • Paediatrics: either > ULN or creatinine clearance falls to < LLN at two consecutive visits.
Il- bżonn li d- doża titnaqqas b’ 10 mg/ kg jekk il- krejatinina fis- serum togħla: o • Adulti: > 33% fuq il- linja bażika u t- tneħħija tal- krejatinina < LLN (90 ml/ min) • Pedjatriċi: jew > ULN jew it- tneħħija tal- krejatinina taqa ’ għal < LLN f’ żewġ żjajjar wara xulxin.
o
Il- bżonn li twaqqaf il- kura wara li titnaqqas id- doża jekk il- livell tal- krejatinina fis - o serum jitla ’: • Adulti u Pedjatriċi: jibqa ’ > 33% fuq il- linja bażika jew it- tneħħija tal- krejatinina < LLN (90 ml/ min)
The need t o interrupt treatment after a dose reduction if serum creatinine rises: • Adults and Paediatrics: remain > 33% above baseline or creatinine clearance < LLN (90 ml/min)
36 Il- bżonn li tikkunsidra bijopsija tal- kliewi: o • Jekk il- krejatinina fis- serum jiġi għoli u tkun instabet xi anormalità oħra (eż. proteina fl- awrina, sinjali ta ’ Sindrome ta ’ Fanconi).
36
• • •
o
L- importanza li titkejjel it- tneħħija tal- krejatinina Tagħrif fil- qosor dwar il- metodi ta ’ kif titkejjel it- tneħħija tal- krejatinina Li żidiet fit- transaminases tas- serum jistgħu jseħħu f’ pazjenti kurati b’ Exjade o Il- bżonn għal testijiet tal- funzjoni tal- fwied qabel ma ’ t- tabib jikteb ir- riċetta, imbagħad f’ intervalli ta ’ xahar jew aktar spissi jekk ikun hemm indikazzjonijiet kliniċi. o Biex ma jinkitbux riċetti għall- pazjenti li jkollhom minn qabel mard qawwi tal- fwied. o Il- bżonn biex titwaqqaf il- kura jekk ikun hemm żidiet persistenti u progressivi ta ’ l - enzimi tal- fwied.
The need to consider renal biopsy: • When serum creatinine is elevated and if another abnormality has been detected (eg. proteinuria, signs of Fanconi’s Syndrome).
• Il- bżonn għal testijiet tas- smigħ u ta ’ l- għajnejn kull sena
• The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance • That rises in serum transaminases occur in patients treated with Exjade o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted. • The need for annual auditory and ophthalmic testing
•
• The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Il- bżonn għal tabella gwida li turi b’ mod ċar il- figuri, qabel ma tinbeda l- kura, tal - krejatinina fis- serum, it- tneħħija tal- krejatinina, proteina fl- awrina, enzimi tal- fwied, ferritin, bħal:
Before initiating treatment
Qabel tibda l- kura
Serum creatinine at Day - X Serum creatinine at Day - Y
Krejatinina fis- serum f’ ġurnata – X Krejatinina fis- serum f’ ġurnata – Y
X and Y are the days (to be determined) when pre-treatment measurements should be performed.
X u Y huma l- ġranet (li għandhom jiġu deċiżi) meta għandhom ikunu meħudin il- figuri qabel il - kura.
• That the safety database of Exjade is limited and physicians are encouraged to enrol patients in a surveillance programme (sentinel site monitoring and paediatric registry) to increase knowledge about the incidence of important ADRs.
• Li d- dejtabejż tas- sigurtà ta ’ Exjade huwa limitat u t- tobba huma mħeġġa li jdaħħlu pazjenti f’ programm ta ’ sorveljanza (Għassa tas- sit ta ’ monitoraġġ u reġistru pedjatriku) biex jiżdied l - għarfien dwar il- frekwenza ta ADR’ s importanti.
The information collected should include: o Anonymised patient details – age, sex, weight o Transfusion history and requirements o Initial dose of Exjade and subsequent changes in dose o Concomitant medications o Record of measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Renal histology, if available o Reason for discontinuation o ADRs
L- informazzjoni miġbura għandha tinkludi: o Dettalji tal- pazjent miġbura b’ mod anonimu – età, sess u piż. o Trasfużjonijiet li sarulu fil- passat u xi ħtiġijiet għandu o Doża tal- bidu ta ’ Exjade u tibdil li sar wara fid- doża o Mediċini oħra li qed jittieħu fl- istess ħin o Reġistru tal- figuri tal- krejatinina fis- serum, tneħħija tal- krejatinina, proteina fl - awrina, enzimi tal- fwied u ferritin. o Ħistoloġija renali, jekk tkun disponibbli o Raġuni għat- twaqqif o ADRs
• The educational programme should prompt doctors to report serious ADRs and certain selected ADRs as below: • All serious ADRs • Persistent and progressive increase in hepatic enzymes • Increase in serum creatinine levels (> 33% above baseline) or clearance creatinine decrease (< 90 ml/min) • Significant changes found in auditory or ophthalmological testing • Gallstones • Unexpected ADRs according to the SPC.
