qanastek/EMEA-V3 huggingface dataset:
Before you take Exforge 3.
Qabel ma tieħu Exforge 3.
How to take Exforge 4.
Kif għandek tieħu Exforge 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Exforge 5.
WHAT EXFORGE IS AND WHAT IT IS USED FOR
X’ INHU EXFORGE U GĦALXIEX JINTUŻA
Exforge tablets contain two substances called amlodipine and valsartan.
Il- pilloli Exforge fihom żewġ sustanzi li jissejjħu amlodipine u valsartan.
Exforge is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Exforge jintuża sabiex jikkura l- pressjoni għolja f’ pazjenti li jkollhom il- pressjoni li ma tkunx qed tiġi kontrollata tajjeb biżżejjed b’ amlodipine jew valsartan waħidhom.
2.
QABEL MA TIEĦU EXFORGE 2.
BEFORE YOU TAKE EXFORGE
dihydropyridine
Do not take Exforge − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Exforge.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal valsartan jew sustanzi oħra ta ’
If you think you may be allergic, talk to your doctor before taking Exforge. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- Jekk qed tieħu dijuretiċi (tip ta ’ pilloli magħrufa bħala “ tal- pipì ” li żżid l- ammont ta ’ awrina li
If any of the above applies to you, do not take Exforge and talk to your doctor.
- Jekk qed tieħu xi mediċini jew sustanzi li jżidu l- livelli ta ’ potassium fid- demm tiegħek (eż ċerti
64 Take special care with Exforge − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
“ mitrijali ”) jew jekk il- ħxuna tal- muskolu ta ’ qalbek kibret aktar minn- normal (magħrufa bħala “ kardjomijopatija ipertrofika ostruttiva ”).
If any of these apply to you, tell your doctor before taking Exforge.
Jekk xi wieħed minn dawn jgħodd għalik, tkellem mat- tabib tiegħek qabel tieħu Exforge.
Exforge is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
Exforge m’ huwiex rakkomandat fil- bidu tat- tqala u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jittieħed wara t- tielet xahar tat- tqala (ara s- sezzjoni “ Tqala u treddigħ ”).
The use of Exforge in children and adolescents is not recommended.
L- użu ta ’ Exforge fi tfal u adolexxenti mhuwiex rakkomandat.
Taking Exforge with food and drink You can take Exforge with or without food.
Meta tieħu Exforge ma ’ l- ikel u max- xorb Tista ’ tieħu Exforge ma ’ l- ikel jew mingħajru.
Exforge and older people Caution is required when increasing the dosage.
Exforge u pazjenti aktar anzjani Kawtela hija meħtieġa meta jkun qed jiżdied id- dożaġġ.
Usually, your doctor will advise you to take another medicine instead of Exforge, as Exforge is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Is- soltu, it - tabib tieghek javżak biex tieħu mediċina oħra minflokk Exforge, għax Exforge mhux irrakkomandat fil- bidu tat- tqala, minħabba li jista ’ jagħmel ħsara lit- tarbija tiegħek jekk jintuża wara 3 xhur tat- tqala.
An appropriate antihypertensive medication must usually replace Exforge before starting a pregnancy.
Mediċina addattata għal kontra il- pressjoni trid tibdel lil Exforge qabel tinbeda tqala.
Your doctor will normally advise you to stop taking Exforge as soon as you know you are pregnant.
It- tabib tiegħek normalment javżak biex tieqaf tieħu Exforge immedjatament kif issir taf li inti tqila.
If you become pregnant during therapy with Exforge, please inform and see your doctor without delay.
Għid u ara lit- tabib tiegħek mingħajr dewmien jekk tinqabad tqila waqt it- terapija b’ Exforge.
Treatment with Exforge is not recommended during breast- feeding.
Kura b’ Exforge mhix rakkomandata waqt it- treddigħ.
Ask your doctor or pharmacist for advice before taking any medicine.
68 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving and using machines This medicine may make you feel dizzy.
Sewqan u tħaddim ta ’ magni Din il- mediċina tista ’ tisturdik.
HOW TO TAKE EXFORGE
KIF GĦANDEK TIEĦU EXFORGE
The usual dose of Exforge is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Exforge with or without food.
- Ikun aħjar li tieħu l- mediċina tiegħek fl- istess ħin kuljum, preferibbilment filgħodu
Do not exceed the prescribed dose.
Tista ’ tieħu Exforge ma ’ l- ikel jew mingħajr ikel.
If you take more Exforge than you should If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.
Jekk tieħu Exforge aktar milli suppost Jekk ħadt iżżejjed mill- pilloli Exforge, jew jekk xi ħadd ieħor ħa l- pilloli tiegħek, ħu parir tat- tabib tiegħek mill- ewwel.
If you forget to take Exforge If you forget to take this medicine, take it as soon as you remember.
Jekk tinsa tieħu Exforge Jekk tinsa ’ tieħu din il- mediċina, ħudha malli tiftakar.
Like all medicines, Exforge can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Exforge jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light- headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Tħossok fuq ix- xwiek, tisfir fil- widnejn (żanżin tal - widnejn); jħossok ħażin; tgħaddi aktar awrina mis- soltu jew tħoss li għandek bżonn tgħaddi aktar awrina; ma jkunx jista ’ jkollok jew iżomm erezzjoni; tħossok tqil; taqalek il- presjoni tad- demm
If any of these affect you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
HOW TO STORE EXFORGE
KIF TAĦŻEN EXFORGE
Do not use Exforge after the expiry date stated on the carton and blister.