• Il- programm edukattiv għandhu jqanqal lit- tobba biex jirrapurtaw ADR’ s serji u ċerti tipi ta ’ ADR’ s kif spjegat hawn taħt: • ADR’ s serji kollha. • Żieda persistenti u progressiva fl- enzimi tal- fwied • Żieda fil- livelli tal- krejatinina (> 33% fuq il- linja bażika) jew tnaqqis fit - tneħħija tal- krejatinina (< 90 ml/ min) • Tibdil sinifikanti fit- testijiet tas- smigħ jew tal- vista • Kalkli • ADR’ s mhux mistennija skond l- SPC.
The Patient inf ormation pack should include the following information: o Patient information leaflet o Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Information that renal biopsy may be considered if significant renal abnormalities occur
Il- pakkett ta ’ tagħrif tal- Pazjent għandu jinkludi din l- informazzjoni: o Il- fuljett ta ’ tagħrif tal- pazjent o Informazzjoni fuq il- bżonn ta ’ monitoraġġ regolari, u ta ’ meta għandu jsir, tal - krejatinina fis- serum, tneħħija tal- krejatinina, proteina fl- awrina, enzimi tal- fwied, ferritin o Informazzjoni li jista ’ jkun hemm bżonn ta ’ bijopsi tal- kliewi jekk ikun hemm anormalità sinifikanti fil- kliewi
Patient booklet where the physician can record the results of the above along with the dose of Exjade
37 Ktieb żgħir tal- pazjent fejn it- tabib jista ’ jniżżel ir- riżultati ta ’ dawn t’ hawn fuq o flimkien mad- doża ta ’ Exjade Kartuna żgħira biex tfakkar id- dati tat- testijiet o
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura ruħu li s- sistema ta ’ farmakoviġilanza tkun kif suppost u taħdem qabel ma jitqiegħed il- prodott fis- suq u sakemm idum jintuża.
Risk Management plan The MAH commits to perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Pjan ta ’ L- immaniġġar tar- Riskju L- MAH jikkommetti ruħu li jgħamel l- istudji u xi attivitajiet oħra ta ’ farmakoviġilanza kif spjegati fid - dettal fil- Pjan ta ’ Farmakoviġilanza.
The MAH must inform the EMEA and the CHMP of the status and results of the surveillance programme in each Member State within 6 months of the Decision and at each update of the EU Risk Management Plan.
L- MAH għandu jinforma lill- EMEA u s- CHMP dwar l- istat u r- riżultati tal- programm ta ’ sorveljanza f’ kull Pajjiż Membru fi żmien 6 xhur mid- Deċiżjoni u ma ’ kull aġġornament tal- Pjan ta ’ l- Immaniġġar tar- Riskju ta ’ l- EU.
This report shall also provide the details of the ADRs as specified above.
Dan ir- rapport għandu jipprovdi wkoll id- dettalji dwar l- ADRs kif speċifikat hawn fuq.
As well as the requirements in the legislation, the following serious ADRs should be forwarded on an expedited basis to the appropriate competent authority as well as summarised in the above reports: o Increase in hepatic enzymes > 10xULN o Serious rise in creatinine o Results of renal biopsies, if available o Cataracts o Hearing loss o Gallstones
Minbarra dawk l- affarijiet meħtieġa bil- liġi, l- ADRs serji li ġejjin għandhom jiġu mgħoddija malajr kemm jista ’ jkun lill- awtorità kompetenti kif ukoll mqassra fir- rapporti t’ hawn fuq: o Żieda fl- enzimi tal- fwied > 10xULN o Żieda serja tal- krejatinina o Riżultati ta ’ bijopsijiet tal- kliewi, jekk ikunu disponibbli o Katarretti o Telf tas- smigħ o Kalkli
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Hekk kif spjegat fil- Linji gwida tas- CHMP fuq is- Sistemi ta ’ l- Immaniġġar tar- Riskji għall- prodotti mediċinali għall- użu fil- bniedem, Pjan ta ’ L- Immaniġġar tar- Riskji aġġornat għandu jkun ipprovdut.
38 ANNEX III
38 ANNESS III
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON
KAXXA
EXJADE 125 mg dispersible tablets Deferasirox
EXJADE 125 mg pilloli li jinxterdu Deferasirox
Each dispersible tablet contains 125 mg of deferasirox.
Kull pillola li tinxtered fiha 125 mg deferasirox.
28 dispersible tablets 84 dispersible tablets 252 dispersible tablets
28 pillola li jinxterdu 84 pillola li jinxterdu 252 pillola li jinxterdu
Use only as directed by a doctor.
Uża biss kif jispjegalek it- tabib.
Take this medicine on an empty stomach.
Ħu din il- mediċina fuq stonku vojt.
Disperse tablets in water or fruit juice before swallowing.
Ħoll il- pilloli fl- ilma jew meraq tal- frott qabel tibla.
Do not swallow whole or chew.
M’ għandekx tibla ’ l- pillola sħiħa jew tomgħodha.
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
EXJADE 250 mg dispersible tablets Deferasirox
EXJADE 250 mg pilloli li jinxterdu Deferasirox
Each dispersible tablet contains 250 mg of deferasirox.
Kull pillola li tinxtered fiha 250 mg deferasirox.
28 dispersible tablets 84 dispersible tablets 252 dispersible tablets
28 pilloli li jinxterdu 84 pilloli li jinxterdu 252 pillola li jinxterdu
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
EXJADE 500 mg dispersible tablets Deferasirox
EXJADE 500 mg pilloli li jinxterdu Deferasirox
Each dispersible tablet contains 500 mg of deferasirox.
Kull pillola li tinxtered fiha 500 mg deferasirox.
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
50 PACKAGE LEAFLET:
50 FULJETT TA ’ TAGĦRIF:
EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets Deferasirox
EXJADE 125 mg pilloli li jinxterdu EXJADE 250 mg pilloli li jinxterdu EXJADE 500 mg pilloli li jinxterdu Deferasirox
- This medicine has been prescribed only for you or your child.
- Din il- mediċina ġiet mogħtija lilek jew lit- tifel/ tifla tiegħek.
Do not give it to anyone else or
Tagħthiex lil persuni oħra u
use it for any other illnesses.
tużhahiex għal xi mard ieħor.
U U
F’ dan il- fuljett:
What EXJADE is and what it is used for 2.
X’ inhu EXJADE u għalxiex jintuża 2.
Before you take EXJADE 3.
Qabel ma tieħu EXJADE 3.
How to take EXJADE 4.
Kif għandek tieħu EXJADE 4.
How to store EXJADE 6.
Kif taħżen EXJADE 6.
WHAT EXJADE IS AND WHAT IT IS USED FOR
X’ INHU EXJADE U GĦALXIEX JINTUŻA
What EXJADE is EXJADE contains an active substance called deferasirox.
X’ inhu EXJADE EXJADE fih sustanza attiva li jisimha deferasirox.
It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).
Huwa kelatur tal- ħadid li hija mediċina li tintuża biex tneħħi l- ħadid żejjed mill- ġisem (kundizzjoni magħrufa bħala tagħbija żejda tal- ħadid).
What EXJADE is used for EXJADE is used to treat iron overload caused by blood transfusions.
Għal xiex jintuża EXJADE EXJADE jintuża għal- kura ta ’ tagħbija żejda tal- ħadid li sseħħ b’ trasfużjonijiet tad- demm.
Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes).
Pazjenti li jsofru minn ċerti tipi ta ’ anemiji (per eżempju talessimja, mard tas- sickle cell jew sindromi majlodisplastiċi) jista ’ jkollhom bżonn trasfużjonijiet tad- demm ripetuti.
However, repeated blood transfusions can cause a build-up of excess iron.
Madankollu, meta jingħataw trasfużjonijiet tad- demm repetuti, dan jista ’ jwassal għall- akkumulazzjoni ta ’ ħadid żejjed.
This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions.
Dan għaliex id- demm fih il- ħadid u ġismek m’ għandux mekkaniżmu naturali sabiex ineħħi l- ħadid żejjed li tieħu bit- trasfużjonijiet tad- demm.
Over time, the excess iron can damage important organs such as the liver and heart.
Maż- żmien, il- ħadid żejjed jista ’ jgħamel il- ħsara f’ organi importanti bħal ma huma l- fwied u l- qalb.
Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.