Tużax Exforge wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Do not use any Exforge pack that is damaged or shows signs of tampering.
Tuża l- ebda pakkett ta ’ Exforge li jkun danneġġat jew li juri sinjali ta ’ tbagħbis.
What Exforge contains − The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Exforge − Is- sustanzi attivi ta ’ Exforge huma amlodipine (bħala amlodipine besylate) u valsartan.
What Exforge looks like and contents of the pack Exforge 5 mg/ 80 mg tablets are round and dark yellow with “ NVR” on one side and “ NV” on the other side.
Id- Dehra ta ’ Exforge u l- kontentuti tal- pakkett Exforge 5 mg/ 80 mg pilloli huma tondi u sofor skuri b ’ “ NVR ” fuq naħa u “ NV ” fuq in- naħa l- oħra.
Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Exforge jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b’ ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola.
68 España Novartis Farmacéutica, S. A.
Novartis Farmacéutica, S. A.
70 Take special care with Exforge − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
“ mitrijali ”) jew jekk il- ħxuna tal- muskolu ta ’ qalbek kibret aktar minn- normal (magħrufa bħala “ kardjomijopatija ipertrofika ostruttiva ”).
Ask your doctor or pharmacist for advice before taking any medicine.
74 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
73 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Kull pillola fiha 5 mg amlodipine u 160 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
What Exforge looks like and contents of the pack Exforge 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
Id- Dehra ta ’ Exforge u l- kontentuti tal- pakkett Exforge 5 mg/ 160 mg pilloli huma ovali u sofor skuri b ’ “ NVR ” fuq naħa u “ ECE ” fuq in- naħa l- oħra.
74 España Novartis Farmacéutica, S. A.
Novartis Farmacéutica, S. A.
BEFORE YOU TAKE EXFORGE
QABEL MA TIEĦU EXFORGE
Do not take Exforge − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Exforge.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal amlodipine jew mediċini oħra tat- tip
Take special care with Exforge − if you have been sick (vomiting or diarrhoea).
- Jekk it- tabib qallek li l- valvoli ta ’ qalbek djiequ (magħrufa bħala “ stenożi ta ’ l- aorta ” jew
77 Ask your doctor or pharmacist for advice before taking any medicine.
80 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
78 If any of these affect you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
What Exforge contains − The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Exforge − Is- sustanzi attivi ta ’ Exforge huma amlodipine( bħala amlodipine besylate) u valsartan.
79 What Exforge looks like and contents of the pack Exforge 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
Id- Dehra ta ’ Exforge u l- kontentuti tal- pakkett Exforge 10 mg/ 160 mg pilloli huma ovali u sofor ċari b ’ “ NVR ” fuq naħa u “ UIC ” fuq in- naħa l- oħra.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAS- SIGURTÀ U L- UŻU EFFIKAĊI TAL- PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU IMPLIMENTATI MILL- ISTATI MEMBRI
1 • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAS- SIGURTÀ U L - • UŻU EFFIKAĊI TAL- PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States shall ensure that in their Member State:
L- Istati Membri għandhom jiggarantixxu li fl- Istati Membru tagħhom:
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:
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) għandu jaċċerta ruħu li, mat- tqegħid fis- suq, it- tobba kollha li huma mistennija jippreskrivu 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) Pakkett ta ’ tagħrif għall- pazjent
The physician information about Exjade should contain the following key elements:
L- informazzjoni għat- tabib dwar Exjade għandu jkollha dawn l- elementi kruċjali:
• The need to monitor serum ferritin monthly
• Il- bżonn li ferritina (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 modification of therapy • Monthly thereafter o 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 o The need to interrupt treatment if serum creatinine rises: • Adults and paediatrics: > 33% above baseline or creatinine clearance < LLN (90 ml/min) o 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).
• Li Exjade jikkawża żieda tal- kreatinina fis- serum f’ xi pazjenti o Il- bżonn li l- kreatinina fis- serum tkun monitorjata • F’ żewġ okkażjonijiet qabel jibda t- trattament • Kull ġimgħa waqt l- ewwel xahar ta ’ meta jkun beda t- trattament jew wara tibdil fit- terapija • Kull xahar minn hemm ‘ il quddiem o Il- bżonn li d- doża titnaqqas b’ 10 mg/ kg jekk il- kreatinina fis- serum togħla: • Adulti: > 33% fuq il- linja ta ’ bażi u t- tneħħija tal- kreatinina < LLN (90 ml/ min) • Pazjenti pedjatriċi: jew > ULN jew it- tneħħija tal- kreatinina taqa ’ għal < LLN o Il- bżonn li twaqqaf it- trattament jekk il- kreatinina fis- serum titla ’: • Adulti u pazjenti pedjatriċi: > 33% fuq il- linja ta ’ bażi u t- tneħħija tal - kreatinina < LLN (90 ml/ min) o Il- bżonn li tikkunsidra bijopsija tal- kliewi: • Meta l- kreatinina fis- serum hija għolja u jekk tkun instabet xi anomalija oħra (eż. proteinurja [proteina fl- awrina], sinjali tas- Sindromu ta ’ Fanconi).