Mediċini li jissejħu kelaturi tal- ħadid jintużaw sabiex jitneħħa l- ħadid żejjed u tnaqqas ir- riskju li tgħamel ħsara lill- organi.
EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
EXJADE jintuża għal- kura ta ’ tagħbija żejda kronika tal- ħadid ikkawżata minn trasfużjonijiet tad - demm frekwent f’ pazjenti ta ’ 6 snin jew akbar li jsofru minn beta- talessimja maġġuri.
EXJADE is also used when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
EXJADE jintuża wkoll meta terapija b’ deferoxamine tkun kontra- indikata jew inadegwata f’ pazjenti li jsofru minn beta- talessimja maġġuri li jkollhom tagħbija żejda tal- ħadid kawżata minn trasfużjonijiet mhux frekwenti, f’ pazjenti li jsofru minn forom oħrajn ta ’ anemiji, u fi tfal ta ’ bejn 2 u 5 snin.
How EXJADE works EXJADE traps and removes excess iron which is then excreted mainly in the stools.
Kif jaħdem EXJADE EXJADE jaqbad u jneħħi l- ħadid żejjed, li mbagħad jitneħħa fil- parti l- kbira ma ’ l- ippurgar.
Monitoring your EXJADE treatment You will have regular blood and urine tests during treatment.
Monitoraġġ tal- kura tiegħek b’ EXJADE Waqt il- kura jridu jsirulek testijiet tad- demm u ta ’ l- awrina b’ mod regolari.
These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working.
B’ dawn ikun hemm monitoraġġ ta ’ l- ammont ta ’ ħadid f’ ġismek (il- livell ta ’ ferritin fid- demm) sabiex isir magħruf kemm qed jaħdem tajjeb EXJADE.
Your doctor will take these tests into consideration when deciding on the dose of EXJADE most suitable for you.
Bit- testijiet, ikun hemm ukoll monitoraġġ tal- funzjoni tal- kliewi (livell tal- krejatinina fid- demm, preżenza ta ’ proteina fl- awrina) u tal- fwied (livell ta 'transaminases fid -
51 You will get a booklet from your doctor which will help you to track your response to EXJADE.
B’ dawn it- testijiet, it- tabib tiegħek ikun jista ’ jiddeċiedi x’ doża ta ’ EXJADE l- aktar tgħodd għalik.
Your doctor will write your blood tests in this booklet at each visit.
It - tabib tiegħek ser jikteb ir- riżultati tat- testijiet tad- demm f’ dan il- ktieb ma ’ kull żjara.
Keep the booklet safe and bring it with you each time you visit your doctor.
Żomm il- ktieb f’ post protett u ħudu miegħek kull darba li żżur lit- tabib tiegħek.
Your eyesight and hearing will be tested each year during treatment as a precautionary measure.
Il- vista u s- smigħ tiegħek se jkunu eżaminati kull sena waqt il- kura bħala miżura ta ’ prekawzjoni.
If you have any questions about how EXJADE works or why this medicine has been prescribed for you, ask your doctor.
Jekk għandek xi mistoqsijiet dwar kif jaħdem EXJADE jew għaliex kitbulek riċetta għal din il - mediċina, staqsi lit- tabib tiegħek.
BEFORE YOU TAKE EXJADE
QABEL MA TIEĦU EXJADE
Follow all the doctor’s instructions carefully.
Segwi bir- reqqa l- istruzzjonijiet kollha tat- tabib.
They may differ from the general information in this leaflet.
Jistgħu jkunu differenti mit- tagħrif ġenerali ta ’ dan il - fuljett.
Do not take EXJADE
Tieħux EXJADE
- if you are allergic (hypersensitive) to deferasirox or any of the other ingredients of EXJADE
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal deferasirox jew sustanzi oħra ta ’
listed in section 6 of this leaflet.
EXJADE imniżżlin f’ sezzjoni 6 ta ’ dan il- fuljett.
If this applies to you, tell your doctor before taking EXJADE.
Jekk dan jgħodd għalik, għid lit- tabib tiegħek qabel ma tieħu EXJADE.
If you think you may be allergic, ask your doctor for advice.
Jekk taħseb li tista ’ tkun allerġiku/ a ħu parir tat- tabib tiegħek.
- if you have kidney disease.
- jekk tbati minn mard tal- kliewi
- if you are currently taking another iron chelator medication.
- jekk bħal issa qed tieħu xi mediċina oħra li hija kelatur tal- ħadid.
Take special care with EXJADE
Oqgħod attent ħafna b’ EXJADE
- if you have a liver problem.
- jekk għandek xi problema tal- fwied
- if you have a cardiac problem due to iron overload.
- jekk għandek xi problema tal- qalb minħabba tagħbija żejda tal- ħadid.
- if you notice a marked decrease in your urine output (sign of kidney problem).
- jekk tinnota tnaqqis konsiderevoli fl- ammont ta ’ awrina li tgħaddi (sinjal ta ’ problema fil -
- if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face
- jekk tiżviluppa raxx sever, jekk tbati biex tieħu n- nifs u sturdament jew nefħa l- aktar tal- wiċċ u
and throat (signs of severe allergic reaction).
l- griżmejn (sinjali ta ’ reazzjoni allerġika severa).
- if you experience a combination of drowsiness, upper right abdominal pain, yellowing or
- jekk tħoss taħlita ta ’ ngħas, uġigħ fin- naħa tal- lemin ta ’ fuq ta ’ l- addome, tisfar jew il- ġilda jew
increased yellowing of your skin or eyes and dark urine (signs of liver problems).
għajnejk jisfaru aktar u l- awrina tiskura (sinjali ta ’ problemi tal- fwied).
- if you vomit blood and/or have black stools.
- jekk tirremetti d- demm u/ jew ikollok ippurgar skur.
- if you experience frequent abdominal pain, particularly after eating or taking EXJADE.
- jekk tħoss uġigħ addominali ta ’ spiss, l- aktar wara l- ikel jew wara li tkun ħadt EXJADE.
- if you experience frequent heartburn.
- jekk tħoss ħruq ta ’ stonku ta ’ spiss.
- if you are taking or have recently taken certain painkillers, anti-inflammatory medicines or oral
- jekk qed tieħu jew jekk dan l- aħħar ħadt ċerti mediċini jew bisfosfonati li jtaffu l- uġigħ jew għal
bisphosphonates (see “Taking other medicines”).
kontra l- infjammazzjonijiet (ara “ Meta tieħu mediċini oħra ”).
- if you are taking or have recently taken anticoagulant medication (see “Taking other
- jekk qed tieħu jew jekk dan l- aħħar ħadt medikazzjoni antikoagulanti (ara “ Meta tieħu mediċini
medicines”).
oħra ”).
If any of these apply to you, tell your doctor straight away.
Jekk kwalunkwe wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek mill- ewwel.
Taking other medicines Antacids (medicines used to treat heartburn) containing aluminium should not be taken at the same time of day as EXJADE.
Meta tieħu mediċini oħra Mediċini ta ’ kontra l- aċidu fl- istonku (mediċini li jintużaw għall- kura ta ’ ħruq ta ’ stonku) li fihom l - aluminju m’ għandhomx jittieħdu fl- istess ħin tal- ġurnata bħal EXJADE.
This includes in particular:
Dawn jinkludu b’ mod partikolari:
- ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such
- ciclosporin (jintuża biex jiġi evitat li l- ġisem jirriġetta organu trapjantat jew għal kondizzjonijiet
as rheumatoid arthritis or atopic dermatitis),
oħra, bħall- artrite rewmatika jew dermatite atopika),
- simvastatin (used to lower cholesterol),
- simvastatin (jintuża biex ibaxxi l- kolesterol),
- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids),
- ċerti mediċini li jtaffu l- uġigħ jew għal kontra l- infjammazzjonijiet (eż. aspirina, ibuprofen,
- oral bisphosphonates (used to treat osteoporosis),
kortikosterojdi),
- anticoagulant medicines (used to prevent or treat blood clotting),
- bisfosfonati orali (użati għall- kura ta ’ osteoporożi),
- repaglinide (used to treat diabetes),
- mediċini antikoagulanti (użati għall- prevenzjoni jew għall- kura ta ’ l- għaqid tad- demm),
- rifampicin (used to treat tuberculosis),
- sustanzi li jintuzaw bħala kontraċettivi ormonali (mediċini li jikkontrollaw it- twelid),
- phenytoin, phenobarbital, carbamazepine (used to treat epilepsy),
- phenytoin, phenobarbital, carbamazepine (użati għal- kura ta ’ l- epilessija),
- ritonavir (used in the treatment of HIV infection),
- ritonavir (użat għal- kura ta ’ infezzjoni b’ HIV),
- paclitaxel (used in cancer treatment).
- paclitaxel (użat għal- kura tal- kanċer).
Older people (age 65 years and over) EXJADE can be used by people aged 65 years and over at the same dose as for other adults.