• 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 or progressive increase in liver enzymes 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:
• L- importanza li titkejjel it- tneħħija tal- kreatinina • Tagħrif fil- qosor dwar il- metodi ta ’ kif titkejjel it- tneħħija tal- kreatinina • Li ż- żidiet fit- transaminażi tas- serum jistgħu jseħħu f’ pazjenti ttrattati 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 jitwaqqaf it- trattament jekk ikun hemm żidiet persistenti u progressivi tal- enzimi tal- fwied. • Il- bżonn għal testijiet tas- smigħ u oftalmiċi kull sena • Il- bżonn għal tabella gwida li turi b’ mod ċar iċ- ċifri, qabel ma jinbeda t- trattament, tal - kreatinina fis- serum, it- tneħħija tal- kreatinina, proteinurja, enzimi tal- fwied, ferritina, bħal:
Before initiating treatment,
Qabel jibda t- trattament,
Serum creatinine at Day - X Serum creatinine at Day - Y
Kreatinina fis- serum f’ ġurnata - X Kreatinina fis- serum f’ ġurnata - Y
Value 1 Value 2
Valur 1 Valur 2
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 iċ- ċifri qabel it - trattament.
• 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 decrease of creatinine clearance (< 90 ml/ min).
• Il- programm edukattiv għandu jġiegħel lit- tobba biex jirrappurtaw ADRs serji u ċerti tipi ta ’ ADRs kif spjegat hawn taħt: • ADRs serji kollha • Żieda persistenti u progressiva fl- enzimi tal- fwied
Significant changes found in auditory or ophthalmological testing Gallstones Unexpected ADRs according to the SPC.
Żieda fil- livelli tal- kreatinina (> 33% fuq il- linja ta ’ bażi) jew tnaqqis fit - tneħħija tal- kreatinina (< 90 ml/ min).
Patient inf ormation leaflet Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin
Tibdil sinifikanti fit- testijiet tas- smigħ jew oftalmiċi Kalkli ADRs mhux mistennija skont l- SPC.
Inf ormation 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 - o kreatinina fis- serum, tneħħija tal- kreatinina, proteinurja, enzimi tal- fwied, ferritina Informazzjoni li jista ’ jkun hemm bżonn ta ’ bijopsija tal- kliewi jekk ikun hemm o anomalija sinifikanti fil- kliewi.
Patient b ooklet where the physician can record the results of the above along with the dose of Exjade
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
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Exjade?
X' inhu Exjade?
Exjade is a medicine that contains the active substance deferasirox.
Exjade huwa mediċina li fiha s- sustanza attiva deferasirox.
It is available as round, white dispersible tablets that are mixed with a liquid to make up a suspension that the patient can drink.
Huwa disponibbli bħala pilloli tondi u bojod li jiddewbu li jitħalltu ma 'likwidu biex jiffurmaw sospensjoni li l- pazjent ikun jista' jixrob.
Each tablet contains 125 mg, 250 mg or 500 mg of deferasirox.
Kull pillola fiha 125 mg, 250 mg jew 500 mg deferasirox.
What is Exjade used for?
Għal xiex jintuża Exjade?
Exjade is used to treat a condition called chronic iron overload (an excess of iron in the body), which results from having repeated blood transfusions. • Exjade is used to reduce the amount of iron in the body of patients from six years of age who suffer from an inherited disease called beta thalassaemia major and who receive frequent blood transfusions to treat it.
Exjade jintuża fit- trattament ta 'kundizzjoni magħrufa bħala eċċess kroniku ta' ħadid (chronic iron overload) fil- ġisem ikkawżata minn trasfużjonijiet tad- demm frekwenti. • Exjade jintuża biex inaqqas l- ammont ta 'ħadid fil- ġisem ta' pazjenti ta 'età' l fuq minn sitt snin li jbatu minn marda ereditarja magħrufa bħala beta talassemija major u li jkollhom jingħataw trasfużjonijiet tad- demm frekwenti biex jittrattawha.
Patients suffering from beta thalassaemia major are unable to make enough haemoglobin (the protein found in red blood cells that carries oxygen around the body), and they need regular blood transfusions.
Il- pazjenti bil- beta talassemija major mhumiex kapaċi jipproduċu biżżejjed emoglobina (il- proteina preżenti fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem), u jkollhom bżonn jieħdu trasfużjonijiet tad- demm regolarment.
Frequent transfusions are defined as at least 7 ml of packed (concentrated) red blood cells per kilogram body weight in a month. • Exjade is also used when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate, in patients who suffer from other types of anaemia, in children aged from two to five years, and in patients with beta thalassaemia major who receive less frequent transfusions.
Trasfużjonijiet frekwenti tfisser ta 'l- inqas 7 ml ċelloli tad- demm ħomor ippakkjati (konċentrati) għal kull kilogramma li jiżen il- pazjent kull xahar. • Exjade jintuża wkoll meta deferoxamine (mediċina oħra użata fit- trattament tal- eċċess kroniku ta' ħadid) ma tistax tintuża jew mhijiex adegwata f' pazjenti li jsofru minn tipi oħrajn ta 'anemija, tfal minn età bejn sentejn u ħames snin u pazjenti bil- beta talassemija major li jirċievu trasfużjonijiet inqas freqwenti.
Because the number of patients with chronic iron overload is low, the disease is considered ‘ rare’, and Exjade was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 13 March 2002.
Billi l- għadd ta 'pazjenti b' eċċess kroniku ta' ħadid huwa baxx, il- marda hija kkunsidrata 'rari', u Exjade ġie kwalifikat bħala 'mediċina orfni' (mediċina użata f' mard rari) fit- 13 ta 'Marzu ta' l- 2002.
How is Exjade used?
Kif jintuża Exjade?
Treatment with Exjade should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload due to frequent transfusions.
It- trattament b' Exjade għandu jinbeda u jiġi sorveljat minn tabib li jkollu esperjenza fit- trattament tal - eċċess kroniku ta 'ħadid minħabba trasfużjonijiet frekwenti.
Only patients who have no problems with their kidneys can be treated with Exjade.
Exjade jista 'jintuża biss għat- trattament ta' pazjenti li ma jkollhomx problemi fil- kliewi.
The treatment starts once the patient has received about 100 ml of packed red blood cells per kilogram body weight, or once there are signs of iron overload (when the levels in the blood of ferritin, the protein in the body that stores iron, are over 1 mg per litre).
It- trattament jinbeda hekk kif il- pazjent ikun ingħata madwar 100 ml ċelloli tad- demm ħomor ippakkjati għal kull kilogramma li jkun jiżen, jew meta jkun hemm sinjali ta 'eċċess ta' ħadid (meta l- livelli fid- demm ta 'ferritina, il- proteina tal- ġisem li taħżen il - ħadid, ikunu ogħla minn 1 mg kull litru).
The treatment usually starts using a dose of 20 mg per kilogram body weight.
It- trattament ġeneralment jinbeda b' doża ta '20 mg għal kull kilogramma li jiżen il- pazjent.
Starting doses of 10 or 30 mg/ kg can also be used, depending on the frequency of the patient ’ s transfusions.
Jistgħu jintużaw ukoll dożi inizjali ta '10 jew 30 mg/ kg, skont kemm
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. ikun qed jirċievi trasfużjonijiet il- pazjent.
Exjade is taken every day, preferably at the same time each day, on an empty stomach (at least 30 minutes before food).
Exjade jittieħed kuljum, preferibilment fl- istess ħin tal- ġurnata, fuq stonku vojt (ta 'l- inqas 30 minuta qabel l- ikel).
The number of tablets of each strength that make up a dose is calculated based on the patient’ s weight.
L- għadd ta 'pilloli ta' kull qawwa li jammontaw għad- doża jiġi kkalkulat skont il- piż tal - pazjent.
The tablets are dispersed by stirring them in a glass of water or fruit juice to make a suspension for the patient to drink.
Il- pilloli jitferrxu billi jitħawdu f' tazza ilma jew meraq tal- frott biex jiffurmaw sospensjoni li l- pazjent jista 'jixrob.
How does Exjade work?
Kif jaħdem Exjade?
When patients receive repeated transfusions to correct anaemia, the transfused red cells bring iron into the body.
Meta l- pazjenti jirċievu trasfużjonijiet ripetuti biex jikkuraw l- anemija, iċ- ċelloli ħomor trasfużi jdaħħlu l- ħadid fil- ġisem.
As the body does not have a natural way of removing excess iron, it can build up and, over time, damage important organs such as the heart or liver.
Minkejja dan, il- ġisem ma għandux mod naturali kif ineħħi l- eċċess ta 'ħadid, b' hekk jista' jakkumula u maż- żmien jagħmel ħsara lill- organi bħall- qalb u l- fwied.
The active substance in Exjade, deferasirox, is an ‘ iron chelator’.
Is- sustanza attiva f' Exjade, deferasirox, hija 'kelatur tal- ħadid' (iron chelator).
It binds to iron in the body to form a compound called a ‘ chelate ’ that can be excreted by the body, mainly in the stools.
Dan jeħel mal- ħadid preżenti fil- ġisem biex jifforma kompost li jissejjaħ 'kelat' (chelate) li jista 'jitneħħa mill- ġisem, l- aktar permezz tal- feċi.
This helps to correct the iron overload and prevent damage due to excess iron.
Dan jgħin biex jikkoreġi l- eċċess ta 'ħadid u jipprevjeni l- ħsara kkawżata minn ħadid żejjed.
How has Exjade been studied?
Kif ġie studjat Exjade?
The effects of Exjade were first tested in experimental models before being studied in humans.
L- effetti ta 'Exjade għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The main study of effectiveness compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
L- istudju ewlieni tal- effikaċja qabbel Exjade ma 'deferoxamine f' 591 pazjent bil- beta talassemija major.
About half of the patients were under the age of 16, and 56 were less than six years old.
Madwar nofshom kellhom età inqas minn 16- il sena, u 56 kellhom età inqas minn sitt snin.
The doctor and patients knew which medicine they were using because Exjade is given by mouth but deferoxamine is given by subcutaneous infusion (very slow injection under the skin) overnight.