Persuni anzjani (li għandhom 65 sena jew aktar) EXJADE jista ’ jintuża minn persuni li għandhom 65 sena jew aktar bl- istess doża ta ’ l- adulti l- oħrajn.
Children and adolescents (age 2 years to 17 years) EXJADE can be used in adolescents and children aged 2 years and over.
Tfal u adolexxenti (li għandhom sentejn sa 17- il sena) EXJADE jista ’ jintuża minn adolexxenti u tfal li għandhom minn sentejn ’ il fuq.
As the patient grows the doctor will adjust the dose.
Hekk kif ikun qed jikber il- pazjent, it- tabib jibdel id- doża.
Pregnancy and breast-feeding EXJADE is not recommended during pregnancy unless clearly necessary.
Tqala u treddigħ Mhux rakkomandat li EXJADE jintuża waqt it- tqala sakemm ma jkunx hemm bżonn ċar.
If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take EXJADE during your pregnancy.
Jekk inti ħriġt tqila jew taħseb li tista ’ tkun ħriġt tqila, għid lit- tabib tiegħek, u dan se jiddiskuti miegħek jekk tkunx tista ’ tieħu EXJADE waqt it- tqala.
Breast-feeding is not recommended during treatment with EXJADE.
Treddigħ mhux rakkomandat waqt kura b’ EXJADE.
Tell your doctor if you are breast- feeding.
Għid lit- tabib tiegħek jekk qed tredda ’.
Driving and using machines If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut wara li tieħu EXJADE, m’ għandekx issuq jew tgħamel użu minn għodda jew magni sakemm terġa ’ tħossok normali.
Important information about some of the ingredients of EXJADE If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ EXJADE Jekk it- tabib tiegħek qallek li għandek nuqqas ta ’ tolleranza għal xi tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE EXJADE
KIF GĦANDEK TIEĦU EXJADE
Always take EXJADE exactly as your doctor has told you.
Dejjem għandek tieħu EXJADE eżatt skond il- parir tat- tabib.
How much EXJ ADE to take The dose of EXJADE is related to body weight for all patients.
Kemm għandek tieħu EXJADE Id- doża ta ’ EXJADE hija marbuta mal- piż tal- ġisem għal pazjenti kollha.
Your doctor will calculate the dose you need and tell you how many tablets to take each day. • The usual daily dose at the start of the treatment is 20 mg per kilogram body weight.
It- tabib tiegħek se jikkalkula d- doża li għandek bżonn u jgħidlek kemm għandek tieħu pilloli kuljum. • Fil- bidu tal- kura, id- doża tal- bidu ħafna drabi tkun 20 mg għal kull kilogramma tal- piż tal - ġisem kuljum.
A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs. • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose. • The maximum recommended daily dose is 30 mg per kilogram body weight.
Doża ogħla jew aktar baxxa tista ’ tkun rakkomandata mit- tabib tiegħek skond il - ħtiġijiet individwali tiegħek. • Skond kif ikun ir- rispons tiegħek għal- kura, it- tabib tiegħek jista ’ jibdel id- doża tiegħek għal waħda ogħla jew aktar baxxa. • L- aktar doża għolja rakkomandata hija 30 mg għal kull kilogramma tal- piż tal- ġisem kuljum.
When to take EXJADE • Take EXJADE once a day, every day, at about the same time each day. • Take the tablets on an empty stomach. • Then wait at least 30 minutes before eating any food.
Meta għandek tieħu EXJADE • Ħu EXJADE darba waħda fil- ġurnata, kuljum, bejn wieħed u ieħor fl- istess ħin tal- jum. • Ħu l- pilloli fuq stonku vojt. • Stenna madwar 30 minuta qabel ma tiekol xi ikel.
Taking EXJADE at the same time each day will help you remember when to take your tablets.
Li tieħu EXJADE fl- istess ħin tal- ġurnata jgħinek tiftakar meta għandek tieħu l- pilloli.
53 How to take EXJADE: • Drop the tablet(s) into a glass of water, or apple or orange juice. • Stir until the tablet(s) dissolve completely.
53 Kif tieħu EXJADE: • Waqqa ’ l- pillola( i) f’ tazza ilma, jew meraq tat- tuffieħ jew tal - larinġ • Ħawwad sakemm il- pillola( i) tinħall kollha.
The liquid in the glass will look cloudy. • Drink everything in the glass.
Il- likwidu fit- tazza jkun jidher bajdani. • Ixrob kollox li hemm fit- tazza.
Then add a little water or juice to what is left in the glass and drink that too.