It - tabib u l- pazjenti jafu liema mediċina kienu qed jużaw billi Exjade jingħata oralment filwaqt li deferoxamine jingħata b' infużjoni minn taħt il- ġilda (injezzjoni magħmula bil- mod ħafna taħt il- ġilda) mal- lejl kollu.
The effectiveness was measured by looking at the level of iron contained in the liver before and after one year of treatment with the medicines.
L- effikaċja tkejlet billi ġie eżaminat il- livell ta 'ħadid fil- fwied qabel u wara sena trattament b' dawn il- mediċini.
An additional study looked at the effectiveness of Exjade in 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
Studju addizzjonali eżamina l- effikaċja ta 'Exjade f' 184 pazjent li ma setgħux jiġu ttrattati b' deferoxamine, fosthom pazjenti bil- beta talassemija major u tipi oħrajn ta' anemija.
What benefit has Exjade shown during the studies?
X' benefiċċji wera Exjade matul l- istudji mwettqa?
At the end of the main study, 53% of the patients receiving Exjade had shown a sufficient response to treatment, compared with 66% of the patients receiving deferoxamine.
Fit- tmiem tal- istudju ewlieni, 53% tal- pazjenti ttrattati b' Exjade urew rispons suffiċjenti għat - trattament, meta mqabbel ma '66% tal- pazjenti ttrattati b' deferoxamine.
This indicates that Exjade may not have been as effective as the comparator medicine.
Dan jindika li Exjade ma setax kien daqshekk effikaċi daqs il- mediċina tat- tqabbil.
However, when looking at the 381 patients who had particularly high levels of iron in their liver at the beginning of the study and who received comparable amounts of Exjade or deferoxamine, the two medicines were as effective as each other.
Madankollu, meta wieħed iħares lejn it- 381 pazjent li fil- bidu tal- istudju kellhom livelli partikolarment għoljin ta 'ħadid fil- fwied u li kienu ħadu ammonti ta' Exjade jew deferoxamine komparabbli, iż- żewġ mediċini rriżultaw effikaċi daqs xulxin.
There were too few patients in this study aged below six years to demonstrate the safety and effectiveness of Exjade in this age group.
In- numru ta 'pazjenti ta' età inqas minn sitt snin li ħadu sehem f' dan l- istudju kien baxx wisq biex tintwera s- sigurtà u l- effikaċja ta 'Exjade f' dan il- grupp tal- istess età.
In the additional study, more than half of the patients who could not be treated with deferoxamine had responded to treatment with Exjade after a year, including patients aged between two and five years.
Fl- istudju addizzjonali, iktar minn nofs il- pazjenti li ma setgħux jiġu ttrattati b' deferoxamine irrispondew għat- trattament b' Exjade wara sena, fosthom pazjenti b' età bejn sentejn u ħames snin.
What is the risk associated with Exjade?
X' inhu r- riskju assoċjat ma 'Exjade?
The most common side effect with Exjade (seen in more than 1 patient in 10) is increased blood creatinine (a marker of kidney problems).
L- effetti sekondarji l- aktar komuni b' Exjade (li dehru f' aktar minn pazjent 1 minn kull 10) huma żieda fil- kreatinina (markatur tal- problemi tal- kliewi).
For the full list of all side effects reported with Exjade, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b' Exjade, ara l- Fuljett ta 'Tagħrif.
Exjade should not be used in people who may be hypersensitive (allergic) to deferasirox or any of the other ingredients, or in people whose creatinine clearance (a measure of the ability of the kidney to remove creatinine from the blood) is below 60 ml per minute.
Exjade ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal deferasirox jew għal xi sustanzi oħra tiegħu, u minn persuni li r- rata ta 'tneħħija tal- kreatinina tagħhom (kejl tal - kapaċità tal- kliewi li jneħħu l- kreatinina mid- demm) tkun inqas minn 60 ml kull minuta.
It should not be used in combination with other iron chelators.
Ma għandux jintuża ma 'kelaturi tal- ħadid oħra.
It is very important that the patient ’ s kidneys and liver are checked with blood tests before treatment with Exjade is started, and regularly during treatment.
Huwa importanti ħafna li l- kliewi u l- fwied tal- pazjent jinżammu taħt kontroll permezz ta 'testijiet tad - demm qabel ma jinbeda t- trattament b' Exjade, u b' rata regolari matul it- trattament.
The dose should be reduced or treatment interrupted if a patient develops kidney or liver problems.
F' każ li l- pazjent jiżviluppa problemi fil- kliewi jew fil- fwied, id- doża għandha titnaqqas jew jiġi sospiż it- trattament.
Exjade is not recommended for patients with severe liver problems as it has not been tested in this group.
Exjade mhuwiex rakkomandat għal pazjenti li jbatu minn problemi epatiċi gravi billi l- mediċina ma ġietx ittestjata f' din il- kategorija ta 'pazjenti.
Why has Exjade been approved?
Għaliex ġie approvat Exjade?
The Committee recommended that the medicine be given marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Exjade huma ogħla mir- riskji tiegħu fit- trattament tal- eċċess kroniku ta' ħadid minħabba trasfużjonijiet tad- demm frekwenti f' pazjenti bil- beta talassemija major u minħabba trasfużjonijiet tad- demm meta t -
2/ 3 Which measures are being taken to ensure the safe use of Exjade?
2/ 3 terapija b' deferoxamine hija kontraindikata jew inadegwata.
The company responsible for making Exjade available must prepare an education pack for doctors, which is distributed whenever the medicine is launched.
Il- kumpanija responsabbli mill- fornitura ta 'Exjade għandha tipprepara u tqassam, qabel it- tqegħid fis - suq, pakkett edukattiv għat- tobba.
This pack will ensure that doctors know about the need to monitor the patient ’ s health, especially kidney function, when they prescribe the medicine.
Dan il- pakkett għandu jiggarantixxi li t- tobba jkunu jafu, meta jippreskrivu l- mediċina, bil- ħtieġa ta 'monitoraġġ ta' saħħet il- pazjent, partikolarment tal- funzjoni renali.
The company will also prepare a similar pack for patients.
Il- kumpanija se tħejji wkoll pakkett simili għall- pazjenti.
Other information about Exjade The European Commission granted a marketing authorisation valid throughout the European Union for Exjade to Novartis Europharm Limited on 28 August 2006.
Aktar tagħrif dwar Exjade Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Exjade lil Novartis Europharm Limited fit- 28 ta 'Awwissu 2006.
The summary of opinion of the Committee for Orphan Medicinal Products for Exjade is available here.
Is- sommarju tal- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Exjade huwa disponibbli hawn.
The full EPAR for Exjade can be found here.
L- EPAR sħiħ għal Exjade jista 'jiġi kkonsultat hawn.
EU/ 1/ 06/ 356/ 001 EU/ 1/ 06/ 356/ 002 EU/ 1/ 06/ 356/ 003 EU/ 1/ 06/ 356/ 004 EU/ 1/ 06/ 356/ 005 EU/ 1/ 06/ 356/ 006 EU/ 1/ 06/ 356/ 007 EU/ 1/ 06/ 356/ 008 EU/ 1/ 06/ 356/ 009
Numru ta ’ l- EU EU/ 1/ 06/ 356/ 001 EU/ 1/ 06/ 356/ 002 EU/ 1/ 06/ 356/ 003 EU/ 1/ 06/ 356/ 004 EU/ 1/ 06/ 356/ 005 EU/ 1/ 06/ 356/ 006 EU/ 1/ 06/ 356/ 007 EU/ 1/ 06/ 356/ 008 EU/ 1/ 06/ 356/ 009
Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade
Isem inventat Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade
125 mg 125 mg 250 mg 250 mg 500 mg 500 mg 125 mg 250 mg 500 mg
Qawwa 125 mg 125 mg 250 mg 250 mg 500 mg 500 mg 125 mg 250 mg 500 mg
Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet
Għamla farmaċewtika Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered Pillola li tinxtered
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
Il- pakkett Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu)
28 tablets 84 tablets 28 tablets 84 tablets 28 tablets 84 tablets 252 tablets 252 tablets 252 tablets
Daqs tal- pakkett 28 pillola 84 pillola 28 pillola 84 pillola 28 pillola 84 pillola 252 pillola 252 pillola 252 pillola
EXJADE 125 mg dispersible tablets
EXJADE 125 mg pilloli li jinxterdu
Each dispersible tablet contains 125 mg deferasirox.
Kull pillola li tinxtered fiha 125 mg deferasirox.
This product contains lactose.
Dan il- prodott fih lactose.
Dispersible tablet
Pillola li tinxtered
Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Pilloli offwajt, tondi, ċatti b’ xifer imżerżaq u timbri (NVR fuq naħa u J 125 fuq l- oħra).
EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/ kg/ month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
EXJADE huwa indikat għall- kura ta ’ tagħbija żejda kronika tal- ħadid minħabba trasfużjonijiet tad - demm frekwenti (≥7 ml/ kg/ xahar ta ’ ċelluli ħomor tad- demm ippakkjati) f’ pazjenti li jsofru minn beta talessimja maġġuri li għandhom minn 6 snin ‘ il fuq.
EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:
EXJADE huwa indikat ukoll għall- kura ta ’ tagħbija żejda kronika tal- ħadid minħabba trasfużjonijiet tad- demm meta terapija b’ deferoxamine tkun kontra- indikata jew inadegwata f’ dawn il- gruppi ta ’ pazjenti:
- in patients with other anaemias,
- f’ pazjenti li jkollhom anemiji oħrajn,
- in patients aged 2 to 5 years,
- f’ pazjenti li għandhom bejn 2 u 5 snin,
- in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions
f’ pazjenti li għandhom beta talessimja maġġuri b’ tagħbija żejda ta ’ ħadid minħabba
(< 7 ml/ kg/ month of packed red blood cells).
trasfużjonijiet tad- demm mhux frekwenti (< 7 ml/ kg/ xahar ta ’ ċelluli ħomor tad- demm ippakkjati).
Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.
Il- kura b’ EXJADE għandha tinbeda u tibqa ’ tingħata minn tabib li għandu esperjenza fil- kura ta ’ tagħbija żejda kronika ta ’ ħadid minħabba trasfużjonijiet tad- demm.
It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/ kg) of packed red blood cells or when there is evidence from clinical monitoring that chronic iron overload is present (e. g. serum ferritin > 1,000 µg/ l).