Imbagħad żid ftit ilma jew meraq ma ’ dak li jibqa ’ fit- tazza u ixrobha wkoll.
Do not dissolve the tablets in fizzy drinks or milk.
M’ għandekx tħoll il- pilloli f’ xorb bil- gass jew fil- ħalib.
Do not chew, break or crush the tablets.
M’ għandekx tomgħod, taqsam jew tfarrak il- pilloli.
Do not swallow the tablets whole.
M’ għandekx tibla ’ l- pilloli sħaħ.
How long to take EXJADE Continue taking EXJADE every day for as long as your doctor tells you.
Kemm għandek iddum tieħu EXJADE Għandek tkompli tieħu EXJADE kuljum sakemm jgħidlek it- tabib tiegħek.
This is a long-term treatment, possibly lasting for months or years.
Din hija kura li tieħu fit- tul, u tista ’ ddum ix- xhur jew is- snin.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 1: “Monitoring your EXJADE treatment”).
(Ara wkoll sezzjoni 1: “ Monitoraġġ tal- kura tiegħek b’ EXJADE ”).
If you have questions about how long to take EXJADE, talk to your doctor.
Jekk għandek xi mistoqsijiet fuq kemm għandek iddum tieħu EXJADE, kellem lit- tabib tiegħek.
If you take more EXJADE than you should If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away.
Jekk tieħu EXJADE aktar milli suppost Jekk ħadt wisq EXJADE, jew jekk xi ħadd jieħu l- pilloli tiegħek bi żball, kellem it- tabib tiegħek jew l - isptar malajr kemm jista ’ jkun.
Show them the pack of tablets.
Urihom il- pakkett tal- pilloli.
Medical treatment may be necessary.
Jista ’ jkun hemm bżonn kura medika.
If you forget to take EXJADE If you miss a dose, take it as soon as you remember on that day.
Jekk tinsa ’ tieħu EXJADE Jekk taqbiżlek doża, ħudha malli tiftakar f’ dik il- ġurnata.
Take your next dose as scheduled.
Ħu d- doża li jmissek hekk kif skedat.
Do not take a double dose on the next day to make up for the forgotten tablet(s).
M’ għandekx tieħu doża doppja il- ġurnata ta ’ wara biex tpatti għal kull pillola( i) li tkun insejt tieħu.
If you stop taking EXJADE Do not stop taking EXJADE unless your doctor tells you to.
Jekk tieqaf tieħu EXJADE M’ għandekx tieqaf tieħu EXJADE sakemm ma jgħidlekx it- tabib.
If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take EXJADE”).
Jekk twaqqafha, il- ħadid żejjed li għandek f’ ġismek ma jibqax jitneħħa (ara wkoll is- sezzjoni hawn fuq “ Kemm għandek iddum tieħu EXJADE ”).
Like all medicines, EXJADE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, EXJADE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Ħafna mill- effetti sekondarji huma ħfief għal moderati u ġeneralment jgħaddu wara ftit ġranet jew ġimgħat tal- kura.
Do not be alarmed by this list of possible side effects.
M’ għandekx tallarma ruħek b’ din il- lista ta ’ effetti sekondarji li jistgħu jiġru.
You may not experience any of them.
Jista ’ jkun li ma tħoss xejn minnhom.
Some side effects could be serious and need immediate medical attention.
Xi effetti sekondarji jistgħu jkunu serji u jkollhom bżonn attenzjoni medika immedjata.
54 • If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems), • If you vomit blood and/or have black stools, • If you experience frequent abdominal pain, particularly after eating or taking EXJADE, • If you experience frequent heartburn, • If you experience partial loss of vision, tell your doctor straight away.
Dawn l- effetti sekondarji huma meqjusa bħala mhux komuni jew rari. • Jekk ikollok raxx qawwi, jew tbati biex tieħu n- nifs u sturdament jew nefħa l- aktar tal- wiċċ u l - griżmejn (sinjali ta ’ allerġija severa), • Jekk tinnota li l- awrina li tgħaddi naqset b’ mod sostanzjali (sinjal ta ’ problema fil- kliewi), 54 • Jekk tħoss taħlita ta ’ tħeddil, uġigħ fil- parti tal- lemin ta ’ l- addome, sfurija jew żieda fl- isfurija tal- ġilda tiegħek jew ta ’ ghajnejk u awrina skura (sinjali ta ’ problemi fil- fwied), • Jew tirremetti d- demm jew tipporga iswed, • Jekk tħoss uġigħ fl- addome ta ’ spiss, l- aktar wara l- ikel jew wara li tkun ħadt EXJADE, • Jekk tħoss ħruq ta ’ stonku ta ’ spiss, • Jekk titlef parti mill- vista, għid lit- tabib tiegħek mill- ewwel.