Huwa rakkomandat li l- kura tinbeda wara trasfużjoni ta ’ madwar 20 unitajiet (madwar 100 ml/ kg) ta ’ ċelloli ħomor tad- demm ippakkjati jew meta jkun jidher minn monitoraġġ kliniku li hemm tagħbija żejda kronika ta ’ ħadid (eż. ferritin fis- serum > 1, 000 µg/ l).
Doses (in mg/ kg) must be calculated and rounded to the nearest whole tablet size.
Id- dożi (f’ mg/ kg) għandhom jiġu ikkalkulati u mogħtija sa l- eqreb pillola sħiħa.
The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden.
L- għanijiet ta ’ terapija b’ kelatur tal- ħadid huma li jitneħħa l- ammont ta ’ ħadid li jingħata waqt trasfużjonijiet u, meta meħtieġ, li titnaqqas it- tagħbija tal- ħadid li jkun hemm.
The recommended initial daily dose of EXJADE is 20 mg/ kg body weight.
Doża tal- bidu Huwa rakkomandat li l- ewwel doża ta ’ EXJADE tkun ta ’ 20 mg/ kg tal- piż tal- ġisem kuljum.
An initial daily dose of 30 mg/ kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/ kg/ month of packed red blood cells (approximately > 4 units/ month for an adult).
F’ pazjenti li jkun hemm bżonn jitnaqqsulhom il- livelli għolja ta ’ ħadid fil- ġisem u li qed jirċievu aktar minn 14 ml/ kg/ xahar ta ’ ċelloli ħomor tad- demm ippakkjati (madwar > 4 unitajiet/ xahar għal bniedem adult), wieħed jista ’ jikkunsidra li d- doża tal- bidu tkun 30 mg/ kg kuljum.
2 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).
2 wieħed jista ’ jikkunsidra li d- doża tal- bidu tkun 10 mg/ kg kuljum.
The patient’ s response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Il- pazjent għandu jinżamm taħt osservazzjoni għar- rispons tal- kura, u żieda fid- doża għandha tkun ikkunsidrata jekk ma tkunx intlaħqet l- effikaċja mixtieqa (ara sezzjoni 5. 1).
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE that is numerically half that of the deferoxamine dose could be considered (e. g. a patient receiving 40 mg/ kg/ day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/ kg/ day of EXJADE).
Pazjent li qed jirċievi 40 mg/ kg/ jum ta ’ deferoxamine għal 5 ijiem fil- ġimgħa (jew ekwivalenti), jista ’ jinqaleb għal doża tal - bidu ta ’ 20 mg/ kg/ jum ta ’ EXJADE).
When this results in a daily dose less than 20 mg/ kg body weight, the patient’ s response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Meta din id- doża taqa ’ taħt 20 mg/ kg piż tal- ġisem, il- pazjent għandu jinżamm taħt osservazzjoni għar- rispons, u żieda fid- doża għandha tkun ikkunsidrata jekk ma tkunx intlaħqet l- effikaċja mixtieqa (ara sezzjoni 5. 1).
It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Doża ta ’ manteniment Huwa rakkomandat li ferritin fis- serum ikun monitorat kull xahar u li d- doża ta ’ EXJADE tinbidel, jekk ikun hemm bżonn, kull 3 jew 6 xhur skond kif ikunu qed ivarjaw il- livelli ta ’ ferritin fis- serum.
Dose adjustments may be made in steps of 5 to 10 mg/ kg and are to be tailored to the individual patient’ s response and therapeutic goals (maintenance or reduction of iron burden).
Id- dożi jistgħu jinbidlu f’ ammonti ta ’ 5 sa 10 mg/ kg u għandhom jitfasslu skond ir- rispons tal- pazjent individwali u skond l- għanijiet terapewtiċi (manteniment jew tnaqqis ta ’ tagħbija tal- ħadid).
Doses above 30 mg/ kg are not recommended because there is only limited experience with doses above this level.
Dożi li jaqbżu 30 mg/ kg mhumhiex rakkomandati għaliex l- għarfien dwar dożi f’ dawn il- livelli huwa limitat ħafna.
If serum ferritin falls consistently below 500 µg/ l, an interruption of treatment should be considered (see section 4.4).
Jekk il- livelli ta ’ ferritin fis- serum jaqaw taħt 500 µg/ l b’ mod konsistenti, wieħed għandu jqis li jwaqqaf il- kura għal kollox (ara sezzjoni 4. 4).
EXJADE must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).
Kif jiġi ppreparat EXJADE għandu jittieħed darba kuljum fuq stonku vojt mill- anqas 30 minuta qabel l- ikel, l- aħjar fl - istess ħin tal- ġurnata kuljum (ara sezzjonijiet 4. 5 u 5. 2).
The tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained.
Il- pilloli jinxterdu billi tħawwadhom f’ tazza ilma, meraq tal- larinġ jew tat- tuffieħ (100 sa 200 ml) sakemm jiffurmaw suspensjoni fina.
The tablets must not be chewed or swallowed whole (see also section 6.2).
Wara li tixrob is- suspensjoni, jekk jifdal xi ftit trab fil- qiegħ, dan għandu jerġa ’ jinħall f’ volum żgħir ta ’ ilma jew meraq u jinxtorob.
The dosing recommendations for elderly patients are the same as described above.