Some side effects could become serious.
Xi effetti sekondarji jistgħu jsiru serji.
These side effects are uncommon, that is they may affect less than 1 in every 100 patients. • If you get blurred or cloudy eyesight, • If you get reduced hearing, tell your doctor as soon as possible.
Dawn l- effetti sekondarji mhumiex komuni, li jfisser li jistgħu jolqtu anqas minn 1 f’ kull 100 pazjent. • Jekk tibda ma tarax ċar jew tara mċajpar, • Jekk tibda tonqos mis- smigħ, għid lit- tabib tiegħek malajr kemm jista ’ jkun.
Some side effects are very common.
Xi effetti sekondarji huma komuni ħafna.
These side effects may affect more than 1 in every 10 patients. • Disturbance in renal function tests.
Dawn l- effetti sekondarji jistgħu jolqtu aktar minn 1 f’ kull 10 pazjenti. • Tibdil fit- testijiet tal- funzjoni tal- kliewi.
Some side effects are common.
Xi effetti sekondarji huma komuni.
T hese side effects may affect between 1 and 10 in every 100 patients. • Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, constipation, indigestion • Rash • Headache If any of these affects you severely, tell your doctor.
Dawn l- effetti sekondarji jistgħu jolqtu bejn 1 u 10 f’ kull 100 pazjent. • Mard gastro- intestinali, bħal dardir, rimettar, dijarea, uġigħ ta ’ żaqq, nefħa, stitikezza, indiġestjoni • Raxx • Uġigħ ta ’ ras Jekk xi waħda minn dawn tolqtok bil- qawwi, għid lit- tabib tiegħek.
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Effetti sekondarji oħrajn m’ humhiex komuni.
These side effects may affect less than 1 in every 100 patients. • Dizziness • Fever • Sore throat • Swelling of arms or legs • Change in the colour of the skin • Anxiety • Sleep disorder • Tiredness If any of these affects you severely, tell your doctor.
Dawn l- effetti sekondarji jistgħu jolqtu anqas minn 1 f’ kull 100 pazjent. • Sturdament • Deni • Uġigħ fil- grieżem • Nefħa tad- driegħ jew tas- saqajn. • Tibdil fil- lewn tal- ġilda • Ansjetà • Nuqqas ta ’ rqad • Għejja Jekk tħoss xi waħda minn dawn b’ mod qawwi, għid lit- tabib tiegħek.
Frequency not known (cannot be estimated from the available data). • A decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia)
Frekwenza mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli). • Tnaqqis fin- numru ta’ ċelluli involuti fit- tgħaqqid tad- demm (tromboċitopenija), jew f’ kull tip ta ’ ċelluli tad- demm (panċitopenija)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jaggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE EXJADE
KIF TAĦŻEN EXJADE
• Keep out of the reach and sight of children. • Do not use EXJADE after the expiry date which is stated on the blister and the carton.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax EXJADE wara d- data ta ’ skadenza li tidher fuq il- folja u fuq il- kartuna.
The expiry date refers to the last day of that month. • Store in the original package in order to protect from moisture. • Do not use any pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. • Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità. • M’ għandek tuża l- ebda pakkett li jkollu xi ħsara jew li juri li kien imbagħbas.
What EXJADE contains The active substance is deferasirox.
X’ fih EXJADE Is- sustanza attiva hi deferasirox.
Each tablet of EXJADE 125 mg contains 125 mg deferasirox.
Kull pillola EXJADE 125 mg fiha 125 mg deferasirox.
Each tablet of EXJADE 250 mg contains 250 mg deferasirox.
Kull pillola EXJADE 250 mg fiha 250 mg deferasirox.
Each tablet of EXJADE 500 mg contains 500 mg deferasirox.
Kull pillola EXJADE 500 mg fiha 500 mg deferasirox.
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium lauryl sulphate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Is- sustanzi l- oħra huma lactose monohydrate, crospovidone type A, povidone, sodium lauryl sulphate, microcrystalline cellulose, colloidal anhydrous silica u magnesium stearate.
What EXJADE looks like and contents of the pack EXJADE is supplied as dispersible tablets.
Id- Dehra ta ’ EXJADE u l- kontenuti tal- pakkett EXJADE issibu bħala pilloli li jinxterdu.
The tablets are off-white, round and flat.
Il- pilloli huma offwajt, tondi u ċatti.