Il- pilloli m’ għandhomx jomgħoduhom jew jibilgħawhom sħaħ (ara wkoll sezzjoni 6. 2).
Paediatric patients (2 to 17 years of age) U
Pazjenti anzjani (≥65 sena) Id- dożi rakkomandati f’ pazjenti anzjani huma l- istess kif spjegat hawn fuq.
The dosing recommendations for paediatric patients are the same as for adult patients.
Pazjenti pedjatriċi (2 sa 17- il sena) Id- dożi rakkomandati għall- pazjenti pedjatriċi huma l- istess bħal dawk tal- pazjenti adulti.
Changes in weight of paediatric patients over time must be taken into account when calculating the dose.
Meta tkun qed tiġi ikkalkulata d- doża, it- tibdil fil- piż ta ’ pazjenti pedjatriċi maż- żmien għandu jkun meqjus.
In children aged between 2 and 5 years, exposure is lower than in adults (see section 5.2).
Fi tfal ta ’ bejn 2 u 5 snin, l- esponiment ikun anqas minn dak fl- adulti (ara sezzjoni 5. 2).
This age group may therefore require higher doses than are necessary in adults.
Għaldaqstant, tfal li jaqaw f’ dan il- grupp ta ’ etajiet jista ’ jkollhom bżonn dożi aktar għoljin milli jkollhom bżonn l - adulti.
However, the initial dose should be the same as in adults, followed by individual titration.
Iżda d- doża tal- bidu għandha tkun l- istess bħal dik ta ’ l- adulti, segwita b’ titrazzjoni individwali.
EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance < 60 ml/ min (see sections 4.3 and 4.4).
Pazjenti b’ indeboliment renali EXJADE ma ġiex studjat f’ pazjenti b’ indeboliment renali u huwa kontra- indikat f’ pazjenti li jkollhom tneħħija tal- krejatinina stmat < 60 ml/ min (ara sezzjonijiet 4. 3 u 4. 4).
EXJADE has not been studied in patients with hepatic impairment and must be used with caution in such patients.
Pazjenti b’ indeboliment tal- fwied EXJADE ma ġiex studjat f’ pazjenti b’ indeboliment tal- fwied u għandu jintuża b’ attenzjoni f’ dawn il - pazjenti.
The initial dosing recommendations for patients with hepatic impairment are the same as described above.
Id- dożi tal- bidu li huma rakkomandati għall- pazjenti li jsofru b’ indeboliment tal- fwied huma l- istess kif spjegat hawn fuq.
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).
Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).
Użu ma ’ terapiji ta ’ kelaturi tal- ħadid oħrajn għax is- sigurtà ta ’ dawn il- kombinazzjonijiet ma ġietx stabilita (ara sezzjoni 4. 5).
Patients with estimated creatinine clearance < 60 ml/ min.
Pazjenti li jkollhom tneħħija tal- krejatinina stmata < 60 ml/ min.
U
Funzjoni renali:
EXJADE has been studied only in patients with baseline serum creatinine within the age-appropriate normal range.
EXJADE ġie studjat biss f’ pazjenti li għandhom linja bażi tal- krejatinina fis- serum li taqa ’ skond il - medda normali ta ’ l- età adattata.
During clinical trials, increases in serum creatinine of > 33% on ≥ 2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients.
Waqt provi kliniċi, żidiet fil- krejatinina tas- serum ta ’ > 33% f ’ ≥2 darbiet wara xulxin, kultant ’ il fuq mill- limitu ta ’ fuq tal- medda normali, seħħet f’ madwar 36% tal- pazjenti.
These were dose- dependent.
Dawn kienu marbuta mad - doża.
About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
Madwar żewġ terzi tal- pazjenti li wrew żieda fil- livell tal- krejatinina fis- serum, reġgħu waqgħu taħt il- livell ta ’ 33% mingħajr tibdil fid- doża.
In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
Fit- terz l- ieħor, iż- żieda tal- krejatinina fis- serum mhux dejjem inbidlet meta kienet imnaqqsa d- doża jew twaqqfet id- doża.
Cases of acute renal failure have been reported following post-marketing use of EXJADE (see section 4.8).
Każijiet ta ’ insuffiċjenza renali akuta kienu rrappurtati wara t- tqegħid fis- suq ta ’ EXJADE (ara sezzjoni 4. 8).
The causes of the rises in serum creatinine have not been elucidated.
Għadhom mhux magħrufa l- kawżi taż- żidiet tal- krejatinina fis- serum.
Particular attention should therefore be paid to monitoring of serum creatinine in patients who are receiving high doses of EXJADE and/ or low rates of transfusion (< 7 ml/ kg/ month of packed red blood cells or < 2 units/ month for an adult).
Għaldaqstant, għandha tingħata attenzjoni partikulari għall- monitoraġġ tal- krejatinina fis- serum ta ’ pazjenti li qed jirċievu dożi għoljin ta ’ EXJADE u/ jew rati baxxi ta ’ trasfużjoni (< 7 ml/ kg/ xahar ta ’ ċelloli ħomor ippakkjati jew < 2 unitajiet/ xahar għal adult).
It is recommended that serum creatinine be assessed in duplicate before initiating therapy.
Huwa rakkomandat li l- krejatinina fis- serum tiġi stmata b’ duplikat qabel ma tinbeda t- terapija.